Untitled

Annual

report

2022

Transforming women’s health through innovation

Message to our shareholders 6

Mithra at a glance 8

What we offer 10

Our milestones 12

2022 Highlights 14

2023 Outlook 16

Research & Development 20

Estetrol (E4) 22

Estelle

Donesta

Beyond women’s health 28

Complex Therapeutics 30

Myring

Tibelia

Zoreline

Mithra CDMO 32

Key gures 34

Mithra share 36

Shareholding structure 37

2022 Financial calendar 38

Analyst coverage 39

ESG: Environmental,

Social and Governance

initiatives at Mithra 40

Board of directors 50

Management committee 54

Board of directors’ report 59

Responsibility statement

125

Auditor report

126

Consolidated statement

of prot and loss

131

Notes to the consolidated

nancial statements

137

ACTIVITY REPORT

CORPORATE GOVERNANCE

AND FINANCIAL STATEMENTS

ACTIVITY REPORT

1. ACTIVITY REPORT > LETTER TO SHAREHOLDERS

Message to

our shareholders

Dear shareholders,

The year 2022 was marked by many operational challenges

and advances for our company, despite a particularly

turbulent international context. We are very satised with the

resilience shown by Mithra and our teams’ ability to deliver

many scientic and commercial achievements. Furthermore,

we recognise that the stock market performance is

disappointing, but we remain more condent than ever that

the current stock market price does not reflect our company’s

intrinsic value.

2022 began with the successful completion of a major

challenge, with the announcement of positive ecacy

results for Donesta

. Our research and development teams’

skill needs no further demonstration, and they once again

reached their targets with the close-out in December 2022

of the selection of patients relating to the extension of the

Donesta

European study (C301). The results of this study

should be known during the rst half of 2024. Furthermore,

in early 2023, we made public the safety data for Donesta

relating to the study carried out in North America (C302),

which was heavily anticipated. These preliminary Phase III

results are once again positive and meet our expectations.

The past year has also been very intense for our Business

Development teams. On one hand, the marketing of our

flagship product Estelle

began in many new countries, such

as the United Kingdom or Australia, in order to help increase

long-term sales revenue. The growth in sales is starting

to contribute to the increase in our revenue and should

continue with the implementation of a television marketing

campaign, as well as a social media campaign, in the United

States, which is the largest market. Elsewhere, our teams

have worked all year long to promote the advantages of our

Donesta

product around the world and raise awareness of

the potential of the menopause market, which is still ignored

far too often. At the end of 2022, we were delighted to

announce the signing of an agreement to market Donesta

in Europe, as well as in other countries, with Gedeon Richter,

a leading player in the women’s healthcare market in Europe.

This agreement enables us to secure the marketing of our

product, but also to guarantee the company’s future with

more stable organic growth that will be more predictable in

future, based on two products with high potential: Estelle

and Donesta

The general economic context has led us to make strategic

choices concerning the allocation of our nancial resources.

As a result, we’ve slowed down investment in certain

projects, in order to focus on the development of our flagship

products, which are Estelle

and Donesta

, assets that will

bring in the most value and growth in the short and medium

term. In terms of other promising projects concerning

neuroprotection and scarring, these will enable us to prepare

for our company’s future with new growth opportunities.

At the same time, 2022 was marked by the conclusion

of agreements for nancing from several sources for an

amount of up to €224 million, resulting in a potential dilution

for our shareholders. Although we would have liked to use

more conventional nancing solutions, the current market

conditions have not enabled us to sign this type of nancing

agreement. Given the progress of our different products, we

preferred to ensure the continuity of our clinical trials. We are

aware of how this may be perceived and the consequences

of this nancing, and we would like to reduce our use of it as

much as possible in the future.

Outlook

2023 should be a year full of achievements on both

commercial and operational levels. In the coming months,

we should begin three new phase II studies as part of the

Donesta

clinical programme. These studies relate to the

impact of estetrol on the quality of skin and hair, as well as

the libido of menopausal patients.

Concerning Donesta

, following the publication of positive

safety data, we are more condent than ever in the signing of

a short-term partnership to market our product Donesta

the United States, a market that accounts for nearly 60% of

the global menopause market’s value.

In addition to these products in the marketing phase, or nearly,

we are continuing to develop new alternatives, whether in the

eld of women’s health, with BCI Pharma in particular, on in

more far-reaching elds such as scarring or neuroprotection.

BCI’s scientic results reveal that pre-clinical studies

conrm the huge potential of innovative and proprietary

CSF-1R inhibitors to treat different pathologies, including

endometriosis, cancer and inflammatory disorders. These

Dr. David H. Solomon,

Chief Executive Ofcer

Mithra Women’s Health

results strengthen Mithra’s intention to acquire BCI Pharma’s

intellectual property rights and to nalise the option to

develop new tyrosine kinase inhibitors for the treatment

of endometriosis, female cancers and other diseases.

Value creation is at the heart of our concerns. This is why

we announced that we are seeking various alternatives to

optimise the potential of our CDMO in the long term. We are

convinced that we will be able to announce the achievement

of these during 2023.

Finally, 2023 also looks likely to be intense in terms of

corporate governance, with the appointment of a new Chief

Executive Ofcer, Dr. David H Solomon made ofcial on April

4, 2023, as well as the renewal of the members of the Board

of Directors, which will take place at the Shareholder’s Annual

General Meeting scheduled for the end of May.

We would like to thank all our shareholders for their ongoing

support and loyalty. We remain condent in the extraordinary

potential of our products and our future indications, and hope

that our various operational and commercial achievements

will result in a stock market valuation that reflects the intrinsic

value of our products.

Christian Moretti,

Chairman of Mithra’s

Board of directors

At the crossroads of my personal and

professional journey, having the opportunity

to lead Mithra is a big pleasure and

opportunity. Women’s health has been

overlooked in medical research for years

and I believe that with Estetrol, we have the

chance to showcase its proven ecacy and

differentiated safety prole in the treatment

of menopause in our new medicine Donesta

For the talented team at Mithra, shareholders,

investors, patients and all parties involved

in Mithra’s journey, it is essential to bring

meaningful value while continuing our

promising developments in 2023.

Dr. David H. Solomon,

CEO Mithra Women’s Health

1. ACTIVITY REPORT > MITHRA AT A GLANCE

Mithra is a Belgian biotech company created in 1999 and listed on Euronext

Brussels (MITRA) since 2015. Dedicated to transforming women’s health,

Mithra offers new choices through innovative products based on a unique

molecule, Estetrol (E4), a native estrogen that offers a safer benet/risk

prole compared to existing hormone-based solutions. For over twenty years,

Mithra dedicated its researches so as to redene women’s health, transform

their daily lives in an innovative way and unlock emerging opportunities in

healthcare with a focus on contraception and menopause.

In 2016, Mithra ofcially opened its own R&D and manufacturing platform

specialized in cutting edge technologies such as polymeric forms and sterile

injectables, Mithra CDMO.

Carried by its innovative mission to transform women’s health, in

2021, Mithra successfully commercialized worldwide its rst

Estetrol-based product, the Estelle

contraceptive pill.

A genuine revolution in the contraception area as the

introduction of a new estrogen and its exploitation had not

been observed for over 60 years.

Thanks to the commitment of over 230 collaborators, in

2022, Mithra reinforces its goals to meet women’s needs

at all stages in their lives through new products offering

better efcacy, safety and convenience. It is with that

perspective that Mithra signed a licence agreement

with Gedeon Richter for the commercialisation of

Donesta

, a novel product candidate for the treatment

of post-menopausal symptoms.

As a company, Mithra’s vision of the future is bright

and goes beyond Estetrol and women’s health. While,

on the one hand, Estetrol already demonstrated its

efcacy supporting its use in clinic in wound healing

and neuroprotection, Mithra, on the other hand, also

strengthens its intent to diversify its asset-based

portfolio throughout the acquisition of BCI Pharma’s IP

rights to develop new tyrosine kinase inhibitors for the

treatment of endometriosis, female cancers and other

diseases.

8 9

Mithra at a glance

Our staff

In a nutshell:

nationalities

Average age:

years

Number

of new hires

in 2022

Men

44%

Women

56%

Over 20 years of

women’s health

Mithra has always been dened by its science

and its innovation. Along the years, our mission

always remains the same: innovate to serve

women.

Today we’re closer than ever to revolutionizing

the eld of women’s health in both contraception

and menopause.

Prof. Dr. Jean-Michel Foidart

Co-founder

Commercial

development/

Performance in

2022

Dedicated to

transforming

women’s health

by offering new

choices through

innovative

products

Mithra as a

company,

as a stock

How we drive

our business

to have a lower

impact on

environment

and society

(ESG)

-59.6

million

EUR net loss

9.2

million

EUR Product sales

of Estelle

64.6

million

EUR milestones

collected

1,000,000

Myring

vaginal

rings produced in our

CDMO

Positive

Top-line safety and

efcacy results for

Donesta Phase III

(C302)

Countries in which

our contraceptive

pill Estelle

commercialized

(+ 19 in 2022)

Patents

covering E4

1999

Foundation

Since

2015

Listed on Euronext

Brussels

R&D collaborators

among 233

employees

dedicated to

innovation

56%

Women

employees

-22%

Reduction in

Greenhouse gas

emission (target

-55% by 2030)

100%

Successful

inspections and

customer audits

55%

Women in

leadership positions

(CEO N-2)

Mithra Women’s Health

Since 1999, our commitment has always been to

provide women with better solutions improving

their quality of life, independently of their age.

Our focus on innovation in women’s health is our

driving force.

After two decades of intensive research and

development, we proudly introduced the rst

Estetrol-based contraceptive pill Estelle® on the

European and US markets in 2021. Estetrol is the

rst new estrogen introduced in the US after more

than 50 years of absence of any meaningful form

of progress.

Today, Mithra’s pipeline includes two different

types of products to meet a large spectrum of

needs. Firstly, Estetrol-based products, among

which Mithra offers commercialized products

(Estelle® contraceptive) as well as products in

different stages of development such as, Neonatal

Hypoxic-Ischemic Encephalopathy (NHIE), a

life-threatening form of brain injury, wound healing

and Donesta® menopause treatment. A Complex

Therapeutics portfolio covering different elds

of female heath care such as contraception,

menopause and cancers.

10 11

1. ACTIVITY REPORT > YOUR VALUES WHAT WE OFFER

We aim to innovate and transform

women’s health, it’s in our DNA.

Yet, we also expand our innovative

potential to other therapeutic

treatments that will provide alternative

solutions to unmet medical needs.

Dr. David H. Solomon,

CEO Mithra Women’s Health

What we offer

Mithra CDMO

Our mission at the CDMO is to provide pharmaceutical

manufacturers a collaboration based on delivering

outstanding services and products not only in women’s

health but also covering a broad range of indications

based on our state-of-the-art technology for polymer and

injectables.

To achieve this, our expertise consists in producing and

delivering high quality products and services thanks to:

> Production areas dedicated to sterile injectable products

and complex polymer shapes and implants

> Flexible and responsive clinical development and

support, including quality control services

Our vision is simple: to combine exibility

and agility in order to put our expertise at

the service of successful pharmaceutical

development for our partners.

Renaat Baes,

CDMO Site Director

12 13

In 1999, Mithra Pharmaceuticals was founded as a

spin-off from the University of Liège.

During the early stage of its development

(1999-2004), Mithra Pharmaceuticals’ core business

were over-the-counter medicines. The Company

targeted gynecologists with a range of intimate

hygiene products, food supplements, medical

devices and products that did not require a medical

prescription. This rst product portfolio has enabled

the spin-off to be recognized by professionals in

the women’s health sector and to collaborate with

well-established pharmaceutical groups in order to

launch their products in Belgium.

The second phase of Mithra’s development was the

longest and the most strategic one. During that phase

(2004-2013), Mithra undertook the development of

its rst generic hormonal drugs alongside with the

marketing of its generic drugs brand.

This strategy allowed Mithra to expand its commercial

development and to be internationally recognized

as an expert in women’s health. Throughout the

years, Mithra acquired a very sharp know-how in the

development of complex products.

In 2013, Mithra began the third phase (2013-2016)

of its development with the strong ambition to grow

in the eyes of the general public. In 2015, Mithra

proceeded to its initial public offering on Euronext

Brussels, where the Company is still listed. One

year later, in September 2016, Mithra inaugurated

its Mithra CDMO in Flemalle (Belgium), a platform

specialized in polymeric forms, sterile injectables and

hormonal tablets.

After several years of development, Mithra

operated its transformation from being a biotech

company to a pharmaceutical company, with the

commercialization of its rst own product, the

contraceptive pill Estelle

, in late 2021.

2021 was the year of Estelle

, our contraceptive

Estetrol-based pill, with a launch in several countries

worldwide.

2022 was more the year of Donesta

, our innovative

hormonal treatment for menopause symptoms, with

positive Phase III Efcacy study results and a license

agreement with Gedeon Richter.

12 13

1. ACTIVITY REPORT > OUR MILESTONES

Our milestones

At Mithra, continuous investment in R&D is essential to the development and

improvement of products and innovative technologies.

1999 - 2004

2004 - 2013

2013 - 2016

2016 - 2022

14 15

1. ACTIVITY REPORT > 2022 HIGHLIGHTS

October

> Positive results from preclinical data from two different

studies conducted by the Hull York Medical School in

collaboration with Mithra, show that Estetrol is able to

promote wound healing, strengthening the case for its

therapeutic use in wound care.

> Approval delivered by the FDA Thailand to OLIC, a

subsidiary of Fuji, our partner for the import license for

NEXTSTELLIS

contraceptive in Thailand.

November

> Organization of “Pharmaceutical in the Environment”, an

institutional, academic and pharmaceutical conference

held at the European Parliament to address current and

future challenges in order to improve the management

of pharmaceuticals residues in the environment and limit

Industry footprint on wildlife and ecosystems.

August

> Launch of a direct-to-consumer (DTC) campaign in the

United States by Mayne Pharma to further increase

awareness of NEXTSTELLIS

contraceptive tablets.

> FDA approval for the commercialization of Myring

Mithra’s contraceptive vaginal ring, under the trademark

HALOETTE

, in the US by Mayne Pharma. Commercial

launch started in January 2023.

> Convertible loan signed with Highbridge Capital

Management and Whitebox Advisors for an amount up

to EUR 100 million available in three tranches, including

repurchase of EUR 34.1 million tranche of the convertible

bonds due in 2025 at a 15% discount to par.

September

> Approval delivered by both Taiwan Food and Drug Adminis-

tration (TFDA) and Hong Kong Drug Ofce, Department

of Health to Lotus Pharmaceutical, our partner for the

commercialization of Estelle

in Taiwan and Hong Kong

under the trademark ALYSSA

April

> Mithra conrmed consolidated efcacy results for

the Donesta

studies and initiated the launch of the

recruitment of 300 additional menopausal non hysterec-

tomised women for the Donesta® European Study (C301),

following the decision of the independent Data and Safety

Monitoring Board (DSMB).

> Collaboration with MedinCell for the development of two

long-acting injectable innovative products: 1) a 3-month

long acting injectable designed as an additional tool to

ght Malaria and; 2) a long-acting injectable of tacrolimus

for transplant patients aiming at improving efcacity,

tolerance and patient observance.

> Extension of the capital commitment agreement with LDA

capital by two years (until April 2025) and increase of the

commitment by EUR 25 million.

June

> Successful equity raise of EUR 23.5 million via a

private placement of new ordinary shares with certain

professional, qualied, institutional and other private

investors. The investors that provided a subscription

commitment include Leon Van Rompay, Alychlo NV (Marc

Coucke), Scorpiaux BV (Bart Versluys), Glenernie Capital,

Prof. Foidart, Noshaq, SRIW and Stijn Van Rompay.

> Changes within Mithra’s Board of Directors: resignation of

Mr. François Fornieri for personal reasons.

July

> Changes within Mithra’s Board of Directors: As a

consequence of Mr. Ajit Shetty’s resignation for personal

reasons; appointment of Mr. Christian Moretti as Chairman

and of Mr. Erik Van Den Eynden as Vice-Chairman.

> Commercial launch of our contraceptive pill Estelle

in Australia by Mayne Pharma under the trademark

NEXTSTELLIS

January

> Positive top-line efcacy results from Donesta

Phase3

Program, demonstrating a meaningful reduction in

vasomotor symptoms (VSM) from baseline and compared

to placebo. All co-primary efcacy endpoints were

statistically (all p<0.05) met in both studies and conrmed

in April 2022. Even in the C302 study, the result for the

severity criteria reached statistical signicance at week

4. Secondary endpoints evaluated at 3 months in the

C301 study suggest a very positive impact of Donesta®

menopause treatment on the quality of life (hot flushes,

mood swings, anxiety, sleep, joint pain, skin & hair quality,

libido…) as measured by validated patient-reported

outcome questionnaire.

February

> Two-year equity nancing agreement entered with

Goldman Sachs International for an aggregate amount of

up to EUR 100 million.

> Commercial launch of the Myring

vaginal contraceptive

ring under the trademark HALOETTE

in Canada by our

partner Searchlight Pharma.

2022 Highlights

December

> Signature of a binding heads of terms with

Gedeon Richter for the commercialization

of Donesta

in in about 90 territories

through an exclusive license in Europe,

Russia, Central Asia, Latin America and

through a semi-exclusive license in Brazil,

Australia and New Zealand. Under the

terms of the agreement, Mithra is eligible to

receive EUR 55 million in upfront payment,

as well as EUR 15 million in additional

milestone payments subject to specic

regulatory achievements and tiered

double-digit royalties depending on net

sales’ evolution throughout time.

Throughout the year, successive commercial launches of Estelle

contraceptive by

our partners Gedeon Richter and Mayne Pharma took place in various geographies

worldwide such as UK, Switzerland, Russia and Australia.

ESTELLE

, DONESTA

, MYRING

, NEXTSTELLIS

, ALYSSA

and HALOETTE

are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

1. ACTIVITY REPORT > 2023 OUTLOOK

2023 Outlook

Increase of Estelle

commercial

geographical footprint

Nearly two years after the commercial launch of our Estelle

innovative contraceptive pill, the journey leading to a further

expansion of its geographical footprint is on track. 2023 will

pave the way to a global expansion mainly in Latin America

and in Asia with commercial launches expected in Brazil,

Chile, Ecuador, Peru, Uzbekistan, Taiwan and Thailand.

Estelle

Post Approval Safety Study

(PASS) to be launched

Early Q2 2023, Mithra anticipates the launch of a post

approval safety study (PASS) for Europe (EMA). The protocol

for the U.S. was sent early 2023. This study is carried out

on 101,000 participants followed up for one to two years in

order to address regulatory requirements.

Donesta

: last steps ahead of

commercialization

Following the signature of a Binding Term Sheet with

Gedeon Richter end December 2022, Mithra and Gedeon

Richter signed a license agreement for the commercia-

lization of Donesta

, the rst Estetrol-based hormone

therapy in February 2023.

The negotiations around the license agreement for

Donesta

in the US are progressing well and Mithra

anticipates the announcement of its US partner in 2023.

Following the announcement early March 2023 of the

positive topline safety results from Donesta

Phase 3

study in North America, our research & development

teams are still analyzing the full data set and we expect to

receive additional results in the rst half of 2023. Based

on these positive efcacy and safety results, our teams

will progress to the submission of the dossier. The next

step is a pre-submission meeting with the FDA in Q2 2023

and then the nal ling of the dossier should occur by the

end of June this year, on track with our initial plan.

On the European study (C301), we had to recruit additional

women for this study to meet the EMA’s requirements to

have 300 biopsies examined and read by pathologists.

The screening of the patients is now completed, with

the last patient being enrolled in the Q1 2023 whose

last visit would be in Q1 2024 and leading to a market

approval submission in Q2 2024. Based on this timeline,

we are condent to start Donesta

‘s commercialization in

Europe during H1 2025.

Mithra took the approach to differentiate and increase

the value of Donesta

in a stepwise manner. The initial

indication will be control of hot flushes, but the company

has embarked on three Phase II proof of concept studies

in order to add to the claims and possibly broaden the

number of indications:

1) A Phase II clinical trial in skin health, this study

treatment will last for six months. Mithra anticipates

having the rst patients screened during Q2 2023;

2) A Phase II clinical trial on hair density and quality, this

is also a six-month treatment study that has been

submitted and requires some adaptations following the

ethics and competent authorities’ feedback. We expect

to start the screening of the patients during Q3 2023;

3) And nally, we have a proof-of-concept study in

female sexual arousal disorder (FSAD) which a

three-month study. Mithra anticipates having rst

patients screened by the end of 2023.

We expect receiving the clinical study reports on these

three studies by the end of 2024. Depending on the data,

Mithra could then decide to do further studies that would

allow the company to include claims or indications in the

product label for these particular factors.

Beyond E4 with tyrosine kinases

inhibitors

Early March 2023, Mithra announced the rst

conclusive data of the preclinical studies conducted

in partnership with BCI Pharma. The positive

progression in this research collaboration with

BCI Pharma, with the identication of 4 distinct

chemical series of selective CSF1R inhibitors is

showing very promising proles in vitro and in vivo

tests. Through those tests, promising compounds

have demonstrated proof of concept in cancer

and endometriosis indications, which were the

initial focus. The full data set to make decision on

acquisition of the IP from BCI Pharma will be available

in Q2 2023. As a reminder, Mithra has an option to

acquire patents covering CSF1R inhibitor series with

upfront payment of EUR 2.25 million on execution of

option, following the rst results conducted by BCI

Pharma. Mithra will fund the preclinical and clinical

development with a focus on female cancers and

endometriosis, with a focus on orphan indications.

Preparation of a clinical study in

the neonates with hypoxic-ischemic

encephalopathy

Beyond women’s health and the use of E4-based solutions

to develop innovative products for contraception and

menopause, Mithra is also working on assessing E4’s

potential in other therapeutic areas, particularly in

neuroprotection.

In this eld, Mithra is currently evaluating the effects

of E4 in the treatment of a neonatal hypoxic ischemic

encephalopathy (NHIE), a life-threatening form of brain

injury), which is explained more in details in another section

of this report. A Phase I study to characterize the safety,

tolerability and pharmacokinetic of a novel formulation in

healthy adult volunteers is currently conducted.

The current study is a prerequisite for the initiation of a

clinical program in the neonatal population which will be

launched in the second part of 2024. Mithra will submit the

Pediatric Investigation Plan (PIP).

Development of a novel formulation of

Estetrol for wound healing

Preclinical data positively demonstrated that, thanks to its

unique gene signature, E4 improves wound closure and

dampens local inflammation compared to other estrogens,

supported by a unique gene signature. This supports the use

of E4 in clinic for wound healing indication.

As a rst step in wound healing indication, Mithra will focus

on development of topically applied E4 in chronic wounds

(ulcers). Mithra is currently nalizing the development of the

formulation and preparing a pilot Phase II to explore safety

and efcacy of topical E4 in venous leg ulcer population. A

proof of concept should be demonstrated in 2025.

Arrival of David H. Solomon as Mithra’s

new CEO

On April 4th, 2023, Mithra ofcially announced the

appointment of Dr. David H. Solomon as the new CEO of

the company starting on April 11th. With over 30 years of

international experience in the life sciences, biotechnology

and pharmaceutical industries, he has held managing

roles that showcased his strong strategic, operational, and

innovation-minded leadership in the US and Europe.

As the former CEO of Zealand Pharma (NASDAQ:ZEAL)

and Silence Therapeutics (NASDAQ:SLN), Dr. Solomon has

a proven track record of successful R&D pipeline delivery,

strategic business development and deal making. He was

also previously the Chairman of the Board of Directors of

Advicenne and a member of the Board of Directors of TxCell

S.A., Onxeo SA and Promosome, LLC.

1919

Research &

Development

1. ACTIVITY REPORT > RESEARCH & DEVELOPMENT

Complex Therapeutics

Mithra has an extensive expertise in the development of complex and innovative products using medical polymer technology

for vaginal rings, implants or intra-uterine devices, which ensures a controlled release of the drug over a period of time with a

minimum of side effects.

Throughout research and development programs, Mithra successfully leverages its top-level know-how worldwide to target

improved, long-lasting delivery of trusted, established approaches to contraception, menopause and hormone-dependent cancers.

Carried by its attraction for constant innovation, Mithra continues to explore

the potential of Estetrol in a wide range of applications in women’s health and

beyond. After having successfully launched the rst Estetrol-based product in

2021, the Estelle

contraceptive pill, Mithra expanded in 2022 its commercial

reach and brought the focus on its second product Donesta

, the next-generation

hormone therapy for menopausal symptoms.

On top of the VMS indication initially examined, our R&D team has been carrying out on Estetrol’s effect on symptoms signicantly

impacting postmenopausal women’s quality of life, such as skin health, hair quality and female sexual arousal disorder, adding

potential intrinsic patient value to our product.

In the meantime, Mithra also leverages its know-how in long-acting drug development and manufacturing using its polymer

technology to produce Complex Therapeutics, directly in its unique manufacturing facility, Mithra CDMO.

Research & Development

Myring

> Contraception

Contraceptive vaginal ring

made of ethylene-vinyl-

acetate (EVA) copolymers

releasing a combination of

hormones.

Already commercialized

in Europe and Canada and

launched in the United States

since January 2023.

Tibelia

> Menopause

Tablet composed of tibolone,

a synthetic steroid used

for hormone therapy in

menopause.

Already commercialized in

17 countries all around the

world including Canada, a

region where Tibelia

is the

only tibolone-based product

available.

Zoreline

> Hormone-dependent cancers

Biodegradable subcutaneous

implant for prostate cancer, breast

cancer and benign gynecological

indications (endometriosis, uterine

broids).

Currently, new formulations are being

developed with a pharmacokinetic

prole closer to Zoladex

Revealing Estetrol’s

capabilities

The many potential applications

of Estetrol (E4) have been at the

core of Mithra’s research for many

years. Produced by the human

fetus passing in maternal blood

at relatively high levels during

pregnancy, this estrogen shows a

specic mode of action compared

to other estrogens.

Estetrol has also a benecial

and positive impact on the

cardiovascular system, brain,

bone and endometrium, but unlike

other estrogens, it has a limited

impact on the liver and breast.

This unique mode of action results

in an improved benet/risk prole

compared to other estrogens.

Thanks to its unique prole,

Estetrol could address unmet

needs in various therapeutic

areas such as contraception,

menopause, neuroprotection in

newborns and wound healing.

Estelle

> Contraception

First E4-based contraceptive pill composed of 15 mg

Estetrol (E4) and 3 mg Drospirenone (DRSP).

Commercialized since 2021, including in the United

States, Canada and Europe, Estelle

signs off a new era in

Combined Oral Contraceptive.

Neuroprotection

Treatment of neonatal hypoxic ischemic encephalopathy

(HIE), a life-threatening form of brain injury.

Currently under clinical program (Phase I study).

Wound healing

Treatment enabling faster and more effective healing.

Positive preclinical data have demonstrated the

efcacy of Estetrol for topical application to promote

wound healing and support its use in clinic.

Donesta

> Menopause

Innovative E4-based hormone therapy targeting several

major menopausal symptoms.

Currently in its last stages of development (Phase III).

Product Indication Preclinical Phase I Phase II Phase III

Commercialization

Estelle

Contraception

Donesta

Menopause

Neuroprotection

- Wound healing

Myring

Contraception

Tibelia

Menopause

Zoreline

Oncology

COMPLEX

THERAPEUTICS

22 23

1. ACTIVITY REPORT > ESTETROL (E4)

Estetrol (E4)

The native estrogen set to transform women’s health

Estrogens are an essential reproductive hormone family

and play a key role in women’s health. As such, they are key

components of contraception and the menopause. Because

women have been largely misled about hormones there is

an ever-greater need for treatments that are safe and can

support women’s condence. With it being demonstrated

that treatments based on traditional estrogens can cause

an increased risk of adverse events such as deep venous

thrombosis and breast cancer, there is an unmet need for

women to have access to safer hormonal options.

Produced by the fetus during pregnancy and now synthetized

from a plant source, E4 (Estetrol) has a unique pharmaco-

logical prole and a unique structure containing 4 hydroxyl

groups. With its unique structure, pharmacokinetic and

pharmacodynamic properties and distinctive mode of action,

E4 represents a novel and attractive estrogen for clinical use

with a favorable safety prole for women. E4 has a benecial

and positive impact on the cardiovascular system, brain,

bone and endometrium but, unlike other estrogens, E4 has a

limited impact on the liver and the breast.

In 2020, Estetrol was recognized as a new active substance

in both Europe and the United States. A nding which

illustrated the profoundly innovative nature of the results of

Mithra’s research on E4 as it is the rst time in over 60 years

that a new active substance, a new estrogen in this case, has

been introduced in the eld of contraceptive solutions.

At the heart of Mithra’s research, Estetrol (E4) is the core

asset that has successfully enabled to achieve two major

milestones: developing and commercializing the rst

E4-based product, the contraceptive pill Estelle

, and

completing the Phase 3 trials for Donesta

, Mithra’s product

candidate for the treatment of menopausal symptoms,

with efcacy conrmation, which led to signing a license

agreement for commercialization.

After these two back-to-back successes, Mithra is committed

to further exploring and unveiling its flagship asset potential

beyond women’s health.

History of Estetrol

The hormone Estetrol (E4) was rst identied by Egon

Diczfalusy at the Karolinska Institute in Stockholm, Sweden

in 1965. Almost 40 years later, in 2001, Herjan Coelingh

Bennink, a Dutch researcher at Pantarhei Biosciences, noted

that the signicantly higher estetrol levels circulating in

the fetus blood compared to the mothers circulation could

represent an attractive safety prole and decided to further

explore the potential of this native hormone present only

during pregnancy.

In line with the increased interest for E4, Pantarhei Biosciences

launched pre-clinical phase I/IIA studies for applications

in women’s health (contraception and menopause) and

oncology. In 2009, to speed up and perform the development

of an E4 and progestin-based combined oral contraceptive

(COC), Pantarhei and Mithra launched a joint venture, Estetra.

After four years of collaboration, Mithra took over Pantarhei’s

shares. In 2015, Mithra Pharmaceuticals acquired full rights

to Estetrol (E4) from Pantarhei Biosciences. In 2021 the

global launch of the contraceptive pill Estelle

, Mithra’s rst

E4-based product composed of 15 mg Estetrol (E4) and 3mg

Drospirenone (DRSP), marked a new era in combined oral

contraception. By the end of H1 2023 (US) and in H1 2024

(Europe), Donesta

, Mithra’s innovative E4-based menopause

therapy targeting several major menopausal symptoms, is

anticipated to be led for a market authorization in H1 2024

(US) and in H1 2025 (Europe).

All biotests show without ambiguity that the

endocrine disruptor effects of Estetrol (E4)

are insignicant in comparison with those

observed for natural and synthetic estrogens,

whether in aquatic organisms or organisms

living in the sediment.

Prof. P. Kestemont

President of the Research Institute Life,

Earth & Environment (ILEE) of UNamur, Belgium

Negligible environmental impact

Diseases treatment relies on effective pharmaceuticals. Yet,

the pollution of soils and waters caused by pharmaceutical

residues has been amply proven and represents a clear

emerging environmental concern.

As shown in various studies recently published, some

pharmaceuticals such as cancer treatments, painkillers

and antibiotics have direct effects on wildlife and natural

ecosystems, even at low concentrations.

Wojnorowski et al. 2021; Czarny et al. 2017.

Mindful of the environmental footprint

of its solutions, Mithra is committed to

monitoring and reducing its environmental

impact and, as such, to conducting an

environmental risk assessment for all new

Mithra product candidates.

Worrying ndings for example showcased the life-threatening

behavioural change of sh exposed to low concentrations of

certain antidepressants as well as the feminisation of sh

and amphibians caused by oral contraceptives based on

synthetic estrogens.

E4, on the contrary, shows a minimal adverse environmental

impact and could contribute to ecosystem protection, as

well as to ground and surface waters preservation. According

to the results of an ecotoxicity study we conducted at

the University of Namur, E4 differs from other estrogens

and has a signicantly more environmentally friendly

prole. In Europe, based on the market size estimation, no

environmental effects are anticipated as a consequence of

the use of E4 in contraception.

24 25

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;.<-'-=">?",*+@

!"#$%&'(%)*

!"#$%&'()*

+,--)./&01&2)*

Estelle

(Estetrol 15 mg / Drospirenone 3 mg)

Around 19 additional countries

2022 was a year of consolidation as regards the commercial

performances of Estelle

, launched in 2021. The extended

worldwide commercialization has earned Mithra accolades

from health-specialists and has sparked international

interest which led to more growth opportunities in service

and product innovation as well as for future milestones.

in Australia

by Mayne Pharma under the trademark NEXTSTELLIS

and in 19 additional countries by Gedeon Richter under the

trademark DROVELIS

and ESTERETTA

(The Netherlands,

Czech Republic, Lithuania, Portugal, Finland, Croatia, Latvia,

Sweden, Spain, Bulgaria, Norway, Romania, Denmark,

Switzerland, Slovenia, United Kingdom, Ireland, Moldavia

and Russia), Mithra maintains a steady course on its global

awareness journey. Built on this momentum, Mithra’s

strategy going forward remains committed to achieving

its operating objectives: pursuing its goal of commercial

expansion and providing women with new contraceptive

choices improving their daily lives.

In 2022, Gedeon

Richter’s sales revenues

reached EUR 16 million,

slightly exceeding their

primary forecast of

EUR 15 million.

Expected milestones for 2023

include the further commercial

launch of Estelle

in Europe,

Latin America and Asia, as

well as additional marketing

authorizations in Montenegro,

Israel, Armenia, Belarus,

Ukraine & Serbia.

A PASS study will start in

2023. Its main focus and

purpose will be to characterize

and compare the Venous

Thromboembolism risks of

E4/DRSP with EE/LNG.

Estelle

®’

s glistening future

It’s the rst major advancement

made in the birth control market in

over 60 years. Not only do all our

big studies show that new birth

control pills incorporating E4 are

just as effective as more traditional

birth control pills, but right now,

it would seem that it’s much safer.

We’re seeing few recorded side

effects and lesser risk of blood

clots compared to other birth

controls

Dr. Mitchell D. Creinin, M.D.

Professor, obstetrician, family planning

specialist and, Director of Complex Family

Planning at the University of California

1. ACTIVITY REPORT > ESTETROL (E4)

https://www.refinery29.com/en-us/birth-control-the-pill-estetrol-e4

DROVELIS

and ESTERETTA

are registered trademarks of Richter Gedeon Nyrt

Commercialized

LSA Signed

Donesta

Innovative oral hormone therapy (HT) is an effective treatment option for

relieving major menopausal symptoms with an expected safer prole

Upon nal study completion and approval,

Donesta

is expected to be a safer alternative

to current existing oral hormone therapy on the

market and will offer women and practitioners a

novel treatment option that addresses the unmet

needs of millions of women going each year

throughout the challenges of the menopause.

2023 outlook

In H1 2023, the Donesta

Phase III Clinical

Program is still ongoing with additional safety

data anticipated for H1 2024. Accordingly, Mithra conrms its ambition to

achieve marketing authorization in H1 2024 for the United States and in H1

2025 for Europe. Owing to a slow recruitment, the marketing authorization

initially anticipated in Q4 2024 has been moved to H1 2025.

2023 will see the initiation of the studies dedicated to Estetrol’s effect on other

symptoms signicantly impacting postmenopausal women’s quality of life,

with the rst studies on skin health and hair quality and a next one on female

sexual arousal disorder.

In quest of an alternative that will alleviate major menopausal

symptoms, such as vasomotor symptoms (VMS), caused

by estrogen progressive decrease, Mithra announced in the

rst half of 2022 positive efcacy data of Donesta

Clinical

Program called “E4 Comfort” launched in 2019. Whereas

these consolidated results further demonstrated week after

week a statistically signicant and meaningful reduction in the

frequency (up to 80%) and severity (up to 56%) of moderate to

severe VMS from baseline and compared to placebo with all

co-primary endpoints statistically met (all p < 0.05), they also

reinforced the promising potential of Donesta

for improving

quality of life and reducing the genito-urinary symptoms of

menopause

End 2022, Mithra signed a license agreement for the

commercialisation of Donesta

with its long-term commercial

partner Gedeon Richter.

Early 2023, Mithra shared Donesta

Phase III North American

Study topline safety results supporting the overall good safety

prole of the product for the treatment of post-menopausal

women aged 40-65 years with moderate to severe vasomotor

symptoms. Among the highlights of these results, all key

secondary endpoints were achieved, including E4’s benecial

effect on cholesterol prole and on bone turnover biomarkers.

These results contribute to showcase the unique prole of E4.

Donesta

is Mithra’s next generation

orally-administrated Estetrol

(E4)-based hormone therapy product

candidate offering a potential

long-term solution for treating the

different symptoms of menopause.

E4 as a whole

E4 activates the nuclear estrogen receptor (ER). E4 has

a unique metabolism that allows it to act differently from

classical estrogens, which results in a low impact on liver

and breast and an overall

improved safety prole.

Thanks to all these

favourable highlights, E4

clinical results suggest

to date point towards

a unique and novel

oral post-menopausal

hormone therapy.

2030

Increase of menopausal

and postmenopausal

women population

worldwide to reach

1.2 billion

To this day,

only 1 in

10 women

affected by

menopausal

symptoms

take hormone

therapy

In the 90’s hormone therapy was considered

as standard of care for menopause. After

the publication of an WHI study in 2002

which created fear towards hormone

therapy, the market collapsed.

Although a large amount of corrective

statements were published since 2006,

none managed to regain the favours of

healthcare practitioners or the FDA.

These excellent ecacy results demonstrate that

Donesta

should offer the most complete prole of

symptom relief compared to any of the existing or

pipeline therapies for menopause symptom treatment.

By the end of 2023 we will be able to demonstrate again

the unique safety prole of E4, building further on the

fantastic potential of this molecule.

Dr. David H. Solomon

CEO Mithra Women’s Health

1. ACTIVITY REPORT > ESTETROL (E4)

K. Hill – The demography of menopause Maturitas 1996

Type and timing of menopausal hormone therapy and breast cancer risk: individual participant meta-analysis of the worldwide epidemiological evidence - PMC (nih.gov)

28 29

Two clinical programs

beyond women’s health,

In addition to its Estetrol-based achievements and

researches, Mithra decided to strengthen its leadership

position in women’s health by agreeing with BCI Pharma an

option to acquire the rights relating to two patent families

related to innovative kinase inhibitors, notably indicated in

the treatment of many pathologies including endometriosis,

oncology and inflammatory disorders.

In 2021, tyrosine kinase inhibitors were the third fastest

growing therapeutic class, with a 14% increase in revenues

representing USD 45.8 billion (IQVIA FY 2022).

In order to pursue this new innovative development axis in a

fast-growing market, Mithra already contributed to funding

the research program (450,000 EUR) so as to launch and

conrm the therapeutic potential of innovative inhibitors

of CSF-1R kinase. As a reminder, Mithra has an option

to acquire patents covering CSF-1R inhibitor series with

Exploring the treatment of

neonates with hypoxic-ischemic

encephalopathy

For the treatment of neonatal hypoxic ischemic encepha-

lopathy (NHIE), Estetrol benets from an orphan drug status

in Europe and the United States. NHIE is a severe form of

brain injury caused by oxygen deprivation and limited blood

flow to the baby’s brain before, during or just after birth,

which affects approximately 30,000 newborns each year in

Europe and the US.

NHIE is a life-threatening condition accounting for 23% of all

neonatal deaths worldwide. Nearly one in four affected infants

will die before leaving the neonatal intensive care unit. Among

surviving infants, there are severe neurological problems and

long-term disability, including cerebral palsy, epilepsy, visual and

auditory problems, learning, language and behavioral disorders.

Currently, infants are treated with therapeutic hypothermia or

‘cooling’ to reduce brain damage, but this treatment has limited

efcacy and comes at high cost. Given its signicant mortality

and morbidity in newborns and the lack of available therapeutic

alternatives, the development of a new Estetrol-based treatment

could address a real unmet medical need.

Mithra has initiated in 2022 a Phase I Study to evaluate, in the

adult male and female population, the safety and tolerability of a

new E4-based formulation developed for intravenous adminis-

tration. This Phase I Study also aims to collect pharmacokinetic

data to inform dose selection for neonatal studies. A rst study

aiming to evaluate the safety, tolerability and pharmacokinetic

in the newborn with HIE should be launched in 2024. Mithra

is currently working on the study protocol preparation as well

as on the Pediatric Investigation Plan (PIP) which must be

submitted to the European authorities.

and Estetrol

Diversication of asset-based pipeline with tyrosine kinases inhibitors

Topical application of

E4 for wound healing

Chronic wounds are dened as wounds that do not heal

properly over a certain period of time (typically 3 months).

It includes venous leg ulcers, the most common type of

ulcers, accounting for 70% of all lower leg ulcers, diabetic

foot ulcers, arterial ulcers and pressure ulcers. Chronic

wounds are a major health problem that has devastating

consequences for patients and contributes to major costs

to healthcare systems and societies. It is estimated that

1–2% of the population in developed countries suffer from

chronic wounds at any time (Gottrup et al 2001; Sen et al,

2009). The amount of money spent on wound care, the loss

of productivity for afflicted individuals and the families who

care for them, and their diminished quality of life (QoL) come

at great cost to society (Hjort and Gottrup, 2010). Given

the aging population, the continued threat of diabetes and

obesity worldwide, and the persistent problem of infection,

it is expected that chronic wounds will continue to be a

substantial clinical, social, and economic challenge in the

future. Currently, there are no EMA-approved pharmaceutical

products for chronic wounds. Regranex is approved by the

FDA for the treatment of lower extremity diabetic neuropathic

ulcers but has safety proles concerns.

In 2022, Mithra has obtained positive results from preclinical

studies demonstrating efcacy of Estetrol to promote wound

healing, improving wound closure and dampening local

inflammation. These results supported the clinical use of E4

for wound healing indication. Mithra intends to initiate the

development of Estetrol in chronic wound ulcers indication.

In 2023, Mithra will work on the production of clinical batches

of the newly developed E4 topical formulation and on the

preparation of a pilot trial to explore safety and efcacy of

topically applied E4 in venous leg ulcer population. A proof-of-

concept should be demonstrated in 2025.

upfront payment of EUR 2.25 million on execution of option,

following the rst results conducted by BCI Pharma. Mithra

is committed to fund the preclinical and clinical development

with a focus on female cancers and endometriosis, with an

emphasis on orphan indications.

Early March 2023, Mithra announced the rst conclusive

data of the preclinical studies conducted in partnership

with BCI Pharma which showed very promising proles in

vitro and in vivo tests and demonstrated proof of concept

in cancer and endometriosis indications. The full data is set

to nalize its decision on acquiring the IP from BCI Pharma.

Neuroprotection

Wound healing

1. ACTIVITY REPORT > ESTETROL (E4)

30 31

1. ACTIVITY REPORT > COMPLEX THERAPEUTICS

Myring

Contraception

Successfully launched in 2019, Myring

is now commercialized in

multiple territories including the United States, the largest market

for contraceptive vaginal rings that is estimated at EUR 516 million

FY 2022.

According to IQVIA, NUVARING

®*

US brand and generic sales were

approximately EUR 516 million in 2022. Throughout the year, over

5.6 million contraceptive rings were sold on the US market.

With the US launch, Mithra has received two additional milestone

payments from Mayne Pharma: EUR 6 million upon FDA approval

in H2 2022 and EUR 1.6 million at the commercial launch early

2023.

In 2023, additional launches in Switzerland, Israel, Moldova,

Ukraine and Latam countries such as Paraguay, Argentina and

Dominican Republic are anticipated.

Complex Therapeutics

Tibelia

Menopause and osteoporosis

Tibelia

is the tibolone-based oral solution for use in hormone

therapy to relieve postmenopausal symptoms and to prevent

osteoporosis in postmenopausal women at high risk of

future fractures that are intolerant of, or contraindicated, for

other drug products.

Developed by Mithra as bioequivalent version of Livial

®*

Tibelia

is a complex oral formulation launched in 2016. Now

commercialized in over 17 countries all around the world

such as Italy, France, UK, Australia, Taiwan and Canada where

Tibelia

is the rst tibolone-based product to be marketed.

In 2023, additional launches are anticipated in South Africa,

Greece, Venezuela and Eastern Europe.

Zoreline

Hormone-dependent cancer

Zoreline

is a complex biodegradable subcutaneous

implant used for the treatment of prostate cancer,

breast cancer and gynecological indications such as

endometriosis and uterine broids.

Zoreline

market opportunity currently represents EUR

883 million (5,62 million in volume), a growth of 20%

compared to last year driven geographically by China.

Market is currently dominated by Zoladex

®**

which has

been off-patent for circa 20 years. Mithra holds global

licensing rights for Zoreline

With the signicant improvements

of the one-month formulation

and the anticipated three-month

formulation, we will be in a stronger

position to engage potential

partners.

Jean-Manuel Fontaine

Chief Commercial & External Affairs Ocer

54 mm

Ø 4 mm

Commercial launch

in Canada

Launch of Myring

in Canada

by Searchlight Pharma under

the trademark HALOETTE

(February 2022). Myring

is the

rst available alternative to the

only one actor present, the original

NUVARING

, in the Canadian

contraceptive ring market.

Approval and launch

in the United States

FDA approval of Myring

under the

trademark HALOETTE

(August

2022), followed in January 2023

by the commercial launch in the

United States, the world’s largest

pharmaceutical market, for which

the vaginal contraceptive ring is to

be produced by the Mithra CDMO.

Mithra has an extensive expertise in the development of complex and

long-acting innovative products using medical polymer technology

13-18 mm

Gosereline

Implant

* Livial

is an Organon trademark

** Zoladex

is a trademark of Astra Zeneca

* NUVARING

is a trademark of N.V. Organon

1. ACTIVITY REPORT > MITHRA CDMO

32 33

Mithra CDMO is a fully integrated

end-to-end contract development and

manufacturing platform designed

to service Mithra’s innovative

pharmaceutical pipeline as well as

to support external parties with their

pharmaceutical development and

manufacturing needs.

Mithra CDMO

Bridging expertise for successful pharmaceutical development

State-of-the-art facility

Mithra CDMO is powered by a sharp expertise and know-how

housed in Flémalle, Belgium. Whereas its specialty consists

in supporting niche areas in polymeric forms and injectables,

its flexibility to adapt to technologies ensures its performance

as an agile organization geared to operating successfully

and able to respond to new requests.

Specialized in sterile injectables and polymeric forms,

Mithra CDMO offers a wide range of services and provides

a highly valued expertise in long-acting polymer-based

formulations. This particular know-how came to fruition with

the development and production (since 2019) of Mithra’s

contraceptive ring, Myring

. As part of its focus on high

value-added development, Mithra CDMO strengthened its

offer in 2022 to provide a complete spectrum of solutions

from early drug development, clinical batches and

commercial manufacturing of products based on special

technologies such as complex polymeric products (vaginal

ring, implants), complex liquid injectables and biologicals

(vials, pre-lled syringes or cartridges).

Collaborations through development and

manufacturing services

Following the accreditation of its injectable facility received

in 2021, Mithra CDMO has inked a series of collaborations

with industry peers to place its expertise at the service of their

success and innovative achievements.

Together with MedinCell, a Montpellier-based pharmaceutical

company who develops a portfolio of long-acting injectable

products in various therapeutic areas by combining its BEPO

technology with active ingredients already marketed, Mithra

CDMO has agreed to develop two long-acting injectable

products: a 3-month long acting injectable designed as

an additional tool to ght Malaria; a long-acting injectable

of tacrolimus for transplant patients aiming at improving

efcacity, tolerance and patient observance.

For VaRi Biosciences, an innovative German biotech company

focusing on novel drug delivery approaches in Female Health,

Mithra CDMO is developing an innovative long-acting vaginal

ring indicated for the treatment of vulvovaginal atrophy for

menopausal women.

Additionally, to utilize its technological expertise and

state-of the-art infrastructure and support Mithra’s growth,

Mithra CDMO produced in 2022 approximately 1 million

vaginal rings, Myring

for markets in Europe, Canada and

Latin-America. In early August 2022, Mithra announced that

the US Food and Drug Administration (FDA) had granted

approval of the Abbreviated New Drug Application (ANDA)

for HALOETTE

, its vaginal hormonal contraceptive ring, and

its manufacturing at the Mithra CDMO. A growing success

story which illustrates the CDMO’s end-to-end capabilities in

bringing a product from its conceptual phase, all the way up to

commercialization in worldwide markets.

This important milestone highlights

Mithra’s world class drug development and

manufacturing capabilities to develop a

complex drug-device pharmaceutical. We

are thrilled to manufacture HALOETTE

ring at our Mithra CDMO and to support

the launch of this affordable contraceptive

alternative in the U.S., the world’s largest

pharmaceutical market.

Dr. David H. Solomon,

CEO Mithra Women’s Health

Flexibility:

small

(pilot, clinical)

to medium

batch sizes

Ability to handle

special and highly

potent drug

products

manufacturing

From concept to commercialization

State-of-the-art

manufacturing

facility and

equipment

To leverage on these specic capabilities and expertise,

Mithra CDMO started in 2022 to collaborate with

external companies for the development of highly

complex formulations, focusing on new vaginal rings and

biodegradable implants and applications, for example.

By upscaling the facility, Mithra CDMO also supports the

development of all products throughout their full-life cycles.

Manufacturing capabilities

> Over 18,000 m

facility in Flémalle

(Belgium)

> Dedicated R&D and production areas

> 3 industrial production units:

> Full drug development services

> Pilot, clinical & commercial batches

> GMP standards compliance (EMA / FDA)

Injectable

Complex

Polymers

HPAPI

Tablets

CMC

Development

Quality

Packaging

& Logistics

At the CDMO, our skilled teams are

extremely motivated to keep on growing

and delivering innovative solutions that

contribute to improve people’s

health and comfort.

Our specic expertise and

our highly versatile and

state-of-the-art technological facility

are key enablers for reliable and agile

partnerships, contributing to prime

pharmaceutical development and

manufacturing.

Renaat Baes, Plant Director Mithra CDMO

End-to-end services

on one site,

from development

to commercial

manufacturing

The initial area of 15.000 m² did not include all building surface of the facility

34 35

1. ACTIVITY REPORT > KEY FIGURES

34 35

Key gures

 As at 31 December

Thousands of Euro (€)

2022 2021



Revenue 66,997 22,668

Cost of sales (19,623) (15,724)

Gross prot 47,374 6,945

Research and development expenses (64,041) (85,243)

General and administrative expenses (14,675) (12,515)

Selling expenses (2,100) (1,871)

Other operating income 7,196 4,809

Loss from operations (26,245) (87,875)

Change in fair value of contingent consideration payable 28,335 (19,265)

Net fair value gains/(losses) on nancial assets at fair value

through prot or loss

- (6,351)

Financial income 9,852 2,838

Financial expenses (23,422) (13,116)

Loss before taxes (11,480) (123,769)

Income taxes (48,139) 6,895

NET LOSS FOR THE PERIOD

(59,620) (116,875)

Figures presented below (in thousands of euro) are management gures • Revenues stand at EUR 67 million compared to

EUR22.7million in 2021, mainly driven by an out-licensing

upfront payment of EUR 44.7 million for Donesta

(being a

portion of the EUR 55 million to be recognized as revenue

according to our IFRS 15 accounting policy). Under the

terms of the licence agreement for the commercialisation

of Donesta

, Mithra received EUR 55 million in upfront

payment – EUR 5 million paid upon signature of the binding

term sheet in December 2022 and EUR 50 million paid upon

signature of this license agreement in February 2023.

• On top, there are EUR 9.2 million of product sales of Estelle

reported in 2022, EUR 6.5 million of product sales of generic

portfolio and EUR 2.3 million of R&D contracting revenue

from CDMO.

• Cash collection of the major out-licensing milestones

on Myring

with Mayne (EUR 6 million) in H2 2022, one

Estelle

out-licensing milestone relating to Latin America

with Gedeon Richter (EUR 1 million) as well as several others

amounts relating to Estelle

(for a total of EUR 1million),

without impact on revenue as already recognized previously

as per IFRS. A milestone payment of EUR 1.6 million

following Myring

commercialization in the U.S. has been

collected in February 2023, a post-closing event.

• R&D expenses stand at EUR 64.0 million in 2022 compared

to EUR 85.2 million in 2021 (-25%). The decrease is the

result of a strategy based on focusing on core R&D projects

(Donesta

and Estelle

) leading to non-core R&D costs being

delayed in 2023.

• EBITDA stands at EUR -14.3 million compared to

EUR -77.5 million in 2021. EBITDA improves thanks to

the upfront payment collected on the Donesta

license

agreement combined with the decrease in operating

expenses (lower R&D expenses) compared to last year.

• Loss before taxes improves thanks to the positive impact

of EUR 28.3 million booked in the change in fair value of the

contingent consideration payable related to Estelle

• Reversal of signicant amount of deferred tax assets

explained by two events that occurred in H2 2022. The

rst one is the reception of a positive ruling from Belgian

tax authorities, enabling Mithra to benet from Innovation

income deduction (IID) for Estelle

and Donesta

that

considers 100% of their revenue as eligible to IID mechanism.

This event is changing our previous assumptions about

future taxation of the related entities. The second one is

arising from a tax audit on scal deductibility of the Uteron

future payments. This tax audit had no cash consequences

but has modied the assumptions to be taken into account

for the deferred taxes computation. Both events result in

a reversal of EUR 47.4 million impacting the deferred tax

assets position on the balance sheet at closing date.

• Net Cash position stands at EUR 28.3 million end 2022

and is strengthened as mentioned above by post-closing

events linked to the collection of an out-licensing upfront

payment on Donesta

of EUR 50 million, the collection of

the Mayne Pharma dividend for c. EUR 3 million and the

milestone payment of EUR 1.6 million following Myring

commercialization in the U.S., which led to a cash position

of EUR67.5million end February 2023. On top of this, Mithra

has access to several facilities of which:

• EUR 52.8 million under the LDA Capital commitment

agreement entered in April 2020 with a maturity in April

2025;

• EUR 25 million from the senior secured convertible

facilities agreement signed on 8 August 2022 with funds

managed by Highbridge Capital and funds managed by

Whitebox Advisors for an amount of EUR 100 million,

with a maturity in August 2025. The rst tranche of EUR

50 million was received upon signing of the agreement,

with around 29 million used to repurchase outstanding

convertible bonds of the Company held by the Lenders.

The second tranche of EUR 25 million was drawn on

October 2022.

• Equity stands at EUR 33.7 million, flat compared to December

2021 (EUR 33.8 million). The total comprehensive loss for

the period (EUR 77.9 million) was compensated by several

capital increases for a total amount of EUR 77.0million (net

of transaction costs):

• EUR 13.0 million from LDA Capital;

• EUR 13.7 million in the framework of flexible equity

nancing agreement with Goldman Sachs International;

• EUR 23.3 million from the private placement completed in

June 2022;

• EUR 26.9 million from the senior secured convertible

facilities agreement with funds managed by Highbridge

Capital and funds managed by Whitebox Advisors

1. ACTIVITY REPORT > SHARE & SHAREHOLDING STRUCTURE

3736

Share performance

Mithra (Euronext: MITRA) is listed on Euronext Brussels since June 2015.

Mithra is part of the BEL Small Index, the BEL Health Care Index and the

Euronext Tech Leaders Index.

In 2022, the average share price was EUR 9.71 per share. The highest share

price was EUR 21.60 on 14 January 2022 (EUR 22.00 intraday) and the

lowest share price was EUR 3.30 on 28 December 2022 (EUR 2.90 intraday

on 21 December 2022).

2022 was a tough and volatile year for nancial markets mainly due

to geopolitical issues, and more specically for risky sectors, including

biotechnology sector. Despite several operational achievements, Mithra’s

share price recorded a decrease of 83% in 2022.

The average daily volume stood at 128,013 shares. The volume of shares

exchanged daily increased in 2022 due to the largest amount of outstanding

shares, following the private placement in June and the convertible loan in

August. Beginning 2022, Mithra started with 44,051,259 shares and ended

the year with 56,314,974 shares, or an increase of 28%.

Shareholding

structure

The graph shows our shareholder structure as at December 31, 2022, based on

the transparency declarations made by shareholders.

Notication obligations are required by Belgian law or according to Mithra’s

articles of association, when the shareholding exceeds the thresholds of 3%, 5%

or any multiple of 5%.

The total number of outstanding shares with voting rights amounts to 56,314,974.

Although Mithra has an international shareholder structure, most of its

shareholders are based in Belgium. The free float percentage increased from

49,0% to 59,5% mainly due to the increase in the number of outstanding shares.

Mithra’s major shareholders are listed in the table:

01/

2022

02/

2022

03/

2022

04/

2022

05/

2022

06/

2022

07/

2022

08/

2022

09/

2022

10/

2022

11/

2022

12/

2022

01/

2023

14/01/2022

28/12/2022

Mithra share at a glance

2021 2022

Average daily trading volume 60,465 128,013

Number of share outstanding 44,051,259 56,314,974

Average share price EUR 21.3 EUR 9.7

Lowest price EUR 17.8 EUR 3.3

Highest price EUR 28.0 EUR 21.6

Free float

(<5%)

63,11%

François

Fornieri

1,3

19.20%

Noshaq

9.75%

Marc

Coucke

2,3

7.94%

% (31 December 2022)

François Fornieri holds warrants entitling him to subscribe 952,790 additional shares

of Mithra through Yima SRL, a company fully owned by François Fornieri

Marc Coucke holds his shareholding partially through Alychlo NV, which he controls.

François Fornieri, Alychlo NV and Noshaq SA jointly hold 300,000 warrants (share lending warrants).

38 39

1. ACTIVITY REPORT >

2022 FINANCIAL CALENDAR & ANALYST COVERAGE

April 18

2022

Annual report

May 25

Annual General

Shareholders’

Meeting

March 7

2022

Full year results

September 26

2023

Half year results

2022 Financial Calendar

Analyst coverage

On December 31, 2022, Mithra was covered by six sell-side analysts who publish

regular reports. It is important to understand that the views expressed by analysts

in their coverage of Mithra are those of the author and do not reflect the views of the

Company as such.

In 2022, Mithra organized four webinars; two to present the nancial results and

two on Donesta

, the rst one to announce the efcacy results of Donesta

Phase3

Study and the second on the signature of the Donesta

deal with Gedeon Richter.

The management of the Company also participated in several conferences and

broker-organized virtual and physical roadshows to meet individual and institutional

shareholders. The purpose of those events is to present the company to the

investment community who is considering the opportunity to take part in the Mithra

journey.

Beatrice

Allen

Laura

Roba

Sushila

Hernandez

Clément

Bassat

Maxime

Stranart

Thomas

Vranken

40 41

1. ACTIVITY REPORT > ESG: ENVIRONMENTAL, SOCIAL AND GOVERNANCE INITIATIVES AT MITHRA

Sustainable mobility plan to be implemented

With more than 200 employees based on two sites, the

environmental impact of our car fleet is not insignicant.

The implementation of structural homeworking in 2021 has

already helped reduce the environmental impact of our fleet

but we are committed to further reducing it by offering our

collaborators mobility solutions that answer to the new ways

of working and that meet their needs. To this end, our human

resources team has developed a mobility planto transition

towards more sustainable and environmentally friendly

alternatives. While the project implementation was initially

planned at the end of 2022, its launch has been postponed to

a later date as we decided to focus on other priority projects,

e.g. our benchmark project, which we needed to attract the

right candidates and retain our employees. Sustainable

mobility nevertheless remains a target that we want to

achieve in the near future.



2021

(reference year)

2022

Target

2030

GhG emissions (tons

of CO

equivalents)

3887

3012

(-23%)

-55%

Energy consumption

(MWh)

11509

9270

(-19%)



Share of energy

(electricity + gas)

from renewable

sources (%)

(+125%)

70%

Water consumption (m

)

25468

23591

(-7%)

-20%

Waste production

(tons)

79 57 (-28%) -20%

initiatives: as of February 2022, we turned down the HVAC

units in our CDMO ofces and open spaces at night and

during the weekends. All our light bulbs were also replaced

with LED alternatives.

Reduction of our greenhouse gas emissions, waste

production and water consumption

We are proud to announce that we reduced our greenhouse

gas emissions by more than 20% from 2021 to 2022 and

that we reduced our waste production by almost 30% in

2022 compared to 2021.

Some steps of our manufacturing processes also require

signicant amounts of water. In 2022, in order to reduce

our water consumption, we optimized the utilization of

these water-intensive utilities and ensured that they only run

when needed instead of continuously. We are also currently

exploring other avenues to optimize our processes and

save water, while of course keeping in mind our business

continuity.

1. Environment

As the signs of human-induced climate change become

increasingly visible each day, and with our planet facing

disruption and human well-being being threatened,

important and immediate actions are required to address

environmental challenges. As a company, we want to play an

active role and reduce the environmental impacts that result

from our operations and products.

Environmental impact of operations

To signicantly reduce the environmental footprint of our

operations by 2030, we have set ambitious targets and

launched a series of initiatives.

Increasing our share of energy from renewable

sources

Our main energy consumer is our development and

manufacturing platform, Mithra CDMO. Since 2018, the

building was already equipped with 1850 solar panels that

covered 9% of its electricity consumption. To increase our

share of energy from renewable sources, a brand-new eld

of 2748 solar panels was installed and made operational

in 2022. With an estimated annual green production of

1,110,000 KWh, i.e. the equivalent of the consumption

of approximately 200 households, these new panels can

represent a CO

saving of around 250 tons per year and we

anticipate that solar energy will cover around 30% of our

Mithra CDMO electrical power consumption going forward.

To the delight of our staff, a flock of around 40 sheep also

joined us in February 2023 to tend the eld where the new

solar panels are installed.

Reducing our energy consumption by almost 20%

While it is key that we increase our share of energy that comes

from renewable sources, it is also crucial that we reduce our

energy consumption. With that aim, we implemented various

ESG:

Environmental,

Social and Governance

initiatives at Mithra

To ensure that sustainability is

embedded in our corporate strategy

and that our sustainability ambitions

translate into reality, we launched a

strategic exercise in 2021 and set up

a Sustainability Committee composed

of our company key representatives.

With the role of developing a

sustainability strategy based on the

17 Sustainable Development Goals

(SDGs) dened by the United Nations,

the Committee identied the key

material topics for Mithra to work on

in terms of sustainability, i.e. patients,

planet, people, ethics and integrity, and

women empowerment.

Improvements take time and progress

is not always as linear as we would

like it to be. In 2022, we continued our

development towards sustainability

and implemented our sustainability

strategy, because we aim at always

rethinking the way we work and

operate to successfully address

climate, social and governance

challenges.

To the delight of our staff, a ock of around

40 sheep also joined us in February 2023 to

tend the eld where the new solar panels are

installed.

???

42 43

Increase of our suppliers and partners global quality

oversight

We are happy to report that, by the end of 2022, we increased

our suppliers and partners global quality oversight to 30%.

Reinforcement of pharmacovigilance team

We are also proud to report that all periodic safety update

reports (PSURs) were submitted on time in 2022. These

reports are pharmacovigilance (PV) documents intended

to provide an evaluation of the risk-benet balance of a

medicinal product at dened time points during the post-

authorization phase. Each marketing authorization holder

is responsible for submitting PSURs for its own products

and should submit PSURs to the EMA according to dened

timelines.

In 2022, we also submitted all 90-days adverse event reports

on time but there were 3 late 15-days adverse event reports

out of a total of 23 reports (87%). As compliance to the

timelines provides assurance that marketing authorization

holders have adequate systems in place for the safety

monitoring of medicines on the market, the decision has

been made to transition to a new PV service provider,

effective early 2023. We also strengthened the internal PV

team with the addition of a Medical Information Ofcer

and a PV Operations Ofcer. These new hires allowed for

a continuous improvement program to have successful

internal audits and audits by partners, and further allowed

the team to bring critical functions in-house like the (deputy-)

EU QPPV and Responsible for Information.

Launch of Estelle

PASS study in 2023

With Estelle

being available for nearly two years now, a

post approval safety study (PASS) must be carried out. Post-

authorisation safety studies (PASS) are carried out after a

medicine has been authorised to obtain further information

on a medicine’s safety, or to measure the effectiveness of

risk-management measures. Estelle

PASS study is expected

to be launched in the second quarter of 2023 in Europe while

the protocol for the U.S. part of the PASS study is currently

being reviewed by the FDA.

contraceptive pill Estelle

and not only the environmental

prole of estetrol alone, a complementary ecotoxicity study

has been conducted at the University of Namur. The results

show that a one-month exposition of the sh to E4 (at up to

300 times the environmentally relevant concentration) with

or without DRSP didn’t affect their survival or their growth.

These studies suggest that E4, alone or in combination with

DRSP, presents a more favourable environmental prole

than ethinylestradiol at their respective environmental

concentrations. Data therefore support that E4- or E4/

DRSP-based products could be valuable eco-friendly

alternatives to products containing ethinylestradiol.

Raising awareness for more environmentally friendly

medicines

While the world gradually realizes how harmful medicine

residues are to our waters and overall biodiversity, we are

convinced of the need to continue to raise awareness on the

importance of product ecotoxicity. To this end, we engaged

in several initiatives. In 2022 our non-clinical team attended

both the European and North American congresses of the

Society of Environmental Toxicology and Chemistry (SETAC)

and presented a different poster in both congresses. They

also submitted one publication entitled “Estetrol has a

lower impact than 17α-ethinylestradiol on the reproductive

capacity of zebrash” in several scientic journals.

In November 2022 we also organized a conference at the

European Parliament that gathered researchers, industry

players and policymakers to address the direct effects of

pharmaceuticals on wildlife, knowledge and policy gaps but

also to discuss solutions to support research and innovation

for less environmentally harmful medicines. Experts from the

panel discussion highlighted the need to improve monitoring

in Europe and to increase support for the development of

more environmentally friendly drugs.

Products ecotoxicity

Favourable environmental prole for Estetrol (E4)

Estrogens, either natural or synthetical, are commonly found

in the aquatic environment and can, as endocrine disruptors,

influence the sexual differentiation of shes and disrupt

aquatic ecosystems.

Mindful of the environmental footprint of its solutions, Mithra

is committed to monitoring and reducing their environmental

impact and, as such, to conducting an environmental risk

assessment for all new Mithra product candidates.

The environmental risk assessment for our product

candidate Donesta

is currently being conducted as part

of our preparation for the market authorization application,

while for Estelle

, the studies conducted on a representative

sh species showed that estetrol, at environmental predicted

concentrations, presented none of the adverse effects

induced by the natural estrogens estrone and estradiol and

by the synthetic estrogen ethinylestradiol (EE2), i.e. reduced

egg production, delay in sexual maturation, and even

feminization. The results also indicated that estetrol has a

low potential to accumulate in living organisms and was

likely to disappear rapidly from both water and sediment.

The PEC/PNEC ratio

of estetrol is therefore below 1 and

we are very proud to claim that the positive environmental

prole of estetrol is highlighted in Estelle

’s leaflet in Europe

and Canada: “Environmental risk assessment studies with

estetrol including the Japanese medaka sh extended one

generation reproduction test indicated that the predicted

environmental exposure to estetrol will not affect the aquatic

ecosystem”.

As our objective was to characterize the environmental prole

of the Estetrol (E4)/Drospirenone (DRSP) combination of our

The PEC/PNEC ratio is the ratio between the Predicted Environmental Concentration and

the Predicted No Effect Concentration. If the PEC/PNEC ratio of a product is below 1, it means

that the use of this product will have no effect on the environment.

Environmental risk assessment studies with

estetrol including the Japanese medaka sh

extended one generation reproduction test

indicated that the predicted environmental

exposure to estetrol will not affect the

aquatic ecosystem.

1. ACTIVITY REPORT > ESG: ENVIRONMENTAL, SOCIAL AND GOVERNANCE INITIATIVES AT MITHRA

2. Social

Patients

As a company dedicated to women’s health, our mission

has always been to offer women innovative solutions that

address their needs and offer them better efcacy, safety

and quality of life.

> Responsible Research & Development

8 manuscripts published in scientic journals

At Mithra we value innovation and expertise to pursue

our mission of a better health for women. To this end, we

invested 53.7 million euros into research and development

in 2022. To ensure that our Research & Development teams

stay at the cutting edge in their eld of expertise, they also

attended no less than 9 international scientic congresses

with 15 abstracts and published 8 manuscripts in scientic

journals.

> Product safety and quality

The safety of our patients is of utmost importance to us.

Our goal is to ensure that our products are safe and efcient

for all patients, both during clinical trials and once they are

commercialized.

To prevent all risks associated with product safety and

quality, we of course comply with all the guidelines issued

by the regulatory authorities. Besides these strict regulations,

we decided in 2021 to pursue three additional ambitious

targets, i.e. succeed all GxP

inspections and customer

audits; digitalize Mithra’s quality system by end 2022; and

increase our suppliers and partners global quality oversight

to 30% by end 2022 and to 100% by end 2025.

100% of successful inspections and audits and 0 recall

We are proud to report that we successfully passed all our

inspections and customer audits in 2022 and that we did not

issue any recall.

Progress in digitalization of quality system

While our target of digitalizing Mithra’s quality system

by the end of 2022 is not entirely achieved, we did make

progress and the rst out of the three waves of the project is

implemented, meaning that quality document management

and trainings are now fully digitalized. Wave 2 (change,

deviation, CAPA and complaint management) and wave 3

(audit and suppliers/subcontractors management) will be

implemented in the near future.

2 Common term for all good practices used in the pharmaceutical sector

44 45

of this project was to align our salaries with those of the market

to allow us to both attract the right candidates and retain our

employees. In 2022, the benchmark study was completed

for several departments, and based on the results, we took

actions and rectied the remunerations that were not in line

with the market, according to our collaborators’ functions. The

benchmark study and potential alignments will be completed

for all departments by end of 2023 and will then allow us to set

up a global wage policy for each function of our company.

Cafeteria plan in development

Building further on the benchmark project, our human

resources team is currently developing a cafeteria plan

to optimize even more our salaries and compensation

packages. Our goal with this project is to meet the various

generational and personal needs of our employees and to

offer them more flexibility and individuality when it comes to

their wage. This project will also help us attract, retain and

motivate current and future employees and will improve

our employer branding. Moreover, we expect this plan to

increase green mobility at Mithra as employees will have

access to soft mobility options.

Mobility project ready for implementation

In the rst quarter of 2022, our human resources and

procurement teams kicked off a mobility project around

the Belgian government’s mobility plan, with the ambition

to reshape our current car fleet with more sustainable and

environmentally friendly alternatives. Our HR team is currently

focusing on other priority projects, but the mobility project is

fully developed and will be implemented in the near future.

2021

(reference year)

2022

Number of employees 252 233

Number of new hires 87 50

Staff turnover rate (%) 26,70% 28%

Staff voluntary turnover rate (%) 86% 84%

Staff involuntary turnover rate (%) 14% 16%

Average length of service (years) 2,7 2,5

2021

(reference year)

2022

Total amount of

training expenditure

142.893,99€ 282.266,30 €

Average amount of

training expenditure

per employee

567,04 € 1.211,44 €

> Attractiveness & turnover

To achieve our mission and ensure the excellence and

specicity of our expertise, we must be in a position to attract

the talents we need and to retain our employees.

As Mithra operates in a highly specialized sector and

therefore in a highly competitive industry in terms of talents,

it is vital that we offer a fullling and caring work environment

with a sense of purpose, a shared vision and common values.

Staff turnover remains a priority

While our staff turnover rate remains above average,

which can also be explained by the low average age of our

employees (36.6 years) and by the highly competitive life

sciences sector, we are determined to keep making Mithra

a safe and caring company that supports its collaborators

and strives for their well-being. Our target is to align our

staff turnover with the chemistry & life science sector staff

turnover, by reducing it to 20% by 2025 and to between 10%

and 15% by 2030.

Upgrade of employee benets program

To attract and retain talents, we upgraded our employee

benets program. It now includes hospitalization, ambulatory

and dental insurance as well as seniority leave.

Market alignment of collaborators remuneration

As our organization was growing quickly and as we evolve in

a highly competitive sector in terms of talents, we felt in 2021

that it was time to deep dive into our remuneration policy and

extra-legal packages, both internally and externally, and we

kicked off a benchmark project in July 2021. The main objective

Number of

countries in which

Myring is available

13 14

Price difference as

compared to market

for reproductive

health products

Maximum

15%

Maximum

15%

Maximum

15%

Our two main commercialized health solutions, Estelle

and

Myring

, target reproductive health, an area dened as a

priority by the World Health Organization (WHO). Our monthly

vaginal ring, Myring

, is now available in 14 countries. As for

our innovative contraception pill Estelle

, which was launched

in 2021, it is now available in 30 countries, meaning that in

the course of 2022 it has become available in 19 additional

countries. Most of the countries in which our products are

currently commercialized are developed countries. However,

we target to increase the number of developing countries in

which our products are available by 2030.

Collaborators

As we embarked on our sustainability journey, the well-being

of our collaborators remained one of our top priorities.

Our ambition is to support them and ensure their work-life

balance, as well as offer them both the chance to develop

their talents and equal opportunities no matter their gender.

> Talent management & continuous development

Doubling our investment in collaborators training

To deliver on our ambition of bringing patients efcient

and safe solutions, we largely depend on the skills of our

collaborators to innovate. It is therefore key to offer our

talents the opportunity to develop their knowledge and skills.

In that sense, we are extremely proud to report that we

doubled our investment in training for our collaborators. It

remains our goal to keep increasing that amount as well as

the number of training hours for our employees.

Our internal mobility plan has also progressed well and is

now fully developed. Once implemented, we will report on

the number of internal position changes and on the number

of internal promotions.

Our HR team is also working on the development of a talent

development plan for all employees, as now legally required.

As of 2023, we will report on that plan, namely on the

percentage of our employees that has had a performance

appraisal.



2021

(reference year)

2022 Target

Rate of successful

inspections and

audits (no critical

observations)

100% 100% 100%

Number of recalls

issued

1 minor

recall

0 0

SOP in place for

suppliers and partners

monitoring

No Yes Yes

Compliance monitoring

adverse event reports -

15 days

100% 87% 100%

Compliance monitoring

adverse event reports -

90 days

100% 100% 100%

Compliance monitoring

periodic safety update

reports

100% 100% 100%

Access to healthcare

Beyond the efcacy, safety and quality of products, biotech-

nological and pharmaceutical companies also have the

social responsibility to make their products available to the

greatest number of people and must therefore pay attention

to their pricing, distribution and affordability policies.

At Mithra, we strive towards universal access to our medicines

in sexual and reproductive health and therefore decided

to increase the geographical availability of our products

to 70 new countries by 2030, of which 30% of developing

countries, and to contribute to healthcare cost containment

and stay within the 15% price range of other similar products

of the same category, for reproductive health products.

2021

(reference year)

2022

Target

2030

Number of countries

in which our products

are available

24 47 (+23) +70

Number of

developing countries

in which our products

are available

3 3 21

Number of countries

in which Estelle is

available

11 30

1. ACTIVITY REPORT > ESG: ENVIRONMENTAL, SOCIAL AND GOVERNANCE INITIATIVES AT MITHRA

46 47

In February 2022, we kicked off the new edition of the Women’s

Mentoring Program,an initiative from HEC Liège supported by

Mithra and dedicated to enable women’s success and their

projects’ development. We were extremely proud to accompany

this new and determined group of mentees and mentors on their

journey towards projects and career development.

At the occasion of the International Women’s Rights Day

2022, we decided to give more visibility on our website

Gyn&Co to projects launched by women for women, such

as the Belgian non-prot organization “Toi mon endo”. This

association works daily to raise awareness among women

and their entourage about endometriosis, a disease that

affects nearly one in ten menstruating women.

We also supported the 2022 Belgian Ladies Open golf

tournament, which took place from May 27 to 29 at

Naxhelet golf course. More than just an international female

golf tournament, this round of the Ladies European Tour

committed to making golf accessible to all and especially to

women with free admission and free golf initiations. It tted

perfectly into the Golf Power campaign, launched in 2021 by

the Belgian French-speaking Golf Association, which was

then the rst Belgian sports federation to commit to more

women in sports. Whether it was in a forum powered with

strong women leaders or directly on the golf course with

talented sportswomen going head-to-head, we couldn’t have

been prouder to have women’s success in our DNA.

As women’s health is at the heart of our mission and because

1 in 8 women in Belgium is affected by breast cancer, it also

seemed more than obvious for us to participate again in

the Think Pink campaign in October 2022. For one month

we organized several activities to raise as much money as

possible to support the association and help ght breast

cancer.

Happy Team

Born from a common desire of the communication and

human resources departments to develop a positive approach

to work, we also have a Happy Team in place that gathers

employees from different departments with the purpose to

coordinate internal activities and various initiatives to promote

cohesion and well-being at work. From the organization of

breakfasts to an outdoor staff day, the collection of waste

around the workplace to a series of fundraisers to raise

awareness of causes that are close to our hearts, the Happy

Team has the joy of Mithra collaborators as its creed.

Committee for Prevention and Protection at Work

The initiatives that we launched and implemented are

evaluated by our Committee for Prevention and Protection

at Work. Created in January 2021 following Mithra’s rst

social elections in 2020 and with representatives from the

unions, the management and our Prevention Advisor, this

Committee is dedicated to contributing to our collaborators’

safety, health and well-being. As such, the Committee has

decided to appoint two “trusted persons”, i.e. two members

of the company to whom our collaborators can turn, in case

of need, to be welcomed, listened to and advised so as to nd

solutions in an informal way.

Society

In 2021 women represented almost 50% of the world

population. Yet, women are too often victims of abuse,

violence and discrimination. So much so that gender equality

has been dened as one of the 17 Sustainable Development

Goals by the United Nations.

At Mithra, women are at the heart of everything we do. We

work each day with the ambition to develop solutions that

meet their needs for efcient and safe health solutions. We

also believe in having a positive social impact on women’s

life beyond our day-to-day activities and we are committed to

supporting meaningful projects and initiatives dedicated to

enable women’s success.

> Equal opportunities irrelevant of gender

56% of women in the company

At Mithra, we work each day with the ambition to improve

women’s life. It is therefore only logical that we ensure

gender equality to our collaborators. Our goal is to achieve

gender parity at all levels of the company and to offer equal

salary for equal function. To achieve this goal, we dened in

2021 two ambitious targets, i.e. raise the number of women

in management to 50% by 2030; and reduce the gender pay

gap to 0% by 2030.

While we are proud to say that we count 56% of women in

the whole company, there is still room for improvement with

regards to the proportion of women in management and

especially in the Management Committee. Our HR team has

had to focus on other priority projects in 2022 but it is our

rm intention to develop an action plan ensuring that gender

parity is achieved for all function levels within our company

and that there no longer exists a gender pay gap.

2021

(reference year)

2022

Target

2030

Women in whole

company (%)

56% 56% 50%

Women in management

(CEO N-2) (%)

23,9% 55% 50%

Women in Management

Committee (%)

14% 16,67% 50%

Gender pay gap (%) 5,92% 5,87% 0%

2.2.4. Safety, health and well-being at work

To support our employees in their mission, we are committed

to offering them a safe and caring environment that ensures

their safety and both their physical and mental well-being,

which we consider as of paramount importance and as

priority objectives.

As a responsible company, our ambition is to achieve

the highest level of safety and health, by limiting the risk

of occupational accidents and diseases, and to create a

pleasant working environment for our employees.

Our target is to reach zero accidents and to reduce

absenteeism.

With our Prevention Advisor, we are of course committed to

respecting the regional, national and European legislations

related to safety and health and to integrating them at all

levels of the company. As such, as part of their onboarding

program, all new employees are required to take a safety

self-training and they also receive a safety welcome brochure

that they can check at any time. We also have a rst aid team

in place, as well as a re prevention team, both of which are

made up of trained employees.

Creation of uniform communication channels

Besides this, in October 2021, we conducted via an online

questionnaire and with the help of our partner Mensura

a survey on well-being at work. The objective was to get

feedback from our collaborators so as to determine how

Mithra scored in terms of well-being indicators, namely with

regards to motivation, stress, absenteeism and work-life

balance, to try and reduce the psychological risks associated

with work. The rst results of this quantitative survey showed

that Mithra was within the benchmark of the other Belgian

companies Mensura conducted a survey for. However, a

point of attention that our collaborators raised through this

survey was their work-life balance, a well-being indicator

that is of paramount importance and that we have been

trying to improve (see below). This quantitative survey has

been followed in 2022 by qualitative interviews with specic

groups, which allowed us to dene an action plan and an

implementation planning until end 2023.

One of the many actions included in the action plan was to set

up communication channels so as to ensure that information

is conveyed to all collaborators in a uniform and systematic

manner. In 2022 we therefore organized four meetings for

all Mithra staff in order to update our collaborators e.g. on

projects progress and to answer any of their questions.

Hybrid working model

To improve the work-life balance of our collaborators and

their overall well-being, we implemented a hybrid working

model in 2021, with a structural homeworking regime that

enables our employees whose function allows it to better

organize their work-life balance.

3 Belgian external service for Prevention and Protection at Work

While we are proud to say that we count

56% of women in the whole company,

there is still room for improvement with

regards to the proportion of women

in management and especially in the

Management Committee.

1. ACTIVITY REPORT > ESG: ENVIRONMENTAL, SOCIAL AND GOVERNANCE INITIATIVES AT MITHRA

48 49

2021

(reference year)

2022

Corporate Governance Charter Yes Yes

Dealing Code Yes Yes

GDPR policy & committee Yes Yes

Business Code of Conduct

(Bribery and anti-corruption policy)

Yes Yes

Independent Chairman of the

Board of Directors

Yes No

Split of the roles of CEO and

Chairman of the Board

Yes Yes

Independency in Board of

Directors

50% 44%

Independency in Audit Committee 67% 33%

Independency in Nomination and

Remuneration Committee

67% 33%

Female representation in Board of

Directors

50% 55%

Female representation in Audit

Committee

0% 33%

Female representation in

Nomination and Remuneration

Committee

33% 67%

Governance & business ethics

We attach great value to good corporate governance and

to business ethics and we are aware that these topics are

of utmost importance for all our stakeholders. With our

corporate governance charter, our dealing code and our

business code of conduct as amended from time to time

to reflect the most recent legal updates, we are condent

to be well equipped to ensure the proper governance of our

company.

Our objective at Mithra is to guarantee that we are compliant

with all governance and business regulations in place and to

create an environment where everyone is committed to the

application of the highest ethical standards.

To achieve this objective, we have dened two targets,

i.e. increase transparency on oversight of management

(ownership and control), on conflicts of interests, on equal

treatment between major and minor shareholders and on

business ethics compliance; and to systematize training on

compliance and ethical standards as part of our employees

overall training programme.

Compliance and ethical standards training for all

collaborators

In addition to the existing training for our Directors and for

our Management Committee members, we are proud to

announce that the compliance and ethical standards training

has been systematized for all staff members as part of their

onboarding process.

Responsible sourcing

In addition to the classic quality and price criteria, we are

committed to applying a due diligence with all partners and

suppliers to avoid violations of human rights and workers’

rights, negative environmental impacts and unfair practices.

Our ambition is to embed a responsible sourcing policy in our

daily purchase practices.

To achieve this objective, our target is to ensure that 50% of

Mithra’s direct and indirect purchases are ethically sourced

by 2025 and to ensure that 75% of Mithra’s direct and indirect

purchases are ethically sourced by 2030.

Ethical questionnaire developed and sent to partners

and suppliers

We are not yet able to report on the percentage of direct

and indirect purchases that are ethically sourced and on

the percentage of suppliers and partners that were ethically

screened. However, our Supply Chain team has developed

in 2022 a questionnaire that was recently sent to our

current partners and suppliers so as to ensure they have

sustainability and compliance policies in place. For future

partners and suppliers, the questionnaire will be integrated

in our quality questionnaire. As communicated, we are rst

focusing on partners and suppliers involved in the E4 project

and we will tackle partners and suppliers involved in other

projects at a later stage.

3. Governance

At Mithra, we strive to create an environment that ensures

we apply the highest ethical standards, whether in terms of

communication, sourcing or governance.

Responsible communication

As a stock listed company, Mithra must ensure a fair and

transparent communication towards all its shareholders and

stakeholders. To achieve this, we set a series of targets in

2021, e.g. improve our nancial and non-nancial disclosures

and increase access to Management for our shareholders.

Sustainability Committee and Sustainability Working

Group

To improve our non-nancial disclosures, we set up a

Sustainability Committee and a Sustainability Working Group

with the mission to develop and implement a corporate social

responsibility strategy. While Mithra does not fall under the

scope of the Non-Financial Reporting Directive (NFRD), we

included a signicant sustainability section in our annual

rapport 2021 and we will continue to do so, so that are our

teams are also prepared for the upcoming requirements of

the Corporate Sustainability Reporting Directive (CSRD).

In 2022, we attended less roadshows and institutional and

retail investors conferences compared to previous years as

the global geopolitical and economic context was causing

investors to be more cautious.

2021

(reference year)

2022

Number of roadshows

attended

5 3

Number of institutional

investors conferences

attended

8 7

Number of retail investors

conferences attended

2 1

Access to Executive

Committee members (CEO,

CFO, CBO & CSO) (number of

days/year)

13 10

MSCI Rating (ranging from

CCC, B, BB, BBB, A, AA to AAA)

BBB (5.1) BBB (5.1)

Sustainalytics Rating (ranging

from 0 (negligible risk) to 40+

(severe risk))

55 39.2

55%

Female representation

in Board of Directors

1. ACTIVITY REPORT > ESG: ENVIRONMENTAL, SOCIAL AND GOVERNANCE INITIATIVES AT MITHRA

1. ACTIVITY REPORT > BOARD OF DIRECTORS

50 51

Board of Directors

Erik Van den Eynden

Vice-Chairman,

Independent Director

Mithra’s board mandate

> Member since 2021

> Vice Chair of the Board since 2022

> End of term: 2023

Experience

• Mr. Van Den Eynden has more

than 30 years of experience in the

banking sector.

• In 1990, he joined ING, where

he held various commercial and

management positions prior to

serve as CEO of ING Belgium from

2017 to 2020. In March 2021,

Mr. Van Den Eynden became CEO

of the Straco Investment Group.

An Cloet

Independent Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Ms. Cloet has over 25 years of

pharmaceutical experience in

multiple therapeutic domains,

particularly in women’s health

(contraception, osteoporosis,

fertility).

• Ms. Cloet built her career within

MSD, where she has held various

positions in Business Development,

Marketing and Corporate Strategy.

Since 2019, Ms. Cloet is External

Affairs Director at MSD Belux.

Christian Moretti,

Chairman,

Non-Executive Director

Mithra’s board mandate

> Member since 2021

> Chair of the Board since 2022

> End of term: 2023

Experience

• Mr Moretti has over 30 years of

experience in the nancial and

industrial elds

• For 10 years, he worked in the

banking sector before founding

the industrial holding Dynaction

listed on Euronext Paris. He then

focused on the development of

PCAS Biosolution, where he was

CEO for 13 years, and enabled it to

become the European leader in the

chemistry of complex molecules.

Appointed in May 2021 for a two-year term mandate, Mithra’s board of directors

can rely on directors with varied and complementary proles with proven track

records in diversied elds going from nancial to pharmaceutical products

development.



Gender Age Nationality

Audit

Committee

Nomination and

remuneration Committee

Christian Moretti M 76 French  1

Erik Van den Eyden M 54 Belgian 1 

An Cloet F 51 Belgian  

Patricia Van Dijck F 57 Belgian  1

Liesbeth Weynants F 50 Belgian  

Valérie Gordenne F 50 Belgian 1 

Gaëtan Servais M 54 Belgian 1 

Amel Tounsi F 41 Belgian  1

Jean-Michel Foidart M 73 Belgian  

In June and July 2022, following the resignation with immediate effect of two members for personal and extrinsic reasons to

the company, François Fornieri and Ajit Shetty, Mithra’s board of directors approved the appointment of Christian Moretti as

Chairman, as well as that of Erik Van Den Eynden as Vice-Chairman. These functions will be exercised until the Annual General

Shareholder’s Meeting in May 2023.

In June and July 2022, following the resignation with immediate effect of two members for personal and extrinsic reasons to the

company, François Fornieri (YIMA SRL) and Ajit Shetty (Sunathim BV), Mithra’s board of directors approved the appointment of

Christian Moretti as Chairman, as well as that of Erik Van Den Eynden (Tica Consult BV) as Vice-Chairman. These functions will be

exercised until the Annual General Shareholder’s Meeting in May 2023.

At the end 2022, the Board comprises a majority of women, with 5 women directors and 4 men directors, and also displays a

well-balanced mix of status with 4 independent and 5 non-independent directors.

52 53

Board of Directors

Valérie Gordenne

Non-Executive Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Ms. Gordenne has over 20 years

of experience in pharmaceutical

Research & Development with

extensive leadership experience

in full drug development across

a range of therapeutic areas,

particularly in women’s health.

• Through the management of

various functions and activities

(CSO of Mithra, CEO of Novalon and

General Manager of Odyssea), she

developed a deep operational and

strategic knowledge and expertise

in drug development. She is

currently Chief Scientic Ofcer at

Auxin Surgery, CEO of the start-up

Odix and advisor in regulatory

affairs.

Gaëtan Servais

Non-Executive Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Mr Servais has nearly 30 years of

experience in economics.

• In 2001, he became Chief of Staff

for several ministers of the Walloon

government. Since 2007, he has

been CEO of the Liège-based

investment fund Noshaq, which

offers nancing solutions for the

creation and growth of companies.

Jean-Michel Foidart

Executive Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Co-founder of Mithra, Professor

Foidart graduated in Gynecology

from the University of Liège and

obtained a PhD in cell biology and

biochemistry, before directing

the Department of Gynecology-

Obstetrics.

• Professor Foidart is the author of

more than 1300 publications on

women’s health and experimental

oncology. He holds the Francqui

Chair, Doctor Honoris Causa of the

Pierre and Marie Curie University

of Paris and the Paul Sabatier

University of Toulouse, and is

Ofcer of the Order of Leopold

II, Commander, Grand Ofcer of

the Order of the Crown, Professor

Extraordinary, Honorary of the

University of Liège and Perpetual

Secretary of the Royal Academy of

Medicine of Belgium.

Amel Tounsi

Non-Executive Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Ms. Tounsi has a broad experience

in cell-therapy development.

• During her career in the biotech

sector (Celyad, Texere, Analis,

Masthercell), she acquired a strong

expertise in Business Development

and Company Development

strategy. Since January 2021, she

works as an Investment Manager

at the Liège-based investment fund

Noshaq.

Liesbeth Weynants

Independent Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Ms. Weynants is specialized in

pharmaceutical and regulatory law

with a focus on the life sciences

sector.

• Ms. Weynants has an extensive

expertise in intellectual property and

patent law for innovative medicines

(AbbVie, Allergan, Biogen, , Merck,

Novartis, Sano...) and is currently

Managing Partner at the law rm

Hoyng Rokh Monegier as well as

Professor of Intellectual Property

Law at the VUB.

Patricia van Dijck

Independent Director

Mithra’s board mandate

> Member since 2021

> End of term: 2023

Experience

• Ms. van Dijck has over 25 years of

experience in the pharmaceutical

industry.

• She began her career in 1996 at

UCB before becoming Medical

Director in 1997 and Managing

Director in 2007 at Lundbeck. In

2011, Ms. van Dijck joined Novartis

Belux as Head of Market Access

& Public Affairs and Head Patient

Access Excellence. Since 2018, she

has been working for GSK Belux

as Market Access & Public Affairs

Director.

1. ACTIVITY REPORT > BOARD OF DIRECTORS

54 5554

Management committee

Dr. David H. Solomon

Chief Executive Ocer

Since April 2023

Jean-Michel Foidart

President of the Scientic Council

Since July 1999

Cedric Darcis

Chief Legal Ocer

Since July 2014

Jean-Manuel Fontaine

Chief Commercial &

External Affairs Ocer

Since June 2015

Renaat Baas

CDMO Site Director

Since April 2019

Benjamin Brands

Chief Supply Chain Ocer

Since February 2015

Benoît Mathieu

Group Investor Relations

Manager

Since February 2021

Maud Vanderthommen

Group Communication Manager

Since January 2019

Christophe Maréchal

Chief Financial Ocer

Since March 2016

Graham Dixon

Chief Scientic Ocer

Since April 2019

Laurence Schyns

Chief Human Resources

Ocer

Since February 2021

Stijn Vlaminck

Group IT Manager

Since May 2021

1. ACTIVITY REPORT > MANAGEMENT COMMITTEE

CORPORATE GOVERNANCE AND FINANCIAL STATEMENTS

Disclaimer

ESTELLE

, DONESTA

, MYRING

, NEXTSTELLIS

, ALYSSA

and HALOETTE

are registered trademarks of Mithra Pharmaceuticals or one of its afliates.

DROVELIS

and ESTERETTA

are registered trademarks of Richter Gedeon Nyrt.

 
59 
Contents 
1.  Report of the Board of directors ......................................................................................................................................... 61 
  Analysis of results / operations .................................................................................................................................. 61 
  Statement of financial position analysis ................................................................................................................... 62 
  Cash flow analysis ......................................................................................................................................................... 63 
  Corporate governance statement ............................................................................................................................... 64 
  Transactions within the authorized capital .............................................................................................................. 86 
  Acquisition of own securities....................................................................................................................................... 88 
  Use of financial instruments by the Group as per art. 3:6 CCA ............................................................................ 88 
  Circumstances that could considerably affect the development of the Group ................................................. 89 
  Research and development ...................................................................................................................................... 108 
  Conflicting interests of directors (Art. 7:96 of the CCA) ...................................................................................... 109 
  Independence and expertise of at least one member of the Audit committee .............................................. 120 
  Going concern assessment ...................................................................................................................................... 121 
  Appropriation of results ............................................................................................................................................. 122 
  Important events after the reporting period .......................................................................................................... 123 
  Grant of discharge to the directors and the statutory auditor ........................................................................... 124 
2.  Responsibility statement.................................................................................................................................................... 125 
3.  Auditor report ........................................................................................................................................................................ 126 
4.  Consolidated statement of profit and loss ..................................................................................................................... 131 
5.  Consolidated statement of comprehensive loss ........................................................................................................... 132 
6.  Consolidated statement of financial position ................................................................................................................ 133 
7.  Consolidated statement of changes in equity ............................................................................................................... 135 
8.  Consolidated statement of cash flow .............................................................................................................................. 136 
9.  Notes to the consolidated financial statements ........................................................................................................... 137 
  General information .................................................................................................................................................... 137 
  Summary of Significant Accounting Policies ........................................................................................................ 138 
  Financial risk management ....................................................................................................................................... 150 
  Critical accounting estimates and judgements .................................................................................................... 154 
  Segment information and revenue .......................................................................................................................... 157 
  Other intangible assets .............................................................................................................................................. 159 
  Property, plant and equipment ................................................................................................................................. 160 
  Lease – Right-of-use assets ..................................................................................................................................... 161 
  Goodwill & IP R&D ....................................................................................................................................................... 161 
  Other non-current assets ........................................................................................................................................... 163 
  Inventories .................................................................................................................................................................... 163 
  Trade and other receivables ..................................................................................................................................... 163 
  Cash and cash equivalents ....................................................................................................................................... 164 
  Equity ............................................................................................................................................................................. 164 

 
60 
  Financial liabilities ....................................................................................................................................................... 167 
  Trade and other payables .......................................................................................................................................... 175 
  Financial instruments ................................................................................................................................................ 176 
  Contract assets ........................................................................................................................................................... 180 
  Other operating income ............................................................................................................................................. 181 
  Expenses by nature .................................................................................................................................................... 182 
  Employee benefit expenses ...................................................................................................................................... 183 
  Retirement benefit schemes .................................................................................................................................... 183 
  Financial income and expense ................................................................................................................................. 184 
  Income tax .................................................................................................................................................................... 185 
  Result per share .......................................................................................................................................................... 187 
  Share-based payments .............................................................................................................................................. 187 
  Contingencies and commercial litigations............................................................................................................. 189 
  Commitments .............................................................................................................................................................. 190 
  Related party transactions ........................................................................................................................................ 191 
  Events after the reporting period ............................................................................................................................. 193 
  Mithra Pharmaceuticals companies consolidation scope ................................................................................. 195 
  Disclosure audit fees .................................................................................................................................................. 196 
  Condensed statutory financial statements of Mithra Pharmaceuticals SA .................................................... 196 
  Alternative performance measures ......................................................................................................................... 199 
 
 

1. Report of the Board of directors

Analysis of results / operations

The net loss for the year 2022 was EUR 59,620k (loss of EUR 116,875k for 2021) on a consolidated basis.

The operating loss of EUR 26,245k in 2022 (compared to an operating loss of EUR 87,875k in 2021) is mainly

explained by the increase of revenues and the decrease of R&D expenses.

The loss before taxes amounts to EUR 11,480k in 2022. The positive gap between operating loss and loss before

taxes is mainly the result of the increase in financial income and fair value gains partly offset by the increase of

financial expenses.

Total income

Revenues stood at EUR 67.0 million compared to EUR 22.7 million in 2021. Revenues breakdown is as follows:

• Product sales, at EUR 15.7 million in 2022, were largely driven by Estelle

(EUR 9.2 million) even if sales

were lower than in 2021 (EUR 13.3 million) because of a slower ramp-up, and Myring

(EUR 4.5 million)

that improves the revenue of our generic portfolio to EUR 6.5 million compared to EUR 3.8 million in

2021.

• Out-licensing revenue, at EUR 49 million in 2022, are essentially Estelle

and Donesta

milestones

(respectively EUR 4.1 million and EUR 44.7 million). On the one hand, EUR 4.1 million relates to out-

licensing revenues of the license and supply agreement with Gedeon Richter for the commercialization

of Estelle

in Latin America. On the other hand, EUR 44.7 million (being a portion of the EUR 55 million

to be recognized as revenue according to our IFRS 15 accounting policy) relates to the terms of the

licence agreement for the commercialisation of Donesta

, where Mithra received EUR 55 million in

upfront payment – EUR 5 million paid upon signature of the binding term sheet in December 2022 and

EUR 50 million paid upon signature of this license agreement in February 2023.

• The revenues also include revenue from the R&D contracting activities of our CDMO for EUR 2.3 million.

Research and development expenses

R&D expenses (including depreciations) decreased by 25% in 2022 to EUR 64 million (2021: EUR 85.2 million). The

decrease is the result of a strategy based on focusing on our core R&D projects, like Donesta

Phase III clinical

studies and Estelle

post approval safety study (PASS). As a consequence, some costs have been postponed to

2023.

General and administrative expenses and selling expenses

G&A and selling expenses increased by 17%, due to a higher impact of share-based payments accounting entries

(charge of EUR 2.0 million compared to charge of EUR 1.1 million in 2021) but also due to an increase in insurance

costs, salaries indexation and, in general, several external fees.

Other operating income

Other operating income of EUR 7.2 million (compared to EUR 4.8 million in 2021) are essentially composed of a R&D

tax credit for EUR 2.1 million which is directly related to R&D expenses level, EUR 1.5 million exemption from the

withholding tax on professional income for R&D staff and EUR 2.2 million of cost reinvoicing.

Change in fair value of contingent consideration payable

The positive impact about EUR 28.3 million of change in fair value gain related to contingent consideration payable

Estelle

is mainly the consequence of conservative review of management estimate and the underlying updated

business plans, as well as discount rate (2022 WACC is 2.44% higher than in 2021 to reach 13.78%).

Financial income

Financial income increase is explained by the positive impact of the remeasurement of refundable government

advances measured at amortized cost (EUR 3.6 million) following the update of forecasts. This update of the

forecasts is explained by a slower ramp-up compared to company’s initial estimates on Estelle

product sales and

by the global contractual landscape agreed with Gedeon Richter concerning the supply of Estetrol for Estelle

Following this agreement, Mithra is no longer entitled to receive supply revenues for Estelle

as Gedeon Richter is in

charge of the supply and the production of the product for all its territories (Europe & Latin America). Mithra is still

eligible to collect the royalties negotiated in the agreement signed in September 2018.

It also includes EUR 3 million of dividend from Mayne Pharma as well as a realized gain of EUR 2.5 million following

the early repurchase of EUR 34.1 million tranche of our convertible bonds due in 2025 at a discount to par, via the

convertible loan signed with Highbridge and Whitebox.

Financial expense

Increase of financial expenses is mostly driven by the interest charges ( EUR 16.8 million), higher than in 2021 and

linked to higher financial liabilities in 2022 and the use of straight's lines and financing solutions as well as a realized

foreign exchange loss for EUR 5.9 million following the early settlement of one of the derivative financial instruments.

Branches

The Company has no branches. Refer to detailed table about the Group structure in note 9.31.

Statement of financial position analysis

Total assets increased to EUR 442,414k as of 31 December 2022 (EUR 421,918k at the end of previous year).

Non-current assets

As of 31 December 2022, the Statement of financial position shows a total of EUR 296.6 million in Non-current assets,

the majority of which are Other intangible assets (EUR 134.9 million), Property, plant and equipment

(EUR 40.7 million), Right-of-use assets (EUR 65.5 million), Deferred tax assets (EUR 16.4 million) and Investments in

equity securities (EUR 21.4 million).

In 2022, a total of EUR 33.3 million has been added to the Other intangible assets amongst which the Tech Transfer

to allow Mithra to control the E4 synthesis industrial ramp-up process to achieve large scale production

(EUR 28.3 million), capitalization of internal development costs incurred for the development of the API E4

(EUR 0.5 million) and capitalization of R&D costs regarding the post approval safety study for Estelle

(EUR 4.3

million). This amount is offset by EUR 3.1 million of depreciation, higher than 2021, as depreciation of Myring

PPA

started in August 2022 (triggered by the FDA approval) and a full year of depreciation for Estelle

PPA (ready for use

since Estelle

’s commercialization from May 2021).

Tangible fixed assets (Property, plant and equipment and the Right-of-use assets) decreased by EUR 1.4 million,

mainly explained by higher depreciations in 2022 (EUR 8.8 million). This impact is partially offset by acquisitions

done in 2022 (EUR 7.8 million), which are mainly the result of the capitalization of internal development costs incurred

for equipment set ups and process improvement in the production zones (polymer, injectable, …) for EUR 5.5 million

and all the related equipments for EUR 1.2 million.

Deferred tax assets decreased by EUR 47.1 million; primarily due to the positive outcome of the ruling from Belgian

Tax Authorities regarding the Innovation Income Deduction which allows 100% of revenues from Estelle

and

Donesta

for as eligible deduction; and secondly because of the conclusion of a tax audit on fiscal deductibility of

Uteron futures payments. Both events have modified our assumptions and tax forecasts which impact this

accounting estimate computation.

Investment in equity securities are decreasing due to the change in fair value explained by the decrease in Mayne's

share price at reporting date as well as the decrease in AUD/EUR conversion rate.

Contract assets amount to EUR 47.8 million (non-current and current) versus EUR 12.8 million in 2021. The variance

relates to out-licensing revenue, mainly from Gedeon Richter (EUR 43.2 million of contract assets), offset by unbilled

revenues recognized in prior years and billed in 2022 (among which EUR 1 million to Gedeon Richter and

EUR 8.1 million to Mayne Pharma).

Current assets

Current assets at the end of 2022 are about EUR 145.9 million and include, besides contract assets describes here

above, Cash and cash equivalents of EUR 28.3 million, Trade & other receivables of EUR 22.3 million, and Inventories

of EUR 50.3 million.

Inventories increased to EUR 50.3 million from EUR 43.9 million in 2021, mainly due to the increase of E4 inventory

(EUR 7million) in 2022, which has been built up in order to be able to meet the demand from partners for Estelle

Equity

Total equity at year-end remained flat at EUR 33.7 million. The total comprehensive loss for the period (EUR 77.9

million) was compensated by several capital increases for a total amount of EUR 77 million (net of transaction costs).

Non-current liabilities

Non-current liabilities decreased to EUR 278.3 million at the end of 2022, compared to EUR 292.3 million end of 2021,

primarily due to a decrease of the fair value of contingent considerations payables (EUR 28.5 million), which are

reported under Other financial liabilities, and to the amortized cost treatment of refundable government advances

(EUR 3.6 million). The other loans increase (EUR 13.4 million) is mainly the result of the convertible bond early

repurchase (EUR 31.3 million) offset by the debt part of the new facility contracted with Highbridge and Whitebox

(EUR 42.1 million). The derivatives financial liabilities increase is explained by the derivative instrument part of the

facility Highbridge and Whitebox (EUR 7.6 million).

Current liabilities

Current liabilities increased to EUR 130.4 million at the end of 2022, compared to EUR 95.8 million in 2021. The

increase of the Current liabilities is mainly explained by the increase of Trade payables (EUR 34.6 million).

Cash flow analysis

Full year cash flow of the Group amounts to EUR -4,440k :

• Cash flow from operating activities of EUR -56,819k for 2022.

• Cash flow from investing activities of EUR -25,490k : the acquisition of tangible assets relates predominately

to the capitalization of development costs in the framework of CDMO facility and equipment and its

production zones (EUR 5.5 million). The acquisition of intangible assets consists in a total cash out of EUR

19.3 million arising mainly from the capitalization of development costs related to the Tech Transfer to allow

Mithra to control the E4 synthesis industrial ramp-up process to achieve large scale production and R&D

costs regarding the post approval safety study for Estelle

• Cash flow from financing activities amounts to EUR 77,869k: during the year, the Group has secured several

capital increases for a total amount of EUR 77.0 million:

▪ EUR 13.0 million from LDA Capital (net of transaction costs);

▪ EUR 13.7 million in the framework of flexible equity financing agreement with Goldman Sachs

International (net of transaction costs);

▪ EUR 23.3 million from the private placement completed in June 2022 (net of transaction costs);

▪ EUR 26.7 million from the senior secured convertible facilities agreement signed on 8 August 2022 with

funds managed by Highbridge Capital and funds managed by Whitebox Advisors for an amount of EUR

100 million, with a maturity in August 2025. The first tranche of EUR 50 million was received upon

signing of the agreement, with around 29 million used to repurchase outstanding convertible bonds of

the Company held by the Lenders. The second tranche of EUR 25 million was drawn on 31st October

2022.

Those proceeds are offset by several (re)payments of subordinated loans and other loans for EUR 31,241k,

leases for EUR 6,663k and by interests’ payments for EUR 9,862k.

Post-closing events such as the collection of an out-licensing upfront payment on Donesta

of EUR 50 million, the

collection of the Mayne Pharma dividend for c. EUR 3 million and the milestone payment of EUR 1.6 million following

Myring® commercialization in the U.S., are reinforcing our treasury.

In consideration of the conservative assumptions mentioned in the note 1.12 Going concern, the Board of directors

has analyzed the financial statements and accounting policies and made the assessment that the current cash

position of EUR 28.3 million at 31 December 2022, taking into account the above post-closing events, will allow the

Group to keep up with operating expenses and capital expenditure requirements at least until April 2024 (twelve

months at least after the issuance of this report).

Corporate governance statement

Introduction

This Corporate Governance Statement is included in the Company's report of the Board of directors on the statutory

accounts for the financial year ended on 31 December 2022 in accordance with Article 3:6, §2 of the Belgian

Companies and Associations Code.

On 17 May 2019, the Belgian royal decree of 12 May 2019 designating the corporate governance code to be complied

with by listed companies was published in the Belgian Official Gazette. On the basis of this royal decree, Belgian

listed companies are required to designate the new 2020 Belgian Corporate Governance Code (the "2020 Code") as

reference code within the meaning of Article 3:6, §2 of the Belgian Companies and Associations Code of 23 March

2019, as amended (the "Belgian Companies and Associations Code"). The 2020 Code applies compulsorily to

reporting years beginning on or after 1 January 2020 (compulsory application).

The 2020 Code is available on the website of the Belgian Corporate Governance Committee

(www.corporategovernancecommittee.be).

Reference code

The Corporate Governance of the Company is organized pursuant to the Belgian Companies and Associations Code,

the Company’s articles of association and the Company’s Corporate Governance Charter.

The Company’s Corporate Governance Charter was adopted by the Board of directors on 20 April 2020 and updated

on 22 April 2020. It was drafted in accordance with the recommendations set out in the 2020 Code.

For the financial year ended on 31 December 2022, the Company complied to a large extent with the provisions of

the 2020 Code, except for the following deviation which the Company believed was justified in view of the Company’s

specific situation. In line with the “comply-or-explain” principle of said 2020 Code, the Company did not fully comply

with the following provision:

• Provisions 4.10 to 4.16 of the 2020 Code: The Company decided not to appoint a formal internal auditor

because of the size of the Company. However, the Risk and Audit committee regularly evaluates the need

for this function and/or commissions external parties to conduct specific internal audit missions and report

back to Board of directors;

• Provision 7.12. of the 2020 Code: As disclosed in the Remuneration Policy of the Company approved by the

annual General Meeting of May 20th, 2021, up until now, there is no possibility for the Company to reclaim

the variable remuneration paid to Executive Management or to the CEO. However, the Board of Directors

undertakes to include this possibility further on and to amend the current contracts containing variable

remuneration provisions to reflect this possibility;

• Provision 4.19 of the 2020 Code: provides that the Board should set up a nomination committee with the

majority of its members comprising independent non-executive board members. Following the resignation

of Sunathim BV (Ajit Shetty), Selva Luxembourg Sarl has been appointed as board member and as member

of the Nomination and Remuneration Committee. This appointment led the Nomination and Remuneration

Committee to be composed of only one independent Director. This deviation from the 2020 Code shall be

remediate after the committees are recomposed following the board renewal during the General Meeting

to be held in May 2023.

The Company’s Corporate Governance Charter, together with the articles of association of the Company, are

available on the Company’s website (www.mithra.com), mentioning the date of the most recent update, in a clearly

recognizable part of the Company’s website under the heading “Investors“, separate from the commercial

information.

Share capital & shares

On 7 February 2022, the Company entered into an equity financing agreement with Goldman Sachs International

(GSI), pursuant to which the Company can at its sole discretion require GSI (subject to certain conditions) to provide

funding to the Company for an aggregate amount of up to EUR 100,000,000 (the “Committed Amount”) in return for

issuing GSI with call options over the Company’s ordinary shares. The arrangement has been entered into for a term

of approximately 2 years. The Company can access this funding through several drawings, which must be at least

22 trading days apart. The first drawing request, exercised on 4 February 2022, amounts to EUR 10 million. The

maximum amount that can be drawn by the Company on each subsequent occasion will be EUR 5 million or, if

certain conditions are satisfied, up to EUR 7.5 million. Following exercise of such call options, the Company will

convert outstanding funding amounts, in whole or in part, into a number of new shares of the Company, subject to

the Company having the right in certain circumstances to elect to pay to GSI the value of that number of shares. The

number of shares to be delivered to GSI will be determined by reference to the lowest daily volume weighted average

price for the Company’s shares during a reference period prior to GSI exercising its call options, less a discount. If

the Company elects instead to cash settle any options exercised by GSI, the amount payable by the Company shall

be determined by valuing the number of shares that would otherwise be deliverable by the Company using the

average of the daily volume weighted average prices for the Company’s shares during a reference period following

the Company’s election to cash settle, plus a premium. Any amount funded that is not settled prior to the maturity

date shall be automatically settled at the maturity date in shares or, at the election of the Company, in cash.

On 18 April 2022, the Company announced the extension of the Capital Commitment Agreement with LDA Capital

by two years as well as the increase of the commitment amount by 25 Mi EUR. As a reminder, under the terms of

the initial agreement entered into in April 2020, LDA Capital had committed an amount of up to EUR 50 million in

cash within a maximum of three years in exchange for new ordinary shares in Mithra. This Capital Commitment can

be released based on drawdowns by the Company in the form of put options that Mithra has the right to exercise at

its sole discretion. Under the terms of the initial agreement and in consideration of the conclusion thereof, (i) in July

2020, 690,000 subscription rights were issued to the profit of LDA Capital, and (ii) in September 2020, 300,000

subscription rights were jointly issued in favour of François Fornieri, Alychlo NV, and Noshaq SA. As a consequence

of the extension of the capital commitment agreement, the respective terms of the LDA subscription Rights and the

subscription rights for the Share Loan will also be extended by two additional years. No new subscription rights have

been issued.

On 24 June 2022, the Company announced the closing of a private placement for an aggregate amount of 23,5 Mi

EUR. The investors that provided a subscription commitment include Leon Van Rompay, Alychlo NV (Marc Coucke),

Scorpiaux BV (Bart Versluys), Glenernie Capital, Prof. Foidart, Noshaq, SRIW and Stijn Van Rompay. The private

placement resulted in the issuance of an aggregate of 3,871,471 new ordinary shares of the Company at an issue

price of EUR 6.07 per share, representing a 5% discount to the closing share price on Friday 17 June 2022. The new

shares have the same rights and benefits as, and rank pari passu in all respects, including as to entitlement to

dividends and distributions, with, the existing and outstanding shares of Mithra at the moment of their issuance and

will be entitled to dividends and distributions in respect of which the relevant record date or due date falls on or after

the date of issue of the new shares.

On 8 August 22, the Company entered into a senior secured convertible facilities agreement with funds managed by

Highbridge Capital Management, LLC (collectively, "Highbridge") and funds managed by Whitebox Advisors LLC

(collectively, "Whitebox", and together with Highbridge, each a "Lender"), for a three-year term, in an amount of up to

EUR 100 million. Part of the proceeds of the loan have been used to repurchase outstanding convertible bonds of

the Company held by the Lenders for a principal amount of EUR 34.1 million at a discount. The loan facility is for a

principal amount of up to EUR 100 million, to be drawn in three tranches, with a maximum amount outstanding at

any time not greater than EUR 65 million or, depending on the satisfaction of certain conditions, EUR 75 million. The

first tranche is for a maximum amount of EUR 50 million, and the second and third tranches are each be for an

amount of up to EUR 25 million, subject to certain conditions. The first tranche has been drawn at the closing of the

transaction and the second tranche has been drawn on 31 October following the satisfaction of relevant conditions.

The loans carry interest of in principle 7.50% per annum. The Company's obligations under the loans are guaranteed

by certain subsidiaries of the Company and secured by a business pledge including particularly all intellectual

property, data, contracts and assets related to E4 such as Estelle

and Donesta

as well as other assets related to

E4, and a pledge on the shares in certain subsidiaries of the Company and on 50% of Estetra's shares in Mayne

Pharma.

Pursuant to the loan facility and a separate conversion agreement entered into between the Company and the

Lenders, the loans plus accrued interest and an option prepayment amount are convertible into new shares of the

Company, either at the option of the respective Lenders or (subject to certain conditions) at the option of the

Company, in each case at a discount of 10% to a relevant volume weighted average trading price of the Company's

shares prior to conversion. The Company may also voluntary prepay the loans in whole or in part at any time for cash

at par plus an option prepayment amount.

The interest on the loans and the option prepayment amount are payable in cash or, at the Company's option, in kind

in Company shares at a discount of 10% to a relevant volume weighted average trading price of the Company's

shares prior to the settlement in shares. The Lenders are entitled to a commitment fee for an aggregate amount of

EUR 2,911,372.65, which shall be settled in kind via an aggregate of 366,667 freely tradable shares of the Company,

at a price per share of EUR 7.9401. A first portion representing 65% of the commitment fee shall be settled in shares

of the Company at the time of the first drawing by the Company. Any remaining portion of the commitment fee that

has not yet been settled in accordance with the provisions of the agreements will be settled in shares at the time of

the last drawing or termination. The new shares issuable by the Company shall be ordinary shares, and rank in all

respect pari passu with the fully paid ordinary shares of the Company outstanding on the date of issue. The shares

will be freely tradable and will need to be admitted to trading on the regulated market of Euronext Brussels at the

time of their issuance. In any event, the loan facility provides that the ownership by a Lender and its affiliates cannot

exceed 9.9% of outstanding shares of the Company's shares.

Repurchase of outstanding convertible bonds Immediately following the closing of the loan facility, the Company will

use a portion of the proceeds of the loan facility to repurchase EUR 34.1 million in principal amount of the EUR 125

million 4.250 per cent. convertible bonds due 2025 issued by the Company on 17 December 2020 (ISIN

BE6325746855) held by the Lenders, at a discounted price of EUR 850 per EUR 1,000 of principal amount of the

relevant bonds, along with accrued interest. Therefore, via this repurchase, the Company will reduce its liabilities in

principal under the existing convertible bonds from EUR 125 million to EUR 90.9 million

During the period under review, a few receivables were converted into shares upon their respective contribution in

kind, list of which can be found in section 1.5 (authorised capital transaction).

On 31 December 2022, the share capital of the Company amounts to EUR 41.227.972,15 and is fully paid-up. It is

represented by 56.314.974 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and

representing one 56.314.974

of the share capital. The Company's shares do not have a nominal value. The

Company’s shares are admitted to listing and trading on the regulated market of Euronext Brussels, under the ticker

“MITRA”.

In addition to the outstanding shares, the Company has a number of subscription rights, that are exercisable into

ordinary shares, consisting of:

• 1,394,900 outstanding share options, issued by the Company on 5 November 2018 to the benefit of

members of the staff, as well as consultants of the Company, subject to the terms and conditions that are

determined by the Board of directors, entitling their holders thereof to subscribe for 1 share upon exercise

of 1 relevant share option (the "2018 Share Options");

• subscription rights exercisable for a maximum number of 690,000 new shares of the Company at an

exercise price of EUR 27.00 per ordinary share (subject to customary adjustments), issued by the Company

on 22 July 2020 to the benefit of LDA Capital Limited, subject to the terms and conditions, entitling LDA

Capital Limited to subscribe for 1 share upon exercise of 1 relevant subscription right (the “LDA Warrants”);

• subscription rights exercisable for a maximum number of 300,000 new shares of the Company at an

exercise price of EUR 27.00 per ordinary share (subject to customary adjustments), issued by the Company

on 7 September 2020 to the benefit of certain shareholders of the Company, subject to the terms and

conditions, entitling their holders to subscribe for 1 share upon exercise of 1 relevant subscription right (the

“Share Lending Warrants”);

• 390,717 outstanding share options, issued by the Company on 20 November 2020 to the benefit of members

of the personnel of the Company, subject to the terms and conditions that are determined by the Board of

directors, entitling their holders thereof to subscribe for 1 share upon exercise of 1 relevant Share Option

(the "2020 Share Options"). On the date of the present report, a total of 316,000 warrants have already been

granted to members of the personnel, while 67.000 remaining;

• On 10 December 2020, the Company issued senior unsecured convertible bonds due 17 December 2025 for

an amount of EUR 125 million. The convertible bonds are convertible into ordinary shares of the Company

at an initial conversion price of EUR 25.1917, representing a 25.00% premium above the reference price of

EUR 20.1533, being the volume weighted average price of a Company's share on Euronext Brussels from

market open to the close of trading on 10 December 2020. The convertible bonds were issued in

dematerialised form in the denomination of EUR 100,000 each. Unless previously converted, redeemed or

purchased and cancelled, the convertible bonds will be redeemed at par on the stated maturity date, which

is expected to be 17 December 2025. The number of ordinary shares potentially to be issued based on this

operation amount to 4,96 million. As a result of the senior secured convertible facilities agreement and

conversion agreement entered into by the Company and announced on 8 August 2021, as announced by the

Company on 2 September 2022, the conversion price of the bonds has been adjusted from EUR 25.1917 to

EUR 24.5425, effective as of 8 August 2022.

• The Master Confirmation Agreement dated 4th February 2022 between the Company and Goldman Sachs

International provides that should a change of control occur, an adjustment on the economics of the

contract shall occur. This Adjustment shall be determined by the Calculation Agent based on the 2006 ISDA

Definitions and the definitions and provisions of the 2002 ISDA Equity Derivatives Definitions rules in each

case as published by the International Swaps and Derivatives Association, Inc, using customary

mechanisms. Should the Adjustment be rejected by the Company following a change of control, it may in

some circumstances cause a termination of the Master Confirmation Agreement.

Post-closing, the following capital increases took place:

- on 14 February 2023, the Company announced that the second quarterly interest payment of the loan facility

concluded with Highbridge and Whitebox was contributed in kind against the issuance of new shares for an

aggregate amount of EUR 721,159.81 through the issuance of 276,120 new shares at an issue price of ca. EUR 2.61

per share.

- On 14 March 2023, another portion of the loan facility concluded with Highbridge and Whitebox (including accrued

interest, as relevant, and an option payment amount) was contributed in kind for an aggregate amount of

EUR 1,854,570.72 through the issuance of 482,528 new shares at an issue price of ca. EUR 3.84 per share.

Therefore, on the date of this report, the capital is therefore EUR 41.783.378,35, with a total number of securities

carrying voting rights of 57,073,622 (all ordinary shares).

Form and transferability of the shares

The shares of the Company can take the form of dematerialized shares. All the company's shares are fully paid-up

and are freely transferable. On 31 December 2022, all of the 56.314.974 existing shares have been admitted to trading

on the regulated market of Euronext Brussels.

Currency

The Company's shares do not have a nominal value, but each reflects the same fraction of the Company's share

capital, which is denominated in euro.

Voting rights attached to the shares

Each shareholder of the company is entitled to one vote per share. Shareholders may vote by proxy, subject to the

rules described in the Company's articles of association.

Voting rights can be mainly suspended in relation to shares:

• which are not fully paid up, notwithstanding the request thereto of the Board of directors of the Company;

• to which more than one person is entitled or on which more than one person has rights in rem (droits réels)

on, except in the event a single representative is appointed for the exercise of the voting right vis-à-vis the

Company;

• which entitle their holder to voting rights above the threshold of 3%, 5%, 10%, 15%, 20% and any further

multiple of 5% of the total number of voting rights attached to the outstanding financial instruments of the

Company on the date of the relevant general shareholders' meeting, in the event that the relevant shareholder

has not notified the Company and the FSMA at least 20 calendar days prior to the date of the general

shareholders' meeting in accordance with the applicable rules on disclosure of major shareholdings; and

• of which the voting right was suspended by a competent court or the FSMA.

Pursuant to the Belgian Companies and Associations Code, the voting rights attached to shares owned by the

Company, or a person acting in its own name but on behalf of the Company, or acquired by a subsidiary of the

Company, as the case may be, are suspended.

Dividends and dividend policy

All of the shares of the Company entitle the holder thereof to an equal right to participate in dividends in respect of

the financial year ending on 31 December 2022 and future years. All of the shares participate equally in the

Company's profits (if any). Pursuant to the Belgian Companies and Associations Code, the shareholders can in

principle decide on the distribution of profits with a simple majority vote at the occasion of the annual general

shareholders' meeting, based on the most recent statutory audited financial statements, prepared in accordance

with Belgian GAAP and based on a (non-binding) proposal of the Company's Board of directors. The Belgian

Companies and Associations Code and the Company's articles of association also authorise the Board of directors

to declare interim dividends without shareholder approval. The right to pay such interim dividends is, however,

subject to certain legal restrictions.

Additional financial restrictions and other limitations may be contained in future credit agreements.

Shareholders & shareholder structure

Shareholders structure

The table below provides an overview of the shareholders that notified the Company of their shareholding in the

Company pursuant to applicable transparency disclosure rules, as of 31st of December 2022.

Shareholder

% of voting rights

Mr François Fornieri

2, 4

19,2%

NOSHAQ SA

9,75%

Mr Marc Coucke

7,94%

Glenernie Capital BV

3,92 %

Bart Versluys

3,6%

1. The percentage of voting rights is calculated as per the closing date and taking into account the total number of outstanding shares of the

Company as of such date.

2. François Fornieri holds in direct and through Yima SRL warrants entitling him to subscribe still 952,790 additional shares of Mithra.

3. Marc Coucke holds his shareholding partially through Alychlo NV, which he controls.

4. François Fornieri, Alychlo NV and Noshaq SA jointly hold 300,000 warrants (share lending warrants).

5. Bart Versluys holds his shareholding directly and through his Company (Scorpiaux BV).

6. On 29 December 2022, Glenernie Capital has notified the Company that it has crossed and consolidated the statutory threshold of 3% on 20,

December 2022. Post period, Glenernie Capital has notified the Company that it has fallen below the legal 3% threshold on 13, January 2023.

No other shareholders, alone or in concert with other shareholders, notified the Company of a participation or an

agreement to act in concert in relation to 3% or more of the current total existing voting rights attached to the voting

securities of the Company.

The most recent transparency declarations, including the abovementioned declarations, are available on the

Company’s website www.mithra.com.

Shareholders’ arrangements

To the Board of directors’ best knowledge, no shareholders’ agreement exists among shareholders of the Company

with respect to the Company.

Board of directors

Composition of the board

The Company has opted for a "one tier" governance structure whereby the Board of directors is the ultimate decision-

making body, with the overall responsibility for the management and control of the Company and is authorized to

carry out all actions that are considered necessary or useful to achieve the Company's object. The Board of directors

has all powers except for those reserved to the general shareholders' meeting by law or by the Company's articles of

association. The Board of directors acts as a collegiate body.

Until June 20

, 2022, the Board of directors consisted of ten (10) members (with a minimum of three (3) members set out

in the articles of association), of which one (1) is Executive Director and nine (9) are Non-Executive Directors, including

five (5) Independent Directors in the meaning of the Article 7:87 of the Belgian Companies and Associations Code.

On June 20

, 2022, YIMA SRL (represented by Mr François Fornieri) have decided to resign from his role as director

with immediate effect.

On July 6

, 2022, the Company announced the resignation with immediate effect of Sunathim BVBA (represented

by Mr. Ajit Shetty). On the proposal of the recommendation of the Nomination and Remuneration Committee, the

Company appointed (by mean of cooptation) Selva Luxembourg SA (represented by Mr. Christian Moretti) as director

and Chairman of the Board of Director as well as Tica Consult BV (represented by Mr. Erik Van Den Eynden) as Vice-

Chairman of the Board of Director. The appointment of Selva Luxembourg has been confirmed by the Extraordinary

General Meeting dated September 22th, 2022.

After June 20

, 2022, and again after July 6

, 2022, the Board of directors consists of nine (9) members (with a

minimum of three (3) members set out in the articles of association), of which one (1) is Executive Director and eight

(8) are Non-Executive Directors, including four (4) Independent Directors in the meaning of the Article 7:87 of the

Belgian Companies and Associations Code.

The Company has continued to comply with the requirement of gender diversity and Article 2.1 of the Company's

Corporate Governance Charter. Indeed, the Board of directors currently has five (5) female directors.

The roles and responsibilities of the Board of directors, its composition, structure and organization are described in

detail in Company’s articles of association and Company's Corporate Governance Charter (available on the

Company’s website, www.mithra.com). The Company's Corporate Governance Charter specifies the criteria that

Directors must satisfy in order to qualify as Independent Directors.

Since the General Shareholders' Meeting of 20 May 2021, directors are appointed for a maximum term of two years,

which is renewable.

The composition of Mithra’s Board of directors was as follows during the financial year 2022:

Name

Position

Term

Nature of

Mandate

Board of directors Committee

Membership

Attendance² to

2022 Board

meetings

Yima SRL

(permanent representative:

Mr. François Fornieri)

Director

2022

Non-Executive

9/9

Sunathim BV

(permanent representative:

Mr. Ajit Shetty)

Director

(Chair)

2022

Chair

Independent

(Nomination and

Remuneration Committee)

11/11

(3/4)

TicaConsult BV

(permanent representative:

Mr. Erik Van Den Eynden)

Director

2023

Vice Chair

Independent

(Risk and Audit committee)

(Chair)

14/16

(13/13)

Noshaq SA

(permanent representative:

Mr. Gaëtan Servais)

Director

2023

Non-Executive

(Risk and Audit committee)

14/16

(11/13)

Eva Consulting SRL

(permanent representative:

Mr. Jean-Michel Foidart)

Director

2023

Executive

16/16

Mrs. Patricia van Dijck

Director

2023

Independent

(Nomination and

Remuneration Committee

(Chair)

5 )

15/16

(9/9)

Mrs. Amel Tounsi

Director

2023

Non-Executive

(Nomination and

Remuneration Committee)

16/16

(9/9)

Alius Modi SRL

(permanent representative:

Mrs. Valérie Gordenne)

Director

2023

Non-Executive

(Risk and Audit committee)

14/16

(12/13)

Mrs. An Cloet

Director

2023

Independent

12/16

Mrs. Liesbeth Weynants

Director

2023

Independent

13/16

Selva Luxembourg SA

(permanent representative

Mr. Christian Moretti)

Director

(Chair)

2023

Non-executive

(Nomination and

Remuneration Committee)

5/5

(4/5)

1. Unless resignation early, the term of the mandate of the Director will expire immediately after the Annual General Shareholders' Meeting held in

the year set forth next to the Director’s name.

2. The number of meetings attended by each Director should take into account the nomination of new Directors during the financial year.

3. On June 20

, 2022, the Company announced the resignation with immediate effect of Yima SRL (François Fornieri as permanent representative)

as non-executive director.

4. On July 6

, 2022, the Company announced the resignation with immediate effect of Sunathim BVBA (represented by Mr. Ajit Shetty) and the

Board of Directors coopted, on the proposal of the recommendation of the Nomination and Remuneration Committee, the appointment of Selva

Luxembourg SA (represented by Mr. Christian Moretti as permanent representative) and its appointment as Chairman, as well as Tica Consult

BV (represented by Mr. Erik Van Den Eynden as permanent representative) as Vice-Chairman. The appointment of Selva Luxembourg has been

confirmed by the Extraordinary General Meeting dated September 22th, 2022.

5. On July 2022, P. Van Dijck has been appointed as Chair of the Nomination and Remuneration Committee.

More detailed information on the Board of directors’ responsibilities, duties, composition and operation can be found

on the Company’s website (www.mithra.com) in the Company's articles of association and Corporate Governance

Charter.

Activity report

In 2022, sixteen Board meetings have been held (in case two distinct meetings take place successively, the two

meetings have been taken into account hereinabove).

The Board meetings were mainly related to the financial results and financial reporting, including the half-year and

financial statements and budget, the Company’s financing strategy and related capital transaction, Supply strategy

and R&D progress, important agreements or (expected) acquisitions and divestments, and continuous evaluation of

the structure and the strategy of the Company.

In addition, the Board of directors met to resolve on various (conditional) capital increases or transaction,

Performance evaluation of the board

Under the lead of the Chair and assisted by the Nomination and Remuneration Committee (and possibly also by

external experts) the Company’s Board of Directors will conduct, every 3 years, a self-evaluation in respect of its size,

composition, performance and those of its Committees, as well as in respect of its interaction with the executive

management. The evaluation shall have the following objectives:

• Assessing how the Board or the relevant Committee operates;

• Checking that the important issues are suitably prepared and discussed;

• Evaluating the actual contribution of each Director’s work, the Director’s presence at Board and Committee

meetings and his constructive involvement in discussions and decision-making; and

• Checking the Board’s or Committee’s current composition against the Board’s or Committee’s desired

composition.

The Non-Executive Directors shall annually assess their interaction with the Executive Management Team. In this

respect, Non-Executive Directors shall meet at least once a year in absence of the CEO and the other executive

directors, if any. No formal Board decision can be taken at such meeting.

There is a periodic evaluation of the contribution of each director aiming at adapting the composition of the Board

of directors. At the time of their re-election, the directors’ commitments and contributions are evaluated within the

Board of directors, and the Board of directors ensures that any appointment or re-election allows an appropriate

balance of skills, knowledge and experience to be maintained. The same applies at the time of appointment or re-

election of the Chairs (of the Board of directors and of the Board committees).

The Board shall act on the results of the performance evaluation by recognising its strengths and addressing its

weaknesses. Where appropriate, this will involve proposing new members for appointment, proposing not to re-elect

existing members or taking any measure deemed appropriate for the effective operation of the Board.

This evaluation took place in fiscal year 2018 and has been renewed in fiscal year 2023 to correspond with the

renewal of the Board of directors). The Board always acts on the results of the performance evaluation by recognizing

its strengths and addressing its weaknesses. Where appropriate, this could involve proposing new members for

appointment, proposing not to re-elect existing members or taking any measure deemed appropriate for the effective

operation of the Board of Directors.

Risk and Audit committee

The Board of directors has set up a Risk and Audit committee, in line with the Belgian Companies and Associations

Code.

More detailed information on the Risk and Audit committee’s responsibilities can be found in the Company's

Corporate Governance Charter, which can be found on Mithra’s website (www.mithra.com).

The Chair of the Risk and Audit committee reports to the meeting of the Board of directors subsequent to each

meeting of the Risk and Audit committee on its activities, conclusions, recommendations and resolutions. On an

annual basis, the Chair of the Risk and Audit committee also reports to the Board of directors on the Risk and Audit

committee’s performance.

Composition

The Risk and Audit committee is composed of three (3) members, which are exclusively Non-Executive Directors. At

least one of its members should be an independent Director in the meaning of article 7:87 of the Belgian Companies

and Associations Code.

At least one of its members has the necessary expertise with regard to accounting and auditing. The Board of

Directors ensures that the Risk and Audit committee has the necessary and sufficient expertise with regards to

accounting, audit and finance, in order to fulfil its role in an adequate manner. The Chair of the Risk and Audit

committee is not the Chair of the Board of directors. The CEO and CFO can attend the meetings in an advisory and

non-voting capacity. At least twice a year, the Risk and Audit committeee meets the Statutory Auditor in order to

discuss questions regarding its mandate, the audit procedure and, in particular, the potential weaknesses identified

in the control.

The following Directors are members of the Risk and Audit committeee: TicaConsult BV (permanent representative:

Mr. Erik Van Den Eynden), Noshaq SA (permanent representative: Mr. Gaëtan Servais), Alius Modi SRL (permanent

representative: Mrs. Valérie Gordenne). TicaConsult BV (permanent represenative: Mr. Erik Van Den Eynden) is an

Independent Director.

Activity report

The Risk and Audit committee met thirteen (13) in 2022. The statutory auditor was present at 2 of these thirteen

meetings.

The main topics discussed were the interim half-year and annual financial information and figures, the budget, the

statutory auditor’s external audit, internal control, risk management and compliance issues the review of the equity

transactions and the progress related to a “Donesta deal”. The opinion of the Risk and Audit committee has also

been specifically requested on transactions and issues where there were conflicts of interest.

Attendance was as follows: Noshaq SA (permanent representative: Mr. Gaëtan Servais): 11/13, TicaConsult BV

(permanent representative: Mr. Erik Van Den Eynden): 13/13, and Alius Modi (permanent representative: Mrs. Valérie

Gordenne): 12/13. The number of meetings attended by each Director should take into account the expiration of the

term of the mandate of certain Directors during the year as well as the nomination of new Directors during the

financial year.

Nomination and remuneration committee

The Board of directors has set up a remuneration committee, in line with the Belgian Companies and Associations

Code. As the remuneration committee also performs the task of a nomination committee, it is called the nomination

and remuneration committee.

More detailed information on the nomination and remuneration committee’s responsibilities can be found in the

Company's Corporate Governance Charter, which can be found on Mithra’s website (www.mithra.com). In principle,

the nomination and remuneration committee will meet at least two (2) times per year.

Composition

The nomination and remuneration committee is composed of three members, which are exclusively non-executive

directors. The majority of its members are independent directors in the meaning of article 7:87 of the Belgian

Companies and Associations Code and Provision 4.19 of the 2020 Corporate Governance Code.

However, as explained earlier, following the resignation of Sunathim BV (with Mr. Ajit Shetty as permanent

representative), Selva Luxembourg Sarl (with Mr. Christian Moretti as permanent representative) has been appointed

as board member and as member of the Nomination and Remuneration Committee. This appointment led the

Nomination and Remuneration Committee to be composed of only one independent Director. This deviation from

the 2020 Corporate Governance Code shall be remediate after the committees are recomposed following the board

renewal during the General Meeting to be held in May 2023.

The nomination and remuneration committee has the necessary expertise in terms of remuneration policy, which is

evidenced by the experience and the previous roles of its members.

The following Directors are members of the nomination and remuneration committee: Mrs. Patricia van Dijck, Mrs.

Amel Tounsi, Selva Luxembourg (with Mr. Christian Moretti as permanent representative) as from the resignation of

Sunathim BV (with Mr. Ajit Shetty as permanent representative) on 6 July 2022. Mrs. Patricia van Dijck is an

Independent Director.

The CEO is invited to attend the meetings of the Nomination and Remuneration Committee in an advisory and non-

voting capacity. He does not attend discussions concerning his own remuneration.

The Chair of the Nomination & Remuneration Committee reports to the Board subsequent to each Committee

meeting on its activities, conclusions, recommendations and resolutions. The Chair of the Nomination &

Remuneration Committee shall, on an annual basis, report to the Board on the Nomination & Remuneration

Committee’s performance. Every three (3) years, the Nomination & Remuneration Committee reviews its terms of

reference and its own effectiveness and recommends any necessary changes to the Board.

Activity report

The Nomination & Remuneration Committee met nine (9) times in 2022.

The main topics discussed were the preparation of the remuneration report, the performance of the CEO and other

members of the Executive Management Team, their appointment, resignation, replacement and remuneration

(including the grant of subscription rights), the composition of the Executive Management Team, the assessment of

the contractual conditions giving right to bonuses to the CEO, the renewal of the Board of directors.

Attendance was as follows: Mrs. Patricia van Dijck (9/9), Mrs. Amel Tounsi (9/9), Sunathim BV (permanent

representative: Mr. Ajit Shetty) (3/) and Selva Luxembourg SA (permanent representative Mr. Christian Moretti) (

4/5).The number of meetings attended by each Director should take into account the expiration of the term of the

mandate of certain Directors during the year as well as the nomination of new Directors during the financial year.

Executive Management

By a decision of 15 June 2015, the Board of directors of the Company set up an Executive Management Team. The

Executive Management Team is an advisory committee of the Board of directors.

The Executive Management Team’s mission is to discuss and consult with the Board and advise the Board on the

day-to-day management of the Company in accordance with the Company’s values, strategy, general policy and

budget, as determined by the Board.

While exercising its advisory responsibilities, the Executive Management Team shall be guided by the interests of

the Company and its business.

More detailed information on the Executive Management Team’s responsibilities can be found in the Company's

Corporate Governance Charter, which can be found on Mithra’s website. (www.mithra.com).

Composition

The Executive Management Team is currently composed of thirteen (13) members: the Chief Executive Officer (CEO),

The Chief Financial Officer (CFO), the Chief Legal Officer (CLO), the Chief Scientific Officer (CSO), the Chief Supply

Chain Officer (CSCO), the Chief Manufacturing Officer (CMO)

, Chief Commercial and External Affairs Officer

(CCEAO), the Chief Human Resources Officer (CHRO), the Group Quality Manager

, the Group Communication

Manager, the Group Investor Relations Manager (IRO), the Group IT Manager (GITM) and the Chair of the Scientific

Advisory Board.

The Executive Management Team is chaired by the CEO of the Company. Furthermore, the Chair may invite additional

personnel to attend a meeting of the Executive Management Team.

The members of the Executive Committee as of the date of this report are listed in the table below:

Name

Function

Van Rompay Management BV (permanent representative:

Mr. Leon Van Rompay)

Chief Executive Officer (CEO)

Eva Consulting SRL (permanent representative:

Mr. Jean-Michel Foidart)

Chair of the Scientific Advisory Board

CMM&C SRL (permanent representative: Mr. Christophe Maréchal)

Chief Financial Officer (CFO)

M. Cédric Darcis

Chief Legal Officer (CLO)

GD Lifescience SRL (permanent representative: Mr Graham Dixon)

Chief Scientific Officer (CSO)

BGL Consulting SRL (permanent representative:

Mr. Benjamin Brands)

Chief Supply Chain Officer (CCO)

MAREBA BVBA (permanent representative: Mr Renaat Baes)

CDMO Site Director

Novafontis SRL (permanent representative: Mr. Jean-Manuel

Fontaine)

Chief Commercial and External Affairs Officer (CCEAO)

Acta Group SA (permanent representative : Ms. Laurence Schyns)

Chief Human Resources Officer (CHRO),

Mr. Benoît Mathieu

Group Investor Relations Manager

Mrs. Maud Vanderthommen

Group Communication Manager

Mr. Frédéric Constant

Group Quality Manager

T Mundi BV (permanent representative : Stijn Vlaminck)

Group IT Manager

1. On 3 March 2022, upon recommendation of the Nomination and Remuneration Committee, the Board of directors changed the job title of

the CMO in order to become the CDMO Site Director of the Company.

2. On 16 December 2022, the Group Quality Manager has left the company.

3. On 1

February 2022, under request of T Mundi BV (permanent representative: Stijn Vlaminck), the performance of its duties have been

transferred to the company Hof Vlaminck SCS (permanent representative: Stijn Vlaminck).

4. Post-Closing, in February 2023, the Group Communication Manager left the Company.

5. Post-Closing, in March 2023, the Group Investor Relations Manager left the Company.

6. Post Closing, in April 2023, Dr David Horn Solomon was appointed as CEO of the Company.

Activity report

In 2022, the Executive Management Team met regularly and at least once every month. The CEO reported and

advised the Board on the day-to-day management at every meeting.

Diversity and inclusiveness

Article 7:86 of the Belgian Companies and Associations Code provides that at least one third of the members of the

Board of directors should be of the opposite gender. In order to calculate the required number of Directors of a

different gender, fractions must be rounded to the nearest whole number. These gender diversity requirements are

applicable to the composition of the Board of directors of companies, the securities of which are listed, for the first

time as from the first day of the sixth year following the date they became publicly listed. If, for any reason

whatsoever, the composition of the Board of directors does not or no longer meets the conditions laid down here

above, the first General Shareholders' Meeting that follows shall constitute a Board of directors that meets these

requirements.

Since the Annual General Shareholders' Meeting of 16 May 2019, the Company complied with the gender diversity

requirements set by article 7:86 of the Belgian Companies and Associations Code (and Article 2.1 of the CBGE). The

Board of directors still comply with the requirement of gender diversity as. The Board of directors currently has five

(5) female directors (representing a ratio of 55% female Directors against 45 % male Directors (4)). In the future, the

Company undertakes to continue taking gender diversity into consideration when renewing the members of its Board

of directors and when filling new positions.

Principal characteristics of internal control and risk management

The Company operates a risk management and control framework in accordance with the Belgian Companies and

Associations Code and the 2020 Code. The Group is exposed to a wide variety of risks within the context of its

business operations that can result in its objectives being affected or not achieved. Controlling those risks is a core

task of the Board of directors (including the Risk and Audit committee), the Executive Management Team and all

other employees with managerial responsibilities.

The Executive Management Team leads the Company within the framework of prudent and effective control, which

enables it to assess and manage risks. The Executive Management Team develops, maintains and ongoingly

improves (including with the support of external advisers) adequate internal control and risk management

procedures so as to offer a reasonable assurance concerning the realization of goals, the reliability of the financial

information, the observance of applicable laws and regulations and to enable the execution of internal control and

risk management procedures.

The Executive Management Team is an advisory committee to the Board of directors and the CEO on the day-to-day

management of the Company. Each member of the Executive Management Team has individually been made

responsible for certain aspects of the day-to-day management of the Company and its business (in case of the CEO,

by way of a delegation from the Board of directors; in case of the other Executive Management Team members, by

way of a formal delegation of authority from the CEO). In the case that any decision to be taken by a member of the

Executive Management Team could be material to the Company (or falls outside the scope of the delegation of

authority), it shall be presented and discussed at a meeting of the Executive Management Team. The Executive

Management Team meets several times per month.

During those Executive Management Team meetings, there is a follow-up on the progress of various Group projects,

clinical studies, business development deals, and other material matters.

The process of gathering financial information is organized on a monthly (work in progress), quarterly, half-year and

annual basis, and reports of such information are made available to the CEO and the Risk and Audit committee. The

finance team produces the accounting figures and reports under the supervision of the CFO. The accounts are kept

by an ERP (D365 upgraded version). The cash and working capital are monitored on a continuous basis.

The quality of the internal control and risk management is assessed during the course of the financial year and on

an ad hoc basis with internal audits (supply chain, IT, PO validation workflows, working capital management, etc.)

carried out on the basis of potential risks identified. The conclusions are shared and validated with the Risk and Audit

committee. During the financial year, the Risk and Audit committee undertakes reviews of the half-year closures and

specific accounting treatments. It reviews the disputes and puts all the questions it deems relevant to the Auditor,

to the CFO or to the Executive Management Team of the Company.

The Risk and Audit committee assists the Board of directors in the execution of its task to control the Executive

Management Team.

Control environment

The Executive Management Team has organized the internal control environment, which is monitored by the Risk

and Audit committee. The Risk and Audit committee decided not to create an internal audit role, since the scope of

the business does not justify a full-time role.

The role of the Risk and Audit committee is to assist the Board of directors in fulfilling its monitoring responsibilities,

as stipulated in the Company’s Corporate Governance Charter and the Business Code of Conduct. These

responsibilities include the financial reporting process, internal control and risk management systems (including the

Company’s process for monitoring compliance with laws and regulations) and the external audit process.

Dealing code

With a view to preventing market abuse (insider dealing and market manipulation), the Board of directors has

established a dealing code. The dealing code describes the declaration and conduct obligations of Directors,

executives and workers of the Group with respect to transactions in shares and other financial instruments of the

Company. The dealing code sets limits on carrying out transactions in shares and other financial instruments of the

Company and allows dealing by the above-mentioned persons only during certain windows.

Statutory auditor

BDO Réviseurs d’Entreprises SRL, with registered office at Rue de Waucomont 51, 4651 Herve, Belgium, member of

the Institut des Réviseurs d’Entreprises/Instituut der Bedrijfsrevisoren, represented by Cédric Antonelli auditor, has

been renewed as Statutory Auditor of the Company on 20 May 2021 for a term of three (3) years ending immediately

after the Shareholders Meeting to be held in 2024 which will deliberate and resolve on the financial statements for

the financial year ended on 31 December 2023. On 28 December 2022, BDO requested a change of his permanent

representative for the benefit of Mr. Christophe Peltzer applicable as of the fiscal year 2022. BDO Réviseurs

d’Entreprises SCRL is a member of the Belgian Institute of Certified Auditors (“Institut des Réviseurs d’Entreprises”)

(membership number B00023).

The Statutory Auditor as the auditor responsible for the audit of the consolidated financial statements, confirms

annually in writing to the Risk and Audit committee his or her independence from the Company, discloses annually

to the Risk and Audit committee any additional services provided to the Company, and discusses with the Risk and

Audit committee the threats to his or her independence and the safeguards applied to mitigate those threats as

documented by him or her.

During the past fiscal year, in addition to its usual activity, the Statutory Auditor performed additional activities on

behalf of the Company mainly for the issuance of special reports, for participation to meeting of the Risk and Audit

committee and for participation to special projects.

In 2022, the Company spent EUR 209,025 for fees related to the activities of the auditor, split as follows:

In Euro (€)

Auditor’s fees for statutory and consolidated financial statements

173,800

Fees for exceptional services or special missions (audit related)

20,902

Tax consultancy (audit related)

Fees for exceptional services or special missions (external to audit)

Tax consultancy (external to audit)

14,323

Total

209,025

Information that has an impact in case of public takeover bids

No takeover bid has been instigated by third parties in respect of the Company’s equity during the current financial

year.

The Company provides the following information in accordance with Article 34 of the Belgian Royal Decree dated

14 November 2007:

Share capital and shares

The share capital of the Company amounts to EUR 41,227,972.15 EUR and is fully paid-up. It is represented by

56,314,974 ordinary shares, each representing a fractional value of (rounded) EUR 0.7321 and representing one

56,314,974th of the capital. The Company's shares do not have a nominal value.

Restrictions, either legal or prescribed by the articles of association, on the transfer of shares

Other than the applicable Belgian legislation on the disclosure of significant shareholdings and the Company's

articles of association, there are no restrictions on the transfer of shares.

Special control rights

There are no holders of any shares with special control rights.

Possible control mechanism provided for in a shareholding system of the personnel, when

control rights are not exercised directly by the personnel

There are no share option plans for the personnel other than the share option plans disclosed elsewhere in this report.

These share option plans contain provisions on accelerated vesting in case of change of control.

Restrictions, either legal or prescribed by the articles of association, on voting rights

Each shareholder of the Company is entitled to one vote per share. Voting rights may be suspended as provided in

the Company's articles of association and the applicable laws and articles.

Agreements between shareholders that may result in restrictions the transfer of securities

and/or the exercise of voting rights

There are no agreements between shareholders which are known by the Company that may result in restrictions on

the transfer of securities and/or the exercise of voting rights.

Rules governing the appointment and replacement of Board members and the amendment of

the issuer’s articles of association

The rules governing appointment and replacement of Board members and amendment to articles of association are

set out in the current versions of the Company's articles of association and the Company's Corporate Governance

Charter.

Powers of the Board of directors

The powers of the Board of directors, more specifically with regard to the power to issue or redeem shares are set

out in the Company's articles of association. The Board of directors was not granted the authorization to purchase

its own shares "to avoid imminent and serious danger to the Company" (i.e., to defend against public takeover bids). The

Board of directors is however authorised to dispose of listed shares or certificates, in accordance with article 7:218

of the Belgian Companies and Associations Code (this authorisation extends to disposals made by its direct

subsidiaries, as defined in article 3:22 of the Belgian Companies and Associations Code).

Change of control clauses

At the date of this report, the Company is a party to the following significant agreements which, upon a change of

control of the Company or following a takeover bid can enter into force or, subject to certain conditions, can be, as

the case may be, amended, terminated by the other parties thereto or give the other parties thereto (or beneficial

holders with respect to bonds) a right to an accelerated repayment of outstanding debt obligations of the Company

under such agreements:

• The asset purchase agreement dated July 28th, 2018 by means of which the Company sold its generic

division to Ceres Pharma NV. The terms of this agreement provide a change of control clause under which,

in the event of Change of Control on the level of Mithra Pharma, all of the earn-outs which are not yet due by

CERES PHARMA at that moment shall be reduced with 50%;

• The agreement of 30

September 2019 between the Company and the former shareholders of Uteron

Pharma concerning the Company’s remaining payment obligations in connection with the earn-outs

agreement. Under the terms of this agreement, any outstanding earn-out amount shall become immediately

and fully payable early in case of Change of Control within the meaning of the aforementioned provision

within the Company;

• A put option agreement entered into on 23 April 2020 by the Company, LDA Capital Limited, LDA Capital,

LLC, and three existing shareholders of the Company (i.e., François Fornieri, Alychlo NV and Noshaq SA) (the

"Put Option Agreement") provides (amongst other things) that it may be terminated forthwith during the

commitment period (as defined in the Put Option Agreement) by LDA Capital Limited by giving written notice

of such termination to the Company if there has been a material change in ownership (which has been

defined as any sale or disposal of shares of the Company or other transaction or event which results in the

officers and Directors of the Company on the date of the Put Option Agreement owning, directly or indirectly,

less than five % the Company's shares in issue from time to time); and

• On 17 December 2020, the Company issued 4.250 per cent. convertible bonds for a total principal amount

of EUR 125,000,000 million due on 17 December 2025. Conditions 5(b)(x) and 6(d) of the terms and

conditions of the convertible bonds provide that, if a change of control over the Company occurs, the

conversion price of the convertible bonds will be adjusted in proportion to the already elapsed time since the

closing date (i.e. 17 December 2020) and the bondholders may request the early redemption of their

convertible bonds at their principal amount, together with the accrued and unpaid interests;

• Furthermore, as aforementioned, the share option plans of the 2015 Share Options, 2018 Share Options, the

LDA warrant plan, the Share Lending Warrants and 2020 Share options issued by the Company also contain

take-over protection provisions pursuant to which, in the event of a liquidity event resulting from a public bid

or otherwise, that modifies the (direct or indirect) control (as defined under Belgian law) exercised over the

Company, the share options holders shall have the right to exercise their share options, irrespective of

exercise periods/limitations provided by the plan;

• As mentioned and described in the remuneration report, on 23th November 2021, the Board of directors

approved a bonus plan. Insofar as needed and applicable (considering its limited financial importance for

the company), this bonus plan provides, among other things, that, in case of a transaction leading inter alia

to a change of control over the Company and/or its affiliates, members of the management team and certain

other managers shall be entitled to a bonus of an aggregate amount of 0.75% of the aggregate purchase

price of the shares sold in the transaction. This bonus plan is no longer into force;

• The Master Confirmation Agreement dated 4th February 2022 between the Company and Goldman Sachs

International provides that should a change of control occur, an adjustment on the economics of the

contract shall occur. This Adjustment shall be determined by the Calculation Agent based on the 2006 ISDA

Definitions and the definitions and provisions of the 2002 ISDA Equity Derivatives Definitions rules in each

case as published by the International Swaps and Derivatives Association, Inc, using customary

mechanisms. Should the Adjustment be rejected by the Company following a change of control, it may in

some circumstances cause a termination of the Master Confirmation Agreement;

• The Senior Secured Convertible Facilities Agreement (the "Convertible Loans Agreement") and a Conversion

Agreement (the "Conversion Agreement", and together with the Convertible Loans Agreement, the

"Agreements") entered into on 8 August 2022 pursuant to which, among other things, the Lenders

(Highbridge and Whitebox) have agreed to provide, for a period of 3 years from the date of the Convertible

Loans Agreement, a financing by loans convertible in shares to the Company for a maximum aggregate

principal amount of EUR 100,000,000.00, to be drawn in several tranches (subject to the fulfilment of certain

conditions), with an outstanding amount at any time not greater than EUR 65,000,000.00 or, subject to the

satisfaction of certain conditions, EUR 75,000,000.00, the loans bearing interest in principle at 7.5% per

annum. Under the Agreements, certain receivable that could be owed by the Company under the Convertible

Loans Agreement and/or the Conversion Agreement, as a principal, interest, option prepayment amount,

commitment fee or otherwise (as contemplated in the Convertible Loans Agreement and the Conversion

Agreement, as amended from time to time) will be convertible into new shares of the Company (by

contributions in kind of the relevant receivables). Clause 8.1 of the Convertible Loans Agreement provides

that in the event of a change of control of the Company, the loans facility will immediately terminate and

cease to be available for further use and all loans, accrued interest and other amounts owed by the Company

under the Agreements will become immediately due and payable. This clause was approved by the

Extraordinary General Meeting dated 22 September;

• Agreements between the Company and the members of its Board or its personnel. At the date of this report,

there is no agreement between the Company and the members of its Board or its personnel, which provide

for indemnities if the Board members resign or have to cease their functions without a valid reason or if the

employment of the members of the personnel is terminated due to a public takeover bid.

Remuneration report

As prescribed by provision 3:6, §3 of the CCA, please find below the remuneration report pursuant to financial year

2022 prepared by the Nomination and Remuneration Committee. It will be submitted to the General Meeting of

Shareholders.

The Remuneration and Nomination Committee confirms that, for the duration of the financial year 2022, the

members of the Board of directors and the executive Committee, were subject to a remuneration policy compliant

with the Corporate Governance Charter which has been amended in April 2020 to reflect the new provisions of the

CCA as well as the Code of Corporate Governance 2020 (CBGE 2020). The Board of directors upon recommendation

of the Nomination and Remuneration Committee prepared a remuneration policy in accordance with provision 7:89

of the CCA which has been approved by the General Meeting of 22 May 2021’s.

The Directors as well as the members of the Executive Management Team are paid by Mithra Pharmaceuticals SA,

parent company of the Mithra Group even though, members can perform tasks for the subsidiaries of the Group.

Directors

Procedure applied in 2022 in order to comply with the remuneration policy and to determine the

individual remuneration

In 2022 still, the Nomination and Remuneration Committee recommended the level of remuneration for Directors,

including the Chairman of the Board, which is subject to approval by the Board of directors and, subsequently, by the

Annual Shareholders Meeting.

The Nomination and Remuneration Committee benchmarked the Directors’ compensation against peer companies.

The level of remuneration should be sufficient to attract, retain and motivate Directors who match the profile

determined by the Board.

Apart from their remuneration, all Directors will be entitled to a reimbursement of out-of-pocket expenses actually

incurred as a result of their participation in meetings of the Board of directors.

The level of remuneration of the Directors was determined at the occasion of the Company’s Initial Public Offering

on 8 June 2015 and explained in the Prospectus issued by the Company in that context. The Company’s policy with

respect to the remuneration of its Directors has been further detailed in its 2020 Corporate Governance Charter.

Those principles have been used by the Board of directors, upon recommendation of the Nomination and

Remuneration Committee, to draft a remuneration policy proposal which has been submitted to the General Meeting

on 20th May 2021. The remuneration of the Directors has been disclosed to the Company’s shareholders in

accordance with the applicable laws and regulations.

The Directors’ mandate may be terminated ad nutum (at any time) without any form of compensation. There are no

employment or service agreements that provide for notice periods or indemnities between the Company and the

members of the Board of directors, who are not members of the Executive Management Team. This information has

been further detailed in the draft remuneration policy which has been submitted for approval to the last General

Meeting (which can be found on Mithra’s website (www.mithra.com).

Remuneration policy applied during 2022

The remuneration package for the Non-Executive Directors (whether or not independent) approved by the

Shareholders Meeting of 8 June 2015 is made up of a fixed annual fee of EUR 20,000. The fee is supplemented with

a fixed annual fee of EUR 5,000 for membership of each committee of the Board of directors, and an additional fixed

annual fee of EUR 20,000 for the Chairman of the Board. Changes to these fees will be submitted to the Shareholders

Meeting for approval.

There is no performance-related remuneration for Non-Executive Directors. Therefore, the percentage for those non-

executive Directors is 100% of fix remuneration.

Apart from the above remuneration for Non-Executive Directors (whether or not independent), all Directors will be

entitled to a reimbursement of out-of-pocket expenses incurred as a result of participation in meetings of the Board

of directors.

The total amount of the remuneration and the benefits paid in 2022 to the Non-Executive Directors (in such capacity)

was EUR 210,000 (gross, excluding VAT), split as follows:

Name

Nature

Remunerations

As member of a

committee

As chairman

of the board

YIMA SRL

Non-exec

NOSHAQ SA

Non-exec

20,000

5,000

Alius Modi SRL

Non-exec

20,000

5,000

A. Tounsi

Non-exec

20,000

5,000

P. van Dijck

Independent

20,000

5,000

A. Cloet

Independent

20,000

L. Weynants

Independent

20,000

Selva Luxembourg SA

Non-exec

10,000

2,500

10,000

Sunathim BV

Independent

10,000

2,500

10,000

TicaConsult BV

Independent

20,000

5,000

1. The Remuneration attended by each Director should take into account the nomination of new Directors during the financial year.

The table below provides an overview of the shares and warrants held by the current members of the Board on the

31st of December 2022.

Share / Warrantholder

Warrants*

Shares and

Warrants

YIMA SRL (permanent

representative: Mr François

Fornieri)

0.00

952,790

35.14

952,790

1.61

Mr François Fornieri

(permanent representative of

YIMA SRL)

10,809,882

19.20

150,000

5.53

11,134,330

18.57

NOSHAQ SA (permanent

representative:

Gaëtan Servais)

5,488,251

9.75

75,000

2.77

5,040,848

9.42

Gaëtan Servais (permanent

representative of NOSHAQ SA)

0.00

Eva Consulting SRL

(permanent representative :

Jean-Michel Foidart)

0.00

52,695

1.94

52,695

0.08

Mr Jean-Michel Foidart

(permanent representative of

Eva Consulting SRL) (together

with Eva Consulting SRL)

20,370

0.04

0.00

20,370

0.00

Mrs Patricia Van Dijck

0.00

Selva Luxembourg SA

(permanent representative M.

Christian Moretti)

689,655

1.22

0.00

689,655

1.16

On the 31

of December 2022

On June 20th, 2022, the Company announced the resignation with immediate effect of Yima SRL (François Fornieri as permanent

representative) as non-executive director.

Christian Moretti (permanent

representative of de Selva

Luxembourg SA)

0.00

Sunathim BV (permanent

representative Ajit Shetty)

0.00

Mr Ajit Shetty (permanent

representative of Sunathim BV)

780

0.01

0.00

TicaConsult BV (permanent

representative Mr Erik Van Den

Eynden)

0.00

Mr Erik Van Den Eynden

(permanent representative of

TicaConsult BV)

0.00

Alius Modi SRL (permanent

representative Valérie

Gordenne )

0.00

Valérie Gordenne (permanent

representative of Alius Modi

BV)

29,000

0.05

0.00

29,000

0.06

Mrs Amel Tounsi

0.00

Mrs An Cloet

0.00

Mrs Liesbeth Weynants

0.00

Subtotal

17,037,938

30.27

1,230,485

45.38

17,919,688

30.89**

* corresponds to the amount of shares following warrant conversion.

**the figures in this table are based on unilateral statements made by the Directors.

During the fiscal year 2022, the Executive-Director perceived its remuneration as a fix amount and there was no

remuneration by means of warrants. No variable remuneration were paid.

Executive Management team

Procedure applied in 2022 in order to comply with the remuneration policy and to determine the

individual remuneration

The remuneration of the members of the Executive Management Team is determined by the Board of directors upon

recommendation of the Nomination and Remuneration Committee and subsequent to the CEO’s recommendation

to this Committee (except for his own remuneration). The Company strives to be competitive in the European market.

Remuneration policy applied during 2022

The level and structure of the remuneration of the members of the Executive Management Team is such that

qualified and expert professionals can be recruited, retained and motivated taking into account the nature and scope

of their individual responsibilities.

The remuneration of the members of the Executive Management Team currently consists of the following elements:

• Each member of the Executive Management Team is entitled to a basic fixed remuneration designed to fit

responsibilities, relevant experience and competences, in line with market rates for equivalent positions;

On July 6th, 2022, the Company announced the resignation with immediate effect of Sunathim BVBA (represented by Mr. Ajit

Shetty) and the Board of Directors coopted, on the proposal of the recommendation of the Nomination and Remuneration

Committee, the appointment of Selva Luxembourg SA (represented by Mr. Christian Moretti as permanent representative) and its

appointment as Chairman, as well as Tica Consult BV (represented by Mr. Erik Van Den Eynden as permanent representative) as

Vice-Chairman. The appointment of Selva Luxembourg has been confirmed by the Extraordinary General Meeting dated September

22th, 2022.

• Each member of the Executive Management Team currently participates in, and/or in the future may be

offered the possibility to participate in a stock based incentive scheme or stock option in accordance with

the recommendations set by the Nomination and Remuneration Committee, upon the recommendation by

the CEO to such committee (except in respect of his own remuneration) and after (in respect of future stock

based incentive schemes) prior shareholder approval of the scheme itself by way of a resolution at the

Annual Shareholders Meeting;

• Each member of the Executive Management Team is entitled to a number of fringe benefits (to the exception,

however, of those managers engaged on the basis of service agreements), which may include participating

in a defined contribution pension or retirement scheme, disability insurance and life insurance, a company

car, and/or a lump-sum expense allowance according to general Company policy.

The Company’s policy with respect to the remuneration of its Executive Management team has been further detailed

in its 2020 Corporate Governance Charter. Those principles have been used by the Board of directors, upon

recommendation of the Nomination and Remuneration Committee, to draft a remuneration policy that was approved

by the General Meeting of 20th May 2021.

In addition to the 2015 Warrant Plan, in order to include new members of the Executive Management team, a short-

and long-term performance-based remuneration and incentive scheme has been elaborated within the Nomination

and Remuneration Committee, validated by the Board of directors and formally approved by the Extraordinary

General Meeting of shareholders on 5 November 2018 (Warrant Plan 2018). Such scheme is based on objectives

which are, in accordance with Article 520bis of the BCC (article 7:90 of the CCA), pre-determined by an explicit

decision of the Board of directors and were chosen so as to link rewards to corporate and individual performance,

thereby aligning on an annual basis the interests of all members of the Executive Management Team with the

interests of the Company and its shareholders and benchmarked with the practices in the sector.

Following the implementation of the BCCA, the Board of directors decided to issue a new warrant plan (Warrant Plan

2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant Plan

2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the

BCCA. The number of share options issued under this plan, 390,717 warrants is the same as the number of share

options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in

accordance with the provisions of the (old) Belgian Companies Code. Therefore, the Board of directors also decided

to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that have not yet been

granted to the selected participants of the Warrant Plan 2018. This Warrant Plan 2020 has a longevity period of 10

years and is not subject to vesting conditions.

The amount of remunerations and benefits paid in 2022 to the CEO and the other members of the Executive

Management Team, (gross, excluding VAT) is shown in the table below:

Thousands of Euro (€)

Total

Of which CEO

Basic remuneration

3,193

481

Variable Remuneration

110

Group Insurance (pension, invalidity, life)

Other benefits (car, cell phone, hospitalization)

Total

3,382

493

Only the members of the Executive Management Team which performed their services through an employment

contract had a Group Insurance scheme which covered pension benefits throughout the year 2022. The Group

insurance amounted to 4% of this yearly gross remuneration (3% in charge of the Company and 1% in his own charge)

and was cashable when the employee would reach sixteen (65) years old. In case the employee would leave the

Company, he would keep the collected amounts and the Group insurance would cease to his profit.

The table below provides an overview of the shares and warrants held by the members of the Executive Management

Team, including the Executive Director on 31 December 2022 (i.e. the CEO). The share-based payment costs related

to warrants held by the members of the Executive Management Team represent EUR 77k, out of the total share-

based payment costs of EUR 909k included in the net loss for the period.

Shares / Warrants holder

Warrants

Shares and

Warrants

Van Rompay Management BV

(permanent representative:

Mr. Leon Van Rompay)

(CEO)

46,125

0.08

46,125

0,07

Mr. Christophe Maréchal

(representative of and together with

CMM&C SRL BVBA)

0.00

235,502

8.69

235,502

0.40

Mr. Jean-Michel Foidart

(representative of and together with

Eva Consulting SRL)

20,370

0.04

0.00

20,370

0.03

Mr. Benjamin Brands

(representative of and together with

BGL Consulting SRL)

0.00

67,695

2.5

67,730

0.11

Mr. Jean-Manuel Fontaine

(representative of and together with

Novafontis SA)

0.00

52,695

1.94

52,723

0.08

Mr. Graham Dixon

(representative of and together with

GD Lifescience SRL)

0.00

25,000

0.92

25,000

0.04

Mr. Cédric Darcis

0.00

52,695

1.94

52,695

0.09

Mr. Renaat Baes (representative of

and together with

MAREBA SRL)

0.00

35,000

1.29

35,000

0.06

Mrs. Maud Vanderthommen

0.00

15,000

0.55

15,000

0.02

Subtotal

66,530

0.12%

483,587

17,83%

550,145

0.93%

Total

56,314,974

100.00%

2,710,900

100.00%

59,025,874

100.00%

The Company has put in place five warrants plans since its incorporation, three of which are performance-related for

the Executive Management Team amongst others.

First, the Extraordinary Shareholders Meeting of the Company of 2 March 2015 approved, upon proposal of the Board

of directors, the issuance of warrants giving right to subscribe for 1,796,850 shares, which, on a fully-diluted basis,

represented 5.56% additional Shares at the time.

These warrants (1089) have been granted free of charge. All warrants have been accepted by the relevant

beneficiaries. Each warrant entitled its holder to subscribe for 1,650 Shares of the Company at a subscription price

of EUR 5,646.00 per 1,650 Shares (a part corresponding to the par value of the existing Shares on the day the

warrants are exercised will be allocated to the share capital). The balance will be booked as an issue premium.

These warrants can be exercised as from 1 January 2019 and have a term of 8 years as from the date of grant. Upon

expiration of the term, they become null and void.

As part of that plan, on 30

of January 2019, an increase of capital took place following the exercise of 15 warrants

pursuant the 2015 Warrant Plan ("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. In accordance

with the 2015 Warrant Plan, the exercise period started on January 1, 2019. An amount of EUR 18,119.48 was

therefore contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the

Company's "share premium" account. This exercise of 15 warrants led to the issue of 24,750 shares (1 warrant being

equivalent to 1,650 shares) which on February 15

, 2019 were admitted to trading on the regulated market. As a

result, Mithra's share capital on January 30, 2019 amounted to EUR 27,573,880.18 corresponding to 37,664,245

ordinary shares.

A second increase took place on 24 April 2019, following the exercise of 15 warrants pursuant the 2015 Warrant Plan

("2015 Warrant Plan") corresponding to a contribution of EUR 84,690. An amount of EUR 18,119.40 was therefore

contributed in cash to the share capital of Mithra and the balance of EUR 66,570.52 was allocated to the Company's

"share premium" account. This exercise of 15 warrants resulted in the issue of 24,750 shares (1 warrant being

equivalent to 1,650 shares) which, on May 9, 2019, were admitted to listing on the regulated market. As a result,

Mithra's share capital at 24 April 2019 amounted to EUR 27,591,999.58 corresponding to 37,688,995 fully paid-up

ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital, which

is denominated in euros. Each share entitles its holder to one voting right. The number of voting rights held by the

shareholders was 37,688,995 at 30 June 2019.

Finally, on 21 May 2021, the third capital increase took place following the exercise of 620 warrants from the 2015

Warrant Plan corresponding to a contribution of EUR 3.500.520. An amount of EUR 748,836 was therefore

contributed in cash to the share capital of the Company and the balance of EUR 2.751.684 was allocated to the

Company’s share premium account. This exercise of 620 warrants resulted in the issue of 1,023,000 shares (1

warrant being equivalent to 1,650 shares) which, on 14 May 2021 were admitted to listing on the regulated market.

As a result, Mithra's share capital at May 21 amounted to EUR 32,019,708;40 corresponding to 43,737,097 fully paid-

up ordinary shares. The shares have no par value but represent the same fraction of the Company's share capital,

which is denominated in euros. Each share entitles its holder to one voting right.

On 5 November 2018, Mithra’s Extraordinary General Meeting approved the issuance of a maximum of 1,881,974

warrants under the Warrant Plan 2018, for the benefit of key employees, members of the management team and

certain Directors. The warrants are expiring five years (maximum holding period) after the date of issuance. They are

generally not transferable and in principle, cannot be exercised prior to the date of the grant’s second anniversary

(i.e. as from 6 November 2020 subject to exercise conditions). The warrants are subject to vesting conditions which

have all been met in 2019. Each warrant gives the right to subscribe to one new Mithra share. Should the warrants

be exercised, Mithra will apply for the listing of the resulting new shares on Euronext Brussels. The warrants as such

will not be listed on any stock exchange market.

Out of the maximum of 1,881,974 warrants which have been issued, a number of 1,394,900 have been offered and

accepted by beneficiaries until the period under review.

Following the implementation of the new BCCA, the Board of directors decided to issue a new warrant plan (Warrant

Plan 2020) within the framework of the authorized capital for members of its personnel. The purpose of the Warrant

Plan 2020 is to create a share option plan for the members of the personnel in accordance with the provisions of the

BCCA. The number of share options issued under this plan, 390,717 warrants, is the same as the number of share

options which have not yet been granted under the Warrant Plan 2018 which was created in November 2018 in

accordance with the provisions of the (old) Belgian Companies Code of 7 May 1999. Therefore, the Board of directors

also decided to no longer grant an equal number of outstanding share options under the Warrant Plan 2018 that

have not yet been granted to the selected participants of the Warrant Plan 2018. The Warrant Plan 2020 has a

longevity period of 10 years and is not subject to vesting conditions.

Additionally, a number of 1,394,900 of new warrants (representing 1,394,900 new shares) shall in principle be

exercisable, as from 6 November 2020 subject to exercise conditions pursuant to the Warrant Plan 2018. The

amount of 390,717 warrants issued as per the Warrant Plan 2020, representing 390,717 new shares are immediately

exercisable upon grant. Up to date an amount of 326,000 warrants has been granted per this 2020 Warrant Plan.

In 2022, nine (9) members of the Executive Management Team (including CEO) perform their functions based on a

service agreement, whereas four (4) members of the Executive Management Team are engaged based on an

employment agreement. Both sorts of contracts can be terminated at any time, subject to certain pre-agreed notice

periods, which may, at the discretion of the Company, be replaced by a corresponding compensatory payment.

The service agreement with the CEO, Van Rompay Management BV, sets out a notice period (or notice indemnity in

lieu of notice period) of 1 month.

The members of the Executive Management Team perceive part of their remuneration as a fix amount and part of

their remuneration in the form of warrants.

The grant of warrants to members of the Executive Management Team has been duly justified in all the issued

warrant plan and is performance related driven in order to keep the Executive Management Team interested in the

long-term performance of the Company. The purpose is to attract high qualified profiles to help the Company achieve

its goals.

Remuneration evolution

In the last five years, the performance of the Company scaled up as the Company progressively signed license and

supply agreements as the clinical studies for its product portfolio were moving forward. Notably the Company has

performed significantly well in 2018 and 2019 signing several landmark deals and cashing in important milestones

payments.

In 2022, the Company did not sign any significant deals reducing its EBIT.

Upon recommendation of the Nomination and Remuneration Committee, on 23th November 2021, the Board of

directors approved a bonus plan, which aims at motivating and retaining management. Among other things, this

bonus plan provides that:

a) in case of a transaction leading inter alia to a change of control over the Company and/or its affiliates,

members of the executive management team and certain other managers shall be entitled to a bonus of an

aggregate amount of 0.75% of the aggregate purchase price of the shares sold in the transaction; or

b) should such transaction as mentioned in a) above have not yet occurred, in case the Company’s market

capitalization exceeds EUR 1,5 billion for a period of 30 consecutive trading days, members of the executive

management team shall be entitled to a bonus of 2% of the average amount by which the market capitalization

exceeds EUR 1,5 billion during the relevant period. The bonus mentioned in b) above shall only become payable once.

This bonus plan is no longer into force.

Remuneration of Executive Committee, Employees and Company Performance over 5 years.

The below table is a summary of the evolution of total remuneration of the CEO, Executive Committee, the average

employee cost compared to company performance over the last five years.

Thousands of Euro (€)

2018

2019

2020

2021

2022

Remuneration of CEO

1,225

1,009

919

440

493

Change year on year

-18%

-9%

-52%

12%

Remuneration of the Executive Management Team

2,353

2,537

2,538

3,259

3,382

Change year on year

28%

Company performance

Research and development expenses

35,713

57,073

78,458

85,243

64,041

Change year on year

60%

37%

-25%

Cash and cash equivalents at end of period

118,949

49,720

138,675

32,872

28,285

Change year on year

-58%

179%

-76%

-14%

Average share price

25.70

26.40

20.40

21.32

9.71

Change year on year

-23%

-54%

FTE during the year

118

160

206

238

249

Change year on year

36%

29%

16%

Average cost of employees on FTE basis

Average cost per FTE

67.49

69.20

67.91

75.32

87.89

Change year on year

-2%

11%

17%

For further explanations with respect to the personnel benefit on a consolidated basis, please refer to section 9.21.

Total Remuneration of CEO versus Lowest Remunerated Employee

The below table shows a comparison of the 2022 remuneration of our CEO (in €), to the 2022 remuneration of the

lowest paid fulltime Company employee (in €). The remuneration includes fixed and variable remuneration as well as

employee benefits, excluding employer social security charge.

2022

Ratio of total remuneration of CEO versus lowest

remunerated employee

1:17

During fiscal year 2022, the lowest remuneration of the Company’s employee amounted to a yearly gross amount of

EUR 29,696 whereas the highest remuneration granted at management level goes to the CEO, with a yearly gross

amount of EUR 492,623.

Claw-back provisions

As disclosed in the Remuneration Policy of the Company approved by the annual General Meeting of May 20

, 2021,

and in deviation from principle 7.12 of the CCG, up until now, there is no possibility for the Company to reclaim the

variable remuneration paid to Executive Management or to the CEO. However, the Board of Directors undertakes to

include this possibility further on and to amend the current contracts containing variable remuneration provisions to

reflect this possibility.

Miscellaneous

In general, the company has no intention to compensate in a subjective or discretionary manner.

Transactions within the authorized capital

By virtue of the resolution of the ordinary and extraordinary general shareholders' meeting of the Company held on

May 2021, as published by excerpt in the Annexes to the Belgian Official Gazette of 27 May 2021 under number

0332497, the Board of directors of the Company has been granted certain powers to increase the Company's share

capital in the framework of the authorized capital. The powers under the authorized capital have been set out in

Article 7 of the Company's Articles of Association. This authorization granted to the board of directors to increase

the share capital of the company in one or several times has been renewed by the extraordinary general meeting

dated 21 October 2022 as from the publication in the Annexes to the Belgian Official Gazette made of 26/10/2022,

with an aggregate total amount equal to up to 100% of the amount of the Company's share capital.

Therefore, in the framework of this authorization granted by the ordinary and extraordinary general shareholders'

meeting, the Board of directors has been authorized to increase, in one or more transactions, the share capital of the

Company within the limits provided by law, in particular by issuing convertible bonds and subscription rights. The

Board of directors is specifically authorized to use this authorization for the following transactions:

• Share capital increases or issuances of convertible bonds or subscription rights with disapplication or

limitation of preferential subscription rights of the shareholders;

• Share capital increases or issuances of convertible bonds or subscription rights with disapplication or

limitation of preferential subscription rights of shareholders to the benefit of one or more specific persons,

other than members of the personnel of the Company and its subsidiaries;

• Share capital increases effected by incorporation of reserves.

The capital increases that can be affected according to the aforementioned authorization may take any form

whatsoever, in particular contributions in cash or in kind, with or without issue premium, and also by incorporation

of reserves and/or issue premiums and/or profits carried forward, to the extent permitted by law.

The aforementioned authorization is valid for a period of five (5) years as of the date of the publication of the relevant

resolution of the extraordinary general shareholders' meeting in the Annexes to the Belgian Official Gazette, i.e.,

starting on 26 October 2022.

During the period under review, the Company used the previous authorization with respect to the use of the

authorized capital granted to the Board of directors on the extraordinary general meeting dated 29 November 2019

as published in the Annexes to the Belgian Official Gazette on the 30 December 2019 under the number 19168869 ,

renewed by the extraordinary general meetings on 20 May 2021 and 21 October 2022 for the following:

- On 7 February 2022, the Company entered into an equity financing agreement with Goldman Sachs

International (GSI), pursuant to which the Company can at its sole discretion require GSI (subject to certain

conditions) to provide funding to the Company for an aggregate amount of up to EUR 100,000,000 (the

“Committed Amount”) in return for issuing GSI with call options over the Company’s ordinary shares. The

first drawing request, exercised on 4 February 2022, amounts to EUR 10 million. This drawing request

resulted in the issuance of 377,198 shares of the Company on the 21 March 2022 and in the issuance of

489,686 shares of the Company on the 19 April 2022. The maximum amount that can be drawn by the

Company on each subsequent occasion will be EUR 5 million or, if certain conditions are satisfied, up to

EUR 7.5 million;

- On 14 February 2022, the Company issued 442,191 new shares following a Put Option Notice issued on 20

December 2021 in the framework of LDA capital commitment agreement. This was the third put option

notice related to this agreement;

- On 21 March 2022, the Company exercised a second drawing request under the equity funding agreement

with Goldman Sachs. This exercise resulted in the issuance of 725,300 shares of the Company on the 25

May 2022;

- On 18 April 2022, the Company announced the extension of the Capital Commitment Agreement with LDA

Capital by two years as well as the increase of the commitment amount by 25 Mi EUR. As a reminder, under

the terms of the initial agreement entered into in April 2020, LDA Capital had committed an amount of up

to EUR 50 million in cash within a maximum of three years in exchange for new ordinary shares in Mithra;

- On 22 June 2022, the Company announced a private placement for an aggregate amount of 23,5 Mi EUR.

The private placement resulted in the issuance of an aggregate of 3.871.471 new ordinary shares of the

Company;

- On 30 June 2022, the Company announced the issuance of 625,000 new shares today following the fourth

Put Option Notice issued on 13 May 2022 in the framework of LDA capital commitment agreement entered

into April 2020 and extended in April 2023;

- On 8 August 22, the Company entered into a senior secured convertible facilities agreement with funds

managed by Highbridge Capital Management, LLC (collectively, "Highbridge") and funds managed by

Whitebox Advisors LLC (collectively, "Whitebox", and together with Highbridge, each a "Lender"), for a three-

year term, in an amount of up to EUR 100 million. The loan facility is for a principal amount of up to EUR

100 million, to be drawn in three tranches, with a maximum amount outstanding at any time not greater

than EUR 65 million or, depending on the satisfaction of certain conditions, EUR 75 million;

- On 10 August 2022, following the first drawdown by the Company under the loan facility concluded with

Highbridge and Whitebox (the “Lenders”), a first portion of the commitment fee due by the Company was

settled in new shares and a first portion of the loans were contributed in kind by the Lenders against the

issuance of 238, 337 new shares. Following the drawdown, a portion of the loans (including accrued

interest, as relevant, and an option payment amount) was contributed in kind for an aggregate amount of

EUR 6,316,288.08 through the issuance of 806,076 new shares at an issue price of EUR 7.84 per share, and

an aggregate amount of EUR 1,263,418.02 through the issuance of 155,248 new shares at an issue price

of ca. EUR 8.14 per share ;

- On 17 August 2022, another portion of the loans (including accrued interest, as relevant, and an option

payment amount) was converted with the issuance of 61,913 new shares ;

- On 22 August 2022, another portion of the loans was converted with the issuance of 799,861 new shares ;

- On 29 August 2022, another portion of the loans was converted with the issuance of 103,128 new shares ;

- On 5 September 2022, another portion of the loans was converted with the issuance of 118,704 new

shares ;

- On 14 September, another portion of the loans was converted with the issuance of 97,670 new shares ;

- On 23 September 2022, another portion of the loans was converted with the issuance of 319,160 new

shares ;

- On 27 September 2022, another portion of the loans was converted with the issuance of 73,972 new shares ;

- On 18 October 2022, another portion of the loans was converted with the issuance of 171,535 new shares ;

- On 2 November 2022, another portion was converted with the issuance of 36,667 new shares ;

- On 17 November 2022, another portion of the loans was converted for a total of 305.961 new shares ;

- On 21 November 2022, another portion of the loans was converted with the issuance of 262,424 new

shares ;

- On 30 November 2022, another portion of the loans was converted with the issuance of 631,359 new

shares ;

- On 2 December 2022, another portion of the loans was converted with the issuance of 286,724 new shares ;

- On 6 December 2022, another portion of the loans was converted with the issuance of 317,985 new shares ;

- On 22 December 2022, another portion of the loans was converted with the issuance of 684,125 new

shares ;

- On 30 December 2022, the Company issued 262,000 new shares following a fifth Put Option Notice issued

on 17 November 2022 in the framework of LDA capital commitment agreement entered into April 20202

and extended in April 20223.

Post-period:

- on 14 February 2023, another portion of the loans was converted with the issuance of 276,120 new shares;

- on 14 March 2023, another portion of the loans was converted with the issuance of 482,528 new shares;

On the date of this report, the capital is therefore of EUR 41.783.378,35, with a total number of securities carrying

voting rights of 57,073,622 (all ordinary shares).

Acquisition of own securities

Neither Mithra Pharmaceuticals SA nor any direct affiliate or any nominee acting in his own name but on behalf of

the Company or of any direct affiliate, have acquired any of the Company’s shares. Mithra Pharmaceuticals SA has

not issued profit-sharing certificates or any other certificates.

Use of financial instruments by the Group as per art. 3:6 CCA

The Group uses derivative financial instruments to manage its exposure to foreign exchange risk arising from

operating activities (cash flow hedge). Mithra's risk management objective is to hedge the US Dollars (USD) foreign

currency exposure arising from the Estelle

license and supply agreement in USD between Mithra and Mayne

Pharma LLC. Mithra has hedged 166 million USD in 2022, arising from the regulatory and sales related license

milestones under the Mayne Pharma agreement, by forward exchange contracts maturing in the period 2023-2025

and entered into by Mithra Pharmaceuticals SA and Estetra SRL.

The Group uses debt instruments. In December 2020, the Group negotiated a EUR 125 million senior unsecured

convertible bonds due 17 December 2025. The Bonds will be convertible into ordinary shares of the company. The

Bonds were issued at 100% of their principal amount and bear a coupon of 4.250% per annum, payable semi-annually

in arrear in equal instalments on 17 December and 17 June of each year, beginning on 17 June 2021.

The Company announced on 8

August 2022 that it has entered into a senior secured convertible facilities

agreement with funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) and funds

managed by Whitebox Advisors LLC (collectively, “Whitebox”, and together with Highbridge, each a “Lender”), for a

three years term, in an amount of up to EUR 100 million. Part of the proceeds of the loan has been used to repurchase

outstanding convertible bonds of the Company held by the Lenders for a principal amount of EUR 34.1 million at a

discount.

Circumstances that could considerably affect the development of

the Group

The Group has a business structure; built on:

(i) a development portfolio which includes the development of Estetrol-based product candidates

in the menopause indications as well as other potential indications such as wound healing, NHIE,

and of Complex Therapeutics;

(ii)

the CDMO development and manufacturing facility, which will manufacture an important part of

its innovative products, but also provides services for customer in terms of development and

manufacturing of third parties’ products);

(iii)

a commercialized portfolio of our Estetrol-based product candidate Estelle

in the field of oral

contraception in several regions, branded generics, OTC products in several regions; and

(iv) a diversification of the R&D pipeline through rights’ acquisition option relating to a development

programs led by the Belgian company BCI Pharma on innovative kinase inhibitors notably

indicated for the treatment of female cancers and endometriosis.

Therefore, the risk factors related to each of these pillars are presented separately (as each has a different set of

risks associated with it). As Mithra has transitioned towards a commercial biopharma company in the years 2021-

2022, most focus is on the development portfolio and products’ commercial launch.

The Group’s exposure to price risk, credit risk, liquidity risk and cash flow risk are detailed in note 9.3 (Financial Risk

Management).

I. Risks relating to Mithra's financial situation

Mithra has incurred net losses, negative operating cash flows and an accumulated deficit since inception and may

not be able to achieve or subsequently maintain profitability.

Mithra has incurred net losses and negative operating cash flows in each period since 2020. As of 31 December

2022, Mithra has a loss brought forward of EUR 367.9 million. These losses have resulted principally from costs

incurred in research and development and general administrative costs. Mithra intends to continue its clinical trial

program for its products’ candidate (including in particular Donesta®), conduct pre-clinical trials in support of clinical

development and regulatory compliance activities, which, together with anticipated general and administrative

expenses, will result in Mithra incurring further significant expenses for the next several years.

On the other hand, the revenues associated with Mithra's current clinical development activities (other than license

revenue), such as Donesta® or Zoreline®, are not expected to materialize before 2025. Mithra launched its Estelle®

product during 2021 and launched its Myring® product in 2019 in Europe and the rest of the world, with launch in

the United States post period in the beginning of 2023. Mithra's revenues from Estelle® and Myring®, have not been

sufficient to compensate for its research and development and general and administrative expenses. This has been

due to a range of factors, including the fact that these products are in the early stages of commercialization and the

relatively long-time scale required for pharmaceuticals companies to realize a return on their research and

development investments. For those reasons, Mithra might continue to incur further losses for the next few years. If

the revenues associated with the launch of its future products do not materialize at the level expected by

management, Mithra's ability to sustain its operations may be impaired.

Mithra will require additional funds during and beyond this period in order to meet its operating and capital

expenditure needs, such as licensing milestones (Donesta® or Estelle®), the proceeds of financing/equity

transactions, exploration of strategic options to unlock the value of our assets and co-development strategies on

some new indications to reduce the amount of R&D expenses supported by Mithra.

On 23 April 2020, the Company, LDA Capital, LLC, and the Share Lending Shareholders entered into the LDA Put

Option Agreement, pursuant to which (as amended), LDA Capital agreed to commit a maximum amount of EUR

75,000,000.00 in cash within a maximum of five years in exchange for new ordinary Shares in the Company. This

amount is to be released, based on drawdowns by the Company in the form of put options which the Company has

the right to exercise at its sole discretion (via so-called "put option notices"). At the date of the annual report, five put

options have been exercised and settled (three of which were settled in 2022), for a total amount of EUR

22,193,021.00, the remaining amount committed by LDA Capital under the LDA Put Option Agreement to be

(potentially) invested in the Company by LDA Capital being EUR 52,806,979.00.

On 4 February 2022, the Company and GSI entered into the GSI Financing Agreement pursuant to which the

Company may require GSI (subject to certain conditions) to provide financing to the Company in an aggregate

amount of up to EUR 100,000,000.00, by way of several drawings and against issuance of new Shares. At the date

of the annual report, two drawdowns have been made and settled for a total amount of EUR 15,000,000.06, the

remaining amount committed by GSI under the GSI Financing Agreement to be (potentially) converted into shares,

being EUR 84,999,999.94. It is, however, noted that one of the conditions for the Company to be able to make a

drawdown under the GSI Financing Agreement is that the lowest daily volume weighted average trading price of the

Company's shares during the 10 trading days preceding the date of the Company's drawdown request must not be

less than EUR 10.00 per share. This limits the use of the GSI Financing Agreement as a source of funding for the

Company as long as the Company's Share price as traded on Euronext Brussels is below such level. [On the date of

this annual report, the Share price is below EUR 10.00].

On 8 August 2022, the Company and the Lenders (as defined below) entered into the Facilities Agreement (as defined

below), pursuant to which, the Lenders agreed to provide, for a period of three years from the date of the Facilities

Agreement, a financing by loans convertible into Shares to the Company for a maximum aggregate principal amount

of EUR 100,000,000.00, to be drawn in several tranches (subject to the fulfilment of certain conditions), with an

outstanding amount at any time not greater than EUR 65,000,000.00 or, subject to the satisfaction of certain

conditions, EUR 75,000,000.00, the loans bearing interest in principle at a rate of 7.5% per annum. At the date of the

annual report, the Company has already drawn down the first tranche in the amount of EUR 50,000,000.00 and the

second tranche in the amount of EUR 25,000,000.00, for a total aggregate drawn amount of EUR 75,000,000.00.

Furthermore, as subsequent drawdowns are subject to the fulfilment of certain conditions, it is not certain whether

to the Company will be able to complete such subsequent drawings under the Facilities Agreements.

Post-period, the 15th February 2023, Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”)

announced that they signed a license agreement for the commercialization of Donesta®, a novel product candidate

for the treatment of post-menopausal symptoms. Under the terms of the license agreement, Mithra is eligible to

receive EUR 55 million in upfront payment – EUR 5 million was paid upon signature of the binding term sheet in

December 2022 and EUR 50 million in February upon signature of the license agreement.

Considering the financing obtained and still available pursuant to the funding initiatives summarized above in

addition to expected licensing milestones and potential sale of assets, Mithra is of the opinion that, taking into

account its available cash and cash equivalents, it does have sufficient working capital to meet its present

requirements and cover the working capital needs for a period of at least 12 months as of the date of this annual

report.

If Mithra is unable to obtain financing or enter into other business arrangements as described above to sustain its

operations, it may not be able to ensure its going concern. In consequence, marketing activities, R&D activities,

regulatory approval processes, studies, etc. would need to be put on hold, which would also prevent Mithra to create

additional revenues, which would then prevent Mithra from being able to operate.

Changes in currency exchange rates could have a material negative impact on the profitability of Mithra.

Fluctuations in exchange rates outside the anticipated range may affect Mithra's revenues, expenses, or the ability

to raise future capital if it is needed. The exchange rates between different currencies may be volatile and vary based

on a number of interrelated factors, including the supply and demand for each currency, political, economic, legal,

financial, accounting and tax matters and other actions that Mithra cannot control.

Mithra is materially exposed to both the U.S. Dollar and the Australian Dollar. The most significant U.S. Dollar

exposure relates to the significant backlog of license milestones which remain to be collected in the coming years

under the U.S. License and Supply contract signed with Mayne Pharma and relating to Estelle

. End of 2022, Mithra

proceeded to an early settlement of a derivative financial instrument of USD 50 million in order to decrease the

impact of the realized foreign exchange loss (EUR 5.5 million).This means that the global amount of regulatory and

sales related milestones payments arising from the contract and hedged has decreased by USD 50 million (USD 167

million as at 31 December 2022 compared to USD 217 million as at 31 December 2021).

The U.S. License and Supply contract with Mayne Pharma also includes consideration received in the form of Mayne

Pharma's ordinary shares. Mayne Pharma issued 4.95% of its outstanding shares to Mithra when signing the

contract and a further 4.65% was issued after receipt of FDA approval for Estelle

in 2021, resulting in the Company

becoming the largest shareholder of Mayne Pharma. Mayne Pharma is an Australian-listed company on ASX. This

exposure to the Australian Dollar is not currently hedged.

Since 2020, Mithra uses derivative financial instruments to manage its exposure to the U.S. Dollar arising from

operational activities in the form of cash flow hedges. Mithra's risk management objective is to hedge the U.S. Dollar

exposure arising from the Estelle

license and supply agreement contracted in U.S. Dollar between Mithra and Mayne

Pharma. This exposure is hedged with foreign exchange forward contracts.

Since the hedging strategy, EUR weakened significantly towards USD, with the foreign currency spot rate decreasing

from 1,13 to 1,07. This has caused the market value of FX derivative hedges to decrease from EUR 3,574k at 31

December 2020 (beginning of hedging strategy) to EUR -10,225k at 31 December 2022

If Mithra is unable to continue to hedge its foreign exchange rate exposure, or if it experiences losses in its hedge

position due to foreign exchange rate fluctuations, this could contribute to the operating losses and negative cash

flows it has historically experienced.

II. Risks relating to the E4 pipeline

If Mithra is unable to enter into a partnership or strategic alliance for the further development and commercialization

of Donesta® or its other product candidates, it may incur additional costs, and/or the development of these products

might be delayed.

Mithra does not have a commercial organization in place to launch its product candidates on its own. Before the

commercialization of Estelle

(outside of Gedeon Richter’s territories), Mithra had never marketed a product outside

of the Benelux region and it therefore has limited experience in sales, marketing and distribution in other markets.

Mithra does currently not intend to deploy itself as a sales and distribution organization anywhere in the world and

will rely for the distribution of its products on license and supply deals with commercial partners.

Moreover, Mithra plans to enter into a strategic alliance or commercial partnership for the further development and

commercialization of Donesta

as well as its future product candidates. Such arrangements may require Mithra to

incur additional expenses, increase its capital expenditures, issue securities that dilute its shareholders or disrupt its

management and business. In addition, Mithra faces significant competition in seeking appropriate strategic

partners and the negotiation process can with such parties be time consuming and complex. Additionally, Mithra

may not be successful in its efforts to establish a partnership or other strategic alliance for Donesta

or its other

future product candidates because these products may be deemed to be at too early development stage for

collaborative effort and third parties may hence not view them as having the requisite potential. Furthermore, Mithra

cannot be certain that, following any strategic alliance or commercial partnership, it will achieve the level of revenues

that would justify such an agreement. Any delays in entering into new strategic partnership agreements related to

Donesta

and/or future product candidates could also delay their development and commercialization and reduce

their competitiveness even if they reach the market.

If Mithra is unable to identify a strategic alliance or commercial partnership for a particular product, it would need to

complete the clinical and manufacturing development, proceed with the associated regulatory filings on its own and

commercialize the product through its own sales force. In that event, Mithra might need to invest significant financial

and management resources. This would likely lead to an increase in its research and development costs, which were

EUR 85.2 million and EUR 64 million end of 2021 and 2022, respectively. Furthermore, its sales force might not be

well equipped to market these products, which could adversely affect the revenues Mithra is able to earn from them.

Other than Estelle

, no Estetrol-based product candidates have been formally registered or commercialised and the

successful development of Mithra's other estetrol-based product candidates remains uncertain due to the

complexity and unpredictability of clinical trials.

Other than Estelle

, which has been approved to date in various countries worldwide, mainly in North America and

Europe, Mithra's estetrol-based product candidates have not been approved or commercialised. Estelle

accounted

for 59.1% and 51.4% of Mithra's revenue end of 2021 and 2022, respectively.

Notwithstanding the approval of Estelle

in these jurisdictions, all of Mithra's estetrol-based product candidates will

be subject to extensive pre-clinical and clinical trials to demonstrate safety and efficacy in humans before Mithra

can apply for the necessary regulatory approval potentially to obtain marketing authorisations from the relevant

regulatory authorities. In particular, Mithra's Donesta

Phase III Clinical Program is ongoing, with topline efficacy

results having been reported in 2022 and primary safety data from the C302 trial (North America) early in 2023 while

the theC301 trial (EU, Russia, Latin America, United States and Canada) is anticipated in H1 2024. Mithra believes

that it could achieve marketing authorisation for Donesta

in the first half of 2024 for the United States and in the

first half of 2025 for Europe. Thereafter, the timing for the commercialisation of Donesta

remains uncertain in the

US, in particular given Mithra's intention to enter into a strategic partnership agreement to achieve this. See " —If

Mithra is unable to enter into a partnership or strategic alliance for the further development and commercialisation

of Donesta

or its other product candidates, it may incur additional costs, and/or the development of these products

might be delayed". See also "Business — Principal activities —Donesta

- An innovative hormone therapy targeting

several major menopausal symptoms".

Furthermore, Mithra is currently developing other Estetrol-based products in neuroprotection for the treatment of

hypoxic-ischemic encephalopathy ("HIE") in neonates and wound healing. Mithra’s Phase I clinical program started

in 2022. Mithra’s wound healing project is in preclinical development. These products will require substantial

technical, preclinical and clinical developments and testing prior to receiving marketing approvals. Their future

commercialization and the generation of additional revenues linked to these products, will significantly depend on

Mithra’s ability to successfully develop, register and commercialize those products.

Prior to initiating a clinical trial, Mithra requires regulatory and ethical approval from the competent authorities.

Mithra and the relevant regulatory authorities may not agree on a clinical trial design or, if a clinical trial design is

accepted, one or more clinical trial endpoints may not be achieved, and that may undermine support for regulatory

approval. Clinical trials remain subject to ongoing review and monitoring throughout their duration, and with certain

exceptions, changes made to the trial protocols after approval is received must also be approved prior to

implementation. Failure to obtain or maintain the approvals required to conduct a clinical trial for Donesta® or any

other estetrol-based products could significantly delay or prevent the completion of such trials, necessitate

additional testing or a re-design of the clinical trial, incur significant additional time and costs and/or prevent Mithra

from achieving or maintaining profitability.

Regulators may also require Mithra to amend ongoing trials or perform additional trials, which could result in

significant delays and additional costs or may be unsuccessful.

Furthermore, clinical trials may not produce the anticipated clinical efficacy outcomes, or may uncover previously

unknown safety issues or risks. Interim results of clinical trials do not necessarily predict final results, and success

in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful. Further trials

may uncover issues not yet discovered by previous pre-clinical or clinical testing, which could lead to delays or

suspension of the clinical trials.

Mithra cannot predict with certainty how long it will take to complete necessary clinical trials or obtain regulatory

approvals of its current or future products. The time needed to complete clinical trials and obtain regulatory

approvals varies by product, indication, and country.

If Mithra's clinical trials are delayed, or if they do not produce the anticipated clinical efficacy outcomes, this could

prevent it from achieving the commercialisation of Donesta

or any of its other estetrol-based products in the

expected timeframe, which would in turn delay the timing of expected revenues from these products or prevent

Mithra from ever earning revenues from these products.

Even if Mithra obtains marketing authorisations for Donesta

or any other Estetrol-based products, future clinical

trials may uncover previously unknown safety issues or risks or suggest that these products do not significantly

improve clinical outcomes. Such results would slow or possibly stop the adoption of these products, or potentially

lead to market authorisation suspension or withdrawal by regulatory authorities.

Further trials designed to support additional indications for an authorised product may not achieve targeted clinical

outcomes. This would jeopardise anticipated further/wider adoption of the product.

If Mithra experiences delays or difficulties in the recruitment of Investigators, obtaining necessary approvals from

trial sites or the enrolment of subjects in clinical trials, or trial sites failure to adhere to trial protocols and good clinical

practices (GCP) regulations or similar regulations its receipt of necessary regulatory approvals could be delayed or

prevented.

Performing clinical trials requires the engagement of many hospitals, clinics, and clinicians. In particular, Mithra must

engage a physician at each clinical trial center to maintain overall responsibility for conduct of the clinical trial. Each

Investigator may have additional physicians working under his or her direction to conduct a trial. Furthermore, Mithra

is required to obtain necessary approvals from the trial sites where it conducts its clinical trials, including approvals

from institutional review boards/ethics committees and competent agencies, which are required for clinical trials.

Mithra may not be able to attract sufficient qualified Investigators to conduct clinical trials within an adequate

timeframe, and those investigators may not be able to attract or enroll sufficient subjects to meet Mithra's clinical

trial objectives and inclusion/exclusion criteria. Any difficulties in enrolling a sufficient number of subjects, failure to

conduct the clinical trial in accordance with regulatory requirements or the approved trial protocols or difficulty

obtaining approvals from trial sites for any of its clinical trials could result in significant delays or suspension of the

trial and could require Mithra to abandon one or more clinical trials altogether. Any such delays may result in

increased research and development costs that may exceed the resources available to Mithra and in delays to

commercially launching Donesta® and/or any future products in target markets, if approved. Mithra's research and

development costs have historically far exceeded its revenue. Mithra recorded research and development costs of

EUR 85.2 million and EUR 64 million end of 2021 and 2022, respectively.

Mithra is currently heavily focused on, and investing in, the development of its estetrol-based product candidates. Its

ability to realise substantial product revenues and, eventually, profitability in line with the investments envisaged will

significantly depend on its ability to successfully develop, register and commercialise estetrol-based product

candidates.

Mithra has, to date, received approvals for Estelle

in various countries worldwide, mainly in North America and

Europe and the product is being commercialised progressively around the world. Nevertheless, it remains at the early

stages of commercialisation. Furthermore, Mithra is still pursuing the development of its other E4-based products,

such as its development programs in menopause, neuroprotection for the treatment of hypoxic-ischaemic

encephalopathy ("HIE") in neonates and wound healing. Mithra is dedicating the majority of its available cash

resources to the development of its product candidates. The development, registration and commercialisation of

these products present significant new challenges. In preparation, Mithra has expanded and continues to expand its

organisation and has attracted and continues to attract a number of experienced collaborators. However, it may not

be able to successfully integrate their experience and know-how, and to continue to further successfully expand its

organisation and successfully conclude every development step. Any failure to do so could cause delays in the

product development or non-clinical formulation and/or the regulatory approval process for these products, which

could ultimately delay or even prevent the commercialisation of Mithra's innovative product candidates.

If Mithra is unsuccessful in developing, commercialising and/or identifying partners with respect to its estetrol-based

products, the nature of Mithra's pipeline would comprise the continued commercialisation of Estelle

, as well as the

development (either directly or indirectly) of complex therapeutics products and injectables. Mithra recorded EUR

13.4 million and EUR 9.2 million in revenue from Estelle

end of 2021 and 2022, respectively, with the remainder of

its revenue in 2022 being attributable to out-licensing revenue related to the signature of a Donesta

deal with

Gedeon Richter. The market opportunities for these products is significantly more limited in scope than the market

opportunity offered by Mithra's E4 pipeline. Accordingly, if Mithra is forced to shift its focus to complex therapeutics

and injectables and away from E4-based products, management expects that Mithra's revenues and profitability

would be severely impacted.

The triggering of certain milestone payments and "royalty payments" may be discontinued at any time based on a

review of available pre-clinical and clinical data, the estimated costs of continued development, market

considerations and other factors.

Mithra has entered into a number of contracts through which it "out-licenses" to customers the intellectual property

it has developed related to drugs that have not yet received regulatory approval. Generally, under the terms of these

licenses, the licensee can further develop the intellectual property and can manufacture and/or sell the resulting

commercialised product. Mithra typically receives an upfront fee, milestone payments for specific clinical or other

development-based outcomes, and sales-based milestones or royalties as consideration for the relevant license.

Some arrangements also include ongoing involvement by Mithra, which may provide research and development

and/or manufacturing services relating to the licensed intellectual property.

During 2022, contract assets amount to EUR 47.8 million (non-current and current) versus EUR 12.8 million in 2021.

The variance relates to out-licensing revenue, mainly from Gedeon Richter (EUR 43.2 million of contract assets),

offset by unbilled revenues recognized in prior years and billed in 2022 (among which EUR 1million to Gedeon Richter

and EUR 8.1 million to Mayne Pharma).

Under the U.S. License and Supply contract signed with Mayne Pharma and well as Mithra's other licensing

arrangements, milestone payments can be suspended based on a review of available pre-clinical and clinical data,

the estimated costs of continued development, market considerations and other factors. For that reason, if the

commercialisation of Estelle® does not proceed as anticipated by Mithra, it may not receive the EUR 287 million that

remains to be collected under the contract in the timeframe it expects or at all. The achievement of the commercial

milestones under the contract will depend on the performance of Mithra's commercial partners in their respective

markets, which are described under " — Risks relating to commercialisation". In addition, Mithra is subject to foreign

exchange risk in relation to the U.S. License and Supply contract due to the payments thereunder being payable in

U.S. Dollars, as well as the Australian listing of Mayne Pharma. See " — Risks relating to Mithra's financial situation

— Changes in currency exchange rates could have a material negative impact on the profitability of Mithra".

Mithra is subject to similar risks in relation to its future product candidates, including Donesta

, with respect to which

it is considering entering into a licensing agreement to fund its future clinical development.

Mithra depends on third party suppliers for manufacturing, pharmaceutical ingredients and other raw materials and

any disruption of the supply chain or unavailability of third-party services could have a material adverse effect on

Mithra. Currently Mithra relies on a key E4 tolling supplier and it has signed binding heads of terms in order to secure

alternative options for the transformation of estetrol in the future. If current negotiations do not result in

commercially favourable terms for Mithra, this could impact its cost of goods and thus the profitability of Estelle

Moreover, if the difficult market conditions arising from the outbreak of COVID-19 and the conflict in Ukraine persist

and impact its supply prices or if this results in a shortage of raw materials, Mithra might not be able to comply with

its supply commitments regarding its partners. See “ — Risks relating to the Mithra’s dependence on third parties

and on key personnel”.

III. Risks relating to commercialisation

Mithra's future financial performance will depend on the commercial acceptance of Estelle

, Donesta

and its other

products in target markets.

At the date of this Prospectus, Estelle

is the only E4-based product that has been commercialised by Mithra. Estelle

accounted for 59.1% and 51.41% of Mithra's revenue in the year ended 31 December 2021 and, in the year, ended 31

December 2022, respectively. Furthermore, Estelle

only received regulatory approval from the FDA relatively

recently, in 2021. Estelle

has been approved in various countries worldwide, mainly in North America and Europe as

of the date of this Prospectus and will be rolled out commercially in other countries in the coming years. Estelle

and

other products launched by Mithra may not gain commercial acceptance in target markets. If Mithra fails to gain and

maintain commercial market acceptance of these products in its target jurisdictions, the amount of revenue

generated from sales of Estelle

and other products in the future could fail to grow as management expects and

could even decrease. In addition, Donesta

has not yet received marketing approval in any jurisdictions and Mithra's

future financial performance will depend on the successful completion of its planned clinical trials on Donesta

Mithra believes that it could achieve marketing authorisation for Donesta

in the first half of 2024 for the United

States and in the first half of 2025 for Europe. Thereafter, the timing for the commercialisation of Donesta

remains

uncertain, in particular given Mithra's intention to enter into a strategic partnership agreement to achieve this. See "

—If Mithra is unable to enter into a partnership or strategic alliance for the further development and

commercialisation of Donesta

or its other product candidates, it may incur additional costs, and/or the development

of these products might be delayed". See also "Business — Principal activities —Donesta

- An innovative hormone

therapy targeting several major menopausal symptoms".

Many factors can influence market acceptance of Mithra's products, including:

- approval from the appropriate regulatory authorities or unavailability of Mithra's products due to

regulatory barriers;

- price and reimbursement levels from third party payers;

- successful completion of the clinical development of Donesta® and Mithra's other products;

- FDA and other target market regulatory authority approval of Donesta® and Mithra's other products;

- macroeconomic conditions in the countries in which Mithra's products are marketed and sold, including

the impact of the COVID-19 outbreak or any similar infectious disease outbreak;

- the timing of the launch of Mithra's products in a particular market;

- inclusion in clinical practice guidelines;

- the availability of clinical evidence through trials and registries, including the Donesta® Phase III clinical

trial;

- accurate anticipation of patients', healthcare providers' and payers' needs and emerging technology

trends;

- frequency and/or severity of complications or side effects arising from Mithra's products;

- competition, the convenience and ease of use of Mithra's products compared to competing products and

other potential advantages and disadvantages over alternative products and services;

- production barriers such as interruptions to the supply of materials or components or Mithra's

manufacturing activities being suspended by regulatory authorities;

- the quality of service that Mithra establishes in order to support customers;

- the ability to demonstrate to physicians and other potential stakeholders the benefits and cost-

effectiveness of Mithra's products relative to other products available on the market;

- the ability of Mithra to maintain relationships with key opinion leaders in the medical community;

- entrance into additional markets or indications and the scope of the indications approved by regulatory

authorities;

- tariffs, trade barriers and other trade protection measures, import or export licensing requirements and

any other restrictive actions by the U.S. or other governments;

- the ability of Mithra to hire new sales and marketing personnel and their effectiveness in developing brand

equity, monitoring commercial performance and executing its business strategy; and

- the ability of Mithra to secure development and commercial partnerships for the marketing of Donesta®

and its other products.

These and other factors present obstacles to commercial market acceptance of Mithra's products in target markets.

Moreover, once these products gain commercial acceptance, there is a risk that they will subsequently become

obsolete, due to the rapid development of technology in the sphere in which Mithra operates and changes to the

operations of its suppliers. This could cause Mithra to fail to generate any meaningful revenue from these products

or, once it has begun to generate revenue, in a substantial reduction in such revenue. Failure, or any substantial delay,

in gaining significant commercial market acceptance of Mithra's products in target markets, on a timely basis or at

all, or the obsolescence of any of these products could limit the revenues Mithra is able to earn from sales of its

products.

Mithra's success depends in part on third party payment from government providers, healthcare insurance providers

or other public or private sources and it could fail to achieve or maintain reimbursement levels in line with its

expectations.

The existence of coverage and adequate reimbursement for Mithra's products by government and/or private payers

will be important to market adoption for its products. Mithra's strategic partners (such as Mayne Pharma in relation

to Estelle

) are responsible for obtaining reimbursement for the relevant product in each of the markets in which it

is being commercialised. If these strategic partners do not obtain adequate reimbursement for the products, this

would have an adverse effect on the revenues achievable from the products and hence the milestone payments

payable to Mithra.

In many countries, payment for Mithra's products will be dependent on obtaining a "reimbursement code" for the

product. For details of the reimbursement arrangements in the countries in which Mithra has commercialised or

plans to commercialise its products, refer to "Business — Government Regulation —Reimbursement". Obtaining a

reimbursement code can be a lengthy process (months to years) and Mithra may not be able to obtain such a code

at satisfactory levels, or at all. Following the grant of a "reimbursement code" payers (e.g. national healthcare

systems or health insurance companies) have to agree to provide coverage for the relevant product. Failure to obtain

attractive reimbursement may adversely affect Mithra's business, financial condition, results of operations and

prospects.

The price that Mithra may receive for, and the marketability of, the products for which Mithra has received or will

receive regulatory approval may suffer if government and/or third-party payers fail to provide adequate coverage and

reimbursement or if further governmental cost containment or other health reform initiatives are adopted or

implemented. From time to time, legislation is enacted that could significantly change the statutory provisions

governing the clearance or approval, manufacture, marketing or taxation of Mithra's products. In addition, regulations

and guidance are often revised or reinterpreted in ways that may significantly affect Mithra's products. It is

impossible to predict whether legislation changes will be enacted, or regulations, guidance or interpretations

changed, and what the impact of such changes, if any, may be. Mithra cannot predict what healthcare programmes

and regulations will be ultimately implemented at the U.S. federal or state level, or at the E.U. level, or within the

implementing legislation of the individual E.U. Member States, or the effect of any future legislation or regulation.

However, these types of provisions, as adopted, could materially change the way healthcare is delivered and financed,

and may materially impact numerous aspects of Mithra's business. Increasing downward pressure on healthcare

pricing and/or any changes that lower reimbursements for Mithra's products could result in product revenues

generated from sales of Mithra's products being lower than anticipated. As a result, Mithra could fail to achieve or

maintain reimbursement levels sufficient to support a commercial infrastructure or realize an appropriate return on

its investment in product development, which could materially and adversely affect Mithra's business, financial

condition, results of operations and prospects.

Mithra may also experience pricing pressures in connection with the sale of its products. Generally, governments

and third-party payers are increasingly exerting downward pressure on pricing and reviewing the cost-effectiveness

of medical products, therapies and services. With this global pressure on healthcare costs, payers are attempting to

contain costs by, for example, limiting coverage of and the level of reimbursement for new therapies.

If Mithra is unable to obtain or maintain reimbursement for its products in its key markets, this would compromise

its ability to commercialise these products on a large scale, which would in turn limit its opportunities to achieve

profitability.

The success of Estelle

and Mithra's other products depends on their acceptance and adoption by physicians and

all stakeholders involved in market access to its products.

The success of Estelle

and Mithra's other products will require acceptance and adoption by physicians and other

stakeholders (healthcare professionals, payers, etc.). Such acceptance will depend on physicians being convinced

of the distinctive characteristics, clinical performance, benefits, safety and cost-effectiveness of Estelle

and

Mithra's other products. Furthermore, physicians will most likely not adopt Estelle

or Mithra's other products unless

they determine, based on experience, clinical data and published peer-reviewed journal articles, that these products

are an attractive solution for patients.

Even if the safety and efficacy of Mithra's products is established, physicians and other healthcare professionals,

may be hesitant to change their medical treatment practices or accept and adopt Mithra's products, including for

the following reasons:

- general conservatism about the adoption of new treatment practices;

- history of adverse events;

- lack or perceived lack of long-term evidence supporting additional patient benefits;

- perceived liability risks associated with the use of new products;

- limited or lack of reimbursement and coverage within healthcare payment systems;

- other products competing for physician time and attention;

- the time commitment that may be required for special training;

- insufficient level of commercial attractiveness to physicians;

- the extent of ongoing support required by the clinician; and

- the extent of ongoing involvement of the patient in therapy.

Economic, psychological, ethical and other concerns may also limit general acceptance and adoption of Mithra's

products. Lack of acceptance and adoption of Mithra's products by a sufficient number of relevant physicians and

other healthcare professionals would substantially reduce Mithra's ability to achieve its sales forecasts and prevent

Mithra from achieving or maintaining profitability. In particular, if Donesta

is not accepted by physicians and other

stakeholders, this would represent a significant setback for Mithra and would limit its revenue growth.

If Mithra’s commercial partners are unable to expand their sales, marketing and distribution capabilities for Mithra,

Mithra may not be successful in commercialising its products in its targeted markets. Moreover, Mithra will need to

invest internally for every product about to be commercialised and from commercialisation onwards in its life cycle

management and overall brand equity.

Mithra will need to expand its internal sales and marketing organisation to commercialise its products in markets

that it will target directly. There are risks involved with expanding Mithra's own sales, marketing and distribution

capabilities. For example, recruiting and training a sales force is expensive and time-consuming and could delay

launch. In addition, Mithra may experience challenges in recruiting qualified sales and marketing personnel.

Furthermore, Mithra intends to enter into additional licensing agreements to distribute its products in other markets,

a process it is continuing to progress in relation to Estelle

. In addition, Mithra intends to enter into new strategic

partnership agreements in relation to Donesta

. See " — Risks relating to the E4 pipeline — If Mithra is unable to enter

into a partnership or strategic alliance for the further development and commercialisation of Donesta

or its other

product candidates, it may incur additional costs, and/or the development of these products might be delayed". If

Mithra is unable to find suitable partners, loses these partners or if Mithra's partners fail to sell its products in

sufficient quantities, on commercially viable terms or in a timely manner, the commercialisation of Mithra's products

could be materially harmed, which could prevent Mithra from achieving or maintaining profitability.

Further factors that may inhibit Mithra's efforts to commercialise its products in target markets include the inability

of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any of

Mithra's future products, and the lack of complementary products to be offered by sales personnel, which may put

Mithra at a competitive disadvantage relative to companies with more products.

If Mithra is unable to expand its own sales, marketing and distribution capabilities or enter into arrangements with

other third parties to perform these services, Mithra's future revenue growth may be limited, particularly if it is unable

to enter into a strategic partnership agreement in relation to Donesta

. In that event, Mithra would need to continue

to rely primarily on Estelle

, which accounted for 59.1% and 67.5% of Mithra's revenue in the year ended 31 December

2021 and the six months ended 30 June 2022, respectively.

IV. Risks related to the cost of producing E4

Mithra is subject to the risk of increasing raw material prices, particularly in relation to solvents used in the synthesis

of estetrol.

Prices of certain common raw materials, such as solvents (e.g. THF and DCM) used in the synthesis of estetrol, have

been increasing significantly since 2021 in the European Union due to lower availability of their feedstocks. Since it

remains unclear when feedstocks will become more readily available, Mithra may continue to experience pricing

pressure for these solvents. In addition, palladium is used as a catalyst in the production of E4. Palladium prices

have doubled over the last several years, with a sharp surge in March 2022. As Russia is a dominant player in the

global production of palladium, the war in Ukraine could continue to have a negative effect on the availability of

palladium in the global market. Since June and July of 2022, prices have come down to the same level as that which

prevailed at the end of 2021 and early 2022 but have remained volatile, leading to significant financial risk for Mithra.

Mithra is working on mitigation plan in order to reduce the amounts of these raw materials used in the synthesis of

E4 in order to optimize its manufacturing costs.

Mithra mitigates the risk that raw materials prices could increase to high levels, such as that it experienced in March

2022 for palladium, through mid- and long-term contracts with suppliers who uses much lower quantities of

palladium and therefore being less prone to volatile palladium prices. Moreover, Mithra considers new synthesis

pathways and internally monitors raw material prices on a continuous basis.

As the world is evolving, the use of raw materials is heavier than in the past, which could lead to a risk of

disappearance of raw materials, in particular due to natural disasters which can have an impact on the production

of certain raw materials. Furthermore, inflation may generally affect the cost of raw materials in Mithra's supply

chain. Inflation has been rampant during the past year due in part to government spending deployed to abate the

consequences of the COVID-19 pandemic during 2020 and 2021, as well as to rising energy prices due to the conflict

in Ukraine. Euro area annual inflation 9.1% in August 2022, having increased from 8.9% in July 2022, according to

the European Commission. Although as discussed above Mithra is seeking to address the risk of significant

increases in raw materials prices through provisions in its contracts such as maximum pricing, there can be no

assurance that its efforts in this regard will be sufficient to insulate it from increases in raw materials prices, whether

as a result of the general trend in inflation or otherwise.

Mithra's energy costs have increased by EUR 639 k for the year 2022 compared to previous year. Over the next

months, the risk of increase will be mitigated by Mithra's solar panel field that should allow Mithra to produce

autonomously a significant part of the energy consumed.

V. Risks relating to the Mithra's dependence on third parties and on key personnel

Mithra depends on third party suppliers for manufacturing, pharmaceutical ingredients and other raw materials and

any disruption of the supply chain or unavailability of third-party services could have a material adverse effect on

Mithra.

Mithra relies on third parties across is operations, including in relation to manufacturing, pharmaceutical ingredients

and other raw materials. In relation to its CDMO, it has entered into several partnerships, namely in the injectables

industry. In addition, it has entered into partnerships for the sourcing of raw materials, including essential active

pharmaceutical ingredients such as E4. Therefore, Mithra's ability to meet its production targets depends on its

sourcing arrangements and its partners' compliance with their own obligations. Mithra was informed by its E4

sourcing partner that it would have difficulties delivering the contractually defined quantities for the year 2021/2022.

In order to mitigate these potential delivery delays, Mithra currently relies on a key E4 tolling supplier and has signed

binding heads of terms in order to secure alternative options for the transformation of estetrol in the future.

In addition, third party suppliers may be subject to circumstances which impact their ability to supply, including

enforcement action by regulatory authorities, natural disasters (e.g. hurricanes, earthquakes, disease and terrorism),

epidemics (e.g. the ongoing COVID-19 outbreak), industrial action (e.g. strikes), financial difficulties including

insolvency, among a variety of other internal or external factors. Any such supply disruptions could in turn result in

production disruptions for an extended period of time, which could delay production and/or commercialisation of its

products and prevent Mithra from achieving or maintaining profitability. Alternative suppliers may be unavailable,

may be unwilling to supply and may not have the necessary regulatory approvals.

Any disruptions in manufacturing or in the supply of pharmaceutical ingredients and other raw materials could result

in production delays and could compromise Mithra's ability to meet its obligations to its customers and/or strategic

partners, which could in turn adversely affect its revenues and cash flows as well as its reputation.

Mithra relies on third parties to conduct its clinical trials, perform data collection and analysis, and provide regulatory

advice and other services that are crucial to its business.

Mithra relies, and will rely in the future, on medical institutions, Investigators, contract research organisations

("CROs"), contract laboratories and collaborators to perform data collection and analysis and to carry out Mithra's

clinical trials. Mithra's development activities or clinical trials conducted in reliance on third parties may be

compromised if the third parties do not devote a sufficient amount of time or effort to Mithra's activities or otherwise

fail to successfully carry out their contractual duties or to meet regulatory obligations or expected deadlines.

Furthermore, if the quality or accuracy of the data obtained by third parties is compromised due to their failure to

adhere to clinical protocols, regulatory requirements, or for other reasons including the loss of data, this could

adversely affect clinical results or require Mithra to repeat the affected trial. In addition, Mithra's third-party

agreements usually contain a clause limiting such third party's liability, such that Mithra may not be able to obtain

full compensation for any losses that Mithra may incur in connection with the third party's performance failures.

If the third parties upon which Mithra depends do not successfully carry out their contractual duties or regulatory

obligations or meet expected deadlines, or in the event of a default, bankruptcy or shutdown of, or a dispute with, a

third party, Mithra would be required to find a replacement third party or acquire a CRO, to conduct the required

activities. Mithra may be unable to enter into a new agreement with another third party on commercially acceptable

terms. While Mithra believes that there are alternative sources to provide these services, in the event that Mithra

seeks such alternative sources, Mithra may not be able to enter into replacement arrangements without incurring

delays or additional costs.

If the third parties upon whom Mithra depends fail to perform to the required standard or if Mithra is required to

replace such third parties, this could result in delays in the regulatory approval for Donesta

and its other products.

This would in turn limit Mithra's revenue, 59.1% and 67.5% of which was attributable to Estelle

in the year ended 31

December 2021 and the six months ended 30 June 2022, respectively.

VI. Risks relating to intellectual property

If Mithra were to lose patent protection for any of its key products (including Estelle

and Donesta

), this could

compromise the revenue it earns from these products as competitors take advantage of the expiration of patent

protection.

Mithra directly holds various families of patents for the Estelle

E4/DRSP pill and the menopause product candidate,

Donesta®. Extensions (from three to five years) of the indication patent end date have been requested (and some

have already been already granted) for the United States, Canada and some European countries based on the initial

marketing authorization for E4/DRSP in those territories. For the Donesta

product candidate, several new patent

applications have been filed to strengthen the protection of the product and product candidate, the outcome and

scope of which are still undetermined. Mithra also holds six families protecting different synthesis pathways for E4,

whose main patents expire in 2032. Mithra will also seek to protect market exclusivity once marketing authorisation

is granted (where applicable) through market/data exclusivity systems (between three and ten years maximum

depending on the territory).

In addition to patents, Mithra relies on a combination of trade secrets, trademarks, design rights, copyright laws, non-

disclosure agreements and other contractual provisions and technical measures that help maintain and develop its

competitive position with respect to intellectual property. Mithra may be unable to obtain the patents it applies for

or to adequately protect its intellectual property rights or may become subject to a claim of infringement or

misappropriation, which it is unable to settle on commercially acceptable terms. Mithra cannot be certain that

patents will be issued with respect to Mithra's pending or future patent applications. In addition, Mithra does not

know whether any issued patents will be upheld as valid or proven enforceable against alleged infringers or that they

will prevent the development of competitive patents or provide meaningful protection against competitors or against

competitive technologies.

Mithra's intellectual property rights may also be challenged, invalidated, circumvented or rendered unenforceable.

Mithra's competitors or other third parties may successfully challenge and invalidate or render unenforceable

Mithra's issued patents, including any patents that may be issued in the future. This could prevent or limit Mithra's

ability to stop competitors from marketing products that are identical or substantially equivalent to Estelle

Donesta® and/or its other products. In addition, competitors may be able to design around Mithra's patents or

develop products that provide outcomes that are comparable to Estelle

, Donesta

and/or its other products but

that are not covered by its patents. Much of Mithra's value is in its intellectual property, and any challenge to Mithra's

intellectual property portfolio (whether successful or not) may impact its value.

Mithra decides on a case-by-case basis the countries in which to seek patent protection. It is not economically

feasible or practical to seek patent protection in every country, and it is possible that one or more third parties may

develop and market products similar or identical to Estelle

contraceptive pill, Donesta

menopausal treatment

and/or its other products in countries where Mithra has not obtained patent protection. Mithra may not be able to

prevent such third-party action, which may limit Mithra's ability to pursue those markets.

In the context of certain financing arrangements with ING Belgium SA/NV and Belfius Bank NV, respectively, as well

as in the context of the Facilities Agreements, Mithra has granted security on the businesses of Estetra SRL

(Belgium), Novalon SA (Belgium) and Mithra Recherche et Développement SA (Belgium) (and, in the case of the

Facilities Agreements, also on the business of the Company). In each case, the pledged businesses include (either

expressly or implicitly) all intellectual property rights owned by the relevant pledger, and in some instances separate

pledge registrations have been taken with the competent offices in respect of particular items of such intellectual

property. If at any time, pursuant to the relevant financing arrangements, the security on the relevant businesses

and/or intellectual property rights were to be enforced, the pledged intellectual property rights may be lost to Mithra.

Mithra could become subject to intellectual property litigation that could be costly, result in the diversion of

management's time and efforts, require Mithra to pay damages, prevent Mithra from marketing Estelle

, Donesta

and/or its other products, and/or reduce the margins for these products.

The pharmaceuticals industry is characterised by rapidly changing products and technologies and there is intense

competition to establish intellectual property and proprietary rights covering the use of these new products and the

related technologies. This vigorous pursuit of intellectual property and proprietary rights has resulted and will

continue to result in extensive litigation and administrative proceedings over patent and other intellectual property

rights. Whether a product infringes a patent involves complex legal and factual issues, and the outcome of such

disputes is often uncertain. There may be existing patents of which Mithra is unaware that are inadvertently infringed

100

by Estelle

contraceptive pill, Donesta

menopausal treatment, and/or its other products. Competitors may have or

develop patents and other intellectual property that they assert are infringed by Estelle

, Donesta

and/or its other

products.

Any infringement claim against Mithra, even if without merit, may cause Mithra to incur substantial costs, and could

place a significant strain on Mithra's financial resources and/or divert the time and efforts of management from the

conduct of Mithra's business. In addition, any intellectual property litigation could force Mithra to do one or more of

the following: (i) stop selling Estelle

, Donesta

and/or its other products or using technology that contains the

allegedly infringing intellectual property; (ii) forfeit the opportunity to license Mithra's technology to others or to

collect royalty payments based upon successful protection and assertion of its intellectual property rights against

others; (iii) pay substantial damages to the party whose intellectual property rights Mithra may be found to be

infringing; or (iv) redesign those products that contain or utilise the allegedly infringing intellectual property. Any of

these circumstances may materially and adversely affect Mithra's business, financial condition, results of operations

and prospects.

The requirement to obtain licenses to third party intellectual property could also arise in the future. If Mithra needs

to license any third-party intellectual property, it could be required to pay lump sums or royalties on its products. In

addition, if Mithra is required to obtain licenses to third party intellectual property, it may not be able to obtain such

licenses on commercially reasonable terms or at all.

In particular, since 2008, Mithra has been involved in a legal proceeding against Organon NV (now Merck Sharp and

Dohme BV). The proceeding concerns the alleged patent infringement caused by the commercialisation by Mithra

and its partner DocPharma BVBA (now Mylan) of a generic drug known as Heria. Currently, Organon is claiming for

provisional damages of EUR 2.8 million, including actual loss of profit as well as the reimbursement of cost for

establishing the infringement attorney’s fees and expert’s expenses. A first instance judgement was rendered on

11 December 2015 that concluded in a partial infringement of Organon’s patent. An expert was appointed by

Commercial Court to advise on the damages suffered by Organon and Merck because of the partial infringement. A

final report of the judicial expert dated 22 November 2019 assessed that damage at EUR 551 thousand. That amount

is, however, questionable in the light of several objective factors. The case is pending at the appeal level and the

hearing has not yet been fixed. A provision of EUR 266 thousand has been recorded in the accounts in accordance

with management's assessment of the liability that can result.

Intellectual property rights do not necessarily address all potential threats to Mithra's competitive advantage.

The degree of protection afforded by Mithra's intellectual property rights is uncertain because intellectual property

rights are limited, and may not adequately protect Mithra's business or permit it to maintain its competitive

advantage or its ability to sell its products. For example:

- others may be able to develop, make and sell products that are similar to or different from that deliver

similar benefits to Estelle

, Donesta

and/or its other products without infringing claims of the Mithra

patents or other Mithra intellectual property rights;

- pending patent applications may not lead to issued patents;

- issued patents may not provide Mithra with any competitive advantages, or may be held invalid or

unenforceable, as a result of legal challenges;

- Mithra's competitors might conduct research and development activities in countries where Mithra does

not have patent rights and sell the resulting competitive products in such countries, or use the information

learned from such activities to develop competitive products for sale in major commercial markets;

- Mithra may develop intellectual property that is not patentable; and/or

- the patents of others may dominate the patents of Mithra, thereby preventing their use, or have an adverse

effect on Mithra's business.

VII. Risks relating to global events

The outbreak of the coronavirus (COVID-19) or any other infectious disease outbreak or other serious public health

concern could result in delays to Mithra's clinical trials and could adversely affect its supply chain and work force,

as well as macroeconomic conditions generally, which could have an adverse effect on demand for its products.

Since December 2019 and as of the date of this Report, there is an ongoing outbreak of the 2019 coronavirus

(COVID-19) which was initially primarily concentrated in China, but has affected countries globally. The outbreak

101

resulted in restrictions on non-essential medical procedures and on non-essential travel for Mithra's employees and

consultants and has necessitated the introduction of mitigation measures, particularly in relation to enrolment in

clinical trials. Enrolment has been affected by the following factors:

- the diversion of healthcare resources away from the conduct of clinical trial matters to focus on

pandemic concerns, including the attention of physicians serving Mithra's clinical trial investigators,

hospitals serving its clinical trial sites and hospital staff supporting the conduct of its clinical trials;

- limitations on travel that interrupted key clinical trial activities, such as clinical trial site initiations and

monitoring, interruption in global shipping affecting the transport of clinical trial materials, such as

investigational drug products used in Mithra's trials;

- employee absences that have delayed necessary interactions with local regulators, ethics committees

and other important agencies and contractors; and

- patients' reluctance to visit hospitals and attend medical check-ups due to COVID-19.

In particular, Mithra's Donesta

Phase III Clinical Program is ongoing, with topline efficacy results having been

reported in 2022 and primary safety early 2023 for the C302 trial (North-America) and anticipated in H1 2024 for the

C301 trial (EU, Russia, Latin America, United States and Canada). While Mithra was able to avoid material delays to

its clinical trials through the implementation of a global Safety Management plan, any future delays could result in

delays to the approval of Donesta

in the United States and Europe, which is currently expected in the first half of

2024 and 2025, respectively.

In addition, the outbreak of COVID-19 has already had an adverse effect on supply chains globally and Mithra's supply

chain may be similarly affected. While Mithra was able to maintain its production schedule at Mithra CDMO during

2020 and 2021 notwithstanding the impact of COVID-19 restrictions, it may encounter future supply chain issues.

Mithra also relies on a relatively small work force and if COVID-19 were to spread across its work force, this could

have a disproportionate impact on it compared to other companies with larger work forces and/or greater financial

resources. Any supply chain or human resources disruption arising from the COVID-19 outbreak could exacerbate

the delays it is already experiencing arising from restrictions on non-essential medical procedures and hospital visits.

Moreover, the COVID-19 outbreak has had a severe impact on global macroeconomic conditions, with the global

economy having contracted by 3.3% in 2020 and bounced back in 2021 with a growth of 6%, according to the IMF.

While the IMF is still forecasting global growth of 3.2% in 2022, this projected growth may be derailed, in particular

due to the environment of rising interest rates, as central banks take action to combat inflation arising in part from

the deployment of funds for COVID-19 relief by governments during the pandemic. Inflation has been high during the

past year due in part to government spending deployed to abate the consequences of the COVID-19 pandemic during

2020 and 2021, as well as to rising energy prices due to the conflict in Ukraine. Euro area annual inflation 9.1% in

August 2022, having increased from 8.9% in July 2022, according to the European Commission. Any decline in

growth may have a broader impact on Mithra's business, given the impact on the resources of government and/or

private payers and their willingness to reimburse costs associated with Mithra's products. There may also be other

infectious disease outbreaks or other serious public health issues, any of which could disrupt Mithra's business or

adversely affect demand for its products.

While there are signs that the outbreak of COVID-19 is abating, any resurgence could require Mithra to delay its

clinical trials, which could prevent it from achieving the commercialisation of the Donesta

and other products in the

expected timeframe, which would in turn delay the timing of expected revenues from these products or prevent

Mithra from ever earning revenues from the sale of these products.

The Russian invasion of Ukraine could have a destabilising impact on Mithra's operations, both directly as a result

of the conduct of clinical trials and indirectly due to the impact on global macroeconomic conditions.

On 24 February 2022, Russia launched a full-scale invasion of Ukraine and the conflict remains ongoing.

While Russia and Ukraine represent a relatively small portion of Mithra's revenue (expected to be approximately

1% in 2022), Mithra's management is continuing to monitor the situation. The conflict is expected to result in delays

of launches of various products in these countries, including the launch of Estelle

in Russia, which had been planned

for the second half of 2022. In addition, approximately 10% of the recruitment sites for Mithra's Donesta

Phase III

Clinical Program were located in Russia and Mithra was required to activate a mitigation plan in order to replace

these sites with other sites in the United States and Europe and to avoid any delay in the submission to the European

102

Medicines Agency (the "EMA"). While this did not result in material delays to the clinical trial, for which topline results

were reported in January and in April 2022, if the situation escalates, there may further adverse impacts to Mithra.

In addition, the Ukraine conflict has disrupted trade and aggravated inflation for basic goods like energy, wood and

metals. Further economic deteriorations could negatively impact Mithra’s future revenues and profits. See also

"Mithra is subject to the risk of increasing raw material prices, particularly in relation to solvents used in the synthesis

of estetrol".

Moreover, the conflict could have an adverse impact on global macroeconomic conditions generally, including due

to the increase in oil and gas prices resulting from the conflict. This could in turn result in suppressed demand for

Mithra's products as well as in higher research and development costs for new products due to an increase in energy

prices.

VIII. Legal and regulatory risks

Seeking and obtaining regulatory approval for drugs can be a long, expensive and uncertain process. Strict or

changing regulatory regimes, government policies and legislation in any of Mithra's target markets may delay,

prohibit or reduce potential sales.

Following completion of the relevant clinical trials, Mithra's products must obtain marketing approval from the

European Commission following an opinion from the European Medicines Agency (the “EMA”), from the United States

Food and Drug Administration (the "FDA") or other competent regulatory authorities before the products can be

commercialised in a given market, and each such approval will need to be periodically renewed. The process of

obtaining marketing approvals, both in the United States and in foreign jurisdictions, is expensive, may take many

years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a

variety of factors, including the type, complexity, and novelty of the product candidates involved. Applications for

regulatory approval may require extensive pre-clinical, clinical and technical testing, all of which must be undertaken

in accordance with the requirements of regulations established by the relevant regulatory agencies.

At the date of this Prospectus, the Estelle

oral contraceptive is the only E4-based product commercialised by Mithra.

The Donesta

menopausal program has reached late clinical development stage. Mithra’s Phase I clinical

programme in neonatal HIE, for which Mithra obtained orphan drug designation in both the United States and the

European Union, started in 2022. Mithra’s wound healing project is in pre-clinical development. These products will

require substantial technical, pre-clinical and clinical developments and testing prior to receiving marketing

approvals.

For details of the regulatory regime applicable to Mithra's products in each of the jurisdictions in which Mithra has

commercialised or intends to commercialise these products, see "Business Overview— Government Regulation".

In the European Union, Mithra would need to obtain a marketing authorisation from the European Commission or

national competent authorities in relevant markets and comply with a body of regulatory requirements including

Directive 2001/83/EC on the Community Code relating to Medicines for Human Use. For further detail of these

obligations, see "Business Overview — Government Regulation ". In the United States, the FDA regulates drug

products under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and implementing

regulations.

Ensuring compliance with these regulations is an intensive process requiring substantial human and financial

resources. The burden of compliance may become significant relative to revenue from Mithra's products. If Mithra

fails to comply with applicable pharmaceutical regulations, it may be forced to withdraw its products from the

relevant market. In addition, it may be exposed to administrative, civil and criminal sanctions and lawsuits.

Failure to comply with the applicable requirements at any time pre- or post-approval may result in a delay of approval

or administrative or judicial sanctions. These sanctions could include imposition of a clinical hold on trials, refusal to

approve pending applications, withdrawal of an approval, issuance of warning or untitled letters, product recalls,

product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, damages

claims or criminal prosecution.

The regulations to which Mithra is subject are complex and have tended to become more stringent over time. Mithra

may be adversely affected by changes in government marketing approval policy or legislation applying to its product

candidates. Varying interpretations of the data obtained from non-clinical and clinical testing could delay, limit, or

prevent marketing approval of a product. Any marketing approval Mithra obtains may be limited or subject to

restrictions or post-approval commitments that render the approved product not commercially viable. Mithra is

103

obliged to comply with regulatory requirements that include obtaining regulatory approval pursuant to the applicable

laws and regulations before it can market or sell its products in each market.

Moreover, each regulatory agency may impose its own requirements and may refuse to grant or may require

additional data before granting marketing approval even if marketing approval has been granted by other agencies.

Changes in regulatory approval policies or enactment of additional regulatory approval requirements may delay or

prevent the products from obtaining or renewing marketing approval. Also, post-approval manufacturing and

marketing of Mithra's products may show different safety and efficacy profiles to those demonstrated in the data on

which approval to test or market said products was based. Such circumstances could lead to the withdrawal or

suspension of approval.

Mithra's CDMO as well as the manufacturing facilities of its third-party suppliers are subject to significant regulations

and approvals. If Mithra or its third-party manufacturers or suppliers fail to comply with these regulations or maintain

these approvals, Mithra could lose the regulatory approvals required to operate the CDMO.

Mithra's CDMO offers a wide range of solutions from early drug development, clinical batches and commercial

manufacturing, with expertise in complex polymeric products (such as vaginal rings and implants. Since July 2021,

Mithra's CDMO also operates a new manufacturing facility dedicated to fill and finish production of complex liquid

injectables and biologicals in vials, pre-filled syringes or cartridges. While currently, Mithra mainly depends on the

CDMO in relation to Myring

, going forward it expects to realise additional revenue from products manufactured for

third parties. In the first half of 2022, Mithra's CDMO generated revenues amounting to approximately EUR 1 million.

The manufacturing practices of Mithra and its third-party suppliers are subject to ongoing regulation and periodic

inspection. Any failure to follow and document the adherence to regulatory requirements by Mithra or its third-party

suppliers may lead to delays in production of Mithra's own and third-party products.

Failure to comply with applicable regulations could also result in regulatory authorities taking various actions,

including:

- levying fines and other civil penalties;

- imposing consent decrees or injunctions;

- requiring Mithra to suspend or put on hold one or more of Mithra's clinical trials;

- suspending or withdrawing regulatory approvals;

- delaying or refusing to approve pending applications or supplements to approved applications;

- requiring Mithra to suspend manufacturing activities, sales, imports or exports;

- requiring Mithra to communicate with physicians and other customers about concerns related to actual or

potential safety, efficacy, and other issues involving Mithra's products;

- mandating product recalls or seizing products;

- imposing operating restrictions; and

- seeking criminal prosecutions.

If Mithra were to lose its regulatory approvals in respect of the CDMO, this could have an adverse effect on its revenue

from Myring® as well as a loss of potential revenue from the production of other products. In addition, if fines were

to be imposed upon it in relation to violations at the CDMO, this would adversely affect Mithra's profitability.

Mithra is subject to the risk of product liability claims or claims of defectiveness, which could result in uninsured

losses for Mithra or recalls of the relevant product.

Mithra is exposed to the risk of potential product liability claims arising from adverse reactions, product failures and

malfunctions and product use. Mithra maintains product liability insurance at levels which management believes are

in line with market practice. To date, no product liability claim has been initiated against Mithra. However, Mithra

may not be able to maintain sufficient insurance coverage on commercially acceptable terms in the future, and its

insurance coverage may not provide adequate protection against any product liability claims or claims of product

defectiveness. As a consequence, Mithra might have to face liabilities for a claim that may not be covered by its

insurance or its liabilities could exceed the limits of its insurance.

Moreover, product failures or safety issues discovered during the clinical trial phase may also lead to the suspension

or termination of the relevant trial. In addition, product failures and malfunctions, quality issues may result in a recall

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of the product, which may relate to a specific manufacturing lot or may impact all products in the field. Recalls may

occur at any time during the life cycle of a product once regulatory approval has been obtained for commercial

distribution. Recalls of Mithra's products would divert managerial and financial resources, can result in damaged

relationships with regulatory authorities such as the FDA, lead to loss of market share to competitors and materially

and adversely affect Mithra's business, financial condition, results of operations and prospects. In addition, any

product recall may result in irreparable harm to Mithra's reputation. Any product liability claims or other claims of

defectiveness or any product recalls could have a financial impact on Mithra (including due to it being required to

record a provision in respect of product liability claims to which it becomes subject) or could be detrimental to

Mithra's reputation.

Mithra has obtained significant grants and subsidies (mostly in the form of "avances récupérables") and the terms

of certain of these agreements may hamper the Company in its flexibility to choose a convenient location for its

activities.

Mithra has been awarded several grants and subsidies by governmental or semi-governmental bodies, consisting

for the most part of so-called "recoverable advances" ("avances récuperables"), which it needs to reimburse over

time. In the year ended 31 December 2021 and in the year ended 31 December 2022, Mithra had refundable

government advances of EUR 14.4 million and EUR 9.5 million. For further detail regarding these refundable

government advances, please refer note 9.15.2 of the 2022 Annual Report, which is incorporated by reference in this

Prospectus. Refundable government advances. Such reimbursements consist of a fixed portion and a variable

portion (dependent on net sales of the relevant product). These reimbursements (comprising the combined fixed

and variable portions) can amount to up to twice the amounts received, i.e., in the aggregate, an amount of maximum

EUR 38 million. While the variable portion of these advances is only due upon commercialisation, the fixed parts will

become due in any event. In most cases, there is an exemption to reimburse the advances if the beneficiary of the

grant renounces the grant (abandoning the project, thereby avoiding having to pay the fixed repayment amount for

a "failed" project) and transfers its rights over the results of the research to the body which has granted the subsidy,

thereby avoiding the payment of any amount after such transfer. However, it cannot be excluded that Mithra will be

obliged to reimburse grants or subsidies in the future. Some of these grants/subsidies will have to be refunded in

the event that the product is successfully commercialised

These subsidies and grants provide that Mithra must maintain its headquarters in the Walloon Region. These

provisions affect Mithra's ability to relocate its activities. Furthermore, the ability of any potential foreign acquirer to

use the Company's intellectual portfolio built on the basis of these grants and subsidies may be impaired by

provisions which would prevent the transfer of such intellectual property outside of Belgium.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about drugs. If

Mithra is found to have made false or misleading claims about its products, or otherwise have violated promotion or

advertising restrictions, it may become subject to significant fines and/or other liabilities.

Regulations promulgated by the FDA and other regulatory agencies require Mithra to sufficiently substantiate any

claims that it make for its products, including claims comparing its products to other companies' products, and must

abide by the FDA or a comparable foreign regulatory authority's strict requirements regarding the content of

promotion and advertising.

If a relevant governmental authority determines that Mithra's promotional materials violate promotional and

advertising requirements, it could request modifications to Mithra's promotional materials or subject Mithra to

regulatory or enforcement actions, which may include the issuance of a warning letter, injunction, seizure, civil fine

and criminal penalties. U.S, E.U. or other applicable governmental authorities might also take action if they consider

Mithra's promotional materials to constitute off label promotion, which could result in significant fines or penalties

under other statutory provisions, such as laws prohibiting false claims for reimbursement. In that event, Mithra's

reputation could be damaged, and adoption of Mithra's products could be impaired. This risk will be heightened as

Mithra commercially launches its products in the United States, given the FDA's focus on false or misleading claims

and the potential for significant fines. Currently, Estelle

and Myring

are approved for marketing in the United States.

In addition, industry codes particularly in the pharmaceutical sector contain further requirements for pharmaceutical

promotion and prohibit companies from engaging in certain promotional activities. Competitors may file complaints

with industry associations and courts in which case such instances may enforce violations of such codes and

applicable regulations with penalties including fines and publication of decisions. If Mithra becomes subject to such

enforcement or court actions its business, financial condition, reputation, stock price and prospects may be

materially harmed.

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Mithra is subject to healthcare fraud and abuse and other laws applicable to Mithra's business activities. If Mithra is

unable to comply with such laws, it could face substantial penalties.

Mithra is subject to various federal and state fraud and abuse laws. Such laws include the federal and state anti-

kickback statutes, physician payment transparency laws and false claims laws. These laws may impact, among

other things, Mithra's and its partners' proposed sales and marketing activities and require it to implement additional

internal systems for tracking certain marketing expenditures and to report to governmental authorities. In addition,

Mithra may be subject to patient privacy and security regulations by both the federal government and the states in

which Mithra conducts its business. The laws that may affect Mithra's ability to operate include, inter alia:

the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly or wilfully

soliciting, receiving, offering or paying any remuneration, overtly or covertly, directly or indirectly, in cash or in kind, in

return for or to induce either the referral of an individual for, or the purchase, lease, order, arrange for, or

recommendation of, any good, facility, item or services for which payment may be made, in whole or in part, under a

federal healthcare program;

federal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or

causing to be presented, claims for payment from or approval by a governmental payer program that are false or

fraudulent;

the federal Health Insurance Portability and Accountability Act of 1996, which established new federal crimes for,

among other things, knowingly and wilfully executing, or attempting to execute, a scheme to defraud any healthcare

benefit program, wilfully obstructing a criminal investigation of a healthcare offense, concealing a material fact, or

making materially false statements in connection with the delivery of or payment for healthcare benefits, items or

services;

an increasing number of state transparency laws that require manufacturers to provide reports to state governments

on pricing and marketing information; and

a federal law known as the Physician Payments Sunshine Act, which requires certain manufacturers of drugs,

devices, biologicals, and medical supplies to report annually to the Centres for Medicare & Medicaid Services

information related to payments and other transfers of value to physicians and teaching hospitals, and ownership

and investment interests held by physicians and their immediate family members.

Mithra is also subject to European and other foreign law equivalents of each of the laws, including reporting

requirements detailing interactions with and transfers of value to healthcare providers, organisations and/or patient

organisations.

If Mithra's operations are found to be in violation of any of the laws described above or any other governmental

regulations that apply to it, it may be subject to penalties, including administrative, civil and criminal penalties,

damages, fines, disgorgement, the curtailment or restructuring of Mithra's operations, the exclusion from

participation in government healthcare programmes and individual imprisonment. In particular, the Anti-Kickback

Statute provides for both criminal and civil penalties for violations. The criminal penalties include fines of up to

US$25,000 per violation and five years' imprisonment. In addition, the Office of the Inspector General for the

Department of Health and Human Services can pursue civil penalties of up to US$50,000 per violation plus three

times the amount of any government overpayment. Penalties for Anti-Kickback Statute violations also frequently

include a period of debarment or exclusion from participation in Medicare, Medicaid, and all other federal plans and

programmes that provide health benefits, which could impact reimbursement for Mithra's products, as applicable, if

it were deemed to have violated the statute. Violations of the other statutes referred to above can result in similar

sanctions to the Anti-Kickback Statute.

Mithra faces risks related to environmental matters and animal testing activities.

Mithra's CDMO is subject to a broad range of environmental laws and requirements, including those governing

discharges to the air and water, remediation of contamination associated with the release of any hazardous

substances at Mithra's manufacturing facility and offsite disposal locations and occupational safety and health.

Mithra is also subject to strict laws and requirements governing the handling or disposal of solid and hazardous

substances and wastes. Mithra has made, and will continue to make, expenditures to comply with such laws and

requirements. Future events, such as changes in existing laws and regulations, or the enforcement thereof, or the

discovery of contamination at Mithra's manufacturing facility, may give rise to additional compliance or remediation

costs that could have a material adverse effect on Mithra's business, financial condition, results of operations and

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prospectus. Such laws and requirements are constantly changing, are different in every jurisdiction and can impose

substantial fines and sanctions for violations. As a manufacturer, Mithra is exposed to some risk of claims with

respect to environmental matters, and material costs or liabilities may be incurred in connection with any such

claims.

In addition, Mithra has been required to use animals to test certain of its products, and may be required to use

animals to test future products. In particular, it is conducting animal testing in relation to its Zoreline® product.

Testing on animals can be vital for the development of a product. If applicable regulations were to ban this practice,

or if, due to pressure from animal welfare groups, Mithra is no longer able to source animals to perform such tests,

it would be difficult and, in some cases, impossible to develop products in certain jurisdictions under the applicable

marketing authorisations. In addition, negative publicity regarding Mithra's use, or the industry's use, of animal

subjects could harm Mithra's reputation.

IX. Risks relating to complex therapeutics

Complex therapeutics products must undergo bioequivalence, pharmacodynamic or other studies, which could be

subject to delays, which in turn could substantially increase costs, or prevent these generic products from reaching

the market on time.

All complex therapeutics products will be subject to bioequivalence, pharmacodynamic or other studies (as deemed

fit by the relevant regulatory agencies), to demonstrate that the relevant generic product is bioequivalent to the

previously approved innovative drug, before they can receive the necessary regulatory approval to enter the market.

For the year ended 31 December 2021 and 2022, Mithra recorded revenue of EUR 3.8 million and EUR 6.5 million

from complex therapeutics products. In 2016, Mithra demonstrated bioequivalence for two complex therapeutics

products, Tibelia

and Myring

. Mithra was involved in the development of Tibelia® from the research phase to

approval from regulatory authorities. Mithra launched Tibelia® in several markets including Canada, where Tibelia®

is the first tibolone-based hormone treatment to be available. Mithra launched Myring® in 2019 in Europe and the

rest of the world, with launch in the United States in the beginning of 2023. In June 2021, Mithra signed an agreement

with SVR Invest BV for the full global licensing and distribution rights for the Zoreline® implant. Zoreline® is currently

under development by Mithra and has not yet received any regulatory approval, which is currently expected in 2026.

Any delays in completing studies for complex therapeutics to demonstrate bioequivalence, will delay Mithra's ability

to generate revenues from product sales of complex therapeutic products.

In addition, in the event Mithra enters the market too late in the cycle for a particular product, that product will suffer

from reduced market share and hence reduced revenues and cash flows compared to management's initial

expectations. Management considers that the point of market saturation is the point at which between three and

five generic products have been approved

X. Risks relating to the research and development pipeline

The strategy chosen by Mithra to diversify its research and development portfolio by triggering an option to purchase

related to a development program led by the Belgian company, BCI Pharma, may not deliver the expected benefits.

In November 2021, Mithra acquired the rights relating to two development programs led by the Belgian company,

BCI Pharma, on innovative inhibitors of CSF1R kinase. These CSF1R inhibitors are part of a new innovative class of

immune-modulatory drugs with established clinical tolerability and proven efficacy. They act on the CSF1 receptor,

which is involved in many inflammatory processes and is over-expressed in many pathologies, in particular cancers,

neurological disorders and autoimmune diseases. Under the terms of the contract, Mithra has an option to acquire

patents covering the CSF1R inhibitor series with an upfront payment of EUR 2.25 million on exercise of the option,

following the first results reported by BCI Pharma. Mithra will fund the pre-clinical and clinical development, with a

focus on female cancers and endometriosis, while potentially targeting other orphan indications, such as metastatic

breast cancer (TNBC). BCI Pharma is expected to initiate clinical development in 2024, with marketing authorisations

expected in 2031. This project diversifies Mithra's portfolio in terms of chemistry and indication. It also provides the

opportunity to obtain composition of matter intellectual property on the compounds themselves. However, the

project might not deliver the benefits expected by management in the cancer or endometriosis indications on which

Mithra is focused. While other opportunities exist in therapeutic indications outside of women's health (e.g. pain,

inflammatory disease and neurodegenerative disorders), these indications may not be relevant to Mithra’s core

business. In addition, two distinct chemical series are being proposed to reduce the risk of relying on only one series.

While first preclinical results confirm the broad potential of innovative and proprietary inhibitors of CSF1R to treat

different pathologies, including endometriosis, cancer and inflammatory disorders, if the project does not deliver the

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expected benefits in those areas, Mithra's revenue potential in connection with the project may not materialise at the

expected level or at all and Mithra may not realise what it considers to be an adequate return on its investment.

XI. Risks relating to the market in which Mithra operates

The pharmaceuticals industry is highly competitive and subject to rapid technological changes and if Mithra's

current or future competitors develop equally or more effective and/or more economical technologies and products,

Mithra's competitive position would be negatively impacted.

The market for pharmaceuticals products is highly competitive. Mithra's competitors in the women's health market

include many established pharmaceuticals, biotechnology and chemicals companies, such as Bayer, MSD, Pfizer,

Therapeutics MD, Exeltis and Allergan, many of which have substantially larger financial, research and development,

marketing and personnel resources than Mithra and could, therefore, adapt more quickly to changes in the

marketplace and regulatory environment. For instance, each of Bayer, Pfizer, Therapeutics MD and Allergan had a

market capitalisation in excess of USD 50 billion, compared to Mithra's market capitalisation as at the date of this

Report of approximately USD 163 million.

Mithra's competitors may develop new products or adapt existing products for the same patients that Mithra is

targeting with Estelle

as well as its other products. In particular, combined birth control pills (consisting of estrogen

and progestin) such as Microgynon, Rigevidon, Yasmin, Cilique, Eloine and Mercilon, compete with Mithra's Estelle

oral contraceptive pill. Any competitors' products currently in clinical trials or in development or which are developed

in the future could have superior clinical results, could be easier to implement clinically, could be more convenient

for patients and/or less expensive than Estelle

and Mithra's other products or could reach commercialisation

sooner in certain target markets. Competing products may gain faster or broader market acceptance than Mithra's

products (if and when marketed) and medical advances or rapid technological development by competitors may

result in Mithra's product candidates becoming non-competitive or obsolete before Mithra is able to recover its

research and development and commercialisation expenses.

In addition, the commercial availability of any approved competing product could potentially inhibit recruitment and

enrolment into Mithra's clinical trials. Mithra may successfully conclude its clinical trials and obtain regulatory

approval, but may fail to compete against competitors or alternative treatments that may be available or developed

for the relevant indication. New products, or modifications of existing products, may emerge which yield clinical

results equal to or better than those achieved with Estelle

or Mithra's other products. Emergence of such new

products may inhibit Mithra's ability to develop and grow the market for Estelle

and its other products. Furthermore,

new entrants into the markets in which Mithra operates could also decide to more aggressively compete on price,

requiring Mithra to reduce prices in an effort to maintain market share, which would adversely impact its profitability.

There is also a risk that Mithra's competitors have better and more extensive experience in manufacturing and

supplying their products, which would provide them with a cost advantage which could in turn impact the profitability

of Mithra by requiring it to reduce prices to retain its distribution partners.

The Company will likely not be in a position to pay dividends in the near future and intends to retain all earnings.

The Company has not declared or paid dividends on the Shares in the past. Any declaration of dividends will be based

upon the Company's earnings, financial condition, capital requirements and other factors considered important by

the board of directors.

Belgian law and the Company's articles of association do not require the Company to declare dividends. Currently,

the board of directors of the Company expects to retain all earnings, if any, generated by the Company's operations

for the development and growth of its business and does not anticipate paying any dividends to the shareholders in

the near future.

Under the Convertible Loans Agreement entered into with the Lenders, no distributions by way of dividend may be

declared or made without the consent of the Lenders (other than the payment of a dividend to the Company or any

other of its subsidiaries designated in the Convertible Loans Agreement). For more information about the Convertible

Loans Agreement, please refer to the Prospectus.

The Company's dividend policy may change from time to time by determination of the Company's board of directors.

108

Research and development

We are committed to fully exploiting the potential of E4 (Estetrol) as well as our technologic platform in Complex

Therapeutics to develop a diverse and broad portfolio of therapeutic treatments focused on Women’s Health.

Additionally, the Company has diversified its R&D portfolio by acquiring an option to purchase development

programs led by the Belgian company BCI Pharma on innovative kinase inhibitors notably indicated for the treatment

of female cancers and endometriosis.

With regard to E4, most focus is on Mithra’s late-stage product candidates, Estelle

for contraception with market

authorization approval obtained in all key geographic areas and Donesta

for menopause (Phase III) with top lines

efficacy results obtained in January 2022, and top lines security results for the C-302 obtained post period in March

2023. Furthermore, Mithra is exploring additional indications in Women’s Health ,as well as indications beyond

Women’s Health, such as, wound healing and neuroprotection.

In January 2020, an ecotoxicity study revealed that Estetrol had a more environmentally friendly profile compared to

other estrogens. Additional comparative studies are ongoing at the University of Namur to deepen this finding. In

November 2020, the Company received the qualification of Estetrol as a "New Active Substance" (NAS) by the

European Medicines Agency (EMA). This is the first NAS designation in contraception in over 80 years and the

achievements of many years of work for the Company. In 2021, the Company received market authorizations for

Estelle

in key geographic areas such as Canada, Europe, US, Russia and Australia. Moreover, the label was revised

with a new wording on the expected low impact of E4 on the environment for its use in contraception.

During the period, the Company obtained efficacy top line results for the Phase III E4Comfort program of oral

hormonal therapy Donesta

(menopause) which demonstrated a meaningful reduction in vasomotor symptoms

from baseline and compared to placebo. The positive efficacy data strongly move forward the Clinical Program,

recently extended with 3 additional studies to further broaden the scope of Donesta

as a global alternative for

millions of menopausal women (i) a proof of concept study on the effect of E4 on skin texture, quality, (ii) a proof of

concept study on the effect on hair texture, quality and appearance, (iii) a proof of concept study on female sexual

arousal disorder.

Post period in March 2023, the Company obtained safety top line results for the Phase III E4Comfort program of oral

hormonal therapy Donesta (menopause) for the C302 study (US). Indeed, previous E4 studies have demonstrated

the overall’s safety profile of Estetrol. Whereas the full dataset analysis is still in progress, these topline safety results

not only confirm Donesta

’s safety profile in the treatment of VMS, but also delineate further E4’s unique benefit/risk

profile for postmenopausal women. In the C302 trial, safety data were captured up to 12 months of treatment either

with the 15 mg and 20 mg E4 doses compared to placebo (efficacy part) or open-label with the 20 mg E4 dose (safety

part). These topline safety results, evaluated general safety and secondary endpoints such as health-related quality

of life, treatment satisfaction, lipid and glucose metabolism and endometrial safety in hysterectomized and non-

hysterectomized women.

Among the highlights of these results, the study confirmed previous clinical and biochemical evidence with minimal

changes in hemostasis parameters and hepatic markers, E4’s positive influence on bone turnover markers and

beneficial effect on cholesterol profile. These results contribute to showcase the unique profile of E4.

At a daily dose of 15 mg or 20 mg, Donesta

was well tolerated in hysterectomized women. In non-hysterectomized

women, as expected for an estrogen administered alone, endometrial proliferation was observed and confirmed the

need of adding a progestogen to curb related events in this population. Therefore, once the estrogen was first

administrated and followed with the administration of progesterone, endometrial thickening was, partially to

completely, reversed within a two-week treatment. Most of the treatment emergent adverse events were mild or

moderate in intensity.

The European study C301 is still ongoing with primary safety data anticipated for H1 2024. Barring any unforeseen

event, Mithra confirms its ambition to achieve marketing authorization for Donesta

in H1 2024 for the United States

and in H1 2025 for Europe. A marketing authorization that was initially anticipated in Q4 2024 and moved to H1 2025

owing to a slow recruitment.

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With this pipeline covering contraception and menopause, Mithra continues to explore in parallel the most judicious

way to meet the specific needs of women during the transitional phase of perimenopause as the Perinesta project

no longer exists.

For the Complex Therapeutics, Mithra launched Myring

in Europe and has obtained FDA approval for Myring

8th August 2022. Post period, in January 2023, the product was launched in the US.

At the same time, the Company continue to advance our research work on Zoreline

formulations, with major

improvement in the 1-month formulation providing new formulations with a closer PK profile to Zoladex. The team

is currently working on the preparation of a clinical study for the 1-month study to be initiated in 2023. Approval is

still expected in 2026.

Furthermore, Mithra will pursue the budgeted investments to further advance the technological CDMO facility in

terms of performance, applicability and scale; in order to offer third-parties the opportunity to develop sterile

injectables; and to prepare the polymeric forms and hormonal tablets zones for the production of its proprietary

products.

Moreover, Mithra is strengthening its leadership position in women's health by acquiring a new innovative

development axis in a fast-growing market: inhibitors of tyrosine kinases, notably indicated in the treatment of cancer

and endometriosis. Mithra acquired the option to purchase the rights relating to two development programs led by

the Belgian company BCI Pharma on innovative inhibitors of CSF1R kinase. These CSF1R inhibitors are part of a new

innovative class of immune-modulatory drugs with established clinical tolerability4 and proven efficacy. They act on

the CSF1 receptor which is involved in many inflammatory processes and is over expressed in many pathologies, in

particular cancers, neurological disorders and autoimmune diseases. The innovative class of tyrosine kinases

inhibitors represents the third fastest growing therapeutic class in 2020, with a 17% increase in revenues to

USD 40.3 billion.

Under the terms of the contract, Mithra has an option to acquire patents covering CSF1R inhibitor series with upfront

payment of EUR 2.25 million on execution of option, following the first results conducted by BCI Pharma. Mithra will

fund the preclinical and clinical development targeting other cancer orphan indications

Post period, in March 2023, the first conclusive data of the preclinical studies conducted in partnership with BCI

Pharma were obtained. The first preclinical data have demonstrated promising anti-tumor activity. The lead

compound, a potent and selective inhibitor of CSF-1R, was well tolerated. Also, data have shown that it significantly

modulated the tumor microenvironment, tumor-associated macrophages populations and significantly decreased

tumor growth in the most widely used preclinical model in immuno-oncology. Additional preclinical studies are

currently ongoing to demonstrate the potential for combinations with immune checkpoint inhibitors in a range of

tumor models. With regard to endometriosis, the use of a potent inhibitor of CSF-1R in a preclinical model resulted

in promising findings as a treatment with the lead compound induced a lower number of endometriotic cysts,

reduced pain and improved the overall well-being in animals with endometriosis. Finally, regarding the treatment of

inflammation, additional preclinical data have shown an inhibitory effect on the production of proinflammatory

cytokines including IL-1β and TNFα in a well-established model used as an in vivo screening for candidate

compounds designed for the treatment of inflammatory conditions and autoimmune diseases, such as

neurodegenerative diseases, multiple sclerosis or psoriasis, for example. The marketing autorizations are expected

for 2031.

In addition, Mithra intends to initiate new discovery programs which might lead to the development and

commercialization of drug candidates; and is committed to seek, maintain and expand the know-how, technologies

and intellectual property position.

Conflicting interests of directors (Art. 7:96 of the CCA)

The Directors report that during the financial year under review two decisions have been taken that fall within the

provisions of Art. 7:96 of the CCA. As required by the law, those minutes parts of the relevant meetings of the Board

of directors relating to such conflicts of interest are reproduced hereunder.

Furthermore, during the same financial year, there has been no transaction or other contractual relationship between

the Group, and a Director or Executive Manager other than those that fall within the provisions of Art. 7:96 of the CCA

or that have been disclosed under “related party transactions” set out below pursuant to Art. 7:97 of the CCA.

110

Meeting of the Board of directors of 3 February 2022 (free translation of minutes from French)

The following directors were present in person, by videoconference and/or represented by a director present at the

meeting of the Board of Directors of Mithra Pharmaceuticals SA (hereafter referred to as the "Company") held on

February 3, 2022, at 20:00.

(…)

STATEMENTS FROM THE PRESIDENT

The meeting was opened at 20:00 by Sunathim BV, with Mr. Ajit Shetty acting as permanent representative, of the

Chairman of the Board of Directors. The Chairman stated that the meeting was duly convened and that it was not

necessary to justify the summons, all directors being present or represented at the meeting. This is confirmed by the

meeting.

The Chairman stated that the meeting's agenda would be as follows:

1. Discussion on and approval of the Financing Agreement (hereafter referred to as the "Financing

Agreement") to be entered into by and between the Company and Goldman Sachs International ("GSI"). Under the

terms of this Agreement, the Company may request financing of a total amount not exceeding 100,000,000.00 Euros

(hereafter referred to as the "Committed Amount") from GSI, subject to certain conditions, through multiple

drawdowns. Under certain conditions, GSI may wholly or partially convert the drawn amounts into shares, as

contributions in kind of claims under these amounts, within a period not exceeding approximately two years after

the Financing Agreement comes into force (hereafter referred to as the "Expiry Date");

2. Discussion on and approval of the Board of Directors’ draft report prepared in compliance with Article 7:198

Juncto Articles 7:179 and 7:197 of the Belgian Code on Companies and Associations of 23 March 2019 (as

occasionally amended) (hereafter referred to as the "Code on Companies and Associations") associated with the

Board of Directors’ proposal to increase the Company's capital within the framework of the Committed Amount, for

a maximum total equal to the Committed Amount (issue premium included, if applicable), in one or more

transactions, by contributions in kind of claims due by the Company under drawdowns made within the scope of the

Financing Agreement, and the issue of new shares as payment for these contributions in kind. The maximum number

and issue price of these are yet to be established, as per the Financing Agreement (the "Board Report");

3. Confirmation of the instruction made to the auditor to prepare a report in compliance with Article 7: 198

Juncto Articles 7:179 and 7:197 of the Belgian Code of Companies and Associations, related to the Board of Directors'

proposal to increase the Company's capital within the framework of the authorised capital, for a maximum amount

equal to the Committed Amount (issue premium included, if applicable), in one or more transactions, by contributions

in kind of claims due by the Company under drawdowns made within the scope of the Financing Agreement, and the

issue of new shares as payment for these contributions in kind. The maximum number and issue price of these are

yet to be determined, as per the Financing Agreement;

4. Subject to the conclusion of the Financing Agreement, a special meeting of the Board of Directors must be

held before a notary to discuss the proposal to increase the Company's capital within the framework of the

authorised capital, for a maximum amount equal to the Committed Amount (issue premium included, if applicable),

in one or more transactions, by contributions in kind of claims due by the Company under drawdowns made within

the scope of the Financing Agreement, and the issue of new shares in compensation for these contributions in kind.

The maximum number and issue price of these are yet to be determined, as per the Financing Agreement;

5. Subject to completion of the transaction stated in the Financing Agreement, approval of the request for

admission to trade new shares on the Euronext Brussels regulated market;

6. Granting of special powers related to the Financing Agreement, including, but not limited to, finalising and

signing the aforementioned Financing Agreement and the Board Report, other contractual documents, notarial deeds

and certificates related to the operation established in the Financing Agreement, and agreeing on the final terms of

the operation established in the Financing Agreement.

PRELIMINARY STATEMENTS OF INDIVIDUAL DIRECTORS

Preliminary statements from Yima SRL

Prior to the Board of Directors’ deliberations and decisions, Yima SRL, represented by his permanent representative,

Company Director Mr. François Fornieri, informed the Board of Directors that the agenda includes the approval of

111

the Financing Agreement with GSI, and he supports the operations set out in the Financing Agreement, considering

that they are in the Company's best interest. He also adds that under the terms of the Financing Agreement, Mr.

François Fornieri does not exercise an executive role within the Company but may continue to be a Company Director

and Shareholder. Even if this reflects the current situation, Yima SRL invokes, where appropriate and applicable,

Article 7:96 of the Belgian Code of Companies and Associations and wishes to apologise and refrain from taking part

in subsequent Board deliberations and decisions.

Yima SRL therefore took no further part in the Board of Directors' deliberations and decisions.

Preliminary statements by other Directors

No other Director states an interest in the decisions to be taken by the Board of Directors, which would require the

application of the procedure established in Articles 7:96 and/or 7:97 of the Belgian Code of Companies and

Associations.

DELIBERATION AND RESOLUTIONS

As proposed by the Chairman, the remaining Board members began discussing the items on the agenda.

Mr. Christophe Maréchal (Chief Financial Officer) informed the meeting that the Company was considering entering

into a Financing Agreement with GSI. In compliance with the Financing Agreement and as described in more detail

in the Summary (as defined below) and the draft Board Report (submitted to the Directors prior to this meeting), the

Company may request financing of a total amount equal to the Committed Amount from GSI, subject to certain

conditions, through multiple drawdowns. If a drawdown is accepted by GSI as per the terms of the Financing

Agreement, GSI must pre-prepay the Company this amount. Under certain conditions, GSI may wholly or partially

convert the drawn amounts into shares, as contributions in kind of claims under these amounts before the Expiry

Date. Any unconverted drawn amount shall, in any case, be converted into shares by a contribution in kind of the

underlying claim remaining on the Expiry Date. However, under certain conditions, the Company is entitled to repay

the drawn amounts in cash. The operation established in the Financing Agreement is referred to in this document as

the "Operation".

The Chairman subsequently submits the following documents to this meeting (referred to jointly as the

"Documentation") regarding the proposed Transaction:

a) the latest draft of the Financing Agreement;

b) a summary of the most important provisions of the Financing Agreement (referred to as the "Summary");

c) the latest draft of the Board's Report, and;

d) the latest draft of the agenda and proposals for formal resolutions to be submitted to the notary by the

Company Board of Directors in connection with the proposal to increase the capital by contributions in kind

(hereafter referred to as the "Board's Notarial Resolutions").

The Chairman asked for the Documentation be attached to these minutes as Appendix A.

The remaining members of the Board of Directors took note of the information and documentation submitted to the

meeting. They then deliberated the following:

• The exact and final terms of the proposed Transaction (including, but not limited to, the Financing

Agreement) still under negotiation and subject to finalising;

• The Financing Agreement is due to be signed on or around 3 February 2022 and announced as soon as

possible afterwards;

• For a broader description and justification of the Financing Agreement and the Operation, the Board of

Directors refers to the content of the Board Report. Specifically, the Board reviewed, noted and confirmed

the rationale for the proposed Transaction established in the Board Report (specifically sections 5 and 6 of

the Board Report);

• The remaining members of the Board of Directors reviewed the Company purpose, as described in Article

3 of the Company Articles of Association. They concluded, where relevant, that the Proposed Transaction

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falls within the scope of the Company purpose, in compliance with the terms established in the

Documentation submitted to the Board of Directors, and the Company's due compliance with their

obligations;

• The remaining Board members also took note of the prior declarations made by Yima SRL, where needed

and applicable, in compliance with Article 7:96 of the Belgian Code of Companies and Associations. The

Board of Directors therefore considers that the Board Report drafted, in compliance with Article 7:198 of

Articles 7:179 and 7:197 of the Belgian Code on Companies and Associations regarding the Transaction,

the latest draft, submitted for approval by the Board of Directors containing (a) a description of the nature

of the Transaction, (b) a description of the patrimonial consequences of the Transaction for the Company,

and for the existing shareholders and holders of subscription rights of the respective Company in

circulation, and (c) the justification for the Transaction. The Board Report also contains additional

information and will be made public on (among others) the Company website. It is referenced in the minutes

of this meeting of the Board of Directors, when relevant. In addition, as mentioned by Yima SRL, the Board

of Directors confirms that the assumption made in the Financing Agreement reflects the current situation.

For all the aforementioned reasons (including those stated in the Board Report submitted to the Board of Directors),

the Board of Directors considers that (a) the proposed Transaction, in compliance with the terms established in the

Documentation submitted to the Board of Directors, and the Company's due compliance with their obligations, are

in the Company's best interests, and (b) the justification for the proposed Transaction, the proposed contributions in

kind and issuing the new shares in consideration of the proposed contributions in kind are justified, as listed in the

Board Report.

The Board of Directors has also decided to delegate authority to the following persons to continue negotiations, to

specify and finalise the terms and schedule of the proposed Transaction, and to implement the Transaction in

compliance with the terms of the Documentation, with the changes, additions and specifications, and actions that

they deem necessary or suitable regarding the Transaction, where relevant.

Following deliberation, and on a duly proposed and seconded motion, it is unanimously:

a) PASSED to approve the financing of the Company through the Transaction in principle, subject to the

finalisation of the terms of the Transaction and the Documentation, taking the aforementioned deliberations

into account.

b) PASSED to approve or, where relevant, ratify the following:

(i) the Financing Agreement, its signature and compliance with the obligations that the Company must

assume and perform in connection with it.

(ii) the Board Report and its signature, and

(iii) negotiating, finalising and signing any other documentation and agreements that Company is or will

be affected by, regarding the Transaction (including opening a customer account with GSI).

(iv) in each case, in compliance with the provisions established in the Documentation submitted to the

Board of Directors or, where relevant, those renegotiated, finalised or amended under the conditions

referred to in (g) below.

c) PASSED to confirm the instructions given to the auditor to prepare a report in compliance with Article 7:

198 of Articles 7:179 and 7:197 of the Belgian Code on Companies and Associations regarding the

Transaction and notes that, where necessary and applicable, in compliance with Article 3:63, §5 of the

Belgian Code of Companies and Associations, the members of the auditing committee approve that these

instructions must be given to the Company auditor in compliance with the rules and conditions required for

reports of this nature.

d) PASSED, subject to the finalisation of the Board and the Commissioner's report regarding this, subject to a

final decision to be taken by the Committee (within the scope of (g) below), to approve the adoption of the

Board's Notarial Resolutions before a notary.

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e) PASSED that, subject to the completion of the respective issuing of new shares within the scope of the

Transaction, one or, where relevant, several applications will be made and all appropriate measures taken

(including, where relevant, the preparation of a prospectus for admission for listing and trading in

compliance with Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on

the prospectus to be published when securities are offered to the public or admitted to trading on a

regulated market, and repealing Directive 2003/71/EC, as amended, to admit listing and trading the new

shares to be issued (where relevant in several drawdowns) within the scope of the Transaction on the

regulated Euronext Brussels market in compliance with all applicable rules and regulations.

f) PASSED that, without prejudice to any decisions previously taken by the Board of Directors, and without

prejudice to and subject to any special powers to be granted under the Board's Notarial Resolutions, a

committee made up of at least two persons, (x) one of whom being the Chief Executive Officer (or other

Director, if the Chief Executive Officer is unavailable), and (y) the other being the Chief Financial Officer (or

any Director other than the one listed in item (x) if the Chief Financial Officer is unavailable) (hereafter

referred to as the "Committee"), is authorised to execute the following actions on behalf of the Company,

where necessary and applicable:

(i) establish and finalise the terms, conditions and schedule of the Transaction in compliance with the

terms of the Documentation submitted to the Board of Directors about it, and to make the amendments

that the Committee deem necessary or appropriate, or those approved to initiate and execute the

Transaction, where relevant (and the Committee's exclusive signature on such documents or the

Committee's mere completion of this shall be considered sufficient evidence of this decision or

approval).

(ii) continue to negotiate, specify, finalise, initial, sign, execute and deliver the Financing Agreement, and

make any changes that the Committee deem necessary or appropriate or as they may agree on (and

the Committee's exclusive signature on the Financing Agreement or the Committee's mere completion

of this shall be considered sufficient evidence of this decision or approval).

(iii) finalise the Board's Report for two Directors to sign on behalf of the Board of Directors, considering any

non-substantial changes that may arise following further review of these documents completed by the

notary, the Company's Commissioner, and GSI and its Boards.

(iv) continue to negotiate, specify, finalise, initial, sign, execute and issue any Documentation connected

with the Transaction, and make any changes that the Committee deem necessary or appropriate or as

they may agree on (and the Committee's exclusive signature on the Financing Agreement or the

Committee's mere completion of this shall be considered sufficient evidence of this decision or

approval).

(v) subject to the completion of the Transaction, file one, or where relevant several, applications for

admission to trade the new shares to be issued (where relevant in several drawdowns) in connection

with the Transaction on the regulated Euronext Brussels market in compliance with applicable laws,

rules and regulations and complete any other necessary act for this admission to trade (and the

Committee's exclusive signature on this document or the Committee's mere completion of this shall

be considered sufficient evidence of this decision or approval), and

(vi) further develop, negotiate, specify, finalise, initial, sign, execute and issue any other agreements, deeds,

certificates, instruments, notices, requests, warrants, notes and other documents and, generally,

perform any other acts, in connection with or related to the Transaction that the Committee deems

necessary or appropriate or that it may approve (and the Committee's exclusive signature on this

document or the Committee's mere completion of this shall be considered sufficient evidence of this

decision or approval).

The Committee is authorised to wholly or partially sub-delegate the exercise of its powers under this decision. The

Committee shall be validly represented by each Committee member, acting individually.

* * *

All items on the agenda now covered, the meeting was closed at 20:40.

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Meeting of the Board of directors of 4 February 2022 (free translation of minutes from French)

AUTHORISED SHARE CAPITAL

The year two thousand and twenty-two, The fourth of February, In Herstal, at the office, Before Maître Jean-Michel

GAUTHY, Notary in Herstal, providing his services through SRL “GAUTHY & JACQUES – Notaires Associés”, having

its registered office in Herstal, rue Hoyoux, 87.

Meeting of the Board of Directors of the limited company “MITHRA PHARMACEUTICALS” with its registered office

located at 4000 Liège, rue Saint-Georges, 5, VAT number 0466.526.646 - RPM Liège (Liège division) (hereinafter the

"Company").

(….)

The session is opened at 1600, under the chairmanship of Ms. TOUNSI Amel.

COMPOSITION OF THE BOARD OF DIRECTORS

The following are present or represented:

1. (….)

STATEMENT FROM THE CHAIRMAN

The Chairman states that:

I. This meeting of the board of directors has the following agenda:

1. Submission of the following reports:

(a) the report from the board of directors in accordance with article 7:198 juncto articles 7:179 and 7:197 of the

Code on Companies and Associations of 23 March 2019 (as modified from time to time) (the “Code of Companies

and Associations”) in relation to the proposal from the board of directors to increase the Company’s share capital in

the context of the authorised share capital, for a maximum amount of EUR 100,000,000.00 (issue premium included,

where applicable) (the “Amount Committed”), in one or more operations, by way of contributions in kind of receivables

due by the Company by virtue of drawdowns carried out in the context of the financing agreement by shares which

was concluded by the Company with Goldman Sachs International ("GSI") on 3 February 2022 (the “Financing

Agreement”), and the issue of new shares in compensation for these contributions in kind, with the maximum number

and issue price of the same remaining to be determined in accordance with the Financing Agreement.

(b) the report from the Company’s auditor in accordance with article 7:198 juncto articles 7:179 and 7:197 of

the Code on Companies and Associations in relation to the proposal from the board of directors to increase the

Company’s share capital in the context of the authorised share capital, for an amount equal to the Amount

Committed (share premium included, where applicable), in one or more operations, by way of contributions in kind

of receivables due by the Company by virtue of drawdowns made under the Financing Agreement, and the issue of

new shares in compensation for these contributions in kind, with the maximum number and issue price of the same

remaining to be determined in accordance with the Financing Agreement.

2. Decision to increase the Company’s share capital within the framework of the authorised share capital

Decision of the Company’s board of directors to increase the Company’s share capital within the framework of the

authorised share capital, as described in article 7 of the Company’s articles of association, for an amount equal to

the Amount Committed (share premium included, where applicable), in one or more operations, by way of

contributions in kind of receivables due by the Company by virtue of drawdowns made under the Financing

Agreement, and the issue of new shares in compensation for these contributions in kind, with the maximum number

and issue price of the same remaining to be determined in accordance with the Financing Agreement, subject to the

following conditions (as modified from time to time, where applicable):

(a) Increase in share capital: The board of directors uses its powers in the context of the authorised capital as

set out in article 7 of the Company’s articles of association to increase the Company’s share capital, in one or more

operations, by way of contributions in kind of receivables due by the Company by virtue of drawdowns made under

the Financing Agreement, for a maximum amount equal to the Amount Committed (share premium included, where

applicable) and the issue of new shares in compensation for these contributions in kind, with the maximum number

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and issue price of the same remaining to be determined in accordance with the Financing Agreement, as set out

below and as described in more detail in the report from the board of directors referred to in point (a) of the agenda.

The increase in share capital is subject to the condition precedent of the implementation of contributions in kind of

receivables due and the issue of new shares in compensation for these contributions, in accordance with the

conditions below.

(b) Contributions in kind: The increase in share capital will take place by way of contributions in kind, in one or

more operations, of receivables which will be created, and which will become due by the Company as a result of

drawdowns carried out by the Company and which will be prepaid to the Company in accordance with the Financing

Agreement.

issued in the context of the increase in share capital in exchange for the respective contributions in kind of

receivables due by the Company and the issue price of these new shares (representing the Company’s share capital

for the amount equal to the par value and, where applicable, the issue premium for what would exceed the par value)

will be determined by the board of directors or the Committee (as defined below) at the time of the implementation

of the respective contributions in accordance with the provisions of the Financing Agreement as summarised in the

report from the board of directors referred to in point (a) of the agenda.

(d) Recognition of the issue price of the new shares: At the time of each increase in share capital by way of

contributions in kind and the issue of new shares in compensation for these contributions, the issue price of each

new share must be recorded as share capital under the liabilities on the Company’s balance sheet, as equity in the

“share capital” account. However, the amount by which the issue price of a new share exceeds the par value of the

Company's existing shares (which, in the date of these decisions, is rounded to EUR 0.7321) will be recorded as an

issue premium, where applicable, as a liability on the Company’s balance sheet as equity in the “Issue premium”

account. The account in which the share premiums are recorded serves, in the same way as the share capital, as a

guarantee for third parties and, with the exception of the possibility to capitalise these reserves, can only be reduced

or eliminated by a decision of the general assembly of shareholders ruling on the conditions required to modify the

Company’s articles of association. If the issue price of the new shares does not exceed the par value of the

Company’s existing shares (that is to say, on the date of these decisions, rounded to EUR 0.7321), the issue price

will be fully recorded as share capital, and after the share capital is increased, all the Company’s shares in circulation

will have the same par value in accordance with article 7:178 of the Code on Companies and Associations.

(e) Nature and form of the new shares: All the new shares to be issued in the context of the increase in share

capital will have the same rights and benefits, and will be pari passu, including regarding rights to dividends and

distributions, relative to the Company’s shares already existing and in circulation at the time of their issue, and will

give entitlement to dividends and distributions for which the recording date or maturity date falls on or after the issue

date of the new shares. Each time, the Company will request that the new shares be listed and traded on the regulated

Euronext Brussels market in accordance with the applicable laws and regulations and the terms and conditions of

the Financing Agreement.

(f) Performance in several tranches: The share capital increase may be carried out in one or more tranches by

way of one or more notarial deeds provided that the effective implementation of the contributions in kind of

receivables due and the issue of shares in compensation for these contributions takes place. If the entirety of the

share capital increase for the Amount Committed (issue premium included, where applicable) is not subscribed via

contributions in kind, the increase in the share capital may be carried out for each contribution in kind made in

accordance with the Financing Agreement, to be determined as above, in accordance with article 7:198 juncto article

7:181 of the Code on Companies and Associations. The board of directors or the Committee may also, to avoid any

doubt, decide not to go ahead with the planned increase in share capital.

(g) Implementation of the increase in share capital, the issue and subscription of the new shares: Subject to

the provisions of the previous paragraphs and subject to the provisions of the Financing Agreement, where

applicable, the board of directors or the Committee will determine the practical implementation of each drawdown

by virtue of the Financing Agreement, each contribution in kind of a receivable created by virtue of the Financing

Agreement and each issue of new shares in compensation for these contributions in kind, including (but not limited

to) the maximum number of new shares to be issued, the issue price of the new shares to be issued, the time of

issue of the new shares, and the resulting increase in share capital, the share subscription conditions and the other

mechanisms for the implementation of the increase in share capital, and this during a period ending five weeks after

the date of the second anniversary of the Financing Agreement.

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(h) Modification of the articles of association: After each capital increase and the issue of new shares as set

out above, the Company’s articles of association will be modified and updated to reflect the resulting share capital

and the number of shares existing and in circulation.

(i) Appointment of a Committee: Subject to the provisions of the preceding decisions, and without prejudice

to the decisions previously taken by the board of directors, the board of directors hereby appoints a committee (the

"Committee") composed of at least two people, of which (x) one must be the Chief Executive Officer (or another

director if the Chief Executive Officer is unavailable), and (y) the other must be the Chief Financial Officer (or any

director (other than the director mentioned in point (x)) if the Chief Financial Officer is unavailable). The Committee

has the power and possibility to increase the share capital subject to the provisions of paragraphs (a) to (h) above,

including (without limitation) the power:

(i) to carry out drawdowns by virtue of the Financing Agreement and implement them;

(ii) to opt for the cash settlement of all the amounts drawn, in accordance with the Financing Agreement;

(iii) to determine the number and issue price of the new shares to be issued in the context of the increase in share

capital;

(iv) to implement contributions in kind, issues and subscriptions of new shares;

(v) to carry out any useful or necessary actions with competent regulatory authorities and Euronext Brussels in terms

of the admission of the new shares to trading on the regulated Euronext Brussels market;

(vi) to proceed with the performance and the setting of the increase in share capital, each time as provided above,

the resulting modification of the articles of association and, where applicable, the setting of the amount of the issue

premium; and

(vii) to carry out any other useful, appropriate or necessary action related to the foregoing, including representing the

company before a notary to record the effective performance of the share capital increase operations.

The Committee is authorised to sub-delegate (in whole or in part) the exercise of the powers which will be conferred

on it by virtue of this decision. The Committee will be validly represented by each member of the Committee, acting

individually.

(j) Special powers: In accordance with article 7:198 juncto article 7:186 Code on Companies and Associations,

the implementation of the increase in share capital can be recorded each time at the request of the board of directors,

the Committee, each Company director, the corporate secretary, the Chief Executive Officer, the Chief Financial

Officer, the Legal Manager and the Compliance Officer, who are hereby appointed individually and specifically for this

purpose. The powers above are in addition to, and are without prejudice to, other powers conferred by the board of

directors prior to this decision in the context of the proposed share capital increase.

II. The attendance list indicates that all directors are present or represented. As a result, there is no need to issue

summonses.

III. Based on the foregoing, it appears that the board of directors is entitled to validly deliberate on the items indicated

on the agenda.

To be passed, proposals on the agenda must receive at least the majority of the votes which are cast, it being recalled

that directors with a potential conflict of interest within the meaning of article 7:96 of the Code on Companies and

Associations relative to proposed resolutions appearing on the agenda of this meeting of the board of directors

cannot take part in the vote.

Advance notifications from Yima SRL

Before the deliberation and the decisions of the board of directors, Yima SRL, represented by its permanent

representative, Mr François Fornieri, Company director, informed the board of directors that the agenda covers,

among other matters, the approval of the operations considered by the Financing Agreement concluded with GSI,

that it supports the operations planned by the Financing Agreement, and considers the latter to be in the Company’s

interests. It also notes that the Financing Agreement assumes that Mr François Fornieri does not hold an executive

role at the company but may continue as director and shareholder of the Company. Even if this reflects the current

situation Yima SRL invokes, as required and applicable, article 7:96 of the Code on Companies and Associations and

asks to be excused from taking part in the subsequent deliberations and decisions of the board of directors.

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Therefore, Yima SRL did not subsequently participate in the deliberations and decisions of the board of directors.

Thoughts of the other directors on the statements from Yima SRL

The remaining members of the board of directors have also acknowledged the advance notifications made by Yima

SRL, as required and applicable, in accordance with article 7:96 of the Code on Companies and Associations. In this

respect, the board of directors considers that the report from the board of directors referred to in point (a) of the

agenda contains (a) a description of the nature of the operations considered, (b) a description of the equity

consequences of the operation considered for the Company, and for the existing shareholders and holders of

subscription rights in the Company respectively in circulation, and (c) justification of the operations considered. The

report from the board of directors referred to in point (a) of the agenda also contains additional information and will

be available publicly via (among other channels) the Company’s website and is, as needed, incorporated by reference

in the minutes of this meeting of the board of directors. In addition, as mentioned by Yima SRL, the board of directors

confirms that the assumption made in the Financing Agreement reflects the current situation.

Advance notifications from the other directors

None of the directors declared having an interest in the operation which would require the application of the

procedure set out in articles 7:96 and/or 7:97 of the Code on Companies and Associations.

DELIBERATIONS

After having recognised that the meeting is validly constituted and entitled to deliberate on the items on the agenda,

the remaining directors discuss the agenda and, after having deliberated, take the following resolutions:

1. Submission of the reports

The following reports are presented:

(a) the report from the board of directors in accordance with article 7:198 juncto articles 7:179 and 7:197 of the

Code on Companies and Associations of 23 March 2019 (as modified from time to time) (the “Code of Companies

and Associations”) in relation to the proposal from the board of directors to increase the Company’s share capital in

the context of the authorised share capital, for a maximum amount of EUR 100,000,000.00 (issue premium included,

where applicable) (the “Amount Committed”), in one or more operations, by way of contributions in kind of receivables

due by the Company by virtue of drawdowns carried out in the context of the financing agreement by shares which

was concluded by the Company with Goldman Sachs International ("GSI") on 04 February 2022 (the “Financing