VIVORYON THERAPEUTICS N.V.
UNAUDITED INTERIM REPORT AS OF AND FOR THE SIX-MONTH PERIOD
ENDED JUNE 30, 2024
These condensed interim financial statements are interim financial statements for Vivoryon Therapeutics N.V.
The condensed financial statements are presented in Euro (EUR). Vivoryon Therapeutics N.V. is a public company
with limited liability under Dutch law, having its statutory seat in Amsterdam, The Netherlands. Its registered office
and principal place of business is in Germany, Halle, Weinbergweg 22.
INDEX TO UNAUDITED CONDENSED INTERIM FINANCIAL STATEMENTS
SIX MONTHS ENDED JUNE 30, 2024 AND 2023
Unaudited Condensed Interim Financial Statements
Interim Management Report (unaudited).......................................................................................................................3
Unaudited Condensed Statements of Operations and Comprehensive Income and Loss for the six months ended June
30, 2024 and 2023 .........................................................................................................................................................8
Unaudited Condensed Statements of Financial Position as of June 30, 2024 and December 31, 2023.........................9
Unaudited Condensed Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2024 and
2023.............................................................................................................................................................................10
Unaudited Condensed Statements of Cash Flows for the six months ended June 30, 2024 and 2023 ........................11
Notes to the Unaudited Condensed Interim Financial Statements...............................................................................12
Vivoryon Therapeutics N.V.
Unaudited Interim Management Report
1. Organizational Structure
The Company is registered with the name Vivoryon Therapeutics N.V. in the Trade Register of the Netherlands
Chamber of Commerce under number 81075480 (Sector ‘Advisering, onderzoek en overige specialistische zakelijke
dienstverlening’, Activiteit (SBI-code) ‘72112 - Biotechnologisch speur- en ontwikkelingswerk op het gebied van
medische producten en farmaceutische processen en van voeding’). Its commercial name is Vivoryon Therapeutics
and the administrative headquarters as well as the business operations remain in Halle (Saale) and Munich Germany.
The Company’s business address is Weinbergweg 22, 06120 Halle (Saale), Germany (contact details: +49 (0)345
555 99 00, info@vivoryon.com).
2. Business Activities
Vivoryon is a biopharmaceutical company focused on discovering, developing, and potentially commercializing
small molecule-based medicines that modulate the activity and stability of pathologically altered proteins. The
Company is determined to create novel therapeutics to treat diseases with exceptionally high unmet medical need.
The Company has established a pipeline of orally available small molecule inhibitors for various indications
including Alzheimer’s disease, inflammatory and fibrotic disorders, including of the kidney, and cancer. In addition
to developing small molecule-based medicines, the Company has also programs to develop selected monoclonal
antibodies. Research work is mainly outsourced to CROs or academic collaboration partners on a fee-for-service
basis. The Company strives to generate future revenues from licensing its product candidates to biopharmaceutical
companies or, in selected cases, by commercializing products upon regulatory market approval by the relevant
competent authorities.
In March 2024 the Company announced topline results from its Phase 2b European VIVIAD study of its lead
investigational candidate varoglutamstat (PQ912), an investigational oral glutaminyl cyclase (QPCT) inhibitor in
development for the treatment of early Alzheimer’s disease (AD). The double-blind, placebo-controlled study did
not meet its primary endpoint and did not show a statistically significant difference in change over time on
cognition. Additionally, the study did not meet key secondary endpoints measuring cognition (Cogstate Brief
Battery, CBB, and complete Cogstate NTB), Instrumental Activities of Daily Living Questionnaire (A-IADL-Q) and
electroencephalogram (EEG) global theta power. Further information about the VIVIAD Phase 2b study can be
found in the press release dated March 4, 2024, as published on the Company’s website
(https://www.vivoryon.com/investors-news/news/) and as filed with the register maintained by the Dutch Authority
for the Financial Markets (AFM) (https://www.afm.nl/en/sector/registers).
Further in-depth analysis of the VIVIAD results showed a statistically significant effect of varoglutamstat on
kidney function. Therefore, in April 2024, Vivoryon announced a strategic shift towards a focus on inflammatory
and fibrotic diseases. Furthermore, in May 2024, the Company presented additional data regarding varoglutamstat`s
beneficial effect of improving kidney function in various sensitivity and subgroup analyses. In July, after the six-
month period to which this Management Report pertains, Vivoryon presented additional kidney function analysis in
a diabetes subgroup together with the Company’s proposed clinical development plan for varoglutamstat in diabetic
kidney disease (DKD; subject to additional funding and/or partnership).
3. Significant Events in the First Half of 2024
Strategic shift towards a focus on inflammatory and fibrotic diseases:
Following the announcement on March 4, 2024, that the VIVIAD Phase 2b study did not achieve its primary
and key secondary endpoints in early AD and the subsequent results showing a statistically significant effect of
varoglutamstat on kidney function, Vivoryon announced on April 24, 2024, a strategic shift towards a focus on
inflammatory and fibrotic diseases.
3
Key priorities now include: preparing for a proposed Phase 2 clinical study for varoglutamstat in diabetic
kidney disease (subject to additional funding and/or partnership); concluding VIVIAD Phase 2b clinical study
program and in-depth analysis; discontinuing the complementary VIVA-MIND Phase 2 clinical study with
varoglutamstat in the U.S. in early AD in the second half of 2024; leveraging the data from VIVA-MIND to inform
next steps in AD; and continuing to actively pursue potential business development and financing opportunities.
Varoglutamstat – kidney disease (until June 30, 2024 and beyond):
Significant effect of varoglutamstat in diabetes subgroup1
•
New analysis of eGFR, a measure of kidney function, in a subgroup of patients with diabetes2 in the
VIVIAD Phase 2b study reveals a substantially higher treatment effect3 of >8mL/min/1.73m2/year
(p=0.02; varoglutamstat n=20 / placebo n=12) compared to the overall VIVIAD study population where the
treatment effect was 3.4mL/min/1.73m2/year (p<0.001; varoglutamstat n=141 / placebo n=117).
•
Promising additional effects observed in the diabetes subgroup in varoglutamstat treated patients included
a reduction in liver transaminases (AST/ALT4 reduction of 6 units average)
o
a mild weight loss (- 4kg)
o
a reduction in diastolic blood pressure (- 6 mmHg)
o
All results reported were observed at 48 weeks of treatment versus baseline. Similar observations
o
were not made in the placebo group nor in the overall VIVIAD study population.
•
Data revealed that the positive effect on kidney function in the diabetes subgroup appears to be independent
of any change in glycemic control (HbA1C remained steady over the period for the varoglutamstat group).
•
A reduction of the plasma concentration of the inflammatory and fibrosis inducing pE-CCL2 (p=0.004) was
observed in the varoglutamstat arm, indicating a strong anti-inflammatory effect.
•
Varoglutamstat was well-tolerated at the dose tested (up to 600mg twice daily) and there were no
meaningful differences in adverse events observed in renal and metabolic system organ classes versus
placebo or the total population.
Proposed Clinical Development Plan in Diabetic Kidney Disease5
•
Despite advances in the standard of care for DKD, there remains a significant unmet need for new therapies
to stabilize kidney function and prevent disease progression.
•
Vivoryon plans to start a Phase 2 study in DKD that is intended to include patients with disease stages more
advanced than those observed in the VIVIAD Phase 2 study, enabling an expansion of the overall target
patient population. The Company envisages a placebo-controlled study of up to approximately 120 subjects
with stage 3b/4 DKD and >100mg/g albuminuria/proteinuria. These subjects would be randomized 1:1 to
varoglutamstat 600mg twice daily or placebo, on top of standard of care medications. Key endpoints are
planned to include eGFR slope analysis, measures of albuminuria (UA(p)CR), inflammation and fibrosis-
related biomarkers, as well as safety.
1Treatment effect – the between-group difference in eGFR slope between varoglutamstat and placebo.
2Estimated glomerular filtration rate (eGFR), a validated measure of kidney function, was calculated as a slope analysis across
two years taking all available data into account.
3Diabetes subgroup defined as patients having at baseline either medical history of diabetes (type 1 or 2) and/or comedication
with drugs used in diabetes and/or untreated with an HbA1c > 6.5%.
4AST: Aspartate Aminotransferase; ALT: Alanine Aminotransferase. 5. The timing and execution of the planned Phase 2 study is
subject to additional funding / partnership.
5The timing and execution of the planned Phase 2 study is subject to additional funding / partnership.
4
Collaboration with Key Experts to Advance Development Strategy
The Company is collaborating with medical advisors and industry leaders to further shape its shift towards
inflammatory/fibrotic disease, including:
•
Tobias B. Huber, MD - Chair of the Center of Internal Medicine and Director of the III. Department of
Medicine - University Medical Center Hamburg-Eppendorf (UKE), Germany. Acting as Medical Advisor
for clinical study design. Research collaboration with Vivoryon focusing on pre-clinical and mechanistic
activities relating to varoglutamstat and the role of QPCT/L on kidney function.
•
Florian Jehle - CEO of Vifor-FMC Renal Pharma. Acting as Industry Expert Advisor to Vivoryon in the
kidney field including strategic business and commercial advice.
•
Kevin Carroll, PhD - CEO, KJC Statistics. Acting as statistical analysis expert, providing and calculating
statistical read-outs and advising on clinical study statistical aspects.
Varoglutamstat – early Alzheimer’s disease (AD):
•
In recent weeks Vivoryon has continued its in-depth analysis of the VIVIAD data, following the March 4,
2024, and April 24, 2024, disclosures. While these analyses remain ongoing, findings to date continue to
confirm there is no consistent effect of varoglutamstat up to 600mg BID on cognition and function,
including in high exposure patients. Data from VIVA-MIND, anticipated by the end of 2024, is expected to
contribute to the overall dataset informing varoglutamstat’s development strategy in AD.
Early-Stage Pipeline:
•
Vivoryon’s main focus is on its clinical-stage activities, however it will continue to explore pre-clinical
QPCT/L inhibitors for use in inflammatory and fibrotic disorders and other indications such as oncology
and CNS as well as pre-clinical meprin inhibitors, in particular for fibrotic disorders, and QPCT/L
inhibitors with good blood brain barrier penetration. The Company’s antibody program, PBD-C06, will
remain active as a candidate for further potential partnering opportunities.
Corporate Development Updates (until June 30, 2024 and beyond):
•
In March 2024, Kugan Sathiyanandarajah and Professor Dr. Morten Asser Karsdal stepped down from
Vivoryon’s Board of Directors. They had been appointed as Non-Executive Directors in June 2023.
•
In March 2024, Anne Doering, CFA, assumed the role of Chief Financial Officer (CFO) of Vivoryon,
following her previous position as Chief Strategy & Investor Relations Officer.
•
Vivoryon held its 2024 Annual General Meeting (AGM) on Friday, June 21, 2024, at 1:00 p.m. (CEST) in
Amsterdam, the Netherlands. All items on the agenda of the meeting were adopted. Agenda items of
particular note include the reappointment of Dr. Michael Schaeffer, Chief Business Officer, as executive
director as well as the amendment to the Company’s articles of association with regard to, among other
changes, the decrease of the nominal value of the shares in the capital of the Company to EUR 0.01 from
EUR 1.00. Following the completion of the creditor opposition procedure in accordance with Dutch law,
with no objection having been filed, the Company has implemented the share capital reduction on
September 5, 2024. Further information can be found under item 19. Significant events after the reporting
date in the notes to the unaudited condensed interim financial statements of this report. The full AGM
agenda and all relevant documents are available on the Company’s website
(https://www.vivoryon.com/2024-annual-general-meeting/).
5
4. Risk Factors
We refer to the description of risk factors in our 2023 annual report, pp. 21–35, which remains valid and
unaltered and which is hereby incorporated by reference.
5. Related Party Transactions
We refer to the description under no. 18 of the Notes to the Unaudited Condensed Interim Financial Statements
below for further information.
Transactions with key management personnel
For the six months ended June 30, 2024, the Company has recognized EUR 935 thousand of share-based
payment expense in the Statements of Operations and Comprehensive Income and Loss, relating to executive board
members:
2024
2023
in kEUR
Compensation
Frank Weber (CEO)
458
—
109
364
Michael Schaeffer (CBO)
Anne Doering (CFO since 03/2024)
334
—
34
260
Florian Schmid (CFO until 02/2024)
Ulrich Dauer (former CEO)
—
463
935
1,087
Total
For the six months ended June 30, 2024, the Company has recognized EUR 129 thousand of share-based
payment expense in the Statements of Operations and Comprehensive Income and Loss, relating to non-executive
board members:
2024
2023
in kEUR
Compensation
Erich Platzer
21
137
Claudia Riedl
33
120
Charlotte Lohmann
21
137
Samir Shah
54
201
Dinnies von der Osten (until June 21, 2023)
—
207
—
207
Jörg Neermann (until June 21, 2023)
Total
129
1,009
6
6. Responsibility Statement on the Unaudited Condensed Interim Financial Statements
The company has have prepared the unaudited condensed interim financial statements of Vivoryon Therapeutics
N.V. for the six months ended June 30, 2024 in accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by
the EU. To the best of our knowledge:
•
The unaudited condensed interim financial statements give a fair view of the assets, liabilities and financial
position as of June 30, 2024, and of the result of our operations for the six-month period ended June 30,
2024; and
•
the unaudited management report for the six-month period ended June 30, 2024 includes a fair view of the
information required pursuant to section 5:25d, paragraphs 8 and 9 of the Dutch Financial Supervision Act
(Wet op het financieel toezicht).
7
Vivoryon Therapeutics N.V.
Unaudited Condensed Statements of Operations and Comprehensive Income and Loss for the six months
ended June 30, 2024 and 2023
For the six months ended June 30,
2024
2023
(unaudited)
(unaudited)
Note
(in kEUR, except for share data)
Research and development expenses
(10,308)
(6,259)
(3,501)
(4,433)
General and administrative expenses
(13,809)
(10,692)
Operating loss
Finance income
6.
303
258
(53)
(327)
Finance expenses
6.
250
(69)
Finance result
6.
(13,559)
(10,761)
Result before income taxes
—
45
Income taxes
(13,559)
(10,716)
Net loss for the period
Items not to be reclassified subsequently to profit or loss
39
(9)
Remeasurement of the net defined benefit pension liability
39
(9)
Total other comprehensive profit / (loss)
(13,520)
(10,725)
Comprehensive loss
Loss per share in EUR (basic and diluted)
(0.52)
(0.44)
16.
The accompanying notes are an integral part of these unaudited condensed interim financial statements.
8
Vivoryon Therapeutics N.V.
Unaudited Condensed Statements of Financial Position as of June 30, 2024 and December 31, 2023
June 30,
2024
December 31,
Note
(unaudited)
2023
(in kEUR)
ASSETS
Non-current assets
Property, plant and equipment
31
40
Intangible assets
904
941
Right-of-use assets
14.
9
36
944
1,017
Total non-current assets
Current assets
Financial assets
74
10,165
7.
Other current assets and prepayments
9.
701
1,085
15,272
18,562
Cash and cash equivalents
10.
Total current assets
16,047
29,812
16,991
30,829
TOTAL ASSETS
Equity
Share capital
11.
26,067
26,067
Share premium
135,671
135,671
Other capital reserves
14,817
13,599
Accumulated other comprehensive loss
(217)
(256)
Accumulated deficit
(162,358)
(148,799)
13,980
26,282
Total equity
Non-current liabilities
Pension liability
1,287
1,353
13.
Provisions long-term
12
12
1,299
1,365
Total non-current liabilities
Current liabilities
Trade payables
1,465
2,894
7.
Lease liabilities
14.
10
38
237
250
Other liabilities
15.
Total current liabilities
1,712
3,182
3,011
4,547
Total Liabilities
TOTAL EQUITY AND LIABILITIES
16,991
30,829
The accompanying notes are an integral part of these unaudited condensed interim financial statements.
9
Vivoryon Therapeutics N.V.
Unaudited Condensed Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2024 and 2023
Accumulated
other
Other
Share
comprehensive
Share
capital
Accumulated
Total
capital
premium
reserves
loss
deficit
equity
(in kEUR)
Note
26,067
135,671
13,599
(256)
(148,799)
26,282
January 1, 2024
Net loss for the period
—
—
—
—
(13,559)
(13,559)
Remeasurement of the net defined
—
—
—
39
—
39
benefit pension liability
—
—
—
39
(13,559)
(13,520)
Comprehensive loss
Proceeds from the issuance of
common shares
—
—
—
—
—
—
11.
Transactions costs of equity
transactions
—
—
—
—
—
—
Share-based payments
—
—
1,218
—
—
1,218
12(c)
—
—
—
—
—
—
Exercise of share options
12(b)
26,067
135,671
14,817
(217)
(162,358)
13,980
June 30, 2024
24,105
113,382
9,656
(180)
(120,457)
26,506
January 1, 2023
Net loss for the period
—
—
—
—
(10,716)
(10,716)
Remeasurement of the net defined
—
—
—
(9)
—
(9)
benefit pension liability
—
—
—
(9)
(10,716)
(10,725)
Comprehensive loss
Proceeds from the issuance of
common shares
1,786
23,214
—
—
—
25,000
11.
Transactions costs of equity
transactions
—
(2,095)
—
—
—
(2,095)
Share-based payments
—
—
2,305
—
—
2,305
12(c)
71
472
—
—
—
542
Exercise of share options
12(c)
25,962
134,973
11,961
(189)
(131,173)
41,534
June 30, 2023
The accompanying notes are an integral part of these unaudited condensed interim financial statements.
10
Vivoryon Therapeutics N.V.
Unaudited Condensed Statements of Cash Flows for the six months ended June 30, 2024 and 2023
For the six months ended
June 30,
2024
2023
Note
(unaudited)
(unaudited)
(in kEUR)
Operating activities
Net loss for the period
(13,559)
(10,716)
Adjustments for:
Finance result
(250)
69
6.
Depreciation and amortization
73
79
Share based payments
1,218
2,305
12(c)
Foreign currency gain (loss) from other items than cash
(25)
(59)
Deferred income tax
—
(45)
Other non-cash adjustments
19
(33)
Changing in:
Financial assets
7.
(4)
(8,938)
9.
Other current assets and prepayments
383
(2,036)
Pension liabilities
13.
(66)
(13)
Trade payables
7.
(1,429)
(1,252)
Other liabilities
15.
(13)
306
Interest received
353
51
Interest paid
—
(1)
(13,300)
(20,283)
Cash flows used in operating activities
Investing activities
Purchase of plant and equipment
—
(9)
Proceeds from sale of financial assets
10,000
—
10,000
(9)
Cash flows used in investing activities
Financing activities
Proceeds from the issuance of common shares
—
25,000
11.
Capital raising costs
—
(2,095)
Proceeds from exercise of share options
—
542
12(b)
Payment of lease liabilities
(28)
(47)
(28)
23,400
Cash flows provided by financing activities
Net change in cash and cash equivalents
(3,328)
3,109
Cash and cash equivalents at the beginning of period
18,562
26,555
10.
Effect of exchange rate fluctuation on cash held
38
(82)
15,272
29,582
Cash and cash equivalents at end of period
10.
The accompanying notes are an integral part of these unaudited condensed interim financial statements.
11
Vivoryon Therapeutics N.V.
Notes to the Unaudited Condensed Interim Financial Statements
1. Company information
Vivoryon Therapeutics N.V. is a Dutch public company with limited liability (‘Naamloze Vennootschap’) that
has its statutory seat in Amsterdam, the Netherlands and branch offices in Halle (Saale) and Munich, Germany. The
Company’s ordinary shares are listed under the ticker symbol ‘VVY’ with NL00150002Q7 on Euronext
Amsterdam, the Netherlands. The Company is registered with the name Vivoryon Therapeutics N.V. in the Trade
Register of the Netherlands Chamber of Commerce under number 81075480. The Company’s registered office and
business address is Weinbergweg 22, 06120 Halle (Saale), Germany.
Vivoryon Therapeutics N.V. (hereinafter also referred to as ‘Vivoryon’ or the ‘Company’), has activities in the
areas of research, preclinical and clinical development of therapeutic drug candidates. The Company has established
a pipeline of orally available small molecule inhibitors for various indications including Alzheimer’s disease,
inflammatory and fibrotic disorders, including of the kidney, and cancer. The activities of the Company are carried
out in Germany, the primary location for its development activities.
2. Basis of accounting
The condensed interim financial statements for the six-month reporting periods ended June 30, 2024 and 2023
have been prepared in accordance with IAS 34 Interim Financial Reporting. These condensed interim financial
statements do not include all the information and disclosures required in the annual financial statements.
Accordingly, this report is to be read in conjunction with the financial statements in our annual report for the year
ended December 31, 2023.
The condensed interim financial statements were authorized for issue by the board of directors on August 30,
2024. The Board declares that, to the best of its knowledge, the condensed interim financial statements for the six
months ended June 30, 2024 provide a true and fair view of the assets, liabilities, financial position and profit or loss
of the Company in accordance with IFRS, and the Report provides a true and fair view of the position of the
Company as at June 30, 2024 and the development of the business during the six months period ended June 30,
2024.
These condensed interim financial statements are presented in thousands of Euro (EUR), which is also the
functional currency of Vivoryon Therapeutics N.V. All financial information presented in Euro has been rounded to
the nearest thousand (abbreviation EUR thousand) or million (abbreviated EUR million).
The accounting policies adopted are consistent with those followed in the preparation of the Company’s annual
financial statements for the year ended December 31, 2023. The Company has not early adopted any other standard,
interpretation or amendment that has been issued but is not yet effective.
3. Going Concern
The Company has evaluated whether there are certain conditions and events, considered in the aggregate, that
may cast significant doubt about the Company’s ability to continue as a going concern.
As a clinical stage biopharmaceutical company, the Company has incurred operating losses since inception. For
the six months periods ended June 30, 2024, the Company incurred a net loss of EUR 13.6 million (including an
operating loss amounting to EUR 13.8 million, resulting in an operating cash outflow of EUR 13.3 million). As of
June 30, 2024, the Company had generated an accumulated deficit of EUR 162.4 million and had an equity position
amounting to EUR 14.0 million. In presenting the report of the Board for the financial year 2023 at the Company’s
AGM held on June 21, 2024, it has been pointed out in accordance with Section 2:108a of the Dutch Civil Code that
it has become apparent to the Board that the Company’s equity may decrease to or below 50% of the Company’s
paid up and called up share capital in the next three months following the AGM. Measures discussed to strengthen
the Company’s liquidity include the reduction of cash utilization, actively pursuing funding and business
development opportunities to bolster the balance sheet and to fund R&D activities as well as focusing on compounds
that create most value for the Company, in particular varoglutamstat in kindey disease. The Company expects it will
continue to generate significant operating losses for the foreseeable future due to, among other things, costs related
to development of its product candidates and its preclinical programs, strategic alliances and its administrative
organization. The negative VIVIAD results, which were announced in March 2024 (see note 9.5 of the Company’s
12
annual financial statements for the year ended December 31, 2023), have negative implications for any fundraising
opportunities.
As of September 12, 2024, the issuance date of the condensed interim financial statements for the six months
periods ended June 30, 2024, the Company expects on the basis of its most recent business plan that its existing cash
and cash equivalents will be sufficient to fund its research and development expenses, general and administrative
expenses and cash outflows from investing and financing, excluding any additional financing, into the second
quarter of 2025. This cash runway guidance reflects an overall reduction in cash utilization including the ramp down
of spending on VIVIAD as it approaches its conclusion, the discontinuation of VIVA-MIND, the discontinuation of
VIVALONG preparation activities given the developments of VIVIAD and VIVA-MIND as well as the
streamlining of manufacturing costs and programs for API development. These activities also represent a change in
focus of research and development resources towards inflammatory and fibrotic disorders, such as of the kidney,
from an emphasis on Alzheimer’s disease. For this assessment, it was assumed that none of the options granted in
connection with the private placement from September 30, 2022, will be exercised (see note 8.11 of the Company’s
annual financial statements for the year ended December 31, 2023). The future viability of the Company beyond the
second quarter of 2025 is dependent on its ability to raise additional funds to finance its operations which also
depends on the success of the above-described research and development activities such as those focusing on
exploring opportunities in kidney disease.
To date the Company has largely financed its operations through equity raises, licensing proceeds and
government grants. In the event the Company does not complete private equity financing transactions, the Company
expects to seek additional funding through government or private-party grants, debt financings or other capital
sources or through collaborations with other companies or other strategic transactions, including partnering deals for
one or more of its product candidates. The Company is currently exploring various financing alternatives to meet its
future cash requirements, seeking additional investors, pursuing industrial partnerships, or obtaining further funding
from existing investors through additional funding rounds. Amongst others, depending on the success of the above-
described research and development activities, the Company may not be able to obtain financing on acceptable
terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of
any financing may adversely affect the holdings or rights of the Company’s shareholders.
If the Company is unable to raise capital on acceptable terms or at all, the Company would be forced to
terminate its product development or future commercialization efforts of one or more of its product candidates, or
may be forced to terminate its operations. Although management continues to pursue these plans, there is no
assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company
to fund continuing operations, if at all.
Management has considered the ability of the Company to continue as a going concern. Based on the
Company’s recurring losses from operations incurred since inception, expectation of continuing operating losses for
the foreseeable future, and the need to raise additional capital to finance its future operations, as of September 12,
2024, the issuance date of the condensed interim financial statements for the six months periods ended June 30,
2024, the Company has concluded that a material uncertainty exists that may cast significant doubt about its ability
to continue as a going concern.
The accompanying condensed interim financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might
result from the outcome of this uncertainty. Accordingly, the accompanying condensed interim financial statements
have been prepared on the basis that the Company will continue as a going concern, which contemplates the
realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
13
4. Change in accounting policy
The following amendments were adopted effective January 1, 2024 and have not a material impact on the
financial statements of Vivoryon:
Standards / Amendments
Impending change
Effective date*
Actual effects
Amendment to IAS 1:
Relates to the presentation of liabilities January 1, 2024 No material effects
Classification of Liabilities in the financial statements. The
on the financial
as Current or Non-current
classification of liabilities as current or
statements.
non-current must be based on rights
that are in existence as of the reporting
date.
Amendments to IFRS 16:
Due to the amendments to IFRS 16, the January 1, 2024 No material effects
Lease Liability in a Sale
standard now specifies that, in
on the financial
and Lease Back
subsequently measuring the lease
statements.
liability, the seller-lessee determines
‘lease payments’ and ‘revised lease
payments’ in a way that does not result
in the seller-lessee recognizing any
amount of the gain or loss that relates
to the right of use it retains.
Amendments to IAS 7 and The amendments introduce targeted
January 1, 2024 No material effects
IFRS 7: Supplier Finance
disclosure requirements that will
on the financial
Arrangements
enhance the transparency of supplier
statements.
finance arrangements and their effects
on a company’s liabilities and cash
flows.
The following amendments will be adopted effective January 1, 2025 or later:
Standards / Amendments
Impending change
Effective date*
Anticipated effects
Amendments to IAS 21:
The amendments clarify how an entity
January 1, 2025 No material effects
Lack of Exchangeability
should assess whether a currency is
on the financial
exchangeable and how it should
statements are
determine a spot exchange rate when
expected.
exchangeability is lacking, as well as
require the disclosure of information
that enables users of financial
statements to understand the impact of
a currency not being exchangeable.
Amendments to IFRS 9
The amendments clarify that a financial January 1, 2026 No material effects
and IFRS 7: Classification liability is derecognised on the
on the financial
and Measurement of
‘settlement date’ and introduce an
statements are
Financial Instruments
accounting policy choice to
expected.
derecognize financial liabilities settled
using an electronic payment system
before the settlement date.
Other clarifications include the
classification of financial assets with
ESG linked features via additional
guidance on the assessment of
contingent features. Clarifications have
been made to non-recourse loans and
contractually linked instruments.
Additional disclosures are introduced
for financial instruments with
14
contingent features and equity
instruments classified at fair value
through OCI.
Amendments published as Amendments to
January 1, 2026 No material effects
part of the ‘Annual
– IFRS 1 First-time Adoption of
on the financial
Improvements to IFRS
International Financial Reporting
statements are
Accounting
Standards (Hedge Accounting by a
expected.
Standards – Volume 11’
First-Time Adopter)
– IFRS 7 Financial Instruments:
Disclosures (Gain or Loss on
Derecognition) & Guidance on
Implementing IFRS 7
– IFRS 9 Financial Instruments
(Derecognition of Lease Liabilities /
Transaction Price)
– IFRS 10 Consolidated Financial
Statements (Determination of a “De
Facto Agent”)
– IAS 7 Statement of Cash Flows (Cost
Method)
New Standard IFRS 18:
IFRS 18 will replace IAS 1
January 1, 2027 Vivoryon is currently
Presentation and
Presentation of Financial Statements
assessing the impact
Disclosure in Financial
and will significantly update the
of adopting IFRS 18.
Statements
requirements for presentation and
disclosures in the financial statements,
with a particular focus on improving
the reporting of financial performance.
New Standard IFRS 19:
IFRS 19 allows eligible entities to elect January 1, 2027 No material effects
Subsidiaries without
to apply IFRS 19’s reduced disclosure
on the financial
Public Accountability:
requirements while still applying the
statements are
Disclosures
recognition, measurement and
expected.
presentation requirements in other
IFRS accounting standards.
* The date of first-time adoption scheduled by the IASB is assumed for the time being as the likely date of first-
time adoption for the entity.
5. Critical judgments and accounting estimates
Information about assumptions and estimation uncertainties that have a significant risk of resulting in a material
adjustment to the carrying amounts of assets and liabilities within the period ending June 30, 2024 is included in the
following notes. The estimates may differ from the actual amounts recognized in subsequent periods. Changes in
assumptions or estimates to be made are recognized in the statement of profit or loss and other comprehensive
income at the time they become known. The circumstances in existence at the time of preparation of the financial
statements are considered as well as the future development in the industry-related environment concerning the
expected future business development of Vivoryon.
Recognition of research and development expenses
As part of the process of preparing the financial statements, Vivoryon is required to estimate its accrued ex-
penses. This process involves reviewing quotations and contracts, identifying services that have been performed on
its behalf, estimating the level of service performed and the associated cost incurred for the service when Vivoryon
has not yet been invoiced or otherwise notified of the actual cost, see note 6.14 of our Annual Report 2023.
Defined benefit plan (pension benefits)
The cost of the defined benefit pension plan and the present value of the pension obligation are determined
using actuarial valuations. An actuarial valuation involves making various assumptions that may differ from actual
15
developments in the future. These include the determination of the discount rate and mortality rates (see note 6.11,
8.13 of our Annual Report 2023). Due to the complexities involved in the valuation and its long-term nature, a
defined benefit obligation is highly sensitive to changes in these assumptions. All assumptions are reviewed at each
reporting date. The parameter most subject to change is the discount rate. In determining the appropriate discount
rate, management considers the interest rates of corporate bonds in currencies consistent with the currencies of the
post-employment benefit obligation with at least an ‘AA’ rating or above, as set by an internationally acknowledged
rating agency, and extrapolated as needed along the yield curve to correspond with the expected term of the defined
benefit obligation. The mortality rate is based on publicly available mortality tables for Germany (see note 6.11,
8.13 of our Annual Report 2023). Those mortality tables tend to change only at intervals in response to demographic
changes. Future pension increases are based on the fixed increases as per contractual agreement (increase is 1 %
p.a.). Further details about pension obligations are provided in note 6.11, 8.13 of our Annual Report 2023.
Accounting for share-based payments (compensation)
Estimating fair value for share-based payment transactions requires determination of the most appropriate
valuation model, which depends on the terms and conditions of the grant. This estimate also requires determination
of the most appropriate inputs to the valuation model including the expected life of the share option, volatility of the
share price and dividend yield and making assumptions about them (see note 6.10, 8.12 of our Annual Report 2023).
The Company initially measures the fair value of equity-settled transactions with employees at the grant date, using
binomial simulation model. When determining the grant date fair value of share-based payment awards, assumptions
must be made regarding the key parameters of the grant (see note 6.10, 8.12 of our Annual Report 2023).
Additionally, the Company must estimate the number of equity instruments which will vest in future periods as
awards may be forfeited prior to vesting due to non-achievement of service conditions (e.g. employment
termination), or performance conditions. An assumption of the forfeiture rate must be made based on historical
information and adjusted to reflect future expectations. At each reporting date, the Company revises the estimate if
necessary. Revisions to the forfeiture rate could result in a cumulative effect of the change in estimate for current
and prior periods to be recognized in the period of change. The assumptions and models used for estimating fair
value for share-based payment transactions are disclosed in note 6.10, 8.12 of our Annual Report 2023 and in note
12. (a) to these unaudited condensed interim financial statements.
Income Taxes
Uncertainties exist with respect to the interpretation of complex tax regulations, changes in tax laws, and the
amount and timing of future taxable income. Given the differences arising between the actual results and the as-
sumptions made, or future changes to such assumptions, could necessitate future adjustments to tax entries already
recorded. Deferred tax assets are recognized for unused tax losses to the extent, that deferred tax liabilities exceed
deferred tax assets, while the provisions of the German Tax Act on the utilization of loss carryforwards was also
considered ('minimum taxation'/’Mindestbesteuerung’). Significant management judgement is required to determine
the amount of deferred tax assets that can be recognized, based upon the likely timing of deferred tax liabilities that
are compensated by deferred tax assets from loss carryforwards under the constraints of German tax law. Due to our
history of loss-making over the last several years as well as our plans for the foreseeable future, we have not
recognized any further deferred tax assets on tax losses carried forward.
16
6. Finance result
For the six months ended
June 30,
2024
2023
in kEUR
Finance income
Interest income
259
98
44
160
Foreign exchange income
303
258
Total
Finance expenses
Foreign exchange expense
(31)
(301)
(22)
(26)
Interest expenses
(53)
(327)
Total
250
(69)
Finance result
Foreign exchange income and expense is mainly derived from the translation of the U.S. Dollar cash held by
Vivoryon Therapeutics N.V. and liabilities denominated in USD from transactions.
Interest income results from the Company`s Euro and U.S. Dollar deposits. Interest expenses for the six months
ended June 30, 2024 as well as for 2023 includes interest expense from pensions and leasing.
7. Financial assets and financial liabilities
Set out below is an overview of financial assets and liabilities, other than cash and cash equivalents, held by the
Company as of June 30, 2024 and December 31, 2023:
As of
As of June 30,
December 31,
2024
2023
in kEUR
Financial assets, current
Term deposits in Euro with a maturity between 3 and 12 months
—
10,000
74
165
Other current financial assets
74
10,165
As of June 30, the fair value of current financial assets is estimated with the carrying amount.
As of
As of June 30,
December 31,
2024
2023
in kEUR
Financial liabilities, current
Trade Payables
1,465
2,894
1
—
Other financial liabilities
1,466
2,894
Trade payables decreased to EUR 1,465 thousand as of June 30, 2024, from EUR 2,894 thousand as of
December 31, 2023 as a higher volume of services had been accrued as of December 31, 2023 which have been paid
in the following six months ended on June 30, 2024.
17
8. Contract balances
As of June 30, 2024 and December 31, 2023 no receivables, contract assets and contract liabilities from
contracts with customers are recognized.
9. Other non-financial assets
in kEUR
As of June 30,
As of December
2024
31, 2023
Other Current assets
Government grants
—
495
Prepayments
368
222
Other tax reclaims
276
189
57
179
Value-added tax receivables
Total
701
1,085
As of June 30, 2024 the prepayments include advance payments for other research and development projects in
the amount of EUR 230 (2023: EUR 70 thousands) and for general administration costs EUR 138 thousands (2023:
EUR 152 thousands).
Other tax reclaims relate to receivables due to withholding taxes on interest income or license payments.
Current VAT tax assets as of June 30, 2024 and December 31, 2023, include regular tax reclaims from incoming
invoices.
10. Cash and cash equivalents
As of June 30,
As of December
2024
31, 2023
in kEUR
Cash Equivalents
Term deposits in Euro with a maturity below three months
10,000
6,000
10,000
6,000
Total
Cash at banks
Cash held in U.S. Dollars
90
1,900
Cash held in Euro
5,182
10,662
5,272
12,562
Total
Total cash and cash equivalents
15,272
18,562
The banks (Deutsche Bank, Landesbank Baden Württemberg and Commerzbank) are all investment graded
(BBB or better; S&P).
11. Equity
As of June 30, 2024, Vivoryon’s issued capital comprised 26,066,809 common shares (as of December 31,
2023: 26,066,808). The nominal amount per share is EUR 1.00. The authorized share capital (maatschappelijk
kapitaal) amounts to EUR 60,000,000, divided into 60,000,000 common shares, each with a nominal value of
EUR 1.00, numbered 1 through 60,000,000.
2024
2023
Shares outstanding on January 1
26,066,808
24,105,278
Issuance of common shares
0
1,785,715
Shares issued as a result of the exercise of share options
1
70,899
26,066,809
25,961,892
Shares outstanding on June 30
18
In the six months ended June 30, 2024, one share option was issued upon the exercise of share options under the
2021 Plan, resulting in EUR 9,39 proceeds to the company. In the six months ending June 30, 2024 no more share
options were exercised.
On May 31, 2023 the Company completed a private placement by way of accelerated book building, placing
1,785,715 registered shares at an offering price of EUR 14.00 per share. As a consequence, the Company’s issued
share capital has increased to EUR 26,066,809. The gross proceeds of the offering amount to EUR 25.0 million.
12. Share based payments
Equity settled share-based payment arrangements
Under the 2014 Share Option Program (“2014 Plan”) the Company granted rights to purchase common shares
of Probiodrug AG (“Probiodrug”), the Company`s former name, to certain members of the management board (as
was installed at that time) and employees of Probiodrug. Under this share option program options were issued in the
years 2014 to 2017. Since December 31, 2017, no new grants could be issued under the 2014 Plan. In April 2023
20,000 and in July 2023 64,874 share options granted under the 2014 Plan have expired, thus 8,000 share options are
still outstanding and exercisable under the 2014 Plan.
Number of share options
2024
2023
8,000
92,874
Outstanding as of January 1,
Granted during the six months ended June 30
—
—
Exercised during the six months ended June 30
—
—
—
(20,000)
Forfeited during the six months ended June 30
8,000
72,874
Outstanding as of June 30,*
thereof exercisable**
8,000
72,874
* The contractual life of the options is 8 years from the date of grant, not exercisable before lapse of 4 years.
** Vesting over 3-year period (33,3% each after first, second and third year).
The Company further established a new share option program on September 13, 2019 (amended on December
4, 2020) (“2020 Plan”), with the purpose of promoting the long-term loyalty of the beneficiaries to the Company.
The 2020 Plan governed issuances of share options to employees and members of the board. The maximum number
of common shares available for issuance under option awards granted pursuant to the 2020 Plan equaled 615,000
options. Since July 1, 2022, no new grants could be issued under the 2020 Plan.
Number of share options
2024
2023
615,000
615,000
Outstanding as of January 1,
Granted during the six months ended June 30
—
—
Exercised during the six months ended June 30
—
—
—
—
Forfeited during the six months ended June 30
615,000
615,000
Outstanding as of June 30,*
thereof exercisable**
—
—
* The contractual life of the options is 8 years from the date of grant, not exercisable before lapse of 4 years.
** Vesting over 3-year period (33,3% each after first, second and third year).
The Company established an omnibus equity incentive plan on June 28, 2021 (the “2021 Plan”) governing
the issuance of equity incentive awards to enhance our ability to attract, retain and motivate key employees. The
initial maximum number of common shares available for issuance under equity incentive awards granted pursuant to
the 2021 Plan equals 2,000,000 common shares. On January 1, 2024 and on January 1 of each calendar year
thereafter, an additional number of common shares equal to 3 % of the total outstanding amount of common shares
on December 31 of the immediately preceding year (or any lower number of common shares as determined by the
board of directors) will become available for issuance under equity incentive awards granted pursuant to the 2021
Plan. The plan is administered by the Compensation Committee, the committee determines designated Participants,
number of shares to be covered as well as the terms and conditions of any award.
19
Number of share options
2024
2023
1,668,935
1,305,000
Outstanding as of January 1,
Granted during the six months ended June 30
915,000
30,000
Exercised during the six months ended June 30
(1)
(70,899)
(103,222)
—
Forfeited during the six months ended June 30
2,480,712
1,264,101
Outstanding as of June 30,*
thereof exercisable**
916,214
570,741
* The contractual life of the options is 10 years from the date of grant, exercisable after vesting.
** Vesting over 2-3-year period (typically approximately one third after first year, the remainder in equal
monthly tranches over two years).
The number of share options granted during the six months ended June 30, 2024 under the 2021 Plan was as
follows:
Fair value per
Share price at grant date
Expected volatility of
Risk-free
Share options
Number
option
/ exercise price
Company`s share*
rate
granted in 2024
January 2
30,000 **EUR 3.22 – 4.16
EUR 8.13
60%
2.14%
January 9
165,000 **EUR 3.13 – 4.06
EUR 7.98
60%
2.21%
January 9
150,000
***EUR 0.05
EUR 7.98
60%
2.21%
January 9
60,000
***EUR 0.00
EUR 7.98
60%
2.21%
June 6
410,000 **EUR 1.07 – 1.40
EUR 2.59
65%
2.54%
100,000 **EUR 0.81 – 1.06
EUR 1.96
65%
2.39%
June 21
915,000
*
Expected volatility is based on the historical volatility of the Company`s shares at the Amsterdam market
place in the three years prior to the valuation date rounded to the nearest 5%; from June 2024 onward
additionally the application of a confidence-interval of 97.5% has been introduced.
** Lifetime of the options was estimated with an early exercise when the share reaches a value of 150% of the
exercise price.
***Lifetime of the options was estimated with an early exercise at the change in control event (after 2.5 years
from grant-date), when the share price would exceed the minimum threshold
Share options exercised
In the six months ended June 30, 2024 one share was issued upon the exercise of share options under the 2021
Plan.
In the six months ended June 30, 2023 70,899 shares were issued upon the exercise of share options under the
2021 Plan, resulting in EUR 542 thousand proceeds to the Company.
Share-based payment expense recognized
For the six months ended June 30, 2024, the Company has recognized EUR 1,218 thousand, (2023: EUR 2,305
thousand) of share-based payment expense in the Statements of Operations and Comprehensive Income and Loss.
None of the share-based payments awards were dilutive in determining earnings per share due to the Company’s
loss position.
20
13. Pension liability
As of
As of June 30,
December 31,
2024
2023
in kEUR
Pension liability
Defined benefit obligation
1,158
1,218
129
136
Obligations for granted and vested pension commitment
Total pension liability
1,287
1,354
Vivoryon has defined benefit pension plan commitments to two former members of the management board. The
pension commitments include entitlements to disability, retirement and survivor benefits in amounts specifically
determined by the individual. The amount of the defined benefit obligation (actuarial present value of the accrued
pension entitlements) is determined based on actuarial methodologies which require the use of estimates.
•
Mortality rates were calculated according to the current 2018 G mortality tables published by Heubeck.
•
The measurement of the pension liability was calculated with a discount rate of 3.66% p.a. as of June 30,
2024 (December 31, 2023: 3.33 % p.a.).
•
In addition, an increase in the pension of 1.0% was assumed.
As of
As of
December 31,
June 30, 2024
2023
Defined benefit obligation
1,218
1,177
As of January 1,
Interest
19
44
Benefit payments
(40)
(79)
Actuarial gains (-)/ losses (+)
-
Changes in financial assumptions
(36)
66
-
Experience adjustments
(3)
10
1,158
1,218
As of June 30 / December 31
In the reporting period, interest expenses in the amount of EUR 19 thousand (total year 2023: EUR 44
thousand) associated with defined benefit obligations were recognized in the statement of profit and loss.
The weighted average duration of the pension commitments was 9.6 years as of June 30, 2024, respectively
10.0 years as of December 31, 2023.
14. Leases
Lease contracts consist of non-cancellable lease agreements mainly relating to the Company`s leases of office
space in Halle (Saale) and München (Germany). Set out below, are the carrying amounts of the Company`s right of
use assets, lease liabilities and recognized expenses in connection with leases:
For the six
For the twelve
months ended
months ended
June 30,
December 31,
2024
2023
in kEUR
Right of use assets
36
127
Balance at January 1
Additions
—
—
(27)
(91)
Depreciation
9
36
Balance at June 30 / December 31
Lease Liabilities
38
133
Balance at January 1
21
Additions
—
—
Repayments
(28)
(96)
—
2
Interest
10
38
Balance at June 30 / December 31
thereof short-term lease liabilities
10
38
For the six months ended
June 30,
2024
2023
in kEUR
Expenses in connection with leases
Depreciation of RoU assets
(27)
(46)
Interest expenses on lease liabilities
—
(1)
Lease expenses of low-value assets
—
—
Total
(27)
(47)
15. Other liabilities
in kEUR
As of June 30,
As of December
2024
31, 2023
Other current liabilities
Withholding taxes
—
10
Liabilities from employee benefits
167
188
Social charges, wage tax
69
51
1
1
Other financial liabilities
Total other liabilities
237
250
16. Loss per share
As of June 30, 2024, Vivoryon’s issue capital consisted of 26,066,809 common shares (26,066,808 on
December 31, 2023). All common shares are registered with no par value common shares. The calculated nominal
amount per share is EUR 1.00. The net loss for the period amounted to EUR 13,559 thousands in the six months
ended June 30, 2024 (2023: net loss of EUR 10,716 thousands). The loss per share was calculated as follows:
For the six months ended
June 30,
2024
2023
Loss per share calculation
Weighted average number of common shares outstanding
26,066,809
25,961,892
(13,559)
(10,716)
Loss for the period (in kEUR)
(0.52)
(0.44)
Loss per share (basic/diluted) in Euro
As of June 30, 2024 and 2023, no items had a dilutive effect. The Company is loss making and therefore any
dilutive additional shares, e.g., share options, were excluded from the diluted weighted average of common shares
calculation because their effect would have been anti-dilutive.
17. Contractual Obligations and Commitments
The Company enters contracts in the normal course of business with CROs and clinical sites for the conduct of
clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other
services.
22
As of the date of these unaudited condensed interim financial statements, we do not have any, and during the
periods presented we did not have any, contractual obligations and commitments other than as described under
“9.2 Contingencies and other financial commitments” in the Annual Report 2023.
There is currently a law mediation procedure going on. Shareholders of Vivoryon applied for court procedures
for verification of the adequacy of our indemnity offer and of the compensation offered to those shareholders.
18. Related party relationships
The following individuals and entities were considered related parties of Vivoryon during the reporting period:
•
Executive members of the board of directors of the Company or a shareholder of the Company
•
Non-executive members of the board of directors
19. Significant events after the reporting date
This section captures the events occurring after the reporting date of June 30, 2024, until the publication of half
year results on September 12, 2024.
On July 18, 2024 Vivoryon Therapeutics N.V. announced new data during an R&D update call and webcast.
The update included data from further kidney function analysis in a diabetes subgroup from the VIVIAD Phase 2b
study of varoglutamstat in Alzheimer’s disease, as well as the Company’s proposed development plan for
varoglutamstat in its initial target indication, diabetic kidney disease (DKD).
Specifically, new analysis revealed a significant and unique treatment effect in patients with diabetes which is
coupled with additional potential health benefits on weight and blood pressure, and an excellent safety profile.
Given these compelling results, it is planned to advance varoglutamstat into a Phase 2 clinical study in patients with
diabetic kidney disease, specifically in more advanced patients with a high risk of end stage kidney disease where
there continues to be a significant unmet need for new therapies to stabilize and protect kidney function. The timing
and execution of the planned Phase 2 study is subject to additional funding and/or partnership.
On September 5, 2024, Vivoryon Therapeutic N.V. announced the completion of the reduction of its share
capital by decreasing the nominal value of the shares in the Company’s capital to EUR 0.01 from EUR 1.00. The
proposal of the Company’s Board of Directors to amend the Company’s articles of association by, among other
items, decreasing the nominal value of the shares in the capital of the Company to EUR 0.01 from EUR 1.00 was
approved by the shareholders at the 2024 annual general meeting, held on June 21, 2024. Following the completion
of the creditor opposition procedure in accordance with Dutch law, with no objection having been filed, the
Company has implemented the share capital reduction on September 5, 2024. The purpose of the reduction in
nominal value is to improve the Company’s capability to attract new financing, pursue M&A activities and
incentivize management, members of the Board and employees of the Company through granting equity awards, and
also improve the Company's equity composition. The nominal value of the shares in the Company is now EUR 0.01
each. The number of ordinary shares of the Company in issue (included shares held in treasury) has not changed and
consists of 26,066,809 ordinary shares. The amount of the capital reduction (being: EUR 0.99 per share that formed
part of the Company’s issued share capital) has been added to the Company’s distributable reserves.
23