As of |
||||||||||||
Notes |
June 30, 2022 |
December 31, 2021 |
||||||||||
(Euros in thousands) |
||||||||||||
| Assets |
||||||||||||
| Current assets |
||||||||||||
| Cash and cash equivalents |
||||||||||||
| Other financial assets |
15 | |||||||||||
| Accounts receivable |
||||||||||||
| Other current assets |
5 | |||||||||||
| |
|
|
|
|||||||||
| Total current assets |
||||||||||||
| Non-current assets |
||||||||||||
| Property, plant and equipment |
9 | |||||||||||
| Intangible assets |
9 | |||||||||||
| Right-of-use assets |
9 | |||||||||||
| Other non-current assets |
5 | |||||||||||
| |
|
|
|
|||||||||
| Total non-current assets |
||||||||||||
| |
|
|
|
|||||||||
| Total assets |
||||||||||||
| |
|
|
|
|||||||||
| Liabilities and shareholders’ equity |
||||||||||||
| Current liabilities |
||||||||||||
| Provisions |
10 | |||||||||||
| Accounts payable |
||||||||||||
| Deferred revenue |
6 | |||||||||||
| Other financial liabilities |
15 | |||||||||||
| Lease liabilities |
||||||||||||
| Other current liabilities |
11 | |||||||||||
| |
|
|
|
|||||||||
| Total current liabilities |
||||||||||||
| Non-current liabilities |
||||||||||||
| Deferred revenue |
6 | |||||||||||
| Lease liabilities |
||||||||||||
| Other non-current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Total non-current liabilities |
||||||||||||
| Shareholders’ equity |
||||||||||||
| Share capital |
||||||||||||
| Share premium |
14 |
|||||||||||
| Accumulated deficit |
14 |
( |
) | ( |
) | |||||||
| Other reserves |
( |
) | ( |
) | ||||||||
| |
|
|
|
|||||||||
| Total shareholders’ equity |
||||||||||||
| |
|
|
|
|||||||||
| Total liabilities and shareholders’ equity |
||||||||||||
| |
|
|
|
|||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||
(Euros in thousands, except share and per share data) |
(Euros in thousands, except share and per share data) |
|||||||||||||||||||
Revenue from collaboration agreements |
6 | |||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Other income |
||||||||||||||||||||
Operating result |
( |
) |
( |
) |
( |
) | ||||||||||||||
Financial income |
7 | |||||||||||||||||||
Financial expenses |
7 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
Change in fair value of warrant liabilities |
7 | ( |
) | ( |
) | ( |
) | |||||||||||||
Financial result |
( |
) |
( |
) | ||||||||||||||||
Profit/(loss) before taxes |
( |
) |
( |
) |
( |
) | ||||||||||||||
Taxes on income |
8 | ( |
) | ( |
) | |||||||||||||||
Net profit/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||||||
Net profit/(loss) per share: |
||||||||||||||||||||
Basic |
( |
) | ( |
) | ( |
) | ||||||||||||||
Diluted |
( |
) |
( |
) |
( |
) | ||||||||||||||
Weighted average shares outstanding: |
||||||||||||||||||||
Basic |
||||||||||||||||||||
Diluted |
||||||||||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||||||
| Net profit/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||||||
| Other comprehensive income/(loss) |
||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss, net of tax |
||||||||||||||||||||
| Currency translation differences from foreign operations |
( |
) | ||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total comprehensive income/(loss) for the period |
( |
) |
( |
) |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
Six months ended June 30, |
||||||||
2022 |
2021 |
|||||||
(Euros in thousands) |
||||||||
| Cash flows from operating activities |
||||||||
| Net profit/(loss) |
( |
) | ||||||
| Adjustments for: |
||||||||
| Interest income |
( |
) | ( |
) | ||||
| Depreciation and amortization |
||||||||
| Interest expense |
||||||||
| Equity settled share-based payment |
||||||||
| Net foreign exchange differences |
||||||||
| Change in fair value of warrant liabilities |
( |
) | ||||||
| Changes in: |
||||||||
| (Increase)/decrease in accounts receivable |
( |
) | ||||||
| (Increase)/decrease in other assets |
( |
) | ||||||
| Increase/(decrease) in accounts payable and other liabilities |
( |
) | ||||||
| Interest received |
||||||||
| Interest paid |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net cash provided by/(used in) operating activities |
( |
) | ||||||
| |
|
|
|
|||||
| Cash flows from investing activities |
||||||||
| Payments for property, plant and equipment |
( |
) | ( |
) | ||||
| Cash paid for investments classified in Other financial assets |
( |
) | ( |
) | ||||
| Cash received from maturity of investments classified in Other financial assets |
||||||||
| Payments for intangible assets |
( |
) | ( |
) | ||||
| Proceeds from disposal of property, plant and equipment |
||||||||
| |
|
|
|
|||||
| Net cash (used in)/provided by investing activities |
( |
) |
( |
) | ||||
| |
|
|
|
|||||
| Cash flows from financing activities |
||||||||
| Proceeds from issuance of shares to equity holders |
— | |||||||
| Transaction costs deducted from equity |
( |
) | — | |||||
| Payments for leases |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net cash provided by/(used in) financing activities |
( |
) | ||||||
| |
|
|
|
|||||
| Net increase/(decrease) in cash and cash equivalents |
( |
) | ||||||
| |
|
|
|
|||||
| Cash and cash equivalents at beginning of period |
||||||||
| |
|
|
|
|||||
| Effects of exchange rate changes on cash and cash equivalents |
||||||||
| |
|
|
|
|||||
| Cash and cash equivalents at end of period |
||||||||
| |
|
|
|
|||||
(Euros in thousands) |
Notes |
Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total share- holders’ equity |
||||||||||||||||||
Balance as of January 1, 2021 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net loss |
— | — | ( |
) | — | ( |
) | |||||||||||||||||
Comprehensive income/(loss) for the year |
— |
— |
( |
) |
( |
) | ||||||||||||||||||
Equity-settled share-based compensation |
12 | — | — | — | ||||||||||||||||||||
Balance as of June 30, 2021 |
( |
) |
( |
) |
||||||||||||||||||||
Balance as of January 1, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net profit |
— | — | — | |||||||||||||||||||||
Comprehensive income for the year |
— |
— |
||||||||||||||||||||||
Equity-settled share-based compensation |
12 | — | — | — | ||||||||||||||||||||
Share options exercised |
— | — | — | |||||||||||||||||||||
Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
Balance as of June 30, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
1. |
Stand-alone selling price for clinical trial services: € |
2. |
Stand-alone selling price for the license grant: € |
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| Value added tax receivable |
||||||||
| Grant receivable |
||||||||
| Other assets |
||||||||
| |
|
|
|
|||||
| Other current assets |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| |
|
|
|
|||||
| Other non-current assets |
||||||||
| |
|
|
|
|||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Amgen |
||||||||||||||||
| Genmab |
||||||||||||||||
| BMS |
||||||||||||||||
| GSK |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Current |
||||||||
| Non-current |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Interest income |
||||||||||||||||
| Foreign currency gains |
||||||||||||||||
| Gain on other financial instruments |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Interest expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Foreign currency losses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Losses on other financial instruments |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial expenses |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Change in fair value of warrant liabilities |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Financial result |
( |
) |
( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Other provision |
||||||||
| Provision for bonuses |
||||||||
| |
|
|
|
|||||
| Total provisions |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Income tax liability |
||||||||
| Payroll tax |
||||||||
| Accrual for vacation |
||||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
2022 |
||||||||
Weighted average exercise price |
Number |
|||||||
| Matching Stock Options outstanding on January 1, |
||||||||
| Matching Stock Options forfeited |
||||||||
| Matching Stock Options exercised |
||||||||
| Matching Stock Options expired |
||||||||
| Matching Stock Options outstanding on June 30, |
||||||||
| Matching Stock Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
2022 |
||||||||
Weighted average exercise price in |
Number |
|||||||
| Converted Options outstanding on January 1, |
||||||||
| Converted Options forfeited |
||||||||
| Converted Options exercised |
||||||||
| Converted Options expired |
||||||||
| Converted Options outstanding on June 30, |
||||||||
| Converted Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
As of March 22, 2022 |
As of March 29, 2022 |
As of June 14, 2022 |
As of June 30, 2022 |
|||||||||||||
| Exercise price in USD |
$ | $ | $ | $ | ||||||||||||
| Underlying share price in USD |
$ | $ | $ | $ | ||||||||||||
| Volatility |
% | % | % | % | ||||||||||||
| Time period (years) |
||||||||||||||||
| Risk free rate |
% | % | % | % | ||||||||||||
| Dividend yield |
% | % | % | % | ||||||||||||
2022 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| Service Options outstanding on January 1, |
||||||||
| Service Options granted in March, |
||||||||
| Service Options granted in June, |
||||||||
| Service Options forfeited |
||||||||
| Service Options exercised |
||||||||
| Service Options expired |
||||||||
| Service Options outstanding on June 30, |
||||||||
| Service Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
2022 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| PSUs outstanding on January 1, |
||||||||
| PSUs granted |
||||||||
| PSUs forfeited |
||||||||
| PSUs outstanding on June 30, |
||||||||
| PSUs exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Research and development expenses |
||||||||||||||||
| General and administrative expenses |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total share-based compensation |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Euros in thousands |
Carrying amount |
Fair value |
||||||||||||||||
IFRS 9 |
June 30, 2022 |
December 31, 2021 |
June 30, 2022 |
December 31, 2021 |
||||||||||||||
| Financial assets |
||||||||||||||||||
| Bonds* |
other financial assets at amortized cost | |||||||||||||||||
| Accounts receivable |
other financial assets at amortized cost | |||||||||||||||||
| Other current/non-current assets |
other financial assets at amortized cost | |||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Total financial assets** |
||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Financial liabilities |
||||||||||||||||||
| Accounts payable |
other financial liabilities at amortized cost | |||||||||||||||||
| Other current liabilities |
other financial liabilities at amortized cost | |||||||||||||||||
| Other financial liabilities |
At fair value through profit or loss |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Total financial liabilities |
||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| * | Bonds are classified within Other financial assets. |
| ** | Financial assets, other than cash and cash equivalents. |
| • | advancing the proprietary pipeline of product candidates focusing on ACTengine and TCR Bispecifics; |
| • | enhancing ACT manufacturing capabilities; |
| • | disrupting the tumor microenvironment through combination therapies, next-generation technologies and novel target classes; |
| • | developing novel personalized multi-TCR-T |
| • | maintaining and enhancing the competitive edge of our target and TCR technology platforms; |
| • | leveraging existing collaborations with Genmab, BMS and GSK and establish additional value-maximizing strategic collaborations and |
| • | expanding our intellectual property portfolio. |
| • | after reviewing trial results, we or our collaborators may abandon projects previously believed to be promising; |
| • | we, our collaborators, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks; |
| • | our potential products may not achieve the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved; |
| • | manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity; |
| • | regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and |
| • | safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials. |
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(euros in thousands, except share and per share data) |
||||||||||||||||
| Revenue from collaboration agreements |
€ | 17,215 | € | 5,189 | € | 120,123 | € | 12,592 | ||||||||
| Research and development expenses |
(25,216 | ) | (20,340 | ) | (50,360 | ) | (43,389 | ) | ||||||||
| General and administrative expenses |
(8,683 | ) | (8,271 | ) | (17,961 | ) | (16,702 | ) | ||||||||
| Other income |
27 | 26 | 32 | 265 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Operating result |
(16,657 |
) |
(23,396 |
) |
51,834 |
(47,234 |
) | |||||||||
| Financial income |
7,015 | 213 | 8,774 | 3,101 | ||||||||||||
| Financial expenses |
(407 | ) | (629 | ) | (1,524 | ) | (1,277 | ) | ||||||||
| Change in fair value of warrant liabilities |
(2,786 | ) | (2,722 | ) | 13,743 | (3,936 | ) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial result |
3,822 |
(3,138 |
) |
20,993 |
(2,112 |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Profit/(loss) before taxes |
(12,835 |
) |
(26,534 |
) |
72,827 |
(49,346 |
) | |||||||||
| Taxes on income |
(1,145 | ) | — | (1,145 | ) | — | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net profit/(loss) |
€ |
(13,980 |
) |
€ |
(26,534 |
) |
€ |
71,682 |
€ |
(49,346 |
) | |||||
| |
|
|
|
|
|
|
|
|||||||||
| Net profit/(loss) per share: |
||||||||||||||||
| Basic |
(0.22 | ) | (0.42 | ) | 1.12 | (0.78 | ) | |||||||||
| Diluted |
(0.22 | ) | (0.42 | ) | 1.11 | (0.78 | ) | |||||||||
| Weighted average shares outstanding: |
||||||||||||||||
| Basic |
64,915,600 | 62,909,095 | 63,932,449 | 62,908,945 | ||||||||||||
| Diluted |
64,915,600 | 62,909,095 | 64,477,256 | 62,908,945 | ||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
||||||||||||||||
| Revenue from collaboration agreements: |
||||||||||||||||
| Amgen |
€ | — | € | 260 | € | — | € | 517 | ||||||||
| Genmab |
4,125 | 2,105 | 7,044 | 4,341 | ||||||||||||
| BMS |
12,107 | 1,297 | 110,532 | 4,590 | ||||||||||||
| GSK |
983 | 1,527 | 2,547 | 3,144 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Total revenue from collaboration agreements |
€ 17,215 |
€ 5,189 |
€ 120,123 |
€ 12,592 |
||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
||||||||||||||||
| Direct external research and development expenses by program: |
||||||||||||||||
| ACT Programs |
€ | 3,910 | € | 3,338 | € | 8,667 | € | 7,393 | ||||||||
| TCR Bispecifics Programs |
1,028 | 1,027 | 2,090 | 3,380 | ||||||||||||
| Other programs |
2,010 | 723 | 3,232 | 1,521 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Sub-total direct external expenses |
€ |
6,947 |
€ |
5,088 |
€ |
13,990 |
€ |
12,294 |
||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Indirect research and development expenses: |
||||||||||||||||
| Personnel related (excluding share-based compensation) |
€ | 9,265 | € | 5,998 | € | 18,244 | € | 11,357 | ||||||||
| Share-based compensation expense |
3,107 | 4,676 | 6,375 | 9,574 | ||||||||||||
| IP Expenses |
2,051 | 2,511 | 4,364 | 5,442 | ||||||||||||
| Facility and depreciation |
1,718 | 1,234 | 3,414 | 2,374 | ||||||||||||
| Other indirect costs |
2,128 | 833 | 3,974 | 2,348 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Sub-total indirect expenses |
€ |
18,268 |
€ |
15,252 |
€ |
36,371 |
€ |
31,095 |
||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total research and development expenses |
€ |
25,216 |
€ |
20,340 |
€ |
50,360 |
€ |
43,389 |
||||||||
| |
|
|
|
|
|
|
|
|||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
||||||||||||||||
| Share-based compensation expense |
€ | 2,453 | € | 3,289 | € | 4,887 | € | 6,695 | ||||||||
| Personnel related (excluding share-based compensation) |
2,626 | 2,397 | 5,240 | 4,443 | ||||||||||||
| Professional and consulting fees |
1,789 | 1,113 | 3,079 | 2,621 | ||||||||||||
| Other external general and administrative expenses |
1,816 | 1,472 | 4,759 | 2,943 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total general and administrative expenses |
€ |
8,683 |
€ |
8,271 |
€ |
17,961 |
€ |
16,702 |
||||||||
| |
|
|
|
|
|
|
|
|||||||||
Six Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
(Euros in thousands) |
||||||||
| Net cash provided by /(used in): |
||||||||
| Operating activities |
€ | 163,722 | € | (36,602 | ) | |||
| Investing activities |
(48,528 | ) | (10,306 | ) | ||||
| Financing activities |
15,203 | (1,348 | ) | |||||
| |
|
|
|
|||||
| Total cash flow |
€ |
130,397 |
€ |
(48,256 |
) | |||
| |
|
|
|
|||||
| 1. | progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enrol patients and manufacture ACT and TCR Bispecific product candidates for our ongoing, planned and potential future clinical trials; |
| 2. | time and cost to conduct IND- or CTA-enabling studies for our preclinical programs; |
| 3. | time and costs required to perform research and development to identify and characterize new product candidates from our research programs; |
| 4. | time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products; |
| 5. | our ability to successfully commercialize our product candidates, if approved; |
| 6. | our ability to have clinical and commercial products successfully manufactured consistent with FDA, the EMA and comparable regulatory authorities’ regulations; |
| 7. | amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; |
| 8. | sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities; |
| 9. | cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; |
| 10. | terms and timing of our current and any potential future collaborations, licensing or other arrangements that we have established or may establish; |
| 11. | cash requirements of any future acquisitions or the development of other product candidates; |
| 12. | costs of operating as a public company; |
| 13. | time and cost necessary to respond to technological, regulatory, political and market developments; |
| 14. | costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
| 15. | costs associated with any potential business or product acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish. |