Affimed N.V.
Unaudited consolidated interim statements of comprehensive loss
(in € thousand)
For the three months ended | For the six months ended | |||||||||
June 30 | June 30 | |||||||||
| Note |
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
Revenue | 3 | | | | | |||||
Other income – net |
|
| |
| |
| |
| | |
Research and development expenses |
|
| ( |
| ( |
| ( |
| ( | |
General and administrative expenses |
|
| ( |
| ( |
| ( |
| ( | |
Operating loss |
| 4 |
| ( |
| ( |
| ( |
| ( |
Finance income / (costs) – net |
| 5 |
| |
| |
| |
| ( |
Loss before tax |
|
| ( |
| ( |
| ( |
| ( | |
Income taxes |
|
| ( |
| |
| ( |
| ( | |
Loss for the period |
|
| ( |
| ( |
| ( |
| ( | |
Total comprehensive loss |
|
| ( |
| ( |
| ( |
| ( | |
Basic and diluted loss per share in € per share (undiluted = diluted) |
|
| ( |
| ( |
| ( |
| ( | |
Weighted number of common shares outstanding |
|
| |
| |
| |
| | |
The notes are an integral part of these condensed consolidated interim financial statements.
1
Affimed N.V.
Consolidated interim statements of financial position
(in € thousand)
|
| June 30, |
| December 31, | ||
Note | 2024 | 2023 | ||||
(unaudited) | ||||||
ASSETS |
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| |
Non-current assets |
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|
| |
Intangible assets |
|
| |
| | |
Leasehold improvements and equipment |
|
| |
| | |
Right-of-use assets |
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| |
| | |
| |
| | |||
Current assets | ||||||
|
|
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| ||
Cash and cash equivalents |
|
| |
| | |
Investments |
| 6 |
| |
| |
Other financial assets | 7 | | | |||
Trade and other receivables |
| 8 |
| |
| |
Inventories |
|
| |
| | |
Other assets and prepaid expenses |
| 9 |
| |
| |
| |
| | |||
TOTAL ASSETS |
|
| |
| | |
EQUITY AND LIABILITIES |
|
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| ||
Equity |
|
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| ||
Issued capital |
|
| |
| | |
Capital reserves |
|
| |
| | |
Fair value reserves |
|
| ( |
| ( | |
Accumulated deficit |
|
| ( |
| ( | |
Total equity |
| 10 |
| |
| |
Non current liabilities |
|
|
|
| ||
Borrowings |
| 12 |
| |
| |
Contract liabilities |
| 3 |
| |
| |
Lease liabilities |
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| | |
Total non-current liabilities |
|
| |
| | |
Current liabilities |
|
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|
| ||
Trade and other payables |
|
| |
| | |
Borrowings |
| 12 |
| |
| |
Lease liabilities |
|
| |
| | |
Contract liabilities |
| 3 |
| |
| |
Total current liabilities |
|
| |
| | |
TOTAL EQUITY AND LIABILITIES |
|
| |
| |
The notes are an integral part of these condensed consolidated interim financial statements.
2
Affimed N.V.
Unaudited consolidated interim statements of cash flows
(in € thousand)
For the six months ended | ||||||
June 30 | ||||||
| Note |
| 2024 |
| 2023 | |
Cash flow from operating activities |
|
| ||||
Loss for the period |
|
| ( |
| ( | |
Adjustments for the period: |
|
|
| |||
- Income taxes |
|
| |
| | |
- Depreciation and amortization |
|
| |
| | |
- Net gain on disposal of leasehold improvements and equipment |
|
| ( |
| | |
- Loss from write-down of inventories |
|
| |
| | |
- Share-based payments | 11 | | | |||
- Finance income / (costs) – net |
| 5 |
| ( |
| |
| ( |
| ( | |||
Change in trade and other receivables |
|
| ( |
| | |
Change in inventories |
|
| |
| ( | |
Change in other assets and prepaid expenses |
|
| |
| ( | |
Change in trade, other payables, provisions and contract liabilities |
|
| ( |
| ( | |
( | ( | |||||
Interest received |
|
| |
| | |
Paid interest |
|
| ( |
| ( | |
Paid income tax | ( | ( | ||||
Net cash used in operating activities |
|
| ( |
| ( | |
Cash flow from investing activities |
|
|
|
|
| |
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets |
|
| ( |
| ( | |
Cash received from the sale of financial assets |
|
| |
| | |
Cash received from the sale of leasehold improvements and equipment | | | ||||
Net cash generated / (used) for investing activities |
|
| |
| ( | |
Cash flow from financing activities |
|
|
|
|
| |
Proceeds from issue of common shares, including exercise of share-based payment awards |
|
| |
| | |
Transaction costs related to issue of common shares |
|
| ( |
| | |
Repayment of lease liabilities |
|
| ( |
| ( | |
Repayment of borrowings |
| 12 |
| ( |
| ( |
Net cash generated / (used) for financing activities |
|
| |
| ( | |
Exchange-rate related changes of cash and cash equivalents |
|
| |
| ( | |
Net changes to cash and cash equivalents |
|
| ( |
| ( | |
Cash and cash equivalents at the beginning of the period |
|
| |
| | |
Cash and cash equivalents at the end of the period |
|
| |
| | |
The notes are an integral part of these condensed consolidated interim financial statements.
3
Affimed N.V.
Unaudited consolidated interim statements of changes in equity for the year
(in € thousand)
|
| Issued |
| Capital |
| Fair Value |
| Accumulated |
| Total | ||
Note | capital | reserves | reserves | deficit | equity | |||||||
Balance as of January 1, 2023 |
|
| |
| |
| ( |
| ( |
| | |
Equity-settled share-based payment awards |
|
| |
|
|
| | |||||
Loss for the period |
|
|
|
|
|
|
| ( |
| ( | ||
Balance as of June 30, 2023 |
|
| |
| |
| ( |
| ( |
| | |
Balance as of January 1, 2024 |
|
| |
| |
| ( |
| ( |
| | |
Issue of common shares |
| 10 |
| |
| |
|
|
|
|
| |
Equity-settled share-based payment awards |
| 11 |
|
|
| |
|
|
|
|
| |
Loss for the period | ( | ( | ||||||||||
Balance as of June 30, 2024 |
|
| |
| |
| ( |
| ( |
| |
The notes are an integral part of these condensed consolidated interim financial statements.
4
1. Reporting entity
Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands, registered with the trade register of the Chamber of Commerce (handelsregister van de Kamer van Koophandel) under number 60673389.
The condensed consolidated interim financial statements are comprised of Affimed N.V. and its controlled (and wholly owned) subsidiaries Affimed GmbH, Heidelberg, Germany and Affimed Inc., Delaware, USA (collectively “Affimed”, the “Company” or the “Group”). Previously the Group also included AbCheck s.r.o., Plzen, Czech Republic, however this wholly owned subsidiary was sold as of December 28, 2023.
Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. The Group’s product candidates are developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. Affimed has its own development programs and strategic collaborations. The Group previously performed research services for third parties under service contracts at its former subsidiary, AbCheck.
In January 2024, Affimed announced a strategic restructuring which led to a reduction of its headcount by approximately
2. Basis of preparation and changes to Group’s accounting policies
Statement of compliance
The unaudited condensed consolidated interim financial statements (referred to as the “interim financial statements”) as of June 30, 2024 and December 31, 2023 and for the three and six months ended June 30, 2024 and 2023 have been prepared in accordance with IAS 34 Interim Financial Reporting. The interim financial statements do not include all the information and disclosures required in the consolidated annual financial statements and should be read in conjunction with Affimed N.V.’s annual consolidated financial statements as of December 31, 2023.
The interim financial statements were authorized for issuance by the Company’s Management Board on September 5, 2024.
Going concern
The interim financial statements have been prepared on the basis that the Group 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. As a clinical-stage biopharmaceutical company, the Group has incurred operating losses since inception. As of June 30, 2024, the Group had an accumulated deficit of €
The Group expects it will incur operating losses for the foreseeable future due to, among other things, costs related to continued clinical programs and its administrative organization. Historically, Affimed has successfully financed its operations through collaborations, licensing, venture loans and equity issuances. Based on current operating and budget assumptions, management anticipates that the Group’s cash and cash equivalents and investments, together with anticipated proceeds from the ATM program and the sale of AbCheck, will finance the Group into the second half of 2025. In addition, management is pursuing various financing alternatives to meet the Group’s future cash requirements, including the issuance of equity to existing or new shareholders, payments from arrangements with strategic partners and other sources. Based on such operating and budget assumptions, management has concluded that the Group is able to continue as a going concern.
We are advancing our product candidates through clinical development. Developing pharmaceutical products, including conducting preclinical studies and clinical studies, is expensive and highly regulated. In order to obtain necessary regulatory approval, we are required to conduct clinical studies for each of our product candidates and each of their indications. The Group’s clinical programs with acimtamig, AFM24 and AFM28 are still in the development stage. Any further development until market approval and successful financing is dependent on meaningful clinical trial results, among other factors. Achieving such results implies uncertainty, including
5
relating to estimated costs for completing ongoing clinical programs, the timing for bringing such programs to market or for substantially partnering or out-licensing arrangements, among others. It is unknown when, if ever, material cash inflows may commence.
Based on the quality of the Group’s clinical data, management believes that it will be able to obtain financing for the implementation of the Group’s business strategy. If the Company is not able to raise sufficient capital when needed, Affimed could be forced to delay, reduce or eliminate the Company’s product development programs and the ability to continue as a going concern would be uncertain. Based on management’s going concern assessment, the interim financial statements do not include any adjustments that may result from the outcome of these uncertainties.
Loss per share
Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.
On March 8, 2024, the Company effected a -for-10 reverse stock split of its outstanding common shares. According to IAS 33.64, the Group has adjusted the weighted average number of ordinary shares and the loss per share (diluted/undiluted) retroactively for the for the three and six months ended June 30, 2023. In addition, all share and per share information (including such information related to share-based payments) have been retroactively adjusted (see note 11).
As of June 30, 2024, the Group has
Critical judgments and accounting estimates
The preparation of the interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
In preparing these interim financial statements, the critical judgments made by management in applying the Group’s accounting policies were the same as those that applied to the audited consolidated financial statements as of and for the year ended December 31, 2023 except for the following issue:
As of March 31 2024, the lease term for the property leased in Mannheim was reassessed (refer details provided in note 13). The lease term was reduced from
| Depreciation |
|
| Depreciation | ||
expense - | expense - | |||||
Impact of the estimation changes | previous | Change | revised | |||
2024 |
| |
| |
| |
2025 |
| |
| |
| |
2026 |
| |
| |
| |
2027 and thereafter |
| |
| ( |
| |
Total |
| |
| ( |
| |
| Interest |
|
| Interest | ||
expense | expense - | |||||
- previous | Change | revised | ||||
2024 |
| |
| ( |
| |
2025 |
| |
| ( |
| |
2026 |
| |
| ( |
| |
2027 and thereafter |
| |
| ( |
| |
Total |
| |
| ( |
| |
6
Functional and presentation currency
These interim financial statements are presented in euro. The functional currency of the Group’s subsidiaries is also the euro. All financial information presented in euro has been rounded to the nearest thousand (abbreviated €) or million (abbreviated € million).
Significant accounting policies
The accounting policies applied by the Group in these interim financial statements are the same as those applied by the Group in its audited consolidated financial statements as of and for the year ended December 31, 2023.
New standards and amendments to standards
A number of new accounting standards and amendments to accounting standards are effective for annual periods beginning on January 1, 2024 but none of the applied standards had a material effect on these interim financial statements.
The following forthcoming amendments to standards have not been applied in preparing these interim financial statements.
Standard/interpretation |
| Effective Date1 |
Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability | January 1, 2025 | |
Amendments to IFRS 9 and IFRS 7 Classification and Measurement of Financial Instruments | January 1, 2026 | |
IFRS 18 Presentation and Disclosure in Financial Statements | January 1, 2027 |
IFRS 18 will have an effect on the presentation of the Group`s financial statements with the following key impacts:
| - | Income and expenses will be classified into five categories including the new categories operation, investing and financing, therefore new subtotals will be introduced; |
| - | Enhanced principles of aggregation and disaggregation will lead to a different grouping of information and/or additional disclosures; and |
| - | Presentation options in the statements of cash flows will be eliminated leading to a reclassification of cash flows (e.g. interest received and interest paid). |
The other amended standards are not expected to have a significant effect on the interim financial statements of the Group.
Fair Value Measurement
All assets and liabilities for which fair value is recognized in the interim financial statements are classified in accordance with the following fair value hierarchy, based on the lowest level input parameter that is significant on the whole for fair value measurement:
| ● | Level 1 – Prices for identical assets or liabilities quoted in active markets (non-adjusted); |
| ● | Level 2 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is directly or indirectly observable for on the market; and |
| ● | Level 3 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is not directly or indirectly observable for on the market. |
The carrying amount of all trade and other receivables, other assets and prepaid expenses, cash and cash equivalents, trade and other payables and loans is a reasonable approximation of the fair value and, therefore, information about the fair values of those financial instruments has not been disclosed. The Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred. There were
1 Shall apply for periods beginning on or after the date shown in the effective date column.
7
3. Revenue
Collaboration with Genentech Inc.
In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc. (Genentech), headquartered in South San Francisco, USA. Under the terms of the agreement, Affimed provided services related to the development of novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Under the terms of the agreement, Affimed received $
The Group recognized €
Under the terms of the agreement, Affimed is eligible to receive up to an additional $
Collaboration with Roivant Sciences Ltd.
On November 9, 2020, Affimed and Affivant Sciences GmbH (formerly Pharmavant 6 GmbH), a subsidiary of Roivant Sciences Ltd. (Roivant), announced a strategic collaboration agreement which granted Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $
The Group recognized €
Contract balances
The following table provides information about receivables and contract liabilities from contracts with customers.
| June 30, 2024 |
| December 31, 2023 | |
Receivables |
| |
| |
Contract liabilities |
| |
| |
An amount of €
The remaining obligation as of June 30, 2024 is approximately €
8
Disaggregation of revenue
Three months | Three months | Six months | Six months | |||||
ended | ended | ended | ended | |||||
| June 30, 2024 |
| June 30, 2023 |
| June 30, 2024 |
| June 30, 2023 | |
Geographic information | ||||||||
Revenue: |
|
|
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|
Germany |
| |
| |
| |
| |
USA |
| |
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Major service lines: |
|
| ||||||
Collaboration revenue |
| |
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| |
Service revenue |
| |
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| |
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| |
Timing on revenue recognition: | ||||||||
Point in time |
| |
| |
| |
| |
Over time |
| |
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| |
| |
| |
| |
| |
| |
4. Operating loss
In January 2024, Affimed announced a strategic restructuring which led to a reduction of its headcount by approximately
In April 2023, Affimed had also conducted a reorganization of its operations to focus on the Group’s
5. Finance income and finance costs
Three months ended |
| Three months ended |
| Six months ended |
| Six months ended | ||
| June 30, 2024 |
| June 30, 2023 |
| June 30, 2024 |
| June 30, 2023 | |
Interest Bootstrap Loan Agreement |
| ( |
| ( |
| ( |
| ( |
Foreign exchange differences |
| |
| |
| |
| ( |
Interest on Government treasury bonds | | | | | ||||
Other finance income/finance costs - net |
| ( |
| |
| ( |
| |
| | | ( |
6. Investments
As of June 30, 2024, the Group holds investments in Government treasury bonds of €
9
7. Other financial assets
On December 28, 2023, the Group entered into an agreement regarding the sale of its wholly owned subsidiary AbCheck s.r.o. (‘AbCheck sale agreement‘) to Ampersand Biomedicines Inc (‘Ampersand’) for a gross purchase price of €
8. Trade and other receivables
The Group had
Other receivables are all due within the short-term and mainly comprise value-added tax receivables of €
9. Other assets and prepaid expenses
The other assets and prepaid expenses as of June 30, 2024 of €
10. Equity
The share and per share information presented in this note retrospectively reflects the effects of the reverse stock split effective March 8, 2024, which was approved by the Company’s shareholders at the Company’s Annual General Meeting of Shareholders on June 21, 2023.
At the annual general meeting, held on June 26, 2024, shareholders approved the increase of the authorized share capital to
As of June 30, 2024, the share capital of €
In November 2021, we entered into a $
11. Share-based payments
In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain members of the Management Board, certain members of the Company’s Supervisory Board, non-employee consultants and employees.
The share and per share information presented in this note retrospectively reflects the effects of the reverse stock split which was effective March 8, 2024.
10
Share-based payments with service conditions
The majority of the awards vest in instalments over
As of June 30, 2024,
Share-based payments with market conditions
During 2022, the Company issued
Fair value of the awards at grant date in 2022 amounted to €
Share-based payment expense
For the three and six months ended June 30, 2024, compensation expense of €
Fair value measurement
The fair value of options with service conditions granted in the six months ended June 30, 2024 and 2023, respectively, was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):
| June 30, 2024 |
| June 30, 2023 | ||||
Fair value at grant date | $ | | $ | | |||
Share price at grant date | $ | | $ | | |||
Exercise price | $ | | $ | | |||
Expected volatility |
| | % |
| | % | |
Expected life |
| |
| | |||
Expected dividends |
| |
| | |||
Risk-free interest rate |
| | % |
| | % | |
Expected volatility is estimated based on the observed daily share price returns of Affimed measured over a historic period equal to the expected life of the awards.
The risk-free interest rates are based on the yield to maturity of U.S. Treasury strips (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the grant date.
12. Borrowings
Bootstrap Europe
In January 2021, the Group entered into a loan agreement with Bootstrap Europe (formerly Silicon Valley Bank German Branch (“SVB”)) which provided Affimed with up to €
11
million upon the achievement of certain conditions, including milestones related to Affimed’s pipeline and market capitalization, and a third tranche of €
The loan is secured by a pledge of
UniCredit Leasing CZ
In April 2019, the Group (through its previously held subsidiary AbCheck s.r.o.) entered into a loan agreement with UniCredit Leasing CZ €
13. Lease liabilities
As part of the original property lease agreement in Mannheim, additional office space has been made available to the Group and occupation was taken on January 1, 2024. This has resulted in an addition to the right-of-use asset of €
The lease term for the property leased in Mannheim has been reassessed considering current events following the restructure relating to exploring financing options and discussions held with the landlord and potential sub lessees. As a result, the Group had concluded that it is highly likely that the Group will opt to exercise the early termination option of the lease and therefore terminate the lease after
14. Related parties
The supervisory board directors of Affimed N.V. received compensation in the amounts of €
The Company recognized share-based payment expenses of €
The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement:
Outstanding balances | ||||
| June 30, 2024 |
| December 31, 2023 | |
Thomas Hecht |
| |
| |
Mathieu Simon* |
| |
| |
Ulrich Grau* |
| |
| |
Bernhard Ehmer | | |||
Annalisa Jenkins | | | ||
Uta Kemmerich-Keil* |
| |
| |
Constanze Ulmer-Eilfort | | |||
* No longer Supervisory Board members, effective June 26, 2024
12