UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of September, 2024
Commission File Number:
Gottlieb-Daimler-Straße 2,
68165 Mannheim
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-260946), Form S-8 (Registration Number 333-198812) and Form S-8 (Registration Number 333-270798) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| AFFIMED N.V. | ||
Date: September 5, 2024 | By: | /s/ Andreas Harstrick | |
Name: | Andreas Harstrick | ||
Title: | Chief Medical Officer | ||
By: | /s/ Denise Mueller | ||
Name: | Denise Mueller | ||
Title: | Chief Business Officer |
EXHIBIT INDEX
Exhibit |
| Description of Exhibit |
99.1 | ||
99.2 | Affimed N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations. | |
99.3 |
Exhibit 99.1
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 |
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Research and development expenses |
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| ( |
| ( |
| ( |
| ( | |
General and administrative expenses |
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| ( |
| ( |
| ( |
| ( | |
Operating loss |
| 4 |
| ( |
| ( |
| ( |
| ( |
Finance income / (costs) – net |
| 5 |
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| |
| |
| ( |
Loss before tax |
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| ( |
| ( |
| ( |
| ( | |
Income taxes |
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| ( |
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| ( |
| ( | |
Loss for the period |
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| ( |
| ( |
| ( |
| ( | |
Total comprehensive loss |
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| ( |
| ( |
| ( |
| ( | |
Basic and diluted loss per share in € per share (undiluted = diluted) |
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| ( |
| ( |
| ( |
| ( | |
Weighted number of common shares outstanding |
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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 |
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Leasehold improvements and equipment |
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Right-of-use assets |
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Current assets | ||||||
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Cash and cash equivalents |
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Investments |
| 6 |
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Other financial assets | 7 | | | |||
Trade and other receivables |
| 8 |
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Inventories |
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Other assets and prepaid expenses |
| 9 |
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TOTAL ASSETS |
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EQUITY AND LIABILITIES |
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Equity |
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Issued capital |
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Capital reserves |
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Fair value reserves |
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| ( |
| ( | |
Accumulated deficit |
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| ( | |
Total equity |
| 10 |
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Non current liabilities |
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Borrowings |
| 12 |
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Contract liabilities |
| 3 |
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Lease liabilities |
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Total non-current liabilities |
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Current liabilities |
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Trade and other payables |
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Borrowings |
| 12 |
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Lease liabilities |
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Contract liabilities |
| 3 |
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Total current liabilities |
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TOTAL EQUITY AND LIABILITIES |
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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 |
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Loss for the period |
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| ( |
| ( | |
Adjustments for the period: |
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- Income taxes |
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- Depreciation and amortization |
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- Net gain on disposal of leasehold improvements and equipment |
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| ( |
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- Loss from write-down of inventories |
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- Share-based payments | 11 | | | |||
- Finance income / (costs) – net |
| 5 |
| ( |
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| ( |
| ( | |||
Change in trade and other receivables |
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| ( |
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Change in inventories |
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Change in other assets and prepaid expenses |
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Change in trade, other payables, provisions and contract liabilities |
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| ( |
| ( | |
( | ( | |||||
Interest received |
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Paid interest |
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| ( |
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Paid income tax | ( | ( | ||||
Net cash used in operating activities |
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| ( |
| ( | |
Cash flow from investing activities |
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Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets |
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| ( |
| ( | |
Cash received from the sale of financial assets |
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Cash received from the sale of leasehold improvements and equipment | | | ||||
Net cash generated / (used) for investing activities |
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| ( | |
Cash flow from financing activities |
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Proceeds from issue of common shares, including exercise of share-based payment awards |
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Transaction costs related to issue of common shares |
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Repayment of lease liabilities |
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| ( |
| ( | |
Repayment of borrowings |
| 12 |
| ( |
| ( |
Net cash generated / (used) for financing activities |
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| ( | |
Exchange-rate related changes of cash and cash equivalents |
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Net changes to cash and cash equivalents |
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| ( |
| ( | |
Cash and cash equivalents at the beginning of the period |
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Cash and cash equivalents at the end of the period |
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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)
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| Issued |
| Capital |
| Fair Value |
| Accumulated |
| Total | ||
Note | capital | reserves | reserves | deficit | equity | |||||||
Balance as of January 1, 2023 |
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| ( |
| ( |
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Equity-settled share-based payment awards |
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Loss for the period |
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| ( |
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Balance as of June 30, 2023 |
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| ( |
| ( |
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Balance as of January 1, 2024 |
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| ( |
| ( |
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Issue of common shares |
| 10 |
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Equity-settled share-based payment awards |
| 11 |
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Loss for the period | ( | ( | ||||||||||
Balance as of June 30, 2024 |
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| ( |
| ( |
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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 |
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| Depreciation | ||
expense - | expense - | |||||
Impact of the estimation changes | previous | Change | revised | |||
2024 |
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2025 |
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2026 |
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2027 and thereafter |
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| ( |
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Total |
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| ( |
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| Interest |
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| Interest | ||
expense | expense - | |||||
- previous | Change | revised | ||||
2024 |
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| ( |
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2025 |
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| ( |
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2026 |
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| ( |
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2027 and thereafter |
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| ( |
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Total |
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| ( |
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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 |
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Contract liabilities |
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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 |
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USA |
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Major service lines: |
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Collaboration revenue |
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Service revenue |
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Timing on revenue recognition: | ||||||||
Point in time |
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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 |
| |
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| ( |
Interest on Government treasury bonds | | | | | ||||
Other finance income/finance costs - net |
| ( |
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| ( |
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| | | ( |
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 |
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Expected dividends |
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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 |
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Mathieu Simon* |
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Ulrich Grau* |
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Bernhard Ehmer | | |||
Annalisa Jenkins | | | ||
Uta Kemmerich-Keil* |
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Constanze Ulmer-Eilfort | |
* No longer Supervisory Board members, effective June 26, 2024
12
Exhibit 99.2
AFFIMED N.V.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three and six month periods ended June 30, 2024 and 2023 (the “interim financial statements”) included as Exhibit 99.1 to the Report on Form 6-K in which this discussion is included. We also recommend that you read “Item 4. Information on the Company” and our audited consolidated financial statements for fiscal year 2023, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2023 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).
Unless otherwise indicated or the context otherwise requires, all references to “Affimed” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Affimed N.V. and its subsidiaries.
We prepare and report our unaudited condensed consolidated interim financial statements and audited consolidated financial statements in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our unaudited condensed consolidated interim financial statements or audited consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Euros. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussion and analysis are in Euros.
Overview
We are a clinical-stage immuno-oncology company focused on developing highly targeted cancer immunotherapies. Our product candidates are being developed in the field of immune-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (natural killer (“NK”) cells and macrophages) and T cells. Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we have the potential to develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct and establish a bridge between innate immune cells and cancer cells. Our innate cell engagers have the ability to bring innate immune cells into proximity and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture (which provides for four binding domains), our innate cell engagers bind to their targets with high affinity and have half-lives that allow regular intravenous administration, with different dosing schemes being explored to allow for improved exposure in heavily pretreated patient populations. We believe, based on their mechanism of action and the preclinical and clinical data we have generated to date, that our product candidates, alone or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate immune cell space, we also have the ability to develop novel tetravalent, bispecific antibody formats with the potential to tailor immune-engaging therapy to different indications and settings.
To date, we have financed our operations primarily through our public offerings of our common shares, private placements of equity securities, the incurrence of loans including convertible loans and through government grants and payments for collaborative research and development services. Through June 30, 2024, we have raised an aggregate of approximately €574.9 million (gross proceeds) through the issuance of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.
We have generated losses since we began our drug development operations in 2000. For the six months ended June 30, 2024, we incurred a net loss of €34.6 million. As of June 30, 2024, we had an accumulated deficit of €570.8 million.
In December 2023 we reached a definitive agreement to sell our former subsidiary AbCheck s.r.o. (“AbCheck”) to Ampersand Biomedicines. No revenues or expenses of AbCheck are therefore included in the three and six month periods ended June 30, 2024, whereas in the three and six month periods ended June 30, 2023, revenues and expenses of AbCheck are included.
On January 8, 2024, we announced a restructuring initiative aimed at transforming us into a focused clinical organization, positioned to successfully advance our programs to key value inflection points. As part of the restructuring, we are directing all resources towards advancing the development of our clinical programs, ultimately resulting in a reduction of up to 50% of our workforce by dissolving our research and preclinical development departments, which aligns with our narrowed strategic priorities. All restructuring measures have been completed. Based on our operating and budget assumptions, our cash runway is into the second half of 2025.
We expect to continue incurring losses as we continue clinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval for our product candidates, build a marketing and sales team to commercialize
our product candidates. Our profitability depends on the successful development, approval and commercialization of our product candidates and our ability to achieve a level of revenues adequate to support our cost structure. We may never achieve profitability and unless and until we do, we will continue to need to raise additional cash. We intend to fund future operations through additional equity and debt financings and we may seek additional capital through arrangements with strategic partners or from other sources. See Note 2, Basis of preparation and changes to Group’s accounting policies, Going concern, in the notes to the interim financial statements.
We have one U.S. subsidiary, Affimed Inc., with senior employees in investor relations, business development, corporate strategy, communication and medical/clinical operations.
Recent Developments
In January 2024, we initiated a strategic restructuring of our operations to focus on our three clinical stage development programs. As a result of the restructuring, we initiated a reduction of our full-time equivalent headcount by approximately 50%. We incurred a one-time cash expenditure for termination payments of approximately €1.6 million. Further, the financial impact from the selling of laboratory equipment resulted in an impairment of €1.6 million in the six months ended June 30, 2024.
On March 6, 2024, we announced a 1-for-10 reverse stock split of our outstanding common shares, effective after market close on March 8, 2024.
Further, in May 2024, the FDA granted a Fast Track designation to the combination of our innate cell engager (ICE®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (“NSCLC”) epidermal growth factor receptor (“EGFR”)-wildtype (“wt”) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy. Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need.
On September 3, 2024, we announced that Shawn M. Leland, PharmD, RPh has been appointed as Chief Executive Officer (CEO). Dr. Andreas Harstrick, who has been serving as acting CEO since January 2024 will continue in his position as Chief Medical Officer.
On September 5, 2024, we announced a AFM24-102 phase 2 study update from the EGFR mutant (“EGFRmut”) cohort. 24 heavily pretreated EGFRmut NSCLC patients are in the trial and of 17 patients that are response evaluable per protocol 1 CR, 3 PRs and 8 SDs were observed. All responses have been confirmed by follow up scan. Median follow-up is more than 7 months and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. Final PFS data from the EGFRmut cohort is expected in H1 2025. The EGFRwt NSCLC cohort for patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment with 40 patients on trial. Data readout for this cohort is expected in Q4 2024.
On September 5, 2024, we announced a data update from the LuminICE-203 study (acimtamig/AlloNK® co-administered combination therapy in relapsed/refractory (“R/R”) Hodgkin lymphoma (“HL”). The recruitment in cohorts 1 and 2 is completed and for the 12 treated refractory Hodgkin Lymphoma (HL) patients, an objective response rate (ORR) of 83.3% with 6 complete responses (CRs) and 4 partial responses (PRs) were observed by independent read. Treatment related adverse events were consistent with previous experience and side effects related to acimtamig and AlloNK were well manageable with standard of care treatment.
On September 5, 2024, we further announced a data update from the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive R/R AML. Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi and 2 patients achieved SD. As previously announced in June 2024, at dose level 5 at 250 mg, out of 6 patients 1 patient showed a CR, lasting 6 months. The other 5 patients reached a stable disease as best response. No dose-limiting toxicities were reported in dose levels 5 and 6. We will enroll additional 6 patients in this study at dose level 6.
Collaboration and License Agreements
We finalized an agreement with Roivant Sciences Ltd. (“Roivant”) providing for the reversion to Affimed of all clinical development and commercialization rights for AFM32, effective April 29, 2024. There have been no other material changes to our license agreements from those reported in “Item 4. Information on the Company—B. Business Overview—Collaborations” in the Annual Report.
Research and Development Expense
We will use our existing liquidity primarily to fund research and development expenses for our ongoing clinical programs. Our research and development expenses are highly dependent on the development phases of our projects and therefore fluctuate widely from period to period. Our remaining research and continued development expenses mainly relate to the following key programs:
● | acimtamig (previously AFM13). The following is a summary of completed and ongoing research and development activities for acimtamig: |
● | In January 2023, the Food and Drug Administration (“FDA”) issued a written response to our pre-investigational new drug (“IND”) meeting request for the acimtamig/AlloNK® co-administered combination therapy in relapsed/refractory (“R/R”) Hodgkin lymphoma (“HL”) and the exploratory arm evaluating the combination in r/r CD30+ peripheral T cell lymphoma (“PTCL”). Based on the written response, we submitted and received clearance from the FDA for an IND application during the second quarter of 2023. We initiated enrollment into the study in October 2023. The recruitment in cohorts 1 and 2 is completed and for the first 12 treated refractory Hodgkin Lymphoma (HL) patients, an overall response rate (ORR) of 83.3% with 6 complete responses (CRs) and 4 partial responses (PRs) was observed by independent read. |
● | In December 2023, we presented final data from the investigator-initiated trial at the American Society of Hematology (“ASH”) 2023 Annual Meeting. A total of 42 patients were enrolled in the study with 36 patients treated at the recommended phase 2 dose (“RP2D”). 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received checkpoint inhibitors (“CPIs”) and brentuximab vedotin (“BV”), and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an objective response rate (“ORR”) of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of cytokine release syndrome (“CRS”), immune effector cell-associated neurotoxicity syndrome (“ICANS”) or graft versus host disease (“GvHD”) of any grade. Mild to moderate infusion related reactions (“IRRs”) were seen in 7.7% of the acimtamig infusions. Across all dose levels, median event free survival (“EFS”) was 8.8 months and median overall survival (“OS”) was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months – with 84% patients alive at 12 months. The median duration of response (“DoR”) was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months. |
● | In December 2022, we released topline data from our phase 2 REDIRECT study investigating acimtamig monotherapy in patients with advanced-stage R/R PTCL. Primary efficacy measures include ORR of 32.4% and a CR rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, PFS and OS. The safety profile of acimtamig was well managed and consistent with previously reported data of prior and ongoing clinical studies with acimtamig. Median DoR was 2.3 months, median PFS was 3.5 months and median OS was 13.8 months. Based on the compelling data seen in HL for the combination of acimtamig with cord blood-derived NK cells in the acimtamig (AFM13-104) study, we believe that the combination with AB-AlloNK® has a higher probability to deliver increased anti-tumor activity and a more durable clinical benefit to address the unmet need in this patient population as compared to acimtamig monotherapy in PTCL. Accordingly, we do not intend to pursue an accelerated approval for acimtamig monotherapy in PTCL and will focus investment on clinical development in the combination of acimtamig and AlloNK®. |
● | In November 2022, we announced a new strategic partnership with Artiva Biotherapeutics, Inc. (“Artiva”) to jointly develop, manufacture and commercialize the combination of acimtamig and AlloNK®. Under the terms of the agreement, we and Artiva will pursue the development of the acimtamig/AlloNK® combination treatment in the United States on a co-exclusive basis. We will lead regulatory activities through phase 2 and any confirmatory studies. We will be responsible for funding clinical study costs through phase 2, while Artiva will be responsible for the costs of supplying AlloNK® and IL-2 for such studies. The companies will share confirmatory study costs on a 50/50 basis. Both companies will retain commercialization and distribution rights and book sales for their respective products. We will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the strategic partnership will be shared, with us receiving 67% of the combination therapy revenue and Artiva receiving 33%. |
We anticipate that our research and development expenses in 2024 for acimtamig will decrease significantly compared to those for 2023, mainly due to lower expenses for manufacturing activities.
● | AFM24. AFM24 is a tetravalent, bispecific epidermal growth factor receptor and CD16A-binding innate cell engager. We reported data at the American Society of Clinical Oncology Annual Meeting in June 2024 and announced a data update on September 5, 2024 from our ongoing combination study with atezolizumab. We anticipate that our research and development expenses in 2024 for AFM24 will decrease compared to those in 2023, primarily due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development. |
● | AFM28. AFM28 is designed to bind to CD123, an established target in myeloid malignancies. We chose CD123 as it is almost universally expressed on leukemic blasts and leukemic stem cells (“LSCs”) in patients with acute myeloid leukemia (“AML”), both at diagnosis and at relapse, and independently of cytogenetic risk. AFM28 is being developed for the treatment of patients with acute myeloid leukemia. In June 2022, we submitted an IND to the FDA for AFM28. Following feedback from the FDA related to the design of the dose escalation study, we made a strategic decision to voluntarily withdraw the IND and to focus early clinical development of AFM28 in jurisdictions outside of the United States. Clinical trial applications were cleared in Belgium, Denmark, France and Spain and we initiated recruitment into a phase 1 clinical |
study in the first quarter of 2023. The enrollment of the sixth and final cohort is now completed. Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi and 2 patients achieved SD. |
● | Other projects and infrastructure costs. Our other research and development expenses relate to our Roivant and Artiva collaborations, and early-stage development/discovery activities, which were active until the end of 2023. We had allocated a material amount of our resources to such discovery activities. The expenses mainly consisted of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incurred a significant amount of costs associated with our research and development that was non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects. We assume that other projects and infrastructure costs will decrease in 2024 due to the dissolving of early-stage discovery activities. |
Results of Operations
The financial information shown below was derived from our interim financial statements for the three months period ended June 30, 2024 and 2023. The discussion below should be read along with these financial statements and is qualified in its entirety by reference to them.
Comparison of the three months ended June 30, 2024 and 2023
| | Three months | ||
| | ended June 30, | ||
| | 2024 | | 2023 |
| | (unaudited) | ||
| | (in € thousand) | ||
| | | | |
Total Revenue |
| 154 |
| 1,390 |
Other income (expenses)—net |
| 56 |
| 717 |
Research and development expenses |
| (11,727) |
| (25,273) |
General and administrative expenses |
| (4,036) |
| (6,276) |
Operating loss |
| (15,553) |
| (29,442) |
Finance income/(costs)—net |
| 105 |
| 47 |
Loss before tax |
| (15,448) |
| (29,395) |
Income taxes |
| (3) |
| 0 |
Loss for the period |
| (15,451) |
| (29,395) |
Other comprehensive loss |
| 0 |
| 0 |
Total comprehensive loss |
| (15,451) |
| (29,395) |
Basic loss per common share in € per share (undiluted = diluted) |
| (1.01) |
| (1.97) |
Revenue
Revenue decreased to €0.2 million in the three months ended June 30, 2024 from €1.4 million for the three months ended June 30, 2023. Revenue in the three months ended June 30, 2024, relates to the Genentech Inc. (“Genentech”) collaboration with €0.2 million in relation to a platform license, while 2023 predominantly related to the Roivant collaboration, which was €1.1 million. Revenue from the Roivant collaboration in the three months ended June 30, 2023 comprised revenue recognized from collaborative research services performed during the quarter.
Research and development expenses
| | Three months ended June 30 |
| ||||
| | 2024 | | 2023 | | Change % |
|
| | (unaudited) |
| ||||
R&D Expenses by Project | | (in € thousand) |
| ||||
Project | | | | | | | |
acimtamig |
| 3,583 |
| 8,132 |
| (56) | % |
AFM24 |
| 3,304 |
| 5,455 |
| (39) | % |
AFM28 |
| 1,533 |
| 1,393 |
| 10 | % |
Other projects and infrastructure costs |
| 2,987 |
| 8,584 |
| (65) | % |
Share-based payment expense |
| 320 |
| 1,709 |
| (81) | % |
Total |
| 11,727 |
| 25,273 |
| (54) | % |
Research and development expenses amounted to €11.7 million in the three months ended June 30, 2024 compared to research and development expenses of €25.3 million in the three months ended June 30, 2023. The variances in project-related expenses between the projects for the three months ended June 30, 2024 and the corresponding period in 2023 are mainly due to the following:
● | acimtamig. In the three months ended June 30, 2024, we incurred lower expenses (56%) than in the three months ended June 30, 2023, primarily due to the decrease of in manufacturing activities for clinical trial material and a decline in clinical trial costs. |
● | AFM24. In the three months ended June 30, 2024, we incurred lower expenses (39%) than in the three months ended June 30, 2023, due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development. |
● | AFM28. In the three months ended June 30, 2024, we incurred higher expenses (10%) than in the three months ended June 30, 2023, due to increased costs for preclinical development activities, as well as manufacturing costs for clinical trial material due to the enrollment of the sixth and final cohort. |
● | Other projects and infrastructure costs. In the three months ended June 30, 2024, expenses were lower (65%) than in the three months ended June 30, 2023, primarily due to a decline in costs incurred with respect to certain of our collaboration projects, such as the Roivant and Genentech collaboration, for which we have completed the work assigned to us under the respective collaboration agreements and a one-time termination expenditure. Further, the decrease is also attributable to lower costs following the sale of our subsidiary AbCheck and lower costs following the restructuring initiatives. |
● | Share-based payment expense. In the three months ended June 30, 2024, this expense decreased by 81% compared to the three months ended June 30, 2023, due to a decrease in the number of newly issued share options and a reduction in head count. |
General and administrative expenses
General and administrative expenses amounted to €4.0 million in the three months ended June 30, 2024 compared to €6.3 million in the three months ended June 30, 2023. These costs have declined (36%) as a result of the decline in head count, decline in legal and consulting, insurance expenses and share-based payment expenses impacted by the decline in head count.
Finance income / (costs)-net
Finance income for the three months ended June 30, 2024 totaled €0.1 million, compared to finance income of €0 million for the three months ended June 30, 2023. Finance income/costs in the three months ended June 30, 2024 and 2023 are primarily made up of foreign exchange gains / losses related to cash, cash equivalents and government treasury bonds denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro, interest on our January 8, 2021 loan agreement with Bootstrap Europe (formerly Silicon Valley Bank German Branch (the “Bootstrap Loan”) and interest earned on the treasury bonds.
Comparison of the six months ended June 30, 2024 and 2023
| | Six months | ||
| | ended June 30, | ||
| | 2024 | | 2023 |
| | (unaudited) | ||
| | (in € thousand) | ||
| | | | |
Total Revenue |
| 309 |
| 5,900 |
Other income (expenses)—net |
| 233 |
| 1,127 |
Research and development expenses |
| (27,118) |
| (54,804) |
General and administrative expenses |
| (8,512) |
| (13,126) |
Operating loss |
| (35,088) |
| (60,903) |
Finance income/(costs)—net |
| 465 |
| (472) |
Loss before tax |
| (34,623) |
| (61,375) |
Income taxes |
| (3) |
| (3) |
Loss for the period |
| (34,626) |
| (61,378) |
Other comprehensive loss |
| 0 |
| 0 |
Total comprehensive loss |
| (34,626) |
| (61,378) |
Basic loss per common share in € per share (undiluted = diluted) |
| (2.28) |
| (4.11) |
Revenue
Revenue decreased from €5.9 million in the six months ended June 30, 2023 to €0.3 million for the six months ended June 30, 2024. Revenue in the six months ended June 30, 2024, relates to the Genentech Inc. (“Genentech”) collaboration with €0.3 million in relation
to a platform license, while 2023 predominantly related to the Roivant collaboration, which was €5.4 million. Revenue from the Roivant collaboration in the six months ended June 30, 2023 comprised revenue recognized from collaborative research services performed during the quarter.
Research and development expenses
| | Six months ended June 30 |
| ||||
| | 2024 | | 2023 | | Change % |
|
| | Unaudited |
| ||||
R&D Expenses by Project | | (in € thousand) |
| ||||
Project | | | | | | | |
acimtamig |
| 6,167 |
| 16,844 |
| (63) | % |
AFM24 |
| 6,262 |
| 12,068 |
| (48) | % |
AFM28 |
| 2,704 |
| 3,205 |
| (16) | % |
Other projects and infrastructure costs |
| 11,432 |
| 18,665 |
| (39) | % |
Share-based payment expense |
| 553 |
| 4,022 |
| (86) | % |
Total |
| 27,118 |
| 54,804 |
| (51) | % |
Research and development expenses decreased from €54.8 million in the six months ended June 30, 2023 to €27.1 million for the six months ended June 30, 2024. The variances in project-related expenses between the projects for the six months ended June 30, 2024 and the corresponding period in 2023 are mainly due to the following:
● | acimtamig. In the six months ended June 30, 2024 we incurred lower expenses (63%) than in the six months ended June 30, 2023 primarily due to the scaling down of manufacturing activities for clinical trial material and a decline in clinical trial costs. |
● | AFM24. In the six months ended June 30, 2024, we incurred lower expenses (48%) than in the six months ended June 30, 2023 due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development. |
● | AFM28. In the six months ended June 30, 2024, we incurred lower expenses (16%) than in the six months ended June 30, 2023 due to overall lower costs for preclinical development activities. |
● | Other projects and infrastructure costs. In the six months ended June 30, 2024, expenses were lower (39%) than in the six months ended June 30, 2023, primarily due to a decline in costs incurred with respect to certain of our collaboration projects, such as the Roivant and Genentech collaboration, for which we have completed the work assigned to us under the respective collaboration agreements. Further, the decrease is also attributable to lower costs following the sale of our subsidiary AbCheck. The decline in other projects and infrastructure costs was offset by a one-time cash expenditure for termination payments of approximately €1.5 million, impairment of laboratory equipment of €1.6 million and impairment of inventory of €0.5 million. |
● | Share-based payment expense. In the six months ended June 30, 2024, this expense decreased by 86% compared to the six months ended June 30, 2023, due to a decrease in the number of newly issued share options and to a reduction in head count, as well as to a reduction in the underlying fair value of newly issued share options. |
General and administrative expenses
General and administrative expenses amounted to €8.5 million in the six months ended June 30, 2024 compared to €13.1 million in the six months ended June 30, 2023. These costs have declined (35%) mainly as a result of a decline in legal and consulting expenses, as well as a decline in share-based payment expense and insurance premiums.
Finance income / (costs)-net
Finance income for the six months ended June 30, 2024 totaled €0.5 million, compared to finance costs of €0.5 million for the six months ended June 30, 2023. Finance income/costs in the six months ended June 30, 2024 are primarily made up of foreign exchange gains / losses related to cash, cash equivalents and government treasury bonds denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro, interest on our Bootstrap Loan and interest earned on the treasury bonds. Finance income/costs in the six months ended June 30, 2023 are primarily made up of foreign exchange gains / losses related to cash and cash equivalents denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro.
Liquidity and Capital Resources
Since inception, we have not generated any revenue from product sales and we have incurred significant operating losses. We have funded our operations to date primarily through public offerings of common shares, private placements of equity securities and loans, grants and payments from collaboration partners.
Cash flows
The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2024 and 2023:
| | Six months ended June 30, | ||
| | 2024 | | 2023 |
| | (unaudited) | ||
| | (in € thousand) | ||
| | | | |
Net cash used in operating activities |
| (40,327) |
| (66,574) |
Net cash generated/(used) in investing activities |
| 11,605 |
| (11) |
Net cash generated/(used) in financing activities |
| 814 |
| (3,214) |
Exchange rate related changes of cash and cash equivalents |
| 143 |
| (431) |
Net changes to cash and cash equivalents |
| (27,908) |
| (69,799) |
Cash and cash equivalents at the beginning of the period |
| 38,529 |
| 190,286 |
Cash and cash equivalents at the end of the period |
| 10,764 |
| 120,056 |
Net cash used in operating activities of €40.3 million in the six months ended June 30, 2024 is lower than net cash used in operating activities in the six months ended June 30, 2023 (€66.6 million), mainly due to our reduction in research and development expenditure and head count reduction. Net cash generated in investing activities in the six months ended June 30, 2024 (€11.6 million) primarily resulted from the sale of government treasury bonds. Net cash generated in financing activities in the six months ended June 30, 2024 (€0.8 million) resulted primarily from the payment of lease liabilities and the monthly Bootstrap loan installments, offset by cash generated from the issuance of common shares, while cash used in financing activities in the six months ended June 30, 2023 was primarily used for the payment of lease liabilities and the monthly Bootstrap loan installments.
Cash and Funding Sources
Our cash and cash equivalents and investments as of June 30, 2024 were €34.4 million, compared with €72.0 million as of December 31, 2023. Funding sources generally comprise proceeds from the issuance of equity instruments, loans, payments from collaboration agreements and government grants.
Going concern
Our interim financial statements have been prepared on the basis that we 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, we have incurred operating losses since inception. As of June 30, 2024, we had an accumulated deficit of €570.8 million and total net equity of €28.7 million.
We expect to incur operating losses for the foreseeable future due to, among other things, costs related to our continued clinical programs and their administrative organization. Historically, we have successfully financed our operations through collaborations, licensing, venture loans and equity issuances. Based on our current operating and budget assumptions, we anticipate that our cash and cash equivalents and investments, together with anticipated proceeds from the ATM program and the sale of AbCheck, will finance us into the second half of 2025. In addition, management is pursuing various financing alternatives to meet 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 is 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. Our 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 relating to estimated costs for completing our 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 we are not able to raise sufficient capital when needed, we could be forced to delay, reduce or eliminate our product development programs and our ability to continue as a going concern would be uncertain. Based on management’s going concern assessment, our interim financial statements do not include any adjustments that may result from the outcome of these uncertainties.
Funding Requirements
We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. In addition, we expect that we will require additional capital to commercialize our product candidates, including acimtamig, AFM24 and AFM28. If we receive regulatory approval for acimtamig, AFM24, AFM28 or other earlier programs, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also continue to incur substantial costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
Based on our current operating and budget assumptions, we believe that our existing liquidity will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2025. We have based this estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:
● | the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities; |
● | the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop; |
● | the number and characteristics of product candidates that we pursue; |
● | the cost, timing, and outcomes of regulatory approvals; |
● | the cost and timing of establishing sales, marketing, and distribution capabilities; and |
● | the terms and timing of any collaboration, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder. |
To address our financing needs, we may raise additional capital through the sale of equity or convertible debt securities. In such an event, the ownership interest of our shareholders will be diluted, and the terms of any such securities may include liquidation or other preferences that adversely affect the rights of holders of our common shares.
For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.
Off-balance Sheet Arrangements
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements.
Quantitative and Qualitative Disclosures About Market Risk
During the six months ended June 30, 2024, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Item 11. Quantitative and Qualitative Disclosures About Risk” in the Annual Report.
Critical Judgments and Accounting Estimates
As of March 31, 2024, the lease term for the property leased in Mannheim has been reassessed and reduced to 5 years from 10 years and the relating right-of-use asset and lease liability have been adjusted accordingly. See Note 2, Basis of preparation and changes to Group’s accounting policies, and note 13, Lease liabilities, in the notes to our interim financial statements.
There have been no additional material changes to the significant accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—A. Operating Results Overview—Critical Judgments and Accounting Estimates” in the Annual Report.
Recent Accounting Pronouncements
We refer to Note 2, Basis of preparation and changes to Group’s accounting policies in the notes to our interim financial statements with regard to the impact of recent accounting pronouncements.
Cautionary Statement Regarding Forward Looking Statements
Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Annual Report. These risks and uncertainties include factors relating to:
● | our operation as a development stage company with a history of operating losses; as of June 30, 2024, our accumulated deficit was €570.8 million; |
● | our ability, based upon our operating and budget assumptions, cash and cash equivalents and investments of approximately €34.4 million as of June 30, 2024, and assumptions regarding proceeds of future issuances under our ATM program and from the sale of AbCheck, to finance our operations into the second half of 2025 and beyond; |
● | our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business; |
● | the possibility that our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; |
● | our reliance on contract manufacturers and contract research organizations over which we have limited control; |
● | our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates. See Note 2, Basis of preparation and changes to Group’s accounting policies, Going concern, in the notes to our interim financial statements for additional information; |
● | our dependence on the success of acimtamig, AFM24 and AFM28 (which are still in clinical development), each of which may eventually prove to be unsuccessful or commercially not exploitable; |
● | the success of the Affimed-Artiva partnership, including in relation to the fact that the current clinical data of acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to AB-101, which is a cryopreserved allogeneic cord blood-derived NK cell that we anticipate will be co-administered with acimtamig; |
● | uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; |
● | decisions made by the United States FDA and other regulatory authorities with respect to the development and commercialization of our products, including decisions regarding accelerated approval with respect to the LuminICE-203 study design; |
● | the outcome of any discussions we may enter into regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; |
● | the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinical or commercial stage; |
● | if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview; |
● | enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; |
● | future legislation may materially impact our ability to realize revenue from any approved and commercialized products; |
● | the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; |
● | our reliance on our current strategic relationships with NKGen Biotech, Artiva, The MD Anderson Cancer Center, and Genentech and the potential failure to enter into new strategic relationships or difficulties with our strategic partners that may slow the progress of our joint developments or lead to the termination of a partnership and the need to enter into a new one, all of which could take substantial time and attention of our management team; |
● | our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; |
● | our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; |
● | our ability to retain key personnel and recruit additional qualified personnel; |
● | the widespread outbreak of an illness or communicable disease or any other public health crisis, similar to the recent COVID-19 pandemic; |
● | the impact on our business of macroeconomic trends, political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict or the conflict in the Middle East, and the instability in the banking sector experienced in the first quarter of 2023; and |
● | other risk factors discussed under “Item 3. Key Information—D. Risk Factors” in the Annual Report. |
Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do transpire or occur, what impact they will have on our results of operations, cash flows or financial condition. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial, or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
Exhibit 99.3
PRESS RELEASE
Affimed Reports Second Quarter 2024 Financial Results & Business Update
● | AFM24 combination with atezolizumab: 24 patients treated in the EGFR mutant (EGFRmut) non-small cell lung cancer (NSCLC) cohort; in 17 response-evaluable patients: 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) were reported. Objective response rate (ORR) is 23.5% (4/17) and disease control rate (DCR) is 70.6% (12/17). Median follow-up of > 7 months, 8 of 17 patients continue on treatment. |
● | The EGFR wild type (EGFRwt) cohort of treatment refractory NSCLC patients has treated 40 patients; ORR and safety data is expected in Q4 2024. |
● | Acimtamig (AFM13) combination with AlloNK® (AB-101): Enrollment for relapsed/refractory (r/r) Hodgkin Lymphoma (HL) patients in cohorts 1 and 2 is completed (n=12); cohort 3 and cohort 4 recruitment on track (10/12 patients). In cohort 1 and 2, an ORR of 83.3% (10/12) and a complete response rate (CRR) of 50% (6/12) were observed. |
● | AFM28 monotherapy phase 1 dose-escalation study: Of the 6 patients with relapsed/refractory Acute Myeloid Leukemia (r/r AML) treated at dose level 6 (300 mg weekly), 3 patients showed either a CR or complete response with incomplete hematological recovery (CRi). Based on the encouraging activity an additional 6 patients will be recruited at 300 mg. |
● | Cash runway into H2 2025: As of June 30, 2024, cash, cash equivalents and investments were €34.4 million. Based on operating and financial plans cash-runway projected into H2 2025. |
Mannheim, Germany, September 5, 2024 – Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the quarter ended June 30, 2024.
“We continue to generate compelling data across our clinical programs," said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "In solid tumors, our combination study is making significant progress, and we are excited to see objective responses and meaningful tumor control, even in patients with EGFR mutant lung cancer — a disease often resistant to immunomodulation. It's particularly encouraging that these outcomes are achieved without chemotherapy, which is important given the intolerance many pretreated patients have for such treatments. Our programs in hematologic malignancies are also advancing well. Recent updates from the 12 patients of the LuminICE-203 study reveal remarkable efficacy, in an advanced Hodgkin
lymphoma population that had exhausted all approved treatment options. Additionally, AFM28 continues to show promise as a monotherapy in AML. The data shared today underscore our strategy of leveraging the innate immune system in our fight against cancer and reinforce our commitment to advancing these clinical programs."
Pipeline Highlights:
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab):
● | 24 heavily pretreated EGFRmut NSCLC patients are in the trial; in 17 patients that are response evaluable per protocol, 1 CR, 3 PRs and 8 SDs were observed. All responses have been confirmed by follow-up scan. ORR is 23.5% (4/17) and DCR is 70.6% (12/17). Median follow-up is > 7 months and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. Final PFS data from the EGFRmut cohort is expected at a scientific conference in H1 2025. |
● | All patients were pretreated with TKIs (~60% with third generation TKIs) and the majority (76%) had also received platinum-based chemotherapy. |
● | The EGFRwt NSCLC cohort of patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment, with 40 patients on trial. ORR and safety for this cohort is expected in Q4 2024. |
● | In May, the Company received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients. |
Acimtamig (AFM13; CD30 / CD16A)
High efficacy observed in the first 12 patients with advanced HL in cohorts 1 and 2 of the Phase 2 LuminICE-203 study showing an ORR of 83.3 % and CRR of 50%.
● | In the multi-center, multi-cohort, open-label Phase 2 LuminICE-203 trial, patients with advanced, treatment refractory Hodgkin Lymphoma receive combination of CD30-targeting innate cell engager acimtamig (AFM13) with AlloNK. |
● | All HL patients were heavily pretreated with a median of 4 lines of prior therapy, having exhausted all standard of care treatment options, including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 50% of patients had also failed prior autologous or allogeneic stem cell transplantation (SCT). |
● | Enrollment in cohorts 1 and 2 (acimtamig doses of 200 mg or 300 mg; AlloNK 2x109 per week for 3 weeks) is completed: In the 12 patients, 6 CRs and 4 PRs were observed. |
● | Enrollment in cohorts 3 and 4 (acimtamig 200 mg or 300 mg; 4x109 in week one and 2x109 AlloNK in weeks 2 and 3) has progressed well with 10/12 patients on study. |
● | Treatment related adverse events were consistent with previous experience and side effects related to acimtamig and AlloNK were well manageable with standard of care treatment. |
● | Data from the study is expected to be presented at a scientific conference in Q4 2024. |
AFM28 (CD123 / CD16A)
In the sixth cohort (300 mg) of the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML,
3 out of 6 patients (50%) showed a CR or CRi.
● | Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi for a composite complete response rate (CRcR, defined as CR+CRi) of 50% (3/6) and 2 patients achieved SD. |
● | Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, lasting 6 months, a CRR of 17% (1/6) ; the other 5 patients achieved SD as best response. |
● | No dose-limiting toxicities were reported in dose levels 5 and 6. |
● | An additional 6 patients will be enrolled at 300 mg of AFM28. |
● | Data from the study is expected to be presented at a scientific conference in Q4 2024. |
Upcoming Milestones:
● | LuminICE-203: Efficacy update of cohorts 1-4 expected to be presented at a scientific conference in Q4 2024. |
● | AFM24-102: ORR and safety data from the EGFRwt cohort in Q4 2024. |
● | AFM28-101: Data from the study is expected to be presented at a scientific conference in Q4 2024. |
● | AMF24-102: Mature PFS data from EGFRmut and EGFRwt cohorts expected to be presented at a future conference in H1 2025. |
Second Quarter 2024 Financial Highlights
Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.
As of June 30, 2024, cash, cash equivalents and short-term investments totaled €34.4 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into the second half of 2025.
Net cash used in operating activities for the quarter ended June 30, 2024 was €16.5 million compared to €33.2 million for the quarter ended June 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses due to the reduction in head count.
Total revenue for the quarter ended June 30, 2024, was €0.2 million compared with €1.4 million for the quarter ended June 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed.
Research and development expenses for the quarter ended June 30, 2024, were €11.7 million compared to €25.3 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.
General and administrative expenses for the quarter ended June 30, 2024, were €4.0 million compared to €6.3 million for the quarter ended June 30, 2023. The decrease was due to declines in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses.
Net loss for the quarter ended June 30, 2024, was €15.5 million, or €1.01 loss per common share compared with a net loss of €29.4 million, or €1.97 loss per common share, for the quarter ended June 30, 2023.
The weighted number of common shares outstanding for the quarter ended June 30, 2024, was 15,300,912 shares.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2024, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast on September 5, 2024, at 8:30 a.m. EDT / 14:30 CET to discuss second quarter 2024 financial results and corporate developments.
The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link: https://register.vevent.com/register/BI53034c7725d043b0854377307e1cd8a3, and you will be provided with dial-in details and a pin number.
Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the
innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statement
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of (AFM13) acimtamig in combination with NK cell therapy is based on AFM13 (acimtamig) precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® (AB-101) and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Affimed N.V.
Unaudited consolidated interim statements of comprehensive loss
(in € thousand)
| | For the three months | | For the six months | ||||
| | ended June 30 | | ended June 30 | ||||
| | 2024 | | 2023 | | 2024 | | 2023 |
Revenue |
| 154 |
| 1,390 |
| 309 |
| 5,900 |
| | | | | | | | |
Other income – net |
| 56 |
| 717 |
| 233 |
| 1,127 |
Research and development expenses |
| (11,727) |
| (25,273) |
| (27,118) |
| (54,804) |
General and administrative expenses |
| (4,036) |
| (6,276) |
| (8,512) |
| (13,126) |
| | | | | | | | |
Operating loss |
| (15,553) |
| (29,442) |
| (35,088) |
| (60,903) |
| | | | | | | | |
Finance income / (costs) – net |
| 105 |
| 47 |
| 465 |
| (472) |
| | | | | | | | |
Loss before tax |
| (15,448) |
| (29,395) |
| (34,623) |
| (61,375) |
| | | | | | | | |
Income taxes |
| (3) |
| 0 |
| (3) |
| (3) |
| | | | | | | | |
Loss for the period |
| (15,451) |
| (29,395) |
| (34,626) |
| (61,378) |
| | | | | | | | |
| | | | | | | | |
Total comprehensive loss |
| (15,451) |
| (29,395) |
| (34,626) |
| (61,378) |
| | | | | | | | |
Basic and diluted loss per share in € per share (undiluted = diluted) |
| (1.01) |
| (1.97) |
| (2.28) |
| (4.11) |
Weighted number of common shares outstanding |
| 15,300,912 |
| 14,933,934 |
| 15,212,555 |
| 14,933,934 |
Affimed N.V.
Consolidated interim statements of financial position
(in € thousand)
|
| June 30, 2024 |
| December 31, 2023 |
| | (unaudited) | | |
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
| 18 |
| 25 |
Leasehold improvements and equipment |
| 2,331 |
| 4,905 |
Right-of-use assets |
| 5,638 |
| 8,039 |
|
| 7,987 |
| 12,969 |
Current assets |
|
|
|
|
Cash and cash equivalents |
| 10,764 |
| 38,529 |
Investments |
| 23,683 |
| 33,518 |
Other financial assets |
| 878 |
| 851 |
Trade and other receivables |
| 5,717 |
| 5,327 |
Inventories |
| 0 |
| 463 |
Other assets and prepaid expenses |
| 4,145 |
| 5,500 |
|
| 45,187 |
| 84,188 |
| | | | |
TOTAL ASSETS |
| 53,174 |
| 97,157 |
| | | | |
EQUITY AND LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Issued capital |
| 1,568 |
| 1,500 |
Capital reserves |
| 599,131 |
| 593,666 |
Fair value reserves |
| (1,231) |
| (1,231) |
Accumulated deficit |
| (570,754) |
| (536,128) |
Total equity |
| 28,714 |
| 57,807 |
| | | | |
Non current liabilities |
|
|
|
|
Borrowings |
| 3,603 |
| 6,319 |
Contract liabilities |
| 155 |
| 464 |
Lease liabilities |
| 4,030 |
| 6,660 |
Total non-current liabilities |
| 7,788 |
| 13,443 |
| | | | |
Current liabilities |
|
|
|
|
Trade and other payables |
| 9,171 |
| 18,916 |
Borrowings |
| 5,833 |
| 5,833 |
Lease liabilities |
| 1,049 |
| 539 |
Contract liabilities |
| 619 |
| 619 |
Total current liabilities |
| 16,672 |
| 25,907 |
| | | | |
TOTAL EQUITY AND LIABILITIES |
| 53,174 |
| 97,157 |
Affimed N.V.
Unaudited consolidated interim statements of cash flows
(in € thousand)
| | For the six months ended | ||
| | June 30 | ||
|
| 2024 |
| 2023 |
Cash flow from operating activities | |
| |
|
Loss for the period |
| (34,626) |
| (61,378) |
Adjustments for the period: |
|
|
|
|
- Income taxes |
| 3 |
| 3 |
- Depreciation and amortization |
| 2,520 |
| 577 |
- Net gain on disposal of leasehold improvements and equipment |
| (24) |
| 0 |
- Loss from write-down of inventories |
| 456 |
| 0 |
- Share-based payments |
| 1,472 |
| 7,389 |
- Finance income / (costs) – net |
| (465) |
| 472 |
|
| (30,664) |
| (52,937) |
Change in trade and other receivables |
| (391) |
| 543 |
Change in inventories |
| 7 |
| (66) |
Change in other assets and prepaid expenses |
| 1,525 |
| (5,473) |
Change in trade, other payables, provisions and contract liabilities |
| (10,308) |
| (8,867) |
|
| (39,831) |
| (66,800) |
Interest received |
| 155 |
| 924 |
Paid interest |
| (648) |
| (695) |
Paid income tax |
| (3) |
| (3) |
Net cash used in operating activities |
| (40,327) |
| (66,574) |
| | | | |
Cash flow from investing activities |
|
|
|
|
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets |
| (20) |
| (11) |
Cash received from the sale of financial assets |
| 10,857 |
| 0 |
Cash received from the sale of leasehold improvements and equipment |
| 768 |
| 0 |
Net cash generated / (used) for investing activities |
| 11,605 |
| (11) |
| | | | |
Cash flow from financing activities |
|
|
|
|
Proceeds from issue of common shares, including exercise of share-based payment awards |
| 4,256 |
| 0 |
Transaction costs related to issue of common shares |
| (112) |
| 0 |
Repayment of lease liabilities |
| (413) |
| (249) |
Repayment of borrowings |
| (2,917) |
| (2,965) |
Net cash generated / (used) for financing activities |
| 814 |
| (3,214) |
| | | | |
Exchange-rate related changes of cash and cash equivalents |
| 143 |
| (431) |
Net changes to cash and cash equivalents |
| (27,908) |
| (69,799) |
Cash and cash equivalents at the beginning of the period |
| 38,529 |
| 190,286 |
Cash and cash equivalents at the end of the period |
| 10,764 |
| 120,056 |
Affimed N.V.
Unaudited consolidated interim statements of changes in equity for the year
(in € thousand)
|
| Issued |
| Capital |
| Fair Value |
| Accumulated |
| Total |
| | capital | | reserves | | reserves | | deficit | | equity |
| | | | | | | | | | |
Balance as of January 1, 2023 |
| 1,493 |
| 582,843 |
| (1,231) |
| (430,190) |
| 152,915 |
| | | | | | | | | | |
Equity-settled share-based payment awards | | |
| 7,389 |
|
|
|
|
| 7,389 |
Loss for the period | | | | |
|
|
| (61,378) |
| (61,378) |
| | | | | | | | | | |
Balance as of June 30, 2023 |
| 1,493 |
| 590,232 |
| (1,231) |
| (491,568) |
| 98,926 |
| | | | | | | | | | |
Balance as of January 1, 2024 |
| 1,500 |
| 593,666 |
| (1,231) |
| (536,128) |
| 57,807 |
| | | | | | | | | | |
Issue of common shares |
| 68 |
| 3,993 | | |
|
|
| 4,061 |
Equity-settled share-based payment awards | | |
| 1,472 |
|
|
|
|
| 1,472 |
Loss for the period | | | | |
|
|
| (34,626) |
| (34,626) |
| | | | | | | | | | |
Balance as of June 30, 2024 |
| 1,568 |
| 599,131 |
| (1,231) |
| (570,754) |
| 28,714 |