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Unaudited consolidated interim
statements of comprehensive loss
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Revenue | 3 | 155 | 1,962 | 464 | 7,862 | |||||||||||||
| Other income and expenses net | 9 | (6 | ) | 242 | 1,121 | |||||||||||||
| Research and development expenses | (10,136 | ) | (21,498 | ) | (37,254 | ) | (76,302 | ) | ||||||||||
| General and administrative expenses | (4,311 | ) | (5,381 | ) | (12,823 | ) | (18,507 | ) | ||||||||||
| Operating loss | 4 | (14,283 | ) | (24,923 | ) | (49,371 | ) | (85,826 | ) | |||||||||
| Finance income / (costs) net | 5 | (855 | ) | 568 | (390 | ) | 96 | |||||||||||
| Loss before tax | (15,138 | ) | (24,355 | ) | (49,761 | ) | (85,730 | ) | ||||||||||
| Income taxes | (1 | ) | 0 | (4 | ) | (3 | ) | |||||||||||
| Loss for the period | (15,139 | ) | (24,355 | ) | (49,765 | ) | (85,733 | ) | ||||||||||
| Total comprehensive loss | (15,139 | ) | (24,355 | ) | (49,765 | ) | (85,733 | ) | ||||||||||
| Basic and diluted loss per share in per share (undiluted = diluted) | (0.94 | ) | (1.63 | ) | (3.20 | ) | (5.74 | ) | ||||||||||
| Weighted number of common shares outstanding | 16,100,185 | 14,933,934 | 15,553,627 | 14,933,934 |
The notes are an integral part of these condensed consolidated interim financial statements.
Consolidated interim statements of financial position
| Note | September 30, 2024 (unaudited) | December 31, 2023 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 15 | 25 | ||||||||||
| Leasehold improvements and equipment | 2,246 | 4,905 | ||||||||||
| Right-of-use assets | 5,307 | 8,039 | ||||||||||
| 7,568 | 12,969 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 7,405 | 38,529 | ||||||||||
| Investments | 6 | 16,695 | 33,518 | |||||||||
| Other financial assets | 7 | 840 | 851 | |||||||||
| Trade and other receivables | 8 | 4,543 | 5,327 | |||||||||
| Inventories | 0 | 463 | ||||||||||
| Other assets and prepaid expenses | 9 | 2,908 | 5,500 | |||||||||
| 32,391 | 84,188 | |||||||||||
| TOTAL ASSETS | 39,959 | 97,157 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,639 | 1,500 | ||||||||||
| Capital reserves | 602,680 | 593,666 | ||||||||||
| Fair value reserves | (1,231 | ) | (1,231 | ) | ||||||||
| Accumulated deficit | (585,893 | ) | (536,128 | ) | ||||||||
| Total equity | 10 | 17,195 | 57,807 | |||||||||
| Non current liabilities | ||||||||||||
| Borrowings | 12 | 2,231 | 6,319 | |||||||||
| Contract liabilities | 3 | 0 | 464 | |||||||||
| Lease liabilities | 3,755 | 6,660 | ||||||||||
| Total non-current liabilities | 5,986 | 13,443 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 9,256 | 18,916 | ||||||||||
| Borrowings | 12 | 5,833 | 5,833 | |||||||||
| Lease liabilities | 1,070 | 539 | ||||||||||
| Contract liabilities | 3 | 619 | 619 | |||||||||
| Total current liabilities | 16,778 | 25,907 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 39,959 | 97,157 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of cash flows
| For the nine months ended September 30 | ||||||||||||
| Note | 2024 | 2023 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (49,765 | ) | (85,733 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 4 | 3 | ||||||||||
| - Depreciation and amortization | 2,945 | 1,273 | ||||||||||
| - Net (gain)/loss on disposal of leasehold improvements and equipment | (24 | ) | 74 | |||||||||
| - Loss from write-down of inventories | 456 | 0 | ||||||||||
| - Share-based payments | 11 | 2,133 | 9,238 | |||||||||
| - Finance income / (costs) net | 5 | 390 | (96 | ) | ||||||||
| (43,861 | ) | (75,241 | ) | |||||||||
| Change in trade and other receivables | 783 | 251 | ||||||||||
| Change in inventories | 7 | (181 | ) | |||||||||
| Change in other assets and prepaid expenses | 2,641 | (3,639 | ) | |||||||||
| Change in trade, other payables, provisions and contract liabilities | (10,276 | ) | (6,442 | ) | ||||||||
| (50,706 | ) | (85,252 | ) | |||||||||
| Interest received | 203 | 1,497 | ||||||||||
| Paid interest | (955 | ) | (1,069 | ) | ||||||||
| Paid income tax | (4 | ) | (3 | ) | ||||||||
| Net cash used in operating activities | (51,462 | ) | (84,827 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets | (25 | ) | (3,220 | ) | ||||||||
| Cash received from the sale of financial assets | 17,529 | 0 | ||||||||||
| Cash paid for investments in financial assets | 0 | (34,246 | ) | |||||||||
| Cash received from the sale of leasehold improvements and equipment | 768 | 0 | ||||||||||
| Net cash generated / (used) for investing activities | 18,272 | (37,466 | ) | |||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 7,331 | 0 | ||||||||||
| Transaction costs related to issue of common shares | (209 | ) | 0 | |||||||||
| Repayment of lease liabilities | (637 | ) | (377 | ) | ||||||||
| Repayment of borrowings | 12 | (4,375 | ) | (4,447 | ) | |||||||
| Net cash generated / (used) for financing activities | 2,110 | (4,824 | ) | |||||||||
| Exchange-rate related changes of cash and cash equivalents | (44 | ) | (352 | ) | ||||||||
| Net changes to cash and cash equivalents | (31,080 | ) | (127,117 | ) | ||||||||
| Cash and cash equivalents at the beginning of the period | 38,529 | 190,286 | ||||||||||
| Cash and cash equivalents at the end of the period | 7,405 | 62,817 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of changes in equity for the year
| Note | Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| Balance as of January 1, 2023 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | |||||||||||||||||
| Equity-settled share-based payment awards | 9,238 | 9,238 | ||||||||||||||||||||||
| Loss for the period | (85,733 | ) | (85,733 | ) | ||||||||||||||||||||
| Balance as of September 30, 2023 | 1,493 | 592,081 | (1,231 | ) | (515,923 | ) | 76,420 | |||||||||||||||||
| Balance as of January 1, 2024 | 1,500 | 593,666 | (1,231 | ) | (536,128 | ) | 57,807 | |||||||||||||||||
| Issue of common shares | 10 | 139 | 6,881 | 7,020 | ||||||||||||||||||||
| Equity-settled share-based payment awards | 11 | 2,133 | 2,133 | |||||||||||||||||||||
| Loss for the period | (49,765 | ) | (49,765 | ) | ||||||||||||||||||||
| Balance as of September 30, 2024 | 1,639 | 602,680 | (1,231 | ) | (585,893 | ) | 17,195 |
The notes are an integral part of these condensed consolidated interim financial statements.
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 50% via the dissolution of its
research and preclinical development departments. During the nine months ended September 30, 2024, the Group incurred 1.6 million as termination expenses, with 1.5 million included in research and development expenses and
0.1 million included in general administrative expenses.
Statement of compliance
The unaudited condensed
consolidated interim financial statements (referred to as the interim financial statements ) as of September 30, 2024 and December 31, 2023 and for the three and nine months ended September 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 November 14, 2024.
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 September 30, 2024, the Group had an accumulated
deficit of 585.9 million and total net equity of 17.2 million.
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 Q4 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 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 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 1-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 nine months ended September 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 September 30, 2024, the Group has 2,842,659 options and warrants outstanding in connection with
share-based payment programs (see note 11) and a loan agreement, which could potentially have a dilutive effect but were excluded from the diluted weighted average number of ordinary shares calculation because their effect would have been
anti-dilutive due to the net loss generated by the Group.
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 10 years to 5 years. The discount rate was adjusted to align with the revised lease term from 9.56% to 8.06%. The financial effect of this reassessment is an overall decrease in the consolidated depreciation and interest expense as shown below:
| Impact of the estimation changes | Depreciation expense - previous | Change | Depreciation expense - revised | |||||||||
| 2024 | 825 | 331 | 1,156 | |||||||||
| 2025 | 825 | 331 | 1,156 | |||||||||
| 2026 | 825 | 331 | 1,156 | |||||||||
| 2027 and thereafter | 5,564 | (3,539 | ) | 2,025 | ||||||||
| Total | 8,039 | (2,546 | ) | 5,493 | ||||||||
| Interest expense - previous | Change | Interest expense - revised | ||||||||||
| 2024 | 629 | (304 | ) | 325 | ||||||||
| 2025 | 577 | (320 | ) | 257 | ||||||||
| 2026 | 521 | (338 | ) | 183 | ||||||||
| 2027 and thereafter | 1,756 | (1,630 | ) | 126 | ||||||||
| Total | 3,483 | (2,592 | ) | 891 |
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
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
| Standard/interpretation | Effective Date 1 | |
| 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 | |
| Annual Improvements Volume 11 | January 1, 2026 |
IFRS 18 will have an effect on the presentation of the Group`s financial statements with the following key impacts:
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:
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 no transfers between levels for the periods presented.
Collaboration with Genentech Inc.
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 $96.0 million ( 83.2 million) in initial upfront
and committed funding on October 31, 2018. As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech.
In the third quarter of 2024, Genentech terminated the research collaboration and license agreement.
The Group recognized 0.2 million and 0.5 million as revenue during the three and nine months ended September 30, 2024 and 2023,
respectively. The revenue recognized relates to a platform license. As of September 30, 2024, the Group held contract liabilities of 0.6 million (December 31, 2023: 1.1 million), which will be recognized as revenue in
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 $60 million in upfront consideration, comprised of $40 million in cash and pre-funded research and development funding, and $20 million of common shares in Roivant. We entered into an agreement with Roivant providing for the reversion to Affimed of all clinical development and
commercialization rights for AFM32, effective April 29, 2024.
The Group recognized 0 million as revenue during the three and nine months
ended September 30, 2024 (2023: 1.6 million and 6.9 million respectively). As of December 31, 2023, Affimed had completed all work on the product candidate and by March 31, 2024 all remaining funds not utilised
for the research project had been refunded. As of December 31, 2023, the liability of 1.4 million with regard to the refund was included under trade and other payables (Contract liabilities as at December 31, 2023: 0).
The following table provides