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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 | 2023 | 2022 | 2023 | 2022 | ||||||||||||||||
| Revenue | 3 | 1,962 | 14,888 | 7,862 | 30,195 | |||||||||||||||
| Other income net | (6 | ) | 118 | 1,121 | 642 | |||||||||||||||
| Research and development expenses | (21,498 | ) | (26,126 | ) | (76,302 | ) | (65,333 | ) | ||||||||||||
| General and administrative expenses | (5,381 | ) | (8,089 | ) | (18,507 | ) | (23,509 | ) | ||||||||||||
| Operating loss | 4 | (24,923 | ) | (19,209 | ) | (85,826 | ) | (58,005 | ) | |||||||||||
| Finance income / (costs) net | 5 | 568 | 2,719 | 96 | 5,443 | |||||||||||||||
| Loss before tax | (24,355 | ) | (16,490 | ) | (85,730 | ) | (52,562 | ) | ||||||||||||
| Income taxes | 0 | 0 | (3 | ) | (2 | ) | ||||||||||||||
| Loss for the period | (24,355 | ) | (16,490 | ) | (85,733 | ) | (52,564 | ) | ||||||||||||
| Other comprehensive loss | ||||||||||||||||||||
| Items that will not be reclassified to profit or loss | ||||||||||||||||||||
| Equity investments at fair value OCI net change in fair value | 7 | 0 | (73 | ) | 0 | (6,846 | ) | |||||||||||||
| Other comprehensive loss | 0 | (73 | ) | 0 | (6,846 | ) | ||||||||||||||
| Total comprehensive loss | (24,355 | ) | (16,563 | ) | (85,733 | ) | (59,410 | ) | ||||||||||||
| Basic and diluted loss per share in per share (undiluted = diluted) | (0.16 | ) | (0.11 | ) | (0.57 | ) | (0.38 | ) | ||||||||||||
| Weighted number of common shares outstanding | 149,339,335 | 149,339,335 | 149,339,335 | 140,036,614 |
The Notes are an integral part of these condensed consolidated interim financial statements.
Consolidated interim statements of financial position
| Note | September 30, 2023 (unaudited) | December 31, 2022 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 41 | 58 | ||||||||||
| Leasehold improvements and equipment | 5,258 | 3,823 | ||||||||||
| Right-of-use assets | 6 | 8,336 | 561 | |||||||||
| 13,635 | 4,442 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 62,817 | 190,286 | ||||||||||
| Financial assets | 8 | 34,659 | 0 | |||||||||
| Trade and other receivables | 9 | 2,446 | 2,697 | |||||||||
| Inventories | 809 | 628 | ||||||||||
| Other assets and prepaid expenses | 10 | 6,098 | 2,459 | |||||||||
| 106,829 | 196,070 | |||||||||||
| TOTAL ASSETS | 120,464 | 200,512 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,493 | 1,493 | ||||||||||
| Capital reserves | 592,081 | 582,843 | ||||||||||
| Fair value reserves | (1,231 | ) | (1,231 | ) | ||||||||
| Accumulated deficit | (515,923 | ) | (430,190 | ) | ||||||||
| Total equity | 11 | 76,420 | 152,915 | |||||||||
| Non current liabilities | ||||||||||||
| Borrowings | 13 | 7,664 | 11,687 | |||||||||
| Contract liabilities | 3 | 619 | 1,083 | |||||||||
| Lease liabilities | 6,874 | 176 | ||||||||||
| Total non-current liabilities | 15,157 | 12,946 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 21,713 | 19,077 | ||||||||||
| Borrowings | 13 | 5,898 | 5,930 | |||||||||
| Lease liabilities | 640 | 396 | ||||||||||
| Contract liabilities | 3 | 636 | 9,248 | |||||||||
| Total current liabilities | 28,887 | 34,651 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 120,464 | 200,512 |
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 | 2023 | 2022 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (85,733 | ) | (52,564 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 3 | 2 | ||||||||||
| - Depreciation and amortization | 1,273 | 1,066 | ||||||||||
| - Net loss on disposal of leasehold improvements and equipment | 74 | 0 | ||||||||||
| - Share-based payments | 12 | 9,238 | 14,779 | |||||||||
| - Finance income / (costs) net | 5 | (96 | ) | (5,443 | ) | |||||||
| (75,241 | ) | (42,160 | ) | |||||||||
| Change in trade and other receivables | 251 | 3,118 | ||||||||||
| Change in inventories | (181 | ) | (252 | ) | ||||||||
| Change in other assets and prepaid expenses | (3,639 | ) | (26 | ) | ||||||||
| Change in trade, other payables, provisions and contract liabilities | (6,442 | ) | (33,888 | ) | ||||||||
| (85,252 | ) | (73,208 | ) | |||||||||
| Interest received | 1,497 | 228 | ||||||||||
| Paid interest | (1,069 | ) | (950 | ) | ||||||||
| Paid income tax | (3 | ) | (2 | ) | ||||||||
| Net cash used in operating activities | (84,827 | ) | (73,932 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | 0 | (30 | ) | |||||||||
| Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets | (3,220 | ) | (263 | ) | ||||||||
| Cash received from the sale of financial assets | 0 | 3,772 | ||||||||||
| Cash paid for investments in financial assets | (34,246 | ) | 0 | |||||||||
| Net cash used for investing activities | (37,466 | ) | 3,479 | |||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 0 | 95,907 | ||||||||||
| Transaction costs related to issue of common shares | 0 | (6,159 | ) | |||||||||
| Repayment of lease liabilities | (377 | ) | (538 | ) | ||||||||
| Repayment of borrowings | 13 | (4,447 | ) | (70 | ) | |||||||
| Net cash used for financing activities | (4,824 | ) | 89,140 | |||||||||
| Exchange rate related changes of cash and cash equivalents | (352 | ) | 6,578 | |||||||||
| Net changes to cash and cash equivalents | (127,117 | ) | 18,687 | |||||||||
| Cash and cash equivalents at the beginning of the period | 190,286 | 197,630 | ||||||||||
| Cash and cash equivalents at the end of the period | 62,817 | 222,895 |
The Notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of changes in equity
| Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | ||||||||||||||||||||
| Note | ||||||||||||||||||||||||
| Balance as of January 1, 2022 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||||||
| Issue of common shares | 259 | 89,423 | 89,682 | |||||||||||||||||||||
| Exercise of share-based payment awards | 101 | 101 | ||||||||||||||||||||||
| Equity-settled share-based payment awards | 14,779 | 14,779 | ||||||||||||||||||||||
| Transfer of cumulative loss on sale of financial assets | 6,865 | (6,865 | ) | 0 | ||||||||||||||||||||
| Loss for the period | (52,564 | ) | (52,564 | ) | ||||||||||||||||||||
| Other comprehensive loss | (6,846 | ) | (6,846 | ) | ||||||||||||||||||||
| Balance as of September 30, 2022 | 1,493 | 578,390 | (5,954 | ) | (392,826 | ) | 181,103 | |||||||||||||||||
| Balance as of January 1, 2023 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | |||||||||||||||||
| Equity-settled share-based payment awards | 12 | 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 |
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, Mannheim, Germany, AbCheck s.r.o., Plzen, Czech Republic, and Affimed Inc., Delaware, USA (collectively Affimed , the
Company or the Group ).
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 research and development programs, strategic collaborations and service contracts, where the Group is performing research services for third parties.
2. Basis of preparation and changes to Group s accounting policies
Statement of compliance
The condensed consolidated
interim financial statements (referred to as the interim financial statements ) as of September 30, 2023 and December 31, 2022 and for the three and nine months ended September 30, 2023 and 2022 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, 2022.
The interim financial statements were authorized for issuance by the
Company s Management Board on November 14, 2023.
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.
As of September 30, 2023, the Group has granted 25,502,956 options and warrants in connection with share-based payment programs (see note 12) 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
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
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 consolidated financial statements as of and for the year ended December 31, 2022.
Functional and presentation currency
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
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 consolidated financial
statements as of and for the year ended December 31, 2022.
New standards and amendments to standards
The following forthcoming standards and amendments to standards have not been applied in preparing these interim financial statements.
| Standard/interpretation | Effective Date 1 | |
| Amendments to IAS 1 Presentation of Financial Statements: | ||
| Classification of Liabilities as Current or Non-current | January 1, 2024 | |
| Amendments to IAS 1 Presentation of Financial Statements: | ||
| Non-current Liabilities with Covenants | January 1, 2024 | |
| Amendments to IFRS 16 Leases: Lease Liability in a | ||
| Sale and Leaseback | January 1, 2024 | |
| Amendments to IAS 7 Statement of Cash Flows and IFRS 7 | ||
| Financial Instruments: Disclosures: Supplier Finance Arrangements | January 1, 2024 | |
| Amendments to IAS 21 The Effects of Changes in Foreign | ||
| Exchange Rates: Lack of Exchangeability | January 1, 2025 |
The 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 measurement of the fair value of preferred
and common shares in other companies held by the group is based on level 1 and 3 inputs (see note 7). The Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred.
The Group measures its treasury bonds at amortized cost with changes in value from initial recognition being recognized in profit and loss as interest income.
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 is providing 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.
The Group recognized 0.2 million and 0.5 million as revenue during the three and nine months ended September 30, 2023 (2022:
9.9 million and 17.1 million). As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech. The remaining revenue recognized during the nine months ended
September 30, 2023 relates to a platform license. As of September 30, 2023, the Group held contract liabilities of 1.2 million (December 31, 2022: 1.7 million), which will be recognized as revenue in subsequent periods.
Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of
specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales.
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 grants 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. The Group is eligible to receive up to an additional $2 billion in milestone payments upon
achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.
The Group recognized
1.6 million and 6.9 million as revenue during the three and nine months ended September 30, 2023 (2022: 5.0 million and 12.9 million). As of September 30, 2023, Affimed had completed all work on the
product candidate and was finalising the refunding of funds not utilised for the research plan of 1.7 million. As of September 30, 2023, the liability from the refunding is included under trade and other payables (December 31, 2022:
contract liabilities 8.6 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
| September 30, 2023 | December 31, 2022 | |||||||
| Receivables | 5 | 0 | ||||||
| Contract liabilities | 1,255 | 10,331 |
An amount of 1.7 million and 7.4 million included in contract liabilities at the beginning of the period
has been recognized as revenue during the three and nine months ended September 30, 2023.
The remaining performance obligations as of
September 30, 2023 are approximately 1.3 million and are expected to be recognized as revenue with 0.6 million in the next 12 months and 0.6 million being realized thereafter.
Disaggregation of revenue
| Three months ended September 30, 2023 | Three months ended September 30, 2022 | Nine months ended September 30, 2023 | Nine months ended September 30, 2022 | |||||||||||||
| Geographic information | ||||||||||||||||
| Revenue: | ||||||||||||||||
| Germany | 5 | 0 | 5 | 151 | ||||||||||||
| USA | 1,957 | 14,888 | 7,857 | 30,044 | ||||||||||||
| 1,962 | 14,888 | 7,862 | 30,195 | |||||||||||||
| Major service lines: | ||||||||||||||||
| Collaboration revenue | 1,713 | 14,888 | 7,384 | 30,041 | ||||||||||||
| Service revenue | 249 | 0 | 478 | 154 | ||||||||||||
| 1,962 | 14,888 | 7,862 | 30,195 | |||||||||||||
| Timing on revenue recognition: | ||||||||||||||||
| Point in time | 0 | 0 | 0 | 0 | ||||||||||||
| Over time | 1,962 | 14,888 | 7,862 | 30,195 | ||||||||||||
| 1,962 | 14,888 | 7,862 | 30,195 |
April 2023, Affimed conducted a reorganization of its operations to focus on the Group s three clinical stage development programs. As a result of the reorganization, the Group incurred a one-time
expenditure for termination payments of 1.1 million during the nine months ended September 30, 2023. The majority of these termination payments were settled during the nine months ended September 30, 2023 and the balance will be
settled in the fourth quarter of 2023.
5. Finance income and finance costs
| Three months ended September 30, 2023 | Three months ended September 30, 2022 | Nine months ended September 30, 2023 | Nine months ended September 30, 2022 | |||||||||||||
| Interest expense Bootstrap (formerly SVB) Loan Agreement | (447 | ) | (408 | ) | (1,394 | ) | (1,167 | ) | ||||||||
| Foreign exchange differences | 353 | 3,009 | (78 | ) | 6,577 | |||||||||||
| Interest treasury bonds (refer note 8) | 138 | 0 | 138 | 0 | ||||||||||||
| Other finance income/finance costs net | 524 | 118 | 1,430 | 33 | ||||||||||||
| 568 | 2,719 | 96 | 5,443 |
6. Right-of-use assets
Affimed GmbH entered into a new lease agreement for office and laboratory premises for a period of 10 years. Occupancy took effect September 1, 2023,
resulting in an addition to the right-of-use assets of 8.3 million, with a corresponding lease liability.
Depreciation and interest for the three months ended September 30, 2023 amounted to 0.1 million and 0.1 million respectively. Upfront payments of
1 million were incurred during the nine months ended September 30, 2023; monthly lease payments only commence in quarter four of 2023.
contractually agreed undiscounted lease payments for the new premises are as follows:
| Payments within 1 year | 1.0 million | |||
| Payments between 1 and 5 years | 4.7 million | |||
| Thereafter | 5.1 million |
The lease agreement provides for an extension option of five years. The Company has not considered this extension option in
quantifying the future lease payments as the exercise of this option is not considered to be reasonably certain.
7. Long-term financial assets
The Group holds preferred shares in Amphivena, which are currently recognized at their fair value of nil. The impairment of the asset was recognized
in 2021 based on the decision made by the board of Amphivena to wind down the company. Based on current information, we continue to estimate that the fair value remains at nil (December 31, 2022: nil).
8. Current financial assets
2023, the Group holds investments in German and US government bonds of 34.7 million. These bonds have generated interest income of 0.1 million for the three and nine months ended September 30, 2023. These investments are
considered short-term as they all mature within a period of six months.
9. Trade and other receivables
The trade receivables as of September 30, 2023 were 5 (December 31, 2022: 0). These trade receivables are all due in the short-term, do