Full Press Release Details
Affimed Reports 2023 Financial Results and Operational Progress
Mature progression free survival (PFS) data from the 15 EGFR-wildtype NSCLC patients and initial efficacy data from the
EGFR-mutant NSCLC cohorts are expected in Q2 2024.
Mannheim, Germany, March 28, 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 year ended December 31, 2023.
The clinical achievements in 2023 with our three programs, AFM24, acimtamig, and AFM28, provide
a strong foundation for us to deliver on meaningful clinical milestones across the portfolio in 2024 and beyond, said Dr. Andreas Harstrick, Chief Medical Officer and interim Chief Executive Officer at Affimed. We have seen
compelling responses in treatment refractory NSCLC EGFR-wt patients and will report mature PFS data of these patients as well as response data from the NSCLC EGFR-mut cohort in the second quarter. With the LuminICE-203 study of acimtamig with AlloNK successfully launched in 2023, we are progressing toward an initial data update in the second quarter. The long-term follow-up data for study for the AFM13-104, presented at ASH, demonstrating that approximately 30% of patients remain in remission beyond 1 year, have further enhanced our confidence in the therapeutic potential of acimtamig in combination with NK
cells. Finally, AFM28 has reached the final dose level in the escalation study providing the basis for continued development. With all three clinical programs moving forward, we are focused on the execution of these programs confident in
Affimed s ability to fulfill our overarching mission of delivering innovative therapies to cancer patients.
AFM24 (EGFR/CD16A tumors)
In addition, the company
continues to enroll in the EGFR-mut NSCLC cohort for a planned number of 25 patients.
Mature PFS data from the first 15 patients
from the EGFR-wt cohort and response data from the EGFR-mut cohort are expected in Q2 2024.
Acimtamig (AFM13; CD30/CD16A tumors)
Corporate Restructuring:
Upcoming Milestones:
Full Year 2023 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 December 31, 2023, cash, cash equivalents and investments totaled 72.0 million compared to 190.3 million on December 31,
2022. Based on our current operating plan and assumptions, we anticipate that our liquidity will support operations into H2 2025.
operating activities for the year ended December 31, 2023, was 110.3 million compared to 104.9 million for the year ended December 31, 2022.
Total revenue for the year ended December 31, 2023, was 8.3 million compared with 41.4 million for the year ended December 31,
2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations for which we have now completed the work assigned to us under the respective collaboration agreements.
Research and development expenses for the year ended December 31, 2023, were 95.0 million compared to 98.8 million in 2022.
General and administrative expenses for the year ended December 31, 2023, were 24.7 million compared to 32.1 million for the year
ended December 31, 2022. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses.
finance income/costs for the year ended December 31, 2023, were 0.7 million compared to 2.1 million for the year ended December 31, 2022. Net finance income/costs are largely due to foreign exchange gains/losses
related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.
The weighted number of common shares outstanding for the year ended December 31, 2023, was
14.9 million, adjusted to reflect the impact of the reverse stock split executed in the first quarter of 2024.
Net loss for the year ended
December 31, 2023, was 105.9 million, or 7.09 loss per common share compared with a net loss of 86.0 million, or 6.04 loss per common share, for the year ended December 31, 2022.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2023, 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.
Call and Webcast Information
Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year
2023 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/BI43eadbb12f6143a5bdcb2c9549ef2e76, 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.
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 corporate restructuring, the associated headcount reduction and the impact this may have on
Company s anticipated savings and total costs and expenses, 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 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 Artiva s Allo-NK NK cells 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
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
| Affimed N.V. Consolidated statements of comprehensive loss (in thousand) | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Revenue | 8,275 | 41,353 | 40,366 | |||||||||
| Other income and expenses net | 4,697 | 1,417 | 1,310 | |||||||||
| Research and development expenses | (94,958 | ) | (98,814 | ) | (81,488 | ) | ||||||
| General and administrative expenses | (24,675 | ) | (32,075 | ) | (24,218 | ) | ||||||
| Operating loss | (106,661 | ) | (88,119 | ) | (64,030 | ) | ||||||
| Finance income / (costs) net | 726 | 2,117 | 6,509 | |||||||||
| Loss before tax | (105,935 | ) | (86,002 | ) | (57,521 | ) | ||||||
| Income taxes | (3 | ) | (2 | ) | (2 | ) | ||||||
| Loss for the period | (105,938 | ) | (86,004 | ) | (57,523 | ) | ||||||
| Other comprehensive loss | ||||||||||||
| Items that will not be reclassified to profit or loss | ||||||||||||
| Equity investments at fair value OCI net change in fair value | 0 | (6,047 | ) | (7,693 | ) | |||||||
| Other comprehensive loss | 0 | (6,047 | ) | (7,693 | ) | |||||||
| Total comprehensive loss | (105,938 | ) | (92,051 | ) | (65,216 | ) | ||||||
| Basic and diluted loss per share in per share (undiluted = diluted) | (7.09 | ) | (6.04 | ) | (4.81 | ) | ||||||
| Weighted number of common shares outstanding | 14,939,916 | 14,236,229 | 11,950,238 |
Consolidated statements of financial position
| December 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 25 | 58 | ||||||
| Leasehold improvements and equipment | 4,905 | 3,823 | ||||||
| Right-of-use assets | 8,039 | 561 | ||||||
| 12,969 | 4,442 | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | 38,529 | 190,286 | ||||||
| Investments | 33,518 | 0 | ||||||
| Other financial assets | 851 | 0 | ||||||
| Trade and other receivables | 5,327 | 2,697 | ||||||
| Inventories | 463 | 628 | ||||||
| Other assets and prepaid expenses | 5,500 | 2,459 | ||||||
| 84,188 | 196,070 | |||||||
| TOTAL ASSETS | 97,157 | 200,512 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 1,500 | 1,493 | ||||||
| Capital reserves | 593,666 | 582,843 | ||||||
| Fair value reserves | (1,231 | ) | (1,231 | ) | ||||
| Accumulated deficit | (536,128 | ) | (430,190 | ) | ||||
| Total equity | 57,807 | 152,915 | ||||||
| Non current liabilities | ||||||||
| Borrowings | 6,319 | 11,687 | ||||||
| Contract liabilities | 464 | 1,083 | ||||||
| Lease liabilities | 6,660 | 176 | ||||||
| Total non-current liabilities | 13,443 | 12,946 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 18,916 | 19,077 | ||||||
| Borrowings | 5,833 | 5,930 | ||||||
| Lease liabilities | 539 | 396 | ||||||
| Contract liabilities | 619 | 9,248 | ||||||
| Total current liabilities | 25,907 | 34,651 | ||||||
| TOTAL EQUITY AND LIABILITIES | 97,157 | 200,512 |
Consolidated statements of cash flows
| 2023 | 2022 | 2021 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (105,938 | ) | (86,004 | ) | (57,523 | ) | ||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 3 | 2 | 2 | |||||||||
| - Depreciation and amortization | 1,749 | 2,899 | 1,334 | |||||||||
| - Net gain from disposal of subsidiary | (4,339 | ) | 0 | 0 | ||||||||
| - Net loss on disposal of leasehold improvements and equipment | 82 | 0 | 0 | |||||||||
| - Share-based payments | 10,714 | 19,110 | 11,820 | |||||||||
| - Finance income / (costs) net | (726 | ) | (2,117 | ) | (6,509 | ) | ||||||
| (98,455 | ) | (66,110 | ) | (50,876 | ) | |||||||
| Change in trade and other receivables | 1,093 | 2,113 | (2,369 | ) | ||||||||
| Change in financial assets | (851 | ) | 0 | 0 | ||||||||
| Change in inventories | 100 | (207 | ) | (175 | ) | |||||||
| Change in other assets and prepaid expenses | (2,737 | ) | 1,075 | (2,274 | ) | |||||||
| Change in trade, other payables, provisions and contract liabilities | (9,766 | ) | (41,048 | ) | (29,990 | ) | ||||||
| (110,616 | ) | (104,177 | ) | (85,684 | ) | |||||||
| Interest received | 1,743 | 564 | 0 | |||||||||
| Paid interest | (1,393 | ) | (1,277 | ) | (905 | ) | ||||||
| Paid income tax | (3 | ) | (2 | ) | (2 | ) | ||||||
| Net cash used in operating activities | (110,269 | ) | (104,892 | ) | (86,591 | ) | ||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | 0 | (37 | ) | (1,654 | ) | |||||||
| Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets | (3,729 | ) | (659 | ) | (2,196 | ) | ||||||
| Cash received from the sale of financial assets | 938 | 6,301 | 0 | |||||||||
| Cash paid for investments in financial assets | (34,246 | ) | 0 | 0 | ||||||||
| Cash received from sale of subsidiary | 978 | 0 | 0 | |||||||||
| Net cash (used)/generated in investing activities | (36,059 | ) | 5,605 | (3,850 | ) | |||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 235 | 95,907 | 124,460 | |||||||||
| Transaction costs related to issue of common shares | (35 | ) | (6,037 | ) | (7,412 | ) | ||||||
| Proceeds from borrowings | 0 | 0 | 17,500 | |||||||||
| Transaction costs related to borrowings | 0 | 0 | (311 | ) | ||||||||
| Repayment of lease liabilities | (491 | ) | (733 | ) | (564 | ) | ||||||
| Repayment of borrowings | (5,929 | ) | (580 | ) | (92 | ) | ||||||
| Net cash (used)/generated in financing activities | (6,220 | ) | 88,557 | 133,581 | ||||||||
| Exchange rate related changes of cash and cash equivalents | 791 | 3,386 | 7,636 | |||||||||
| Net changes to cash and cash equivalents | (152,548 | ) | (10,730 | ) | 43,140 | |||||||
| Cash and cash equivalents at the beginning of the period | 190,286 | 197,630 | 146,854 | |||||||||
| Cash and cash equivalents at the end of the period | 38,529 | 190,286 | 197,630 |
Consolidated statements of changes in equity
| Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | ||||||||||||||||
| Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||
| Issue of common shares | 240 | 114,197 | 114,437 | |||||||||||||||||
| Exercise of share-based payment awards | 11 | 2,906 | 2,917 | |||||||||||||||||
| Equity-settled share-based payment awards | 11,820 | 11,820 | ||||||||||||||||||
| Loss for the period | (57,523 | ) | (57,523 | ) | ||||||||||||||||
| Other comprehensive loss | (7,693 | ) | (7,693 | ) | ||||||||||||||||
| Balance as of December 31, 2021 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||
| Balance as of January 1, 2022 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||
| Issue of common shares | 259 | 89,545 | 89,804 | |||||||||||||||||
| Exercise of share-based payment awards | 0 | 101 | 101 | |||||||||||||||||
| Equity-settled share-based payment awards | 19,110 | 19,110 | ||||||||||||||||||
| Transfer of cumulative loss on sale of financial assets | 10,789 | (10,789 | ) | 0 | ||||||||||||||||
| Loss for the period | (86,004 | ) | (86,004 | ) | ||||||||||||||||
| Other comprehensive loss | (6,047 | ) | (6,047 | ) | ||||||||||||||||
| Balance as of December 31, 2022 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | |||||||||||||
| Balance as of January 1, 2023 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | |||||||||||||
| Issue of common shares | 7 | 109 | 116 | |||||||||||||||||
| Equity-settled share-based payment awards | 10,714 | 10,714 | ||||||||||||||||||
| Loss for the period | (105,938 | ) | (105,938 | ) | ||||||||||||||||
| Balance as of December 31, 2023 | 1,500 | 593,666 | (1,231 | ) | (536,128 | ) | 57,807 |