Affimed Reports 2023 Financial Results and Operational Progress

Published
  • AFM24 combination with atezolizumab (AFM24-102): Follow-up of the Phase 1/2a combination study confirmed four responses in the non-small cell cancer (NSCLC) EGFR-wildtype cohort: one complete response (CR), three partial responses (PR), and seven stable disease patients in the 15 heavily pretreated patients who were evaluated. 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.
  • Acimtamig (AFM13) combination with AlloNK® (AB-101) natural killer (NK) cells (LuminICE-203): Company on track to report initial efficacy and safety data in Q2 2024.
  • AFM28: Currently enrolling patients in the sixth and final cohort of the Phase 1 dose-escalation study in patients with CD123-positive relapsed/refractory (r/r) AML.
  • Restructuring completed: Company is focused on advancing its three clinical programs.
  • Cash runway into H2 2025: As of December 31, 2023, cash, cash equivalents and investments were €72.0 million.

MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- 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.”

Program Updates

AFM24 (EGFR/CD16A tumors)

  • As of January 4, clinical response update to the Phase 1/2a AFM24-102 trial in EGFR-wt NSCLC reported 4 confirmed responses, including 1 CR, 3 PRs, and 7 stable diseases in 15 heavily pre-treated patients, resulting in a disease control rate of 73 percent. All patients were pre-treated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1. Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients. 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)

  • Initial safety and efficacy data from the LuminICE-203 (AFM13-203) study expected in Q2 2024. LuminICE-203 is a Phase 2 clinical study investigating acimtamig in combination with Artiva’s AlloNK cells in patients with r/r classical Hodgkin lymphoma (HL). Safety Review Committee meeting and initiation of enrollment in cohorts 3 and 4 is expected mid-April.
  • Updated Phase 1/2 AFM13-104 study data demonstrated an ORR of 97% and a CR rate of 78% in 32 patients with r/r HL, presented at ASH 2023. As of the cutoff date, the median EFS was 9.8 months with 84% patients alive at 12 months. The median duration of response was 8.8 months. The treatment regimen continues to demonstrate 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. The oral presentation included a total of 42 patients enrolled, with 36 patients treated at the recommended Phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment.

AFM28 (CD123/CD16A)

  • Completed enrollment of the fifth cohort, recruiting patients in the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML. No dose-limiting toxicities were reported. Further clinical development of AFM28 is planned in combination with an allogeneic off-the-shelf NK cell product.

Corporate Restructuring:

  • The corporate restructuring announced earlier this year has been fully implemented.
  • The restructuring included a streamlining of operations resulting in a 50% reduction in the Company’s workforce.
  • The Company is focusing resources on advancing its clinical programs, AFM24, acimtamig, and AFM28, through the various stages of development.

Upcoming Milestones:

  • Data from the NSCLC expansion cohorts in the Phase 1/2a AFM24+atezolizumab combination study expected in Q2 2024.
  • Initial data readout from the LuminICE-203 (AFM13 combination with AlloNK NK cells) study expected in Q2 2024.
  • Further progress updates from AFM28-101 dose escalation expected in Q2 2024.

Full Year 2023 Financial HighlightsAffimed’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.

Net cash used in 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.

Net 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.

Conference Call and Webcast InformationAffimed 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.

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 StatementThis 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 Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +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 
       
       

Affimed N.V.     
Consolidated statements of financial position     
(in € thousand)     
  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 
      
      

Affimed N.V.       
Consolidated statements of cash flows       
(in € thousand)       
  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 
        
        

Affimed N.V.          
Consolidated statements of changes in equity          
(in € thousand)          
  Issued Capital Fair Value  Accumulated  Total 
  capital reserves reserves  deficit  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 
           

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Source: Affimed N.V.

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