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Affimed Reports 2023 Financial Results and Operational Progress

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)

Acimtamig (AFM13; CD30/CD16A tumors)

AFM28 (CD123/CD16A)

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.

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 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.

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 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 Fudukidis
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  
             
             
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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