- 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,
“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.
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 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
Net cash used in operating activities for the year ended
Total revenue for the year ended
Research and development expenses for the year ended
General and administrative expenses for the year ended
Net finance income/costs for the year ended
The weighted number of common shares outstanding for the year ended
Net loss for the year ended
Additional information regarding these results is included in the notes to the consolidated financial statements as of
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
Conference Call and Webcast Information
Affimed will host a conference call and webcast on
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 (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,
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
Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
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 | |||||
(in € thousand) | |||||
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 | |||||||
(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 | ||||
Consolidated statements of changes in equity | |||||||||||||
(in € thousand) | |||||||||||||
Issued | Capital | Fair Value | Accumulated | Total | |||||||||
capital | reserves | reserves | deficit | equity | |||||||||
Balance as of | 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 | 1,234 | 474,087 | (5,973) | (333,397) | 135,951 | ||||||||
Balance as of | 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 | 1,493 | 582,843 | (1,231) | (430,190) | 152,915 | ||||||||
Balance as of | 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 | 1,500 | 593,666 | (1,231) | (536,128) | 57,807 | ||||||||
Source:
2024 GlobeNewswire, Inc., source