- Initial data from the LuminICE-203 study shows 85.7% overall response rate (ORR) (6 of 7 patients); 4 out of 7 patients with complete response (CR) -
- AFM28 shows single agent efficacy with 2 CR/CRi and 3 stable disease (SD) in 6 patients treated at dose level of 300 mg weekly -
- Acimtamig (AFM13) combination with AlloNK® (AB-101) natural killer (NK) cells: Recruitment in cohorts 1 and 2 completed. In the first 7 treatment refractory Hodgkin Lymphoma (HL) patients, an ORR of 85.7% observed, with 4 CRs and 2 partial responses (PRs) were observed by independent read.
- AFM24 combination with atezolizumab: In 17 EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients who failed chemotherapy and PD-1/PD-L1 treatment, 1CR, 3PRs and 8 SDs were observed. Disease control was 71%.
- 3 of the 4 responses were ongoing for more than 7 months and median progression free survival (mPFS) was 5.9 months.
- Initial efficacy data from the EGFR mutant (EGFRmut) NSCLC cohort showed objective responses in 4 out of 13 response-evaluable patients; 1 CR, 3 PRs and 6 SDs. Disease control was 77%. All responses confirmed by follow-up scans.
- AFM28 monotherapy phase 1 dose-escalation study: Completed enrollment of patients in the sixth and final cohort of the study without any unexpected safety signals or dose limiting toxicities. Of the 6 patients treated at dose level 6, a CR/CRi rate of 33% was reported (1 CR, 1 CRi and 3 SDs were observed).
- Cash runway into H2 2025: As of
March 31, 2024 , cash, cash equivalents and investments were €48.5 million.
MANNHEIM,
“We continue to make remarkable progress across our three clinical programs, AFM24, acimtamig, and AFM28,” said Dr.
Program Updates
Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.
- All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
- Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK® related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
- Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab): 4 confirmed responses (1CR, 4PR) and 8SD in 17 heavily pretreated EGFRwt NSCLC patients; mPFS of 5.9 months; 3 out of 4 responses ongoing for more than 7 months.
- All patients were pretreated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1.
- On
May 29 , the Company announced that it received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients. - In 13 response-evaluable, heavily pretreated EGFRmut NSCLC patients, the combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs and 6 SDs. All responses are ongoing and have been confirmed by follow up scan.
- ORR and PFS data from the 25 patient EGFRmut NSCL cohort is expected in Q3 2024; data from the 40 patient EGFRwt cohort is expected in Q4 2024.
AFM28 (CD123 / CD16A)
Completed enrollment of 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 acute myeloid leukemia (AML).
- Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of 33%.
- Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a SD as best response.
- No dose-limiting toxicities were reported in dose levels 5 and 6.
- Data from the study is expected to be presented at a future scientific conference.
- Further clinical development of AFM28 to be pursued in combination with an allogeneic, off-the-shelf NK cell product.
Upcoming Milestones:
- Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024.
- ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
- ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.
First Quarter 2024 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 quarter ended
Total revenue for the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Net finance income/costs for the quarter ended
Net loss for the quarter ended
The weighted number of common shares outstanding for the quarter ended
Additional information regarding these results will be 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/BId697f70815a8448d80b68becf533be98, 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 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 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
Unaudited consolidated statements of comprehensive loss | ||||||
(in € thousand) | ||||||
For the three months ended | ||||||
2024 | 2023 | |||||
Revenue | 155 | 4,510 | ||||
Other income – net | 177 | 410 | ||||
Research and development expenses | (15,391 | ) | (29,531 | ) | ||
General and administrative expenses | (4,476 | ) | (6,850 | ) | ||
Operating loss | (19,535 | ) | (31,461 | ) | ||
Finance income / (costs) – net | 360 | (519 | ) | |||
Loss before tax | (19,175 | ) | (31,980 | ) | ||
Income taxes | 0 | (3 | ) | |||
Loss for the period | (19,175 | ) | (31,983 | ) | ||
Total comprehensive loss | (19,175 | ) | (31,983 | ) | ||
Basic and diluted loss per share in € per share (undiluted = diluted) | (1.27 | ) | (2.14 | ) | ||
Weighted number of common shares outstanding | 15,129,952 | 14,933,934 | ||||
Consolidated statements of financial position | ||||||
(in € thousand) | ||||||
ASSETS | ||||||
Non-current assets | ||||||
Intangible assets | 22 | 25 | ||||
Leasehold improvements and equipment | 2,404 | 4,905 | ||||
Right-of-use assets | 5,970 | 8,039 | ||||
8,396 | 12,969 | |||||
Current assets | ||||||
Cash and cash equivalents | 14,348 | 38,529 | ||||
Investments | 34,158 | 33,518 | ||||
Other financial assets | 869 | 851 | ||||
Trade and other receivables | 6,038 | 5,327 | ||||
Inventories | 0 | 463 | ||||
Other assets and prepaid expenses | 6,044 | 5,500 | ||||
Assets held for sale | 700 | 0 | ||||
62,157 | 84,188 | |||||
TOTAL ASSETS | 70,553 | 97,157 | ||||
EQUITY AND LIABILITIES | ||||||
Equity | ||||||
Issued capital | 1,523 | 1,500 | ||||
Capital reserves | 595,674 | 593,666 | ||||
Fair value reserves | (1,231 | ) | (1,231 | ) | ||
Accumulated deficit | (555,303 | ) | (536,128 | ) | ||
Total equity | 40,663 | 57,807 | ||||
Non-current liabilities | ||||||
Borrowings | 4,966 | 6,319 | ||||
Contract liabilities | 309 | 464 | ||||
Lease liabilities | 4,300 | 6,660 | ||||
Total non-current liabilities | 9,575 | 13,443 | ||||
Current liabilities | ||||||
Trade and other payables | 12,891 | 18,916 | ||||
Borrowings | 5,833 | 5,833 | ||||
Lease liabilities | 972 | 539 | ||||
Contract liabilities | 619 | 619 | ||||
Total current liabilities | 20,315 | 25,907 | ||||
TOTAL EQUITY AND LIABILITIES | 70,553 | 97,157 | ||||
Unaudited consolidated statements of cash flows | |||||||
(in € thousand) | |||||||
For the three months ended | |||||||
2024 | 2023 | ||||||
Cash flow from operating activities | |||||||
Loss for the period | (19,175 | ) | (31,983 | ) | |||
Adjustments for the period: | |||||||
- Income taxes | 0 | 3 | |||||
- Depreciation and amortization | 2,090 | 289 | |||||
- Net loss on disposal of leasehold improvements and equipment | 46 | 0 | |||||
- loss from write-down of inventories | 456 | 0 | |||||
- Share-based payments | 789 | 4,158 | |||||
- Finance income / (costs) – net | (360 | ) | 519 | ||||
(16,154 | ) | (27,014 | ) | ||||
Change in trade and other receivables | (700 | ) | 655 | ||||
Change in inventories | 7 | (39 | ) | ||||
Change in other assets and prepaid expenses | (269 | ) | (2,781 | ) | |||
Change in trade, other payables, provisions and contract liabilities | (6,460 | ) | (4,235 | ) | |||
(23,576 | ) | (33,414 | ) | ||||
Interest received | 104 | 520 | |||||
Paid interest | (346 | ) | (347 | ) | |||
Paid income tax | 0 | (3 | ) | ||||
Net cash used in operating activities | (23,818 | ) | (33,244 | ) | |||
Cash flow from investing activities | |||||||
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets | (1 | ) | (8 | ) | |||
Net cash used for investing activities | (1 | ) | (8 | ) | |||
Cash flow from financing activities | |||||||
Proceeds from issue of common shares, including exercise of share-based payment awards | 1,270 | 0 | |||||
Transaction costs related to issue of common shares | (24 | ) | 0 | ||||
Repayment of lease liabilities | (205 | ) | (124 | ) | |||
Repayment of borrowings | (1,458 | ) | (510 | ) | |||
Net cash used for financing activities | (417 | ) | (634 | ) | |||
Exchange-rate related changes of cash and cash equivalents | 55 | (552 | ) | ||||
Net changes to cash and cash equivalents | (24,236 | ) | (33,886 | ) | |||
Cash and cash equivalents at the beginning of the period | 38,529 | 190,286 | |||||
Cash and cash equivalents at the end of the period | 14,348 | 155,848 | |||||
Unaudited consolidated statements of changes in equity for the year | |||||||||||||
(in € thousand) | |||||||||||||
Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||
Balance as of | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | ||||||
Equity-settled share-based payment awards | 4,158 | 4,158 | |||||||||||
Loss for the period | (31,983 | ) | (31,983 | ) | |||||||||
Balance as of | 1,493 | 587,001 | (1,231 | ) | (462,173 | ) | 125,090 | ||||||
Balance as of | 1,500 | 593,666 | (1,231 | ) | (536,128 | ) | 57,807 | ||||||
Issue of common shares | 23 | 1,219 | 1,242 | ||||||||||
Equity-settled share-based payment awards | 789 | 789 | |||||||||||
Loss for the period | (19,175 | ) | (19,175 | ) | |||||||||
Balance as of | 1,523 | 595,674 | (1,231 | ) | (555,303 | ) | 40,663 | ||||||
Source:
2024 GlobeNewswire, Inc., source