On November 14, 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, reported financial results and provided an update on clinical and corporate progress for the quarter ended September 30, 2024 (Press release, Affimed, NOV 14, 2024, View Source [SID1234649279]).
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"Our innate cell engager therapies are meeting the critical needs of cancer patients who often come to us after exhausting nearly all other treatment options. The responses we’ve observed, even in the heavily pre-treated populations, give us tremendous confidence," said Dr. Shawn Leland, Chief Executive Officer of Affimed. "With clinical proof of concept established for all our innate cell engagers, the demonstrated activity across both hematological and solid tumors, combined with a strong safety profile, underscores the potential of our platform. We are refining our strategy to focus on clinical priorities and commercial viability, ensuring that our therapies deliver meaningful, long-term impact. I’m also very excited about expanding our efforts to seek collaborations with potential partners who share our vision to drive success for both patients and stakeholders."
Pipeline Highlights:
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab):
The cohort of NSCLC EGFRwt patients who failed chemotherapy and PD-1/PD-L1 has completed enrollment. ORR and safety data for this cohort will be presented on a Company conference call on December 17, 2024.
As previously reported at ASCO (Free ASCO Whitepaper) 2024, in 17 EGFRwt NSCLC patients who failed chemotherapy and PD-1/PD-L1 treatment, 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) had been observed. Disease control was 71%. At the time, 3 of the 4 responses were ongoing for more than 7 months and median progression free survival (PFS) was 5.9 months.
PFS data from the EGFRwt and ORR and PFS data from the EGFR mutant (EGFRmut) cohorts expected to be presented at a major scientific conference in H1 2025.
Acimtamig (AFM13) (CD30 / CD16A)
Updated clinical data from the four cohorts of the run-in phase of the LuminICE-203 study will be shared in a poster session at ASH (Free ASH Whitepaper) 2024.
As previously reported on the Company’s Q2 2024 earnings call, in the phase 2 LuminICE-203 trial, 12 patients with advanced, treatment-refractory Hodgkin Lymphoma in cohorts 1 and 2, treated with a combination of the CD30-targeting innate cell engager acimtamig (AFM13) and AlloNK, demonstrated high efficacy, with an ORR of 83.3% and a CRR of 50%.
AFM28 (CD123 / CD16A)
An oral presentation at ASH (Free ASH Whitepaper) 2024 will feature updated clinical data including efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML).
A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.
As previously reported, initial data on the six patients treated at dose level 6 at 300 mg in the multi-center phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML, showed 1 patient with a CR, 2 patients with a CRi for a composite complete remission (CRc) rate (defined as CR+CRi) of 50% (3/6).
An additional six patients have been enrolled in the 300 mg cohort.
Upcoming Milestones:
LuminICE-203: Efficacy update of four cohorts to be presented at ASH (Free ASH Whitepaper) 2024.
AFM24-102: ORR and safety data from the EGFRwt cohort to be presented at a Company conference call on December 17, 2024.
AFM28-101: Updated data from the dose escalation to be presented at ASH (Free ASH Whitepaper) 2024.
AMF24-102: ORR and PFS data from the EGFRmut and PFS data from the EGFRwt cohorts expected to be presented at a major scientific conference in H1 2025.
Third 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 September 30, 2024, cash, cash equivalents and short-term investments totaled €24.1 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into Q4 of 2025.
Net cash used in operating activities for the quarter ended September 30, 2024, was €11.1 million compared to €18.3 million for the quarter ended September 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses.
Total revenue for the quarter ended September 30, 2024, was €0.2 million compared with €2.0 million for the quarter ended September 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed.
Research and development expenses for the quarter ended September 30, 2024, were €10.1 million compared to €21.5 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.
General and administrative expenses for the quarter ended September 30, 2024, were €4.3 million compared to €5.4 million for the quarter ended September 30, 2023. The decrease was due to the decline in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses.
Net loss for the quarter ended September 30, 2024, was €15.1 million, or €0.94 loss per common share compared with a net loss of €24.4 million, or €1.63 loss per common share, for the quarter ended September 30, 2023.
The weighted number of common shares outstanding for the quarter ended September 30, 2024, was 16,100,185 shares.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of September 30, 2024, 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 November 14, 2024, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2024 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 View Source To access the call by phone, please use link: https://register.vevent.com/register/BIb9251d6bc6504a4da37a53cdb1b0ac94, 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.