Affimed N.V. reports on clinical trials, financial results, and updates on cash position through Q4 2025.
Quiver AI Summary
Affimed N.V. announced the completion of enrollment in the EGFR wild-type non-small cell lung cancer (NSCLC) cohort in their AFM24 clinical trial, with results on objective response rate and safety set to be shared in a conference call on December 17, 2024. They also plan to present updated clinical data for the acimtamig (AFM13) and AlloNK® combination therapy at ASH 2024, as well as for AFM28 monotherapy in a separate oral presentation. As of September 30, 2024, the company reported cash reserves of €24.1 million, which will fund operations into the fourth quarter of 2025. Affimed is focusing on enhancing the commercial viability of its immuno-oncology therapies, having shown promising response rates in heavily pre-treated patient populations. The company's financial report indicated reduced operating expenses and a net loss of €15.1 million for the quarter, significantly improved from the previous year.
Potential Positives
- Completion of enrollment in the AFM24 trial for NSCLC with anticipated presentation of objective response rate (ORR) and safety data on December 17, 2024.
- High efficacy observed in the AFM13 combination therapy, with an overall response rate (ORR) of 83.3% in treatment-refractory Hodgkin Lymphoma patients.
- Updated clinical data from the AFM28 phase 1 study will be presented at ASH 2024, showcasing the company's ongoing commitment to advancing its product pipeline.
- Strong financial position with cash runway projected into Q4 2025, indicating operational stability and funding for continued clinical development.
Potential Negatives
- Net revenue for the quarter ended September 30, 2024, decreased significantly to €0.2 million from €2.0 million for the same quarter in 2023, indicating a potential loss of business and demand for the company’s products.
- The company reported a net loss of €15.1 million for the quarter, although this was an improvement from a greater loss in the previous year; however, continued losses can raise concerns about its financial sustainability.
- Cash and cash equivalents declined to €7.4 million by September 30, 2024, compared to €38.5 million at the beginning of the period, indicating increasing pressure on liquidity and raising concerns about funding future operations.
FAQ
What is the AFM24 trial about?
The AFM24 trial focuses on non-small cell lung cancer (NSCLC) EGFR wild-type patients, evaluating the combination with atezolizumab.
When will the AFM24 data be presented?
The objective response rate (ORR) and safety data for the AFM24 trial will be presented on a conference call on December 17, 2024.
What updates can we expect at ASH 2024?
ASH 2024 will feature updated clinical data for acimtamig (AFM13) and AFM28 from their respective studies.
How much cash does Affimed have?
As of September 30, 2024, Affimed reported cash and investments totaling €24.1 million, ensuring operations into Q4 2025.
What is the significance of the recent trial results?
The recent trials demonstrate promising efficacy and safety profiles for Affimed's therapies, indicating potential for significant patient impact.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AFMD Hedge Fund Activity
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