Affimed N.V.

For the quarter ended September 30, 2024, revenue was €0.2 million versus €2.0 million a year ago. R&D expense was €10.1 million versus €21.5 million, G&A was €4.3 million versus €5.4 million, and net loss was €15.1 million, or €0.94 per common share, versus a net loss of €24.4 million, or €1.63 per share, in the prior-year quarter. Net cash used in operating activities was €11.1 million versus €18.3 million a year ago. The company ended the quarter with €24.1 million in cash, cash equivalents and investments, down from €72 million on December 31, 2023. Management said existing cash plus anticipated ATM proceeds and the sale of AbCheck should fund operations into Q4 2025. For AFM24, the EGFR wild-type cohort is fully enrolled and the company expects final response data on Dec. 17; PFS data and mutant-cohort data are expected to mature and be presented in first half of 2025. For AFM28, management said the program has escalated through six cohorts to 300 mg weekly with no dose-limiting toxicities at that dose, and the company is adding six more patients to confirm the signal.

Shawn Leland said he joined Affimed because the company already has clinical proof of concept across three assets in solid tumors and hematologic malignancies, and he emphasized the differentiated safety profile of the innate cell engagers. His tone was confident but pragmatic: he said the company will use clinical benchmarks, competitive dynamics and commercial potential to prioritize programs, and he stressed that partnerships will be important to accelerate development and bring in non-dilutive capital. He also repeatedly framed the company as more streamlined and focused, with a goal of delivering meaningful clinical data while improving financial stability.

Michael Wolf focused on the quarter’s financial decline and the balance sheet. He reported €24.1 million in cash, cash equivalents and investments at September 30, 2024, versus €72 million at year-end 2023, and said the current cash plus anticipated ATM proceeds and proceeds from AbCheck should finance operations into Q4 2025. He also noted net cash used in operating activities of €11.1 million, revenue of €0.2 million, R&D expense of €10.1 million, G&A expense of €4.3 million, and net loss of €15.1 million, or €0.94 per share, all lower than the prior-year quarter. His remarks were brief and largely limited to the key figures and runway assumption.

Analysts pressed management on how much durability to expect from AFM28, whether the added patients had relevant prior therapies and molecular features, and when management might approach the FDA for a registration path. Management said the additional six AFM28 patients were enrolled more recently, so follow-up is still too short for durability conclusions, and noted heavy prior treatment including HMA/venetoclax in 80% of patients, anthracycline/R-CHOP-like therapy in roughly 55%, stem cell transplant in about one-third, and roughly two-thirds with negative molecular features such as RANK1 or p53. On AFM24, analysts asked about December data expectations, the path to registration, and partnership interest; management said December will center on response and safety in about 40 EGFR wild-type patients, PFS is not mature yet, and a decision on a potential registration-directed trial is expected after more mature data in first quarter or first half 2025. Management also said partnership talks are broadening beyond prior multinational-only thinking to include regional deals, co-development and other structures, with partners generally asking for more mature data.