Affimed Q1 2024 Financial Results & Business Update

Initial data from the LuminICE-203 study shows an 85.7% overall response rate (ORR) in seven patients, with four achieving complete response (CR). The AFM28 monotherapy phase 1 dose-escalation study reported 33% CR/CRi (1 CR, 1 CRi, and 3 stable diseases (SDs) in six patients at the highest dose level without unexpected safety signals. The study included six patients treated at a dose level of 300 mg weekly, showing promising efficacy with 2 CR/CRi and 3 SDs.

Affimed's acimtamig (AFM13) combined with AlloNK® (AB-101) NK cells showed an ORR of 85.7% in the initial seven treatment-refractory Hodgkin Lymphoma (HL) patients, achieving four CRs and two partial responses (PRs). This is impressive as all patients were heavily pretreated, including combination chemotherapy and checkpoint inhibitors, with 71% having failed prior autologous stem cell transplantation (ASCT). Treatment-related adverse events were mostly mild to moderate, including infusion-related reactions (IRRs) or cytokine release syndrome (CRS), and were manageable with standard care.

The AFM24 combination with atezolizumab in a trial involving 17 heavily pretreated EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients showed a disease control rate of 71%, with one CR, three PRs, and eight SDs. Notably, three of the responses persisted for over seven months, with a median progression-free survival (mPFS) of 5.9 months. For the EGFR mutant (EGFRmut) NSCLC cohort, efficacy data showed objective responses in four out of 13 response-evaluable patients, achieving one CR, three PRs, and six SDs, with a disease control rate of 77%. All responses were confirmed by follow-up scans.

For AFM28 monotherapy in a phase 1 study, the sixth and final cohort of six patients was treated at a dose level of 300 mg weekly. This dose level showed a CR/CRi rate of 33%, with one CR, one CRi, and three SDs. No dose-limiting toxicities were observed at this dose level, further supporting its safety and efficacy.

Financially, Affimed reported as of March 31, 2024, that it had cash, cash equivalents, and investments totaling €48.5 million, providing a cash runway into the second half of 2025. Net cash used in operating activities for the quarter ended March 31, 2024, was €23.8 million, down from €33.2 million in the same period in 2023, mainly due to reduced research and development expenses. Total revenue for the quarter was €0.2 million, compared to €4.5 million the previous year, primarily due to a decrease in collaborative research revenue.

Research and development costs for the quarter were €15.4 million, down from €29.5 million in 2023, primarily due to lower expenses related to the AFM13 and AFM24 programs. General and administrative expenses also decreased to €4.5 million from €6.9 million the previous year, attributed to lower headcount and reduced legal, consulting, and insurance expenses. Net finance income for the quarter was €0.4 million, compared to a net finance cost of €0.5 million in the prior year. The net loss for the quarter was €19.2 million, or €1.27 per common share, an improvement from the €32.0 million net loss, or €2.14 per share, in the same period in 2023.

Affimed’s progress across its clinical programs AFM24, acimtamig, and AFM28 shows significant advancements. Acimtamig combined with AlloNK® cells has shown substantial efficacy in refractory HL patients. The AFM24 and atezolizumab combination offers promising results in heavily pretreated NSCLC patients, both in EGFRwt and EGFRmut subpopulations. AFM28 demonstrated good safety and efficacy in its monotherapy phase 1 study. Affimed continues to leverage the innate immune system's potential in fighting cancer, showing promising results across its different clinical programs.