Affimed (AFMD) investor relations material

Executive leadership and company strategy

• Sean Nilan, new CEO of Affimed, brings extensive experience in biotech leadership, fundraising, and clinical development, having previously led Elevation Oncology and Forbio.

• Affimed is prioritizing its pipeline based on investor and partner feedback, focusing on programs with the highest commercial potential.

• Pipeline prioritization will be influenced by the next financing round, with AFM24 and AFM28 receiving the most interest.

• The company is considering deprioritizing programs with lower commercial potential, such as the asymptomatic program.

• Investor and partner interests are aligned, with both groups focusing on late-phase, high-potential assets.

Clinical program updates and data readouts

• AFM24, an EGFR/CD16A innate cell engager, has shown encouraging monotherapy and combination activity in non-small cell lung cancer (NSCLC), with response rates of 21-24% and median PFS of 5.6 months in both EGFR wild-type and mutant cohorts.

• Higher exposure to AFM24 correlates with improved efficacy; a new 720mg cohort is planned, aiming for >30% ORR and >7 months median PFS.

• AFM28, a CD123 NK cell engager for AML, demonstrated a 40% composite CR rate and response durations of 2.5–6.5 months at the 300mg dose, surpassing recent regulatory benchmarks.

• Dose escalation for AFM28 continues, with data from the next cohort expected in 6–9 months.

• The company is optimizing trial design by excluding prior taxane exposure in the next AFM24 cohort to enrich for better PFS outcomes.

Partnering, commercial, and regulatory considerations

• The partnership with Artiva for the asymptomatic program introduces economic complexities, but combination therapy is seen as necessary for durable responses.

• Expanding into relapsed/refractory PTCL is viewed as key to unlocking greater commercial potential for the asymptomatic program.

• Registration paths for AFM24 in NSCLC will require Phase 3 trials versus docetaxel, with regulatory discussions on contribution of parts pending.

• NK cell engager approaches are differentiated by a wider therapeutic index and reduced toxicity compared to T-cell engagers and other modalities.

• Commercial viability and scalability are central to development decisions, especially in transitioning from academic to industry-grade NK cell sources.