Samenvatting cc:
Affimed reported 3Q22 GAAP EPS of (€0.11), above our (€0.17) and Street's (€0.18)
estimates, with narrower loss driven by higher recognition of collaborative revenue. After
recently securing partner Artiva to manufacture NK cells, Affimed plans to submit IND for
potentially registrational Phase 2 study of AFM13+AB101 in CD30+ lymphoma in 1H23,
following expected FDA feedback for regulatory path forward in 1Q23. Additional data will
be available for AFM13+NK Phase 1/2 study during oral presentation at ASH on December
10th. Additionally, we expect to see AFM13 monotherapy PTCL ORR data in mid-
December from registration-directed REDIRECT study, with FDA discussions expected
following data analysis. Affimed also plans to present updates for AFM24 monotherapy,
AFM24+NK combination, and AFM24+Tecentriq combination at scientific conferences in
2Q and 3Q 2023. We update our model for 3Q22 earnings, with our PT remaining at $7.
• AFM13 monotherapy data in PTCL mid-December. Affimed is on track to report topline
data from registration-directed REDIRECT study of AFM13 monotherapy in r/r CD30+
PTCL in mid-December. We expect the update to focus on primary endpoint of ORR
as assessed by IRC, as well as preliminary assessment of duration of responses and
safety. Management plans to initiate discussions with the FDA following analysis of the
data for potential accelerated filing.
• AFM13 + AB101 IND submission 1H23. Following the collaboration with Artiva (RTVA,
not covered) securing access to commercially viable NK cells, the companies plan to
submit IND for AFM13 + AB-101 in 1H23. Mgmt expects to receive feedback from
the FDA in 1Q23 on clinical trial design and potential path to registration in r/r CD30+
lymphoma. We look for additional AFM13+NK data from MDACC study at the ASH oral
presentation on Saturday, December 10th at 1:15 pm CST, after abstract showed 71%
CR rate and 100% ORR in 24 patients treated with RP2D.
• Multiple AFM24 updates next year. AFM24 continues to enroll patients in all 3 ongoing
studies, including expansion cohorts of AFM24 monotherapy and dose escalation
cohorts for AFM24+Tecentriq and AFM24+SNK01 combinations. AFM24+Tecentriq
preliminary combination data presented at SITC showed clinical activity in 2 patients,
including PR in gastric cancer patient and SD in pancreatic adenocarcinoma, both at 160
mg. Enrollment is ongoing in second dose cohort of 480 mg, and we believe unexpected
activity at the lower combo dose bodes well for the dose escalations with both Tecentriq
and SNK01. Affimed plans to provide updates from all three ongoing studies at scientific
conferences in 2Q23 and 3Q23.