Affimed NV (NASDAQ: AFMD) posted revenues of Euro 11.7 million (up 129.41% YoY) in Q1 2021, mainly from the collaboration with Roivant and Genentech.
Its cash equivalents and cash balance at the end of Q1 2021 is Euro 240.7 million (up 63.85% QoQ). The company could fund its operations using these cash resources through Q2 2023.
Operational spending at Euro 16 million
Spending on operating activities in Q1 2021 is Euro 16.0 million against Euro 16.5 million in the same quarter the previous year.
Its R&D spending in Q1 2021 is Euro 11.4 million. The company’s G&A expenses surged to Euro 4.5 million (up 27.3% YoY) in Q1 2021.
Affimed’s CEO, Adi Hoess, said the company is building momentum with its clinical programs. As a result, the company is emerging a leading player in the innate immuno-oncology field.
The company released clinical data for its AFM13 and it supports the three-pronged development strategy of ICE as a monotherapy in combination therapy with NK cells.
Affimed expects to initiate several clinical trials for its lead drug candidates – AFM13, and AFM24 in the coming months.
Recruits subjects in the REDIRECT study
Affimed is enrolling patients for its REDIRECT clinical trial of AFM13-202 after achieving positive data readout from the interim futility analysis in Q1 2021. In addition, the company combined low and high CD30 expressing cohorts in a single one.
The company would complete the enrollment in H1 2022 for its registration-directed, phase 2 clinical trial (REDIRECT) of AFM13, a monotherapy to treat patients with refractory or relapsed CD30 PTCL (positive peripheral T-cell lymphoma).
Affimed completed the enrollment for its AFM13-104 at Texas-based MD Anderson Cancer Center, where it will conduct an investigator-sponsored trial with three dose-escalation cohorts. In addition, it will assess the dose-escalation trial of cord-blood-derived NK cells.
According to the preclinical data readout, AFM13 showed its potential to kill tumor cells in combination therapy with NK Cells in in-vivo and in-vitro versus NK cells alone. This data is sufficient to propose IND application for phase 1 clinical trial of AFM13 and pre-complexed with NKC (NK Cells).
Affimed targets phase 1 clinical study of AFM24 for 320 mg dosed (cohort 5) completed patients suffering from EGFR-expressing solid tumors. The company is also recruiting subjects for cohort 6 (480 mg).