We expect to continue incurring losses as we continue clinical development programs, apply for marketing
approval for our product candidates and, subject to obtaining regulatory approval for our product candidates, build a marketing and sales team to commercialize our product candidates. Our profitability depends on the successful development, approval
and commercialization of our product candidates and our ability to achieve a level of revenues adequate to support our cost structure. We may never achieve profitability and unless and until we do, we will continue to need to raise additional cash.
We intend to fund future operations through additional equity and debt financing and we may seek additional capital through arrangements with strategic partners or from other sources. See Note 2, Basis of preparation and changes to Groups
accounting policies, Going concern, in the notes to the interim financial statements.
We have one U.S. subsidiary, Affimed Inc., with senior employees in
investor relations, business development, corporate strategy, communication and medical/clinical operations.
Recent Developments
In January 2024, we initiated a strategic restructuring of our operations to focus on our three clinical stage development programs. As a result of the
restructuring, we reduced our full-time equivalent headcount by approximately 50%. We incurred a one-time cash expenditure for termination payments of approximately 1.6 million. Further, the
financial impact from the selling of laboratory equipment resulted in an impairment of 1.6 million in the six months ended June 30, 2024.
On March 6, 2024, we announced a 1-for-10 reverse stock split of our
outstanding common shares, effective after market close on March 8, 2024.
In May 2024, the U.S. Food and Drug Administration granted a Fast Track
designation to the combination of our innate cell engager (ICE®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic
non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR)-wildtype (wt) after progression on PD-(L)1 targeted
therapy and platinum-based chemotherapy. Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical
need.
On June 1, 2024, we announced a AFM24-102 phase 2 study update from the NSCLC EGFRwt cohort. As of the
updated data cutoff on May 13, 2024 for the 17 EGFRwt patients previously reported on, 15 patients were response-evaluable. Four confirmed objective responses were seen: 1 complete response (CR) and 3 partial responses
(PR). In addition, 8 patients achieved stable disease (SD), resulting in a disease control rate of 71%. Importantly, all responding patients had a documented progression on their previous PD targeting therapy. Median
progression-free survival was 5.9 months with median follow-up of 7.4 months. These data are remarkable as little progress has been made in the therapy for NSCLC patients who fail platinum-based therapy as
well as PD1. Standard of care is still single agent Docetaxel which produces a response rate of approximately 10% and a PFS of 4.0 4.5 months.
On
June 26, 2024, we held our annual general meeting, at which, among other things, shareholders authorized our management board to issue, and/or grant rights to subscribe for, up to an additional 15,227,463 shares in the share capital of the
Company until December 26, 2025, that is, up to a maximum of 30,454,926 shares, of which 15,227,463 shares were issued and outstanding as of the date of the meeting, and to exclude pre-emptive rights
accruing to shareholders in respect of an issuance of such shares, or granting of such rights, until December 26, 2025.
On September 3, 2024,
we announced that Dr. Shawn M. Leland, PharmD, RPh was appointed as Chief Executive Officer (CEO). Dr. Andreas Harstrick, who had been serving as acting CEO since January 2024, remained in his position as Chief Medical Officer.
On September 5, 2024, we announced a AFM24-102 phase 2 study update from the EGFR mutant (EGFRmut)
cohort. 24 heavily pretreated EGFRmut NSCLC patients are in the trial and, of 17 patients that are response evaluable per protocol, 1 CR, 3 PR and 8 SD were observed. All responses were confirmed by follow-up
scan. Median follow-up is more than 7 months, and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. The EGFRwt NSCLC cohort for patients who failed
chemotherapy and PD-1/PD-L1 has continued enrollment with 40 patients on trial. ORR and safety data from the EGFRwt cohort are expected in Q4 2024. Overall response and
PFS data from EGFRmut and PFS data from the EGFRwt cohorts are expected to be presented at a major scientific conference in H1 2025.
On September 5,
2024, we announced a data update from the LuminICE-203 study (acimtamig/AlloNK® co-administered combination
therapy in relapsed/refractory (R/R) Hodgkin lymphoma (HL). The recruitment in cohorts 1 and 2 is completed and for the 12 treated refractory HL patients, an objective response rate of 83.3% with 6 CRs and 4 PRs were observed
by independent read. Treatment-related adverse events were consistent with previous experience, and side effects related to acimtamig and AlloNK® were well manageable with standard of care
treatment. Recruitment in cohorts 3 and 4 has meanwhile been completed and updated study results will be reported at the 66th ASH Annual Meeting and Exposition in December 2024.