Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Regarding AFM 28, what durability should we expect from the data update at ASH, and can you comment on the mutational status and prior treatment of the patients enrolled? A: Andreas Harstrick, Chief Medical Officer, explained that the six patients reported previously will have a meaningful follow-up period to assess durability. Most of the additional six patients were recruited recently, so their follow-up may be too short for conclusions. About 80% of patients had prior treatment with a hypermethylating agent and venetoclax, 55% with an racy regimen, and roughly a third had a stem cell transplant. Two-thirds had negative molecular profiles.
Q: When would you be in a position to discuss a registrational path with the FDA for AFM 28, and what patient population will you target? A: Andreas Harstrick stated that they plan to add at least one higher dose cohort to capture the full therapeutic potential. The safety profile allows further dose escalation. The patient population will include those with unmet medical needs, having exhausted options like racy or hypermethylating agents, and targeted therapies for specific mutations.
Q: Can you elaborate on broadening the scope of collaborations? A: Shawn Leland, CEO, mentioned that given the financial position, they are evaluating all strategic options, including regional deals, to bring in non-dilutive capital. Previously, the focus was on multinational partnerships, but now they are considering a wider range of collaborations.
Q: What are the data expectations for AFM 24 in December, and will there be enough data by the first half of 2025 to make a development decision? A: Andreas Harstrick noted that the December focus will be on the EGFR wild-type cohort, with response and safety data being the main focus. PFS data will need more time to mature, expected to be presented in the first half of 2025.
Q: What are your thoughts on future prioritization between AFM 13 and AFM 28 given the current cash position? A: Shawn Leland stated that all three programs, including AFM 13 and AFM 28, will continue to be developed in parallel due to compelling and differentiated data addressing significant unmet medical needs.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.