Release Date: September 05, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Affimed NV (AFMD, Financial) has achieved clinical proof of concept across three assets, each with distinct indications, showing significant commercial potential.
- The company reported encouraging early efficacy data for the EGFR mutant cohort in the AFM24-102 trial, with a 23.5% objective response rate and a 70.6% disease control rate.
- The LuminICE-203 study for AFM13 in multi-refractory Hodgkin's lymphoma showed an impressive 83.3% response rate, including a 50% complete response rate.
- AFM28 demonstrated promising monotherapy activity in acute myeloid leukemia, with a 50% complete response rate in the highest dose cohort.
- Affimed NV (AFMD) has a strong financial position, with cash and investments expected to finance operations into the second half of 2025.
Negative Points
- Total revenue for the quarter ended June 30, 2024, was significantly lower at EUR0.2 million compared to EUR1.4 million for the same period in 2023.
- The company reported a net loss of EUR15.5 million for the quarter, although this was an improvement from the EUR29.4 million loss in the same quarter of the previous year.
- Enrollment in some clinical trials has been slow, with some patients experiencing rapid tumor progression before starting treatment.
- The capital markets have been challenging for biotechs in 2024, which may impact future funding opportunities.
- There is still a need for more mature data to confirm the durability and long-term efficacy of the treatments, particularly for AFM24 and AFM28.
Q & A Highlights
Q: For the new EGFR mutant data, are you observing any differences among patients who had prior third-gen TKIs versus those who are getting first- or second-gen TKIs?
A: No, we have not seen any differences. Three of the four responders had been pretreated with third-generation TKIs, indicating no cross-resistance or lower response rate compared to first- or second-generation TKIs. (Andreas Harstrick, Chief Medical Officer)
Q: For the LuminICE study, what are the expectations for the higher NK cell dose for cohorts 3 and 4? Are you seeing any biological efficacy or safety differences between the 200 mg and 300 mg doses for cohorts 1 and 2?
A: So far, we have not seen any differences in terms of response rate between the 200 mg and 300 mg doses. Early data for cohorts 3 and 4, which use a higher cell dose, are very encouraging, but we need to wait for the data to mature. (Andreas Harstrick, Chief Medical Officer)
Q: When you update in Q4 2024, will you have the go-forward doses selected at that point as well?
A: Yes, the aim is to select two cohorts for continuation in Stage 1 of the Hodgkin lymphoma program based on the data from the initial four cohorts. (Andreas Harstrick, Chief Medical Officer)
Q: How are you considering your development strategy for AFM28 and AFM24?
A: For AFM28, the encouraging monotherapy activity has led us to expand cohort 6 by adding six more patients. For AFM24, we are seeing consistent efficacy results in both EGFR wildtype and mutant cohorts, and we are evaluating all strategic options to move these programs forward. (Shawn M. Leland, CEO and Andreas Harstrick, Chief Medical Officer)
Q: Is there a durability of response threshold you would like to see for a potential single-agent path forward in AML?
A: Responses need to be durable to be meaningful. In heavily pretreated patients, a progression-free survival of around six months would be significant, especially with low toxicity. (Andreas Harstrick, Chief Medical Officer)
Q: Can you give us a hint of some of the mutations that AML patients harbor?
A: We are compiling and collecting these data. So far, it appears to be a representative mutation pattern for a pretreated AML population. Detailed data will be available in Q4. (Andreas Harstrick, Chief Medical Officer)
Q: For AFM13 cohort 1 and 2, how many patients are still on study, and what are you seeing in terms of durability?
A: The majority of patients are still on treatment. The six complete responses were all achieved after the first cycle. We need to complete treatment of the partial responders to comment on response kinetics. (Andreas Harstrick, Chief Medical Officer)
Q: What is the screening failure rate for AFM13, and what factors contributed to the enrollment progress for cohorts 3 and 4?
A: Initial screening failures were due to infectious complications. Now, with more sites and better patient selection, enrollment has improved. This indicates the treatment can be administered across various sites. (Andreas Harstrick, Chief Medical Officer)
Q: Is there a dose response on the CR rate for acimtamig in cohorts 1 and 2?
A: No difference in response rates or toxicity between the 200 mg and 300 mg doses. We are evaluating whether a higher dose of AlloNK cells in cohorts 3 and 4 will make a difference. (Andreas Harstrick, Chief Medical Officer)
Q: How do you plan to take the AFM24 studies forward now that you have data from both wildtype and mutant EGFR patient cohorts?
A: We have expanded the EGFR wildtype cohort to 40 evaluable patients and expect response data by year-end. Strategic decisions on further development will be data-driven, and we will start interactions with regulatory agencies. (Andreas Harstrick, Chief Medical Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
