Release Date: August 23, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mendus AB (OSTO:IMMU, Financial) raised approximately SEK69 million in April through the exercise of warrants, with participation from all major shareholders.
- The company presented positive data from the ALISON trial in ovarian cancer at the ESMO Gynecological Cancers Conference.
- Mendus AB (OSTO:IMMU) has a strong cash position of about SEK30 million, providing a cash runway into the third quarter of 2025.
- The company announced a collaboration with Institut Bergonie, a leading cancer center in France, to study their intra-tumoral primary product in soft-tissue sarcomas.
- The company successfully completed the first large-scale manufacturing runs as part of their alliance with Nordex Biologics, preparing for large-scale production to support clinical trials and potential commercial launch.
Negative Points
- The company experienced a relatively limited cash burn of SEK22 million in the second quarter, which may still be a concern for long-term financial sustainability.
- There is no current approved immunotherapy for AML, indicating a high-risk development path for Mendus AB (OSTO:IMMU)'s Vididencel.
- The company is still in the process of seeking regulatory feedback from the EMA and FDA, with outcomes expected only towards the end of the year.
- The ALISON trial in ovarian cancer showed that 7 out of 17 patients had image-confirmed recurrence, indicating mixed results.
- The company is heavily reliant on collaborations and investigator-sponsored trials, which, while cost-efficient, may limit control over trial execution and timelines.
Q & A Highlights
Highlights of Mendus AB (OSTO:IMMU) Q2 2024 Earnings Call
Q: Can you tell us a bit more about the interaction you have with the regulatory authorities regarding the proposal and AML trial? And is there any clarity on the potential to buy in the amount of patients?
A: (Jeroen Rovers, Chief Medical Officer) The interactions with regulatory authorities are ongoing, and we expect to have outcomes from both EMA and FDA towards the end of the year.
Q: Can we expect the immune response to be further studied in the Cadence trial?
A: (Jeroen Rovers, Chief Medical Officer) Yes, the first part of the Cadence trial will include immuno-monitoring assays similar to those performed in the ADVANCE II study, allowing us to compare immune responses.
Q: When can we expect to hear an update on the trial with Institut Bergonié, and what would be the next steps if the data is supportive?
A: (Jeroen Rovers, Chief Medical Officer) We expect to get regulatory approval for the trial amendment by the end of the year. Once the study starts recruiting patients, we will provide updates. The next steps will depend on the trial outcomes.
Q: What's the rationale for participating in a broad study with multiple cohorts versus an exclusive trial?
A: (Erik Manting, CEO) The broad study allows us to treat a significant patient population in a high-quality setting, making it a valuable trial. The support from pharma companies and the quality of the centers involved also add to its value.
Q: Can you elaborate on the resources needed for the regulatory trial and its impact on your burn rate and funding runway?
A: (Erik Manting, CEO) The trial is part of our current activities and included in our cash runway projections. Investigator-sponsored trials are cost-efficient, and we will support the trial by providing the drug and working closely with the centers.
Q: Do you see a possibility to use your understanding of immune system activation for patient selection in a pivotal stage trial?
A: (Erik Manting, CEO) Currently, there is no reason to exclude patients based on immune system activation. The safety profile of our product is excellent, and we aim to treat a broad patient population.
Q: Did you see any correlation between immune responses and clinical outcomes in the ALISON trial for ovarian cancer?
A: (Jeroen Rovers, Chief Medical Officer) It is too early to comment on this as we are still completing the initial evaluation. We need more follow-up to draw any conclusions on the correlation.
Q: What is the rationale for combining ilixadencel with a tyrosine kinase inhibitor?
A: (Erik Manting, CEO) Tyrosine kinase inhibitors help reduce tumor burden and positively affect the immune system. We expect synergies between these inhibitors and ilixadencel, which has shown safety and efficacy in combination with other drugs.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
