Release Date: October 24, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Alligator Bioscience AB (STU:7AL, Financial) reported outstanding phase two results for mitazalimab, justifying further investment.
- The company has shown significant progress in its pipeline, particularly with the CD40 Bispecific molecule 4066 and the bispecific antibody 527.
- Mitazalimab has demonstrated a median overall survival benefit of close to four months in first-line metastatic pancreatic cancer patients.
- The company has completed manufacturing development for phase three, maintaining momentum towards the trial.
- Alligator Bioscience AB is actively engaging with global pharmaceutical companies for potential licensing and development partnerships.
Negative Points
- The company reported lower sales compared to the previous year, indicating potential revenue challenges.
- Alligator Bioscience AB has a cash position of 48 million SEK, which is considered low and requires additional funding.
- The company faces significant costs related to ongoing clinical trials and phase three enabling activities.
- There is uncertainty regarding the timing of securing a partnership for mitazalimab, with expectations now pushed to Q1 2025.
- The current cash runway is limited to approximately one quarter, necessitating urgent financial strategies.
Q & A Highlights
Q: How is the work progressing on the phase three study protocol for mitazalimab, and do you need the results from the 450 mcg cohort to finalize it?
A: We are advancing with the preparations for phase three and the protocol. While we don't necessarily need the 450 mcg data to finalize the protocol, we do need it to select and agree on the final dose with the FDA before starting the phase three study. We expect to deliver that data in mid-Q1, enabling a late H1 start of the phase three.
Q: When do you anticipate having a partner in place for mitazalimab?
A: We are working diligently on securing a partner. Realistically, we expect to finalize a deal in Q1 next year. Some potential partners have requested additional data, such as the 450 mcg cohort results and the finalized phase three protocol, which we aim to provide soon.
Q: Can you provide an indication of the cost and patient enrollment for the phase three study in first-line metastatic pancreatic cancer?
A: We estimate the cost to be approximately $150,000 per patient. The study will need to be global to support worldwide approval. We are exploring designs to reduce patient numbers and costs without compromising statistical validity.
Q: How are you prioritizing capital allocation between mitazalimab and other programs?
A: Mitazalimab is our highest priority, both as the lead project and in terms of investment for phase three preparations. This will drive costs in Q4 and beyond.
Q: What is the current cash runway for Alligator Bioscience?
A: We have approximately 48 million SEK in cash as of the end of September, which provides about one quarter of runway. This is not sufficient, and we are actively working on securing additional funding, including exploring the exercise of warrants and other avenues.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
