Release Date: July 11, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mitazalimab Phase 2 data in first-line pancreatic cancer showed a significant increase in median overall survival to 14.9 months, compared to 11.1 months for FOLFIRINOX monotherapy.
- The Phase 2 study results were published in the prestigious Lancet Oncology journal, validating the significance of the data.
- Alligator Bioscience AB (FRA:7AL, Financial) has seen increased interest from physicians wanting to conduct trials with mitazalimab, including a new trial at Moore Cancer Center funded by the US National Cancer Institute.
- Orion Corporation exercised its option to develop bispecific antibodies from Alligator's second development program, triggering a milestone payment.
- A successful capital raise of SEK80 million extended the company's cash runway into Q1 2024, supporting strategic investments and licensing negotiations.
Negative Points
- Net sales for Q2 2024 decreased to SEK7.6 million from SEK17.4 million in the prior year, primarily due to collaboration agreements.
- Operating loss for the quarter was SEK47.4 million, although reduced from SEK63.7 million in the previous year, indicating ongoing financial challenges.
- The cash flow from operations was negative at SEK46.9 million, reflecting continued financial strain.
- The company relies on a loan facility with Fenja Capital, which includes convertible bonds that could lead to shareholder dilution.
- The average cash burn is estimated to be between SEK40 million to SEK45 million per quarter, indicating a need for careful financial management.
Q & A Highlights
Q: How important are the 18-month OS and 12-month PFS numbers for OPTIMIZE-1, and how do they impact the partnering discussion?
A: These data are extremely important as they indicate a mature data set and confirm the strong signal observed in the primary analysis. The 18-month time point is particularly significant as it shows a doubling of the survival rate, which is unprecedented in this context. These data will play a crucial role in our partnering activities. - Sumeet Ambarkhane, Chief Medical Officer
Q: Will these data influence the Phase 3 design, given their potential to demonstrate superiority?
A: Yes, they boost our confidence in the drug's efficacy and highlight the immune contribution from mitazalimab. This will influence the Phase 3 design to ensure a sufficiently long follow-up period to demonstrate superiority in a randomized trial. - Sumeet Ambarkhane, Chief Medical Officer
Q: How are partnership discussions progressing, and what is the strategy if a partner is not secured?
A: Discussions are progressing well, with increased interest following the recent data release. We are in talks with several global pharmaceutical companies. If a partner is not secured, we will explore alternative scenarios to advance mitazalimab into Phase 3 independently. - Soren Bregenholt, Chief Executive Officer
Q: What are the next steps for the Orion collaboration?
A: Orion has taken the development option for both bispecific antibody programs. The responsibility for preclinical and clinical development now lies with Orion, and they will communicate the next steps as per their discretion. - Soren Bregenholt, Chief Executive Officer
Q: Could you provide an update on the Phase 1 study of the 527 molecule?
A: The Phase 1 study is progressing well, with dose escalation expected to complete soon. We aim to present early data at upcoming scientific meetings, such as the ESMO meeting in early fall. - Sumeet Ambarkhane, Chief Medical Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
