Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Altimmune Inc (ALT, Financial) has fully enrolled its Phase 2B impact trial for PTI IN MS, with top-line efficacy data expected in Q2 2025.
- The company achieved alignment with the FDA on a comprehensive Phase 3 registration program for its obesity program, indicating a clear regulatory path forward.
- Altimmune Inc (ALT) plans to expand its R&D investments into three additional indications, leveraging the enhanced glucagon activity of its product.
- The company has a strong cash position, with $139.4 million in cash, cash equivalents, and short-term investments, projected to fund operations into the first half of 2026.
- Altimmune Inc (ALT) has received positive feedback from the FDA regarding the safety profile of its product, with no safety signals identified in its trials.
Negative Points
- The company's net loss for Q3 2024 was $22.8 million, an increase from the $20.7 million loss in the same period of 2023.
- Research and development expenses increased to $19.8 million in Q3 2024 from $18.4 million in Q3 2023, indicating rising costs.
- General and administrative expenses also rose to $5 million in Q3 2024 from $4.5 million in Q3 2023, primarily due to increased professional services costs.
- The company is still seeking strategic partnerships, indicating potential challenges in securing collaborations for its obesity program.
- There is uncertainty regarding the timing and sequencing of the Phase 3 trials, which could impact the overall development timeline.
Q & A Highlights
Q: How important was the alignment with the FDA for the Velocity Studies in terms of strategic discussions and partnerships? Will the studies occur sequentially or simultaneously? Can you shed light on the additional indications for which you're filing INDs?
A: The FDA alignment is a significant milestone, providing a clear path for Pemvidutide's development. The studies are ideally run in parallel, but the sequence is still being determined. The additional indications leverage the advantages of glucagon in Pemvidutide, focusing on liver defatting and serum lipid improvement. Details will be shared after regulatory discussions are completed. - Dr. Vipin Garg, CEO, and Dr. Scott Harris, CMO.
Q: How does the recent top-line GLP-1 Essence trial data in NASH affect your expectations for the Impact trial? What would be competitive for incretins in the NASH space?
A: The Essence trial results were expected, showing modest effects due to longer treatment duration. Pemvidutide's liver fat reduction is class-leading, and we expect it to be the first incretin-based agent to show significant results in NASH at 24 weeks, combined with weight loss. This positions Pemvidutide as a potential leader in NASH treatment. - Dr. Scott Harris, CMO.
Q: Does the FDA view cardiac safety as a class effect, and how might this impact your Phase 3 program? What about the timing of additional indications?
A: The FDA does not view cardiac safety as a class effect for Pemvidutide, as no safety signals have been identified. The additional indications will be launched in the first half of next year, potentially before or after the NASH readout. - Dr. Scott Harris, CMO.
Q: Are the three additional indications part of ongoing partnership discussions, and does the cash runway cover these indications?
A: The additional indications are designed to enhance Pemvidutide's value and can be pursued independently or as part of a partnership. The current cash runway covers the initial plans and Phase 2 trials for these indications. - Dr. Vipin Garg, CEO.
Q: How have strategic partnership discussions evolved, and are they expanding across multiple indications?
A: Discussions have been ongoing, with companies still determining their strategic initiatives in obesity. The preservation of lean mass and the NASH indication are gaining traction, and the additional indications will create more value. The successful FDA meeting is a key milestone in advancing these discussions. - Ray J., Chief Business Officer.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
