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Sep 30, 2024
Altimmune Q3 2024 Earnings Report
Altimmune announced financial results for the third quarter ended September 30, 2024, and provided a business update, highlighting the completion of enrollment in the Phase 2b IMPACT trial of pemvidutide in MASH and successful completion of the obesity End-of-Phase 2 meeting with the FDA.
Key Takeaways
Altimmune reported a net loss of $22.8 million, or $0.32 net loss per share, for the third quarter ended September 30, 2024. The company's cash, cash equivalents and short-term investments totaled $139.4 million as of September 30, 2024. Enrollment was completed in the Phase 2b IMPACT trial of pemvidutide in MASH, with top-line efficacy data expected in Q2 2025.
Completed enrollment in Phase 2b IMPACT trial of pemvidutide in MASH; top-line efficacy data expected in Q2 2025.
Successfully completed obesity End-of-Phase 2 meeting with the FDA, reaching agreement on Phase 3 clinical trials.
Plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning Q4 2024.
Cash, cash equivalents and short-term investments of $139.4 million on September 30, 2024.
Altimmune
Altimmune
Forward Guidance
Altimmune anticipates several key milestones in the near future, including the readout of top-line efficacy data from the Phase 2b IMPACT trial in Q2 2025 and the submission of IND applications for pemvidutide in additional indications.
Positive Outlook
- Top-line efficacy data from the Phase 2b IMPACT trial of pemvidutide in MASH is expected in Q2 2025.
- Agreement reached with the FDA on the design of the Phase 3 obesity program for pemvidutide.
- Plan to submit IND applications for pemvidutide in up to three additional indications beginning in Q4 2024.
- First trial for additional indications is planned to initiate in H1 2025.
- Data from Phase 2 MOMENTUM trial highlighted class-leading preservation of lean mass and preferential reduction in visceral adipose tissue.
Challenges Ahead
- Forward-looking statements are subject to numerous assumptions, risks, and uncertainties.
- Delays in regulatory review, manufacturing and supply chain interruptions, and access to clinical sites could impact timelines.
- Adverse effects on healthcare systems and disruption of the global economy could affect results.
- Reliability of study results relating to human safety and possible adverse effects could impact product development.
- Success of future product advancements, including the success of future clinical trials, is uncertain.