Altimmune Q2 2024 Earnings Report
Key Takeaways
Altimmune reported recent presentations at major medical meetings provide further support for the differentiated profile of pemvidutide in obesity and metabolic dysfunction-associated steatohepatitis (MASH). The company's cash, cash equivalents and short-term investments were $164.9 million on June 30, 2024.
Presentations at medical meetings support pemvidutide's profile in obesity and MASH.
Enrollment is progressing in the Phase 2b IMPACT trial of pemvidutide in MASH, with topline data expected in Q1 2025.
Cash, cash equivalents, and short-term investments totaled $164.9 million on June 30, 2024.
The company continues to advance IMPACT, its biopsy-driven Phase 2b trial of pemvidutide in MASH
Altimmune
Altimmune
Forward Guidance
The company is seeking agreement from the Agency on the Phase 3 trial design and study endpoints that highlight the differentiation of pemvidutide in the treatment of obesity, including its ability to reduce serum lipids and liver fat content (LFC) and its class-leading preservation of lean mass among incretin agents.
Positive Outlook
- Subjects receiving pemvidutide achieved weight loss of up to 15.6% with weight loss continuing at the end of treatment.
- Class-leading lean mass preservation among incretin agents with only 21.9% of weight loss attributable to lean mass and 78.1% attributable to fat.
- Treatment with pemvidutide also resulted in robust reductions of triglycerides (55.8%), total cholesterol (20.0%) and LDL cholesterol (17.4%) in subjects with elevated baseline lipids on the 2.4mg dose.
- Data from the Phase 1 first-in-human trial of pemvidutide demonstrated robust reductions in pro-inflammatory lipids associated with atherogenesis and cardiovascular risk.
- Higher proportions of subjects receiving pemvidutide achieved FibroScan-aspartate aminotransferase (FAST) score, MRI-PDFF and alanine aminotransferase (ALT) responses than subjects receiving placebo
Challenges Ahead
- The IMPACT trial expects to enroll approximately 190 subjects with and without type 2 diabetes (T2D), randomized to receive 1.2mg or 1.8mg of pemvidutide or placebo.
- Primary efficacy measures are MASH resolution or fibrosis improvement at Week 24.
- The biopsy readout at Week 24 represents the earliest time point of any incretin-based MASH clinical trial.
- End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected to take place in late Q3 2024
- The Company is seeking agreement from the Agency on the Phase 3 trial design and study endpoints that highlight the differentiation of pemvidutide in the treatment of obesity