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Mar 31, 2023
Altimmune Q1 2023 Earnings Report
Announced financial results for Q1 2023 and provided a business update.
Key Takeaways
Altimmune reported a net loss of $20.1 million, or $0.40 net loss per share, and its cash, cash equivalents and short-term investments totaled $165.8 million as of March 31, 2023. The company is on course for mid-year initiation of IMPACT, its Phase 2b biopsy trial of pemvidutide in subjects with NASH.
Initiation of the IMPACT Phase 2b trial of pemvidutide in NASH expected mid-2023.
Top-line 48-week results from the MOMENTUM Phase 2 obesity trial expected Q4 2023.
Top-line results from the Phase 2 trial of HepTcell in chronic hepatitis B (CHB) expected Q1 2024.
Positive interim data readout from 24-week MOMENTUM Phase 2 obesity trial in March 2023 showed mean weight loss of 10.7% and 9.4% at the 2.4 mg and 1.8 mg doses, respectively, at Week 24, compared to mean weight loss of 1.0% in the placebo group.
Forward Guidance
The company anticipates several key milestones for its clinical assets, including data readouts for the Phase 2 trials of HepTcell in CHB and pemvidutide in obesity, as well as the initiation and data readout of the Phase 2b IMPACT trial of pemvidutide in NASH.
Positive Outlook
- Mid-year initiation of IMPACT Phase 2b NASH trial expected.
- Top-line 48-week results from MOMENTUM Phase 2 obesity trial expected Q4 2023.
- Top-line results from Phase 2 trial of HepTcell in CHB expected Q1 2024.
- IMPACT trial has potential to show a statistically significant impact on the key endpoints of NASH resolution and fibrosis improvement.
- Dose reduction will be allowed for subjects who experience GI intolerance in the IMPACT trial.
Challenges Ahead
- Delays in regulatory review.
- Manufacturing and supply chain interruptions.
- Access to clinical sites and enrollment issues.
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