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Sep 30, 2021
Altimmune Q3 2021 Earnings Report
Altimmune reported a net loss for Q3 2021, while making progress in clinical trials for pemvidutide and HepTcell.
Key Takeaways
Altimmune reported a net loss of $33.5 million for the third quarter of 2021, compared to a net loss of $17.8 million for the same period in 2020. The company's cash, cash equivalents, and short-term investments totaled $199.9 million as of September 30, 2021. Pemvidutide's Phase 1 clinical trial showed positive results, including a reduction in liver fat to undetectable levels in subjects with hepatic steatosis.
Pemvidutide Phase 1 trial showed reduction of liver fat to undetectable levels after 6 weeks.
Approximately $200 million in cash and short-term investments to advance pipeline.
IND application for NASH cleared and enrollment initiated in Phase 1b clinical trial in NAFLD.
Weight loss data from 12-week Phase 1 clinical trial of pemvidutide showed positive results.
Altimmune
Altimmune
Forward Guidance
Altimmune anticipates several key milestones in the development of its clinical assets. They expect to submit an Investigational New Drug application (IND) for obesity by the end of the year and commence a 48-week Phase 2 obesity study in the first half of 2022. Data readouts from the pemvidutide 12-week Phase 1b NAFLD trial and the pemvidutide drug/drug interaction trial are expected in the first half of 2022. A 12-week Phase 1 study to further characterize the safety and pharmacokinetics of pemvidutide in diabetic subjects is expected to be initiated in Q1 2022.
Positive Outlook
- IND for obesity expected by year end
- 48-week Phase 2 obesity study expected to commence in the first half of 2022
- Pemvidutide 12-week Phase 1b NAFLD trial data readout expected in the first half of 2022
- Pemvidutide drug/drug interaction trial data readout expected in the first half of 2022
- 12-week Phase 1 study in diabetic subjects expected to be initiated in Q1 2022
Challenges Ahead
- Potential impacts due to the COVID-19 pandemic such as delays in regulatory review
- Manufacturing and supply chain interruptions
- Access to clinical sites
- Enrollment challenges
- Adverse effects on healthcare systems and disruption of the global economy