Q2 2026 Altimmune Inc Earnings Call Transcript
Key Points
- Initiated the global PERFORMA Phase 3 trial for MASH, with rapid site activation and strong engagement from the medical community.
- Reported positive top-line data from the RECLAIM Phase 2 trial in AUD, meeting primary and key secondary endpoints, including FDA-recognized registrational endpoints.
- Demonstrated potential liver benefits in AUD patients, with 50% of pemvidutide-treated patients showing improvement in FIB-4 index versus 17% for placebo.
- Completed patient enrollment in the RESTORE trial for ALD, with a protocol amendment to assess liver stiffness at both 48 and 24 weeks, strengthening the liver benefit assessment.
- Strong financial position with $519 million in cash, providing runway through the MASH Phase 3 52-week readout in 2029.
- AUD market presents significant unmet need with no new drug approvals in 20 years, and pemvidutide's dual mechanism could disrupt the market.
- Potential for non-dilutive funding for a Phase 3 AUD trial, including royalty, debt, or strategic partnerships.
- Phase 3 AUD trial is not yet funded, and the company plans to use non-dilutive means, which may not be guaranteed.
- Competitive landscape for MASH trials is intense, with multiple ongoing Phase 3 programs, potentially impacting patient enrollment.
- Discontinuation rates in the RECLAIM trial were similar between active and placebo arms, with GI-related AEs in the active arm, indicating tolerability concerns.
- The RESTORE trial's primary endpoint change to a hierarchical analysis may complicate regulatory interpretation and delay clear results.
- The company has not yet provided specific timing for the Phase 3 AUD trial, pending FDA feedback, which could delay progress.
- The AUD market has low diagnosis and treatment rates, which may require significant educational efforts to drive adoption.
- The company's cash runway does not include the AUD Phase 3 trial, and financing options are not yet secured.
Good morning, ladies and gentlemen. Welcome to the Altimmune Second Quarter 2026 Financial Results Conference Call. (Operator Instructions) As a reminder, this call is being recorded. I'm going to introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations.
Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's second quarter 2026 financial results and business update call. On today's call, you will hear from Jerry Durso, our Chairman and Chief Executive Officer; Dr. Christophe Arbet-Engels, Chief Medical Officer; Linda Richardson, Chief Commercial Officer; and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we'll open the line for questions.
Our second quarter 2026 earnings release was issued this morning and can be found in the Investor Relations section of our website. Before we begin, I would like to remind everyone that remarks made about future expectations, plans, and prospects
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