- **Clinical Momentum**: 24-week MASH resolution data drove FDA Phase III meeting; AUD trial enrollment completed 5 months early.
- **Financial Strength**: $211M cash, $127M raised YTD; R&D/G&A expenses aligned with clinical expansion.
- **Strategic Differentiation**: Dual-agonist mechanism vs. triple-agonist competitors; oral formulation in preclinical phase.
- **Endpoint Innovation**: FDA evaluating NITs as primary endpoints; AI biopsy validation underway for Phase III.

**【CEO Summary Section】**
- Highlighted progress in pemvidutide clinical trials, including 24-week IMPACT trial results showing rapid MASH resolution and antifibrotic activity.
- Announced completion of RECLAIM Phase II trial in AUD ahead of schedule, with strong physician and patient interest.
- Preparing for FDA end-of-Phase II meeting to discuss Phase III MASH program design, emphasizing flexibility in endpoints (e.g., NITs vs. biopsy reads).
- Enrolled ALD Phase II trial and expanded leadership team with key hires in medical, commercial, and legal roles.

**【CFO Financial Commentary】**
- Cash balance increased to $211 million (up 60% year-to-date), supported by $127 million raised through Q3.
- R&D expenses: $15 million (Q3 2025) vs. $19.8 million (Q3 2024), driven by clinical trial costs.
- G&A expenses: $5.9 million (Q3 2025) vs. $5 million (Q3 2024), due to stock-based compensation.
- Net loss of $19 million (Q3 2025) vs. $22.8 million (Q3 2024), with improved financial flexibility via debt amendments and ATM facility.

**【Q&A Key Highlights】**
- **Phase III Design**: FDA-endorsed 24-week data sufficiency for Phase III planning; 48-week IMPACT data expected to confirm trends in NITs and weight loss.
- **Endpoints Debate**: FDA considering NITs as primary endpoints vs. traditional biopsy reads; AI-based histology validation underway.
- **Competitive Positioning**: Pemvidutide's 1:1 glucagon/GLP-1 ratio offers dual liver and metabolic benefits, contrasting Lilly's triple agonist Retatrutide.
- **Oral Formulation**: Preclinical success in oral delivery; IND filing expected soon, targeting MASH and AUD indications.
- **AUD/ALD Pipeline**: RECLAIM trial enrollment 5 months ahead of schedule; ALD trial on track, with VCT/ELF endpoints for liver fibrosis assessment.

Altimmune, Inc. (ALT) Q3 2025 Earnings Call Transcript

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ALT

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