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- **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

- **IMPACT Trial Triumph**: 59.1% MASH resolution, 6.2% weight loss, and superior cT1 results (145ms vs. 27.5ms placebo) validate pemvidutide's efficacy.
- **Phase II Expansion**: AUD and ALD trials launched with 2.4mg dose, targeting alcohol reduction and liver stiffness.
- **FDA Readiness**: $183.1M cash to fund Phase III prep and 48-week data release, with end-of-Phase II meeting in Q4.
- **Strategic Differentiation**: Unique dual mechanism, no dose titration, and AI-driven endpoints set pemvidutide apart.
- **Oral Formulation Breakthrough**: Preclinical success paves way for cost-effective, non-gastric absorption commercialization.

**【CEO Opening Remarks】**
- **IMPACT Trial Success**: Pemvidutide achieved 59.1% MASH resolution (p < 0.001) and significant anti-inflammatory effects, with 6.2% weight loss at 24 weeks. Non-invasive fibrosis tests (ELF, VCTE) showed statistically significant improvements.
- **Phase II Expansion**: Initiated AUD (RECLAIM) and ALD (RESTORE) trials, targeting weekly 2.4mg dose for efficacy and tolerability.
- **Leadership Update**: Appointed Jerry Durso as Chairman, leveraging his experience in liver disease commercialization.
- **Financial Strength**: $183.1M cash balance, supporting Phase III preparation and 48-week IMPACT data release.

**【CMO Clinical Update】**
- **Safety & Tolerability**: Only 1 adverse event-related discontinuation in pemvidutide arms vs. 2 in placebo, without dose titration.
- **cT1 Imaging**: 145-147ms relaxation time reduction vs. 27.5ms in placebo,优于竞品（50-107ms）.
- **AUD/ALD Potential**: Animal studies show 80% alcohol reduction; Phase II trials testing weight loss and liver stiffness endpoints.

**【CFO Financial Summary】**
- **Q2 2025 Results**: Net loss $22.1M ($0.27/share), down 10% YoY. R&D expenses $17.2M (62% on pemvidutide), G&A stable at $5.7M.
- **Capital Strategy**: Raised $88M equity + $15M debt, supporting Phase III readiness. Cash up 40% YoY to $183.1M.

**【Q&A Highlights】**
- **FDA Meeting Expectations**: Seeking Phase III design alignment, including non-invasive endpoints (cT1, AI-based biopsies). 48-week IMPACT data to inform longer-term efficacy.
- **Competitive Position**: Pemvidutide's dual liver and metabolic mechanism, plus class-leading tolerability, positions for NASH leadership.
- **Oral Formulation Progress**: Preclinical breakthrough enabling non-gastric absorption, targeting cost-efficient commercialization.
- **Partnership Strategy**: Exploring collaborations for global Phase III execution, with focus on U.S. commercialization.


Altimmune, Inc. (ALT) Q2 2025 Earnings Call Transcript

- **Breakthrough NASH Potential**: Pemvidutide poised for 24-week MASH resolution readout with 76.4% liver fat reduction, highest in class.
- **Diversified Portfolio**: AUD/ALD trials launching Q2/Q3 with novel dual mechanism (weight loss + liver fat reduction).
- **Strengthened Balance Sheet**: $150M cash + $100M Hercules facility ensure 2026+ runway for clinical development.
- **Strategic Flexibility**: No partnership dependency; Phase 3 MASH on track with existing funding.

**【CEO Summary Section】**
- **IMPACT Phase 2b Trial Update**: Expected Q2 readout with dual primary endpoints (MASH resolution or fibrosis improvement). Pemvidutide targets NASH with 76.4% liver fat reduction in Phase Ib, class-leading efficacy. 
- **New Indications Expansion**: AUD (alcohol use disorder) and ALD (alcohol liver disease) Phase 2 trials launching Q2/Q3. Pemvidutide's dual mechanism (weight loss + liver fat reduction) addresses unmet need in cardiometabolic diseases.
- **Financial Strength**: $100M credit facility with Hercules Capital to support clinical development. Q1 2025 cash balance: $150M, up from $132M YoY.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Net loss $19.6M (-19.6% YoY). R&D expenses $15.8M (down 26% YoY) driven by cost optimization. G&A up 13% to $6M.
- **Funding Strategy**: $35M raised via ATM in Q1, $16M+ since April. Hercules credit facility provides $15M upfront, $25M 2025 subject to milestones, $60M 2026+.
- **Cash Runway**: Current cash + Hercules facility extends runway to Q3 2026+.

**【Q&A Key Themes】**
1. **IMPACT Trial Design**: Blinded biopsy rereads reduce placebo response. 212 enrolled (vs. 180 target), 76.4% liver fat reduction in Phase Ib precedent.
2. **Patient Population Focus**: 80%+ MASH patients obese. Pemvidutide targets root cause (obesity) + liver fibrosis.
3. **Partnership Strategy**: Open to partnerships but Phase 3 MASH development on track without external funding.
4. **AUD/ALD Trials**: 2.4mg dose with 8-week titration for tolerability. Primary endpoints: alcohol consumption reduction + liver stiffness (FibroScan).

Altimmune (ALT)-13 May 25-2025 Q1 Earnings call transcript

- **Upcoming Data**: Q2 2025 top-line results for NASH trial, positioning for Phase 3 in early 2026.
- **New Indications**: Two Phase 2 trials launching mid-2025, with potential 2026 data.
- **Financial Strength**: $132M cash runway into mid-2026.
- **Competitive Edge**: 76% liver fat reduction vs. peers, superior tolerability with no dose titration.
- **Strategic Expansion**: Virtual R&D Day on March 13 to detail new opportunities.

**【CEO Summary Section】**
- **2024 Milestones**: Completed enrollment in the Phase 2b IMPACT trial for pemvidutide in NASH, with top-line data expected in Q2 2025. Submitted INDs for two new indications, cleared by FDA for Phase 2 trials starting mid-2025.
- **Pemvidutide Differentiation**: Combines direct liver action with weight loss, targeting both NASH resolution and cardiovascular benefits. Phase 3 readiness in MASH anticipated for early 2026 following FDA end-of-Phase 2 meeting.
- **Strategic Initiatives**: Virtual R&D Day on March 13 to detail new indications. Expanded board with industry veterans in MASH and metabolic disease.
- **Leadership Transition**: CMO Scott Harris retiring in early 2026, with plans for smooth transition and successor search.

**【CMO Clinical Update】**
- **IMPACT Trial Details**: Dual endpoints of NASH resolution and fibrosis improvement at 24 weeks. Statistical significance target supported by 76% liver fat reduction vs. competitors' 62%. Placebo control via triple reader mode and blinded rereads.
- **New Indications**: FDA-cleared INDs for two Phase 2 trials, with potential data in 2026. Pemvidutide's GLP-1/glucagon dual agonism positions it for additional metabolic opportunities.
- **Competitive Profile**: Superior tolerability (no dose titration) and safety profile (FDA no signals in 700+ subjects) vs. semaglutide and FGF21s.

**【CFO Financial Commentary】**
- **Cash Position**: $132M as of Q4 2024, sufficient for operations into mid-2026.
- **Q4 2024 Results**: R&D expenses $19.8M (vs. $16.9M 2023), G&A $5.1M (vs. $4.3M 2023). Net loss $23.2M (vs. $31.6M 2023), driven by higher R&D investment.
- **Annual 2024**: R&D $82.2M (+25%), G&A $21M (+16%). Net loss $95M (vs. $88M 2023).

**【Q&A Key Highlights】**
- **Phase 2 Trials**: Expect at least one indication to show proof-of-concept in 2026. No third IND planned for 2025.
- **Competitive Success**: Pemvidutide's 24-week fibrosis improvement could outperform incretins and FGF21s. Cirrhosis study potential as F3 extension.
- **Real-World Adherence**: Low discontinuation rates (e.g., 20% in survodutide vs. pemvidutide's tolerability) suggest strong compliance.
- **Phase 3 Timing**: End-of-Phase 2 meeting by end-2025, Phase 3 start early 2026. 48-week IMPACT data to inform safety and biomarkers.

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