What does Altimmune do and what are its main business segments?

What is Altimmune's gross profit margin?

What factors drove the changes in Altimmune's revenue and profit?

What were the key takeaways from Altimmune's earnings call?

Did Altimmune beat or miss consensus estimates last quarter?

What is the revenue and EPS growth rate for Altimmune year over year?

What guidance did Altimmune's management provide for the next earnings period?

What were the key takeaways from Altimmune’s earnings call?

- **Phase III Trial Initiation**: FDA-aligned design with 990 patients (F2/F3) targeting MASH resolution and fibrosis improvement, powered for 1.8 mg dose.
- **FDA Breakthrough Designation**: Pemvidutide recognized for potential to substantially improve MASH outcomes.
- **Capital Strength**: $340 million cash runway after $75 million capital raise, supporting Phase III execution into 2028.
- **Tolerability Differentiation**: Simple 1-2 step titration and 7.5% weight loss at 1.8 mg dose in Phase IIb, with low discontinuation rates.
- **Competitive Edge**: Dual glucagon/GLP-1 mechanism addresses liver fat and metabolic drivers, with potential for lean muscle preservation.

**【CEO Summary Section】**
- Emphasized Altimmune's focus on liver diseases, particularly MASH, and highlighted pemvidutide's potential as a dual glucagon/GLP-1 agonist with a 1:1 ratio for liver fat reduction and weight loss.
- Announced FDA Breakthrough Therapy designation for pemvidutide in MASH and a $75 million capital raise to support Phase III trial initiation.
- Discussed Phase III trial design alignment with FDA, including 1.8 mg and 2.4 mg dose evaluations, and the importance of tolerability through a simple titration scheme.
- Highlighted the company's strategic team expansion and financial strength to execute the MASH Phase III program.

**【CMO Financial Commentary】**
- Presented Phase IIb MASH trial results showing 48-week anti-fibrotic activity (ELF and liver stiffness improvements) and 7.5% weight loss at 1.8 mg dose.
- Detailed Phase III trial design: 990 patients (F2/F3) with primary endpoints of MASH resolution and fibrosis improvement, powered at 90% for 1.8 mg dose.
- Discussed plans for AUD and ALD Phase II trials, with top-line data expected in Q3 2026 (AUD) and later 2026 (ALD).
- Highlighted the dual mechanism of action (glucagon for liver fat, GLP-1 for weight loss) and potential for lean muscle preservation.

**【CCO Commercial Perspective】**
- Shared market research showing high physician interest in pemvidutide (70% likelihood to prescribe) due to its favorable tolerability, straightforward titration, and ability to address unmet needs in MASH (e.g., semaglutide discontinuation, weight loss limitations).
- Highlighted differentiation from competitors through simpler dosing (1-2 steps vs. multi-dose titration), quality weight loss with lean muscle preservation, and direct liver effects.
- Discussed plans to leverage Phase III data to position pemvidutide as a first- or second-line therapy in MASH.

**【CFO Financial Update】**
- Q4 2025 financials: Net loss of $27.4 million, R&D expenses of $18.4 million (down 7% YoY), G&A expenses of $10.5 million (up 108% YoY due to one-time charges).
- Year-end 2025 cash of $274 million, with a pro forma cash position of $340 million after a $75 million registered direct offering in January 2026.
- Forecasted cash runway into 2028, with Phase III costs expected to increase this year.
- Emphasized financial discipline and strategic capital management to support clinical development.

**【Q&A Highlights】**
- **Phase III Design**: Confirmed alignment with FDA on 990-patient trial design, with 1.8 mg and 2.4 mg dose evaluations. No plans to amend for NITs as primary endpoints due to FDA guidance.
- **Competitive Landscape**: Highlighted pemvidutide's differentiation through simpler titration, dual mechanism, and potential for lean muscle preservation vs. GLP-1 agonists like semaglutide.
- **Regulatory Strategy**: Submitted EU scientific advice request, with no expected changes to Phase III design. AIM-MASH Assist AI biopsy tool being integrated to reduce variability.
- **Manufacturing Readiness**: Confirmed CMC readiness for global Phase III supply, with focus on MASH rather than obesity indications.
- **Muscle Preservation**: Discussed plans to assess lean mass preservation in Phase III through DEXA and MRI, with potential for mechanistic studies.


Altimmune, Inc. (ALT) Q4 2025 Earnings Call Transcript

- **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.

Actual										-0.26	-0.94	-0.54	-0.17	-0.38	-0.6	-0.81	-0.57	-0.44	-0.42	-0.48	-0.43	-0.4	-0.32	-0.39	-0.54	-0.34	-0.35	-0.32	-0.33	-0.26	-0.27	-0.21	-0.27
Forecast										-0.32	-0.285	-0.76	-0.8033	-0.5067	-0.5047	-0.4457	-0.66	-0.59	-0.5	-0.505	-0.5014	-0.48	-0.465	-0.4525	-0.455	-0.37	-0.3486	-0.3566	-0.3325	-0.3519	-0.3362	-0.2721	-0.234
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+18.75%	-229.82%	+28.95%	+78.84%	+25.00%	-18.88%	-81.74%	+13.64%	+25.42%	+16.00%	+4.95%	+14.24%	+16.67%	+31.18%	+13.81%	-18.68%	+8.11%	-0.40%	+10.26%	+0.75%	+26.12%	+19.69%	+22.82%	-15.38%

Actual	--	--	--	--	--	--	--	--	--	2.21M	721.64K	2.94M	2.31M	837.52K	137.62K	157.56K	3.28M	32.00K	8.00K	2.00K	-110.00K	21.00K	6.00K	362.00K	37.00K	5.00K	5.00K	5.00K	5.00K	5.00K	5.00K	5.00K	26.00K
Forecast	--	--	--	--	--	--	--	--	--	500.00K	1.35M	1.05M	1.78M	2.07M	1.89M	70.67K	90.33K	1.03M	871.50K	867.83K	28.86K	0	3.00K	857	2.14K	0	714	714	0	0	1.43K	1.43K	556
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+342.54%	-46.55%	+179.81%	+29.68%	-59.55%	-92.73%	+122.96%	+3528.42%	-96.90%	-99.08%	-99.77%	-481.19%	0.00%	+100.00%	+42140.37%	+1626.55%	0.00%	+600.28%	+600.28%	0.00%	0.00%	+249.90%	+249.90%	+4576.26%

ALT

ALT fundamentals

ALT Q4 2025 Earnings

Earnings Call

You can ask Aime

ALT

ALT fundamentals

ALT Q4 2025 Earnings

Earnings Call

ALT Earnings Call Summary for Q4/20258:30 AM on Mar 5, 2026

ALT Earnings Call Summary for Q3/20258:30 AM on Nov 6, 2025

ALT Earnings Call Summary for Q2/20258:30 AM on Aug 12, 2025

ALT Earnings Call Summary for Q1/20258:30 AM on May 13, 2025

ALT Earnings Call Summary for Q4/20248:30 AM on Feb 27, 2025

You can ask Aime