Altimmune, Inc. (ALT)·Q1 2025 Earnings Summary

Executive Summary

• Altimmune reported Q1 2025 net loss of $19.6M ($0.26 per share) with minimal revenue, reflecting a typical clinical-stage profile; cash, cash equivalents and short-term investments ended the quarter at $150M, bolstered by ATM usage and a new $100M Hercules credit facility .
• EPS beat consensus, while revenue missed: actual EPS of -$0.26 vs S&P Global consensus of -$0.345; revenue of $0.005M vs $0.560M consensus; EBITDA less negative than expected, supported by lower R&D in the quarter [*Values retrieved from S&P Global].
• Guidance reiterated key clinical catalysts: top-line 24-week results from IMPACT Phase 2b (MASH) expected in Q2 2025; Phase 2 trials in AUD (Q2) and ALD (Q3) to initiate; end-of-Phase 2 FDA meeting for MASH planned in Q4 2025 .
• Strategic financing enhances runway: $35M net raised via ATM in Q1 and $16M post-quarter, plus $100M credit facility (interest-only up to 42 months, no warrants), extending runway through Q3 2026 with potential one-year extension if fully drawn .

What Went Well and What Went Wrong

What Went Well

• Strong balance sheet and flexible financing: cash/investments at $150M and $100M Hercules facility with interest-only period and no warrants, significantly extending runway .
• Clinical execution ahead of key catalysts: IMPACT Phase 2b enrolled 212 participants (above plan), with dual primary endpoints and biopsy rereads to reduce placebo; Phase 2 AUD/ALD programs advancing .
• Management confidence and biomarker support: EASL analysis showed >90% MASHResInd responses at 1.8/2.4mg doses, increasing confidence in 24-week histology endpoints; CMO emphasized class-leading liver fat reduction driving outcomes .

What Went Wrong

• Continued operating losses and minimal revenue: Q1 revenue was $0.005M with net loss of $19.6M, highlighting dependence on external financing and clinical milestones .
• Interest income declined year-over-year ($1.5M vs $2.4M) and higher G&A vs prior year, indicating some cost pressure despite lower R&D in the quarter .
• Revenue missed consensus ($0.005M vs $0.560M), underscoring limited near-term top-line and reliance on R&D progress for valuation [*Values retrieved from S&P Global].

Financial Results

Estimates comparison – Q1 2025:

Note: *Values retrieved from S&P Global.

Segment breakdown: not applicable; Altimmune reports consolidated results only .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We believe that achieving statistical significance on MASH resolution and fibrosis improvement at only 24 weeks, coupled with clinically meaningful weight loss, would position pemvidutide as the best-in-class therapeutic candidate for the treatment of MASH.” — Vipin K. Garg, CEO .
• “To maximize the integrity and robustness of our histology readout… independent reads from 3 pathologists and a modal approach… significantly reduces the placebo response rate.” — Scott Harris, CMO .
• “We’ve raised $35 million net off the ATM in Q1… an additional $16 million since April 1… $100 million credit facility… optional, flexible, and significantly extends our cash runway… no warrants.” — Gregory Weaver, CFO .
• “The MASHResInd response rates greater than 90% at the 1.8 and 2.4 mg pemvidutide doses give us further confidence in… 24-week biopsy-based endpoints.” — Altimmune (EASL release) .

Q&A Highlights

• Placebo responses and rereads: Management expects placebo fibrosis responses to be in single-to-low double digits with blinded rereads (7–13% seen in comparable trials), bolstering statistical power .
• Weight loss importance and benchmarks: Weight loss is critical to broad MASH treatment; expectations scaled to semaglutide timing, with differentiation via direct hepatic action and earlier 24-week readout .
• Phase 3 design: Strong consideration of 2.4mg dose for greater weight loss; potential for dual readouts at six and twelve months to accelerate timelines, subject to FDA discussion .
• F4 strategy: Planning an F4 fibrosis-improvement trial aimed at accelerated approval, with follow-up to outcomes for full approval .
• Partnering stance: Open to partnering if compelling, but Phase 3 progression in MASH, AUD, ALD will not be gated by partnership .

Estimates Context

• Q1 2025 EPS beat: Actual -$0.26 vs S&P Global consensus -$0.345; lower R&D ($15.8M vs $21.5M prior year) aided the beat [*Values retrieved from S&P Global].
• Q1 2025 revenue miss: Actual $0.005M vs $0.560M consensus; reflects limited near-term revenue typical of clinical-stage biotechs [*Values retrieved from S&P Global].
• EBITDA less negative than expected: Actual -$21.786M vs consensus -$26.596M [*Values retrieved from S&P Global].
• Estimates for Q2 2025 remain negative EPS with minimal revenue expectations, consistent with pre-commercial profile [*Values retrieved from S&P Global].

Key Takeaways for Investors

• Near-term catalyst: IMPACT Phase 2b top-line (24-week biopsy endpoints) in Q2 2025; positive results across MASH resolution, fibrosis, and weight loss could be a major stock catalyst .
• Financing risk mitigated: ATM proceeds and $100M Hercules facility (no warrants; interest-only up to 42 months) extend runway through Q3 2026 with option to extend ~1 year, reducing near-term dilution risk .
• Differentiation thesis: Dual GLP-1/glucagon mechanism with class-leading liver fat reduction and lean mass preservation; EASL MASHResInd analyses (>90% responses at higher doses) support efficacy confidence .
• Broader platform: Phase 2 initiations in AUD (Q2) and ALD (Q3) add optionality and potential label expansion if efficacy translates .
• Trial design choices matter: Expect discussions with FDA on 2.4mg dosing and potential six-month readouts in Phase 3 to accelerate timelines; monitoring of NITs (ELF, FibroScan) at 24/48 weeks may inform outcomes forecasting .
• Execution focus: Watch for adverse events/discontinuations and placebo rates at readout; management indicates favorable trends vs benchmarks .
• Trading implications: Into the Q2 readout, risk/reward is binary but supported by biomarker data and trial powering; financing reduces downside from capital concerns while positive data could re-rate the asset.

References:

• Q1 2025 8-K and earnings press release, exhibits and financials .
• Q1 2025 earnings call transcripts .
• Prior quarters: Q4 2024 8-K/press release and financials ; Q3 2024 8-K/press release and financials .
• Additional press releases (R&D Day; EASL predictive analyses; earnings date) .
• S&P Global estimates and consensus values: see tables with asterisked entries [*Values retrieved from S&P Global].