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Altimmune, Inc. (ALT)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered a cleaner P&L with lower R&D and G&A, net loss narrowed to $22.1M and diluted EPS of $(0.27), while cash, cash equivalents and short-term investments strengthened to $183.1M as of June 30, 2025 .
  • Clinical momentum: IMPACT Phase 2b 24-week readout showed statistically significant MASH resolution (up to 59.1%), robust weight loss (up to 6.2%), significant cT1 reductions, and potentially best-in-class tolerability; End-of-Phase 2 FDA meeting and full 48-week data are targeted for Q4 2025 .
  • Versus consensus: EPS beat (actual $(0.27) vs $(0.312)), while revenue missed given de minimis operating revenue (actual $5K vs $560K) — both consensus values from S&P Global .
  • Near-term catalysts: full 48-week IMPACT data and End-of-Phase 2 FDA meeting (Q4 2025); continued execution in newly initiated Phase 2 trials in AUD (RECLAIM) and ALD (RESTORE) .

Estimates marked with * retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • Strong efficacy and tolerability in IMPACT: “Pemvidutide demonstrated rapid and robust MASH effects, meaningful weight loss and impressive safety and tolerability… We are preparing for an End-of-Phase 2 Meeting with the FDA” — CEO Vipin Garg .
  • Potentially class-leading cT1 improvements: Mean cT1 decreases of 145.0 ms and 147.9 ms at 24 weeks in 1.2 mg and 1.8 mg arms vs 27.5 ms in placebo (p<0.001), indicating anti-inflammatory and anti-fibrotic activity — CMO Scott Harris .
  • Strengthened balance sheet and optionality: Total cash of $183.1M on 6/30/25 and access to $100M Hercules facility (with $15M drawn), supporting Phase 3 readiness — CFO Greg Weaver and company filings .

What Went Wrong

  • Fibrosis improvement did not reach statistical significance at 24 weeks (ITT analysis); management expects significance with longer duration and larger Phase 3 trials .
  • Revenue remained minimal ($5K), underscoring non-commercial stage; consensus revenue was higher, leading to a miss vs estimates .
  • Regulatory uncertainty persists around acceptance of NIT/AI endpoints in U.S.; management will seek alignment at End-of-Phase 2, noting shifting FDA views and EMA acceptance of AI-assisted pathology .

Financial Results

Income Statement Summary (oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Thousands)$5 $5 $5
R&D Expense ($USD Thousands)$21,155 $15,827 $17,236
G&A Expense ($USD Thousands)$5,595 $5,993 $5,691
Total Operating Expenses ($USD Thousands)$26,750 $21,820 $22,927
Net Loss ($USD Thousands)$(24,640) $(19,575) $(22,146)
Diluted EPS ($USD)$(0.35) $(0.26) $(0.27)
Interest Income ($USD Thousands)$2,182 $1,545 $1,132
Weighted Avg Shares (Basic & Diluted)70,924,371 75,547,746 81,477,548

Notes: Margin metrics are not meaningful given de minimis revenue .

Liquidity

MetricQ4 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Short-term Investments ($USD Millions)$131.9 $150.0 $183.1

KPIs and R&D Mix

KPIQ1 2025Q2 2025
Direct Costs related to Pemvidutide ($USD Millions)$9.2 $11.2
IMPACT Phase 2b spend ($USD Millions)—$5.5
AUD/ALD Phase 2 startup costs ($USD Millions)—$2.6
Oral formulation preclinical ($USD Millions)—$1.0

Segment breakdown: Not applicable (single program focus) .

Results vs Wall Street Consensus (Q2 2025)

MetricActualConsensus# of Estimates
Diluted EPS ($USD)$(0.27) $(0.3118)*8*
Revenue ($USD Thousands)$5 560*9*

Estimates marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IMPACT 24-week toplineQ2 2025Expected Q2 2025 Reported June 26, 2025 Achieved
IMPACT 48-week dataQ4 2025Readout expected Q4 2025 Maintained Q4 2025 Maintained
End-of-Phase 2 FDA meeting (MASH)Q4 2025By end of 2025 Targeted Q4 2025 Specified timing
AUD (RECLAIM) Phase 22025Initiation expected Q2 2025 Initiated May 2025 Initiated
ALD (RESTORE) Phase 22025Initiation expected Q3 2025 Initiated July 2025 Initiated
Balance sheet financing2025$100M facility contemplated $100M facility secured; $15M drawn Executed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
MASH efficacy endpointsConfidence in achieving MASH resolution and fibrosis improvement at 24 weeks IMPACT topline expected Q2; >90% MASHResInd responses in Phase 1b analysis Significant MASH resolution at 24 weeks; fibrosis improvement trends; strong NIT and AI fibrosis signals Positive confirmation
NITs/AI-based pathologyN/AR&D Day highlighted predictive non-invasive metrics Discussed FDA’s evolving views; EMA acceptance of AI-assisted readings; potential Phase 3 use Increasing regulatory receptivity
Dosing strategy for Phase 3N/AN/ALikely to include 2.4 mg to enhance weight loss and possibly efficacy; other doses under review Moving to higher dose
Safety/tolerabilityN/AN/AVery low AE-related discontinuations; no SAEs related to drug; no dose titration needed Differentiated profile
Commercialization/partneringBoard strengthened (Durso appointment later) $100M facility enhances runway New Chairman (Jerry Durso); positioning for Phase 3 and commercialization Scaling for registrational stage
AUD/ALD executionINDs cleared; Phase 2s to start mid-2025 Phase 2 AUD/ALD expected to initiate AUD initiated (May); ALD initiated (July); confident in endpoints Program ramp-up
R&D spend cadenceN/AN/APhase 2 AUD/ALD spend baked into budget; modest burn impact Stable near-term

Management Commentary

  • “We are preparing for an End-of-Phase 2 Meeting with the FDA which will position us well for Phase 3 development… we look forward to reporting the full 48-week data in the fourth quarter” — Vipin K. Garg, Ph.D., CEO .
  • “Mean decreases from baseline in cT1 relaxation time were 145.0 ms and 147.9 ms… compared with a decrease of 27.5 ms in placebo (p < 0.001 for both)” — Dr. Scott Harris, CMO .
  • “We finished the second quarter with total cash of $183.1M… raised $88M gross equity and added the flexibility of a $100M Hercules debt facility; drew down $15M” — Greg Weaver, CFO .
  • “We think it’s going to be very attractive to put the 2.4 mg dose into Phase 3… weight loss trajectory indicated there was a lot more weight loss to be had” — Dr. Scott Harris .

Q&A Highlights

  • Regulatory pathway: Management sees FDA views evolving toward NIT-based endpoints; EMA has accepted AI-assisted pathology; ALT will pursue innovative Phase 3 designs and align at End-of-Phase 2 .
  • Phase 3 design: Considering dual endpoints (MASH resolution and fibrosis improvement), higher 2.4 mg dose for weight loss/efficacy; potential to reduce safety exposure requirements leveraging large safety database .
  • Comparative efficacy (cT1): ALT’s ~145–148 ms reductions compare favorably to public data for resmetirom (~50–60 ms) and tirzepatide (~up to 107 ms), suggesting class-leading fibro-inflammatory impact .
  • AUD/ALD: Trials initiated; animal data and GLP-1 literature support alcohol reduction; endpoints include heavy drinking days, WHO risk level, PEth biomarker; Phase 3 path to be discussed post Phase 2 .
  • Spend trajectory: AUD/ALD studies are modest in size and within budgeted runway; no unusual near-term burn expected .

Estimates Context

  • Q2 2025 EPS beat: Actual $(0.27) vs consensus $(0.3118); Q2 2025 revenue miss: Actual $5K vs consensus $560K .
  • Consensus coverage: 8 EPS estimates and 9 revenue estimates*; near-term estimate revisions likely to focus on R&D cadence and trial timelines rather than revenue/EPS given pre-commercial profile*.

Estimates marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical profile is differentiating: Significant MASH resolution at 24 weeks, robust weight loss, strong non-invasive fibrosis signals, and standout tolerability without dose titration support Phase 3 readiness .
  • Near-term catalysts are meaningful: Full 48-week IMPACT dataset and End-of-Phase 2 FDA meeting in Q4 2025 should shape Phase 3 design and regulatory expectations — watch for clarity on NIT/AI endpoint acceptance .
  • Balance sheet durability: $183.1M cash and a $100M credit facility (with $15M drawn) provide flexibility to advance programs toward registrational trials .
  • Fibrosis endpoint risk mitigated: Though 24-week fibrosis improvement was not statistically significant, management’s thesis is longer duration and larger sample sizes should achieve significance; AI/NITs may reduce placebo noise .
  • Dosing strategy likely upshift: Discussion points to 2.4 mg in Phase 3 to maximize weight loss and potentially efficacy; expect dose-finalization post End-of-Phase 2 .
  • Adjacent indications broaden optionality: AUD and ALD Phase 2 trials are underway; positive signals could expand addressable market and add portfolio value .
  • Trading lens: Expect stock sensitivity around Q4 data/meeting outcomes and any updates on Phase 3 endpoints/design (dual endpoints vs co-primary; NIT incorporation) and competitive read-throughs .