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Altimmune, Inc. (ALT)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 results were in line-to-better on EPS but missed on revenue versus Street: EPS of ($0.21) beat consensus ($0.26) while revenue of $0.005M missed consensus $0.56M; Altimmune reaffirmed major near-term catalysts including the 48-week IMPACT readout and End-of-Phase-2 (EOP2) FDA meeting in Q4 2025 . Values retrieved from S&P Global.*
  • Operating execution strengthened: cash, cash equivalents and short-term investments rose to $210.8M, up ~60% YoY; R&D declined to $15.0M (timing of CRO costs), and net loss improved to ($19.0M) YoY .
  • Regulatory and clinical narrative advanced: EOP2 meeting granted based on 24-week data; 48-week IMPACT readout will add longer-term NITs and weight loss; RECLAIM (AUD) completed enrollment early; RESTORE (ALD) enrollment ongoing .
  • Balance sheet and financing flexibility increased via a Hercules debt amendment to $125M with a $20M draw and extended interest-only period, plus planned shelf and ATM facilities referenced on the call—key funding optionality ahead of Phase 3 .

What Went Well and What Went Wrong

What Went Well

  • “We are approaching a major inflection point for the pemvidutide MASH program… the 48-week data from the IMPACT trial is expected before year end” (CEO) .
  • EOP2 meeting granted on strength of 24-week biopsy and NIT results; flexibility to adapt Phase 3 endpoints to potential regulatory acceptance of NITs and AI reads (CMO/CEO) .
  • AUD program momentum: RECLAIM Phase 2 enrollment completed months ahead of schedule; Fast Track designation in AUD; topline expected 2026 .

What Went Wrong

  • Revenue miss: actual $0.005M vs consensus $0.56M (typical for pre-revenue biotech, but a formal miss) . Values retrieved from S&P Global.*
  • Fibrosis improvement at 24 weeks did not reach statistical significance in top-line (per earlier context), though robust NITs and AI fibrosis reductions support anti-fibrotic activity—necessitating longer duration/Phase 3 scale for a registrational endpoint .
  • Continued net losses typical of clinical-stage development: Q3 net loss ($19.0M), though improved YoY; G&A rose due to fees and stock-based comp .

Financial Results

Income Statement and Cash Trends

Metric (USD $000s)Q1 2025Q2 2025Q3 2025
Revenues5 5 5
Research & Development15,827 17,236 14,960
General & Administrative5,993 5,691 5,904
Total Operating Expenses21,820 22,927 20,864
Interest Income1,545 1,132 2,426
Net Loss(19,575) (22,146) (19,014)
Diluted EPS($0.26) ($0.27) ($0.21)

Year-over-Year (YoY) Reference

Metric (USD $000s)Q3 2024Q3 2025
Research & Development19,803 14,960
General & Administrative4,969 5,904
Net Loss(22,845) (19,014)
Diluted EPS($0.32) ($0.21)

Liquidity

MetricQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Short-term Investments (USD $000s)149,826 183,147 210,776
Reported Cash + ST Investments headline (USD $MM)$150.0 $183.1 $210.8

Estimates vs Actual (Q3 2025)

MetricConsensusActual
Revenue (USD $000s)560.05.0
Primary EPS (USD)(0.2629)(0.21)
# of EPS Estimates7—
# of Revenue Estimates9—
Values retrieved from S&P Global.*

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
IMPACT 48-week readout (NITs & weight loss)Q4 2025Q4 2025 targetReiterated Q4 2025Maintained
EOP2 FDA meeting for MASHQ4 2025Q4 2025 targetedScheduled in-person in Q4 2025Clarified/timed
RECLAIM (AUD) topline20262026 expectedReiteratedMaintained
RESTORE (ALD) enrollmentOngoingInitiated July 2025OngoingMaintained
Debt facility (Hercules)Facility size$100M initialIncreased to $125M; drew $20M; interest-only extended to 30 monthsRaised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Regulatory pathway: NITs/AI biopsyPlanning for EOP2; strong NITs (ELF, VCTE, cT1); PathAI accepted by EMA; exploring NIT-based designs Flex Phase 3 to incorporate NITs/AI as endpoints pending FDA discussions Broadening acceptance; design flexibility rising
Phase 3 design (dose, timing)Considering 2.4mg dose; early 6/12-month biopsy cohorts; leverage obesity safety db Emphasized flexible endpoint design aligned with evolving regs; frequency of NIT tracking Advancing toward EOP2 decisions
AI-based fibrosis assessmentSupplemental AI analysis showed significant fibrosis reductions Liver Explore™ results highlight reductions in early/advanced fibrosis; late-breaker poster Strengthening external validation
Clinical programs beyond MASHInitiated AUD/ALD Phase 2; Fast Track in AUD RECLAIM enrolled early; RESTORE ongoing; AUD endpoint clarified (heavy drinking days) Execution momentum
Commercial readinessBoard succession; commercial inputs to Phase 3 CCO appointed; payer/physician research positive on profile, lean mass sparing, tolerability Building launch foundations
Financing & runway$100M Hercules facility; ATM use; cash building to fund Phase 2/3 Facility amended to $125M; $20M drawn; shelf/ATM referenced; strong cash Increased flexibility

Management Commentary

  • “Later this quarter we expect two milestones… End-of-Phase 2 Meeting with the FDA… and the 48-week data from the IMPACT trial” (CEO) .
  • “The phase three trial will include the flexibility of using NITs and AI reads as an approvable endpoint… if regulatory process moves in that direction” (CMO) .
  • “RECLAIM… completed recruitment and randomization… ahead of schedule… a strong indicator of… significant interest and unmet need” (CMO) .
  • “Our cash position continued to strengthen… we amended our Hercules debt agreement… increased… to $125 million and funded $20 million… filing a $400M shelf and a new $200M ATM” (CFO) .

Q&A Highlights

  • NITs vs. AI biopsy: management aims for a flexible Phase 3 design to pivot to NITs/AI endpoints as FDA policy evolves; PathAI workflows can be implemented seamlessly with digitized slides .
  • MASH Phase 3 endpoints: discussion of dual/co-primary strategies for MASH resolution and fibrosis improvement, with continued attention to robust NITs (ELF, VCTE, cT1) to support efficacy .
  • AUD endpoints: primary endpoint is change in heavy drinking days per week; WHO risk level and PEth biomarker as secondary measures .
  • Competitive positioning: balanced 1:1 glucagon/GLP-1 mechanism described as differentiated vs. triples in MASH; emphasis on anti-inflammatory/fibrotic liver effects and lean mass sparing .

Estimates Context

  • Q3 2025 results vs consensus: EPS ($0.21) vs ($0.2629) — bold beat; Revenue $0.005M vs $0.56M — bold miss. Values retrieved from S&P Global.*
  • Implication: Street may need to adjust for minimal revenue model (pre-commercial biotech) but recognize operating discipline (lower R&D) and stronger interest income and cash runway ahead of Phase 3 .

Financial/Clinical KPIs

IMPACT Phase 2b (24-week outcomes)

EndpointPlaceboPemvidutide 1.2 mgPemvidutide 1.8 mg
MASH resolution without worsening of fibrosis (% LSM)20 58 **** 52 ****
LSM change (kPa)-0.7 -3.7 *** -2.2 *
ELF change+0.03 -0.6 *** -0.5 ***
cT1 change (ms)-14.7 -124.6 *** -134.7 ***
MRI-PDFF normalized ≤5% (%)4% 31% **** 44% ****
Body weight reduction (%)-0.5 -4.8 *** -5.8 ***
AE-related discontinuations (%)2 0 1

AI-based fibrosis analysis (24-week)

Measure (≥60% reduction)Placebo1.2 mg1.8 mg
Total fibrosis area (%)8 12 (p=0.5) 31 (p=0.0003)
Early fibrosis area (%)9 24 (p=0.017) 34 (p<0.0001)
Advanced fibrosis area (%)11 5 (p=0.32) 27 (p=0.0063)

Key Takeaways for Investors

  • Near-term catalysts: EOP2 FDA meeting and 48-week IMPACT NITs/weight-loss readout in Q4 2025—key drivers of Phase 3 design clarity and potential valuation re-rating .
  • Clinical differentiation: strong 24-week MASH resolution; robust NITs (ELF, VCTE, cT1) and AI fibrosis reduction bolster anti-fibrotic profile; lean mass sparing supports commercial positioning .
  • AUD optionality: early-completed RECLAIM enrollment underscores demand; endpoints (heavy drinking days/WHO/PEth) set up a clean efficacy read in 2026 .
  • Financing runway: $210.8M cash and enhanced $125M facility with $20M drawn plus potential shelf/ATM—adequate to bridge through Phase 3 initiation .
  • Estimates lens: EPS beat suggests cost discipline; revenue miss is non-core for a pre-commercial biotech; focus should remain on clinical/regulatory execution. Values retrieved from S&P Global.*
  • Phase 3 strategy: expect use of higher dose (2.4 mg) for added weight loss and to integrate NITs/AI endpoints pending FDA feedback; potential earlier assessment points to accelerate timelines .
  • Trading implications: watch for AASLD late-breakers, EOP2 outcomes, and 48-week IMPACT NITs confirming durability—each a narrative lever for sentiment and partner/financing discussions .

*Values retrieved from S&P Global.