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Altimmune, Inc. (ALT)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 in-line with expectations for a pre-revenue biotech: minimal revenue ($5k), disciplined OpEx (R&D $19.8m; G&A $5.1m), and net loss narrowed YoY to $23.2m (from $31.6m, which had a 2023 impairment) .
  • Cash, cash equivalents and short-term investments were $131.9m at 12/31/24; management guided runway “well into the second half of 2026,” an improvement vs prior quarter’s “well into the first half of 2026” .
  • Program momentum remains the core narrative: Phase 2b IMPACT MASH top-line still expected in Q2 2025; FDA-cleared INDs in two additional indications with Phase 2 trials to begin mid-2025; R&D Day scheduled for March 13, 2025 to disclose new indications .
  • Management emphasized differentiation of pemvidutide: potential 24-week histology efficacy plus meaningful weight loss, plus strong tolerability without titration and no new safety signals per FDA interactions; if confirmed, could shift competitive positioning in MASH and support partnering optionality .
  • Near-term stock catalysts: March 13 R&D Day; Q2’25 IMPACT data; clarity on Phase 2 starts in two new indications; and evolving partner dialogue centered on obesity and broader pemvidutide franchise .

What Went Well and What Went Wrong

What Went Well

  • Cash runway extended: CFO reiterated ~$132m total cash/investments and guided funding “well into the second half of 2026,” up from Q3’s “well into the first half of 2026,” providing cushion through IMPACT readout and Phase 2 starts in new indications .
  • Program readiness and regulatory momentum: Two pemvidutide INDs cleared by FDA with Phase 2 efficacy trials planned mid-2025; management to detail indications at March 13 R&D Day .
  • Clear strategic differentiation narrative: Management underscored potential to be the first incretin-based therapy with statistically significant fibrosis improvement at 24 weeks while also driving weight loss; highlighted safety/tolerability and lack of need for dose titration vs peers .

What Went Wrong

  • Continued limited revenue: ALT remains effectively pre-revenue ($5k in Q4; $20k for FY), underscoring reliance on external financing events and clinical catalysts to drive valuation .
  • R&D OpEx elevated YoY as investments ramp into pemvidutide and new indications (Q4 R&D $19.8m vs $16.9m YoY; FY R&D $82.2m vs $65.8m), a necessary spend but a near-term earnings headwind .
  • EPS/consensus context unavailable: We were unable to retrieve S&P Global EPS and revenue consensus due to a data access limit, preventing a formal beat/miss assessment for Q4 (see Estimates Context) [GetEstimates—Daily Request Limit Exceeded].

Financial Results

Sequential comparison (Q2 2024 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Thousands)$5 $5 $5
R&D Expense ($USD Millions)$21.155 $19.803 $19.781
G&A Expense ($USD Millions)$5.595 $4.969 $5.090
Interest Income ($USD Millions)$2.182 $1.910 $1.569
Net Loss ($USD Millions)$(24.640) $(22.845) $(23.180)
Net Loss per Share ($)$(0.35) $(0.32) $(0.33)
Cash + Short-term Investments ($USD Millions)$164.9 $139.4 $131.9

Year-over-year (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024
Revenue ($USD Thousands)$37 $5
R&D Expense ($USD Millions)$16.909 $19.781
G&A Expense ($USD Millions)$4.332 $5.090
Interest Income ($USD Millions)$1.964 $1.569
Net Loss ($USD Millions)$(31.641) $(23.180)
Net Loss per Share ($)$(0.54) $(0.33)

KPIs

KPIQ2 2024Q3 2024Q4 2024
Pemvidutide Direct R&D Spend ($USD Millions)$13.8 $12.4 $13.6
Weighted Avg Shares (Basic & Diluted)70,924,371 71,084,787 71,260,875

Notes: FY 2024 net loss was $95.1m versus $88.4m in FY 2023; 2023 included a $12.4m non-cash impairment related to discontinuation of HepTcell, impacting YoY comparisons .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
IMPACT Phase 2b MASH top-line readoutQ2 2025Q2 2025 (Q3’24 update) Q2 2025 reaffirmed Maintained
End-of-Phase 2 meeting (MASH)By end-2025Q4 2025 (Q3’24 call) By end of 2025 reaffirmed Maintained
Additional INDs (two indications)InitiationINDs to begin Q4’24/H1’25 (Q3’24) FDA-cleared; Phase 2 trials to start mid-2025 Upgraded (now cleared + timing set)
Cash runwayFunding horizonWell into H1 2026 (Q3’24) Well into H2 2026 Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2–Q3 2024)Current Period (Q4 2024)Trend
MASH (IMPACT) timing and endpointsFully enrolled; top-line in Q2’25; 24-week histology endpoints (resolution/fibrosis) Top-line reaffirmed for Q2’25; strong confidence in 24-week histology success; 48-week follow-up ongoing Steady progress; confidence increasing
Obesity program regulatory pathEoP2 FDA meeting completed; 4 pivotal “VELOCITY” trials aligned Safety profile reaffirmed; no additional CV safety trial required; tolerance advantage highlighted Positive de-risking
Additional indicationsPlan up to 3; first IND by YE’24; H1’25 start Two INDs cleared; Phase 2 efficacy trials mid-2025; details at 3/13 R&D Day Accelerating
Competitive landscape (GLP-1s/FGF21s)Differentiation via liver fat reduction + weight loss; lean mass preservation Expect to be first incretin to show 24-week histology efficacy; better tolerability vs survodutide; no safety signals Sharper differentiation narrative
Cash and partneringCash to H1’26; pursue obesity-centered partnership; create pipeline-in-a-product Runway to H2’26; broadening indications to enhance partnering optionality Improved runway; broader scope
Organizational updatesNew CFO appointed (Nov 2024) CMO retirement planned for Feb 2026; two seasoned biopharma executives added to Board Strengthened governance; managed transition

Management Commentary

  • “With a positive IMPACT readout, pemvidutide would be the first incretin-based agent to achieve fibrosis improvement at 24 weeks and the first therapeutic candidate in any class to achieve significant fibrosis improvement and meaningful weight loss in a 24-week treatment period.” – CEO, Vipin Garg .
  • “Our key metric for the success in the IMPACT trial will be the ability to achieve statistical significance on the fibrosis improvement endpoint at 24 weeks…we have greater liver fat reduction at 24 weeks than any of the MASH agents currently in development.” – CMO, Scott Harris .
  • “We reported our year-end 2024 total cash and investments of $132 million…expected to fund operations well into the second half of 2026…includes funding of the Phase II trials for our additional indications.” – CFO, Gregory Weaver .
  • “Two additional indications…INDs…have been cleared by FDA, which positions us to start Phase II efficacy trials in mid-2025. We will disclose the additional indications at our R&D Day on March 13.” – CEO, Vipin Garg .

Q&A Highlights

  • Phase 3 design and NITs: Management is at the forefront of non-invasive tests (e.g., MRI-PDFF) discussions but awaits FDA direction; cirrhosis development remains of interest with potential high likelihood of success based on defatting and antifibrotic profile .
  • Placebo control in histology trials: IMPACT uses a three-reader, mode adjudication approach with blinded rereads to minimize placebo rates, modeled after successful FGF21 trials (e.g., pegozafermin) .
  • Competitive context: Semaglutide’s longer-duration modest histology effects highlight the need for direct liver action; management expects pemvidutide to differentiate at 24 weeks with both histology efficacy and weight loss; also emphasized tolerability and lack of titration burden vs survodutide .
  • Indications and prioritization: Two FDA-cleared INDs will start mid-2025 with potential PoC data for at least one indication in 2026; obesity strategy remains partner-centric while ALT progresses MASH Phase 3 planning post-IMPACT .
  • Oral formulation: Progress continues on oral pemvidutide with focus on commercially viable bioavailability; updates deferred to a future venue .

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q4 2024 (Primary EPS Consensus Mean, Revenue Consensus Mean, and # of estimates) but were unable to access due to a data request limit, so a formal beat/miss determination versus estimates is not available at this time. Values were unavailable from S&P Global due to access limits.

Key Takeaways for Investors

  • Cash runway extended “well into H2 2026,” covering Q2’25 IMPACT readout and initiation of two Phase 2 indications—reduces financing risk through near-term catalysts .
  • IMPACT Phase 2b is the central re-rating event: if 24-week histology endpoints hit, pemvidutide’s dual liver/weight-loss profile could reshape MASH positioning and accelerate Phase 3 initiation in early 2026 .
  • Strong regulatory momentum: Two FDA-cleared INDs and planned Phase 2 starts mid-2025 expand the “pipeline-in-a-product” narrative and partnership optionality centered on obesity .
  • Differentiation thesis intact: management emphasizes class-leading liver fat reduction, histology ambitions at 24 weeks, and favorable tolerability (no dose titration), addressing limitations seen in incretin-only programs .
  • Watch near-term events: March 13 R&D Day for new indication disclosures and trial design details; Q2’25 top-line MASH data for efficacy confirmation .
  • Trend checks: Sequential OpEx remained consistent (R&D ~$19.8m), YoY net loss improved due to absence of prior-year impairment; revenue remains de minimis, keeping valuation tied to clinical outcomes .
  • Organizational continuity with planned CMO retirement in Feb 2026 and Board additions with deep commercial and liver disease expertise supports late-stage execution .