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GeoVax Labs, Inc. (GOVX)·Q4 2024 Earnings Summary

Executive Summary

  • GeoVax’s Q4 2024 revenue was $0.86M*, missing Wall Street’s $2.38M* consensus as BARDA cost-reimbursement billings came in light; FY24 revenue was $4.0M vs. $0 in FY23 and net loss narrowed to $25.0M from $26.0M . The CFO reiterated the BARDA award structure (GeoVax share $26M, up to $45M; separate $433M to Allucent) and that revenues track reimbursable costs .
  • Management advanced key programs: 10,000‑subject BARDA/Project NextGen Phase 2b (80 sites confirmed; initiation targeted “later this year” or early 2026), completion of a cGMP clinical batch for GEO‑MVA (Mpox/Smallpox) with clinical evaluation expected in 2H25, and completion of enrollment in the healthy-adult booster study with H1’25 data expected .
  • Positive clinical signal: In the CLL booster trial, the DSMB found the mRNA control arm failed its primary endpoint and recommended continuing only the GEO‑CM04S1 arm—supportive of potential superiority in this immunocompromised population .
  • Risks/pressures: Q4 revenue missed consensus; Gedeptin Phase 2 initiation was pushed from H1’25 to “mid‑ to latter part of next year,” citing product supply and cell line issues, signaling a delay vs. prior expectations .
  • Stock catalysts in 2025–2026: H1’25 CM04S1 booster data, potential CLL data presentations and publication, GEO‑MVA clinical start in 2H25, and BARDA NextGen Phase 2b initiation targeted by Q4’25 with possibility of early 2026; emergency-use pathways for Mpox could add optionality per management .

What Went Well and What Went Wrong

What Went Well

  • DSMB outcome favored CM04S1 in CLL: “while the mRNA control arm…failed to meet the predetermined primary endpoint, the study should continue enrollment of the…GEO‑CM04S1 vaccine” .
  • GEO‑MVA manufacturing readiness: cGMP clinical batch successfully produced and released, with clinical evaluation “expected to begin in late 2025” .
  • BARDA/NextGen execution: Sites confirmed for the 10,000‑participant Phase 2b; ongoing weekly coordination with BARDA; CRO confirmation of 80 sites; regulatory/CMC filings on schedule . Management tone: “We remain in close contact with BARDA…to initiate the trial later this year or in early 2026” .

What Went Wrong

  • Revenue miss vs. consensus: Q4 revenue of $0.86M* versus $2.38M* expected—reflecting timing of reimbursable BARDA costs; CFO emphasized revenue directly correlates with billable costs under the contract .
  • Gedeptin delay: Program shifted from a planned H1’25 start to “mid‑ to latter part of next year,” driven by manufacturing supply and cell line issues; analyst characterized as a “substantial pushback” .
  • Funding/dilution overhang: Cash at YE’24 was $5.5M; CFO noted $24.7M used in operations in 2024 and ongoing funding needs with potential for further equity raises; outstanding shares “currently” ~13.9M post‑financing .

Financial Results

Quarterly revenue and EPS (actuals vs. estimates and prior periods)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD)$0.301M $2.789M $0.864M*
Revenue Consensus ($USD)——$2.380M*
Diluted EPS (GAAP)$(1.99) $(0.91) N/A
EPS Consensus (GAAP)——$(0.768)*

Values with an asterisk (*) are retrieved from S&P Global.

Notes: Q4 revenue missed consensus (actual $0.864M* vs. $2.380M*); company did not report quarterly EPS in the year-end press release, so Q4 EPS actual is not available there .

Full-year results (YoY)

MetricFY 2023FY 2024
Revenue ($USD)$0.0M $4.0M
Net Loss ($USD)$(26.0)M $(25.0)M
R&D Expense ($USD)$20.7M $23.7M
G&A Expense ($USD)$6.0M $5.4M
Diluted EPS (GAAP)$(14.29) $(4.82)
Cash & Equivalents (YE) ($USD)$6.45M $5.51M

Context: FY24 revenue reflects BARDA Project NextGen cost‑reimbursement billings initiated mid‑2024; R&D increased on clinical manufacturing and BARDA‑related costs; G&A decreased on lower stock‑based comp and other items .

KPIs and operational milestones

KPIQ2 2024Q3 2024Q4 2024 / Current
BARDA/Project NextGen 10,000‑pt P2bAward announced; Allucent CRO engaged Target sites confirmed; study preparations ongoing 80 sites confirmed; initiation targeted Q4’25 or early 2026
GEO‑MVA (Mpox/Smallpox)cGMP Master Seed at OXB in place cGMP clinical batch anticipated Q4’24 cGMP batch produced/released; clinical evaluation expected 2H’25
CM04S1 CLL booster (City of Hope)—Interim readout anticipated Q4’24 DSMB: mRNA arm failed; continue CM04S1 arm
Healthy‑adult booster—Interim readout anticipated Q4’24 Enrollment completed; H1’25 data expected

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Gedeptin Phase 2 initiation (H&N, with ICI)Start timingInitiate in H1 2025 “Mid‑ to latter part of next year” (per Mar‑2025 call) Lowered/Delayed
CM04S1 healthy‑adult booster dataData timingInterim data in Q4 2024 Data in H1 2025 Delayed
GEO‑MVA clinical evaluationStart timingcGMP batch Q4 2024 (no start given) Clinical evaluation to begin in late 2025 New specific start window
BARDA P2b (10k subjects)Trial startSites confirmed; preparations (no start given) Targeting start by Q4’25; “later this year or early 2026” Window specified; start remains ahead

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2024)Current Period (Q4 2024 call)Trend
BARDA/Project NextGenAward announced; Allucent engaged; manufacturing transfer to OXB 80 sites confirmed; weekly BARDA coordination; start targeted Q4’25/early ’26 Execution progressing; timing window defined
CM04S1 in immunocompromisedQ3: multiple Phase 2 studies; interim readouts expected Q4’24 CLL DSMB favored CM04S1; healthy‑adult booster H1’25 data; transplant cohort readouts expected 2026 Supportive signals; timelines extended
GEO‑MVA (Mpox/Smallpox)cGMP batch anticipated Q4’24 cGMP batch completed; clinical start late ’25; potential emergency‑use pathways discussed Manufacturing milestone achieved; path to clinic clarified
Manufacturing/ProcessTransfer to OXB; AGE1 continuous process development underway AGE1 process touted for faster, flexible MVA supply; onshoring emphasized Capacity narrative strengthened
Funding/RunwayBalance sheet strengthened in Q3; cash $8.6M at 9/30 YE cash $5.5M; exploring partnerships, non‑dilutive funding, and equity Ongoing funding need acknowledged
Gedeptin (Oncology)H1’25 initiation planned Start pushed to mid‑/late next year; cell‑line/supply issues Delay

Management Commentary

  • Strategic posture: “We remain in close contact with BARDA…to initiate the trial later this year or in early 2026” and see CM04S1 addressing a gap for ~40M+ U.S. immunocompromised adults .
  • CLL trial insight: “the mRNA control arm of the study failed to meet the predetermined primary endpoint,” with continuation of the CM04S1 arm—supporting next‑gen vaccine potential in immunocompromised patients .
  • Funding mechanics: “This is a cost reimbursement contract, so our revenues directly correlate with billable personnel time and incremental expenses incurred…total contract value to GeoVax is $26M but may increase to as much as $45M…a separate contract of $433M was awarded to Allucent” .
  • Mpox readiness and optionality: “We produced more than enough product to support…clinical need…there is opportunity with WHO through emergency use licensing…Africa…need 20–25M doses…current supplier…no more than 5M by year‑end” .
  • GEO‑MVA clinical plan: non‑inferiority immunological endpoints vs. JYNNEOS, ~400 subjects proposed, primarily Europe plus a Sub‑Saharan Africa site .

Q&A Highlights

  • Emergency‑use revenue optionality: Management outlined potential WHO emergency use pathways for GEO‑MVA given supply shortages, noting unmet demand (~20–25M doses) vs. limited current supplier capacity (~5M by YE) .
  • GEO‑MVA trial design: Non‑inferiority vs. JYNNEOS with immunologic endpoints; ~400 subjects; studies in Europe (cost) plus Africa to address population‑specific questions .
  • Gedeptin delay drivers: Product supply and cell‑line issues necessitate pushing initiation to “mid‑ to latter part of next year,” a notable slippage vs. H1’25 plan .
  • BARDA stability: Weekly engagement; directive remains to start by year‑end (Q4’25); management acknowledged isolated program pauses elsewhere but said guidance to them remains “business as usual” .

Estimates Context

  • Q4 2024: Revenue $0.864M* vs. consensus $2.380M* (miss); EPS consensus $(0.768)* (company did not report quarterly EPS in its year‑end release). Revenues vary with cost‑reimbursable BARDA billings, explaining quarterly volatility .
  • FY 2024: Revenue $3.9546M* vs. consensus $5.3201M* (miss); GAAP EPS actual $(4.82) vs. consensus $(5.1025)*—a smaller loss than expected .

Values with an asterisk (*) are retrieved from S&P Global.

Key Takeaways for Investors

  • Q4 printed a revenue shortfall vs. Street as BARDA billings lagged expectations; expect quarterly lumpiness tied to reimbursable cost timing until the BARDA Phase 2b is underway .
  • Clinical momentum is building: DSMB outcome in CLL supports CM04S1 in immunocompromised patients; H1’25 healthy‑adult booster readout and additional conference presentations/publication are near‑term catalysts .
  • Program timelines were clarified: BARDA Phase 2b targeted to start by Q4’25/early ’26; GEO‑MVA clinical evaluation expected in 2H’25; Gedeptin pushed to mid‑/late next year—investors should reset timelines accordingly .
  • Funding remains a swing factor; management flagged partnerships, non‑dilutive sources, and potential equity raises to advance CM04S1, GEO‑MVA, and Gedeptin through value inflections .
  • Watch Mpox developments: Completed cGMP batch plus acute global supply gaps create optionality for emergency‑use pathways and earlier revenue contribution if regulatory latitude emerges .
  • Dilution watch: Share count rose to ~13.9M post‑financing per CFO; additional raises are possible as programs advance .
  • Event‑driven setup: Stock likely to react to H1’25 booster data, BARDA P2b start signals, GEO‑MVA trial initiation/any procurement signals, and visibility on Gedeptin’s new timeline .