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GeoVax Labs, Inc. (GOVX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was a transition quarter: revenue was $0 as BARDA Project NextGen revenues ceased in April, while net loss widened to $6.32M; EPS was $(0.31), modestly worse than S&P Global consensus of $(0.265) despite lower R&D spend . Estimates marked with * are from S&P Global.
  • GEO-CM04S1 delivered positive clinical signals in immunocompromised populations: robust T-cell and cross-variant antibody responses; CLL trial achieved its primary immunogenicity endpoint and discontinued the comparator mRNA arm .
  • GEO-MVA (Mpox/Smallpox) development accelerated with EMA guidance enabling a Phase 3 immunobridging path; management initiated fill/finish of clinical supply and is engaged with WHO/ASPR/BARDA for potential emergency pathways and commercialization discussions .
  • Oncology strategy sharpened: Gedeptin® protocol shifted to first-line resectable HNSCC with pembrolizumab; expansion into TNBC and cutaneous cancers is underway; Phase 2 initiation remains targeted for 2H 2026 .
  • Potential near-term stock catalysts: further CM04S1 clinical readouts, EMA/FDA alignment on GEO-MVA immunobridging, and partnership or non-dilutive funding updates given active dialogues and U.S. onshoring policy momentum .

What Went Well and What Went Wrong

What Went Well

  • CLL study success and safety: “No serious adverse events attributed to GEO-CM04S1… robust T-cell and cross-variant antibody responses… Primary endpoint achieved… comparator mRNA arm discontinued” .
  • Regulatory tailwind for GEO-MVA: EMA scientific advice supports bypassing Phase 1/2 to a Phase 3 immunobridging trial, with fill/finish of clinical batch underway and early 2026 trial path; management cited increased partnering interest .
  • Strategic manufacturing alignment: Oxford Biomedica CDMO partnership and focus on CEF platform for fastest registration; exploration of Vaxxas HD-MAP to improve stability and dose-sparing for global access .

What Went Wrong

  • Revenue drop and widened loss: BARDA contract termination resulted in zero Q3 revenue versus $2.79M in Q3 2024; net loss rose to $6.32M QoQ/YoY from $5.37M in Q2 and $5.82M in Q3’24 .
  • Funding dependence persists: CFO reiterated reliance on partnerships, non-dilutive sources, or additional equity offerings to extend runway amid stepped-up investment needs in CM04S1, GEO-MVA, and Gedeptin .
  • Timelines remain extended: GEO-MVA and Gedeptin Phase 2 starts targeted for 2H 2026, implying a multi-year path to potential revenues; interim milestones hinge on enrollment and regulatory coordination .

Financial Results

Core P&L and Cash Trends (Sequential)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD)$1,637,000 $852,282 $0
Net Loss ($USD)$(5,358,000) $(5,370,000) $(6,319,000)
Loss per Share ($USD)$(0.45) $(0.35) $(0.31)
R&D Expense ($USD)$5,355,000 $4,728,998 $5,043,504
G&A Expense ($USD)$1,687,000 $1,542,190 $1,329,711
Cash & Equivalents ($USD)$7,439,000 $3,093,862 $5,008,997

Year-over-Year (Q3 vs Q3 2024)

MetricQ3 2024Q3 2025
Revenue ($USD)$2,789,484 $0
Net Loss ($USD)$(5,815,468) $(6,318,914)
Loss per Share ($USD)$(0.91) $(0.31)

Estimates vs Actuals (S&P Global consensus)

MetricQ1 2025Q2 2025Q3 2025
Revenue Actual ($USD)$1,637,000 $852,282 $0
Revenue Consensus ($USD)$1,250,000*$533,330*$0*
EPS Actual ($USD)$(0.45) $(0.35) $(0.31)
EPS Consensus ($USD)$(0.6575)*$(0.36)*$(0.265)*
# of EPS Estimates4*4*4*
# of Revenue Estimates4*3*3*

Estimates marked with * are Values retrieved from S&P Global.

KPIs and Share Count

KPIQ1 2025Q2 2025Q3 2025
Common Shares Outstanding (period-end)13,839,478 15,924,593 29,705,360
Common Shares Outstanding (management current)—25.2M (as of call date) 27.7M (as of call date)

Note: Management-reported current shares may differ from period-end shares due to subsequent financing and corporate actions .

Segment Breakdown

GeoVax reported government contract revenue only; no product sales or segment revenue breakdown was disclosed .

Guidance Changes

Metric/ProgramPeriodPrevious GuidanceCurrent GuidanceChange
GEO-MVA Phase 3 immunobridging startDevelopment timelinePhase 3 to initiate in 2H 2026 EMA-aligned immunobridging path; clinical supply fill/finish underway; early availability for clinical evaluation next year; Phase 3 target remains 2H 2026 Maintained timeline; operational progress
GEO-MVA delivery (HD-MAP)Platform/Dose-sparingNot highlighted in Q1/Q2New collaboration with Univ. of Queensland/UniQuest evaluating Vaxxas HD-MAP for needle-free delivery New initiative
GEO-CM04S1 (CLL/immunocompromised)Clinical outcomesOngoing Phase 2; Pfizer arm halted in CLL at interim Primary endpoint achieved; strong T-cell/cross-variant responses; no SAEs; next-gen KP.2 construct planned for 2026 trial launch Progressed
Gedeptin® Phase 2 (HNSCC, first-line)Development timelinePhase 2 initiation targeted for 2H 2026; endpoint major pathological response Phase 2 initiation still targeted for 2H 2026; expansion into TNBC and cutaneous cancers Maintained timeline; expanded scope
Financial guidance (Revenue/Margins/OpEx)FY/QuarterNone provided None provided Maintained (none)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
EMA path for GEO-MVAEMA agreed to bypass Phase 1/2; Phase 3 immunobridging in 2H 2026; cGMP batch produced and quality released Fill/finish initiated; vaccine available early next year; expanded stakeholder engagement (WHO, White House, HHS) Improving operational readiness
BARDA Project NextGenStop Work/termination; net impact < $750k annually; Q2 last revenue recognition No Q3 revenue; continued dialogue on manufacturing funding “basket” Stabilized post-termination
CM04S1 efficacy in immunocompromisedMulti-antigen strategy; ongoing Phase 2s; CLL Pfizer arm halted Robust T-cell responses; primary endpoint achieved; no SAEs; 2026 next-gen construct Strengthening clinical profile
Oncology (Gedeptin) strategyProtocol pivot post KEYNOTE-689; first-line neoadjuvant with Pembro; major pathologic response endpoint; 2H 2026 start Expansion to TNBC and cutaneous; 2H 2026 initiation reaffirmed Broadening scope
Manufacturing/onshoringPursuing U.S.-based advanced MVA manufacturing; Oxford Biomedica partnership; BARDA basket for AG1 process U.S. policy alignment emphasized; CDMO partnership active; additional supply planning Positive policy tailwind
Partnerships/fundingActive conference-based partnering dialogues; exploring strategic, non-dilutive funding Increased interest reported; runway extension options reiterated Ongoing

Management Commentary

  • “EMA…providing an expedited development path for GEO-MVA…allowing us to bypass phase I and phase II clinical trials and proceed directly to a phase III immunobridging trial.”
  • “No serious adverse events attributed to GEO-CM04S1… Robust T-cell and cross-variant antibody responses… Primary endpoint achieved… Sustained cellular responses… Next-generation construct incorporating Omicron KP.2 Spike planned for 2026.”
  • “Our partner…we use CDMOs… we are partnered with Oxford Biomedica in the U.K.… in the process of packaging our clinical supplies… discussions with other potential manufacturers to add additional supply.”
  • “We continue to explore…strategies to fund these programs… strategic partnerships, non-dilutive funding, or additional offerings of our common stock.”
  • “We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply…addressing epidemic outbreaks and stockpile opportunities worldwide.”

Q&A Highlights

  • Emergency use pathways: Management does not expect use prior to clinical evaluation but acknowledges potential WHO emergency licensing in certain scenarios .
  • Collaboration/partnership scope: Company retains worldwide rights; open to regional development/regulatory collaborations; North America could be retained internally .
  • GEO-MVA delivery and manufacturing: Vaxxas HD-MAP evaluation underway; primary registration route via standard delivery; manufacturing on CEF with Oxford Biomedica; scaling plans for commercialization .
  • Geographic/public health priorities: Southern Hemisphere focus for mpox; emerging strain activity in U.S. and Europe; global stockpiles and endemic response envisioned .
  • Gedeptin endpoints/design: Major pathological response as primary; Simon two-stage design; ~36–40 patients; event-free survival at one year as secondary .

Estimates Context

  • Q3 2025: Revenue $0 vs $0* (inline); EPS $(0.31) vs $(0.265)*, a modest miss, driven by absence of BARDA revenue and higher net loss .
  • Q2 2025: Revenue beat ($0.85M vs $0.53M*); EPS slightly beat ($(0.35) vs $(0.36)*) .
  • Q1 2025: Revenue beat ($1.64M vs $1.25M*); EPS beat ($(0.45) vs $(0.6575)*) .

Estimates marked with * are Values retrieved from S&P Global.

Implication: With BARDA revenues gone, future consensus may shift toward zero near-term revenue until product commercialization or non-dilutive contracts emerge; EPS trajectories will hinge on R&D cadence, financing costs, and any partnership income .

Key Takeaways for Investors

  • Near-term fundamentals reflect a pre-revenue biotech pivoting from BARDA funding; monitoring cash, financing pace, and OpEx discipline is critical .
  • CM04S1’s immunocompromised focus and CLL success represent a differentiated clinical path; additional data and regulatory dialogue could be catalysts .
  • GEO-MVA enjoys EMA-backed expedited registration via Phase 3 immunobridging; fill/finish and stakeholder engagement (WHO/ASPR) position it for potential emergency use discussions and eventual commercialization .
  • Oncology optionality: Gedeptin’s move to first-line HNSCC and expansion into TNBC/cutaneous cancers increases addressable markets; watch for trial start and interim reads post-initiation .
  • Manufacturing narrative is a strategic asset: Oxford Biomedica partnership, potential U.S. onshoring, and HD-MAP evaluation could de-risk supply and support global access .
  • Funding/partnerships remain key: Active dialogues and non-dilutive sources could extend runway and share risk; equity raises will affect dilution and share counts .
  • Trading lens: Near-term news flow likely tied to CM04S1 presentations, EMA/FDA interactions on GEO-MVA, and any partnership/funding announcements; EPS prints will be driven by OpEx pace in absence of contract revenue .