Sign in

You're signed outSign in or to get full access.

GL

GeoVax Labs, Inc. (GOVX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $1.64M from BARDA’s Project NextGen contract (no revenue in Q1 2024), and net loss narrowed to $5.36M ($0.45 per share) from $5.85M ($2.47) YoY . Against S&P Global consensus, revenue beat ($1.64M vs $1.25M*) and EPS beat (-$0.45 vs -$0.66*) .
  • Post-quarter, BARDA terminated the NextGen award for convenience; management expects a final Q2 settlement bill and then no further contract revenue, with net financial impact < ~$0.75M per year, limiting operational disruption .
  • Clinical catalysts remain intact: healthy adult booster trial enrollment completed with readout targeted in Q2 2025; CLL Phase 2 continues after DSMB halted the mRNA control arm; stem cell/CAR-T trial enrollment continues .
  • GEO-MVA (Mpox/Smallpox) cGMP batch completed and vialing toward H2 2025 clinical start; management is engaging U.S. and global stakeholders amid strong onshoring and supply urgency themes .

What Went Well and What Went Wrong

  • What Went Well
    • Revenue introduced via BARDA contract and YoY loss narrowed; EPS improved to -$0.45 vs -$2.47 YoY .
    • Clinical progress and near-term readouts: healthy adult booster data expected in Q2 2025; CLL study continued with DSMB stopping the mRNA arm, supporting CM04S1 differentiation in immunocompromised populations .
    • Vaccine manufacturing and biosecurity positioning: GEO-MVA clinical material completed and moving to H2 2025 clinical evaluation; management underscores WHO-stated global need and U.S. onshoring momentum .
  • What Went Wrong
    • BARDA Project NextGen termination (for convenience) post-quarter reduces forward revenue visibility; management expects only a Q2 final settlement and then no additional revenue under the award .
    • R&D intensity remains elevated YoY (driven by BARDA, Gedeptin, GEO-MVA), up ~21% YoY to $5.4M in Q1 .
    • Oncology timing risk: management indicated Gedeptin Phase 2 start likely slid toward mid-to-late next year from earlier expectations, adding execution/timeline uncertainty .

Financial Results

MetricQ1 2024Q3 2024Q1 2025Q1 2025 Cons.
Revenue ($USD)$0 $2,789,000 $1,637,000 $1,250,000*
Net Loss ($USD)$(5,850,000) $(5,815,000) $(5,358,000) —
Diluted EPS ($)$(2.47) $(0.91) $(0.45) $(0.66)*

  • Operating Expenses | Metric ($USD) | Q1 2024 | Q3 2024 | Q1 2025 | |---------------|---------|---------|---------| | R&D Expense | $4,426,000 | $7,402,884 | $5,355,000 | | G&A Expense | $1,457,000 | $1,241,176 | $1,687,000 |

  • Balance Sheet / Share Metrics | Metric | Sep 30, 2024 | Dec 31, 2024 | Mar 31, 2025 | |--------|---------------|--------------|--------------| | Cash & Cash Equivalents ($USD) | $8,593,000 | $5,507,000 | $7,439,000 | | Total Liabilities ($USD) | $2,608,000 | $3,107,000 | $2,935,000 | | Stockholders’ Equity ($USD) | $8,504,000 | $5,049,000 | $7,898,000 | | Common Shares Outstanding (end of period) | 8,609,308 | 10,536,875 | 13,839,478 | | Weighted Avg. Shares (quarter) | — | — | 11,954,797 |

Notes:

  • Prior quarter Q4 2024 was reported on a full-year basis; detailed Q4-only quarterly line items were not available in the filings reviewed. The latest quarterly comp before Q1 2025 is Q3 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial guidance (revenue, EPS, margins)2025None disclosedNone disclosed; management discussed qualitative milestones and BARDA settlement mechanicsMaintained (no formal guidance)
Program milestones – CM04S1 booster (healthy adults)1H 2025“Data in 1H25”Readout targeted around mid-June (Q2 2025)Clarified timing
Program milestones – GEO-MVA (Mpox/Smallpox)2H 2025“Begin clinical eval. in 2H25”On track; cGMP product complete; vialing for H2 startMaintained
Program milestones – Gedeptin (H&N)2025-2026Planned Phase 2 initiation 2025Indication of push to mid/late next yearLowered timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q3 2024; Q-1: Q4 2024)Current Period (Q1 2025)Trend
BARDA/NextGenPreparing 10k-pt Phase 2b; sites/manufacturing underway Contract terminated for convenience; expect Q2 final settlement and then none; financial impact < ~$0.75M/yr Negative on funding; operational focus continues
CM04S1 (COVID-19)Phase 2 trials ongoing; booster/CLL/hematologic cohorts; broad/durable profile emphasized Healthy booster data mid-June; CLL arm continued as mRNA halted; stem cell/CAR-T enrolling Positive clinical momentum
GEO-MVA (Mpox/Smallpox)cGMP batch produced; global emergency reiterated; non-inferiority plan vs Jynneos discussed Vialing and H2 clinical start; strong onshoring/supply need; safety profile of MVA emphasized Positive readiness/positioning
Advanced MVA manufacturing (onshoring)AGE.1 process; U.S. supply chain interest noted U.S. manufacturing intent reiterated; BARDA manufacturing proposal “worthy” but pending funding Positive strategic direction; funding pending
Gedeptin (oncology)Planning Phase 2; CRO selection; materials prep Pushed timing to mid/late next year; validating studies and Phase 2 ops continuing Slower than prior plan

Management Commentary

  • “Despite the recent and unexpected termination of our Project NextGen award by BARDA, our commitment to advancing GEO-CM04S1 remains unwavering…particularly for the over 40 million immunocompromised individuals in the U.S.” — David Dodd, CEO .
  • “There will be a final settlement amount billed to BARDA during Q2 of this year and then nothing more going forward…net financial impact…less than $750,000 annually.” — Mark Reynolds, CFO .
  • “We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply…addressing both epidemic outbreaks and stockpile opportunities worldwide.” — David Dodd .

Q&A Highlights

  • BARDA termination context: Management attributes the termination to government efficiency rather than product issues; two other Project NextGen programs also experienced pauses; Vaxart’s hold was lifted, while others varied (Gritstone bankruptcy) .
  • Trial timing/next steps: Healthy adult booster data targeted for mid-June 2025; CLL trial continues with only CM04S1 arm; stem cell/CAR-T study enrolling with encouraging preliminary signals .
  • Focus population: Company prioritizes immunocompromised patients over healthy adult market, positioning CM04S1 as a differentiated solution where single-antigen vaccines underperform .
  • Mpox vaccine safety/onshoring: MVA platform cited for strong safety; intention to migrate manufacturing to the U.S. in partnership with Oxford Biomedica as funding allows .

Estimates Context

  • Q1 2025 actuals vs S&P Global consensus: Revenue $1.64M vs $1.25M* (beat); EPS -$0.45 vs -$0.66* (beat) . Where estimates may adjust: revenue removal post-Q2 due to BARDA contract termination likely reduces out-quarter revenue expectations; clinical readouts could drive reassessment of R&D timing and cash needs .
  • Consensus detail (S&P Global): EPS mean -0.6575* (4 est.); Revenue mean $1.25M* (4 est.). Actual revenue captured alongside consensus [GetEstimates].

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

Key Takeaways for Investors

  • Near-term catalysts remain: mid-June booster data, continued CLL Phase 2 progress, and H2 2025 initiation for GEO-MVA; these readouts are likely the principal stock drivers near term .
  • Post-quarter BARDA termination removes a contract revenue pillar; expect a Q2 settlement and then no BARDA revenue, shifting focus to financing/partnerships and cost discipline .
  • CM04S1’s immunocompromised focus and multi-antigen profile provide a differentiated clinical narrative that could support expedited regulatory paths if data remain favorable .
  • GEO-MVA positions GeoVax to address a validated public health need with cGMP product in hand and a potential U.S.-based supply story; regulatory and partnership execution will be critical .
  • Oncology optionality via Gedeptin persists but with timing pushed; clarity on trial start and external funding could re-rate program expectations .
  • Share count continues to rise to fund operations; CFO flagged funding strategies (partnerships, non-dilutive, equity), making data-driven inflection points central to minimizing dilution .