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VI

Vaxart, Inc. (VXRT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue surged to $20.9M, driven primarily by BARDA-funded government contracts; net loss improved to $15.6M ($0.07 per share) from $24.4M ($0.14 per share) in Q1 2024 .
  • Operating update: HHS/ATI lifted the stop-work order (Apr 24), screening resumed, and dosing in the 10,000-participant Phase 2b COVID study is expected to begin in Q2 2025; BARDA later approved dosing initiation (May 15) .
  • Norovirus: completed Phase 1 enrollment (60 participants); DSMB recommended continuation without modifications; topline data expected mid-2025 .
  • Cash, cash equivalents, and investments were $41.9M as of Mar 31, 2025; management now guides cash runway into Q1 2026 (raised vs prior guide into Q4 2025) and is pursuing partnerships/non-dilutive funding .
  • Corporate governance catalyst: reverse split proposal narrowed (max 1-for-20 and proportional authorized share reduction) to maintain Nasdaq listing; ISS and Glass Lewis recommended FOR; vote outcome could drive near-term stock reaction .

What Went Well and What Went Wrong

  • What Went Well

    • Stop-work order lifted for the 10,000-participant portion of the COVID-19 Phase 2b trial, enabling immediate screening and Q2 dosing start; later received BARDA approval to initiate dosing .
    • Norovirus Phase 1 completed enrollment rapidly; DSMB interim review supported continuation with no changes, and topline data is on track for mid-2025 .
    • Management emphasized platform differentiation and government support: “We believe that the additional review and scrutiny…will ultimately instill greater confidence” (Steven Lo) .
  • What Went Wrong

    • Elevated R&D spending ($30.7M) from COVID/norovirus trials increased OpEx despite G&A reductions; net loss remains sizable at $15.6M .
    • NASDAQ minimum bid non-compliance persists; management discussed last-resort reverse split to avoid delisting, highlighting risk to liquidity/coverage if delisted .
    • The earlier 60-day pause impacted timeline; enrollment/dosing reactivation required site restarts and logistics coordination (20 sites activated; ~199 individuals in screening as of the call) .

Financial Results

MetricQ3 2024Q1 2024Q1 2025
Revenue ($USD Millions)$4.9 $2.2 $20.9
Net Loss ($USD Millions)$14.1 $24.4 $15.6
Diluted EPS ($USD)$(0.06) $(0.14) $(0.07)

Notes: Q4 2024 quarterly figures were not disclosed at a quarterly granularity in the FY press release; only full-year data was provided .

KPIs and Balance Sheet Highlights:

KPIQ1 2025
Cash, Cash Equivalents & Investments ($M)$41.9
Cash RunwayInto Q1 2026
Project NextGen Total Award (Up to, $M)$460.7
Available for Payment (Up to, $M)$240.1
Cash Received to Date (as of Mar 31, 2025, $M)$85.6
Norovirus Phase 1 Enrollment60 completed; DSMB continuation
COVID Phase 2b Sites Activated / Screening (as of call)20 sites; ~199 individuals screened

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-levelInto Q4 2025 Into Q1 2026 Raised
COVID Phase 2b Dosing Start10,000-part cohortPending stop-work resolution Dosing expected to begin Q2 2025; BARDA approval to initiate dosing granted May 15 Clarified/advanced
COVID Phase 2b Enrollment Duration10,000-part cohortN/A~5–6 months projected (management comment) New disclosure
Norovirus Phase 1 ToplinePhase 1As early as mid-2025 Mid-2025 Maintained
Norovirus Next StepPhase 2bCould begin as early as H2 2025 (pending funding/partnership) Maintained Maintained
Avian Influenza PreclinicalPreclinical readout“Publish when complete” Publication intended upon full analysis completion Maintained
Nasdaq Listing/Reverse SplitCorporateProposal under consideration Narrowed—max 1-for-20; proportional authorized share reduction if passed Clarified/narrowed

Earnings Call Themes & Trends

TopicQ3 2024 MentionsQ4 2024 MentionsQ1 2025 Current PeriodTrend
COVID Phase 2b trial statusSentinel cohort enrollment initiation; plan for 10k post DSMB/FDA review Stop-work order received; continued sentinel follow-up Stop-work lifted; screening underway; BARDA approved dosing initiation; Q2 dosing expected Improving operational momentum
Norovirus programFDA feedback on correlates; next-gen constructs; plan for Phase 1 Initiated Phase 1; design and correlates context Phase 1 enrollment completed; DSMB continuation; topline mid-2025 Executing as planned
Cash runway/cost actionsCash into 2026 guided Workforce reductions post stop-work; runway into Q4 2025 Runway raised to Q1 2026; continued cost discipline Improved outlook
NASDAQ compliance/reverse splitN/AN/AManagement framed reverse split as last resort to avoid delisting; later narrowed proposal Heightened governance focus
Avian influenza preclinicalN/APlatform capabilities; planning preclinical 100% protection in ferret challenge model; intend peer-reviewed publication Strengthening data story

Management Commentary

  • Steven Lo on stop-work lift and confidence in study: “We believe that the additional review and scrutiny…will ultimately instill greater confidence in the study’s results” .
  • James Cummings on COVID Phase 2b operations: reactivating sites, screening participants, shipment logistics; efficacy assessed across symptomatic and asymptomatic disease .
  • Sean Tucker on avian flu: “Our new avian flu influenza vaccine was 100% protective against death in a robust ferret…compared with 0% survival in placebo” with plans for peer-reviewed reporting .
  • Steven Lo on reverse split: “We consider the reverse stock split a measure of last resort…to ensure our continued listing on NASDAQ” .

Q&A Highlights

  • COVID dosing gating factors and enrollment cadence: Management expects ~5–6 months to enroll the 10,000-participant cohort; operational gating involves site reactivation, screening, and logistics .
  • Sentinel cohort interim considerations: Team intends to engage BARDA on possible interim analysis; blinded double-blind design with 12-month safety follow-up completing by December 2025 .
  • Norovirus Phase 1 “success” definition: New constructs should trend better than old constructs on key immunogenicity endpoints; study not powered for statistical significance .
  • Norovirus DSMB review: Clean safety profile, very similar to placebo; parameters include functional serum antibodies and fecal IgA .
  • Reverse split rationale and process: To avoid delisting, aim for minimal ratio necessary; optionality to appeal timeline if needed .

Estimates Context

Wall Street consensus (S&P Global/Capital IQ) for VXRT’s Q1 2025 EPS and revenue was unavailable via our estimates tool at this time; therefore, estimate comparison and beat/miss analysis cannot be provided. We attempted to fetch “Primary EPS Consensus Mean,” “Revenue Consensus Mean,” and related counts for the last three quarters, but the dataset returned empty. Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst: BARDA approval and Q2 initiation of dosing in the 10,000-participant COVID Phase 2b cohort provide a tangible operational inflection; enrollment pace (~5–6 months expected) will shape the 2025–2026 readout path .
  • Norovirus readout (mid-2025) is critical for partnership/non-dilutive funding pathways and could strengthen the platform’s commercial viability; DSMB endorsed continuation with no changes .
  • Financial trajectory improved: substantially higher Q1 revenue and lower net loss/EPS versus prior year; cash runway raised to Q1 2026 under current plan .
  • Governance risk management: reverse split proposal narrowed (max 1:20 and proportional authorized share reduction) to maintain Nasdaq listing—vote outcome may drive stock liquidity and coverage dynamics .
  • Program optionality: avian influenza preclinical data (ferret model) offers potential BD optionality and incremental platform validation .
  • Watch for sentinel cohort updates: interim discussions with BARDA could accelerate insights; full 12-month follow-up remains key for efficacy durability .
  • Funding mechanics: Project NextGen award terms provide significant external funding for trial execution, with $85.6M received to date and $240.1M currently available, but do not fully fund corporate operations—partnerships remain a priority .