Sign in

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

VI

Vaxart, Inc. (VXRT)·Q4 2024 Earnings Summary

Executive Summary

  • FY24 revenue rose to $28.7M (from $7.4M in 2023) on BARDA-related government contracts; FY24 net loss narrowed to $66.9M ($0.33/share) vs $82.5M ($0.57/share) in 2023 . Q4 revenue is implied at ~$15.19M (FY less 9M), with Q4 net loss implied at ~$12.0M (FY less 9M) as BARDA funding ramped late in the year .
  • COVID-19 Phase 2b: 400-person sentinel cohort completed in Dec-2024; DSMB recommended proceeding without modification in Jan-2025, but on Feb 21, 2025 the U.S. government issued a stop-work order pausing the 10,000-participant portion pending further decision within 90 days (follow-up on the 400-person cohort continues) .
  • Norovirus: Initiated Phase 1 trial in Mar-2025 to test second-generation constructs head-to-head vs first-gen, with topline data as early as mid-2025; complete Phase 1b data in elderly published in Science Translational Medicine showed strong mucosal/systemic immunogenicity and favorable safety .
  • Liquidity and runway: Cash, cash equivalents and investments were $51.7M at 12/31/24 with runway into 4Q25; management implemented ~10% workforce reduction after the stop-work order and is exploring partnerships/non-dilutive funding. Key near-term catalysts: resolution of stop-work order and norovirus Phase 1 readout .

What Went Well and What Went Wrong

  • What Went Well

    • DSMB safety green-light: “an independent DSMB … recommended that the study continue without any modifications” for the 400-patient COVID-19 sentinel cohort; FDA review ongoing .
    • Norovirus advancement and data: Phase 1 trial of second-gen constructs initiated; published elderly Phase 1b data showed “strong and durable antibody responses” including mucosal IgA in saliva and nasal cavity; vaccine was well tolerated with only mild-moderate solicited events .
    • CEO tone on platform: “Our candidates have demonstrated … long duration of protection … and importantly, a benign safety and tolerability profile” across 19 trials/7 viruses, reinforcing the differentiation of mucosal, oral pill vaccines .

  • What Went Wrong

    • COVID-19 trial uncertainty: Stop-work order on Feb 21, 2025 halted the 10,000-participant portion of the BARDA-funded Phase 2b study; Vaxart has not been provided a reason; decision to cancel/extend/terminate expected within 90 days .
    • Cash runway shortened: Guidance moved from “into 2026” (as of Q3) to “into 4Q25” at year-end, accompanied by ~10% workforce reduction after the stop-work order .
    • Estimates context: Street consensus for Q4 2024 revenue/EPS was unavailable via S&P Global, limiting beat/miss assessment versus expectations (see Estimates Context) (Values retrieved from S&P Global)*.

Financial Results

Quarterly trend (sequential)

MetricQ2 2024Q3 2024Q4 2024 (derived)
Revenue ($M)$6.40 $4.93 $15.19 (FY24 $28.70 – 9M24 $13.52)
Net Loss ($M)$(16.47) $(14.08) $(11.99) (FY24 $(66.95) – 9M24 $(54.96))
Net Income Margin %(257.2%) (−16.47/6.40) (285.4%) (−14.08/4.93) (79.0%) (−11.99/15.19)
Diluted EPS ($)$(0.09) $(0.06) n/a – not disclosed at Q4; FY only

YoY comparison (quarter)

MetricQ4 2023 (derived)Q4 2024 (derived)YoY Change
Revenue ($M)$3.27 (FY23 $7.38 – 9M23 $4.13) $15.19 (FY24 $28.70 – 9M24 $13.52) +$11.92M
Net Loss ($M)$(17.41) (FY23 $(82.47) – 9M23 $(65.09)) $(11.99) (FY24 $(66.95) – 9M24 $(54.96)) +$5.42M (improvement)
Net Income Margin %(533.0%) (−17.41/3.27) (79.0%) (−11.99/15.19) +4540 bps

Balance sheet and liquidity

MetricJun 30, 2024Sep 30, 2024Dec 31, 2024
Cash, Cash Equivalents & Investments ($M)$62.6 $58.7 $51.7
Deferred Government Revenue ($M)n/a$65.45 $65.40

Notes:

  • FY24 results: Revenue $28.7M; Net loss $66.9M; diluted net loss/share $0.33 .
  • Q4 2024 quarterly figures are derived from FY less 9M; EPS for the quarter not disclosed in filings .

Segment breakdown: Not applicable; Vaxart is a clinical-stage biotech without revenue-generating product segments .

KPIs:

  • COVID-19 Phase 2b sentinel cohort completed (400 participants), DSMB recommended continuing without modification; 10k expansion paused by stop-work order pending decision .
  • Norovirus Phase 1 (second-gen constructs) initiated; topline as early as mid-2025 .

Guidance Changes

Metric/TopicPeriodPrevious Guidance/StatusCurrent Guidance/StatusChange
Cash RunwayMulti-quarterInto 2026 (as of Q3 2024) Into 4Q25 (as of FY24 update) Lowered
COVID-19 Phase 2b (10k pts)2025 executionExpected to progress to 10k in early 2025 pending DSMB/FDA review Stop-work order (Feb 21, 2025) pauses work on 10k portion; sentinel 400 follow-up continues Paused
Workforcen/aNot previously disclosed~10% reduction after stop-work order New cost action
Norovirus program2025 milestonesFDA requested new clinical data; evaluating next steps Phase 1 initiated (Mar 2025); topline as early as mid-2025 Advanced

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024 call)Trend
COVID-19 Phase 2b trialBARDA award up to ~$453–$456M; planning 10k trial; sentinel 400 to complete; interim at 255 cases Sentinel 400 completed; DSMB recommended proceed; stop-work order issued; continuing 400-cohort follow-up; working with HHS/BARDA Mixed: safety positive; program paused pending decision
NorovirusFDA requested additional data; new GI.1/GII.4 constructs with higher potency in preclinical Phase 1 initiated; topline mid-2025; elderly Phase 1b published; immunogenicity focus (serum NBAA, fecal IgA) Advancing with data momentum
ManufacturingPrepared for trial; sufficient vaccine supply GMP capacity in U.S.; shelf life expected ~2 years; flexibility to pivot strains Ready/robust
Cash runway/fundingInto 2026; post-award $64.7M payment received; exploring partnerships Into 4Q25; cost reductions; pursuing partnerships/non-dilutive funding Runway shortened; funding focus elevated
Regulatory/political environmentFrequent FDA dialogue (COVID, norovirus) Engaging FDA; defers comment on stop-work details; collaborative posture with HHS/BARDA Increased external dependency

Management Commentary

  • CEO on platform differentiation: “Our candidates have demonstrated … reduction in viral transmission and shedding, long duration of protection … and importantly, a benign safety and tolerability profile. Across 19 clinical trials … our vaccine candidates have shown favorable safety data.”
  • CEO on stop-work order approach: “We recognize and appreciate the importance of oversight … and we are committed to working collaboratively with … HHS, BARDA … as they evaluate … the 10,000 participant portion of the Phase 2b study” .
  • CSO on second-gen norovirus constructs: “Through the power of machine learning, we created new … constructs … designed to express the antigenic protein at higher levels in the intestinal space … [with] substantially improved immune responses compared to our first generation constructs” .
  • CMO on elderly data: The vaccine “generated robust and durable systemic antibody responses … [and] strong and durable IgA responses in the saliva and the nasal cavity … [and] was safe and well tolerated” .
  • CTO on manufacturing/shelf life: “We maintain our own GMP manufacturing facilities … shelf life is expected to last for two years” .

Q&A Highlights

  • Norovirus construct and endpoints: Phase 1 enrolls ~60 adults 18–49 across dose cohorts; immunogenicity readouts will focus on serum norovirus blocking antibody assay (NBAA) titers and fecal IgA, which correlated with protection in the challenge model .
  • Translational potency: Second-gen constructs showed stronger immune responses in animals; management expects even small human increases could materially improve protective efficacy based on modeling .
  • Sentinel cohort/Regulatory: DSMB recommended proceeding with no modifications; FDA received the same 30-day safety data; manufacturing in place to support continuation if authorized .
  • Market opportunity/competition: Management highlights ~$10B U.S. annual economic burden of norovirus and believes an oral option will be competitive even as large players pursue injected candidates .
  • Funding/partnerships: Company is engaging multiple parties for partnerships and non-dilutive funding; will update when appropriate .

Estimates Context

  • Street consensus for Q4 2024 revenue and EPS was unavailable via S&P Global; therefore, we cannot assess beats/misses versus estimates for the quarter. Management did not provide formal numeric guidance for revenue/EPS, limiting forward estimate anchoring (Values retrieved from S&P Global)*.

Key Takeaways for Investors

  • Safety de-risking achieved on COVID program (DSMB positive), but program visibility depends on resolution of the federal stop-work order; any favorable decision would be a material catalyst .
  • Norovirus is the clearer near-term value driver: Phase 1 underway with topline as early as mid-2025; recent peer-reviewed elderly data bolster the mucosal platform case .
  • FY24 revenue inflected on BARDA contracts, with implied Q4 revenue step-up; net loss improved YoY, and quarterly net loss narrowed sequentially into Q4 as spend and revenue timing shifted .
  • Runway moved up to 4Q25 with cost actions; partnership/non-dilutive funding remains important to extend runway and advance programs amid stop-work uncertainty .
  • Manufacturing readiness and pill-based logistics (stable shelf life, U.S. GMP) remain strategic advantages for pandemic preparedness and potential partnering .
  • Near-term trading setup: Watch for stop-work resolution by ~90 days from Feb 21, 2025 and norovirus Phase 1 topline mid-2025; both could drive step-changes in narrative and risk profile .

Supporting detail excerpts and sources:

  • FY24 results press release and attached financials (8-K Item 2.02): revenue $28.7M; net loss $66.9M; cash/investments $51.7M; runway into 4Q25; ~10% workforce reduction; stop-work order description .
  • COVID sentinel/DSMB: DSMB recommended “continue without modifications” (Jan-14-2025) .
  • Norovirus Phase 1 initiation (Mar-11-2025) and Science Translational Medicine publication (Mar-5-2025) .
  • Q3 2024 (for 3Q and 9M figures used in derivations): revenue $4.93M; net loss $14.08M; 9M24 revenue $13.52M; 9M24 net loss $54.96M; cash/investments $58.7M; prior runway “into 2026” .
  • Q2 2024 (for trend): revenue $6.40M; net loss $16.47M; cash/investments $62.6M .
  • Q4 2024 earnings call transcript (program updates, Q&A details, quotes) .