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VI

Vaxart, Inc. (VXRT)·Q3 2025 Earnings Summary

Executive Summary

  • Vaxart delivered a revenue surge to $72.4M in Q3 2025, driven by BARDA-related contract revenue, narrowing net loss to $8.1M ($0.04) from $14.1M ($0.06) YoY, while R&D rose sharply to support clinical programs .
  • Signed an exclusive worldwide license with Dynavax for the oral COVID-19 vaccine: $25M upfront, $5M equity investment, up to $700M in milestones plus low-to-mid teens royalties; extends cash runway into Q2 2027—a key liquidity and validation milestone .
  • COVID-19 Phase 2b trial enrollment completed (~5,400); 400-patient sentinel cohort topline in Q1 2026; full 12‑month topline in late 2026; BARDA continues funding for follow-up despite earlier stop-work order on further enrollment .
  • Norovirus: additional Phase 1 data showed markedly higher fecal IgA responses with second‑gen constructs; next clinical trial now targeted for 2026 pending partnership/funding—a shift from prior timelines .
  • Stock narrative catalysts: Dynavax partnership validation and upfront cash, concrete 2026 readout milestones, and ongoing BARDA-funded follow-up; governance/OTCQX listing remain watch items .

What Went Well and What Went Wrong

  • What Went Well

    • Dynavax partnership validated platform and added non-dilutive capital: “Vaxart could potentially receive up to $700 million... and tiered royalties” with $25M upfront and $5M equity; runway now into Q2 2027 .
    • Clinical execution: completed ~5,400 participants in COVID-19 Phase 2b; sentinel topline in Q1 2026; overall topline in late 2026; BARDA funding continues for follow-up .
    • Norovirus immunogenicity improved: second‑gen constructs showed 25‑fold (GII.4) and 10‑fold (GI.1) fecal IgA increases at high dose vs baseline; management: “our oral pill vaccine has the potential to transform global public health” .
  • What Went Wrong

    • R&D expenses spiked to $75.9M (vs $15.1M YoY) due to COVID-19 trial costs, pressuring operating loss despite revenue spike .
    • Norovirus timelines pushed: next clinical now expected in 2026, contingent on partnership/funding, vs prior expectation of potentially 2H25 .
    • Ongoing structural/market overhangs: shares trade on OTCQX (post‑Nasdaq suspension); shareholder activism around reverse split reflected governance tension in September .

Financial Results

  • Income statement comparisons (oldest → newest)
MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$4.933 $20.876 $39.730 $72.413
R&D Expense ($USD Millions)$15.066 $30.744 $49.735 $75.947
G&A Expense ($USD Millions)$4.342 $5.067 $4.598 $4.277
Total Operating Expenses ($USD Millions)$19.408 $35.811 $54.333 $80.224
Operating Loss ($USD Millions)$(14.475) $(14.935) $(14.603) $(7.811)
Net Loss ($USD Millions)$(14.080) $(15.591) $(14.986) $(8.141)
Diluted EPS ($)$(0.06) $(0.07) $(0.07) $(0.04)
  • Estimates vs Actuals (S&P Global)
MetricQ3 2025 ActualS&P Global ConsensusBeat/Miss
Revenue$72.413M N/AN/A
Diluted EPS$(0.04) N/AN/A

S&P Global Wall Street consensus estimates were unavailable for VXRT at retrieval time; as a result, a beat/miss analysis could not be performed. Values retrieved from S&P Global.

  • Segment breakdown: Vaxart does not report operating segments; Q3 revenue was primarily government contract revenue related to BARDA .

  • KPIs and balance sheet highlights

KPIQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Investments ($M)$41.9 $26.3 $28.8
Accounts Receivable ($M)$1.500 $4.281 $42.716
Unbilled Govt Receivable ($M)$14.622 $36.781 $43.229
Deferred Government Revenue ($M)$65.353 $65.377 $64.828
COVID-19 P2b Enrollment (participants)~5,000 enrolled at stop-work ~5,400 completed
BARDA Cash Received (Cumulative)$85.6M (as of 3/31/25) $98.9M (as of 6/30/25) $125.9M (as of 9/30/25)
Cash RunwayInto Q1 2026 Into 2026 Into Q2 2027 (post Dynavax)
Dynavax Consideration$25M upfront + $5M equity

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayLiquidityInto Q1 2026 (Q1 release) Into Q2 2027 (post Dynavax) Raised/Extended
Norovirus next clinical trial startProgram timingPotentially as early as 2H 2025 pending funding (Q2) 2026, pending partnership/funding Lowered/Deferred
COVID-19 P2b sentinel toplineData timingQ1 2026 (Q2) Q1 2026 Maintained
COVID-19 P2b all-participants toplineData timingLate 2026 (Q2) Late 2026 Maintained

No formal revenue, margin, or OpEx numeric guidance was issued; management emphasized liquidity extension and clinical timelines .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025 and Q2 2025)Current Period (Q3 2025)Trend
BARDA/Project NextGen and trial statusQ1: Stop‑work lifted for 10k cohort; screening underway . Q2: New stop‑work; ~5,000 enrolled; BARDA to fund follow-up .BARDA continues to fund follow-up for ~5,400 enrolled; toplines in Q1’26/Q4’26 .Stable execution post-enrollment halt; timelines intact.
Dynavax partnershipNot discussed in Q1/Q2.Exclusive license for oral COVID-19 vaccine; $25M upfront, $5M equity; up to $700M milestones + royalties; runway into Q2’27 .New strategic validation and funding.
Norovirus programQ1: Phase 1 topline mid‑2025; partnership sought . Q2: Positive topline (blocking antibodies); targeting Phase 2b pending funding .Additional Phase 1 data (fecal IgA up to 25x/10x); next trial moved to 2026 pending funding .Immunogenicity stronger; timeline deferred for funding.
Manufacturing/strain agility (COVID)Q1: Ramp-up to dosing; site activations .Able to manufacture for XBB and KP.2 strains; emphasized flexibility .Positive capability signal.
Liquidity/cost actionsQ1: Runway into Q1’26; workforce reductions . Q2: Runway into 2026; further RIF; expect >50% of contract collected .Runway into Q2’27 with Dynavax; prudent OpEx mgmt reiterated .Improved liquidity outlook.
Listing/governanceQ1: Nasdaq compliance focus; reverse split vote . Q2: OTCQX trading; Nasdaq extension efforts .Footnote: trades on OTCQX; separate shareholder activism in Sept .Continuing overhang.

Management Commentary

  • “Vaxart could potentially receive up to $700 million in total license, regulatory, and milestone fees, as well as royalties for our oral COVID-19 vaccine candidate… Combined with our current cash position, our cash runway now extends into the Q2 of 2027.” — CEO Steven Lo .
  • “We remain on track to report 12‑month top‑line data from the 400‑participant Sentinel cohort in Q1 of 2026 and… all participants in Q4 of 2026.” — CMO James Cummings .
  • “The data showed a 25‑fold increase in the GII.4 fecal IgA response and a 10‑fold increase in the GI.1 fecal IgA response… after a single tablet.” — CSO Sean Tucker .
  • “Our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration.” — CEO Steven Lo .

Q&A Highlights

  • Dynavax deal timing and diligence: Management cited platform science/mucosal immunity and a strong strategic fit; both parties conducted diligence while blinded to trial data; partnership aligns pre‑data due to expertise and timing .
  • Norovirus funding prioritization: Upfront payments extend runway, but management still prioritizes securing a partner before starting the next trial; 2026 start targeted .
  • Market potential for oral COVID and strain flexibility: Team emphasized large remaining market and convenience advantages; manufacturing demonstrated responsiveness to XBB and KP.2; cross‑reactivity a focus over 12‑month efficacy observation .
  • Transmission impact: Management noted mucosal responses may reduce transmission based on animal models, potentially improving public health benefit vs injectables .

Estimates Context

  • S&P Global consensus for Q3 2025 revenue and EPS was unavailable for Vaxart at retrieval time, so a beat/miss assessment could not be performed. Values retrieved from S&P Global.
  • Given limited coverage and OTCQX trading status, estimate visibility appears constrained; we expect models to update around Dynavax economics and 2026 clinical readout timing .

Key Takeaways for Investors

  • Dynavax licensing is a pivotal validation and liquidity event (upfront $30M combined; up to $700M milestones + royalties), extending runway into Q2 2027 and reducing near‑term financing risk .
  • COVID-19 Phase 2b execution remains on course post‑enrollment halt: ~5,400 participants enrolled; two 2026 toplines (Q1 sentinel, late‑year all participants) are the core value inflections .
  • Revenue ramp reflects BARDA program accounting; near‑term P&L will remain program‑driven while R&D stays elevated into readouts; Q3 operating loss narrowed on higher revenue .
  • Norovirus continues to show improved immunogenicity with second‑gen constructs; timing shift to 2026 underscores the importance of a partner; watch for BD updates .
  • Overhangs include OTCQX listing status and shareholder activism; any clarity on relisting path and governance could improve investor access and sentiment .
  • Near‑term catalysts: details of Dynavax collaboration mechanics, any non‑dilutive funding, and continued BARDA cash receipts during follow‑up; medium‑term: 2026 sentinel/all‑participants toplines .
  • Position sizing should reflect binary clinical outcomes and funding dependencies; the Dynavax deal partially de‑risks capital needs ahead of 2026 readouts .

Additional Relevant Press Releases (Q3 2025)

  • Conference logistics for Q3 results and fireside chat (11/13 call; 11/18 chat) .
  • World Vaccine Congress Europe presentations on norovirus and COVID (Oct 13–16) .
  • Additional Phase 1 norovirus data (fecal IgA increases; correlates of protection) presented at 9th International Calicivirus Conference .
  • Chairman retirement announcement (effective Sep 30) ; separate shareholder soliciting PR opposed reverse split (Sep 2) .

Cross-References and Reconciliations

  • Q3 revenue and EPS cited consistently across 8‑K/press release and call remarks (Revenue: $72.4M; EPS: $(0.04)) .
  • R&D increase attribution (COVID-19 trial costs) appears in the 8‑K press release commentary .
  • Clinical timelines (Q1’26 sentinel, late‑’26 overall) consistent across press release and call .