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
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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” .
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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)
- Estimates vs Actuals (S&P Global)
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.
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Segment breakdown: Vaxart does not report operating segments; Q3 revenue was primarily government contract revenue related to BARDA .
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KPIs and balance sheet highlights
Guidance Changes
No formal revenue, margin, or OpEx numeric guidance was issued; management emphasized liquidity extension and clinical timelines .
Earnings Call Themes & Trends
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 .