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VI

Vaxart, Inc. (VXRT)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered a sharp revenue inflection driven by BARDA project revenue ($39.73M, +520% YoY) while net loss narrowed modestly to $15.0M; EPS was -$0.07 versus -$0.09 last year .
  • Operationally, the COVID-19 Phase 2b trial was halted on Aug 5 via a stop-work order after ~5,000 of the planned 10,000 participants were enrolled; follow-up continues for those dosed and the 400-person sentinel cohort, with topline data anticipated in late 2026 and sentinel cohort data in Q1 2026 .
  • Norovirus program advanced meaningfully: Phase 1 topline showed statistically significant increases in blocking antibodies with second-generation constructs (GI.1 +141%, GII.4 +94%), supporting improved protection potential; Phase 2b start is contingent on funding/partnership and could begin as early as H2 2025 .
  • Cash and investments were $26.3M at quarter end, with runway into early 2026; workforce was reduced by ~21% in Q2 following a ~10% reduction earlier in 2025 to align costs with program needs .
  • Near-term stock catalysts: Nasdaq relisting process (reverse split proposal vote Sept 5; panel hearing Aug 14; fireside chat Aug 20), BARDA follow-up clarity, and potential norovirus partnership progress .

What Went Well and What Went Wrong

What Went Well

  • Norovirus second‑generation constructs delivered statistically significant antibody improvements versus first generation (GI.1 +141%, GII.4 +94%) with clean safety, strengthening the case for Phase 2b and potential partnership interest .
  • COVID-19 Phase 2b enrollment ramped rapidly to ~5,000 prior to the stop-work order, indicating strong participant demand; DSMB permitted continuation without modification in July, validating safety profile .
  • Avian influenza preclinical candidate showed 100% survival in ferret challenge versus 0% for placebo, reinforcing platform potential and partnership opportunities .

Management quotes:

  • “We continue to make significant progress in advancing our novel, oral vaccine platform” .
  • “We believe the robust enrollment pace showcases the demand for a better COVID vaccine” .
  • “These data are highly compelling and have the potential to support a partnership or business development opportunity” (avian flu) .

What Went Wrong

  • A second stop-work order (Aug 5) paused COVID Phase 2b screening/enrollment mid‑execution, creating timeline uncertainty and funding visibility risk despite continued follow-up for ~5,000 already dosed and the sentinel cohort .
  • R&D expenses surged to $49.7M (+184% YoY) due to trial activity, outpacing revenue growth and pressuring operating results despite improved YoY net loss .
  • Nasdaq listing suspension and OTCQX trading reduced institutional investor access and potential partner perception; company is seeking shareholder approval for a reverse split to support relisting .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$6.40 $20.90 $39.73
Net Loss ($USD Millions)$(16.47) $(15.60) $(14.99)
EPS ($USD)$(0.09) $(0.07) $(0.07)
R&D Expense ($USD Millions)$17.48 $30.70 $49.74
G&A Expense ($USD Millions)$5.18 $5.10 $4.60
  • Drivers: Q2 revenue primarily from BARDA government contracts; YoY increase reflects project ramp; R&D spike linked to COVID and norovirus trial costs; G&A decreased YoY on lower professional fees .

KPIs and Operational Metrics

KPIQ4 2024Q1 2025Q2 2025
COVID Phase 2b sentinel cohort (400) statusEnrollment completed; DSMB Jan: proceed without modification Per protocol follow-up continued; 12‑month follow-up concludes Dec 2025 Data expected Q1 2026
COVID Phase 2b 10k cohortStop-work order (Feb 21) paused planning Stop-work order lifted Apr 24; screening and site reactivation underway Second stop-work order Aug 5; ~5,000 enrolled; follow-up continues; topline late 2026
Norovirus Phase 1 toplineEnrollment completed; topline mid‑2025 guided GI.1 +141% and GII.4 +94% NBAA increases; well‑tolerated
Avian influenza preclinical100% survival vs placebo in ferret clade 2.3.4.4b model (ongoing publishing plan) Maintained: 100% survival; plan to publish
Cash & investments ($MM)$41.90 $26.30
BARDA cash receipts cumulative$85.6MM through Mar 31, 2025 $98.9MM through Jun 30, 2025
Workforce reductions~10% in 2025 to date Additional ~21% in Q2 2025

Segment Breakdown

  • Vaxart reports as a single operating segment (no segment breakdown disclosed) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
COVID Phase 2b 10k cohort toplineLate 202612‑month follow-up after last dosing; timeline implied for late 2026 Topline data anticipated in late 2026 Maintained
COVID sentinel cohort toplineQ1 2026Follow-up concludes Dec 2025; data 3–6 months thereafter Data anticipated in Q1 2026 Clarified timing
Norovirus Phase 2b start (funding-dependent)H2 2025 (potential)Phase 2b could begin as early as H2 2025 pending funding/partnership Maintained expectation pending funding/partnership Maintained
Cash runwayInto 2026Into Q1 2026 Into Q1 2026 (current plan); pursuing BD/non‑dilutive funding to extend Maintained
BARDA contract collection (post stop-work)2025–2026N/AExpect >50% of original contract value to be collected given fixed costs New expectation
Stock listing plan2025Reverse split proposal; appeal/hearing with Nasdaq Reverse split ratio 1:5–1:20 proposed; special meeting Sept 5; fireside chat Aug 20 Reaffirmed with narrower ratio

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
COVID Phase 2b executionQ4: stop-work order (Feb); sentinel cohort safe; platform alignment with BARDA/HHS Rapid enrollment to ~5,000; second stop-work order; DSMB OK; follow-up funded; topline late 2026 Mixed: execution strong; external halt creates uncertainty
Norovirus programQ4/Q1: initiated Phase 1; endpoints NBAA, fecal IgA; Phase 2b contingent on funding Phase 1 topline: GI.1 +141%, GII.4 +94%; safety clean; active BD discussions Positive momentum toward Phase 2b
Avian influenzaQ4/Q1: new construct; 100% survival in ferrets; plan to publish Reiterated ferret survival; BD interest; publication plan Continued strength; early-stage
Funding/partnershipsQ4/Q1: pursuing BD, non-dilutive funding; CFO transition Active discussions; norovirus partnership gating; >50% BARDA collection expected Ongoing; visibility improving slightly
Stock listing / NasdaqQ1: reverse split proposal rationale OTCQX trading; Nasdaq hearing Aug 14; reverse split vote Sept 5; fireside chat Aug 20 High-priority relisting effort
R&D execution/costsQ1: site reactivation, screening; R&D $30.7M R&D $49.7M; workforce reductions ~21% in Q2 Elevated spend; cost actions taken
Regulatory/legalQ4/Q1: DSMB OK; FDA data sharing; contractual constraints with BARDA/HHS DSMB mid‑July OK; awaiting rationale for stop-work Stable safety oversight; policy uncertainty persists

Management Commentary

  • “We believe the strong enrollment we achieved not only validates the demand for an alternative to current COVID-19 vaccines, but also enables us to generate meaningful data... against an injectable mRNA comparator.” (CEO) .
  • “The difference was statistically significant in the high dose cohort... we’re optimistic that this will translate into a greater reduction in infection in a field study.” (CMO, norovirus) .
  • “One hundred percent of the ferrets receiving the new H5 vaccine survived... decreased viral load was statistically significant.” (CSO, avian flu) .
  • “Vaxart ended the second quarter with cash, cash equivalents and investments of $26.3 million... expects cash runway into 2026.” (CFO) .
  • “Our listing on NASDAQ has been suspended... we strongly believe that voting for the proposal is in the best interest of Vaxart.” (CEO) .

Q&A Highlights

  • COVID Phase 2b design/statistics: ~5,000 enrolled in the randomized study; ~1:1 ratio test vs mRNA comparator; statistical analysis plan being revisited to maximize utility of available data .
  • Norovirus Phase 2b gating: Advancement contingent on funding/partnership; CRO work lined up; no additional gating beyond financing .
  • BARDA/stop-work impact: No specific rationale provided yet; BARDA continues funding per protocol follow-up; company anticipates collecting >50% of original contract due to fixed cost components .
  • Avian flu pathway: Publication planned; targeting at-risk populations; exploring federal funding avenues .
  • R&D spend outlook: Follow-up activities reimbursed; strategy to extend runway via BD and non-dilutive sources .

Estimates Context

  • S&P Global consensus for Q2 2025 EPS and revenue was not available for VXRT at the time of this review; likely limited or no formal analyst coverage given OTCQX status and stage of development. Values retrieved from S&P Global.*

Implications: Without consensus benchmarks, the quarter’s apparent operational “beat” is the revenue ramp versus internal history (BARDA-driven) and strong program execution prior to the stop-work order. Sell-side models, where they exist, may need to reflect: higher recognized BARDA revenue, elevated R&D from trial activity, and extended sentinel/10k cohort data timelines .

Key Takeaways for Investors

  • Revenue inflection is BARDA-driven and lumpy; durability depends on Project NextGen execution and funding continuity amid stop-work uncertainty .
  • Norovirus data are a genuine de‑risking event (statistically significant NBAA increases) that can catalyze a partnership; funding remains the critical gate for Phase 2b initiation .
  • COVID-19 trial narrative: strong demand and safety validation (DSMB), but external policy decisions dictate timeline; follow-up on ~5,000 participants still targets meaningful late‑2026 readout .
  • Balance sheet: $26.3M cash/investments and runway into Q1 2026; cost actions implemented; expect >50% of contract collections despite halt, supporting liquidity near term .
  • Stock microstructure matters: Relisting via reverse split likely necessary to broaden investor base and improve partnership optics; watch Aug 14 Nasdaq hearing and Sept 5 vote .
  • Trading: Near-term stock moves likely tied to relisting developments and BARDA communications; medium-term thesis hinges on norovirus partnership, COVID data path, and avian flu BD traction .
  • Risk/reward: Platform breadth (mucosal + systemic) and multiple shots on goal vs. regulatory/funding overhang and high R&D intensity; catalysts are discrete and event‑driven .