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Vistagen Therapeutics, Inc. (VTGN)·Q1 2026 Earnings Summary

Executive Summary

  • Q1 FY26 results were in line to slightly better vs consensus on both revenue and EPS driven by higher sublicense/other revenue and disciplined G&A; R&D spend stepped up as PALISADE-3/4 advanced toward topline readouts . Versus S&P Global consensus, revenue of $0.244M beat $0.216M* and EPS of ($0.47) matched ($0.47)*.
  • Operating expenses rose as planned on Phase 3 execution (R&D $11.7M vs $7.6M YoY), widening net loss to ($15.1M) from ($10.7M) YoY; cash and marketable securities were $63.2M at quarter-end, positioning for upcoming data catalysts .
  • Management reiterated timing: PALISADE‑3 topline in Q4 2025 and PALISADE‑4 in 1H 2026; PH80 U.S. IND submission targeted for Q4 2025, and itruvone Phase 2 planning continues .
  • Potential stock catalysts: PALISADE‑3 topline (Q4’25) and PH80 IND (Q4’25); subsequent to the quarter, VTGN confirmed last patient completed the randomized portion of PALISADE‑3 (TLR still by year‑end) .

What Went Well and What Went Wrong

  • What Went Well

    • Clear clinical execution milestones: management maintained guidance for PALISADE‑3 TLR in Q4’25 and PALISADE‑4 in 1H’26; “We are on track to report topline data… this quarter” .
    • Strong OLE interest/retention: “We’ve… seen 80%+ of subjects moving into the open label and… good retention,” supporting long‑term exposure requirements and real‑world use signals .
    • Cost discipline in G&A: G&A decreased slightly YoY ($4.4M vs $4.6M), while R&D increases were targeted to Phase 3 workstreams .

  • What Went Wrong

    • Elevated R&D spend widened losses: Net loss increased to ($15.1M) vs ($10.7M) YoY on higher clinical and CMC spend for PALISADE .
    • No commercial revenue; topline remains milestone‑driven: revenue was $0.244M (sublicense/other) and remains de minimis, highlighting binary near‑term clinical risk .
    • Site management/enrollment frictions: management acknowledged pausing or terminating underperforming sites to protect protocol rigor (e.g., a Pennsylvania site), indicating ongoing operational vigilance and potential timeline friction points .

Financial Results

Quarterly P&L (USD, thousands except per-share). Note: Q4 FY25 quarter figures were not disclosed in company materials reviewed.

MetricQ1 FY25 (3mo to 6/30/24)Q3 FY25 (3mo to 12/31/24)Q1 FY26 (3mo to 6/30/25)
Revenues$84 $234 $244
Research & Development$7,648 $11,305 $11,678
General & Administrative$4,567 $4,049 $4,370
Net Loss($10,733) ($14,089) ($15,095)
Basic & Diluted EPS($0.35) ($0.46) ($0.47)
Weighted Avg Shares30,603,435 30,711,872 31,930,665

Balance Sheet KPIs (end of period)

KPIQ3 FY25 (12/31/24)Q1 FY26 (6/30/25)
Cash & Equivalents$74,715 $48,985
Marketable Securities$13,845 $14,195
Cash + Marketable Securities$88,560 $63,180

Actual vs S&P Global Consensus (Q1 FY26)

MetricActualConsensusSurprise
Revenue$244,000 $215,670*+$28,330
EPS (Basic/Diluted)($0.47) ($0.4733)*+$0.0033

*Values retrieved from S&P Global.

Context on next quarter (Q2 FY26) consensus and actual (reported after Q1):

  • Q2 FY26 consensus at the time: Revenue $145,800*; EPS ($0.476)*; actuals reported later were revenue $258,000 and EPS ($0.54) .
    *Values retrieved from S&P Global.

Segment/Breakdown: Not applicable (no commercial products). Revenue is primarily sublicense/other .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Fasedienol PALISADE‑3 toplineCalendar Q4 2025On track for Q4 2025 (6/2/25) Anticipated later this year (Q4 2025) (8/7/25) Maintained
Fasedienol PALISADE‑4 topline1H 20261H 2026 (6/2/25) 1H 2026 (8/7/25) Maintained
PH80 U.S. IND submission2H 2025Preparing U.S. IND to facilitate Phase 2 (6/17/25) Expect submission in Q4 2025 (8/7/25 call) Narrowed window (2H → Q4)
Itruvone (MDD) next stepsPhase 2 planningPlanning further Phase 2 under U.S. IND (6/17/25) Phase 2 planning continues (8/7/25) Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 FY25, Q4 FY25)Current Period (Q1 FY26)Trend
Phase 3 timing (fasedienol)Expect PALISADE‑3 TLR in Q4’25; PALISADE‑4 in 1H’26 “On track… report topline… this quarter”; PALISADE‑4 in 2026 Consistent; reiterated milestones
Operational rigor/site oversightEmphasis on protocol enhancements and stringent eligibility to limit variability Continued in‑person training, secondary eligibility review; willingness to pause/terminate sites Heightened oversight sustained
Open-Label Extension (OLE)Noted OLE as part of exposure requirements “80%+” conversion to OLE with good retention Positive uptake, favorable long-term exposure metrics
Efficacy endpoints and subgroupsDesign modeled after PALISADE‑2; intent to limit variability Plan to disclose primary/secondaries; no male/female differences expected (consistent with PAL‑2) Aligned with prior expectations
Competitive landscapeN/AManagement contrasted non‑systemic MOA to oral alpha‑7 competitor; views first‑mover advantage Heightened competitive positioning narrative
PH80 IND timing2H’25 plan Targeting Q4’25 submission Clearer timing within 2H’25

Management Commentary

  • “We had another very productive quarter… With no FDA-approved acute treatment, we remain optimistic about fasedienol’s potential to impact the lives of over 30 million U.S. adults affected by social anxiety disorder.”
  • “We expect to report top line data from our PALISADE‑3 Phase 3 trial… in Q4 of this year… [and] PALISADE‑4… in 2026.”
  • On OLE uptake: “We’ve… seen 80%+ of subjects moving into the open label and… good retention… moving us towards the ICH requirements for total exposures.”
  • On operational controls: they created an internal secondary eligibility review team of experienced psychometricians to review screenings and public speaking challenges for protocol adherence .

Q&A Highlights

  • Timeline clarity: Company will announce LPO; ~6–8 weeks from database lock to topline; still guiding Q4’25 for PALISADE‑3 .
  • OLE conversion/retention: 80%+ conversion into OLE; good retention, aiding long-term exposure requirements .
  • Demographic consistency: No significant efficacy differences observed between male and female in PALISADE‑2; expect similar in PALISADE‑3/4 .
  • Baseline SUDS and design: Expect similar baseline SUDS to prior studies; PAL‑3/4 require ≥2 minutes at SUDS ≥75 in first speech to randomize (stricter than PAL‑2) .
  • Site management: Proactive retraining and, when needed, pausing/terminating underperforming sites to ensure study integrity .

Estimates Context

  • Q1 FY26 results vs S&P Global consensus: Revenue $0.244M vs $0.216M* (beat); EPS ($0.47) vs ($0.4733)* (in line to slight beat) .
  • Street likely to adjust near-term OpEx trajectory higher given R&D step-up ($11.7M vs $7.6M YoY) while maintaining timeline assumptions for PALISADE‑3/4 .
  • Looking ahead, Q2 FY26 consensus at the time implied revenue $0.146M* and EPS ($0.476)*; later actuals were revenue $0.258M and EPS ($0.54), indicating volatility in non‑product revenue and OpEx as trials progressed .

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term binary catalyst: PALISADE‑3 topline in Q4’25 remains the dominant driver; a successful readout plus PALISADE‑2 could establish substantial evidence supporting NDA filing (pending PALISADE‑4) .
  • Execution quality signals improving: in‑house eligibility review and strong OLE conversion bolster confidence in data quality and exposure requirements .
  • Financial posture: cash and marketable securities of $63.2M at 6/30/25 support near-term milestones; continued R&D intensity likely as PALISADE‑3/4 complete .
  • Risk balance: limited revenue base means stock path is tied to clinical outcomes and regulatory interactions; operational rigor mitigates some execution risk but does not eliminate clinical risk .
  • PH80 and itruvone offer medium‑term optionality: PH80 IND targeted for Q4’25 and itruvone Phase 2 planning continue, broadening potential value creation beyond fasedienol .
  • Trading implications: into Q4’25, shares are likely to trade on event probability and readout timing updates; watch for LPO and database lock updates as signals for TLR window .