Executive Summary

VTGN reported Q2 FY2026 results with total revenue of $0.26M, net loss of $19.4M (-$0.54 EPS), driven by higher R&D to advance Phase 3 PALISADE trials; cash and marketable securities totaled $77.2M at quarter-end .
Management reiterated topline timing: PALISADE‑3 readout by calendar year‑end 2025 and PALISADE‑4 in 1H 2026; if PALISADE‑3 is positive, an NDA submission is targeted “around the middle of 2026” .
Versus S&P Global consensus, revenue slightly beat ($0.26M vs $0.15M*), while EPS missed (-$0.54 vs -$0.476*), reflecting elevated R&D expenses tied to registrational studies .
Liquidity/tone: management said current cash “covers all known aspects” of the PALISADE program including potential NDA submission, but the 10‑Q concluded substantial doubt about going‑concern beyond 12 months from issuance date—an important tension to monitor .
Near‑term stock catalyst: PALISADE‑3 topline by year‑end with clinician- and patient‑reported endpoints (CGI‑I, PGIC) and safety data expected in the release; site rigor and eligibility controls were emphasized to limit variability .

What Went Well and What Went Wrong

What Went Well

Program momentum: “last patient completed” the randomized portion of PALISADE‑3; PALISADE‑4 progressing with same design/endpoints as the successful PALISADE‑2 Phase 3 trial .
Clear milestones and optionality: Management reaffirmed PALISADE‑3 readout by year‑end and indicated an NDA could be filed mid‑2026 if data are positive; commercialization paths being kept flexible with an “optionality” mindset .
Operational rigor: Enhanced subject eligibility reviews, in‑person training, and direct site surveillance designed to reduce variability vs earlier trials; target randomization N≈236 was achieved through LPLV .

What Went Wrong

EPS miss vs consensus: Q2 EPS of -$0.54 was below S&P Global consensus of -$0.476*, primarily reflecting higher R&D expenses (Q2 R&D $15.9M, +56% YoY) to advance registrational programs .
Increased cash burn: Net cash used in operating activities was $32.6M for the six months ended Sep 30, 2025, reflecting broader spend on PALISADE and pipeline activities .
Going‑concern flag: Despite management’s confidence on funding the PALISADE program/NDA, the 10‑Q cites substantial doubt about ability to continue as a going concern beyond 12 months from issuance date .

Financial Results

Headline P&L, Operating Spend, and Liquidity

Metric	Q2 FY2025 (YoY Comp)	Q1 FY2026	Q2 FY2026
Revenues ($USD Millions)	$0.18	$0.24	$0.26
Research & Development ($USD Millions)	$10.22	$11.68	$15.92
General & Administrative ($USD Millions)	$4.20	$4.37	$4.40
Loss from Operations ($USD Millions)	$(14.23)	$(15.80)	$(20.05)
Net Loss ($USD Millions)	$(12.96)	$(15.10)	$(19.42)
Diluted EPS ($)	$(0.42)	$(0.47)	$(0.54)
Net Income Margin %	-7,082% (calc. from revenue & net loss)	-6,188% (calc.)	-7,527% (calc.)
Cash & Marketable Securities (Period-End, $USD Millions)	—	$63.2	$77.2

Notes: Net Income Margin % is computed from reported revenue and net loss; revenue is predominantly sublicense/other revenue (AffaMed) .

Revenue Components (no segments disclosed)

Revenue Component	Q2 FY2026
Sublicense and other revenue ($USD Millions)	$0.26

Key Operating/Balance Sheet KPIs

KPI	Q2 FY2026
Weighted Avg. Shares (basic & diluted)	35.75M
Deferred Revenue – Current ($USD Millions)	$2.14
Cash used in Ops (6M ended Sep 30, 2025) ($USD Millions)	$32.61

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
PALISADE‑3 Topline	Q4 2025	Q4 2025	Q4 2025	Maintained
PALISADE‑4 Topline	1H 2026	1H 2026	1H 2026	Maintained
NDA Submission (if PAL‑3 positive)	Mid‑2026	—	“Around the middle of 2026”	New disclosure
Funding view for PALISADE/NDA	Through NDA	—	“Current cash covers all known aspects… including potential NDA submission”	New/Updated mgmt. view
Going‑Concern Conclusion	Next 12 months from issuance	—	Substantial doubt exists	New/Explicit in 10‑Q

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 FY2025, Q1 FY2026)	Current Period (Q2 FY2026)	Trend
Clinical execution/rigor	Emphasis on enhanced eligibility, site training, and direct surveillance to reduce variability	Reaffirmed; secondary eligibility review by internal psychometricians; randomized LPLV achieved for PAL‑3 at target N≈236	Consistent strengthening
Milestone timing	PAL‑3 TL by YE25; PAL‑4 TL in 1H26	Maintained timelines; PAL‑3 LPLV complete	On track
Regulatory path	—	If PAL‑3 positive, NDA “around mid‑2026”	Clearer timing
Commercial strategy	Optionality; evaluate partner vs. self‑launch	Reiterated optionality; telehealth/digital psychiatry channels noted	Optionality preserved
Open‑label usage patterns	Weekday, work/school‑aligned usage; LSAS tracked over time	Similar pattern reiterated; safety/abuse liability profile emphasized	Stable usage/safety profile
Sites & enrollment	Staggered starts; stringent I/E prolonged screening	Some site terminations for fit/enrollment; controlled wind‑down	Execution discipline
Liquidity/funding	FY25 cash $80.5M; building toward catalysts	Mgmt: cash covers PALISADE/NDA; 10‑Q: going‑concern substantial doubt beyond 12 months	Mixed signals to monitor
Competitive landscape	Acknowledge others; PSC design alignment; non‑systemic MOA differentiator	Similar framing; first‑mover advantage emphasized	Unchanged narrative

Management Commentary

“We are now preparing for the release of top-line results from the PALISADE‑3 study by the end of this calendar year.”
“We believe current cash covers all known aspects of our ongoing U.S. registration-directed PALISADE program… including potential NDA submission if our PALISADE program is successful.”
“We estimate… if everything goes according to plan… we could see an NDA submission if PALISADE‑3 is positive sometime around the middle of 2026.”
On execution rigor: “…our CERT teams for subject eligibility review… enhancements into the execution of the study… got to the last patient’s last visit with the full complement we had modeled… end target was 236.”
On commercialization: “We always position for optionality… very solid potential commercial plan… also opportunities should other strategic arrangements bring greater value potential.”

Q&A Highlights

Timing mechanics: Expect ∼6–8 weeks from LPLV to TL, with release including SUDS primary, clinician (CGI‑I) and patient (PGIC) secondaries, and safety data—mirroring PALISADE‑2 disclosures .
NDA prerequisites: Package expected to include pivotal data, repeat‑dose study, long‑term safety OLE, human factors, and preclinical safety (reprotox, CARC) .
Site/network adjustments: Some non‑performing sites terminated; controlled wind‑down at end of study to reduce variability and speed to topline .
Usage patterns: Higher weekday usage in open‑label consistent with work/school stressors; no signs suggestive of abuse liability; LSAS tracked monthly .
Commercialization approach: Optionality (partner vs. self‑launch) with attention to telehealth and digital psychiatry channels .

Estimates Context

Metric	S&P Global Consensus (Q2 FY2026)	Actual (Q2 FY2026)	Surprise
Revenue ($USD)	$145,800*	$258,000	+$112,200 (Beat)
EPS (Primary)	-$0.476*	-$0.54	-$0.064 (MISS)

Values retrieved from S&P Global.
Context: EPS miss stems from higher R&D tied to Phase 3 PALISADE execution (Q2 R&D $15.9M vs $10.2M YoY), while revenue remains de minimis, driven by recognition under existing collaboration deferrals (AffaMed) .

Key Takeaways for Investors

Binary near‑term catalyst: PALISADE‑3 topline by year‑end with pre‑specified endpoints (SUDS, CGI‑I, PGIC) is the primary stock driver; operational enhancements aim to reduce variability vs prior studies .
NDA visibility: If PALISADE‑3 is positive, management targets NDA submission around mid‑2026; PALISADE‑4 topline in 1H 2026 could further support the package .
P&L trajectory: Elevated R&D spend is deliberate to complete registrational work; expect continued high opex until readouts and regulatory steps are complete .
Liquidity watch: Cash/marketable securities of $77.2M provide runway, but the 10‑Q’s going‑concern language signals potential financing needs within 12 months—plan for dilution/partnership optionality .
Commercial strategy: Management is preparing for either self‑launch or partnership; telehealth/digital psychiatry channels could accelerate adoption if approved .
Safety/utilization: Open‑label patterns and safety data to date support as‑needed, situational use without abuse liability signals—aligned with the target product profile .
Trading setup: Into topline, focus on design continuity with PALISADE‑2, execution controls, and guidance cadence (TL content, sequencing of endpoints/safety) as indicators of regulatory package readiness .

Appendix: Additional Relevant Press Releases (Q2 FY2026 period)

Nov 3, 2025: “Last patient completed” randomized portion of PALISADE‑3; topline expected by year‑end .
Nov 10, 2025: Announced Q2 FY2026 earnings call timing/logistics .

Source Documents

Q2 FY2026 8‑K/Press Release & Financials: .
Q2 FY2026 Earnings Call Transcript: .
Q1 FY2026 Press Release & Financials: .
Q1 FY2026 Earnings Call Transcript: .
FY2025 Press Release / Q4 FY2025 Call: .
PALISADE‑3 completion 8‑K/PR: .
10‑Q (Q2 FY2026): going‑concern, cash flows, deferrals: .

Vistagen Therapeutics, Inc. (VTGN)·Q2 2026 Earnings Summary