VistaGen Therapeutics, Inc. Q1 FY2026 earnings call

• Advancing lead late-stage clinical programs in neuroscience pipeline, including intranasal fasedienol in Phase III for acute treatment of social anxiety disorder (SAD). Expecting top line data from PALISADE-3 in Q4 2025 and PALISADE-4 in H1 2026. - Advancing Itruvone for major depressive disorder and PH80 for menopausal hot flashes, with plan to submit U.S. IND for PH80 in Q4 2025. - Welcomed Elissa Cote as Chief Corporate Development Officer, bringing experience in biopharma strategic planning and corporate development.

Research and development expenses for the fiscal quarter ended June 30, 2025 were $11.7 million, compared to $7.6 million in the same period last year. General and administrative expenses were $4.4 million, versus $4.6 million in the prior year. Net loss attributable to common stockholders was $15.1 million for the quarter, compared to $10.7 million in the same period last year. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $63.2 million.

• Expect to report top line data from PALISADE-3 Phase III trial in SAD in Q4 2025. - PALISADE-4 Phase III trial top line results expected in H1 2026. - Plan to announce enrollment completion (LPO) for trials, with encouraging conversion rates to open-label extension seen so far.

• Forward-looking statements involve risks and uncertainties, actual results could differ materially. - Potential issues with clinical trial site conduct, enrollment challenges, and adherence to protocols.

Q: Do you still plan to announce when you complete enrollment for the study? Any estimation on when that could possibly be? Any commentary on dropouts or retention or even conversion to the open-label extension?

A: Yes, we will announce LPO. We're sticking with guidance of TLR in Q4. Encouraging conversion rates from randomized study into open-label, with 80% plus of subjects moving into open label and good retention.

Q: In the top line data in Q4, what do you envision sharing in your press release as well as the accompanying slides? Do you plan to share efficacy kinetics over time, secondary endpoints as well?

A: Similar to PALISADE-2, focusing on primary and secondary endpoints including PGIC and LSAS. Secondary endpoints in PALISADE-3 and 4 include those similar to PALISADE-2.

Q: On PALISADE-4, can you comment on enrollment? Any room to adjust design if needed?

A: Both PALISADE-3 and 4 are enrolling, set in steady state. No need to adjust protocols given enhancements and rigor built in. Staggered start helps with training and oversight, expected to continue without protocol adjustment.

Q: What sort of things do you measure in the open-label phase besides safety? Opinion on competing Phase III trial for SAD?

A: In open label, measure safety, patient withdrawal checklist, LSAS. On competing program, different approach with fasedienol's nonsystemic, rapid onset vs oral alpha-7 nicotinic; wish others success but confident in own study design. Open label also measures utilization and abuse liability potential, with safety profile of fasedienol showing low TEAEs like headache at 8.7%.

Q: In mid-June, you terminated a site in Pennsylvania. Can you remind us on related to clinical site conduct? What was done to remedy?

A: Constant dialogue with sites on eligibility, enrollment, and execution. Pause enrollment, retrain sites as needed. Sites terminated if not fitting study execution and enrollment needs, with 3 recruitment programs customized for sites.