Executive Summary
VistaGen reported a modest revenue base for QQ1 2026 (quarter ended 2025-06-30): revenue of $244,000 with gross profit of $75,000 and a net loss of $15.1 million. The quarterly R&D spend was elevated at $11.68 million, complemented by SG&A of $4.37 million, driving an operating loss of $15.8 million and an EBITDA loss of $14.93 million. The company held $63.2 million in cash and marketable securities at quarter-end, underscoring a finite runway given the current burn profile. Management reaffirmed a clear near-term product development cadence centered on the PALISADE Phase III program for intranasal fasedienol in the acute treatment of social anxiety disorder (SAD), with topline readouts anticipated in Q4 2025 (PALISADE-3) and the first half of 2026 (PALISADE-4). In addition, VistaGen signaled ongoing IND activity (PH80 in Q4 2025) and ongoing expansion of Phase II work for other pherine programs (Itruvone and PH80). The earnings call highlighted strong open-label conversion rates (80%+ moving from randomized to open-label) and continued emphasis on nose-to-brain neurocircuitry as a differentiator in high-prevalence CNS disorders. The balance of the quarter reflects a high-octane clinical development agenda with corresponding cash burn, potential for meaningful value inflection if PALISADE data meet efficacy and safety thresholds, and notable execution risks including site performance and enrollment dynamics. Investors should monitor PALISADE topline outcomes, enrollment dynamics across PALISADE-3/4, the timing and success of the PH80 IND, and the company’s ability to extend its cash runway through financing, given the current burn trajectory.
Key Performance Indicators
QoQ: -4.52% | YoY:-39.13%
QoQ: -7.14% | YoY:-58.54%
QoQ: -2.17% | YoY:-34.29%
Key Insights
Revenue: $244k (YoY +23.7%, QoQ +4.3%). Gross profit: $75k; gross margin 30.7% (YoY margin contraction despite top-line growth). Operating loss: -$15.804M; EBITDA: -$14.926M; Net income: -$15.051M; EPS: -$0.47; R&D expense: $11.678M; SG&A expense: $4.37M; Total operating expenses: $15.879M; Weighted average shares outstanding: 31.93M; Cash & equivalents/marketable securities: $63.2M as of 2025-06-30. Cash burn implied by opEx suggests a runway of roughly 4 quarters at current burn ra...
Financial Highlights
Revenue: $244k (YoY +23.7%, QoQ +4.3%). Gross profit: $75k; gross margin 30.7% (YoY margin contraction despite top-line growth). Operating loss: -$15.804M; EBITDA: -$14.926M; Net income: -$15.051M; EPS: -$0.47; R&D expense: $11.678M; SG&A expense: $4.37M; Total operating expenses: $15.879M; Weighted average shares outstanding: 31.93M; Cash & equivalents/marketable securities: $63.2M as of 2025-06-30. Cash burn implied by opEx suggests a runway of roughly 4 quarters at current burn rate, barring additional financing. Management commentary emphasizes near-term catalysts (PALISADE-3 topline in Q4 2025; PALISADE-4 topline in 1H2026) and potential IND activity for PH80 in Q4 2025.
Income Statement
| Metric |
Value |
YoY Change |
QoQ Change |
| Revenue |
244.00K |
23.67% |
4.27% |
| Gross Profit |
75.00K |
-61.99% |
2.74% |
| Operating Income |
-15.80M |
-39.13% |
-4.52% |
| Net Income |
-15.10M |
-58.54% |
-7.14% |
| EPS |
-0.47 |
-34.29% |
-2.17% |
Management Commentary
- Strategy and clinical progress: VistaGen’s lead program is intranasal fasedienol for SAD, advancing through late-stage development with topline data anticipated in Q4 2025 (PALISADE-3) and in the first half of 2026 (PALISADE-4). The company expects these data readouts to provide substantial evidence toward a potential FDA NDA submission if results are favorable. (Shawn K. Singh)
- Near-term catalysts and pipeline expansion: In parallel with PALISADE, VistaGen plans to advance Phase II development for Itruvone (MDD) and PH80 (menopausal hot flashes) with a US IND targeted for PH80 in Q4 2025. (Shawn K. Singh)
- Open-label safety and efficacy signals: The open-label phase is tracking safety and LSAS changes, with LSAS reductions observed and a focus on how utilization evolves over time. Safety in open-label data collection includes the patient withdrawal checklist to address abuse potential. (Joshua S. Prince)
- Enrollment and site management: The company disclosed it sometimes pauses enrollment and retrains sites to improve enrollment; one site in Pennsylvania was terminated mid-study due to conduct/enrollment dynamics, reflecting ongoing site-oversight efforts to ensure data quality and efficient progression. (Joshua S. Prince)
- Financial discipline and near-term outcomes: CFO Cindy Anderson highlighted R&D investments into PALISADE while managing G&A; cash position provides a runway contingent on continued burn and fundraising activity. (Cynthia Lynn Anderson)
"we expect to report top line data from our PALISADE-3 Phase III trial of fasedienol assessing the efficacy and safety of this asset for the acute treatment of SAD in Q4 of this year"
— Shawn K. Singh
"we've definitely seen really good conversion from open label -- or from the public speaking challenge into the open label, even higher than we saw in PALISADE-1 and PALISADE-2... we're seeing 80% plus of subjects moving into the open label, and we're seeing good retention as well"
— Joshua S. Prince
Forward Guidance
Near-term catalysts define VistaGen’s investment thesis. Key milestones include: 1) PALISADE-3 topline data for fasedienol in SAD expected in Q4 2025, with PALISADE-4 topline in 1H2026; 2) US IND submission for PH80 anticipated in Q4 2025 to enable additional Phase II study in menopausal hot flashes; 3) Continued KOL engagement and expansion of Phase II development for Itruvone (MDD) and PH80 to diversify the CNS portfolio. The management commentary implies a high-uncertainty but high-upside path contingent on positive SAD data and the ability to secure additional funding to support further development. Achievability hinges on consistent enrollment across PALISADE-3/4, topline signals surpassing efficacy thresholds, and successful navigation of regulatory endpoints for an acute SAD indication. Investors should monitor: (1) PALISADE trial enrollment and randomization timelines; (2) topline efficacy/safety data (SATs, LSAS, PGIC) and AE profiles; (3) status of PH80 IND and Itruvone development; (4) cash burn and potential financing activity to extend runway beyond current estimates. If PALISADE readouts are positive and regulatory pathways align, VistaGen could realize substantial value inflection via potential NDA submission; conversely, delayed data or weaker efficacy could significantly increase funding needs and compress upside.