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Dec 31, 2022
Vistagen Q3 2023 Earnings Report
Vistagen reported financial results for the fiscal year 2023 third quarter and provided a corporate update.
Key Takeaways
Vistagen reported a net loss attributable to common stockholders of approximately $9.8 million for the fiscal quarter ended December 31, 2022. The company's cash and cash equivalents were approximately $25.0 million as of December 31, 2022. Vistagen completed the acquisition of Pherin Pharmaceuticals, securing full ownership of PH94B and PH10.
Pherin acquisition completed, eliminating future royalty payment obligations related to PH94B and PH10, and adding three new drug candidates to Vistagen’s pipeline.
PH94B Phase 3 program for social anxiety disorder is advancing towards important next steps.
PH10 Phase 1 study initiated to facilitate plans for Phase 2B development of PH10 for major depressive disorder; FDA Fast Track designation granted.
Company remains confident in PH94B Phase 3 development program for treatment of social anxiety disorder (SAD).
Vistagen
Vistagen
Forward Guidance
Vistagen is preparing to meet with the FDA to discuss its broader Phase 3 development plan for PH94B. The Company expects to announce its plans regarding PALISADE-2 concurrently with other updates to its PH94B Phase 3 development plan. The Company anticipates reporting topline results from this exploratory Phase 2A AjDA trial by the end of the first quarter of calendar 2023.
Positive Outlook
- Company remains confident in PH94B Phase 3 development program for treatment of social anxiety disorder (SAD).
- Encouraging preliminary data from PALISADE Open Label Study inform Phase 3 path forward in SAD.
- PH10 receives Fast Track designation in major depressive disorder (MDD) from FDA; Phase 1 clinical trial underway to facilitate Phase 2B program.
- AV-101 + Probenecid Phase 1B trial progressing.
- Acquisition of Pherin Pharmaceuticals, Inc. completed.
Challenges Ahead
- After further analysis of PALISADE-1, a single administration Phase 3 public speaking challenge study, the Company has identified several potential explanations for the unexpected results of the study, primarily complexities associated with the single-dose assessment public speaking challenge methodology and conducting the study during surges in the COVID-19 pandemic.
- Upon reviewing information and data available this time, the Company believes it is not yet advisable to make a decision about resuming PALISADE-2 before discussing its broader Phase 3 development plan for PH94B with the FDA and before further assessing the potential impact of the proposed adjustments to the PALISADE-2 protocol in light of two recently completed public speaking challenge SAD studies conducted by peers, each of which did not achieve its primary efficacy endpoint.
- There can be no guarantee that any of the Company’s drug candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful.
- Delays in launching, conducting and/or completing other ongoing and planned clinical trials, including adverse effects resulting from the COVID-19 pandemic
- Fluctuating costs of materials and other resources required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials