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Jun 30, 2024
Vistagen Q1 2025 Earnings Report
Reported financial results for the first quarter of fiscal year 2025 and provided a corporate update.
Key Takeaways
Vistagen reported a net loss of $10.7 million for the first quarter of fiscal year 2025, with research and development expenses increasing to $7.6 million due to the PALISADE-3 trial and preparations for PALISADE-4. The company's cash, cash equivalents, and marketable securities totaled $108.4 million as of June 30, 2024.
PALISADE-3 Phase 3 trial for fasedienol remains on track to produce top-line results in 2025.
Preparations to initiate PALISADE-4 Phase 3 trial are progressing as planned in the second half of 2024, with top-line results expected in 2025.
Phase 2B trial of itruvone for major depressive disorder is in the preparation and planning stages.
U.S. IND-enabling program for PH80 is ongoing to support further Phase 2 clinical development in the U.S.
Vistagen
Vistagen
Forward Guidance
Vistagen is focused on advancing its PALISADE Phase 3 program for fasedienol, with PALISADE-3 underway and preparations for PALISADE-4 progressing as planned. The company is also progressing its itruvone and PH80 development programs.
Positive Outlook
- PALISADE-3 Phase 3 trial remains on track to produce top-line results in 2025.
- Preparations to initiate PALISADE-4 Phase 3 trial are progressing as planned in the second half of 2024.
- Phase 2B trial of itruvone for major depressive disorder is in the preparation and planning stages.
- U.S. IND-enabling program for PH80 is ongoing to support further Phase 2 clinical development in the U.S.
- Favorable safety profiles have been observed in all clinical studies of Vistagen’s pherine product candidates completed to date.
Challenges Ahead
- There can be no guarantee that any of the Company’s drug candidates will successfully complete ongoing or, if initiated, planned or future clinical trials
- Delays in launching, conducting and/or completing ongoing and planned nonclinical studies and clinical trials, including PALISADE-3 and PALISADE-4 or additional Phase 2 clinical trials of itruvone or PH80
- The period over which the Company anticipates its available financial resources will fund its operating expenses
- Fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and nonclinical trials
- Other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s product candidates.