Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Vistagen Therapeutics Inc (VTGN, Financial) has a diverse pipeline with multiple clinical stage product candidates in Phase 2 and Phase 3 development.
- The company reported historic clinical success in a Phase 3 trial for the acute treatment of Social Anxiety Disorder (SAD).
- Enrollment for the PALISADE-3 Phase 3 study is on track, with plans to initiate the PALISADE-4 Phase 3 study in the second half of the year.
- Vistagen's lead product candidates are formulated as nasal sprays, offering a non-systemic treatment option with favorable safety profiles.
- The company has a strong financial position with $108.4 million in cash, cash equivalents, and marketable securities as of June 30, 2024.
Negative Points
- Research and development expenses increased significantly to $7.6 million for the quarter, up from $4.2 million in the same period last year.
- General and administrative expenses also rose to $4.6 million, compared to $3 million for the same period last year.
- The net loss attributable to common shareholders was $10.7 million for the quarter, compared to $6.9 million last year.
- There is no guarantee of FDA approval for their lead product candidates, despite positive trial results.
- The company faces the challenge of replicating the success of previous trials in ongoing and future studies.
Q & A Highlights
Q: Can you provide any color on the types of patients currently enrolling for the Phase III trials for fasedienol?
A: Joshua Prince, COO, explained that the patients are similar to those in the PALISADE-2 study, with inclusion criteria such as LSAS scores greater than 70 and no other primary mental health disorders. The focus is on primary SAD diagnosis with high severity.
Q: Are you seeing higher screen failure rates in PALISADE-3 compared to PALISADE-1 and 2?
A: Joshua Prince, COO, noted that screen failure rates are consistent with projections, and the study is progressing as expected with rates similar to previous studies.
Q: What's the latest on the PALISADE-2 publication and potential breakthrough designation filing?
A: Shawn Singh, CEO, mentioned that a manuscript is being prepared for submission to a suitable journal. They have achieved Fast Track designation and are optimistic about moving beyond it, although no guarantees can be made.
Q: Have you discussed self-administration versus HCP administration with the FDA, and how might it impact dosing language in the label?
A: Shawn Singh, CEO, stated that the protocols submitted to the FDA include HCP administration, consistent with Phase II. They aim for the drug to be used on demand, multiple times a day, and discussions with the FDA support this approach.
Q: What are the gating steps for the MDD Phase IIb trial, and could the dose change from the current 6.4 microgram dose?
A: Shawn Singh, CEO, indicated that they are finalizing the protocol with KOLs and plan to submit it to the agency by year-end. The 6.4 microgram dose is likely to remain, based on success in Phase IIa studies.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
