secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2023-08-10T23:59:59+00:00
Accession:  0001437749-23-023114
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen reports positive Phase 3 PALISADE-2 fasedienol results for SAD; Q1 net loss $6.9M
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- Phase 3 PALISADE-2: fasedienol met primary endpoint (SUDS LS mean diff -5.8, p=0.015) and secondary CGI-I responder rate (37.7% vs 21.4%, p=0.033).
- Net loss for Q1 FY2024 was $6.9M, down from $19.8M YoY; R&D expense decreased $11.1M to $4.2M.
- Cash $9.6M at June 30, 2023; raised ~$16.9M from shares in July/Aug 2023, with additional $15.2M expected by Aug 14.
- Itruvone (PH10) moving to Phase 2B for MDD after successful US Phase 1; PH80 Phase 2A showed significant hot flash reduction (p<.001).
- Planning Phase 3 PALISADE-3 and FEARLESS in 2024; fasedienol well-tolerated with no serious AEs.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000143774923023114/0001437749-23-023114-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000143774923023114/vtgn20230810_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-023114

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