secwatch.observer — SEC 8-K summary
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Issuer:     RELMADA THERAPEUTICS, INC. (RLMD)
CIK:        0001553643
Form:       8-K
Filed at:   2025-11-13T23:59:59+00:00
Accession:  0001213900-25-110088
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relmada reports NDV-01 92% CR rate; FDA alignment for Phase 3; closes $100M financing
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- NDV-01 9-month data: 92% complete response (CR) at any time in NMIBC; 91% in BCG-unresponsive subgroup; no Grade 3 TRAEs.
- FDA aligned on two Phase 3 registrational paths for NDV-01 in high-risk BCG-unresponsive and intermediate-risk NMIBC; trials start H1 2026.
- Closed $100M underwritten offering of stock and pre-funded warrants on Nov 5; net ~$94M; cash runway extended into 2028.
- Q3 2025 net loss $10.1M ($0.30 per share) vs $21.7M ($0.72) in Q3 2024; R&D expense fell to $4.0M from $11.1M.
- Appointed Dr. Max Kates to Clinical Advisory Board; Sepranolone Phase 2 in Prader-Willi syndrome expected H1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025110088/0001213900-25-110088-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025110088/ea026563001-8k_relmada.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-110088

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer