---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-110088"
form_type: "8-K"
ticker: "RLMD"
cik: "0001553643"
company_name: "RELMADA THERAPEUTICS, INC."
filed_at: "2025-11-13T23:59:59+00:00"
generated_at: "2026-05-16T20:20:57.340985+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Relmada reports NDV-01 92% CR rate; FDA alignment for Phase 3; closes $100M financing

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-110088
- form_type: 8-K
- ticker: RLMD
- cik: 0001553643
- company_name: RELMADA THERAPEUTICS, INC.
- filed_at: 2025-11-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1553643/000121390025110088/0001213900-25-110088-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1553643/000121390025110088/ea026563001-8k_relmada.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-110088
- JSON: https://secwatch.observer/filing/0001213900-25-110088.json
- Plain text: https://secwatch.observer/filing/0001213900-25-110088.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.