---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-22-078255"
form_type: "8-K"
ticker: "RLMD"
cik: "0001553643"
company_name: "RELMADA THERAPEUTICS, INC."
filed_at: "2022-12-07T23:59:59+00:00"
generated_at: "2026-06-21T08:07:32.304414+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Relmada phase 3 RELIANCE I trial for REL-1017 fails primary endpoint; post-hoc analysis shows significance

## Summary
- RELIANCE I did not achieve statistical significance on MADRS at Day 28: REL-1017 -15.1 vs placebo -12.9 (2.2-point difference).
- Response rate statistically significant: 39.8% REL-1017 vs 27.2% placebo (p<0.05).
- Post-hoc analysis excluding two high-enrolling centers with implausible placebo response showed 4.1-point MADRS difference (p=0.02).
- Safety profile favorable: no opioid-like, withdrawal, or psychotomimetic effects; no QTcF prolongation.
- Company is applying protocol and operational changes to the ongoing RELIANCE II trial.

## SEC filing metadata
- accession: 0001213900-22-078255
- form_type: 8-K
- ticker: RLMD
- cik: 0001553643
- company_name: RELMADA THERAPEUTICS, INC.
- filed_at: 2022-12-07T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/0001213900-22-078255-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/ea169812-8k_relmada.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-22-078255
- JSON: https://secwatch.observer/filing/0001213900-22-078255.json
- Plain text: https://secwatch.observer/filing/0001213900-22-078255.txt

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