Highest-materiality recent filing
NDV-01 12-month Phase 2 in high-risk NMIBC: 95% CR at any time, 76% durable CR; BCG-unresponsive: 94% CR, 80% durable.
Relmada FY2025 net loss $57.4M; NDV-01 76% CR at 12 months; $160M PIPE closed
FY2025 net loss $57.4M ($1.45/share) vs $80.0M in FY2024; Q4 net loss $19.9M ($0.27/share).
Relmada raises $160M private placement; NDV-01 12-month Phase 2 CR rate 76%
Oversubscribed PIPE financing of ~$160M gross from 29.47M shares at $4.75/share plus pre-funded warrants, expected to close March 11, 2026.
Relmada reports NDV-01 92% CR rate; FDA alignment for Phase 3; closes $100M financing
NDV-01 9-month data: 92% complete response (CR) at any time in NMIBC; 91% in BCG-unresponsive subgroup; no Grade 3 TRAEs.
Relmada prices $100M underwritten offering of common stock and pre-funded warrants at $2.20/share
Priced 40.1M shares of common stock at $2.20/share and pre-funded warrants for 5.3M shares at $2.199/warrant.
FDA supports single-arm registrational trial in refractory BCG-unresponsive NMIBC and randomized trial in intermediate-risk NMIBC.
Relmada regains Nasdaq minimum bid price compliance; stock remains listed on Capital Market
Received Nasdaq written notice on Sept 15, 2025, confirming compliance with $1.00 minimum bid price rule after 10 consecutive trading days.
Relmada adds NDV-01 and sepranolone; NDV-01 Phase 2 shows 91% CR rate, Phase 3 planned 1H 2026
Added two Phase 2 candidates: NDV-01 (NMIBC) and sepranolone (Prader-Willi Syndrome/compulsivity disorders).
Relmada reports Q2 net loss $9.9M; NDV-01 91% overall response rate in NMIBC
Q2 net loss $9.9M ($0.30/shr) vs $17.8M ($0.59) a year ago; R&D expense fell to $2.8M from $10.7M.
Relmada Therapeutics gets Nasdaq transfer to Capital Market and 180-day bid-price extension
Nasdaq approved transfer to Capital Market effective July 24, 2025.
Relmada terminates esmethadone license agreement with Inturrisi and Manfredi
On July 7, 2025, Relmada delivered termination notice for the esmethadone License Agreement with Drs. Inturrisi and Manfredi.
Relmada appoints Dr. Raj S. Pruthi as CMO-Urology for NDV-01 NMIBC program
Dr. Raj S. Pruthi appointed Chief Medical Officer-Urology effective June 17, 2025.
Marcum dismissed as independent auditor on May 8, 2025, following CBIZ CPAs' Nov 1, 2024 acquisition of Marcum's attest business.
Relmada reports 90% ORR at any time point in Phase 2 NDV-01 trial for NMIBC
90% (18/20) achieved high-grade disease-free status at any time point; 85% ORR at 3 months.
Relmada reports FY2024 net loss $80M; cash $44.8M; new Phase 2 programs NDV-01 and sepranolone
Q4 2024 net loss $18.6M ($0.62/sh) vs $25.1M ($0.84/sh) in Q4 2023; FY2024 net loss $80M ($2.65/sh) vs $98.8M ($3.28/sh).
Relmada licenses NDV-01 from Trigone for $3.5M + 3M shares; Phase 2 data at AUA April 2025
Upfront: $3.5M cash + 3,017,420 shares (10% of outstanding) for exclusive worldwide rights (ex-India, Israel, S. Africa).
Relmada acquires Sepranolone for €3M; Phase 2b-ready for Tourette syndrome
Acquired Sepranolone (GAMSA neurosteroid) from Asarina Pharma AB for €3 million; €2.756M due within 10 business days.
Relmada Therapeutics receives Nasdaq deficiency notice for bid price below $1; 180-day cure period
Received Nasdaq notice on Jan 21, 2025, for failing minimum bid price of $1.00 for 30 consecutive business days through Jan 17, 2025.
Relmada appoints Paul Kelly as COO; amends NEO employment agreements, suspends retention payments
Paul Kelly named COO effective Jan 1, 2025; salary $476K, target bonus 40%, severance 6 months.
Relmada halts REL-1017 Phase 3 trials after DMC review; begins strategic review
Discontinues Reliance II and Relight Phase 3 studies for major depressive disorder candidate REL-1017.
Relmada Phase 3 Reliance II trial for REL-1017 in MDD deemed futile at interim analysis
DMC interim analysis indicates Reliance II is futile, unlikely to meet primary efficacy endpoint with statistical significance.
Relmada reports FY 2023 net loss of $98.8M; advancing Phase 3 MDD trials with data expected H2 2024
Q4 2023 net loss $25.2M ($0.84/share) vs $37.9M ($1.28) in Q4 2022; full-year net loss $98.8M ($3.28/share).
Relmada Therapeutics CMO Cedric O'Gorman departs; separation agreement includes $414,500 payment
Dr. Cedric O'Gorman's service as Chief Medical Officer ended January 3, 2024, by mutual agreement.
Relmada provides 2024 outlook: REL-1017 study 302 ~50% enrolled; psilocybin Phase 1 planned
REL-1017 Phase 3 study 302 (Reliance II) is approximately 50% enrolled (target ~300 patients); full enrollment expected H1 2024.
Relmada Therapeutics CMO Cedric O'Gorman departs effective Jan 3, 2024
Dr. Cedric O'Gorman concluded his role as Chief Medical Officer on January 3, 2024, by mutual agreement.
Relmada reports positive preclinical psilocybin data for MASLD; Phase 1 in early 2024
Low-dose psilocybin (0.05 mg/kg, daily oral) in HFHFD mice reduced liver steatosis, body weight (12% reduction), and fasting blood glucose (p<0.05).
Relmada reports Phase 3 open-label data for REL-1017 in MDD: rapid, sustained symptom improvement
In 204 de novo patients, mean MADRS total score improved 11.3 points at Day 7 and 22.5 points at Month 12.
Relmada Q2 net loss narrows; Phase 3 MDD trials on track for 2024
Net loss $25.3M ($0.84/share) vs $39.9M ($1.33) in Q2 2022; R&D expense down to $13.7M from $30.9M.
Relmada provides Phase 3 update for REL-1017 in MDD; cash $132.4M
Cash and equivalents $132.4M as of 3/31/23; ~30.1M common shares outstanding (45.6M as-converted).
Relmada Therapeutics reports Q1 2023 net loss of $26.3M; provides REL-1017 trial update
Net loss of $26.3M ($0.87 per share) vs $39.7M ($1.40) in Q1 2022.
Q4 2022 net loss $37.9M ($1.28/diluted share), vs $34.4M ($1.80) in Q4 2021; full-year net loss $157.0M.
Relmada confirms no cash or securities held at Silicon Valley Bank
Company discloses under Regulation FD that it holds no deposits or securities at SVB.
Relmada Therapeutics appoints Cedric O'Gorman MD as Chief Medical Officer
Dr. O'Gorman appointed CMO effective January 9, 2023, leading medical, clinical, and regulatory for REL-1017 MDD program.
RELIANCE I did not achieve statistical significance on MADRS at Day 28: REL-1017 -15.1 vs placebo -12.9 (2.2-point difference).
Paul Kelly was elected by the Board of Directors (the “Board”) to the position of Chief Operating Officer of Relmada Therapeutics, Inc. (the “Company”).
On January 3, 2024, Dr. Cedric O’Gorman concluded his service as Chief Medical Officer of Relmada Therapeutics, Inc. (the “Company”), as mutually agreed upon between him and the Company.
On January 3, 2024, Dr. Cedric O’Gorman concluded his service as Chief Medical Officer of Relmada Therapeutics, Inc. (the “Company”), as mutually agreed upon between him and the Company.
On September 5, 2023, Eric Schmidt, a member of the Board of Directors (the “Board”) of Relmada Therapeutics, Inc. (the “Company”), notified the Company that he would resign from the Board, effective immediately.
increased the number of directors constituting the whole board from five to six and appointed Fabiana Fedeli as a Class I director of the Company
Max materiality 0.90 · Median 0.60 · Most common event other_material