UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to __________________ Commission File Number: 000 - 55347 Relmada Therapeutics, Inc. (Exact name of registrant as specified in its charter) Nevada (Sta ...

Outcome of pre-planned Reliance II interim analysis anticipated by YE 2024 Enrollment in Phase 3 Reliance II study expected to be completed by YE 2024 Preparations on track to initiate Phase 1 study for REL-P11 for metabolic disorders by YE 2024 Cash position of $70.4 million provides runway through key milestones, into 2025 Management hosting conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., Aug. 7, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), ...

CORAL GABLES, Fla., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced plans to host a conference call and webcast on Wednesday, August 7, 2024 at 4:30 PM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2024. Conference Call and Webcast Information: Date: Wednesday, August 7, 2024 at 4:30 PM ET Participant Dial-in ...

CORAL GABLES, Fla., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced plans to host a conference call and webcast on Wednesday, August 7, 2024 at 4:30 PM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2024. Conference Call and Webcast Information: Date: Wednesday, August 7, 2024 at 4:30 PM ET Participant Dial-in ...

About Reliance I The side effect profile of REL-1017 was consistent with previous phase 1 and phase 2 studies of REL1017, with no observations of treatment-related serious AEs and no observed signal for abuse potential and compares favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD. About Relmada Therapeutics, Inc. "The overall results from this trial are clearly consistent with the evidence, produced by the prior phase 2 trial, for the efficacy, safety, and tolerabi ...

Relmada management will also be available for one-one-one investor meetings during the conference. Please contact your Goldman Sachs representative to schedule a meeting. About Relmada Therapeutics, Inc. Investor Contact: Tim McCarthy LifeSci Advisors [email protected] The webcast can also be accessed via the Investors section of the Relmada website at https://www.relmada.com/for-investors. An archived replay will be available for 90 days following the conclusion of the event. Relmada Therapeutics is a late ...

Financial Data and Key Metrics - Net loss for Q1 2024 was $21.8 million ($0.72 per share), compared to $26.3 million ($0.87 per share) in Q1 2023 [23] - Cash, cash equivalents, and short-term investments stood at $83.6 million as of March 31, 2024, down from $96.3 million at the end of 2023 [23] - Cash used in operations for Q1 2024 was $13 million [23] - R&D expenses decreased by $2.6 million to $13.3 million in Q1 2024 compared to Q1 2023 [61] - G&A expenses decreased by $2.6 million to $9.7 million in Q1 2024 compared to Q1 2023 [38] Business Line Data and Key Metrics - The company is advancing its Phase 3 program for REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD) [17][34] - Reliance II (Study 302) is expected to complete enrollment of 300 patients with top-line data anticipated in H2 2024 [18] - Relight (Study 304) is also enrolling approximately 300 patients, with the primary endpoint being the change in MADRS total score from baseline to day 28 [34] - The company is initiating a Phase 1 trial for its modified release psilocybin formulation in obese patients in H1 2024, with data expected in H1 2025 [1][36] Market Data and Key Metrics - The company operates in a niche space with lower competition, particularly in adjunctive treatment for depression [5][52] - Competition exists in the broader psychedelic space, particularly with psilocybin trials for depression, PTSD, and MDD, but the company's focus on specific indications reduces direct competition [5][52] Company Strategy and Industry Competition - The company has implemented revisions to its screening and enrollment processes to improve patient quality and reduce placebo response, increasing the screen failure rate to 80% compared to 50% in previous trials [19][33] - The company is leveraging its close relationships with clinical sites to drive trial awareness and enrollment [33] - The company is confident in its financial position, with cash on hand expected to fund operations into 2025 [21][23] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of patient selection and quality control in clinical trials, with ongoing monitoring of blinded data to ensure consistency [40][41][65] - The company is optimistic about the potential of its REL-1017 program and the novel psilocybin derivative program, with key milestones expected over the next 12-18 months [36][82] - Management highlighted the safety and tolerability of REL-1017, with no significant safety concerns reported [46] Other Important Information - The company has completed preclinical manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing, with a focus on completing the remaining Phase 3 studies [35] - The company is exploring the metabolic benefits of low-dose psilocybin, with preclinical data showing potential improvements in lipids and glucose levels [20] Q&A Session Summary Question: Monitoring of blinded data in Reliance and Relight trials - Management explained that blinded data is used to monitor consistency and quality, with a focus on identifying inconsistencies in patient responses (e.g., zigzag patterns in MADRS scores) [40][41][63] - Sites with inconsistent data may be closed or paused from enrollment to maintain trial integrity [68][69] Question: Interim analysis and DSMB role - No interim analysis is planned for Reliance II, but the DSMB will review data close to the end of the trial to assess sample size adequacy and monitor safety [45][46] Question: Competition and site selection - The company faces limited competition in adjunctive depression trials, with site selection being an ongoing process to ensure quality and avoid over-enrollment [52][53][73] Question: Phase 1 psilocybin trial design - The Phase 1 trial will involve a single ascending dose of modified release psilocybin in obese healthy volunteers, with a focus on pharmacokinetic data [54][84] Question: Screening failure rates - The screening failure rate for Reliance II is approximately 80%, driven by stricter inclusion criteria and the requirement for medical and pharmacy records [19][77][88] - Management is working to optimize enrollment rates without compromising trial quality [86]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________________ Commission File Number: 000-55347 RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its charte ...

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q4 2023 Earnings Conference Call March 19, 2024 4:30 PM ET Company Participants Tim McCarthy - IR, Advisors Sergio Traversa - CEO Maged Shenouda - CFO Conference Call Participants Basma Radwan - Leerink Partners Uy Ear - Mizuho Andrew Tsai - Jefferies Andrea Tan - Goldman Sachs Operator Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics Inc. Fourth Quarter and Full Year 2023 Results Call. At this time, all lines are in a listen-only mode. F ...

Exhibit 99.1 Upcoming Anticipated Milestones Relmada Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results CORAL GABLES, Fla., Mar 19, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2023. The Company will h ...