NDV-01 is a novel, sustained-release, intravesical gemcitabine/docetaxel, ready-for-use product candidate for the treatment of non-muscle invasive bladder cancer (NMIBC, U.S. prevalence of ~600,000 patients, with ~62,000 newly diagnosed patients annually) Topline efficacy and safety Phase 2 data expected to be reported at the American Urological Association meeting (AUA), being held April 26-29, 2025 in Las Vegas NDV-01 has the potential to be a first-line therapy for NMIBC, presenting attractive clinical b ...

Relmada purchases Sepranolone, a Phase 2b ready asset, for the treatment of Tourette syndrome (TS) and other compulsion-related conditions from Asarina Pharma AB Phase 2a results signaled improvement in Tourette symptoms, quality of life and robust overall safety, supporting Sepranolone as a new potential first line treatment option for TS Sepranolone (isoallopregnanolone) is a first-in-class compound from new subgroup of neurosteroids known as GAMSAs- GABAA Modulating Steroid Antagonists - acting selective ...

On Wednesday, Relmada Therapeutics, Inc. RLMD announced a preplanned interim analysis of the Reliance II Phase 3 study.Reliance II is designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), to be used in combination with other approved anti-depressants.The Independent Data Monitoring Committee (DMC) analysis indicated that the Reliance II Phase 3 study is futile and unlikely to meet the primary efficacy endpoint with statistical significance.No new safety signals were r ...

The DMC did not identify any new safety concerns Relmada to evaluate potential next steps for the REL-1017 program Relmada to continue to focus on the development of REL-P11 for metabolic disease Relmada is well capitalized with approximately $54.1 million in cash and cash equivalents as of September 30, 2024 CORAL GABLES, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous ...

Core Insights - Relmada Therapeutics has initiated dosing in a Phase 1 Single-Ascending Dosing (SAD) study for REL-P11, a low-dose, modified-release psilocybin formulation aimed at treating metabolic diseases [1][2] - The Phase 1 study is expected to define the pharmacokinetic, safety, and tolerability profile of REL-P11, with a Phase 2a proof-of-concept study anticipated to begin in the first half of 2025 if results are positive [2][3] Company Overview - Relmada Therapeutics is a late-stage biotechnology company focused on diseases of the central nervous system (CNS), particularly major depressive disorder (MDD) [4] - The company’s lead program, REL-1017, is a novel NMDA receptor channel blocker in late-stage development as an adjunctive treatment for MDD in adults [4] Research and Development - Relmada acquired the rights to develop a novel psilocybin and derivatives program in July 2021, identifying low-dose psilocybin as a potential treatment for metabolic diseases [3] - Preclinical studies presented at AASLD 2023 indicated that REL-P11 improved multiple metabolic parameters without adverse CNS effects, suggesting its potential as a therapeutic option in obesity and metabolic syndrome [2][3]

Financial Data and Key Metrics Changes - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of approximately $54.1 million, down from $96.3 million as of December 31, 2023 [12] - Cash used in operations in Q3 2024 was $16.7 million, compared to $11.6 million for the same period in 2023 [12] - The net loss for Q3 2024 was $21.7 million or $0.72 per share, compared to a net loss of $22 million or $0.73 per share in Q3 2023 [15] Business Line Data and Key Metrics Changes - Total research and development expense was approximately $11.1 million in Q3 2024, an increase from $10.5 million in the same period of 2023, primarily due to ramp-up expenses related to studies 302 and 304 [13] - Total general and administrative expense for Q3 2024 was approximately $11.9 million, a slight decrease from $12.2 million in Q3 2023, driven by a reduction in stock-based compensation [14] Market Data and Key Metrics Changes - Approximately 10 million people were treated for a major depressive episode in the last year in the U.S., with 40% of these patients requiring combination therapy [5] Company Strategy and Development Direction - The company's primary focus is on advancing the development of new treatments for CNS disorders, particularly major depressive disorder (MDD) [4] - The company aims to complete the Phase 3 program and the NDA package for REL-1017, with an interim analysis expected by year-end 2024 [5][16] - The clinical program for REL-1017 includes two studies, Reliance II and Relight, designed to evaluate the drug in patients with clinical depression [6] Management's Comments on Operating Environment and Future Outlook - Management believes the interim analysis for the Reliance 2 Phase 3 study could be an important derisking event for the study and the REL-1017 program [5] - The company plans to begin the Phase 2a study for the psilocybin-based metabolic disease program in 2025 [10] Other Important Information - The company expects its current cash position to support operations through key near-term milestones into 2025 [12] Q&A Session Summary Question: What can be expected in the interim release? - Management indicated that the details will depend on the outcome and will provide as much information as possible [16] Question: Clarification on the futility threshold? - The futility threshold is set at approximately 2 points, which is the delta between drug and placebo [18] Question: Will additional patient data be available in the interim readout? - Management confirmed that only the three potential outcomes will be shared, maintaining data integrity [21] Question: If no changes are recommended, what will be the enrollment strategy? - The planned number for enrollment is between 300 and 340, with a slight increase to account for dropouts [23] Question: Confirmation on alpha penalty for interim analysis? - Management confirmed there is no alpha penalty as the interim analysis does not involve an early stop [24] Question: Update on screen failure rates in Reliance II? - The dropout rate is in the mid-single digits, lower than previous trials, indicating good patient compliance [24]

Pre-planned Phase 3 Reliance II interim analysis, anticipated by YE 2024, could represent an important de-risking event for REL-1017 and the Company Phase 1 study for REL-P11 for metabolic disease expected to begin by YE 2024 Cash position of $54.1 million provides runway through key near-term milestones, into 2025 Management hosting conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a lat ...

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 September 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 c ...

CORAL GABLES, Fla., Nov. 04, 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 Thursday, November 7, 2024 at 4:30 PM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2024. Conference Call and Webcast Information:Date: Thursday, November 7, 2024 at 4:30 PM ETParticipant Dial ...

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Relmada Therapeutics, Inc. (NASDAQ: RLMD) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. If you are a long-term RLMD stockholder please contact Justin Kuehn, Esq. here or call (833) 672-0814. The consultation and case are free wi ...