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Relmada Therapeutics, Inc. (Nasdaq: RLMD) is a clinical-stage biotechnology company focusing on the development of treatments for central nervous system (CNS) disorders, particularly major depressive disorder (MDD). The company's lead product candidate, REL-1017, is a new chemical entity (NCE) and NMDA receptor channel blocker. It is currently being evaluated in late-stage clinical trials as an adjunctive treatment for MDD in adults.
REL-1017 has shown promise in clinical studies, demonstrating rapid and sustained improvements in depressive symptoms with a favorable safety profile. The ongoing clinical development program includes two Phase 3 trials: Reliance II (Study 302) and Relight (Study 304), which are designed to assess the efficacy and safety of REL-1017 in patients with MDD who have an inadequate response to their current antidepressant therapies.
Relmada Therapeutics is also advancing a novel non-psychedelic/low dose psilocybin program (REL-P11) for the treatment of metabolic conditions. Initial preclinical studies have shown significant therapeutic potential in improving metabolic parameters, and the company plans to initiate Phase 1 and Phase 2a trials in obese patients with steatotic liver disease.
In recent corporate updates, Relmada has reported significant progress in its clinical development plans, with study enrollments proceeding as expected and additional preclinical and Phase 1 studies supporting future regulatory submissions. The company is well-funded to continue its research and development activities, aiming for multiple clinical milestones and potential regulatory filings in the near future.
Relmada Therapeutics (Nasdaq: RLMD) reported its preliminary financial results for Q4 and full-year 2022, highlighting a net loss of $37.9 million, or $1.28 per diluted share, up from a loss of $34.4 million, or $1.80 per diluted share, a year prior. Full-year losses increased to $157 million from $125.8 million in 2021. The company is focused on advancing REL-1017 for major depressive disorder, making changes to the ongoing Study 302 and initiating Study 304. Cash, cash equivalents, and short-term investments totaled approximately $148.3 million as of December 31, 2022. A conference call is scheduled for March 23, 2023.
Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology firm specializing in CNS diseases, will announce its financial results for Q4 and full-year 2022 post-market on March 23, 2023. This will be followed by a corporate update conference call and webcast at 4:30 PM ET the same day. The company is advancing its lead program, REL-1017, targeting major depressive disorder as an adjunctive treatment. Forward-looking statements highlight potential risks, such as failure in clinical trial efficacy, regulatory approval challenges, and other uncertainties impacting future performance.
Relmada Therapeutics (Nasdaq: RLMD) announced the appointment of Fabiana Fedeli as an independent director on its Board of Directors. Fedeli, currently Chief Investment Officer at M&G Investments, brings extensive experience in international capital markets and corporate strategy. Her expertise is expected to enhance the Board's diversity and strengthen Relmada's potential commercialization efforts for its lead program, REL-1017, an adjunctive treatment for major depressive disorder (MDD). The Board looks forward to leveraging Fedeli’s insights for long-term shareholder value.
Relmada Therapeutics (Nasdaq: RLMD) has appointed Cedric O'Gorman, MD, as Chief Medical Officer. With over 20 years in life sciences, O'Gorman will oversee the clinical and regulatory aspects of the late-stage REL-1017 development program, targeting major depressive disorder (MDD). Previously, he held leadership roles in clinical development at Alpha Cognition and Axsome Therapeutics, focusing on CNS therapeutics. CEO Sergio Traversa emphasized O'Gorman's relevant expertise, particularly in aligning with REL-1017's development as they prepare for FDA regulatory discussions.
Relmada Therapeutics (Nasdaq: RLMD) announced the results of the RELIANCE I study, evaluating REL-1017 for Major Depressive Disorder. The study did not achieve its primary endpoint of significant improvement in depression symptoms compared to placebo. Despite this, the REL-1017 treatment arm showed a MADRS reduction of 15.1 points versus 12.9 points for placebo. A post-hoc analysis excluding two high enrolling centers revealed a 4.1 point difference. Relmada is implementing protocol changes for its ongoing RELIANCE II trial based on findings from RELIANCE I and III.
Relmada Therapeutics (Nasdaq: RLMD) provided an update on its financial results for Q3 and the first nine months of 2022. The company reported a net loss of $39.4 million, or $1.31 per diluted share, for Q3, improving from a net loss of $42.6 million in the same period last year. For the nine months, the net loss rose to $119.1 million, compared to $91.4 million in 2021. Relmada is evaluating data from its Phase 3 RELIANCE III trial for REL-1017 for major depressive disorder (MDD) while expecting results from ongoing studies in 2022 and 2023. The company maintains a strong balance sheet with $184.2 million in cash.
Relmada Therapeutics (Nasdaq: RLMD) announced it will release its financial results for Q3 and nine months ended September 30, 2022, after market close on November 10, 2022. A conference call and webcast will follow at 4:30 PM Eastern Time.
The company continues to advance REL-1017, a novel NMDA receptor channel blocker, in late-stage development for major depressive disorder, reporting positive results from its Phase 2 trial.
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced that its RELIANCE III study of REL-1017, aimed at treating Major Depressive Disorder (MDD), did not meet its primary endpoint of statistically significant symptom improvement compared to placebo. The treatment group showed a MADRS reduction of 14.8 points, marginally higher than the placebo's 13.9 points. Despite these disappointing results, the safety profile of REL-1017 remained favorable. Relmada continues enrollment in two ongoing Phase 3 trials (RELIANCE I and II) for REL-1017 as an adjunctive treatment for MDD.
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