Relmada Therapeutics(RLMD)

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Relmada Therapeutics Acquires Potential Therapy for Tourette Syndrome from Asarina Pharma AB
Globenewswire· 2025-02-06 12:30
Core Insights - Relmada Therapeutics has acquired Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma AB for EUR 3 million, aimed at treating Tourette syndrome (TS) and other compulsive disorders [1][7] - Sepranolone has shown promising Phase 2a results, indicating significant improvements in TS symptoms and quality of life, with a favorable safety profile [2][4][5] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for central nervous system (CNS) and metabolic disorders [13] - The company aims to enhance shareholder value by identifying and developing novel compounds [2] Product Details - Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist (GAMSA) that selectively targets the GABAA pathway, potentially alleviating the negative effects of Allopregnanolone in TS and other compulsive disorders [3][9] - The Phase 2a study demonstrated a 28% reduction in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) [5] - Sepranolone achieved a 69% greater increase in quality of life and a 50% greater reduction in impairment compared to standard care [5] Clinical Data - The Phase 2a study involved 26 subjects treated with Sepranolone (10 mg, administered subcutaneously twice weekly) alongside standard care, showing no CNS off-target effects [4][6] - Sepranolone has been evaluated in multiple clinical studies involving over 335 participants, demonstrating a favorable safety profile [8] Market Context - Tourette syndrome affects over 350,000 children in the U.S., with existing treatments often limited by significant side effects [11] - Current therapies primarily target dopamine and other neurotransmitters, while Sepranolone's modulation of Allopregnanolone offers a novel treatment approach [12]
Relmada Therapeutics Stock Plummets Losing 80% Value - Here's Why
Benzinga· 2024-12-04 19:02
Core Insights - Relmada Therapeutics announced that the interim analysis of the Reliance II Phase 3 study for REL-1017 as an adjunctive treatment for major depressive disorder (MDD) indicated that the study is futile and unlikely to meet the primary efficacy endpoint with statistical significance [1] - The company will evaluate the full dataset to determine next steps for the REL-1017 program while continuing to advance the Phase 1 study of REL-P11 for metabolic disease [3] - No new safety signals were reported during the analysis [2] Company Developments - Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July 2021, which has potential neuroplastogen effects for neurodegenerative conditions [3] - The company identified the potential to use low-dose psilocybin to treat metabolic diseases and published relevant data at the American Society for the Study of Liver Disease [4] - In a previous Phase 3 trial (Study 310) of REL-1017, patients treated daily for up to one year experienced rapid and sustained improvements in depressive symptoms [5] Market Reaction - Following the announcement, RLMD stock experienced a significant decline of 75.4%, trading at $0.68 [6]
Relmada Therapeutics Reports That Data Monitoring Committee (DMC) Assessment Indicates That the Phase 3 Reliance II Trial is Futile at its Interim Analysis and is Unlikely to Meet the Primary Efficacy Endpoint with Statistical Significance
GlobeNewswire News Room· 2024-12-04 12:30
Core Insights - The interim analysis of the Reliance II Phase 3 study for REL-1017 indicated that the study is unlikely to meet its primary efficacy endpoint with statistical significance, although no new safety concerns were identified [1][2] - Relmada Therapeutics will evaluate the full dataset to determine the next steps for the REL-1017 program while continuing to advance the Phase 1 study of REL-P11 for metabolic disease [2] - As of September 30, 2024, Relmada has approximately $54.1 million in cash and cash equivalents, indicating a strong capital position [1] Company Overview - Relmada Therapeutics is a late-stage biotechnology company focused on diseases of the central nervous system (CNS) and metabolic disorders [5] - The company is committed to making a difference in the lives of patients and their families through innovative treatments [5] Product Information - REL-1017 is a novel NMDA receptor channel blocker that targets hyperactive channels while maintaining physiological glutamatergic neurotransmission [3] - REL-P11 is an investigational agent for metabolic disease, with potential applications identified through the acquisition of a psilocybin derivatives program [4]
Relmada Therapeutics Initiates Phase 1 Dosing with REL-P11 for Metabolic Disease
GlobeNewswire News Room· 2024-11-14 12:30
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]
Relmada Therapeutics (RLMD) Loses -43.35% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2024-08-12 14:36
A downtrend has been apparent in Relmada Therapeutics, Inc. (RLMD) lately with too much selling pressure. The stock has declined 43.4% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical i ...
Relmada Therapeutics(RLMD) - 2024 Q2 - Earnings Call Transcript
2024-08-09 10:25
Financial Data and Key Metrics Changes - Research and development expenses for Q2 2024 were approximately $10.7 million, a decrease of $3 million from $13.7 million in Q2 2023, primarily due to reduced study costs associated with the completion of two Phase 3 trials [12] - General and administrative expenses for Q2 2024 were approximately $8.1 million, down from $12.3 million in Q2 2023, mainly due to a decrease in stock-based compensation [12] - The net loss for Q2 2024 was $17.8 million, or $0.59 per share, compared to a net loss of $25.3 million, or $0.84 per share in Q2 2023 [12] - As of June 30, 2024, the company had cash and short-term investments of approximately $70.4 million, down from $96.3 million at the end of 2023 [13] Business Line Data and Key Metrics Changes - The company is focused on the Phase 3 program for REL-1017, which is designed as a potential adjunctive treatment for major depressive disorder (MDD) [4][6] - Two pivotal Phase 3 studies, Reliance II and Relight, are currently enrolling up to 340 subjects each, with a focus on patients with documented clinical depression [6][8] - The ongoing studies are designed to assess the impact of REL-1017 on the MADRS score, with a target delta of 2 to 2.5 points at day 28 [6] Market Data and Key Metrics Changes - The company is targeting the central nervous system disorder market, specifically focusing on major depressive disorder and metabolic diseases [4][10] - REL-P11, a proprietary psilocybin program, is in development for metabolic diseases, with plans to initiate a Phase 1 study shortly [10][11] Company Strategy and Development Direction - Completing the Phase 3 program for REL-1017 is the company's top priority, with plans for an interim analysis by year-end 2024 [5][14] - The company aims to utilize its current cash position to support operations into 2025, focusing on key clinical milestones [13][14] - The decision to conduct the psilocybin study in Canada is due to favorable regulatory conditions and infrastructure for Phase 1 trials [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program's progress and the potential for REL-1017 to meet important milestones [3][4] - The company is taking a cautious approach to patient enrollment and study design to mitigate risks associated with clinical trials [7][8] - Management emphasized the importance of the upcoming interim analysis as a tool to assess the study's viability and make informed decisions moving forward [9][24] Other Important Information - The company is observing an approximately 80% screen failure rate in the ongoing studies, indicating stringent enrollment criteria [8] - The interim analysis will include a futility analysis and may lead to adjustments in sample size if necessary [9][25] Q&A Session Summary Question: Can you remind us the baseline measures for the ongoing Reliance II study? - The baseline MADRS average for the patient population is in the mid-30s, around 33-34 for all studies [15] Question: Will the sample size re-estimation impact the timeline for the second trial? - It may impact the timeline, but not materially; the company is confident in finishing enrollment in about six months [16][19] Question: Why did the estimated patient enrollment number change to 340? - The number is a guideline for the FDA and does not mean the company will necessarily enroll 340 patients [21][22] Question: Is there a statistical penalty with the futility option? - There is no alpha penalty in the futility analysis as it does not involve early stopping for efficacy [26] Question: What would be the threshold for futility? - The threshold has not been finalized, but it will be set close to a non-clinically meaningful threshold [27] Question: What proportion of the study will be completed ahead of the interim analysis? - The interim analysis is expected to take place when approximately 70-80% of the trial is completed, likely by the end of the year [30][31] Question: Why is the psilocybin study being conducted in Canada? - Canada has a favorable regulatory environment and good facilities for Phase 1 trials, making it easier than in the U.S. [32]
Relmada Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Prnewswire· 2024-08-07 20:05
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"), ...
Relmada Therapeutics to Report Second Quarter 2024 Financial Results on August 7, 2024
Newsfilter· 2024-08-05 11:30
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 ...
Relmada Therapeutics to Report Second Quarter 2024 Financial Results on August 7, 2024
GlobeNewswire News Room· 2024-08-05 11:30
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 ...
Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry
Prnewswire· 2024-06-18 12:30
Company Overview - Relmada Therapeutics, Inc. is a late-stage biotechnology company focused on diseases of the central nervous system (CNS), particularly major depressive disorder (MDD) [6] - The company's lead program, REL-1017, is a new chemical entity (NCE) and a novel NMDA receptor (NMDAR) channel blocker designed to target hyperactive channels while maintaining physiological glutamatergic neurotransmission [6] Clinical Trial Results - The Reliance I study was a 28-day, Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 (75 mg on day 1, followed by 25 mg daily on days 2 through 28) as an adjunctive treatment for MDD [10] - The intent-to-treat (ITT) population included 227 randomized patients, while the per protocol (PP) population comprised 198 patients who completed treatment [10] - Although the primary endpoint was not met in the ITT analysis, REL-1017 demonstrated a statistically significant improvement in response rate compared to placebo (P = .044) and a nonsignificant trend for improvement in remission rate (P = .076) [5] - In post hoc analyses of patients with severe depression (MADRS score ≥35 at baseline), significant improvements were observed with REL-1017 versus placebo in both ITT and PP populations (MD CFB 6.9 and 7.9; P = .0059 and P = .0015; ES = 0.57 and 0.68, respectively) [5] Future Developments - Relmada is currently conducting two Phase 3 randomized, double-blind, placebo-controlled studies for REL-1017: Reliance II (Study 302) and Relight (Study 304), which share the same key study design parameters [5] - Top-line data from Reliance II is anticipated in the second half of 2024, with data from Relight expected approximately six months after the completion of Study 302 [12] Publication and Recognition - Clinical data from the Reliance I study has been published in the peer-reviewed journal, The Journal of Clinical Psychiatry, highlighting the efficacy and safety of esmethadone (REL-1017) in patients with MDD who have inadequate responses to standard antidepressants [9]