Relmada Therapeutics(RLMD)

Search documents
Relmada Therapeutics(RLMD) - 2024 Q4 - Annual Report
2025-03-27 20:40
Financial Performance - Relmada reported a net loss of approximately $79,979,400 for the year ended December 31, 2024, compared to a net loss of $98,791,700 for 2023, with an accumulated deficit of approximately $640,882,000 as of December 31, 2024[46]. - The company expects to continue operating at a net loss for at least the next several years due to ongoing research and development efforts[139]. - The company has Federal net operating loss carryforwards of approximately $127.04 million, which begin expiring in 2027[143]. - The company has a history of losses and may never achieve or sustain profitability[141]. - There is substantial doubt about the company's ability to continue as a going concern for the next 12 months[152]. - The company had cash, cash equivalents, and short-term investments of approximately $44.9 million as of December 31, 2024[141]. Drug Development and Pipeline - The company has paused the development of esmethadone (REL-1017) after a Phase 3 study indicated it was unlikely to meet primary efficacy endpoints, leading to a strategic review of its development pipeline[21][22]. - The company has paused the REL-P11 program due to changing regulatory landscapes and the acquisition of more advanced product candidates[20][43]. - The company is now focusing on two new drug candidates, NDV-01 and Sepranolone, which are in early stages of development, with limited data on their safety and efficacy[126]. - The company aims to prioritize mid- to late-stage programs to concentrate resources on assets with a clear path to commercialization[23]. - Key upcoming milestones include the presentation of NDV-01 Phase 2a data at the 2025 American Urological Association Meeting and the initiation of clinical trials for Sepranolone in Prader-Willi syndrome by year-end 2025[33]. Acquisitions and Licensing - Relmada has successfully closed two significant transactions: the acquisition of Sepranolone for €3,000,000 (approximately $2,756,000) and the in-licensing of NDV-01, aimed at treating non muscle-invasive bladder cancer (NMIBC)[27][53]. - The Company entered into an Exclusive License Agreement with Trigone for NDV-01, making an upfront payment of $3,500,000 and issuing 3,017,420 shares, representing 10% of outstanding shares[55]. - The Company acquired rights to a psilocybin program from Arbormentis for an upfront fee of $12.7 million and potential milestone payments totaling up to approximately $160 million[59]. - Relmada paid an upfront, non-refundable license fee of $180,000 for the esmethadone license, with ongoing payments of $45,000 every three months until certain conditions are met[57]. - The License Agreement for esmethadone includes tiered royalties with a maximum rate of 2%, decreasing to 1.5% under certain circumstances[57]. Regulatory Environment - The FDA approval process for new drugs typically takes many years and involves multiple phases of clinical trials[66]. - FDA may require substantial post-approval testing and surveillance to monitor the drug's safety or efficacy[74]. - FDA's Fast Track Designation allows expedited review for drugs addressing serious conditions, with a decision made within 60 days of request[77]. - Orphan Drug Designation grants a seven-year exclusive marketing period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[79]. - The company faces risks related to compliance with federal and state pharmaceutical regulations, which could increase operational costs and expose it to potential fines[121]. - The company may need to shift its strategic focus to new therapeutic areas due to limited experience in areas outside of depression[176]. - Regulatory approvals may be subject to ongoing FDA obligations and additional post-marketing requirements, which could result in significant expenses[165]. - The overall regulatory environment remains uncertain, which could impact future business strategies[222]. Competition and Market Position - The pharmaceutical industry is characterized by intense competition, with many competitors having significantly more resources[62]. - The company competes with larger pharmaceutical firms and biotechnology companies, which may have greater financial resources and R&D capabilities, posing a risk to its market position[197]. - The company’s ability to generate revenue is contingent upon successfully developing and commercializing its drug candidates, which is subject to various risks[132]. Intellectual Property - Relmada's intellectual property portfolio includes over 40 patents related to Sepranolone, providing potential coverage beyond 2030, and over 10 patents related to NDV-01, with coverage extending beyond 2038[48][49]. - The company’s ability to secure and protect intellectual property is critical for its commercial success, with uncertainties surrounding patent validity and enforcement[201]. Human Capital and Operations - The company had a total of 17 employees as of December 31, 2024, emphasizing that human capital is its greatest asset[112]. - The company maintains a competitive compensation and benefits package, including performance-based incentives tied to both company and individual performance[113]. - The company employed a third-party consultant in 2023 to evaluate pay practices, finding no meaningful differences in compensation based on gender, race, or other characteristics[113]. Risks and Liabilities - The company currently carries clinical trial insurance but does not have product liability insurance, which may expose it to substantial liabilities if product liability claims arise[163]. - The company is exposed to liability claims associated with the use of hazardous materials, which could materially affect its financial condition[198]. - The company does not currently carry product liability insurance, which could expose it to significant liabilities from adverse reactions to its product candidates[200]. Strategic Focus and Future Outlook - The strategic review initiated in December 2024 has led to a refined approach focused on innovation, addressing unmet medical needs, and pipeline diversification[26][23]. - The company plans to expand its business through acquisitions, which may involve substantial cash expenditures and risks[149]. - The transition to new drug candidates may increase operational costs and extend development timelines, with no guarantee of success[126]. - The company is monitoring the situation closely to mitigate potential impacts on its operations[222].
Relmada Therapeutics Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update
Globenewswire· 2025-03-27 20:05
Core Insights - Relmada Therapeutics is advancing its clinical pipeline with a focus on two key programs: NDV-01 for high-grade non-muscle invasive bladder cancer and sepranolone for Tourette syndrome and other compulsion-related disorders [1][2][4] Company Updates - The company has a cash balance of $44.8 million as of December 31, 2024, which is deemed sufficient to support operations through key milestones into the first half of 2026 [2][9] - Management is hosting a conference call to discuss recent business progress and financial results [1][8] Clinical Development - NDV-01 is in a single-arm Phase 2 study for high-grade non-muscle invasive bladder cancer, with topline data expected to be presented at the American Urological Association meeting in April 2025 [4][5] - Sepranolone is being prepared for a Phase 2b study in Tourette syndrome, with plans to evaluate its potential in other compulsion-related disorders, including Prader-Willi syndrome [1][2][4] Financial Performance - For the fourth quarter of 2024, research and development expenses totaled $11.0 million, down from $14.7 million in the same period of 2023, primarily due to reduced study costs [9] - The net loss for the fourth quarter of 2024 was $18.6 million, or $0.62 per share, compared to a net loss of $25.1 million, or $0.84 per share, for the same period in 2023 [9] - For the full year 2024, the net loss was $80 million, or $2.65 per share, compared to a net loss of $98.8 million, or $3.28 per share, for 2023 [9][28] Market Opportunity - The U.S. market for non-muscle invasive bladder cancer is significant, with an estimated prevalence of approximately 450,000 patients, and the potential for NDV-01 to become a first-line therapy [4][14] - Sepranolone targets a market with a U.S. prevalence of around 350,000 for Tourette syndrome, with additional potential in other compulsion-related disorders [4][19]
Relmada Therapeutics to Report Fourth Quarter 2024 Financial Results on Thursday, March 27, 2025
GlobeNewswire News Room· 2025-03-26 13:00
Group 1 - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies with potential clinical benefits for targeted patient populations [2] - The company plans to host a conference call and webcast on March 27, 2025, at 4:30 PM ET to discuss recent business progress and financial results for Q4 ended December 31, 2024 [1][4] - The lead investigational program, NDV-01, is being evaluated in a Phase 2 study for High-Grade Non-Muscle Invasive Bladder Cancer [3] Group 2 - Preparations are underway to advance sepranolone, a Phase 2b-ready investigational program for compulsion-related disorders, including Tourette's Syndrome, into further studies [3]
Relmada Therapeutics Licenses Phase 2 Bladder Cancer Candidate, NDV-01, from Trigone Pharma, Ltd.
Globenewswire· 2025-03-25 11:30
Core Insights - NDV-01 is a novel sustained-release formulation of gemcitabine and docetaxel for treating non-muscle invasive bladder cancer (NMIBC), with a U.S. prevalence of approximately 600,000 patients and around 62,000 new diagnoses annually [1][2][15] - The first Phase 2 data for NDV-01 is expected to be reported at the American Urological Association meeting in April 2025 [1][2][7] Company Developments - Relmada Therapeutics has completed an exclusive licensing agreement with Trigone Pharma for NDV-01, which includes a $3.5 million upfront payment and 3,017,420 shares of common stock [2][10] - The agreement allows Relmada to pay up to $200 million in development, regulatory, and sales milestones, along with a 3% royalty on net sales [10] Clinical Program - NDV-01 is currently being evaluated in a Phase 2, Single-Arm Study to assess safety and efficacy in patients with high-grade NMIBC, with an enrollment target of up to 70 subjects [6] - The formulation is designed for intravesical dosing, providing a sustained release of the drug over a 10-day period, which may enhance treatment effectiveness and patient compliance [11][12] Market Opportunity - The NMIBC market is estimated to be a multi-billion dollar opportunity, driven by the high recurrence rates of bladder cancer and limited approved treatment options [16] - NDV-01's sustained-release formulation and ease of administration position it as a potential first-line therapy, with further opportunities for use in salvage treatments and other NMIBC subtypes [12][16] Strategic Outlook - Relmada aims to diversify its pipeline with NDV-01 and other assets, balancing risk and potential upside [5] - The company plans to host an investor update on NDV-01's development steps later in 2025 [9]
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]