Company Overview - DIMERx, Inc. is a late-stage clinical biopharmaceutical company focused on developing covalently bonded dimer therapeutics [1][5] - The company is pioneering a proprietary dimer technology platform to create novel chemical entities for high-impact, underserved medical conditions [5] Leadership Appointment - Sergio Traversa, PharmD, has been appointed as an Independent Director to the Board of Directors, effective June 25, 2025 [1] - Dr. Traversa is currently the CEO of Relmada Therapeutics and has extensive experience in the healthcare sector, including senior roles at Eli Lilly and Johnson & Johnson [2][4] Strategic Importance - The appointment of Dr. Traversa is seen as critical for DIMERx's growth, especially with support from the NIH HEAL Initiative and momentum in clinical programs [3] - Dr. Traversa emphasizes the urgent need for innovative solutions in chronic pain management, aligning with public health priorities [3] Product Development - DIMERx's lead asset, DMX-101, is in phase 2 clinical development for chronic lower back pain and has shown a favorable safety profile and analgesic benefits in over 400 human subjects [6] - The second program, DMX-201, is being developed for conditions involving endothelial dysfunction, such as vaso-occlusive crisis pain in sickle cell disease [7] Collaboration and Research Initiatives - DIMERx collaborates closely on clinical strategy with Maurizio Fava, MD, Chair of the Mass General Brigham Academic Medical Centers Psychiatry Department [5] - The NIH HEAL Initiative aims to accelerate research to address the opioid overdose crisis and chronic pain, which aligns with DIMERx's mission [8]

Core Viewpoint - Relmada Therapeutics has appointed Dr. Raj S. Pruthi as Chief Medical Officer-Urology to advance the development of NDV-01, a novel therapy for non-muscle invasive bladder cancer (NMIBC), with a Phase 3 trial expected to begin in the first half of 2026 [2][4]. Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on innovative therapies for oncology and central nervous system conditions [11]. - The lead program, NDV-01, is designed for the treatment of NMIBC and aims to address significant unmet medical needs in this area [11]. Appointment of Dr. Raj S. Pruthi - Dr. Pruthi brings over 25 years of experience in urologic oncology, clinical trials, and robotic surgery, having previously served as Chief Medical Officer at enGene Holdings Inc. and Global Medical Affairs leader at Johnson and Johnson [3][5]. - His expertise includes developing practice guidelines for NMIBC and executing global clinical studies for bladder cancer treatments [3][6]. NDV-01 Program - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed for intravesical administration, allowing for gradual drug release over 10 days [9]. - The formulation aims to enhance local exposure while minimizing systemic toxicity and is designed for in-office administration in under 10 minutes without the need for anesthesia [9]. - Positive initial Phase 2 data presented at the AUA 2025 indicated impressive response rates and favorable tolerability for NDV-01 [4][10]. Market Opportunity - NMIBC accounts for approximately 75% of all bladder cancer cases, with a high recurrence rate of 50-75% over seven years, indicating a significant market opportunity for effective treatments [10]. - With over 600,000 prevalent cases in the U.S. and limited treatment options, NDV-01 has the potential to serve as a frontline or salvage therapy across multiple NMIBC subtypes [10].

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of approximately $27.1 million, down from $44.9 million as of December 31, 2024 [20] - Cash used in operations for the first quarter of 2025 was $18.1 million, compared to $13 million for the same period in 2024 [21] - The net loss for the first quarter of 2025 was $17.6 million, or $0.58 per basic and diluted share, compared to a net loss of $21.8 million, or $0.72 per basic and diluted share for the first quarter of 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses for the first quarter of 2025 totaled $12 million, down from $13.3 million in the first quarter of 2024, primarily due to lower study costs [21] - General and administrative expenses for the first quarter of 2025 were $6.3 million, compared to $9.7 million in the first quarter of 2024, driven by a decrease in stock-based compensation expense [22] Market Data and Key Metrics Changes - The market opportunity for NDV-one includes approximately 75,000 new cases of bladder cancer diagnosed each year in the US, with about 50% having high-grade disease at high risk of recurrence [8] - The potential market for sopranolone includes Prader Willi syndrome, which affects approximately 350,000 people worldwide, including about 20,000 in the US [17] Company Strategy and Development Direction - The company aims to advance its pipeline to important clinical milestones with a disciplined development plan and a clean balance sheet [6][20] - The strategic focus includes bringing NDV-one for bladder cancer and sopranolone for Prader Willi syndrome and Tourette syndrome to patients as soon as possible [5][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one to improve care for bladder cancer patients, citing positive Phase two data presented at the AUA meeting [7][14] - The company plans to secure U.S. IND clearance for NDV-one in the second half of 2025 and is preparing for the next set of studies [15][24] Other Important Information - NDV-one is a novel sustained release formulation of gemcitabine and docetaxel, designed to maximize local dosage concentration while minimizing systemic toxicity [9] - The initial Phase two data for NDV-one showed an overall response rate of 85% at three months and 90% at any time point, with a 100% complete response rate in carcinoma in situ patients [12][13] Q&A Session Summary Question: What gives confidence that the current data from the Phase two study would be sufficient for the FDA to agree for NDV-one to move into registrational study? - Management highlighted the well-known efficacy and safety of the drug combination and the advantages of the new formulation that allows for easier administration [29][30] Question: Could you elaborate on scaling up supply? - The company is looking to secure manufacturing capacity for commercial needs and plans to have at least two manufacturers for risk management [47] Question: When should updates on the complete response rate for the entire population be expected? - The next data point will be the six-month results, expected around June or July, with further updates planned for nine and twelve months [52][53] Question: What would the Phase three trial design look like? - Management discussed potential routes for approval, including a single-arm trial or a randomized trial against placebo, depending on FDA feedback [62][64]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of approximately $27.1 million, down from $44.9 million as of December 31, 2024 [21] - Cash used in operations for Q1 2025 was $18.1 million, compared to $13 million for the same period in 2024 [22] - The net loss for Q1 2025 was $17.6 million, or $0.58 per share, compared to a net loss of $21.8 million, or $0.72 per share, for Q1 2024 [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled $12 million, down from $13.3 million in Q1 2024, primarily due to lower study costs [22] - General and administrative expenses for Q1 2025 were $6.3 million, down from $9.7 million in Q1 2024, mainly due to a decrease in stock-based compensation [23] Market Data and Key Metrics Changes - The market opportunity for NDV-one includes approximately 75,000 new bladder cancer cases diagnosed each year in the U.S., with about 50% classified as high-grade disease [8] - Prader Willi syndrome, the first candidate indication for sopranolone, is estimated to affect approximately 350,000 people worldwide, including about 20,000 in the U.S. [16] Company Strategy and Development Direction - The company aims to advance its pipeline with two innovative product candidates, NDV-one for bladder cancer and sopranolone for Prader Willi syndrome and Tourette syndrome, both showing promising Phase two data [5][24] - The strategic plan includes securing U.S. IND clearance for NDV-one and progressing sopranolone into clinical development in early 2026 [15][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one to improve care for bladder cancer patients, citing strong Phase two data and a favorable safety profile [14][32] - The company is optimistic about the upcoming discussions with the FDA regarding the registration study for NDV-one, highlighting the well-known efficacy and safety of the drug combination [30][32] Other Important Information - NDV-one is designed to be administered in less than ten minutes in a doctor's office, contrasting with conventional chemotherapy that requires lengthy preparation and administration [10] - The company has a clean balance sheet and a disciplined approach to its development plan, positioning it well for advancing its clinical milestones [6][25] Q&A Session Summary Question: What gives confidence that the current data from the Phase two study would be sufficient for the FDA to agree for NDV-one to move into registrational study? - Management highlighted the established use of gemcitabine and docetaxel, the safety profile of NDV-one, and the ease of administration as key factors for confidence in FDA discussions [30][32] Question: Could you elaborate on scaling up supply? - Management indicated that scaling up supply involves preparing for commercial quantities and ensuring multiple manufacturers for risk management [44] Question: When should we look forward to sharing the complete response rate for the entire population? - The next data point will be the six-month assessment, expected around June or July, with further updates planned for nine and twelve months [48][49] Question: What would you want the phase three trial to look like in terms of time points, endpoints, and types of patients? - Management discussed potential routes for the phase three trial, including a single-arm chemoablation route or a randomized trial against placebo, depending on FDA feedback [56][58]

Clinical Programs - Relmada has paused the REL-1017 program for Major Depressive Disorder (MDD) after interim analysis indicated it was unlikely to meet primary efficacy endpoints[113]. - NDV-01 is currently in a Phase 2 clinical trial, with initial data showing a 100% disease-free status in evaluable patients at the 6-month assessment[132]. - Sepranolone demonstrated a 28% reduction in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) in a Phase 2a study[123]. - The company anticipates key milestones over the next 12 months, including the initiation of clinical trials for Sepranolone in Prader-Willi syndrome in the first half of 2026[119]. - NDV-01 allows for a single administration of chemotherapy in less than 10 minutes, providing sustained localized treatment for up to 10 days[126]. - The overall response rate for NDV-01 in the ongoing Phase 2 study is reported at 85% with no treatment-related adverse events greater than Grade 1[139]. - Relmada has terminated the psilocybin program due to strategic review and changing regulatory landscapes[137]. Financial Performance - The company reported a net loss of approximately $17,559,500 for the three months ended March 31, 2025, compared to a net loss of $21,828,100 for the same period in 2024, representing a decrease of approximately 19%[153]. - Total operating expenses decreased to $18,218,435 for the three months ended March 31, 2025, down from $22,987,860 in 2024, a reduction of approximately 21%[149]. - Research and development expenses were approximately $11,951,000 for the three months ended March 31, 2025, down from $13,305,300 in 2024, a decrease of approximately 10%[150]. - General and administrative expenses decreased to approximately $6,267,400 for the three months ended March 31, 2025, compared to $9,682,600 in 2024, a reduction of approximately 65%[150]. - Cash used in operating activities was $18,067,033 for the three months ended March 31, 2025, compared to $13,036,748 in 2024, indicating an increase in cash outflow of approximately 39%[157]. - The company had an accumulated deficit of approximately $658,441,500 as of March 31, 2025[142]. Strategic Focus - The company aims to prioritize mid- to late-stage programs to concentrate resources on assets with clear paths to commercialization[118]. - Relmada's strategic review has led to a refined approach focused on maximizing shareholder value through pipeline diversification and addressing unmet medical needs[115]. Intellectual Property and Regulatory Designations - The company has more than 40 issued patents and pending patent applications related to Sepranolone, potentially providing market exclusivity beyond 2030[144]. - The company has secured an Orphan Drug Designation from the FDA for d-methadone, which carries 7-year marketing exclusivity upon potential NDA approval[146]. Liquidity Concerns - The company is projecting insufficient liquidity to sustain operations through one year following the issuance of the financial statements[155]. - Management is evaluating financing strategies, including public or private sales of equity or debt securities, to address liquidity concerns[156].

Core Insights - Relmada Therapeutics has reported positive initial Phase 2 proof-of-concept data for NDV-01, showing a 90% overall response rate in non-muscle invasive bladder cancer (NMIBC) [1][4] - The company plans to initiate a Phase III registration trial for NDV-01 in the first half of 2026 and a Phase 2 study for sepranolone in Prader-Willi syndrome in the same timeframe [1][4] Pipeline Highlights - **NDV-01**: A sustained-release intravesical formulation of gemcitabine and docetaxel targeting high-grade NMIBC with a U.S. market opportunity of approximately 600,000 prevalent cases. The recent data shows a 90% overall response rate and 100% complete response in carcinoma in situ [5][10] - **Sepranolone**: A first-in-class GABAA Modulating Steroid Antagonist targeting disorders linked to excess GABAergic activity, with an estimated U.S. prevalence of 20,000 patients for Prader-Willi syndrome. A Phase 2 study is being prepared for initiation [5][11] Financial Results - For Q1 2025, the company reported a net loss of $17.5 million or $0.58 per share, compared to a net loss of $21.8 million or $0.72 per share in Q1 2024 [14][21] - Research and development expenses were $11.9 million, down from $13.3 million in Q1 2024, reflecting reduced trial costs [14][20] - Cash, equivalents, and short-term investments totaled $27.1 million as of March 31, 2025, down from $44.9 million at year-end 2024 [14][18]

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][3] - The company plans to host a conference call and webcast on May 12, 2025, at 4:30 PM ET to discuss its financial results for Q1 2025 and recent business progress [1][4] - The lead investigational program, NDV-01, is currently being evaluated in a Phase 2 study for High-Grade Non-Muscle Invasive Bladder Cancer [3] Group 2 - Preparations are underway to advance sepranolone, an investigational product for compulsion-related disorders, into further studies [3] - The conference call will provide insights into the company's financial performance and strategic developments [1][4] - Contact information for investor relations and media inquiries is provided for further engagement [3]

Relmada Therapeutics (RLMD) Update / Briefing April 28, 2025 09:27 PM ET Speaker0 Good afternoon, and welcome to the Realmada Pharmaceuticals Virtual KOL event. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the q and a text box at the bottom of the webcast player. As a reminder, this call is being recorded and a replay will be made available on the Realmada website followin ...

Core Insights - Relmada Therapeutics announced positive initial data from the Phase 2 study of NDV-01, showing that 90% of patients achieved high-grade disease-free status, indicating strong clinical activity for treating non-muscle invasive bladder cancer (NMIBC) [1][2][5] - The data was presented at the American Urology Association 2025 Annual Meeting, with a data cutoff date of April 20, 2025 [1][2] Efficacy Data - At the 3-month assessment, the overall response rate (ORR) was 85% (17 out of 20 patients), with high-grade recurrence-free survival (HGRFS) in papillary disease at 83.3% (15 out of 18 patients) [5] - Complete response (CR) in carcinoma in situ (CIS) patients was 100% (2 out of 2 patients) [5] - The treatment effect of NDV-01 was consistent across all patient groups, regardless of prior BCG exposure or disease pathology [3] Safety Profile - NDV-01 was well tolerated, with no treatment-related adverse events greater than Grade 1 [4] - The most common treatment emergent adverse events (TEAEs) were mild and transient, including urinary urgency, flank pain, and dysuria, resolving within 24-28 hours [4] Study Overview - The Phase 2 study is an open-label, single-arm, single-center study evaluating NDV-01 in patients with high-grade NMIBC, with a biweekly induction phase followed by monthly maintenance for up to one year [10] - The primary efficacy endpoints are safety and complete response rate at 12 months, while secondary endpoints include duration of response and event-free survival [7][10] Market Opportunity - The U.S. NMIBC market is estimated to be a multi-billion-dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective, minimally invasive therapies like NDV-01 [12] - NDV-01 stands out due to its ease of administration and potential for durability of action, with expansion opportunities beyond first-line treatment [12]

Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [11] - The lead investigational program, NDV-01, is being evaluated for high-grade non-muscle invasive bladder cancer (HG-NMIBC) in a Phase 2 study [12] Product Details - NDV-01 is a novel, investigational sustained-release formulation of gemcitabine and docetaxel, designed for intravesical therapy [3][6] - The formulation aims to maximize local drug concentration while minimizing systemic toxicity, providing a gradual and sustained release over a 10-day period [7] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used in patients who have failed other treatments, including BCG immunotherapy [10] Market Opportunity - The U.S. prevalence of non-muscle invasive bladder cancer (NMIBC) is approximately 600,000 patients, with an estimated 62,000 new diagnoses annually [3][9] - The NMIBC market is considered a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [10] - High recurrence rates in NMIBC lead to frequent re-treatment, highlighting the need for effective and minimally invasive therapies like NDV-01 [10] Upcoming Event - A virtual key opinion leader (KOL) event will be held on April 28, 2025, featuring discussions on topline efficacy and safety data from the Phase 2 study of NDV-01 [1][2]