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]

Company Overview - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing innovative therapies for targeted patient populations [7] - The lead investigational program, NDV-01, is aimed at treating High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) and is currently in a Phase 2 study [8] Product Details - NDV-01 is an investigational sustained-release formulation combining gemcitabine and docetaxel, designed for intravesical dosing without the need for anesthesia or specialized equipment [2][3] - The formulation aims to maximize local drug concentration and prolong exposure while minimizing systemic toxicity, with a gradual release over a 10-day period [3] - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be used for patients who have failed other treatments, including BCG immunotherapy [3][6] Market Opportunity - The U.S. market for Non-Muscle Invasive Bladder Cancer (NMIBC) is estimated to be a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies [6] - NMIBC has a high recurrence rate of 50-75% over seven years, leading to frequent re-treatment and progression, highlighting the need for effective solutions like NDV-01 [5][6] - The global market is expected to grow significantly, with limited approved treatment options currently available [6] Clinical Presentation - An abstract regarding NDV-01 will be presented at the American Urology Association (AUA2025) conference on April 28, 2025, at 10:04 AM PT [2]

CORAL GABLES, Fla., April 14, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (NASDAQ:RLMD, "Relmada", "the Company")), a clinical-stage biotechnology company, today announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas. Abstract OverviewAbstract Title:Prospective Open Label Study to Evaluate the Safety and Efficacy of Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Ri ...

Financial Data and Key Metrics Changes - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled approximately $44.9 million, down from $96.3 million as of December 31, 2023 [34] - Net cash used in operating activities for Q4 2024 was approximately $8.8 million, compared to $10.2 million for the same period in 2023 [34] - The net loss for Q4 2024 was $18.6 million or $0.62 per basic and diluted share, compared to a net loss of $25.1 million or $0.84 per basic and diluted share for Q4 2023 [37] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2024 totaled $11 million, down from $14.7 million in Q4 2023, a decrease of $3.7 million [35] - General and administrative expenses for Q4 2024 were $8.1 million, compared to $12.1 million in Q4 2023, a decrease of approximately $4 million [36] Company Strategy and Development Direction - The company is focused on three priorities: progressing its product pipeline, exploring product acquisition opportunities, and maintaining careful resource prioritization [7][39] - The acquisition of NDV-01 and Sepranolone aligns with the company's strategy to maximize shareholder value and address underserved markets [10][22] - The company aims to present top-line safety and efficacy data for NDV-01 at the American Urological Association Meeting in April 2025 [14][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strategic product acquisition process and the potential of NDV-01 and Sepranolone to address significant medical needs [9][39] - The company is cautious about the competitive landscape in metabolic disease and is reevaluating the development of REL-P11 [31][32] - Management highlighted the importance of aligning with the FDA on regulatory paths for both NDV-01 and Sepranolone [40] Other Important Information - The company has identified additional attractive opportunities for strategic product acquisition following the discontinuation of Phase 3 studies for REL-1017 [10] - NDV-01 is currently in a Phase 2 study for high-grade non-muscle invasive bladder cancer, with expectations for positive results [12][15] Q&A Session Summary Question: Understanding the acquisition process for NDV-01 and data expectations at the AUA meeting - Management indicated that the acquisition of NDV-01 was competitive, with Relmada's strong development capability being a key factor in winning the bid [45][48] - Regarding data expectations, management noted that the data will be collected in real-time and will not be included in the abstract due to ongoing patient evaluations [51][52] Question: Safety profile of Sepranolone and its potential in Prader-Willi syndrome - Management confirmed that Sepranolone has a well-known safety profile with low incidence of side effects, making it a well-tolerated drug [60] - There is confidence that Sepranolone can complement existing treatments for Prader-Willi syndrome due to its unique mechanism of action [61] Question: Approvable endpoints for pivotal studies and potential for accelerated approval for NDV-01 - Management stated that endpoints for Tourette syndrome will likely include the Yale scale, focusing on both tic control and compulsive behavior [66] - Discussions regarding the regulatory process for NDV-01 will occur after data presentation, with hopes for an accelerated approval pathway [70] Question: Future in-licensing of compounds - Management remains open to in-licensing opportunities but emphasizes the need for selectivity in acquiring products that meet their strategic criteria [72][74]

Relmada Therapeutics (RLMD) Q4 2024 Earnings Call March 28, 2025 12:39 AM ET Company Participants Brian Ritchie - Managing DirectorSergio Traversa - CEO & Member of Board of DirectorsMaged Shenouda - Chief Financial OfficerUy Ear - Vice PresidentBasma Radwan - Equity Research AssociateAndrew Tsai - SVP Operator Greetings, and welcome to La Ramada Therapeutics Incorporated Quarter four twenty twenty four Financial Results Call. At this time, all participants are in a listen only mode. A question and answer s ...

Financial Performance - The net loss for Q4 2024 was $18.6 million, or $0.62 per share, compared to a net loss of $25.1 million, or $0.84 per share, in Q4 2023[7] - The net loss for the full year 2024 was $80 million, or $2.65 per share, compared to a net loss of $98.8 million, or $3.28 per share, in 2023[13] - Net loss for 2024 was $79,979,354, compared to a net loss of $98,791,746 in 2023, indicating an improvement of about 19%[33] Cash and Assets - The company reported a cash balance of $44.8 million as of December 31, 2024[1] - Cash and cash equivalents decreased to $3,857,026 as of December 31, 2024, down from $4,091,568 as of December 31, 2023[30] - Total current assets fell to $45,795,843 in 2024 from $97,508,917 in 2023, a decline of approximately 53%[30] Expenses - Research and development expenses for Q4 2024 totaled $11.0 million, a decrease of 25.2% from $14.7 million in Q4 2023[7] - General and administrative expenses for Q4 2024 were $8.1 million, down approximately 33.1% from $12.1 million in Q4 2023[7] - For the full year 2024, research and development expenses totaled $46.2 million, down from $54.8 million in 2023, a decrease of 15.7%[13] - Total operating expenses decreased to $83,891,036 in 2024 from $103,702,293 in 2023, representing a reduction of approximately 19%[33] - Research and development expenses decreased to $46,175,512 in 2024 from $54,807,348 in 2023, a reduction of approximately 16%[33] - General and administrative expenses decreased to $37,715,524 in 2024 from $48,894,945 in 2023, a decline of about 23%[33] Equity and Liabilities - Additional paid-in capital increased to $676,373,822 in 2024 from $646,229,824 in 2023, reflecting an increase of about 5%[30] - Total liabilities decreased to $10,295,857 in 2024 from $12,194,800 in 2023, a reduction of approximately 16%[30] - Stockholders' equity decreased to $35,521,961 in 2024 from $85,357,242 in 2023, a decline of about 58%[30] Development Programs - The company is advancing NDV-01, a Phase 2 program for high-grade non-muscle invasive bladder cancer, with topline data expected at AUA 2025[4] - Sepranolone, a Phase 2b-ready neurosteroid for Tourette syndrome, is also being developed with plans for evaluation in other compulsion-related disorders[4] - The company aims to initiate a registration-track study for NDV-01 in late Q4 2025 to early 2026[7] - The U.S. NMIBC market is estimated to be a multi-billion opportunity, driven by the increasing incidence of bladder cancer and demand for effective therapies[15] Share Information - The weighted average number of common shares outstanding increased to 30,163,751 in 2024 from 30,099,203 in 2023[33]

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].

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]

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]

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]