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 ...

90% of patients achieved high grade disease-free status at any time point with NDV-01, demonstrating strong proof-of-concept for sustained-release “GEM/DOCE” formulation* NDV-01 showed promising clinical activity in BCG-naïve and BCG-unresponsive patients, with favorable overall tolerability Data to be reviewed at Investor Event on April 28, 2025 at 4:30 PM ET CORAL GABLES, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechn ...

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]

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 intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBCSession: P2 ...

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 ...

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]

CORAL GABLES, Fla., March 26, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, or “the Company”), a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies, today announced plans to host a conference call and webcast on Thursday, March 27, 2025 at 4:30 PM ET to discuss recent business progress and financial results for the fourth quarter ended December 31, 2024. Conference Call and Webcast Information: Date: Thursday, March 27, 2025 at 4:30 ...