RLMD

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Relmada Therapeutics Inc (NASDAQ:RLMD) reported strong phase 2 data for NDVO1, with 95% of patients achieving a complete response at any time and 76% having a durable complete response at 12 months. The company has a strong balance sheet with $217.7 million in cash, expected to fund operations through 2029, including the completion of the phase 3 program for NDVO1. Relmada Therapeutics Inc (NASDAQ:RLMD) has FDA alignment on two planned registrational pathways for NDVO1, de-risking the regulatory path forward. The company has a clear plan to file INDs for both NDVO1 and sopranolol by the end of 2026, with clinical trial sites already engaged and prepared to enroll patients. The addition of a new Chief Business Officer with nearly three decades of experience in uro-oncology, including leading the US launch of the first FDA-approved intravesical gene therapy for NMIBC, strengthens the team's commercial and development expertise. Relmada Therapeutics Inc (NASDAQ:RLMD) has delayed the NDVO1 IND filing from mid-2026 to the end of 2026 due to manufacturing scale-up challenges, including scheduling with GMP manufacturing partners. The company has not yet decided on the timing or format of initial phase 3 clinical data disclosure, with the 3-month complete response data potentially pushed into the first half of 2027. Manufacturing for NDVO1 remains the final and critical gating factor, with the company needing to complete GMP batch production and stability data before filing the IND. Relmada Therapeutics Inc (NASDAQ:RLMD) has not yet reviewed the 18-month phase 2 data, as management has been entirely focused on phase 3 preparation, leaving a potential data gap for investors. The company's net loss increased to $12.9 million in Q2 2026 from $9.9 million in Q2 2025, driven by higher R&D and manufacturing costs. Warning! GuruFocus has detected 2 Warning Signs with RLMD. Is RLMD fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more color on the gating factors for the manufacturing and CMC activities for NDV01? Is it an issue with the release of the chemo from the gel, scaling, consistency, or stability? A: Sergio Traversa (CEO) and Bipin Dalmia (Chief Business Officer) clarified that the formulation and process have been locked. The remaining work is purely manufacturing executionproducing GMP batches at a scalable quantity with an external partner. The development activities are complete; the next focus is getting on the manufacturer's schedule and producing the batches needed for the IND filing. Q: Do you need FDA input on the GMP manufacturing batch prior to filing the IND? A: Bipin Dalmia (Chief Business Officer) stated that no additional FDA input is needed before filing the IND. The company already has minutes from prior FDA meetings on development, so they will proceed directly to filing. Q: How many sites are planned for the Phase 3 trial, and how quickly can you go from IND clearance to first patient dose? A: Sergio Traversa (CEO) confirmed that approximately 80 sites are enrolled, with 60 primary and 20 backup sites. Once the IND is cleared (30 days after filing), the company can begin enrolling patients almost immediately, as all other components are ready. Q: Do you have plans to disclose the 18-month data cut from the Phase 2 study later this year? A: Sergio Traversa (CEO) noted that the company has been entirely focused on Phase 3 preparation and has not yet reviewed the 18-month data. While they will likely publish it at some point, there is no specific plan or timeline for disclosure at this time. Q: What steps or tasks took longer than expected for the NDV01 IND, given the initial guidance for mid-2026? A: Sergio Traversa (CEO) explained that nothing was unexpected, but manufacturing timelines are inherently uncertain. The biggest hurdle is securing a slot on the GMP manufacturer's schedule, which can take one to three months. The actual manufacturing process itself takes only about two days, but scheduling is the bottleneck. Q: Should we expect the initial 3-month CR data from the Phase 3 trial in the first half of 2027, or are you reevaluating the initial disclosures? A: Sergio Traversa (CEO) indicated that the company has not yet decided on the disclosure timeline. They prefer to wait until a meaningful number of patients (likely 15-20) have data, as results from only 4-5 patients would not be significant. Additionally, the 6-month data may be more representative than 3-month data, given that retreatment is allowed after 3 months for non-responders. Q: Does the induction count towards the primary CR endpoint, or is it captured as a secondary endpoint, given that clinicaltrials.gov allows one reinduction after disease recurrence? A: Sergio Traversa (CEO) clarified that the primary endpoint is "response at any time." Patients can have one reinduction if needed, and the highest response rate observed during the trial is what matters for the primary endpoint. Q: Is there any read-through from the FDA Adcom on the Reprimune product to your second-line development for NDV01? A: Sergio Traversa (CEO) declined to comment on other companies' outcomes, noting it would be imprudent. He added that in their meetings with the FDA, there is no fixed number for the expected response rate; the FDA wants to see overall data on response rate and durability, which is different from other comparisons. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Relmada Therapeutics, Inc.? Here are five stocks we like better. NDV-01 manufacturing is Relmada’s immediate priority as it targets an investigational new drug application (IND) filing by the end of 2026, followed by a Phase III registrational study for non-muscle invasive bladder cancer. The company has completed formulation and process development, with GMP production and stability data remaining. Relmada reported encouraging Phase II results for NDV-01, including a 95% complete response rate at any time and a 76% durable complete response rate at 12 months. The sustained-release gemcitabine/docetaxel formulation is intended to provide prolonged bladder exposure through a brief, office-based administration. The company also expects to file an IND for sepranolone in Prader-Willi syndrome by year-end 2026. Relmada ended Q2 with $217.7 million in cash, cash equivalents and short-term investments, which management expects will fund operations through 2029, including the NDV-01 Phase III program. Relmada Therapeutics (NASDAQ:RLMD) said it is prioritizing manufacturing activities for NDV-01, its sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer, as it targets an investigational new drug application filing by the end of 2026. Chief Executive Officer Sergio Traversa said the company has entered a “critical execution phase,” with manufacturing representing the remaining major step before the planned registrational program can begin. Relmada expects to initiate its Phase III rescue registrational study after the IND is cleared. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth NDV-01 is designed to provide sustained delivery of the chemotherapy combination gemcitabine and docetaxel, or gem/doce, in a single intravesical formulation. Traversa said the program builds on the established safety and efficacy experience of conventional gem/doce, while seeking to offer prolonged bladder exposure without a physical device. Traversa said Relmada has aligned with the FDA on two planned registrational pathways for NDV-01. The company reported Phase II results showing that 95% of patients achieved a complete response at any time and that 76% had a durable complete response at 12 months. He said safety had been favorable throughout the study. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High However, the company’s immediate focus is completing production at scalable, good manufacturing practice standards. Traversa said the formulation and process have been locked, with the remaining work centered on producing GMP batches and generating stability data needed to support the IND filing. “Manufacturing is the final piece,” Traversa said. “We are confident in our plan and in our team.” → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling During the question-and-answer session, Traversa said the company is working with Piramal as its manufacturing partner. He noted that the product itself can be made in roughly two days, but obtaining a production slot with an external manufacturer can take months because of scheduling requirements. Chief Business Officer Bipin Dalmia said development work on the formulation, scalable process and analytical program has been completed. “The development activities are complete,” Dalmia said. “The manufacturing activities are our next focus.” Dalmia added that Relmada does not expect to require further FDA input before filing the NDV-01 IND. Once the IND is filed and cleared, Traversa said the company could begin enrolling patients quickly. Relmada has approximately 80 trial sites lined up, including about 60 primary sites and 20 backup sites, according to Traversa. The company said it expects the IND review period to be 30 days and that trial sites are otherwise prepared to begin enrollment once clinical material becomes available. Dalmia, who joined Relmada during the quarter, said his responsibilities will include corporate strategy, commercial planning, new product planning and potential business development for NDV-01. He also said he will be closely involved in the program’s development and manufacturing activities. He said the non-muscle invasive bladder cancer market is evolving, particularly for patients with BCG-unresponsive disease, where preserving the bladder is increasingly a treatment objective. Dalmia said physicians and patients face trade-offs among efficacy, durability, safety, tolerability and convenience with currently available and emerging therapies. According to Dalmia, NDV-01 could potentially differentiate itself through its use of a chemotherapy combination familiar to urologists, its sustained-release delivery approach and an office-based administration procedure that can be completed in approximately five minutes. Relmada believes the therapy could have applicability across much of the NMIBC population, including potential future settings such as intermediate-risk and BCG-naïve disease, if approved. The company has not set a specific timetable for disclosing 18-month data from its Phase II NDV-01 study. Traversa said Relmada’s focus has been on preparing for the registrational program, though the company may publish the longer-term data at some point. For the planned Phase III study, he said Relmada has not finalized its approach to early clinical disclosures. The company had previously discussed reporting a three-month complete-response analysis, but Traversa said it may wait until it has data from approximately 15 to 20 patients. He also said six-month results may be more meaningful because patients who do not respond after three months may receive reinduction treatment. Relmada also plans to file an IND by year-end for sepranolone, its program for Prader-Willi syndrome, a rare condition the company estimates affects 350,000 to 400,000 people globally. Traversa said formulation development for sepranolone has been completed, with finalization of its prefilled-syringe delivery system remaining. The company expects to begin a Phase II proof-of-concept study after IND clearance. Relmada ended the second quarter with $217.7 million in cash, cash equivalents and short-term investments, up from $93 million at Dec. 31, 2025. Chief Financial Officer Maged Shenouda said the company expects its current cash resources to support operations through 2029, including completion of the Phase III rescue program for NDV-01. Research and development expense was $8.4 million, compared with $2.8 million in the prior-year quarter, primarily reflecting higher NDV-01 and sepranolone study costs as well as increased manufacturing and drug-storage costs. General and administrative expense was $6.6 million, down from $7.4 million a year earlier, driven by lower stock-based and employee compensation, partly offset by higher stock appreciation rights expense and consulting costs. Net cash used in operating activities was $9.6 million, compared with $6.4 million in the second quarter of 2025. Net loss was $12.9 million, or $0.11 per basic and diluted share, compared with a loss of $9.9 million, or $0.30 per share, in the prior-year period. Traversa said the company’s near-term priorities are completing NDV-01 manufacturing work and filing INDs for both NDV-01 and sepranolone by the end of 2026. Relmada Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada's research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications. Relmada's lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Relmada Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Advancing NDV-01 toward IND filing expected by year-end 2026 with GMP manufacturing of clinical trial material underway. Initiation of the Phase 3 RESCUE registrational program upon IND clearance. Sepranolone IND filing expected by year-end 2026 and initiation of Phase 2 proof-of-concept study in Prader-Willi Syndrome upon IND clearance. Strengthened the leadership team with appointment of Bipin Dalmia as Chief Business Officer. Added to the Russell 2000® and Russell 3000® Indexes effective June 26, 2026. Cash balance of $217.7 million as of June 30, 2026, expected to fund operations through 2029, including completion of the NDV-01 Phase 3 RESCUE program. Management to host a conference call and webcast today at 4:30 PM ET. CORAL GABLES, Fla., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “Relmada has entered a critical execution phase as we prepare NDV-01 for registrational development. With FDA alignment, a robust clinical dataset, an experienced leadership team, and capital expected to fund operations through completion of the Phase 3 RESCUE program, we believe the Company is well positioned to create significant long-term value,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. “Our immediate priority is manufacturing execution for NDV-01. Bringing a novel, sustained-release therapy of this kind into registrational development requires careful execution, and we are focused on completing the remaining activities needed to support the IND filing.” Manufacturing and CMC Update The Company is advancing manufacturing and chemistry, manufacturing, and controls (CMC) activities to support planned IND filings for both NDV-01 and sepranolone by year-end 2026. Each program is progressing along its own development path. NDV-01: Manufacturing and CMC activities supporting the planned NDV-01 IND submission are ongoing. The Company expects to submit the NDV-01 IND by year-end 2026 and initiate the Phase 3 RESCUE registrational program upon IND clearance. Clinical trial sites are engaged and prepared to begin enrollment following IND clearance. Sepranolone: Formulation development for sepranolone is complete, and the Company is finalizing the pre-filled syringe delivery system. This is the remaining step ahead of the sepranolone IND submission, which is expected by year-end 2026. The company expects to initiate the Phase 2 proof-of-concept study in Prader-Willi Syndrome following IND clearance. Corporate Update During the quarter, Relmada strengthened its leadership team with the appointment of Bipin Dalmia, PhD, MBA, as Chief Business Officer. He brings nearly three decades of biopharmaceutical leadership experience spanning business development, portfolio strategy, commercial planning, and uro-oncology, including leadership of the U.S. launch, indication expansion, global commercialization, and long-term manufacturing strategy for the first FDA-approved intravesical gene therapy for NMIBC. “Since joining Relmada, I have become increasingly convinced that NDV-01 represents one of the most compelling opportunities in NMIBC,” said Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. “As the NMIBC treatment landscape continues to evolve, patients and physicians are seeking therapies that deliver meaningful efficacy and durability without compromising convenience, tolerability, or ease of use. As we advance toward registrational development, NDV-01’s highly differentiated profile and potential applicability across multiple patient populations position it to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum.” Expected Upcoming Relmada Milestones: NDV-01: NDV-01 United States IND filing – By YE26 NDV-01 Phase 3 RESCUE program initiation – Upon IND Clearance Sepranolone: Sepranolone United States IND filing – By YE26 Sepranolone Phase 2 initiation in Prader-Willi Syndrome – Upon IND Clearance Financial Results Second Quarter 2026 Financial Results Research and development expense for the three months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the three months ended June 30, 2025, an increase of $5.6 million. The increase was primarily attributable to higher NDV-01 and sepranolone study costs and increased manufacturing and drug storage costs, partially offset by lower employee compensation. General and administrative expense for the three months ended June 30, 2026, totaled $6.6 million compared to $7.4 million for the three months ended June 30, 2025, a decrease of approximately $0.8 million. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services. Net cash used in operating activities for the three months ended June 30, 2026, totaled $9.6 million compared to $6.4 million for the three months ended June 30, 2025. The net loss for the three months ended June 30, 2026, was $12.9 million, or $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 per basic and diluted share, for the three months ended June 30, 2025. As of June 30, 2026, the Company’s cash, cash equivalents, and short-term investments balance were $217.7 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025. The Company’s current cash, cash equivalents, and short-term investments as of June 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program. The Company had 106,669,846 shares outstanding, as of August 4, 2026 Conference Call and Webcast Information:Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results. Conference Call and Webcast Information: Date: Thursday, August 6, 2026 at 4:30 PM ET Participant Dial-in (US): 1-800-717-1738 Participant Dial-in (International): 1-646-307-1865 Webcast Access: Click Here A replay of the webcast will be available in the Investors section of the Relmada website at https://ir.relmada.com/investors/events/. About NDV-01 NDV-01 is a novel, sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and sustained drug release over approximately 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. NDV-01 is encompassed by multiple patent applications that if issued, could provide protection until 2047. About the NDV-01 Phase 3 RESCUE Registrational Pathways: Relmada has received written FDA feedback confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations, and primary endpoints. The Company expects to submit an IND by year-end 2026 and initiate the Phase 3 RESCUE program upon IND clearance. About NMIBC NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence rates (50 – 80% over 5 years) and disease progression in a subset of these patients. With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-risk BCG-unresponsive disease represents the biggest unmet need in NMIBC, with limited and suboptimal bladder-sparing treatment options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies and patients with recurrence must undergo repeated surgical resections. NDV-01 has the potential to serve as a foundational frontline or salvage therapy across the NMIBC disease spectrum. About Sepranolone and GABA Modulation Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi Syndrome (PWS), Tourette Syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile. The Company expects to submit an IND by year-end 2026 and initiate the Phase 2 study in Prader-Willi syndrome upon IND clearance. About Prader-Willi Syndrome (PWS) PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology. About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through clinical development with the potential to address significant unmet needs. For more information, visit www.relmada.com Forward-Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to successfully execute manufacturing and CMC activities for NDV-01 and/or sepranolone, including GMP manufacture of clinical trial material, manufacturing scale-up, process validation, timing of completion of manufacturing activities, and regulatory acceptance of manufacturing-related submissions, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list. Investor Contact:Brian RitchieLifeSci [email protected] Media Inquiries:Corporate [email protected]

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Relmada Therapeutics Inc (NASDAQ:RLMD) reported robust 12-month data for NDV01 in non-muscle invasive bladder cancer (NMIBC), demonstrating high response rates and durable efficacy. The company successfully completed a $160 million private placement financing, strengthening its financial position. Relmada Therapeutics Inc (NASDAQ:RLMD) achieved FDA alignment for its planned Phase III rescue program, enhancing the likelihood of regulatory approval. A provisional patent application was filed for NDV01, potentially extending patent protection to 2047, which could significantly expand global IP protection. The company has a strong cash balance of $234 million, expected to fund operations through 2029, including the completion of the Phase III Rescue Program for NDV01. Research and development expenses decreased by $3.9 million compared to the previous year, which may indicate reduced investment in new projects. General and administrative expenses increased by $5.1 million, primarily driven by higher compensation costs. The net loss for the first quarter of 2026 was $19.1 million, an increase from the previous year's net loss of $17.6 million. The company faces potential risks and uncertainties associated with forward-looking statements, which could impact future results. There is a potential for variability or dilution of efficacy in the Phase III trial due to broad inclusion criteria, which could affect trial outcomes. Warning! GuruFocus has detected 3 Warning Signs with RLMD. Is RLMD fairly valued? Test your thesis with our free DCF calculator. Q: How should we think about the growing literature on GemDosi and its relevance to NDV01? Also, what are your thoughts on the upcoming data for the BCG unresponsive second-line cohort? A: (Dr. Sergio Traversa, CEO) The growing literature on GemDosi is positive as it reinforces the urology community's belief in its effectiveness for treating bladder cancer. (Dr. Rajpruthi, CMO) We expect to share three-month response and safety data for the BCG unresponsive cohort by the end of the year or early next year, with updates every three months into 2027. Q: What would be considered a positive readout at the 12-month mark for the BCG unresponsive population? A: (Dr. Rajpruthi, CMO) For the BCG unresponsive population, achieving an 80% complete response rate at the 12-month mark would be considered best in class, especially compared to other approved agents that show around 45% response rates. Q: Can you clarify the implications of your provisional patent filing and its potential impact on future clinical trials? A: (Dr. Sergio Traversa, CEO) The provisional patent, if granted, would extend our patent life into 2047, providing significant IP protection. This could allow us to explore additional clinical trials, including combination studies, after the rescue programs are completed. Q: How are you addressing the potential variability in efficacy for the Phase III BCG unresponsive setting with broad inclusion criteria? A: (Dr. Rajpruthi, CMO) We have set guardrails for up to two prior first-line therapies to manage resistance mechanisms. We will evaluate efficacy based on one or two lines of prior therapies and consider the impact of prior intravesical chemotherapy. Q: Does the FDA's acceptance of CR at any time imply a need for durable responses in the Phase III primary endpoint? A: (Dr. Rajpruthi, CMO) The FDA wants to see a complete response at any time (CRNE) along with the duration of response. They will consider the totality of the data, including durability, as there are currently no approved agents in this space. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Relmada Therapeutics, Inc.? Here are five stocks we like better. Relmada said it is still on track to start its Phase 3 RESCUE registrational program for NDV-01 in mid-2026, after sharing 12-month Phase 2 data in non-muscle invasive bladder cancer and aligning with the FDA on the trial plan. The Phase 2 results for NDV-01 were strong, with a 95% complete response rate at any time in high-risk NMIBC, no progression to muscle-invasive disease, no radical cystectomies, and no grade 3 or higher treatment-related adverse events. Relmada strengthened its financial position with a $160 million private placement, ending the quarter with $234 million in cash and saying its resources should fund operations through 2029, including completion of the RESCUE program. Relmada Therapeutics (NASDAQ:RLMD) said it remains on track to begin its Phase 3 RESCUE registrational program for NDV-01 in mid-2026 after reporting 12-month Phase 2 data in non-muscle invasive bladder cancer and strengthening its balance sheet through a private financing. On the company’s first-quarter earnings call, Chief Executive Officer Dr. Sergio Traversa said the company has made “excellent progress” this year, citing 12-month efficacy data for NDV-01, alignment with the U.S. Food and Drug Administration on the planned registrational program, a new provisional patent filing and completion of a $160 million private placement financing. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? NDV-01 is a ready-to-use, sustained-release intravesical formulation of gemcitabine and docetaxel, commonly referred to as Gem/Doce. Traversa said the product is designed to build on the established safety and efficacy profile of conventional Gem/Doce while offering a treatment that can fit into real-world urology practice. Dr. Raj Pruthi, Relmada’s chief medical officer for urology, said NDV-01 demonstrated high response rates and durable efficacy in an ongoing open-label, single-arm Phase 2 study of patients with high-risk non-muscle invasive bladder cancer, or NMIBC. → MercadoLibre Boldly Invests in Growth: Discount Deepens The study was designed to enroll up to 70 patients. Participants receive six biweekly doses, followed by monthly maintenance for up to one year. The primary endpoints are safety and complete response rate at 12 months. Pruthi said the 12-month data showed: A 95% complete response rate at any time and a 76% complete response rate at 12 months in high-risk NMIBC patients. A 94% complete response rate at any time and an 80% complete response rate at 12 months in the BCG-unresponsive subpopulation. No progression to muscle-invasive disease. No radical cystectomies. No grade 3 or higher treatment-related adverse events. No dose interruptions or discontinuations due to adverse events. → MP Materials Is Quietly Building a Rare Earth Powerhouse Pruthi said most treatment-related adverse events were grade 1. He added that the data “compare favorably to other programs in this space” and support NDV-01’s potential as a best-in-class therapy if approved. Relmada plans to present the 12-month data and details of the Phase 3 RESCUE program at the American Urological Association annual meeting. Pruthi said Relmada expects to file the U.S. investigational new drug application and initiate the RESCUE program across an estimated 80 sites in North America in mid-2026. The program includes two separate approval pathways. The first pathway focuses on second-line BCG-unresponsive patients with carcinoma in situ who are refractory to first-line therapies that are approved or in development. Pruthi estimated that approximately 5,000 patients per year in the U.S. fall into this setting. The single-arm study will use complete response rate at any time as the primary endpoint, with secondary endpoints including duration of response, progression-free survival and recurrence-free survival. Pruthi said Relmada expects to report the first three-month response data around year-end. During the question-and-answer session, he said the company hopes to have “a handful of patients” with three-month response and safety data by the end of the calendar year or early next year, with updates anticipated every three months into 2027. The second pathway will evaluate NDV-01 as an adjuvant therapy after transurethral resection of bladder tumor, or TURBT, in intermediate-risk NMIBC. Pruthi estimated that about 75,000 U.S. patients per year fall into this group. The trial is designed as an open-label, randomized controlled study comparing NDV-01 with observation. The primary endpoint is disease-free survival, with secondary endpoints including high-grade recurrence-free survival, progression-free survival and quality-of-life measures. Relmada executives emphasized NDV-01’s practical advantages for urology practices. Pruthi said NDV-01 forms a soft matrix in the bladder to enhance local urothelial exposure while minimizing systemic toxicity. He said it can be administered in a physician’s office by a nurse or licensed practical nurse in under five minutes and does not require a specialized pharmacy or hub. Traversa also highlighted an April provisional patent application in the U.S. covering formulations and methods of treatment for NDV-01. He said that, if granted, the patent could serve as the basis for worldwide filings and extend coverage for NDV-01 into 2047, which he said would provide a nine-year extension of commercial exclusivity. In response to an analyst question, Traversa said he would not expect a response from the patent office for at least 12 months. Chief Financial Officer Maged Shenouda provided an update on sepranolone, which he described as a novel neurosteroid intended to modulate the GABA neurotransmitter pathway and normalize GABA-A receptor activity. Relmada is developing sepranolone for compulsivity disorders, including obsessive-compulsive disorder, Tourette syndrome and Prader-Willi syndrome. Shenouda said the company plans to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Preparations include engaging with the FDA on the proposed trial design and establishing a supply chain. Relmada ended the first quarter with $234 million in cash, compared with $94 million at Dec. 31, 2025. Shenouda said the balance included approximately $150 million in net proceeds from the private financing announced March 9. The company expects its current cash resources to fund operations through 2029, including completion of the Phase 3 RESCUE program for NDV-01. Research and development expense was $8.1 million for the quarter ended March 31, 2026, down from $12 million in the same period of 2025. Shenouda said the decrease was primarily due to nonrecurring costs in 2025 tied to the acquisition of sepranolone and the NDV-01 license agreement, partially offset by increased costs related to startup of the NDV-01 Phase 3 trials, the sepranolone study and additional R&D personnel. General and administrative expense rose to $11.4 million from $6.3 million a year earlier, driven primarily by increased compensation costs, partly offset by lower stock-based compensation. Net cash used in operating activities was $15.1 million, compared with $18.1 million in the prior-year period. Relmada reported a first-quarter net loss of $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million, or $0.58 per basic and diluted share, in the year-earlier quarter. In closing remarks, Traversa said the company is focused on execution as it prepares to initiate the RESCUE program and expects to provide additional updates in coming quarters. Relmada Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada's research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications. Relmada's lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Relmada Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Positive 12-Month Phase 2 data for NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months in high-risk non-muscle invasive bladder cancer (NMIBC), and a 94% CR rate at any time and a durable 80% CR rate at 12 months in the BCG-unresponsive subpopulation, reinforcing best-in-class potential in NMIBC On track to initiate Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 Filed provisional patent application with the USPTO in April 2026 covering NDV-01 pharmaceutical formulations and methods of treatment; if issued, patents claiming priority to the provisional filing would have a term until April 2047 Relmada will feature two NDV-01 presentations at the American Urological Association Annual Meeting (AUA2026), highlighting the 12-month Phase 2 data and the Phase 3 RESCUE program design and rationale Cash balance of $234.0 million as of March 31, 2026 expected to fund operations through 2029, including completion of the NDV-01 Phase 3 RESCUE program Management to host a conference call and webcast today at 4:30 PM ET CORAL GABLES, Fla., May 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. “We made significant progress in the first quarter, highlighted by the robust 12-month Phase 2 data for NDV-01 in NMIBC and the successful completion of a $160 million PIPE financing, which has well-capitalized our balance sheet to fund the NDV-01 RESCUE Phase 3 program through completion,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. “We remain on track to file the NDV-01 IND and initiate the Phase 3 RESCUE registrational program in mid-2026 – a milestone that would mark a major inflection point for Relmada and for the patients we aim to serve. We believe NDV-01 has the potential to be a best-in-class therapy for patients with NMIBC and remain focused on maximizing its potential for success. To this end, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings, and have a term into 2047.” “The AUA2026 Annual Meeting provides an important opportunity to introduce NDV-01 to the broader urologic community,” said Raj S. Pruthi, MD, Chief Medical Officer – Urology of Relmada Therapeutics. “Our presentations will highlight the 12-month Phase 2 data generated to date for NDV-01, including observed complete responses and safety findings. We will also be sharing the design and rationale for the Phase 3 RESCUE program. NDV-01 is a sustained-release gemcitabine and docetaxel (Gem/Doce) designed to support streamlined, in-office administration in less than five minutes. We believe AUA2026 provides an important national forum to increase awareness and engagement within the investigator community as we approach the initiation of the RESCUE program in mid-2026.” Upcoming AUA2026 Presentations and NDV-01 Phase 2 Data Highlights: Relmada will present two abstracts at AUA2026 including: (1) NDV-01 Phase 2 data (12-month follow-up), and (2) the Phase 3 RESCUE program design (Clinical Trials in Progress session). The presentations are intended to raise awareness of NDV-01 and build investigator interest in the RESCUE registrational program. Key data to be highlighted include: 95% complete response (CR) rate at any time and durable 76% CR rate at 12 months in high-risk NMIBC patients 94% CR rate at any time and durable 80% CR rate at 12 months in BCG-unresponsive NMIBC patients No patient had progression to muscle-invasive disease, and no patient underwent a radical cystectomy Favorable overall tolerability – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions NDV-01 Intellectual Property: In April 2026, Relmada filed a provisional patent application with the United States Patent and Trademark Office (USPTO) directed to pharmaceutical formulations and methods of treatment related to NDV-01. The provisional filing has the potential to form the basis for a comprehensive world-wide patent filing program for NDV-01. If issued, patents claiming priority to the provisional filing will be expected to have a term until April 2047. Expected Upcoming Relmada Milestones: NDV-01 United States IND filing – Mid-2026 NDV-01 Phase 3 RESCUE Program initiation – Mid-2026 Sepranolone Phase 2 initiation in Prader-Willi syndrome – Mid-2026 Initial 3-month NDV-01 data from Phase 3 2L BCG-unresponsive study – YE 2026 Financial Results First Quarter 2026 Financial Results Research and development expense for the three months ended March 31, 2026, totaled $8.1 million, compared to $12.0 million for the three months ended March 31, 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurring costs associated with the acquisition of sepranolone and the license agreement of NDV-01 recognized in 2025. This 2026 decrease was partially offset by increased costs related to the start-up of the Phase 3 NDV-01 trials and Phase 2b sepranolone study and additional R&D personnel. General and administrative expense for the three months ended March 31, 2026, totaled $11.4 million compared to $6.3 million for the three months ended March 31, 2025, an increase of approximately $5.1 million. The increase was primarily driven by an increase in compensation costs partially offset by a decrease in stock-based compensation costs. Net cash used in operating activities for the three months ended March 31, 2026, totaled $15.1 million compared to $18.1 million for the three months ended March 31, 2025. The net loss for the three months ended March 31, 2026, was $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million, or $0.58 per basic and diluted share, for the three months ended March 31, 2025. The Company’s balance of $234.0 million in cash, cash equivalents, and short-term investments, includes net proceeds of approximately $150 million from the private placement financing announced March 9, 2026. This compares to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025. The Company’s current cash, cash equivalents, and short-term investments as of March 31, 2026, is expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program. The Company had 104,890,223 shares outstanding, as of May 7, 2026 Conference Call and Webcast Information: Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results. Conference Call and Webcast Information: Date: Tuesday, May 12, 2026 at 4:30 PM ET Participant Dial-in (US): 1-800-717-1738 Participant Dial-in (International): 1-646-307-1865 Webcast Access: Click Here A replay of the webcast will be available in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar. About NDV-01 NDV-01 is a ready-to-use, sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and controlled drug release over approximately 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. It is encompassed by multiple patent applications that if issued, could provide protection until 2047. About the NDV-01 Phase 2 Study The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year. Patients were evaluated at 3-month intervals using cystoscopy and cytology, with biopsies performed at the treating physician’s discretion. Time-to-event endpoints, including complete response (CR) and event free survival (EFS) rates, were analyzed as landmark events and using Kaplan–Meier (KM) analysis. The primary efficacy endpoints are safety and CR rate at 12 months, and secondary efficacy endpoints are duration of response (DOR) and EFS. Treatment-related adverse events (TRAEs) were graded according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0). About the NDV-01 Phase 3 RESCUE Registrational Pathways: Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints. IND filing and program initiation remain on track for mid-2026. Registration Pathway 1 – An open-label single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time. Registrational Pathway 2 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (Transurethral Resection of Bladder Tumor, NDV-01 vs. observation). There are no approved adjuvant treatments for intermediate risk NMIBC, which we estimate affect ~75,000 patients/year in the US. The primary endpoint of the study is disease free survival (DFS). About NMIBC NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes. About Sepranolone and GABA Modulation Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile. About Prader-Willi Syndrome (PWS) PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology. About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs. For more information, visit www.relmada.com Forward-Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list. Investor Contact: Brian Ritchie LifeSci Advisors [email protected] Media Inquiries: Corporate Communications [email protected]

NDV-01 showed durable Phase 2 efficacy with a 12-month complete response rate of 76% overall (80% in BCG-unresponsive patients) and high overall CRs (95% any-time) with no progression to muscle-invasive disease or grade ≥3 treatment-related adverse events; the company plans to start the two-pathway registrational Phase 3 RESCUE program in mid-2026 (≈80 North American sites) and expects initial 3-month data from the second-line arm by year-end 2026. Sepranolone (a GABA-modulating steroid antagonist) is being prepared for a proof-of-concept study in Prader-Willi syndrome slated to begin in mid-2026, with prior proof-of-concept signals in Tourette syndrome and ongoing FDA engagement on trial design. Relmada closed 2025 with about $93 million in cash and reported net proceeds from recent financings (including a ~$160 million private placement), which management says, together, are expected to fund operations through 2029; Q4 2025 net loss was $19.9 million ($0.27 per share). Interested in Relmada Therapeutics, Inc.? Here are five stocks we like better. Relmada Therapeutics (NASDAQ:RLMD) outlined progress on its lead urology oncology program and reviewed fourth-quarter results during its fourth quarter and full year 2025 earnings call, highlighting durable Phase 2 data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), plans to begin a Phase 3 registrational program in mid-2026, and upcoming clinical work for sepranolone. Chief Executive Officer Dr. Sergio Traversa said 2025 was a “transformational year” for the company, pointing to “compelling responses and durable 12-month efficacy data” from the ongoing Phase 2 study of NDV-01. NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel being developed for NMIBC. → Forget Chipmakers: Walmart and Target Are the Real AI Plays Chief Medical Officer (Oncology/Urology) Dr. Raj Pruthi provided details on the 12-month dataset, describing NDV-01’s performance as a high response rate with durable efficacy in an open-label, single-arm Phase 2 trial enrolling up to 70 patients with high-risk NMIBC. Patients in the study received six biweekly doses followed by monthly maintenance for up to one year, with regular assessments including cystoscopy and cytology. Pruthi reported the following efficacy and safety outcomes discussed on the call: 12-month complete response (CR) rate: 76% overall. 12-month CR rate in BCG-unresponsive patients: 80%. CR at any time: 95% overall (based on 38 patients) and 94% among BCG-unresponsive patients. Safety: No progression to muscle-invasive disease, no radical cystectomies, no grade 3 or higher treatment-related adverse events, and no interruptions or discontinuations due to adverse events; most treatment-related adverse events were grade 1. → Members of Congress Bought These 5 Stocks—Should You? Pruthi also emphasized administration and design elements he believes could help NDV-01 fit in routine practice, saying the product is designed to form a “soft matrix” in the bladder to enhance local exposure while minimizing systemic toxicity, and that it can be delivered in an office setting in “less than 5 minutes.” Management said it reached alignment with the FDA on a Phase 3 registration strategy built around two independent pathways within the planned RESCUE program. Traversa said the company plans to initiate the Phase 3 program in the middle of 2026, while Pruthi added the company expects to secure U.S. IND clearance and begin RESCUE in mid-2026 at an estimated 80 sites in North America. → Expedia Stock Turns Volatile After Rally. Where Does It Go Next? The two registrational studies described were: Pathway 1 (intermediate-risk adjuvant post-TURBT): An open-label randomized controlled trial evaluating NDV-01 versus observation after TURBT. The primary endpoint is disease-free survival, with secondary endpoints including high-grade recurrence-free survival, progression-free survival, and quality-of-life metrics. Pruthi estimated about 70,000 to 75,000 U.S. patients per year in this setting, and Traversa cited approximately 75,000. Pathway 2 (BCG-unresponsive carcinoma in situ, second-line): A single-arm open-label trial in patients with BCG-unresponsive CIS who are refractory to first-line therapies. The primary endpoint is CR at any time, with secondary endpoints including duration of response, progression-free survival, and recurrence-free survival among responders. Pruthi estimated about 5,000 U.S. patients per year in this setting. Pruthi said the company expects to report initial 3-month response data from the second-line BCG-unresponsive study by the end of 2026. In the Q&A, he added that once enrollment begins mid-year, the company expects it will be able to share 3-month data externally by year-end and then provide additional follow-up data roughly every three months as 6-, 9-, and 12-month data mature. During questions, Pruthi said the company’s 12-month Phase 2 NDV-01 data have been accepted for presentation at the American Urological Association (AUA) meeting, and that the company also expects to present a “trial in progress” as RESCUE gets underway. In response to investor questions about whether the second-line study could include more heavily pretreated patients, Pruthi said the protocol limits prior therapies to a maximum of two lines, offering an example of allowing prior Adstiladrin followed by Anktiva. He also said the company plans to look at outcomes at three months among the first 15 patients stratified by whether they received one versus two prior therapies, and noted this approach reflects conversations with the FDA. Asked whether the FDA stipulated a minimum follow-up duration for all patients prior to a potential NDA submission in the second-line setting, Pruthi said the agency had not required a specific minimum follow-up time, but indicated it wants to see a response along with some level of durability, describing the agency’s interest as the “totality of the data.” On enrollment, Pruthi acknowledged the BCG-unresponsive space has been crowded historically, but argued that RESCUE’s second-line positioning offers a competitive advantage, adding that he was not aware of other pivotal studies in that specific second-line setting. For intermediate-risk disease, he cited investigator interest in the category and said he expects enrollment could be “pretty rapidly ahead of schedule,” referencing another company’s experience in intermediate-risk trials. On how the company is thinking about benchmarks, Pruthi discussed historical complete response data in first-line BCG-unresponsive CIS therapies, citing Valrubicin, Keytruda, and Adstiladrin, and said he believes second-line expectations should be in line with or lower than first-line levels as a precedent. In response to questions about CIS versus papillary disease comparisons, he referenced a 2020 Journal of Urology paper by Steinberg describing similar outcomes for gemcitabine/docetaxel in CIS and papillary populations, and noted Relmada’s own CIS subset numbers were small. Chief Financial Officer Maged Shenouda reviewed the company’s plans for sepranolone, describing it as a “GABA Modulating Steroid Antagonist” (GAMSA). He said sepranolone’s mechanism could have potential across compulsive disorders, including obsessive-compulsive disorder, Tourette syndrome, and Prader-Willi syndrome. Shenouda said the company is preparing to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026, with immediate efforts focused on study preparations, FDA engagement on trial design, and establishing a supply chain. Traversa also noted sepranolone previously demonstrated proof-of-concept in Tourette syndrome. Shenouda said Relmada closed 2025 with $93 million in cash, compared with approximately $45 million in cash equivalents and short-term investments at December 31, 2024. He stated the year-end cash balance included net proceeds of approximately $94 million from an underwritten stock offering announced November 5, 2025. He also discussed a $160 million private financing announced March 9, 2025, with net proceeds of approximately $160 million. Management said the financing, together with year-end cash, is expected to fund operations through 2029, including completion of the Phase 3 RESCUE program. For the fourth quarter, Shenouda reported: R&D expense: $8.1 million for Q4 2025 versus $11.0 million for Q4 2024, with the decrease primarily tied to reduced study costs following completion of two Phase 3 trials for REL-1017, partially offset by costs related to NDV-01 Phase 3 startup, a sepranolone Phase 2b study, and additional R&D personnel. G&A expense: $12.3 million for Q4 2025 versus $8.1 million for Q4 2024, driven primarily by higher compensation costs, partially offset by lower stock compensation costs. Net cash used in operating activities: $14.6 million for Q4 2025 versus $8.8 million for Q4 2024. Net loss: $19.9 million, or $0.27 per basic and diluted share, for Q4 2025, compared with a net loss of $18.7 million, or $0.62 per basic and diluted share, for Q4 2024. In closing remarks, Traversa said the company is focused on execution as it prepares to initiate the RESCUE registrational program and plans to update investors in coming quarters. Relmada Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada's research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications. Relmada's lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings. The article "Relmada Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.

Image source: The Motley Fool. Thursday, Mar. 19, 2026 at 4:30 p.m. ET Chief Executive Officer — Dr. Sergio Traversa Chief Medical Officer, Oncology — Dr. Raj S. Pruthi Chief Financial Officer — Maged S. Shenouda Need a quote from a Motley Fool analyst? Email [email protected] With me on today's call are Relmada Therapeutics, Inc.'s CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj S. Pruthi, Relmada Therapeutics, Inc.'s CMO, Oncology, who will provide an NDV01 program update; and Relmada Therapeutics, Inc.'s CFO, Maged S. Shenouda, who will provide an update on sopranolone and a review of the company's Q4 financial results. After that, we will open the line for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio? Sergio Traversa: Thank you, Brian. Good afternoon and welcome everyone to the Relmada Therapeutics, Inc. Fourth Quarter and Year End 2025 Conference Call. 2025 has been a transformational year for Relmada Therapeutics, Inc., marked by significant progress for our lead program NDV01. As a reminder, NDV01 is a sustained-release formulation of gemcitabine and docetaxel. We are developing this investigational product candidate for the treatment of non-muscle invasive bladder cancer, or NMIBC. Most recently, we reported compelling responses and durable 12-month efficacy data for our ongoing Phase II study of NDV01. We achieved FDA alignment for our planned registrational Phase III RESCUE programs. We fortified our team and we substantially strengthened our balance sheet. As we reflect on our recent accomplishment and planned next steps, I would like to highlight four key areas. First, NDV01. We believe that the strength of the recently reported 12-month follow-up data could position NDV01 as a potential best-in-class therapy for the treatment of NMIBC. Furthermore, the strength of the clinical data and the unique easy-to-administer sustained-release formulation give us confidence that NDV01 has the potential to provide what urologists and patients with NMIBC need: a simple, durable, effective treatment that readily fits into real-world practice settings. We plan to initiate the Phase III RESCUE program in the middle of this year. Our Phase III regulatory strategy agreed upon with the FDA includes two independent registrational pathways. Pathway one is focused on adjuvant therapy following TURBT in patients with intermediate-risk bladder cancer, which affects about 75,000 patients in the United States. Pathway two is focused on second-line treatment in BCG-unresponsive patients, which represents about 5,000 patients in the United States. Second, sopranolone. Sopranolone has previously demonstrated proof of concept in Tourette syndrome. It is a disorder characterized by compulsive behavior. We are getting ready to begin a proof-of-concept study in Prader-Willi syndrome in the middle of this year. And third, our team. We substantially strengthened our development team with the appointment of Dr. Raj S. Pruthi, a highly regarded physician-scientist and urologic oncologist, as Chief Medical Officer, Oncology. In addition, we established a scientific advisory board comprised of similarly distinguished peers to further support the NDV01 program: Dr. Yair Lotan from the University of Texas Southwestern Medical Center and Dr. Moussa “Moe” Ates from Johns Hopkins University School of Medicine. Fourth and last, financial strength. We just completed a successful $160,000,000 private financing. Based on existing forecasts, these funds plus our existing cash balance provide Relmada Therapeutics, Inc. with capital through 2029, and importantly, through the completion of the planned NDV01 program. Looking ahead, 2026 is poised to be another important year of value creation for Relmada Therapeutics, Inc., with the initiation of our Phase III RESCUE program for NDV01 in bladder cancer and the Phase II proof-of-concept trial for sopranolone in Prader-Willi syndrome. With that, I also would like to express my appreciation for the trust and support of our investors, employees, collaborators, and the patients who participate in our studies. Next, I will turn the call over to Dr. Raj S. Pruthi, who will provide a review of the NDV01 program, including 12-month follow-up data from the ongoing Phase II study and the summary of our Phase III plans. Raj? Raj S. Pruthi: Thank you, Sergio. Good afternoon, everyone. It is a privilege to share an update on the clinical progress we have made this year, headlined by the truly compelling and best-in-class results for NDV01 in NMIBC. Bladder cancer is a high-frequency cancer that has a major impact on the lives of patients, generally diagnosed in their early to mid-70s. High recurrence rates and burdensome treatments disrupt quality of life at a time when patients are eager to enjoy life. I want to touch on three topics during today's call. One, an overview of the NDV01 12-month data. Two, a summary of our planned Phase III program. And three, a discussion of how NDV01 might fit into the practice of urologic oncology. As Sergio noted, NDV01 is a novel, sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or gem-dose, as we say. Our program builds on physicians' established familiarity with the efficacy and safety profile of conventional gem-dose. More specifically, in patients who are unresponsive to BCG, this combination offers a salvage, bladder-sparing option that may help avoid a radical cystectomy. Moving on to the 12-month data, we are pleased to report that NDV01 has demonstrated a high response rate and durable 12-month efficacy from the ongoing Phase II study. We believe these data stand out in comparison to other benchmark programs that could position NDV01 as a best-in-class treatment option for patients with bladder cancer, if approved. The study is an open-label, single-arm trial in patients with high-risk NMIBC. Patients receive six biweekly doses every other week times six, followed by monthly maintenance for up to one year. Patients undergo regular assessments with cystoscopy, pathology, and, if needed, biopsy. The study was designed to enroll up to 70 patients with high-risk NMIBC. The primary endpoints are safety and complete response rate at 12 months. Secondary endpoints are duration of response and event-free survival. The data demonstrated a 12-month complete response rate of 76% with a favorable safety profile. Notably, the study also showed a 12-month complete response rate of 80% in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. These findings support the advancement into the Phase III registrational program, which we are calling RESCUE. The program will evaluate NDV01 in both second-line BCG-unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following TURBT. When you look at the complete responses, or CR, at any time in the overall population, we see a CR any time of 95%, based on 38 patients. Among those with BCG-unresponsive disease, we see a CR rate at any time of 94%. Given the burdensome nature of recurrent bladder cancer treatment, safety is a critical element of our product profile. We continue to be encouraged by the favorable safety profile observed for NDV01 across our clinical program. In the 12-month data set for NDV01, no patients had progression to muscle-invasive disease, no patients underwent a radical cystectomy, no patients had a grade 3 or higher treatment-related adverse event, no interruptions or discontinuations of treatment due to adverse events occurred, and most treatment-related adverse events were at the grade 1 level. Moving on to the planned Phase III RESCUE program. We believe our 12-month response and durability data compare quite favorably to the current commercial and development-stage therapies. We have constructed our Phase III registrational pathways to maximize our probability of success and create the most efficient path to FDA approval. The entire RESCUE registration program was designed in alignment with the FDA to provide two separate approval pathways. We expect to secure U.S. IND clearance and initiate the Phase III RESCUE program in the middle of this year. Let us review the two studies that form the RESCUE program. Registrational pathway one focuses on the evaluation of NDV01 in patients with intermediate-risk bladder cancer as an adjuvant therapy following TURBT surgery. We estimate there are about 75,000 patients each year in the U.S. in this setting. This study is planned to be an open-label, randomized controlled trial. Since there are no approved treatments for adjuvant intermediate-risk NMIBC, the study will evaluate NDV01 versus observation. The primary endpoint is disease-free survival, or DFS. Secondary endpoints include high-grade recurrence-free survival, progression-free survival, and quality-of-life metrics. We feel that the opportunity to incorporate NDV01 into patient care post-TURBT is very attractive, and it could pave the way for an important clinical indication and broader adoption. Registrational pathway number two is focused on the evaluation of NDV01 in the second-line setting in patients who are BCG-unresponsive with carcinoma in situ, or CIS, or refractory to first-line therapies approved or in development. We estimate that there are about 5,000 patients per year in the U.S. in this setting. Since these patients have few, if any, effective treatment alternatives to radical cystectomy, the study is designed as a single-arm, open-label trial. The primary endpoint is CR any time. Secondary endpoints will include the duration of response, or DOR, progression-free survival, and recurrence-free survival among responders. We expect to report the initial three-month response data from this study by the end of 2026. We are excited about this pathway because it could offer a rapid route to approval. Before I hand the call over to Maged, I would like to make a note about how we feel NDV01 might fit into clinical practice. NDV01 is formulated to create a soft matrix in the bladder to enhance local bladder urothelial exposure and minimize systemic toxicity. It is delivered in the office in less than five minutes. This simple formulation and administration model has the potential to optimize the delivery experience for patients and providers, offering a level of simplicity and time savings that stands out among the others. And I will hand the call over to our CFO, Maged S. Shenouda. Our Phase II data give us high confidence in our registrational program. By addressing a clear unmet need with a unique sustained delivery profile, we believe NDV01 is uniquely positioned to redefine the standard of care in bladder cancer. We look forward to initiating the RESCUE registrational program at an estimated 80 sites in North America in the middle of this year, as we work to bring NDV01 to bladder cancer patients as soon as possible. Maged? Maged S. Shenouda: Thanks, Raj, and good afternoon, everyone. Today, I will spend a few minutes on 2025 financial results. Because sopranolone modulates GABA, one of the most important neurotransmitters, it is defined as a GABA, or GABA-modulating steroid antagonist. Sopranolone's novel action on the GABA neurotransmitter pathway gives it the potential to normalize the activity of the GABAA receptor and alleviate the repetitive symptoms of compulsivity disorders. These disorders affect millions of people around the world and include indications such as obsessive-compulsive disorder, Tourette's syndrome, and Prader-Willi syndrome. We are preparing to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and establishing a robust supply chain. Moving now to our financial results. As noted earlier by Brian, this afternoon, Relmada Therapeutics, Inc. issued a press release announcing our business and financial results for the fourth quarter and twelve months ended December 31, 2025. During this call, I will review our fourth quarter 2025 financial results and refer you to our press release and Form 10-K filing issued this afternoon for financial information for the last twelve months. Starting with our cash balance. Relmada Therapeutics, Inc. closed 2025 with a cash balance of $93,000,000. This includes net proceeds of approximately $94,000,000 from an underwritten stock offering announced on 11/05/2025. This compares to cash, cash equivalents, and short-term investments of approximately $45,000,000 at 12/31/2024. On 03/09/2025, the company announced a $160,000,000 private financing with net proceeds of approximately $150,000,000. This financing, along with our cash balance as of 12/31/2025, is expected to provide sufficient resources to fund company operations through 2029, including completion of the Phase III RESCUE program for NDV01. Moving through our fourth quarter financial results. Research and development expense for the three months ended 12/31/2025 totaled $8,100,000 compared to $11,000,000 for the three months ended 12/31/2024, a decrease of $2,900,000. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase III trials for REL-1017, partially offset by increased costs related to the start-up of the Phase III NDV01 trials and Phase 2b sopranolone study, and additional R&D personnel. General and administrative expense for the three months ended 12/31/2025 totaled $12,300,000 compared to $8,100,000 for the three months ended 12/31/2024, an increase of approximately $4,200,000. The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock compensation costs. Net cash used in operating activities for the three months ended 12/31/2025 totaled $14,600,000 compared to $8,800,000 for the three months ended 12/31/2024. The net loss for the three months ended 12/31/2025 was $19,900,000, or $0.27 per basic and diluted share, compared to a net loss of $18,700,000, or $0.62 per basic and diluted share, for the three months ended 12/31/2024. Before we open the call for questions, I will turn back to Sergio for some closing comments. Sergio? Sergio Traversa: Thank you, Maged. In closing of our prepared remarks, I would like to share that I am very confident and optimistic about our clinical programs and the long-term prospects for Relmada Therapeutics, Inc. As we are getting ready to initiate the RESCUE registrational program for NDV01, we are focused on execution and looking forward to updating you on our progress in the coming quarters. Operator, I would now like to open the call for questions. Operator: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press 1 on your telephone keypad. One moment, please, while we poll for questions. Our first question is from Uy Sieng Ear with Mizuho Securities. Uy Sieng Ear: Hey, guys. Congrats on the great data and the PIPE. Yeah. It seems like you guys did a lot of work this quarter. So maybe, you know, maybe we are getting some questions on whether you will present additional data from your Phase II study. Should we kind of expect, going forward, maybe updates every three months? And will you also have data, I guess, at AUA by any chance? So that is the first question. And the second question that we have been kind of getting is there has been, I guess, some investors are a little bit concerned that the second-line patients may not be necessarily second-line, but maybe, by the time they get to your regimen, it could be their third line. Maybe just help us understand what you are doing exactly to ensure that those patients are truly second-line patients. And the third question is, you indicated that you have three-month data from your Phase III BCG-unresponsive second-line unresponsive patients. Will this be from the entire patient population, or would this be sort of interim and as partial or a portion of the number of patients that you expect to enroll? Thanks. Sergio Traversa: Thank you, Uy, for the questions. I think Raj can answer these questions. I pass it to Raj. Raj S. Pruthi: Yeah. Thank you, Sergio. Good to hear from you, Uy. Regarding the data, we will be presenting updated data, this 12-month data, at the AUA. It has been accepted to that. We will also be presenting a trial-in-progress as we get RESCUE going. Our plan is to focus on introducing data, and I think this is your last question, in the BCG-unresponsive second-line group, starting at the end of the year. So as we start the trial in midyear, we should have some three-month data to be able to share externally by the end of the year as it is a single-arm, open-label study. And our thought is to then actually, at a cadence of about every three months, share the data as we get six-, nine-, and twelve-month follow-up on that data set. I think you provide an excellent question on second line, third line, fourth line. And we are indeed limiting the number of prior therapy lines to two. So you can have had one line of therapy and still have been, for example, BCG-unresponsive, while allowing a second line of those to be intravesical chemotherapy. We are also allowing a maximum of two prior lines. We are also going to look at 15 patients at three months for those who received one prior line of therapy versus two just to make sure there is nothing concerning that would suggest that those should be excluded, and this is reflective of the conversations we have had with the FDA. I think it is a good question. Limiting the number of kind of third or fourth lines. Uy Sieng Ear: Thank you. Right. Thank you. Operator: Our next question is from Farzin Hak with Jefferies. Congrats on the progress, and thank you for taking my questions. Farzin Hak: So I have one on the operational standpoint. The NMIBC space is becoming congested with active trials and drugs approved too. So are there, like, what is your expectation for enrollment cadence across your two studies? And can the drug’s in-office profile potentially serve as a recruitment advantage? Sergio Traversa: Thank you, Farzin. Raj, do you want to take that? Raj S. Pruthi: Yeah. Thank you. Yeah, Farzin. Good to hear from you. I think you are right. I think the high-risk, BCG-unresponsive setting has been a crowded space, but I think ours, coming in as a second-line therapy, provides a unique advantage. And there are no drugs that have been approved in that setting and none that I am aware of that are even being investigated as a pivotal study in that setting. So I think we have a competitive advantage in that we can go to sites that, even with drugs in development, can follow them in this unique path. And same for intermediate risk. I think right now, it is becoming a bigger, expansive interest. But what I have seen, for example, CG Oncology has an intermediate-risk trial that looks like it is ahead of schedule and accrued very rapidly. I think there is a lot of interest from investigators in looking at intermediate-risk patients. So I expect us to enroll that pretty rapidly, ahead of schedule like CG did. Thanks for the question, Farzin. Farzin Hak: Got it. And then for the second-line high-grade settings, beyond the primary endpoint of CR rate at any time, has the FDA stipulated a minimum duration of follow-up required for all patients by submitting the NDA? Raj S. Pruthi: Another great question. They have not required a minimum of follow-up. They said they want to see CR any time, as you said, and durability of response, or duration of response. I think the wording they used, which I think is important, is they want to see the totality of the data. So they want to see do you have a response and is there some level of durability. I mean, they have not specified what that number is. Farzin Hak: Got it. Thank you so much. Operator: Thank you. Thank you, Farzin. Your next question is from Christopher with Lucent. Christopher: Hey, guys. Thanks for the question. I was just wondering, given the population differences between your Phase II and Phase III RESCUE, what are you expecting to see in terms of the CR rate at the three-month mark as well as what we should be benchmarking against? Sergio Traversa: Thank you, Christopher. Raj, do you want to take this one as well? Raj S. Pruthi: Yes. Sure. Yeah. Thanks, Christopher. Thanks for the question. So in the intermediate risk, we are looking at, and we have structured the trial to look at, the statistics around a two-year RFS of 75%. And that actually is reflected in the literature with gem-dose. I think with what we have seen in this population and with sustained release, we should exceed that, but that is our target number. That drives the statistics. It is an event-driven study. So that is kind of the driver. And with 128 events, it is the target. Regarding the BCG-unresponsive second-line, it is interesting that in first line, the first drug approved was valrubicin in 1998 at 8% 12-month CR, followed by Keytruda at 19% and then other agents at 24%. So I think I am glad that the FDA was not fixated on a certain number. But I think that number should be at those levels or lower than what we have seen in first-line therapy, just as a precedent. If that makes sense. Thanks for the question. Christopher: Got it. Operator: Our next question is from Kelsey Goodwin with Piper Sandler. Kelsey Goodwin: Hey, thanks so much for taking my question, and congrats on the recent clinical update. Regarding, I guess, specifically to that update, regarding the patient baseline characteristics and the CIS versus papillary split, how should we be comparing this data set to that of competitors with primarily CIS patients there? And any data to support that gem-dose looks similar in CIS and papillary patients? Sergio Traversa: Hi, Kelsey. It is Sergio here. Raj, it seems that this one also is for you. Raj S. Pruthi: Yeah. Great question, Kelsey. Starting with the last part of your question first. It is interesting as a clinician, you often think, okay, if the patient is BCG-unresponsive, this might be more virulent. But we do not often, I think, ask is it CIS versus papillary? Some people show pure CIS behaves better, but T1 actually worsens outcomes. So it is a mixed bag. It is actually interesting for gem-dose. There is an article by Steinberg in 2020 in the Journal of Urology that looked at heavily pretreated, basically BCG-unresponsive patients, and at twelve months, the RFS in those patients, or CRs, was 60% in the CIS population and 61% in papillary. So there is not a marked difference typically between them. But even if you go back and look at our data of what we showed, ours at twelve months is 80%, twelve-month CR at 84%. That does include four patients with CIS. We had four out of four with complete response at any time, two out of two at twelve months. Completely understood these are small numbers, but I think it still compares quite favorably. Even if you take NDV01 and the BCG-unresponsive population, our entire population including CIS, and compare it to the best-in-class categories, I think their twelve-month CR was 74%. So even taking our entire cohort, we have significantly higher, so I think it is still best in class. I hope I answered your question. Kelsey Goodwin: Yeah. No. That is super helpful. Thank you so much for that. And then maybe just one follow-up if I can. With respect to the intermediate-risk setting and that kind of market overall, how much do you think that market might need to be built out by these early launches, just given we have not had an approved agent until last year? Thanks so much. Raj S. Pruthi: You bet, Kelsey. Another great question. Right now, we mentioned it is about 75,000 to 80,000 patients with intermediate-risk disease. And if you look at the data now, only about 35% of those patients will receive adjuvant therapy. What is important in our studies and in CG’s study is that in our intermediate-risk population, we do include small, less than three-centimeter Ta high-grade patients. I think that is very important because 20% of the intermediate-risk disease is these high-grade Ta patients, and those are the ones probably more than anybody who need adjuvant therapy to prevent recurrence. So if we go back to what we call about 35% receiving an adjuvant therapy, I think it is exactly what you are alluding to. Right now, there is not an approved therapy. There is not a lot of data. There are not a lot of agents that can be reimbursed to the urologist in a buy-and-bill model, for example. I think that 35% number is going to only grow as you see data from programs like Moonlight, or from PIVOT-006, or from our intermediate study as we get data. It gives patients confidence that, hey, here is an agent that might reduce my risk of having another TURBT and gives urologists confidence that I have an agent that I can deliver in my office that will reduce TURBT risk for my patients. It is only going to go up. Kelsey Goodwin: That is great. Thank you so much. Sergio Traversa: Thank you, Kelsey. Operator: Thank you. This concludes our question-and-answer session. I would now like to hand the floor back over to Sergio Traversa for any closing remarks. Sergio Traversa: Well, the closing remarks is a big thank you to everybody that has allowed Relmada Therapeutics, Inc. to get where we are now. We created data with a drug that can really help patients with bladder cancer. We are looking forward to updating everybody on our progress. Thank you, and enjoy the rest of the day. Thank you. Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation. Before you buy stock in Relmada Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Relmada Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $510,710!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,105,949!* Now, it’s worth noting Stock Advisor’s total average return is 927% — a market-crushing outperformance compared to 186% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 19, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Relmada (RLMD) Q4 2025 Earnings Call Transcript was originally published by The Motley Fool