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 .
Positive Points
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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.
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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.
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Relmada Therapeutics Inc ( NASDAQ:RLMD ) has FDA alignment on two planned registrational pathways for NDVO1, de-risking the regulatory path forward.
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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.
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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.
Negative Points
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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.
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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.
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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.
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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.
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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.
Q & A Highlights
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 .
