Relmada Therapeutics, Inc. Q1 FY2026 earnings call

NDVO-1 Clinical Development Progress

• Released solid, durable 12-month efficacy data from the ongoing Phase II study of NDVO-1 for high-risk non-muscle invasive bladder cancer (NMIBC), demonstrating 76% complete response (CR) at 12 months for all high-risk patients, and 80% CR at 12 months for the hard-to-treat BCG unresponsive subpopulation, with 95% overall CR at any time; no patients experienced disease progression to muscle invasive disease or required radical cystectomy
• No grade 3 or higher treatment-related adverse events were reported, no dose interruptions or discontinuations due to adverse events, and most adverse events were grade 1, confirming a favorable safety profile
• Secured FDA alignment on the Phase III registrational (rescue) program design, which is on track for initiation in mid-2026
• Filed a U.S. provisional patent application for NDVO-1 formulations and treatment methods; if granted, the patent will provide IP protection through 2047, extending commercial exclusivity by 9 years and supporting global patent filings
• The 12-month Phase II data and Phase III program will be presented at the 2026 American Urological Association (AUA) Annual Meeting later the same week

Phase III Program Design

• The program includes two separate regulatory approval pathways to streamline approval and reduce execution risk, planned to open at ~80 sites across North America following IND filing
  1. Second-line BCG unresponsive carcinoma in situ (CIS): single-arm trial with primary endpoint of CR at any time; ~5,000 annual U.S. patients in this segment, with few alternatives to radical cystectomy; first 3-month response data expected around year-end 2026, potentially enabling a rapid approval pathway
  2. Adjuvant therapy post-transurethral resection (TURBT) for intermediate-risk NMIBC: open-label randomized controlled trial vs. observation with primary endpoint of disease-free survival; ~75,000 annual U.S. patients in this segment with no currently approved treatments, creating a large market opportunity for broad adoption
• NDVO-1 is a differentiated ready-to-use sustained-release intravesical formulation of gemcitabine and docetaxel, that can be administered in-office in under 5 minutes with no specialized infrastructure required, making it far more convenient than conventional gem dosing

Sepranolone Program Update

• Sepranolone is a novel neurosteroid targeting the GABA neurotransmitter pathway for treatment of compulsivity disorders including obsessive compulsive disorder, Tourette syndrome, and Prader-Willi syndrome
• The company is on track to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026; current preparations focus on aligning trial design with the FDA and building out a robust drug supply chain

Financing and Balance Sheet

• Completed a $160 million private placement financing in March 2026, generating net proceeds of $150 million that strengthened the balance sheet
• Current cash resources are expected to fund all operations through 2029, including full completion of the NDVO-1 Phase III rescue program

As a clinical-stage biotech company, Realmada Therapeutics does not report revenue-generating product segments. All current activity is focused on clinical development of pipeline candidates. The Q1 2026 financial performance is as follows: closing cash balance of $234 million (up from $94 million at the end of 2025, including $150 million in net proceeds from a March 2026 private placement); research and development expense of $8.1 million (down from $12 million in Q1 2025, driven by 2025 non-recurring acquisition and licensing costs, partially offset by increased costs for NDVO-1 Phase III startup, Sepranolone Phase IIb work, and additional R&D headcount); general and administrative expense of $11.4 million (up from $6.3 million in Q1 2025, driven by higher compensation costs, partially offset by lower stock-based compensation); net cash used in operating activities of $15.1 million (down from $18.1 million in Q1 2025); net loss of $19.1 million, or $0.22 per basic/diluted share (compared to a net loss of $17.6 million, or $0.58 per basic/diluted share in Q1 2025).

• NDVO-1 Phase III rescue program initiation remains on track for mid-2026, unchanged from prior plans
• The proof-of-concept study for sepranolone in Prader-Willi syndrome remains on track for initiation in mid-2026
• The company expects current cash resources to support all operations, including full completion of the NDVO-1 Phase III program, through 2029
• Enrollment for the Phase III program is modeled at 15-18 months for the intermediate-risk adjuvant trial and 12 months for the second-line BCG unresponsive trial; management notes strong investigator enthusiasm that could enable enrollment to meet or exceed these timelines
• First 3-month response data from the second-line BCG unresponsive trial is expected by the end of 2026 or early 2027, with data updates planned every three months through 2027
• The newly filed NDVO-1 provisional patent is not expected to receive a regulatory response for at least 12 months due to backlogs at the patent office

• Forward-looking statements regarding trial timelines, regulatory approval, and drug performance are subject to material risks and uncertainties that could cause actual results to differ materially from expectations
• Patent protection for NDVO-1 is not guaranteed: the newly filed provisional patent application is still early in the review process, and approval of the claimed exclusivity is not certain
• Clinical trial enrollment could take longer than modeled, even with current strong investigator interest
• Efficacy results from the Phase II study may not be replicated in the larger Phase III program
• Regulatory approval depends on the FDA's review of the totality of trial data, with no guarantee that trial results will meet agency requirements for approval
• The company's extended cash runway depends on controlled operating spending; unexpected cost increases could shorten the current cash runway through 2029

Q: How should growing literature on conventional gemcitabine/docetaxel (gem/dosi) be interpreted for NDVO-1, and how much 3-month data can we expect from the BCG unresponsive trial by the end of 2026? / A: Management notes that growing positive data on conventional gem/dosi reinforces the urology community's belief that this combination is an effective bladder cancer treatment, which is a positive for NDVO-1. Multiple new studies also highlight the significant time burden of conventional sequential gem/dosi for both patients and providers, which NDVO-1's convenient sustained-release formulation is specifically designed to address. For the second-line trial, management expects to have a small number of patients enrolled and 3-month response and safety data to share by the end of 2026, with regular updates every three months after that into 2027.

Q: What would you consider a positive 12-month data readout at AUA for NDVO-1? / A: Management highlights that the most important benchmark is performance in the hard-to-treat BCG unresponsive population, where NDVO-1 has an 80% 12-month CR rate. This compares favorably to the ~45% 12-month CR rate of the best approved agents in this space, and outperforms the ~70% CR rate of other developmental candidates, combined with a strong safety profile. Management views this 80% CR rate as a best-in-class result that positions NDVO-1 very well for late-stage development.

Q: Can you clarify the new NDVO-1 provisional patent and the 2047 expiration date, and do the extended exclusivity terms open up opportunities for additional clinical trials beyond the current Phase III program? / A: The new provisional patent covers novel formulation and manufacturing work done for NDVO-1, and as a new filing, it will receive a 20-year patent term that runs through 2047 if granted. The company has 12 months to file corresponding international patent applications, and no regulatory response is expected for at least one year due to patent office backlogs. Management notes that the extended exclusivity creates opportunities to expand NDVO-1 development beyond the current program, including testing in high-risk BCG-naive NMIBC, a large patient population, if ongoing trials confirm conventional gem/dosi is non-inferior to BCG in this segment.

Q: How are you addressing potential efficacy dilution from the broad inclusion criteria of up to two prior lines of therapy in the BCG unresponsive Phase III trial, and what are your enrollment expectations? / A: The trial protocol includes pre-planned subgroup analysis to break down efficacy by one vs. two prior lines of therapy, and the team will closely monitor efficacy across subgroups as data accumulates. The broad inclusion criteria reflects the current clinical reality: there are no approved second-line treatments for BCG unresponsive NMIBC after first-line approved/developmental agents, so NDVO-1 can fill a clear unmet need in this space. Management expects enrollment to take 12 months for the second-line trial and 15-18 months for the intermediate-risk trial. Strong investigator enthusiasm and the lack of competing trials for the second-line indication make management confident enrollment will meet or exceed this timeline.