Relmada Therapeutics, Inc. Q2 FY2026 earnings call

Company Strategic Position

• The company has entered a critical execution phase for its lead asset NDV-01 and second asset cepranolone, with a strong balance sheet, strengthened leadership team, and clear regulatory and development plans.
• Bipin Dahlia, an industry veteran with nearly 30 years of experience in uro-oncology, product development, and commercial launch, joined the company this quarter as Chief Business Officer to lead NDV-01 strategy and execution.

Lead Asset: NDV-01 (Non-Muscle Invasive Bladder Cancer)

• NDV-01 is a novel sustained-release intravesical formulation of gemcitabine-docetaxel (GENDOSY), designed to deliver prolonged drug exposure without a physical device, administered as a 5-minute office-based procedure.
• Phase II 12-month data is compelling: 95% of patients achieved complete response at any time, 76% achieved durable complete response at 12 months, with a favorable safety profile. The company has already secured FDA alignment on two planned registrational pathways, and has strong engagement from the uro-oncology clinical community.
• The formulation and scalable manufacturing process for NDV-01 are locked, with all analytical development completed. All development activities are finished, and the company is now focused on executing GMP batch production and stability testing to support the IND filing.
• 80 clinical sites are prepared and prepped to enroll patients in the Phase III program, with 60 primary sites and 20 backup sites to speed enrollment. The program is ready to initiate immediately after IND clearance.

Second Asset: Cepranolone (Prader-Willi Syndrome)

• Cepranolone is a development program for Prader-Willi Syndrome, a rare underserved condition affecting 350,000 to 400,000 people globally.
• Formulation development for cepranolone is complete, and the only remaining pre-IND step is finalization of the pre-filled syringe delivery system.

RealMada Therapeutics is a clinical-stage biopharmaceutical company with two pipeline product programs, and does not generate any commercial revenue as of Q2 2026. Total operating expenses for Q2 2026 were $15.0 million: research and development (R&D) expense was $8.4 million (56% of total operating expenses), and general and administrative (G&A) expense was $6.6 million (44% of total operating expenses). Net loss for Q2 2026 totaled $12.9 million. As of quarter end, the company held $217.7 million in total cash, cash equivalents, and short-term investments.

• The company reaffirms guidance to file the IND for NDV-01 by the end of 2026, and initiate the Phase 3 registrational program immediately upon IND clearance.
• The company also reaffirms guidance to file the IND for cepranolone by the end of 2026, and initiate the Phase 2 proof-of-concept study immediately upon IND clearance.
• The company's current cash and investment balance of $217.7 million is expected to fund all operations through 2029, including full completion of the NDV-01 Phase III registrational program.
• Initial 3-month complete response data from the Phase III program, previously guided for late 2026, is now expected to be disclosed no earlier than the first half of 2027. Management is also evaluating whether 6-month data will be more clinically meaningful for initial disclosure, and no final decision on disclosure timing or endpoint has been made.

• Manufacturing of NDV-01, a novel combination product, requires specialized capabilities, coordination across multiple supply chain partners, and scaling from lab prototype to full GMP production, which carries inherent execution uncertainty.
• GMP production is dependent on external manufacturing partner scheduling, which can introduce unanticipated delays to the IND filing timeline.
• All forward-looking statements related to development timelines, trial initiation, and regulatory outcomes are subject to inherent risks that could lead to actual results differing materially from current expectations, as disclosed in the company's SEC filings.

Q: What is Bipin Dahlia's role at RealMada, and what are the current gating factors for NDV-01 manufacturing and CMC? / A: Bipin Dahlia as CBO is responsible for corporate strategy, commercial planning, business development for NDV-01, and will also oversee development and manufacturing activities given his deep industry experience. All NDV-01 formulation, process, and analytical development work is complete; the remaining work is just execution of GMP batch production and stability testing for the IND filing, with the primary near-term step being securing production slot time at the external partner's GMP cleanroom facility. It is standard execution work with no unresolved development issues.

Q: Do you need additional FDA input on manufacturing prior to NDV-01 IND filing, and how quickly can you enroll the first patient after IND clearance? / A: Management confirms no additional FDA input is required before filing, as the company already has formal aligned meeting minutes from prior FDA interactions covering the full development and regulatory path. Around 80 sites are already engaged and prepared for enrollment, with 60 primary sites. Per FDA standard review timelines, the company expects clearance 30 days after IND filing, and can begin enrolling patients immediately after clearance once clinical material is available.

Q: Why was the NDV-01 IND filing delayed from the prior mid-2026 guidance to year-end 2026, and what is the new timeline for initial Phase III data disclosure? / A: There were no unexpected technical issues or failures with NDV-01; the delay was entirely due to the standard lead time required to secure an available production slot at the external manufacturer's facility, which was an anticipated scheduling constraint rather than an unexpected problem. Initial data disclosure, previously expected in late 2026, will likely be pushed to the first half of 2027, as management prefers to report data from a clinically meaningful number of patients (15-20) and is evaluating whether 6-month data, which accounts for allowed re-treatment, is more meaningful than 3-month data for initial disclosure.

Q: Is there any regulatory read-through for NDV-01 from the recent FDA adcom meeting for the competing Repromune NMIBC product? / A: Management declined to comment on another company's program, noting that NDV-01 has a different development and indication profile than Repromune. The company already has prior alignment with the FDA on its registrational path, and the FDA has not specified a fixed required response rate for NDV-01 approval, instead requesting a full overall dataset covering both response rate and durability.