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.
NDV-01 Manufacturing Focus and Regulatory Plans
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.
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.”
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.
Commercial Perspective on Bladder Cancer Program
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.
Sepranolone IND Also Expected by Year-End
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.
Second-Quarter Financial Results
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.
About Relmada Therapeutics (NASDAQ:RLMD)
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.
