Q1 2025 Relmada Therapeutics Inc Earnings Call Transcript
Key Points
- Relmada Therapeutics Inc (RLMD) has added two unique product candidates, NDV-01 for bladder cancer and sepranolone for Prader-Willi syndrome and Tourette syndrome, to its portfolio, both showing promising Phase II data.
- The company reported positive initial proof-of-concept Phase II data for NDV-01 at the American Urology Association (AUA) 2025 meeting, indicating potential as a class-leading bladder-sparing chemotherapy.
- NDV-01 demonstrated an overall response rate of 90% and a high-grade recurrence-free survival rate of 89% in papillary disease patients, with a 100% complete response in carcinoma in situ patients.
- The safety profile of NDV-01 is favorable, with no treatment-related adverse events greater than grade 1 reported.
- Relmada Therapeutics Inc (RLMD) maintains a $27 million cash balance and a clean balance sheet, positioning the company well to advance its pipeline to important clinical milestones.
- Relmada Therapeutics Inc (RLMD) experienced a decrease in cash, cash equivalents, and short-term investments from $44.9 million as of December 31, 2024, to $27.1 million as of March 31, 2025.
- Cash used in operations increased to $18.1 million for the first quarter of 2025, compared to $13 million for the same period in 2024.
- The net loss for the first quarter of 2025 was $17.6 million, or $0.58 per basic and diluted share, compared with a net loss of $21.8 million, or $0.72 per basic and diluted share for the first quarter of 2024.
- The market for NDV-01 is considered crowded, with existing treatments like BCG and potential competitors such as CG Oncology.
- There is uncertainty regarding the FDA's approval process for NDV-01, as the company awaits feedback on whether the current Phase II data will suffice for moving into registrational studies.
Good afternoon. Welcome to the Relmada Therapeutics first-quarter 2025 earnings call. (Operator Instructions) As a reminder, this conference is being recorded, and will be available for replay on the location website. I would like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.
Good day, and thank you, everyone, for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 months ended March 31, 2025. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
These forward-looking statements are
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