Relmada Therapeutics Inc (RLMD) Q1 2025 Earnings Call Highlights: Promising Pipeline ...

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Tue, May 13, 2025, 1:09 AM 4 min read

Cash Balance: $27.1 million as of March 31, 2025.
Cash Used in Operations: $18.1 million for Q1 2025.
Research and Development Expense: $12 million for Q1 2025, down from $13.3 million in Q1 2024.
General and Administrative Expense: $6.3 million for Q1 2025, down from $9.7 million in Q1 2024.
Net Loss: $17.6 million for Q1 2025, or $0.58 per share.
Previous Net Loss: $21.8 million for Q1 2024, or $0.72 per share.

Warning! GuruFocus has detected 2 Warning Signs with RLMD.

Release Date: May 12, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

Relmada Therapeutics Inc (NASDAQ: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 (NASDAQ:RLMD) maintains a $27 million cash balance and a clean balance sheet, positioning the company well to advance its pipeline to important clinical milestones.

Negative Points

Relmada Therapeutics Inc (NASDAQ: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.

Q & A Highlights

Q: What gives you confidence that the current Phase II data for NDV-01 will be sufficient for the FDA to agree to move into registrational studies? Also, could you elaborate on scaling up supply? A: Sergio Traversa, CEO: The combination of gemcitabine and docetaxel is well-known and used by many urologists, recognized for its efficacy and safety. The limitation has been in the practicality of administration, which NDV-01 addresses by allowing for easier, in-office administration. We believe these factors, along with the safety profile, will support FDA approval to move into larger registration studies. Regarding supply, we are looking to scale up manufacturing capacity and secure a second manufacturer for risk management.

Q: How does NDV-01 fit into the treatment paradigm given the crowded market with competitors like BCG and CG Oncology? A: Yair Lotan, Professor of Urology and Chief of Urologic Oncology: Patients want to keep their bladder, and while the BCG-unresponsive space is busy, NDV-01 offers a familiar and effective treatment option. It could fit well in the intermediate risk space, where there are fewer options, and potentially in the chemoablative space. If the BRIDGE trial shows equivalence or superiority, NDV-01 could also compete in the BCG naive space.

Q: When can we expect to see the complete response rate for the entire NDV-01 population, and what are your expectations for success? A: Sergio Traversa, CEO: We expect to present 6-month data for the 20 patients around June or July, followed by 9 and 12-month data. The current data looks promising, with a 90% response rate at 3 months and 100% at 6 months for the 7 patients evaluated. The combination of GEM/DOCE is known for its efficacy, and we expect good results.

Q: What would you want the Phase III trial for NDV-01 to look like in terms of time points, endpoints, and patient types? A: Yair Lotan, Professor of Urology and Chief of Urologic Oncology: There are easier and harder routes. A single-arm chemoablation trial could be the quickest route if approved by the FDA. Alternatively, a randomized trial in intermediate risk patients, similar to PIVOT-6, could be another approach. The trial design would focus on demonstrating superiority against placebo in a population with a high risk of recurrence.

Q: How do you plan to address the potential differentiation of NDV-01 in a crowded market? A: Yair Lotan, Professor of Urology and Chief of Urologic Oncology: NDV-01 offers ease of use and sustained release, which could make it more attractive compared to other treatments. Its potential use in intermediate risk and chemoablative spaces, where there are fewer options, provides differentiation. The ongoing BRIDGE trial could further establish its position in the BCG naive space.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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