• Cash Equivalents and Short-term Investments: $44.9 million as of December 31, 2024, compared to $96.3 million as of December 31, 2023.
• Cash Used in Operations: $8.8 million for Q4 2024, compared to $10.2 million for Q4 2023.
• Research and Development Expense: $11 million for Q4 2024, compared to $14.7 million for Q4 2023.
• General and Administrative Expense: $8.1 million for Q4 2024, compared to $12.1 million for Q4 2023.
• Net Loss: $18.6 million or $0.62 per share for Q4 2024, compared to $25.1 million or $0.84 per share for Q4 2023.

• Warning! GuruFocus has detected 2 Warning Signs with RLMD.

Release Date: March 27, 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 successfully acquired rights to two promising candidates, NDVA1 for non-muscle invasive bladder cancer and Sopranoon for compulsion-related disorders, enhancing their product pipeline.
• The company is focusing on strategic product acquisitions to maximize shareholder value, demonstrating a proactive approach to growth.
• Relmada's financial management shows a decrease in both research and development expenses and general administrative expenses compared to the previous year, indicating improved cost efficiency.
• The company maintains a strong development capability with a history of conducting multiple Phase 3 and Phase 1 trials, which is attractive to potential partners.
• Relmada has a cash position of approximately $44.9 million as of December 31, 2024, providing a financial cushion for ongoing and future projects.

Negative Points

• Relmada Therapeutics Inc (NASDAQ:RLMD) experienced a significant decrease in cash equivalents and short-term investments from $96.3 million in 2023 to $44.9 million in 2024, indicating a substantial cash burn.
• The company reported a net loss of $18.6 million for the fourth quarter of 2024, which, although reduced from the previous year, still reflects ongoing financial challenges.
• There is uncertainty regarding the future development of RP11 due to a competitive landscape and regulatory challenges, which may impact the company's strategic focus.
• The discontinuation of Phase 3 studies for 1,017 in major depressive disorder has shifted the company's focus, potentially delaying progress in this therapeutic area.
• Relmada's reliance on strategic acquisitions for growth may pose risks if future acquisitions do not meet expectations or if integration challenges arise.

Q & A Highlights

Q: Can you explain the process involved in the acquisition deals, particularly for NDVO1, and why these companies chose Relmada over other bidders? A: Sergio Traversa, CEO, explained that the acquisition of Soprano was straightforward due to a long-standing relationship with Azarina. For NDVO1, the decision was influenced by Relmada's strong development capabilities and existing infrastructure. The focus on NDVO1 as a primary project and the collaborative approach with Trigon also played a role. Additionally, Trigon shareholders are now also shareholders of Relmada, which aligns interests.

Q: What should we expect in terms of data at the upcoming AUA meeting for NDVO1? A: Sergio Traversa stated that no specific data will be included in the abstract as it is being collected in real-time. The data will be presented at the AUA conference. The expectation is for the data to be at least as good as the existing immediate release formulations used in bladder cancer treatment.

Q: Could you elaborate on the safety profile of Soprano and its potential in the Prader-Willi syndrome market? A: Sergio Traversa noted that Soprano has a well-known safety profile with over 350 patients, showing only minor injection site reactions. Despite recent approvals in the Prader-Willi space, there is room for Soprano due to its unique mechanism of action on the GABA-A pathway, which complements existing treatments.

Q: What are the approvable endpoints for Soprano in pivotal studies, and how does it compare to current treatments for Tourette's? A: Sergio Traversa explained that for Tourette's, the endpoints typically involve scales measuring the number of tics and compulsive behaviors. Soprano's mechanism of action focuses on compulsive components, which could offer a complementary approach to existing dopamine blockers and antipsychotics.

Q: After reporting data at the medical conference, will you discuss an accelerated approval pathway with the FDA for the bladder cancer compound? A: Sergio Traversa mentioned that discussions with the FDA will follow the data presentation to determine the approval path. Given the existing use of the combination of gemcitabine and docetaxel, there is hope for a streamlined approval process, potentially requiring only one open-label study.

Q: Can we expect Relmada to license more compounds this year? A: Sergio Traversa stated that while they are open to opportunities and constantly evaluating potential licenses, they will only pursue compounds that fit their strategic criteria. There is no immediate plan to license new compounds, but they remain vigilant for suitable opportunities.

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