Relmada Therapeutics’ Earnings Call Highlights Clinical and Financial Success

Relmada Therapeutics Inc ((RLMD)) has held its Q3 earnings call. Read on for the main highlights of the call.

Relmada Therapeutics Inc’s recent earnings call was marked by a predominantly positive sentiment, underscoring significant strides in clinical trials, regulatory progress, and financial robustness. The only point of concern was the previous depletion of cash reserves, which has since been mitigated by a successful capital raise.

Successful Phase Two Study for NDV-01

The phase two study of NDV-01 in non-muscle invasive bladder cancer (NMIBC) was a focal point of the call, boasting a 92% overall response rate at any time with a favorable safety profile. This positions NDV-01 as a promising candidate for becoming a best-in-class treatment, reflecting the company’s strong research capabilities.

FDA Alignment on Phase Three Program for NDV-01

Relmada has achieved a significant milestone by securing FDA alignment on the phase three program for NDV-01. This alignment allows for two distinct and independent registrational tracks, which is crucial for reducing risks associated with the drug’s development and approval process.

Strong Financial Position

The company has bolstered its financial standing with a $100 million underwritten finance, ensuring that it is well-capitalized to support operations through 2028. This financial stability is a key factor in Relmada’s ability to continue its ambitious research and development initiatives.

Reduction in Operating Expenses

Relmada reported a significant reduction in operating expenses, with research and development expenses decreasing by $7.1 million and general and administrative expenses by $5.6 million compared to the previous year. This reduction highlights the company’s commitment to maintaining financial efficiency.

Appointment of Key Personnel

The appointment of Dr. Raj S. Pruthi as Chief Medical Officer, along with new advisory board members, strengthens Relmada’s focus on advancing novel therapies for NMIBC. This strategic move is expected to enhance the company’s clinical and strategic capabilities.

Decreased Cash Reserves Before Capital Raise

Before the recent capital raise, Relmada’s cash reserves had decreased significantly, with cash, cash equivalents, and short-term investments dropping to approximately $13.9 million as of September 30, 2025, from $44.9 million at the end of 2024. However, the recent financial infusion has addressed this concern.

Forward-Looking Guidance

Relmada provided optimistic guidance for its key clinical programs during the earnings call. NDV-01, targeting NMIBC, is set to initiate two phase three registrational studies in 2026, supported by FDA alignment. Additionally, Sepranolone, aimed at Prader-Willi syndrome, is expected to enter phase two studies in 2026. The company anticipates that the recent $100 million financing will support operations into 2028, despite reporting a net loss of $10.1 million for the third quarter.

In summary, Relmada Therapeutics Inc’s earnings call painted a positive picture of the company’s current and future prospects. With significant achievements in clinical trials, strategic regulatory alignments, and a strong financial position, Relmada is well-positioned to advance its innovative therapies. The recent capital raise has effectively addressed previous concerns about cash reserves, setting the stage for continued growth and development.