Relmada Therapeutics (NASDAQ:RLMD) Releases Quarterly Earnings Results

Key Points

• Relmada reported a quarterly loss of $0.12 per share, beating analyst estimates of a $0.14 loss.
• In NDV-01’s Phase II study, 12 of 14 evaluable patients remained in complete response at 18 months; however, two BCG-naive patients progressed, and results for the planned Phase III population have not yet been analyzed. The company targets an IND filing by year-end 2026, with the first Phase III patient potentially dosed in Q1 2027.
• Relmada ended the quarter with $202.1 million in cash and short-term investments, which management expects to fund operations through 2029, including the NDV-01 Phase III studies.

Relmada Therapeutics (NASDAQ:RLMD - Get Free Report) posted its quarterly earnings data on Thursday. The company reported ($0.12) earnings per share for the quarter, topping analysts' consensus estimates of ($0.14) by $0.02, FiscalAI reports.

Here are the key takeaways from Relmada Therapeutics' conference call:

• NDV-01’s phase II results showed that 12 of 14 evaluable patients remained in complete response at 18 months, including seven of eight in the BCG-unresponsive subgroup. However, two BCG-naive patients with T1 disease progressed to muscle-invasive cancer at month 15, and the company has not yet analyzed outcomes specifically for patients matching the planned phase III population.
• Relmada remains on track to file NDV-01’s IND by year-end 2026 and expects to begin the SPECTRUM phase III program after clearance; management said the first patient could be dosed in the first quarter of 2027 if clearance comes in a reasonable timeframe. SPECTRUM includes separate registrational pathways for BCG-unresponsive high-risk disease and low-grade, intermediate-risk disease.
• The company said it has optimized new manufacturing processes and completed GMP batches, with nine-week stability results so far within FDA requirements. Further stability data are still pending, although management said it expects to complete the IND filing by year-end.
• Relmada ended the quarter with $202.1 million in cash, cash equivalents, and short-term investments, which management expects to fund operations through 2029, including completion of the NDV-01 phase III studies.

Relmada Therapeutics Stock Down 6.1%

Shares of NASDAQ RLMD traded down $0.27 during mid-day trading on Thursday, hitting $4.16. 1,036,117 shares of the company were exchanged, compared to its average volume of 1,670,682. The stock has a 50 day simple moving average of $3.77 and a 200-day simple moving average of $5.33. Relmada Therapeutics has a 1-year low of $3.07 and a 1-year high of $8.00. The firm has a market cap of $443.75 million, a price-to-earnings ratio of -4.62 and a beta of 0.62.

Analyst Upgrades and Downgrades

Separately, Weiss Ratings restated a "sell (d-)" rating on shares of Relmada Therapeutics in a research note on Monday, September 14th. One investment analyst has rated the stock with a Strong Buy rating, five have given a Buy rating, one has given a Hold rating and one has assigned a Sell rating to the company. According to data from MarketBeat, Relmada Therapeutics currently has a consensus rating of "Moderate Buy" and an average price target of $12.00.

Insider Buying and Selling at Relmada Therapeutics

In other Relmada Therapeutics news, CFO Maged Shenouda bought 79,800 shares of the company's stock in a transaction on Thursday, September 10th. The shares were bought at an average price of $4.25 per share, for a total transaction of $339,150.00. Following the transaction, the chief financial officer owned 1,000,000 shares of the company's stock, valued at approximately $4,250,000. This trade represents a 8.67% increase in their position. The transaction was disclosed in a legal filing with the SEC, which is accessible through this link. 14.50% of the stock is currently owned by insiders.

Relmada Therapeutics Company Profile

Relmada Therapeutics, Inc. is a clinical-stage biotechnology company developing investigational treatments for central nervous system disorders, with a focus on depression. The company's work centers on advancing drug candidates through clinical research; it does not have an approved commercial product. Its best-known candidate, REL-1017 (esmethadone), is an oral compound that acts on NMDA receptors. Relmada has studied it as an add-on treatment for adults with major depressive disorder who have not responded adequately to existing antidepressants.

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