Relmada Therapeutics discontinues Phase 3 studies and explores strategic alternatives to enhance shareholder value.

Quiver AI Summary

Relmada Therapeutics, Inc., a biotechnology company focused on central nervous system diseases, has announced the discontinuation of its Reliance II and Relight Phase 3 studies based on recent evaluations by a data monitoring committee. The company will proceed with a Phase 1 study for REL-P11, an experimental treatment for metabolic disease. In light of these changes, Relmada is exploring strategic options to enhance shareholder value, including potential asset sales, mergers, or acquisitions. They are engaging a financial advisor to assist in this review process but have not set a timeline or committed to any specific alternatives.

Potential Positives

• The company is advancing the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, indicating a continued focus on promising drug development.
• Relmada Therapeutics is exploring strategic alternatives to maximize shareholder value, which could lead to beneficial transactions for investors.
• Engagement of a financial advisor to assist in the strategic review process suggests proactive management and commitment to improving company positioning.
• Relmada has identified potential uses for low-dose psilocybin in treating metabolic diseases, which may open new avenues for research and development.

Potential Negatives

• The decision to discontinue the Reliance II and Relight Phase 3 studies raises concerns about the efficacy and potential of the REL-1017 program, which may negatively impact investor confidence.
• The announcement of exploring strategic alternatives, including a potential sale or merger, indicates financial distress or lack of viable options to move forward with their current pipeline, which could alarm stakeholders.
• The lack of a clear timetable for the exploration of strategic alternatives might lead to uncertainty and speculation among investors regarding the company's future direction and stability.

FAQ

Why did Relmada Therapeutics discontinue the Reliance II and Relight Phase 3 studies?

Relmada discontinued these studies following the evaluation of the full dataset by the data monitoring committee.

What is the focus of Relmada's ongoing Phase 1 study?

The Phase 1 study focuses on REL-P11, an investigational agent for treating metabolic disease.

What strategic alternatives is Relmada considering?

Relmada is exploring options such as asset sales, mergers, and acquiring rights for new product developments.

What is the significance of the REL-1017 program?

REL-1017 is a novel NMDA receptor channel blocker that targets hyperactive channels while maintaining glutamatergic neurotransmission.

How can I learn more about Relmada Therapeutics?

For more information, visit Relmada Therapeutics' official website at .

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$RLMD Insider Trading Activity

$RLMD insiders have traded $RLMD stock on the open market 8 times in the past 6 months. Of those trades, 8 have been purchases and 0 have been sales.

Here's a breakdown of recent trading of $RLMD stock by insiders over the last 6 months:

• SERGIO TRAVERSA (Chief Executive Officer) has traded it 3 times. They made 3 purchases, buying 140,000 shares and 0 sales.
• MAGED SHENOUDA (Chief Financial Officer) has traded it 3 times. They made 3 purchases, buying 53,432 shares and 0 sales.
• CHARLES J CASAMENTO purchased 13,000 shares.
• PAUL EDWARD KELLY purchased 25,000 shares.

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

$RLMD Hedge Fund Activity

We have seen 15 institutional investors add shares of $RLMD stock to their portfolio, and 61 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• VESTAL POINT CAPITAL, LP removed 710,000 shares (-59.2%) from their portfolio in Q3 2024
• DEEP TRACK CAPITAL, LP removed 559,940 shares (-45.3%) from their portfolio in Q3 2024
• MILLENNIUM MANAGEMENT LLC added 497,469 shares (+773.0%) to their portfolio in Q3 2024
• FRANKLIN RESOURCES INC added 289,490 shares (+28.6%) to their portfolio in Q3 2024
• TANG CAPITAL MANAGEMENT LLC removed 187,049 shares (-78.6%) from their portfolio in Q3 2024
• SHAY CAPITAL LLC added 175,547 shares (+inf%) to their portfolio in Q3 2024
• OPALEYE MANAGEMENT INC. removed 120,000 shares (-20.0%) from their portfolio in Q3 2024

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

CORAL GABLES, Fla., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada", "the Company"), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that in light of the recent data monitoring committee (DMC) evaluation of the full dataset from the Reliance II Phase 3 study of the Company's REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study.

In connection with this decision, the Company has commenced a process to explore strategic alternatives to maximize shareholder value. As part of this process, the Company plans to consider a wide range of options with a focus on maximizing shareholder value, including, but not limited to, the sale of Company assets, a sale of the Company, a merger or a reverse merger, the acquisition of assets or rights for the development of other products, or other strategic transaction(s). There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. The Company is in the process of engaging a financial advisor to assist in the strategic review process.

The Company has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.

About REL-1017

REL-1017 is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission.

About REL-P11

Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021. Psilocybin has neuroplastogen effects that have the potential to ameliorate neurodegenerative conditions. Relmada identified the potential to use low-dose psilocybin as a treatment for metabolic diseases and published the data at the American Society for the Study of Liver Disease (AASLD 2023).

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS) and metabolic disorders. Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Learn more at



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Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects", "anticipates", "believes", "will", "will likely result", "will continue", "plans to", "potential", "promising", and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the ongoing Phase 1 and planned Phase 2a trials of REL-P11, the Company's low-dose, modified-release formulation of psilocybin, to be successfully carried out and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:

Tim McCarthy

LifeSci Advisors

Tim@LifeSciAdvisors.com

Media Inquiries:

Corporate Communications

media@relmada.com