Relmada Therapeutics Inc Stock Price, News & Analysis

Relmada Therapeutics (NASDAQ: RLMD) has secured an exclusive licensing agreement with Trigone Pharma for NDV-01, a novel sustained-release bladder cancer treatment. NDV-01 is a gemcitabine/docetaxel formulation targeting non-muscle invasive bladder cancer (NMIBC), which affects approximately 600,000 U.S. patients with 62,000 new diagnoses annually.

The drug candidate is currently in Phase 2 trials, with topline efficacy and safety data expected at the American Urological Association meeting in Las Vegas (April 26-29, 2025). NDV-01's key advantages include:

• Sustained delivery lasting up to 10 days versus hours for conventional treatments
• Potential for both inpatient and outpatient clinic use
• Good safety profile and easy dosing procedure

This acquisition, along with the recently acquired sepranolone, represents Relmada's strategy to diversify its pipeline while balancing risk and upside potential. The company positions NDV-01 as a potential first-line therapy for NMIBC, particularly beneficial for patients unresponsive to BCG therapy.

Relmada Therapeutics (NASDAQ: RLMD) has acquired Sepranolone, a Phase 2b ready neurosteroid therapy for Tourette syndrome (TS), from Asarina Pharma AB. Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist that targets the GABAA pathway to counteract Allopregnanolone effects in TS and other compulsive disorders.

In a Phase 2a study involving 26 subjects over 12 weeks, Sepranolone demonstrated promising results, including a 28% reduction in tic severity (p=0.051) and significant improvements in secondary endpoints: 69% increase in Quality of Life, 50% reduction in impairment, and 44% reduction in premonitory urge to tic. The treatment showed no CNS off-target effects or systemic side effects.

The company views this acquisition as strategic in addressing unmet needs in CNS disorders and plans to host an investor update on Sepranolone's development later in 2025.

Relmada Therapeutics (Nasdaq: RLMD) announced the discontinuation of its Reliance II and Relight Phase 3 studies of REL-1017 following a data monitoring committee evaluation. The company will continue advancing the Phase 1 study of REL-P11, an investigational treatment for metabolic disease. In response to these developments, Relmada has initiated a process to explore strategic alternatives to maximize shareholder value, including potential sale of company assets, mergers, acquisitions, or other strategic transactions. The company is engaging a financial advisor for the strategic review process but has not set a specific timeline for completion.

Relmada Therapeutics (NASDAQ: RLMD) announced that the Phase 3 Reliance II trial for REL-1017, designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD), is unlikely to meet its primary efficacy endpoint according to the Data Monitoring Committee's interim analysis. No new safety concerns were identified.

The company will evaluate the complete dataset to determine next steps for the REL-1017 program while continuing to advance the Phase 1 study of REL-P11 for metabolic disease. Relmada maintains a strong financial position with approximately $54.1 million in cash and cash equivalents as of September 30, 2024.

Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology company focusing on central nervous system diseases, has announced its participation in the Jefferies London Healthcare Conference. CEO Sergio Traversa will present on Wednesday, November 20, 2024, at 12:00 PM GMT. The presentation will be available via webcast, with a replay accessible on Relmada's website investor page for 90 days after the conference.

Relmada Therapeutics has initiated Phase 1 dosing of REL-P11, a proprietary low-dose, modified-release psilocybin formulation for metabolic disease. The Single-Ascending Dosing (SAD) study will evaluate safety and pharmacokinetics in obese and normal weight subjects. Preclinical rodent studies presented at AASLD 2023 demonstrated improved metabolic parameters without detrimental CNS effects. With positive results, the company plans to advance to a Phase 2a proof-of-concept study in H1 2025.

Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million, while general and administrative expenses decreased to $11.9 million from $12.2 million. The company maintains a cash position of $54.1 million, expected to fund operations into 2025. Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 and initiation of a Phase 1 study for REL-P11 for metabolic disease.

Relmada Therapeutics (RLMD) reported Q3 2024 financial results with a net loss of $21.7 million ($0.72 per share), compared to $22.0 million ($0.73 per share) in Q3 2023. Research and development expenses increased to $11.1 million from $10.4 million year-over-year, while G&A expenses decreased to $11.9 million from $12.2 million. The company's cash position stands at $54.1 million, expected to fund operations into 2025.

Key upcoming milestones include a pre-planned Phase 3 Reliance II interim analysis by year-end 2024 for REL-1017 in major depressive disorder, and initiation of a Phase 1 study for REL-P11 in metabolic disease.

Relmada Therapeutics (Nasdaq: RLMD), a late-stage biotechnology company focused on central nervous system diseases, has announced it will host a conference call and webcast on November 7, 2024 at 4:30 PM ET. The event will discuss business progress and financial results for the third quarter ended September 30, 2024. The company has provided dial-in numbers for US and international participants, along with a webcast option. A replay will be available in the Investors section of Relmada's website.