Gold prices steady with focus on Ukraine-Russia, Jackson Hole
CORAL GABLES, Fla. - Relmada Therapeutics, Inc. (NASDAQ: RLMD), a biotechnology firm with a market capitalization of $9.11 million, has entered into an exclusive licensing agreement with Trigone Pharma, Ltd. for NDV-01, a novel therapy for Non-Muscle Invasive Bladder Cancer (NMIBC). According to InvestingPro data, the company’s stock has experienced significant pressure, declining over 93% in the past year. The treatment is currently undergoing a Phase 2 study, with initial results expected to be shared at the American Urological Association meeting from April 26-29, 2025.
NDV-01 is a sustained-release intravesical formulation combining gemcitabine and docetaxel, which may offer clinical advantages for patients and healthcare providers, including a good safety profile and convenient dosing. This treatment could potentially become a first-line therapy for NMIBC, a condition with a significant unmet need for more effective treatments, particularly for patients not responding to BCG1 therapy.
Relmada’s agreement with Trigone involves an upfront payment of $3.5 million and the issuance of 3,017,420 shares of common stock, equating to 10% of the company’s outstanding shares. Additionally, up to $200 million in development, regulatory, and sales milestones are contingent upon successful commercialization, plus a 3% royalty on net sales. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 6.89, and importantly, holds more cash than debt on its balance sheet. Post-Phase 2 study completion, Relmada will take over the development, manufacturing, and commercialization duties for NDV-01.
The Phase 2 study of NDV-01 is designed to include up to 70 subjects with high-grade NMIBC. The topline data from the first 20 participants will be presented at the upcoming AUA meeting in Las Vegas. NDV-01’s sustained-release mechanism aims to maximize drug concentration and prolong exposure while minimizing systemic toxicity. The formulation could improve treatment efficacy and patient compliance by offering a more manageable alternative to current hospital-based therapies.
Relmada’s strategic outlook includes evaluating additional product opportunities to leverage its development capabilities. The company plans to provide an investor update on NDV-01’s next development steps later in 2025. While analysts have set price targets ranging from $0.60 to $1.00 per share, InvestingPro’s Fair Value analysis suggests the stock is currently undervalued. For deeper insights into biotech valuations and comprehensive analysis, investors can access detailed Pro Research Reports covering over 1,400 US stocks through InvestingPro.
NMIBC presents a growing market opportunity, with a high recurrence rate and limited treatment options. NDV-01’s potential extends beyond first-line therapy, with possibilities for use in patients who have failed other treatments and expansion into other NMIBC subtypes.
This article is based on a press release statement from Relmada Therapeutics.
In other recent news, Relmada Therapeutics has announced the acquisition of Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma AB for approximately 3 million EUR. This compound is being developed as a potential treatment for Tourette syndrome, with promising Phase 2a data suggesting it may offer a safer alternative to current treatments. Relmada’s financial position, with approximately $54 million in cash, is expected to fully fund the upcoming Phase 2b trials for Sepranolone. Meanwhile, Mizuho analysts maintained a Neutral rating on Relmada, noting the acquisition’s potential to enhance shareholder value but not anticipating any immediate mergers or sales.
Additionally, Relmada Therapeutics faces a potential Nasdaq delisting due to non-compliance with the minimum bid price requirement. The company has been given until July 21, 2025, to regain compliance by maintaining a $1 minimum bid price. In another development, Relmada appointed Paul Kelly as Chief Operating Officer, effective January 1, 2025, and revised employment agreements to align with cost-reduction measures, including freezing salary increases and bonuses for top executives. These actions are part of Relmada’s strategic efforts to manage expenses and maintain financial stability.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.