8-K: Relmada Therapeutics Licenses Phase 2 Bladder Cancer Candidate NDV-01 from Trigone Pharma

Relmada Therapeutics acquires exclusive rights to NDV-01, a novel bladder cancer treatment, from Trigone Pharma, expanding its pipeline.

Summary

• Relmada Therapeutics has entered into an exclusive license agreement with Trigone Pharma for NDV-01, a treatment for non-muscle invasive bladder cancer (NMIBC).
• The agreement grants Relmada worldwide rights to NDV-01, excluding India, Israel, and South Africa.
• Relmada will pay Trigone an upfront fee of $3.5 million and issue 3,017,420 restricted shares of Relmada's common stock.
• Trigone is eligible for up to $105 million in development and regulatory milestone payments, and up to $95 million in commercialization milestone payments.
• Relmada will also pay Trigone a 3% royalty on net sales of NDV-01.
• Relmada is responsible for the clinical development, manufacturing, and commercialization of NDV-01.
• Topline Phase 2 data for NDV-01 is expected to be reported at the American Urological Association meeting in April 2025.
• Relmada anticipates hosting an investor update on NDV-01's next development steps later in 2025.

Sentiment

Score: 7

Explanation: The document presents a positive outlook on the acquisition of NDV-01 and its potential in the bladder cancer treatment market. The management's comments are optimistic, and the deal terms seem reasonable. However, there are inherent risks associated with drug development, which temper the overall sentiment.

Positives

• NDV-01 has the potential to be a first-line therapy for NMIBC.
• NDV-01 offers a good safety profile, easy dosing procedure, and superior drug delivery profile.
• The sustained-release formulation of NDV-01 could improve treatment effectiveness and patient compliance.
• The acquisition diversifies Relmada's pipeline and balances its risk and upside potential.
• NDV-01 is protected by several patents related to methods of treatment and formulation whose terms go out to 2038.

Negatives

• Relmada is required to spend at least $5 million per year on research, development, and commercialization activities related to NDV-01, starting January 1, 2026, or Trigone may terminate the agreement.
• Relmada will be required to pay Trigone 20% of any payments (including up-front payments, annual payments, royalties and milestone payments) and other consideration, including non-cash consideration, that we receive in connection with the grant of a sublicense, in lieu of the consideration due Trigone under the License Agreement, provided that in no case shall the sublicense payments to be paid to Trigone in connection with net sales generated by such sublicense and/or development and regulatory milestone or commercial milestone be less than such otherwise to be paid to Trigone under the License Agreement.

Risks

• Clinical trials may not deliver statistically and/or clinically significant evidence of efficacy and/or safety.
• Top-line results may not accurately reflect the complete results of the trial.
• Relmada may fail to secure FDA agreement on the regulatory path for NDV-01.
• Relmada may fail to secure adequate NDV-01 drug supply.
• The company is subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

Future Outlook

Relmada plans to advance NDV-01's development and anticipates hosting an investor update later in 2025 to discuss next steps.

Management Comments

• Sergio Traversa, CEO of Relmada Therapeutics, stated that NDV-01 represents an exceptional value-creation opportunity for Relmada and its investors.
• Sergio Traversa believes Trigone's novel intravesicular sustained-release formulation could enable NDV-01 to be a first-line therapy for non-muscle invasive bladder cancer.
• Maged Shenouda, CFO of Relmada, added that NDV-01 is an excellent strategic complement to their recently acquired asset, sepranolone.
• Dan Touitou, CEO of Trigone, believes the sustained-release formulation of NDV-01 has the potential to improve treatment effectiveness and patient compliance.

Industry Context

The acquisition addresses the unmet need for effective treatments for NMIBC, particularly in patients who don't respond to BCG therapy, and positions Relmada in a growing market with limited approved treatment options.

Comparison to Industry Standards

• Gemcitabine and docetaxel (Gem/Doce) therapy in HG-NMIBC has been widely adopted in clinical practice.
• The highest efficacy has been demonstrated in sequential intravesical treatment (Kates et al., 2020).
• Approved treatment options remain limited (mainly the immunotherapy, BCG, which has been supply constrained for some time), with high recurrence rates leading to frequent re-treatment and progression.
• Other emerging programs include immunotherapy combinations, single agent chemotherapy formulations and targeted therapies.

Stakeholder Impact

• Shareholders: The acquisition is expected to create value for Relmada and its investors.
• Patients: NDV-01 has the potential to improve treatment effectiveness and patient compliance for NMIBC.
• Employees: The acquisition may lead to new job opportunities within Relmada.
• Trigone Pharma: Trigone will receive upfront payments, milestone payments, and royalties from the agreement.

Next Steps

• Relmada will assume responsibility for NDV-01's development, manufacturing, and commercialization.
• Topline Phase 2 data is expected to be presented at the American Urological Association meeting in April 2025.
• Relmada anticipates hosting an investor update on NDV-01's next development steps later in 2025.

Key Dates

Keywords

NDV-01, Relmada Therapeutics, Trigone Pharma, bladder cancer, NMIBC, licensing agreement, gemcitabine, docetaxel, intravesical, oncology