Relmada licenses NDV-01 from Trigone, agrees to pay $3,500,000 and issue 3,017,420 shares

Relmada Therapeutics, Inc. (Nasdaq: RLMD) entered into an exclusive license agreement with Trigone Pharma, Ltd., an Israeli company, on March 24, 2025. The license covers NDV-01, a fixed-dose formulation of gemcitabine and docetaxel for bladder cancer. Relmada reported the agreement in a Form 8-K filed March 26, 2025, signed by Sergio Traversa, Chief Executive Officer.

Who arranged it

The 8-K and its press release name Trigone as the licensor and Relmada as the licensee. Neither names an investment bank, placement agent, financial adviser or outside counsel for the deal. The shares are issued directly to Trigone, so no underwriter or agent appears in the filing.

What Relmada pays

Relmada will pay Trigone a non-refundable, non-creditable initial license fee of $3,500,000 and will issue 3,017,420 restricted shares of its common stock. The press release says those shares represent 10% of Relmada's outstanding shares. The 8-K says the shares will be issued without registration under Section 4(a)(2) of the Securities Act or Rule 506(b) of Regulation D.

The further payments depend on results. Development and regulatory milestones carry a maximum of $105,000,000, and commercialization milestones a maximum of $95,000,000. The press release describes the combined figure as up to $200 million. Relmada will also pay quarterly royalties of 3% on net sales of licensed products in the territory, which covers the world except India, Israel and South Africa.

Relmada must spend at least $5,000,000 a year on research, development or commercialization of the product from January 1, 2026 until its first commercial sale. If it falls short for reasons within its control, Trigone may terminate the license. The 8-K also says Relmada would owe Trigone 20% of any sublicense income, and that either party may end the agreement for uncured material breach or insolvency. Relmada may also end the agreement without cause on 30 days' prior notice.

Control and the lock-up

At the same time, Relmada and Trigone signed a Shareholder Voting and Lock Up Agreement. Trigone agreed to vote its Relmada shares as the board recommends. For 12 months it agreed not to offer, pledge, sell, contract to sell or otherwise transfer those shares or securities tied to them.

What the data stage means

The drug has not yet produced its key data. NDV-01 is being tested in a Phase 2 study in non-muscle invasive bladder cancer, and the press release says first data are expected at the American Urological Association meeting, held April 26 to 29, 2025, in Las Vegas. The study was designed to enroll up to 70 subjects with localized, non-metastatic high-grade non-muscle invasive bladder cancer. The first data, covering 20 patients, are expected to be presented at that meeting, and Relmada expects to host an investor update on NDV-01's next development steps later in 2025.

The release calls NDV-01 an exceptional value-creation opportunity and describes the team as able to be opportunistic. Those are the company's words. The release also says that NDV-01 complements sepranolone, a neurosteroid Relmada recently acquired and describes as Phase 2b-ready. Relmada is therefore paying for a Phase 2 asset with no reported efficacy data, using shares and cash, while its pipeline is already expanding.

Who signed

Sergio Traversa, Chief Executive Officer, signed the 8-K for Relmada Therapeutics, Inc. on March 26, 2025. The press release quotes Chief Financial Officer Maged Shenouda and Trigone's chief executive, Dan Touitou.

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