Edesa Biotech, Inc. filed a Form 8-K on November 9, 2026, disclosing that on November 8, 2026, the company entered into a Collaboration and License Agreement with Kyorin Pharmaceutical Co., Ltd. and terminated its at-the-market offering agreement with H.C. Wainwright & Co., LLC.

Key Highlights

  • Upfront payment: Kyorin will pay Edesa Biotech a one-time, non-creditable and non-refundable upfront payment of $12 million.
  • Milestone potential: The company is eligible to receive development and regulatory milestone payments of up to $55 million in the aggregate, plus sales-based milestone payments of up to ¥12.0 billion in the aggregate.
  • Licensed territory: Kyorin received an exclusive, royalty-bearing license to develop and commercialize paridiprubart (EB05) for the treatment of acute respiratory distress syndrome in Japan only.
  • Royalties: Kyorin will pay the company low double-digit tiered royalties on net sales of licensed products in Japan, subject to specified reductions and adjustments.
  • Retained rights: According to the filing, the company retains all rights to paridiprubart outside Japan, including in the United States, Europe, and Canada, as well as the right to manufacture paridiprubart.
  • ATM agreement terminated: The company provided notice on November 8, 2026, to H.C. Wainwright & Co., LLC terminating its At The Market Offering Agreement, effective November 16, 2026, with no termination penalties.

Edesa Biotech's Japan License Deal with Kyorin: Terms and Structure

Trading on NASDAQ:EDSA, Edesa Biotech, Inc. disclosed that on November 8, 2026, it entered into a Collaboration and License Agreement with Kyorin Pharmaceutical Co., Ltd. Under the agreement, Edesa granted Kyorin an exclusive, royalty-bearing license, with the right to grant sublicenses subject to the terms of the License Agreement, to develop and commercialize paridiprubart (EB05), the company's anti-TLR4 monoclonal antibody, for the treatment of acute respiratory distress syndrome in Japan. The filing notes that paridiprubart is itself licensed to Edesa by NovImmune SA, operating under the brand Light Chain Bioscience, pursuant to a License Agreement dated April 17, 2020.

According to the filing, Kyorin is generally responsible, at its own expense, for development, regulatory activities, and commercialization of licensed compounds and products in Japan, and is required to use commercially reasonable efforts to conduct these activities. Kyorin will fund specified activities conducted for the Licensed Territory and share specified costs of any multi-regional clinical studies. Edesa will manufacture and supply licensed products to Kyorin under supply agreements to be entered into by the parties. The License Agreement also grants Kyorin a right of first negotiation with respect to acute kidney injury and a non-exclusive right to negotiate with respect to certain other indications in Japan.

The filing states that unless earlier terminated, the License Agreement will continue until the fifteenth anniversary of the first commercial sale of a licensed product in Japan, subject to automatic renewal for successive two-year periods. Kyorin may terminate for convenience upon specified prior written notice, and both parties have termination rights for uncured material breach and specified bankruptcy or insolvency events. Separately, the company disclosed that it terminated its At The Market Offering Agreement with H.C. Wainwright & Co., LLC, originally dated October 4, 2024, with an effective termination date of November 16, 2026, and stated it "is not subject to any termination penalties" in connection with that termination.

What Was Disclosed

Edesa Biotech reported entering into an exclusive Japan license agreement for paridiprubart with Kyorin Pharmaceutical, including a $12 million upfront payment, up to $55 million in development and regulatory milestones, and up to ¥12.0 billion in sales milestones. The company also terminated its ATM agreement with H.C. Wainwright effective November 16, 2026.