DUALITYBIO-B (09606) announced that on May 12, 2026, Hong Kong Time (the "Exercise Date"), the company provided written notice to BioNTech SE ("BioNTech"), whose shares are listed on the Nasdaq Stock Market (Nasdaq: BNTX), exercising the exclusive U.S. cost and profit/loss sharing option for DB-1311/BNT324 ("DB-1311/BNT324 Cost and Profit/Loss Sharing Option") granted to the company under the License and Collaboration Agreement ("Collaboration Agreement") entered into with BioNTech on March 31, 2023, regarding DB-1311.
Under the Collaboration Agreement, BioNTech granted the company the right to exercise the exclusive DB-1311/BNT324 cost and profit/loss sharing option in accordance with the terms of the agreement. The company was entitled to exercise this option at any time within a specified period following the successful completion of the first Phase 2 clinical trial for the first DB-1311/BNT324 product.
According to the terms of the Collaboration Agreement, upon exercising the DB-1311/BNT324 cost and profit/loss sharing option, the company is required to pay BioNTech its share of past development costs attributable to the United States. The DB-1311/BNT324 cost and profit/loss sharing option becomes effective after the company makes these payments. This move enables the company to share in the development costs, as well as commercialization profits and losses, for the first DB-1311/BNT324 product in the United States, in accordance with the terms of the Collaboration Agreement.
The Board of Directors believes that DB-1311/BNT324 has shown encouraging clinical data across multiple tumor indications and that the product holds significant commercial potential in the United States. Exercising the DB-1311/BNT324 cost and profit/loss sharing option allows the company to capture the potential of DB-1311 in the U.S. market. The board considers the exercise of this option to be in the overall best interests of the company and its shareholders.
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