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License Agreement | 12 Months Ended
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Dec. 31, 2025
License Agreement |
License Agreement | 11. License Agreement On April 8, 2021, the Company entered into a license agreement with Pfizer Inc. (“Pfizer”) to research, develop, manufacture and commercialize gedatolisib. During 2021, the Company paid $5.0 million in upfront fees and issued 349,406 shares of the Company’s common stock to Pfizer pursuant to an Equity Grant Agreement. The Company is also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $335.0 million. One of these milestone events requires a $5.0 million payment within 60 days following the FDA regulatory filing of a New Drug Application (“NDA”) for gedatolisib. The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and the Company completed its final NDA submission to the FDA in November 2025. The Company recorded the $5.0 million NDA filing milestone as research and development expense in June 2025. As of December 31, 2025, this amount was included in other accrued expenses on the Company’s balance sheets. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid patent claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product, or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, a valid claim of a licensed patent right. The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party.

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