10. License Agreement

On April 8, 2021, the Company entered into the License Agreement with 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 required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $335.0 million, consisting of up to $155.0 million related to development milestone and up to $180.0 million related to commercial milestones, payable within 60 days of the milestone achievement.

The development milestones include payments of (i) $5.0 million following the FDA regulatory filing of an NDA for gedatolisib; (ii) $50.0 million following the FDA regulatory approval of an NDA for gedatolisib; (iii) and seven other development milestones totaling $100.0 million.

The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review program, and the Company completed its final NDA submission to the FDA in November 2025. The FDA accepted the Company's NDA submission on January 16, 2026. The Company recorded the $5.0 million NDA filing milestone as research and development expense in June 2025 and paid this amount in January 2026.

On July 14, 2026, subsequent to the balance sheet date but prior to the issuance of these condensed financial statements, the Company received FDA Approval, which triggered a one-time regulatory milestone payment of $50.0 million to Pfizer. The Company concluded that FDA Approval provided additional evidence with respect to the contingent contractual obligation that existed as of June 30, 2026, and accordingly accounted for FDA Approval as a recognized subsequent event. As a result, the Company recognized an accrued license milestone of $50.0 million and a corresponding intangible asset for the licensed rights as of June 30, 2026. The intangible asset will be amortized on a straight-line basis over its estimated useful life, commencing upon commercial launch, and will be evaluated for impairment whenever events or changes in circumstances indicate the carrying amount may not be recoverable. The milestone payment is due to Pfizer within 60 days of FDA Approval.

Additionally, the Company will pay Pfizer tiered royalties on sales of REVTORPYK 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.