0000950170-24-118958 | 10-Q | XBRL Viewer | DAY ONE Biopharmaceuticals INC

Significant Agreements	9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Significant Agreements	5. Significant Agreements Takeda asset purchase agreement On December 16, 2019, a subsidiary of the Company entered into an asset purchase agreement, or the Takeda Asset Agreement, with Millennium Pharmaceuticals, Inc., a related party and an affiliate of Takeda Pharmaceutical Company Limited, or Takeda. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the Takeda Asset Agreement. Pursuant to the Takeda Asset Agreement, the Company purchased certain technology rights and know-how related to TAK-580 (which is now OJEMDA™ (tovorafenib)) that provides a new approach for treating patients with primary brain tumors or brain metastases of solid tumors. The Company also received clinical inventory supplies to use in the Company's research and development activities of such RAF-inhibitor and an assigned investigator clinical trial agreement. Takeda also assigned to the Company its exclusive license agreement, or the Viracta License Agreement, with Viracta. Takeda also granted the Company a worldwide, sublicensable exclusive license under specified patents and know-how and non-exclusive license under other patents and know-how generated by Takeda under the Takeda Asset Agreement. The Company also granted Takeda a grant back license, as defined in the Takeda Asset Agreement, which is terminable either automatically or by the Company in the event Takeda does not achieve specified development milestones within the applicable timeframes set forth under the Takeda Asset Agreement. This grant back license to Takeda was terminated at the time of conversion in connection with the Millennium Stock Exchange Agreement. The term of the Takeda Asset Agreement will expire on a country-by-country basis upon expiration of all assigned patent rights and all licensed patent rights in such country. Takeda may terminate the Takeda Asset Agreement prior to the Company's first commercial sale of a product if the Company ceases conducting any development activities for a continuous and specified period of time and such cessation is not agreed upon by the parties and is not done in response to guidance from a regulatory authority. Additionally, Takeda can terminate the Takeda Asset Agreement in the event of the Company's bankruptcy. In the event of termination of the Takeda Asset Agreement by Takeda as a result of the Company's cessation of development or bankruptcy, all assigned patents, know-how and contracts (other than the Viracta License Agreement) will be assigned back to Takeda and Takeda will obtain a reversion license under patents and know-how generated to exploit all such terminated products. In consideration for the sale and assignment of assets and the grant of the license under the Takeda Asset Agreement, the Company made an upfront payment of $1.0 million in cash and issued 9,857,143 shares of Series A redeemable convertible preferred stock in the Company’s subsidiary in December 2019. The fair value of issued shares was estimated as $9.9 million, based on the price paid by other investors for issued shares in the Series A financing of the Company’s subsidiary. Based on the terms of the Millennium Stock Exchange Agreement, Takeda exchanged the 9,857,143 shares of Series A redeemable convertible preferred stock of the Company’s subsidiary for 6,470,382 shares of the Company's common stock upon the effectiveness of the conversion, on May 26, 2021. License agreement with Viracta On December 16, 2019, a subsidiary of the Company amended and restated the Viracta License Agreement that was assigned pursuant to the Takeda Asset Agreement. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under Viracta License Agreement. Under the Viracta License Agreement, the Company received a worldwide exclusive license under specified patent rights and know-how to develop, use, manufacture, and commercialize products containing compounds binding the RAF protein family. The term of the Viracta License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company’s obligation to pay royalties to Viracta with respect to such product in such country. The Company has the right to terminate the Viracta License Agreement with respect to any or all of the licensed products at will upon a specified notice period. The Company paid $2.0 million upfront in cash to Viracta, which was recorded as research and development expenses as the technology does not have an alternative future use. On March 4, 2024, the Company entered into an amendment to the Viracta License Agreement. As part of the amendment, the Company made a one-time payment in March 2024 to Viracta of $5.0 million, which was recorded as research and development expenses during the nine months ended September 30, 2024, in exchange for reduced future payment obligations ranging from the mid-teens to the high single-digit percentage related to the future sale or use of the rare pediatric disease PRV received. On April 23, 2024, the FDA approved OJEMDA (a tablet formulation and powder solution formulation of tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The indication was approved under accelerated approval based on response rate and duration of response. With the approval, the Company received a rare pediatric disease PRV from the FDA. The Company made a $9.0 million milestone payment to Viracta in May 2024 for the achievement of this milestone. The $9.0 million milestone was accounted for as a finite-lived intangible asset and will be amortized over the life of the underlying asset. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations. On May 29, 2024, the Company sold its rare pediatric disease PRV for $108.0 million to an undisclosed buyer. As part of the transaction, $8.1 million of the total consideration received from the sale of the rare pediatric disease PRV was paid to Viracta to fully satisfy PRV-related obligations under the Viracta License Agreement. The gross proceeds of $108.0 million were recorded as a gain from sale of priority review voucher in the accompanying condensed statements of operations during the nine months ended September 30, 2024. As of September 30, 2024, the $8.1 million paid to satisfy PRV-related obligations was capitalized as a finite-lived intangible asset, which will be amortized on a straight-line basis over its estimated useful life. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations. As of September 30, 2024, the Company could be required to make additional milestone payments of up to $40.0 million upon achievement of specified development and regulatory milestones for each licensed product in two indications, with milestones payable for the second indication upon achievement of a specified milestone event being lower than milestones payable for the first indication. Commencing with the first commercial sale of OJEMDA in a country, the Company is obligated to pay tiered royalties ranging in the mid-single-digit percentages on net sales of licensed products. The obligation to pay royalties will end on a country-by-country and licensed product-by-licensed product basis commencing on the first commercial sale in a country and continuing until the later of: (i) the expiration of the last valid claim of the Viracta licensed patents, jointly owned collaboration patents or specified patents owned by the Company covering the use or sale of such product in such country, (ii) the expiration of the last statutory exclusivity pertaining to such product in such country or (iii) the tenth anniversary of the first commercial sale of such product in such country. License agreement with Merck KGaA, Darmstadt, Germany On February 10, 2021, a subsidiary of the Company entered into a license agreement, or the MRKDG License Agreement, with Merck KGaA, Darmstadt, Germany, a pharmaceutical corporation located in Darmstadt, Germany. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the MRKDG License Agreement. Under the MRKDG License Agreement, Merck KGaA, Darmstadt, Germany granted to the Company an exclusive worldwide license, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to research, develop, manufacture and commercialize products containing and comprising the pimasertib and MSC2015103B compounds. The Company also received clinical inventory supplies to use in its research and development activities. The Company's exclusive license grant is subject to a non-exclusive license granted by Merck KGaA, Darmstadt, Germany’s affiliate to a cancer research organization and Merck KGaA, Darmstadt, Germany retains the right to conduct, directly or indirectly, certain ongoing clinical studies relating to pimasertib. Under the MRKDG License Agreement, the Company has obligations to use commercially reasonable efforts to develop and commercialize at least two licensed products in at least two specified major market countries by the year 2029. The term of the MRKDG License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company's obligation to pay royalties to the licensor with respect to such licensed product in such country and will expire in its entirety upon the expiration of all of the Company's payment obligations with respect to all licensed products and all countries under the MRKDG License Agreement. In consideration for the rights granted under the MRKDG License Agreement and clinical supplies, the Company made an upfront payment of $8.0 million, which was recorded as research and development expenses, as the technology does not have an alternative future use and supplies are used for research activities. As of September 30, 2024, the Company could be required to make additional payments of up to $364.5 million based upon the achievement of specified development, regulatory, and commercial milestones, as well a high, single-digit royalty percentage on future net sales of licensed products, if any. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. In November 2023, the Company discontinued its monotherapy substudy due to a limited duration of response in this rare patient population despite observing responses with a generally well tolerated therapy. In July 2024, the Company decided to close the program as the Company determined that the benefit/risk profile, as well as the market opportunity, did not justify the significant investment required to continue the trial despite observing some clinical responses. Research collaboration and license agreement with Sprint Bioscience AB On August 15, 2023, the Company entered into a research collaboration and license agreement, or the Sprint License Agreement, with Sprint Bioscience AB, or Sprint, a Swedish corporation located in Huddinge, Sweden. Under the Sprint License Agreement, Sprint granted to the Company an exclusive, worldwide license, with the right to grant sublicenses through multiple tiers, to research, develop, and commercialize pharmaceutical products and to engage in research aimed at discovery, optimization and development of Vaccinia Related Kinase 1, or VRK1. The term of the Sprint License Agreement will expire on a licensed product and country basis upon the expiration of the royalty term with respect to such licensed product and such country, unless terminated earlier. The Company has the right to terminate the Sprint License Agreement in its entirety, or on a licensed product-by-licensed product basis, at will upon a specified notice period. The Company paid $3.0 million upfront in cash to Sprint, which was recorded as research and development expenses as the technology does not have an alternative future use. As of September 30, 2024, the Company could be required to make milestone payments of up to $309.0 million based upon achievement of specified development, regulatory, and commercial milestones for each licensed product, as well as tiered royalties ranging in the single-digit percentages on future net sales of licensed products, if any. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. License agreement with MabCare Therapeutics On June 17, 2024, the Company entered into a license agreement, or the MabCare License Agreement, with MabCare Therapeutics, or MabCare, a pharmaceutical corporation located in Shanghai, China. Under the MabCare License Agreement, MabCare granted to the Company an exclusive worldwide license, excluding Greater China, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to develop, manufacture and commercialize DAY301 (formerly MTX-13), a novel Antibody Drug Conjugate, or ADC, targeting protein-tyrosine kinase 7, or PTK7. The Company will also receive clinical inventory supplies to use in its research and development activities. Under the MabCare License Agreement, the Company has obligations to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one licensed product in one indication in each of the United States, Japan, and three European countries. The term of the MabCare License Agreement will expire in its entirety upon the expiration of the last to expire royalty term with respect to all licensed products in the Company's territory, unless terminated earlier. Following the expiration of the royalty term for a licensed product in a country, the license grant to the Company shall become non-exclusive, fully paid-up, royalty-free, perpetual, and irrevocable for such licensed product in such country. Upon the expiration of the term, the license granted to the Company shall become non-exclusive, transferable, sublicensable, fully paid, royalty free, perpetual, and irrevocable in its entirety. In consideration for the rights granted under the MabCare License Agreement, the Company made a $55.0 million upfront payment in July 2024. The upfront payment was recorded as research and development expenses, as the technology and supplies licensed do not have an alternative future use. As of September 30, 2024, the Company could be required to make additional payments of $1,152.0 million based upon the achievement of specified development, regulatory, and commercial success-based milestones plus low-to-mid single-digit royalties on net sales outside of Greater China. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due. License agreement with Ipsen Pharma SAS On July 23, 2024, the Company entered into the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Ipsen shall have the right to grant sublicenses to third-parties. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $70.8 million and (ii) the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $40.0 million, at a price per share representing a 17.0% premium to the VWAP of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. As of September 30, 2024, the Company is also eligible to receive up to approximately $350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The royalty payment obligations under the Ipsen License Agreement expire on a country-by-country basis no earlier than ten years following the first commercial sale of tovorafenib in the applicable country. In addition, the Ipsen License Agreement provides that the Company will supply to Ipsen, and Ipsen will purchase from the Company, all required quantities of tovorafenib for all territories outside the United States in accordance with a supply agreement to be entered into by and between the Company and Ipsen, or the Ipsen Supply Agreement. The Company determined that the cost-plus rate to be charged for the supply of tovorafenib does not represent a material right. Ipsen has the right to request a manufacturing technology transfer of the then-current manufacturing process of tovorafenib under the Ipsen License Agreement, such consent shall not be unreasonably withheld, such that upon completion of the manufacturing technology transfer, Ipsen or a third-party would be solely responsible for the manufacture of tovorafenib for all territories outside the United States. Following the two-year anniversary of July 23, 2024, the effective date of the Ipsen License Agreement, Ipsen may terminate the Ipsen License Agreement for convenience with six months’ prior written notice or for certain other specified reasons. The Company may terminate the Ipsen License Agreement if Ipsen or any of its affiliates challenge the validity of any patents controlled by the Company that are licensed under the Ipsen License Agreement. Both Ipsen and the Company may terminate the Ipsen License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the Ipsen License Agreement or (ii) the other party’s bankruptcy event. The Company evaluated the Ipsen License Agreement under Accounting Standards Codification, or ASC, 606 and concluded that Ipsen represents a customer in the transaction. The Company identified two distinct performance obligations for licenses to intellectual property in the form of the exclusive license to commercialize tovorafenib outside the United States for both (i) relapsed or refractory and (ii) front-line pLGG; and three distinct research and development performance obligations related to tovorafenib for completion of (i) the pivotal Phase 2 relapsed or refractory pLGG trial, or FIREFLY-1, (ii) the pivotal Phase 3 front-line pLGG trial, or FIREFLY-2, and (iii) the European Union, or EU, companion diagnostic for pLGG. Both the FIREFLY-1 and FIREFLY-2 trials related to pLGG pertain to later-stage intellectual property and only involve validating the efficacy of tovorafenib with respect to each distinct designation and are not expected to significantly modify or customize the licensed intellectual property. The FIREFLY-1 and FIREFLY-2 trials, and EU companion diagnostic research and development services related to pLGG could be performed by a third-party. The Company determined that the promise of the manufacturing technology transfer is a customer option that does not represent a material right given the value of the services is not material and fulfillment of this promise is ancillary to the main transaction. Accordingly, the manufacturing technology transfer is not a performance obligation at the outset of the arrangement. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $78.2 million, representing the aggregate of the upfront license fee of $70.8 million and the premium paid by Ipsen on its equity investment in the Company of $7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. Commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties on net sales upon commercialization by Ipsen were excluded from the transaction price and will be recognized when the related sales occur as they were determined to predominantly relate to the intellectual property and, therefore, have been excluded from the transaction price in accordance with the sales-based royalty exception. The Company allocated the transaction price to the performance obligations based on their relative standalone selling price. The Company developed the estimated stand-alone selling price for each license using discounted cash flow models. In developing this estimate, the Company applied judgment in the determination of the assumptions relating to forecasted future revenues, the discount rate, and the probability of success. The stand-alone selling price for each of the research and development services was estimated based on the Company’s forecasted costs to be incurred to fulfill the obligations plus a reasonable margin. The portion of the transaction price allocable to the relapsed or refractory and front-line pLGG licenses to intellectual property was determined to be $73.5 million and was recognized as license revenue at the point in time in which Ipsen had the right to use the license/know-how, which occurred during the third quarter of 2024. The portion of the transaction price allocable to the relapsed or refractory, front-line and companion diagnostic research and development services performance obligations was determined to be $4.7 million, which will be recognized over time as the services are delivered based on costs incurred relative to the total estimated cost to deliver the services. During the three and nine months ended September 30, 2024, $0.2 million of deferred revenue was recognized as license revenue related to the research and development services performance obligations with $1.4 million and $3.1 million of the undelivered services included in current and non-current deferred revenue, respectively.

Significant Agreements

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Takeda asset purchase agreement

On December 16, 2019, a subsidiary of the Company entered into an asset purchase agreement, or the Takeda Asset Agreement, with Millennium Pharmaceuticals, Inc., a related party and an affiliate of Takeda Pharmaceutical Company Limited, or Takeda. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the Takeda Asset Agreement. Pursuant to the Takeda Asset Agreement, the Company purchased certain technology rights and know-how related to TAK-580 (which is now OJEMDA™ (tovorafenib)) that provides a new approach for treating patients with primary brain tumors or brain metastases of solid tumors. The Company also received clinical inventory supplies to use in the Company's research and development activities of such RAF-inhibitor and an assigned investigator clinical trial agreement. Takeda also assigned to the Company its exclusive license agreement, or the Viracta License Agreement, with Viracta. Takeda also granted the Company a worldwide, sublicensable exclusive license under specified patents and know-how and non-exclusive license under other patents and know-how generated by Takeda under the Takeda Asset Agreement. The Company also granted Takeda a grant back license, as defined in the Takeda Asset Agreement, which is terminable either automatically or by the Company in the event Takeda does not achieve specified development milestones within the applicable timeframes set forth under the Takeda Asset Agreement. This grant back license to Takeda was terminated at the time of conversion in connection with the Millennium Stock Exchange Agreement.

The term of the Takeda Asset Agreement will expire on a country-by-country basis upon expiration of all assigned patent rights and all licensed patent rights in such country. Takeda may terminate the Takeda Asset Agreement prior to the Company's first commercial sale of a product if the Company ceases conducting any development activities for a continuous and specified period of time and such cessation is not agreed upon by the parties and is not done in response to guidance from a regulatory authority. Additionally, Takeda can terminate the Takeda Asset Agreement in the event of the Company's bankruptcy. In the event of termination of the Takeda Asset Agreement by Takeda as a result of the Company's cessation of development or bankruptcy, all assigned patents, know-how and contracts (other than the Viracta License Agreement) will be assigned back to Takeda and Takeda will obtain a reversion license under patents and know-how generated to exploit all such terminated products.

In consideration for the sale and assignment of assets and the grant of the license under the Takeda Asset Agreement, the Company made an upfront payment of $1.0 million in cash and issued 9,857,143 shares of Series A redeemable convertible preferred stock in the Company’s subsidiary in December 2019. The fair value of issued shares was estimated as $9.9 million, based on the price paid by other investors for issued shares in the Series A financing of the Company’s subsidiary. Based on the terms of the Millennium Stock Exchange Agreement, Takeda exchanged the 9,857,143 shares of Series A redeemable convertible preferred stock of the Company’s subsidiary for 6,470,382 shares of the Company's common stock upon the effectiveness of the conversion, on May 26, 2021.

License agreement with Viracta

On December 16, 2019, a subsidiary of the Company amended and restated the Viracta License Agreement that was assigned pursuant to the Takeda Asset Agreement. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under Viracta License Agreement. Under the Viracta License Agreement, the Company received a worldwide exclusive license under specified patent rights and know-how to develop, use, manufacture, and commercialize products containing compounds binding the RAF protein family.

The term of the Viracta License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company’s obligation to pay royalties to Viracta with respect to such product in such country. The Company has the right to terminate the Viracta License Agreement with respect to any or all of the licensed products at will upon a specified notice period.

The Company paid $2.0 million upfront in cash to Viracta, which was recorded as research and development expenses as the technology does not have an alternative future use.

On March 4, 2024, the Company entered into an amendment to the Viracta License Agreement. As part of the amendment, the Company made a one-time payment in March 2024 to Viracta of $5.0 million, which was recorded as research and development expenses during the nine months ended September 30, 2024, in exchange for reduced future payment obligations ranging from the mid-teens to the high single-digit percentage related to the future sale or use of the rare pediatric disease PRV received.

On April 23, 2024, the FDA approved OJEMDA (a tablet formulation and powder solution formulation of tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The indication was approved under accelerated approval based on response rate and duration of response. With the approval, the Company received a rare pediatric disease PRV from the FDA. The Company made a $9.0 million milestone payment to Viracta in May 2024 for the achievement of this milestone. The $9.0 million milestone was accounted for as a finite-lived intangible asset and will be amortized over the life of the underlying asset. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations.

On May 29, 2024, the Company sold its rare pediatric disease PRV for $108.0 million to an undisclosed buyer. As part of the transaction, $8.1 million of the total consideration received from the sale of the rare pediatric disease PRV was paid to Viracta to fully satisfy PRV-related obligations under the Viracta License Agreement. The gross proceeds of $108.0 million were recorded as a gain from sale of priority review voucher in the accompanying condensed statements of operations during the nine months ended September 30, 2024. As of September 30, 2024, the $8.1 million paid to satisfy PRV-related obligations was capitalized as a finite-lived intangible asset, which will be amortized on a straight-line basis over its estimated useful life. Related amortization expense will be recorded as cost of product revenue in the Company’s statements of operations.

As of September 30, 2024, the Company could be required to make additional milestone payments of up to $40.0 million upon achievement of specified development and regulatory milestones for each licensed product in two indications, with milestones payable for the second indication upon achievement of a specified milestone event being lower than milestones payable for the first indication. Commencing with the first commercial sale of OJEMDA in a country, the Company is obligated to pay tiered royalties ranging in the mid-single-digit percentages on net sales of licensed products. The obligation to pay royalties will end on a country-by-country and licensed product-by-licensed product basis commencing on the first commercial sale in a country and continuing until the later of: (i) the expiration of the last valid claim of the Viracta licensed patents, jointly owned collaboration patents or specified patents owned by the Company covering the use or sale of such product in such country, (ii) the expiration of the last statutory exclusivity pertaining to such product in such country or (iii) the tenth anniversary of the first commercial sale of such product in such country.

License agreement with Merck KGaA, Darmstadt, Germany

On February 10, 2021, a subsidiary of the Company entered into a license agreement, or the MRKDG License Agreement, with Merck KGaA, Darmstadt, Germany, a pharmaceutical corporation located in Darmstadt, Germany. Effective December 31, 2021, the subsidiary was merged with and into the Company, with the Company being the surviving corporation and assuming the subsidiary’s obligations under the MRKDG License Agreement.

Under the MRKDG License Agreement, Merck KGaA, Darmstadt, Germany granted to the Company an exclusive worldwide license, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to research, develop, manufacture and commercialize products containing and comprising the pimasertib and MSC2015103B compounds. The Company also received clinical inventory supplies to use in its research and development activities. The Company's exclusive license grant is subject to a non-exclusive license granted by Merck KGaA, Darmstadt, Germany’s affiliate to a cancer research organization and Merck KGaA, Darmstadt, Germany retains the right to conduct, directly or indirectly, certain ongoing clinical studies relating to pimasertib. Under the MRKDG License Agreement, the Company has obligations to use commercially reasonable efforts to develop and commercialize at least two licensed products in at least two specified major market countries by the year 2029.

The term of the MRKDG License Agreement will expire on a licensed product-by-licensed product and country-by-country basis upon the expiration of the Company's obligation to pay royalties to the licensor with respect to such licensed product in such country and will expire in its entirety upon the expiration of all of the Company's payment obligations with respect to all licensed products and all countries under the MRKDG License Agreement.

In consideration for the rights granted under the MRKDG License Agreement and clinical supplies, the Company made an upfront payment of $8.0 million, which was recorded as research and development expenses, as the technology does not have an alternative future use and supplies are used for research activities. As of September 30, 2024, the Company could be required to make additional payments of up to $364.5 million based upon the achievement of specified development, regulatory, and commercial milestones, as well a high, single-digit royalty percentage on future net sales of licensed products, if any. Milestones

and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due.

In November 2023, the Company discontinued its monotherapy substudy due to a limited duration of response in this rare patient population despite observing responses with a generally well tolerated therapy. In July 2024, the Company decided to close the program as the Company determined that the benefit/risk profile, as well as the market opportunity, did not justify the significant investment required to continue the trial despite observing some clinical responses.

Research collaboration and license agreement with Sprint Bioscience AB

On August 15, 2023, the Company entered into a research collaboration and license agreement, or the Sprint License Agreement, with Sprint Bioscience AB, or Sprint, a Swedish corporation located in Huddinge, Sweden. Under the Sprint License Agreement, Sprint granted to the Company an exclusive, worldwide license, with the right to grant sublicenses through multiple tiers, to research, develop, and commercialize pharmaceutical products and to engage in research aimed at discovery, optimization and development of Vaccinia Related Kinase 1, or VRK1.

The term of the Sprint License Agreement will expire on a licensed product and country basis upon the expiration of the royalty term with respect to such licensed product and such country, unless terminated earlier. The Company has the right to terminate the Sprint License Agreement in its entirety, or on a licensed product-by-licensed product basis, at will upon a specified notice period.

The Company paid $3.0 million upfront in cash to Sprint, which was recorded as research and development expenses as the technology does not have an alternative future use. As of September 30, 2024, the Company could be required to make milestone payments of up to $309.0 million based upon achievement of specified development, regulatory, and commercial milestones for each licensed product, as well as tiered royalties ranging in the single-digit percentages on future net sales of licensed products, if any. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due.

License agreement with MabCare Therapeutics

On June 17, 2024, the Company entered into a license agreement, or the MabCare License Agreement, with MabCare Therapeutics, or MabCare, a pharmaceutical corporation located in Shanghai, China. Under the MabCare License Agreement, MabCare granted to the Company an exclusive worldwide license, excluding Greater China, with the right to grant sublicenses through multiple tiers, under specified patent rights and know-how for the Company to develop, manufacture and commercialize DAY301 (formerly MTX-13), a novel Antibody Drug Conjugate, or ADC, targeting protein-tyrosine kinase 7, or PTK7. The Company will also receive clinical inventory supplies to use in its research and development activities. Under the MabCare License Agreement, the Company has obligations to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one licensed product in one indication in each of the United States, Japan, and three European countries.

The term of the MabCare License Agreement will expire in its entirety upon the expiration of the last to expire royalty term with respect to all licensed products in the Company's territory, unless terminated earlier. Following the expiration of the royalty term for a licensed product in a country, the license grant to the Company shall become non-exclusive, fully paid-up, royalty-free, perpetual, and irrevocable for such licensed product in such country. Upon the expiration of the term, the license granted to the Company shall become non-exclusive, transferable, sublicensable, fully paid, royalty free, perpetual, and irrevocable in its entirety.

In consideration for the rights granted under the MabCare License Agreement, the Company made a $55.0 million upfront payment in July 2024. The upfront payment was recorded as research and development expenses, as the technology and supplies licensed do not have an alternative future use. As of September 30, 2024, the Company could be required to make additional payments of $1,152.0 million based upon the achievement of specified development, regulatory, and commercial success-based milestones plus low-to-mid single-digit royalties on net sales outside of Greater China. Milestones and royalties are contingent upon future events and will be recorded when the milestones are achieved and when payments are due.

License agreement with Ipsen Pharma SAS

On July 23, 2024, the Company entered into the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Ipsen shall have the right to grant sublicenses to third-parties.

Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $70.8 million and (ii) the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $40.0 million, at a price per share representing a 17.0% premium to the VWAP of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and

including the date of the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024.

As of September 30, 2024, the Company is also eligible to receive up to approximately $350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The royalty payment obligations under the Ipsen License Agreement expire on a country-by-country basis no earlier than ten years following the first commercial sale of tovorafenib in the applicable country.

In addition, the Ipsen License Agreement provides that the Company will supply to Ipsen, and Ipsen will purchase from the Company, all required quantities of tovorafenib for all territories outside the United States in accordance with a supply agreement to be entered into by and between the Company and Ipsen, or the Ipsen Supply Agreement. The Company determined that the cost-plus rate to be charged for the supply of tovorafenib does not represent a material right. Ipsen has the right to request a manufacturing technology transfer of the then-current manufacturing process of tovorafenib under the Ipsen License Agreement, such consent shall not be unreasonably withheld, such that upon completion of the manufacturing technology transfer, Ipsen or a third-party would be solely responsible for the manufacture of tovorafenib for all territories outside the United States.

Following the two-year anniversary of July 23, 2024, the effective date of the Ipsen License Agreement, Ipsen may terminate the Ipsen License Agreement for convenience with six months’ prior written notice or for certain other specified reasons. The Company may terminate the Ipsen License Agreement if Ipsen or any of its affiliates challenge the validity of any patents controlled by the Company that are licensed under the Ipsen License Agreement. Both Ipsen and the Company may terminate the Ipsen License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the Ipsen License Agreement or (ii) the other party’s bankruptcy event.

The Company evaluated the Ipsen License Agreement under Accounting Standards Codification, or ASC, 606 and concluded that Ipsen represents a customer in the transaction. The Company identified two distinct performance obligations for licenses to intellectual property in the form of the exclusive license to commercialize tovorafenib outside the United States for both (i) relapsed or refractory and (ii) front-line pLGG; and three distinct research and development performance obligations related to tovorafenib for completion of (i) the pivotal Phase 2 relapsed or refractory pLGG trial, or FIREFLY-1, (ii) the pivotal Phase 3 front-line pLGG trial, or FIREFLY-2, and (iii) the European Union, or EU, companion diagnostic for pLGG. Both the FIREFLY-1 and FIREFLY-2 trials related to pLGG pertain to later-stage intellectual property and only involve validating the efficacy of tovorafenib with respect to each distinct designation and are not expected to significantly modify or customize the licensed intellectual property. The FIREFLY-1 and FIREFLY-2 trials, and EU companion diagnostic research and development services related to pLGG could be performed by a third-party. The Company determined that the promise of the manufacturing technology transfer is a customer option that does not represent a material right given the value of the services is not material and fulfillment of this promise is ancillary to the main transaction. Accordingly, the manufacturing technology transfer is not a performance obligation at the outset of the arrangement.

Upon execution of the Ipsen License Agreement, the transaction price was determined to be $78.2 million, representing the aggregate of the upfront license fee of $70.8 million and the premium paid by Ipsen on its equity investment in the Company of $7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. Commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties on net sales upon commercialization by Ipsen were excluded from the transaction price and will be recognized when the related sales occur as they were determined to predominantly relate to the intellectual property and, therefore, have been excluded from the transaction price in accordance with the sales-based royalty exception.

The Company allocated the transaction price to the performance obligations based on their relative standalone selling price. The Company developed the estimated stand-alone selling price for each license using discounted cash flow models. In developing this estimate, the Company applied judgment in the determination of the assumptions relating to forecasted future revenues, the discount rate, and the probability of success. The stand-alone selling price for each of the research and development services was estimated based on the Company’s forecasted costs to be incurred to fulfill the obligations plus a reasonable margin. The portion of the transaction price allocable to the relapsed or refractory and front-line pLGG licenses to intellectual property was determined to be $73.5 million and was recognized as license revenue at the point in time in which Ipsen had the right to use the license/know-how, which occurred during the third quarter of 2024. The portion of the transaction price allocable to the relapsed or refractory, front-line and companion diagnostic research and development services performance obligations was determined to be $4.7 million, which will be recognized over time as the services are delivered based on costs incurred relative to the total estimated cost to deliver the services. During the three and nine months ended September 30, 2024, $0.2 million of deferred revenue was recognized as license revenue related to the research and development services performance obligations with $1.4 million and $3.1 million of the undelivered services included in current and non-current deferred revenue, respectively.

Balance Sheet Items (Tables)

9 Months Ended

Sep. 30, 2024

Balance Sheet Related Disclosures [Abstract]

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Prepaid research and development expenses	$	6,382	$	5,657
Prepaid insurance		1,355		918
Other prepaid expenses and other assets		3,446		2,352
Total prepaid expenses and other current assets	$	11,183	$	8,927

Schedule of Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Accrued research and development expenses	$	16,299	$	12,643
Accrued payroll related expenses		11,502		9,165
Accrued professional service expenses		2,893		3,675
Other		4,495		1,041
Total accrued expenses and other current liabilities	$	35,189	$	26,524

Condensed Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands	Total	Common Shares [Member]	Additional Paid-in Capital [Member]	Accumulated Other Comprehensive Income (Loss) [Member]	Accumulated Deficit [Member]
Beginning Balance at Dec. 31, 2022	$ 332,039	$ 7	$ 601,771	$ (71)	$ (269,668)
Beginning Balance (In shares) at Dec. 31, 2022		73,458,176
Issuance of common stock upon exercise of stock options (share)		75,184
Issuance of common stock upon exercise of stock options, Amount	1,184		1,184
Issuance of common stock upon release of restricted stock units, shares		60,673
Unvested common stock forfeiture		(21,400)
Share-based compensation expenses	9,447		9,447
Unrealized gain (loss) on available-for-sale securities	138			138
Net Income (Loss)	(42,393)				(42,393)
Ending Balance at Mar. 31, 2023	300,415	$ 7	612,402	67	(312,061)
Ending Balance (In shares) at Mar. 31, 2023		73,572,633
Beginning Balance at Dec. 31, 2022	332,039	$ 7	601,771	(71)	(269,668)
Beginning Balance (In shares) at Dec. 31, 2022		73,458,176
Unrealized gain (loss) on available-for-sale securities	64
Net Income (Loss)	(134,406)
Ending Balance at Sep. 30, 2023	389,627	$ 9	793,699	(7)	(404,074)
Ending Balance (In shares) at Sep. 30, 2023		87,042,933
Beginning Balance at Mar. 31, 2023	300,415	$ 7	612,402	67	(312,061)
Beginning Balance (In shares) at Mar. 31, 2023		73,572,633
Issuance of common stock upon exercise of stock options (share)		2,704
Issuance of common stock upon exercise of stock options, Amount	39		39
Issuance of common stock upon release of restricted stock units, shares		69,020
Share-based compensation expenses	9,477		9,477
Unrealized gain (loss) on available-for-sale securities	(76)			(76)
Issuance of common stock pursuant to follow-on offering, net of issuance costs, Shares		13,269,231
Issuance of common stock pursuant to follow-on offering, net of issuance costs, Amount	161,409	$ 2	161,407
Issuance of common stock pursuant to Employee Stock Purchase Plan, Shares		57,740
Issuance of common stock pursuant to Employee Stock Purchase Plan, Amount	653		653
Net Income (Loss)	(45,863)				(45,863)
Ending Balance at Jun. 30, 2023	426,054	$ 9	783,978	(9)	(357,924)
Ending Balance (In shares) at Jun. 30, 2023		86,971,328
Issuance of common stock upon exercise of stock options (share)		10,571
Issuance of common stock upon exercise of stock options, Amount	115		115
Issuance of common stock upon release of restricted stock units, shares		61,034
Share-based compensation expenses	9,606		9,606
Unrealized gain (loss) on available-for-sale securities	2			2
Net Income (Loss)	(46,150)				(46,150)
Ending Balance at Sep. 30, 2023	389,627	$ 9	793,699	(7)	(404,074)
Ending Balance (In shares) at Sep. 30, 2023		87,042,933
Beginning Balance at Dec. 31, 2023	346,540	$ 9	805,107	9	(458,585)
Beginning Balance (In shares) at Dec. 31, 2023		87,227,132
Issuance of common stock upon exercise of stock options (share)		4,862
Issuance of common stock upon exercise of stock options, Amount	48		48
Issuance of common stock upon release of restricted stock units, shares		157,724
Unvested common stock forfeiture		(12,555)
Share-based compensation expenses	12,644		12,644
Unrealized gain (loss) on available-for-sale securities	(14)			(14)
Net Income (Loss)	(62,412)				(62,412)
Ending Balance at Mar. 31, 2024	296,806	$ 9	817,799	(5)	(520,997)
Ending Balance (In shares) at Mar. 31, 2024		87,377,163
Beginning Balance at Dec. 31, 2023	346,540	$ 9	805,107	9	(458,585)
Beginning Balance (In shares) at Dec. 31, 2023		87,227,132
Unrealized gain (loss) on available-for-sale securities	(15)
Net Income (Loss)	(29,782)
Ending Balance at Sep. 30, 2024	555,463	$ 10	1,043,826	(6)	(488,367)
Ending Balance (In shares) at Sep. 30, 2024		100,810,357
Beginning Balance at Mar. 31, 2024	296,806	$ 9	817,799	(5)	(520,997)
Beginning Balance (In shares) at Mar. 31, 2024		87,377,163
Issuance of common stock upon exercise of stock options (share)		22,151
Issuance of common stock upon exercise of stock options, Amount	324		324
Issuance of common stock upon release of restricted stock units, shares		211,635
Unvested common stock forfeiture		(12,860)
Share-based compensation expenses	13,052		13,052
Unrealized gain (loss) on available-for-sale securities	(17)			(17)
Issuance of common stock pursuant to Employee Stock Purchase Plan, Shares		94,827
Issuance of common stock pursuant to Employee Stock Purchase Plan, Amount	973		973
Net Income (Loss)	(4,407)				(4,407)
Ending Balance at Jun. 30, 2024	306,731	$ 9	832,148	(22)	(525,404)
Ending Balance (In shares) at Jun. 30, 2024		87,692,916
Issuance of common stock upon exercise of stock options (share)		67,540
Issuance of common stock upon exercise of stock options, Amount	977		977
Issuance of common stock upon release of restricted stock units, shares		156,688
Issuance of common stock in connection with private placement, net of placement agent fees and offering costs(Share)		12,893,213
Issuance of common stock in connection with private placement, net of placement agent fees and offering costs(Value)	178,177	$ 1	178,176
Issuance of prefunded warrants to purchase common stock in connection with private placement, net of issuance costs	20,941		20,941
Share-based compensation expenses	11,584		11,584
Unrealized gain (loss) on available-for-sale securities	16			16
Net Income (Loss)	37,037				37,037
Ending Balance at Sep. 30, 2024	$ 555,463	$ 10	$ 1,043,826	$ (6)	$ (488,367)
Ending Balance (In shares) at Sep. 30, 2024		100,810,357

Defined Contribution Plan	9 Months Ended
Defined Contribution Plan	Sep. 30, 2024
Retirement Benefits [Abstract]
Defined Contribution Plan	11. Defined Contribution Plan The Company maintains an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. All employees are eligible to participate provided that they meet the requirements of the plan. For each of the three months ended September 30, 2024 and 2023, the Company made matching contributions of $0.4 million and $0.2 million, respectively. For the nine months ended September 30, 2024 and 2023, the Company made matching contributions of $1.4 million and $1.0 million, respectively.

Balance Sheet Items - Summary of Prepaid and Other Current Assets (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Prepaid Expense and Other Assets, Current [Abstract]
Prepaid research and development expenses	$ 6,382	$ 5,657
Prepaid insurance	1,355	918
Other prepaid expenses and other assets	3,446	2,352
Total prepaid expenses and other current assets	$ 11,183	$ 8,927

Share-based Compensation

9 Months Ended

Sep. 30, 2024

Stockholders' Equity Note [Abstract]

Share-based Compensation

Share-based compensation expense recorded in the accompanying condensed statements of operations is as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development expense	$	3,816	$	3,312	$	13,178	$	10,102
Selling, general and administrative expense		7,738		6,294		24,050		18,428
Total share-based compensation expense	$	11,554	$	9,606	$	37,228	$	28,530

2022 Equity Inducement Plan

In October 2022, the board of directors and stockholders approved the 2022 Equity Inducement Plan, or the 2022 Plan. The 2022 Plan provides for the grant of non-statutory stock options and restricted stock units. The number of shares of common stock reserved for issuance under the 2022 Plan is 1,000,000 shares.

2021 Equity Incentive Plan

In May 2021, in connection with the IPO, the board of directors and stockholders approved, the 2021 Equity Incentive Plan, or the 2021 Plan, which became effective on the day before the date of the effectiveness of the IPO. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, awards of restricted stock, restricted stock units and other share-based awards. The number of shares of common stock reserved for issuance under the 2021 Plan is equal to the sum of: (x) 6,369,000 shares of common stock; plus (y) 4,719,605 shares of common stock issued in respect of the conversion of incentive shares that were subject to vesting immediately prior to the effectiveness of the registration statement for the IPO that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right. The number of shares available for grant and issuance under the 2021 Plan will be automatically increased on the first day of each fiscal year, beginning with the fiscal year commencing on January 1, 2021 and continuing for each fiscal year until, and including, the fiscal year commencing on January 1, 2031, by the lesser of (a) 5% of the number of shares of all classes of the Company’s common stock, plus the total number of shares of Company common stock issuable upon conversion of any preferred stock or exercise of any warrants to acquire shares of Company common stock for a nominal exercise price issued and outstanding on each December 31 immediately prior to the date of increase or (b) such number of shares determined by the board of directors.

Stock Options

The following table provides a summary of stock option activity during the nine months ended September 30, 2024.


	Options			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Term		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2023		10,211,758		$	17.10
Granted		2,830,362		$	14.31
Exercised		(94,553	)	$	14.26			$	134
Forfeiture		(1,021,246	)	$	16.62
Outstanding at September 30, 2024		11,926,321		$	16.51		7.9	$	2,367
Vested and expected to vest at September 30, 2024		11,926,321		$	16.51		7.9	$	2,367
Exercisable at September 30, 2024		6,722,507		$	16.66		7.4	$	1,224

Aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise price of outstanding, in-the-money options. The total intrinsic value of options exercised during the nine months ended September 30, 2024 and 2023 was less than $0.1 million and $0.6 million, respectively.

The total fair value of options that vested during the nine months ended September 30, 2024 and 2023 was $25.7 million and $19.8 million, respectively. The weighted-average grant date fair value of options granted during the nine months ended September 30, 2024 and 2023 was $9.24 per share and $13.37 per share, respectively.

Unamortized share-based compensation for stock options as of September 30, 2024 was $53.3 million, which is expected to be recognized over a weighted-average period of 2.3 years.

The Company used the Black-Scholes option pricing model to estimate the fair value of stock option awards granted with the following assumptions:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected term (in years)	6.06 - 6.11	5.65 - 6.14	5.27 - 6.74	5.27 - 6.25
Expected volatility	68.46% - 68.72%	68.82% - 71.43%	68.27% - 70.57%	68.82% - 81.98%
Risk-free interest rate	3.43% - 4.40%	4.02% - 4.56%	3.43% - 4.47%	3.47% - 4.56%
Expected dividend yield	—	—	—	—

Restricted Stock Units

The following table provides a summary of restricted stock units activity during the nine months ended September 30, 2024:


	Number of Shares			Weighted Average Grant Date Fair Value Per Share
Unvested restricted stock units at December 31, 2023		1,031,545		$	18.27
Granted		1,584,280		$	14.38
Vested		(526,047	)	$	16.52
Forfeiture		(202,532	)	$	16.14
Unvested restricted stock units at September 30, 2024		1,887,246		$	15.72

Unamortized share-based compensation for restricted stock units as of September 30, 2024 was $27.9 million, which is expected to be recognized over a weighted-average period of 2.8 years.

Restricted Stock Awards

The following table provides a summary of the unvested common stock awards activity during the nine months ended September 30, 2024.


	Number of Shares			Weighted Average Grant Date Fair Value Per Share
Unvested common stock as of December 31, 2023		747,679		$	16.00
Vested		(556,424	)	$	16.00
Forfeiture		(25,415	)	$	16.00
Unvested common stock as of September 30, 2024		165,840		$	16.00

Unamortized share-based compensation for restricted stock awards as of September 30, 2024 was $1.1 million, which is expected to be recognized over a weighted-average period of 0.5 years.

2021 Employee Stock Purchase Plan

In May 2021, the board of directors adopted and the stockholders approved the 2021 Employee Stock Purchase Plan, or the ESPP, which became effective on May 26, 2021. A total of 603,000 shares of common stock were initially reserved for issuance under the ESPP. The number of shares of the common stock reserved for issuance under the ESPP will automatically increase on the first day of each fiscal year, beginning with the fiscal year commencing on January 1, 2021 and continuing for each fiscal year until, and including, the fiscal year commencing on January 1, 2031, by the lesser of: (a) 1% of the total number of outstanding shares of common stock of the Company (on an as converted basis outstanding on the immediately preceding December 31 (rounded down to the nearest whole share)) and (b) an amount determined by the board of directors. 331,014 shares have been issued under the ESPP as of September 30, 2024. The Company recognized compensation expense related to the ESPP of $0.2 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively, and $0.6 million and $0.6 million for the nine months ended September 30, 2024 and 2023, respectively.

The fair value of our common stock to be issued under the ESPP is estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions:


	Nine Months Ended September 30,
	2024	2023
Expected term (in years)	0.5	0.5
Expected volatility	63.45%	63.57%
Risk-free interest rate	5.40%	5.24%
Expected dividend yield	—	—

Share-based Compensation - Summary of Share/Stock-based Compensation Expense Recorded in The Accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 11,554	$ 9,606	$ 37,228	$ 28,530
Research and development expense
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	3,816	3,312	13,178	10,102
Selling, general and administrative expense
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 7,738	$ 6,294	$ 24,050	$ 18,428

Balance Sheet Items

9 Months Ended

Sep. 30, 2024

Balance Sheet Related Disclosures [Abstract]

Balance Sheet Items

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Prepaid research and development expenses	$	6,382	$	5,657
Prepaid insurance		1,355		918
Other prepaid expenses and other assets		3,446		2,352
Total prepaid expenses and other current assets	$	11,183	$	8,927

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Accrued research and development expenses	$	16,299	$	12,643
Accrued payroll related expenses		11,502		9,165
Accrued professional service expenses		2,893		3,675
Other		4,495		1,041
Total accrued expenses and other current liabilities	$	35,189	$	26,524

Recurring Fair Value Measurement - Schedule of fair value, assets and liabilities measured on recurring basis (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Money market funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	$ 249,276	$ 47,003
U.S. treasury securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	68,594	110,645
U.S. government agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	81,762	63,202
Fair Value, Recurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	535,250	356,413
Fair Value, Recurring \| Fair Value, Inputs, Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	249,276	47,003
Fair Value, Recurring \| Fair Value, Inputs, Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	285,974	309,410
Fair Value, Recurring \| Fair Value, Inputs, Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| Money market funds
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	249,276	47,003
Fair Value, Recurring \| Money market funds \| Fair Value, Inputs, Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	249,276	47,003
Fair Value, Recurring \| Money market funds \| Fair Value, Inputs, Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| Money market funds \| Fair Value, Inputs, Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| U.S. treasury securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	194,476	246,208
Fair Value, Recurring \| U.S. treasury securities \| Fair Value, Inputs, Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| U.S. treasury securities \| Fair Value, Inputs, Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	194,476	246,208
Fair Value, Recurring \| U.S. treasury securities \| Fair Value, Inputs, Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| U.S. government agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	91,498	63,202
Fair Value, Recurring \| U.S. government agency securities \| Fair Value, Inputs, Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	0	0
Fair Value, Recurring \| U.S. government agency securities \| Fair Value, Inputs, Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	91,498	63,202
Fair Value, Recurring \| U.S. government agency securities \| Fair Value, Inputs, Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents, fair value disclosure	$ 0	$ 0

Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Summary of Restricted Stock Units Activity

The following table provides a summary of restricted stock units activity during the nine months ended September 30, 2024:


	Number of Shares			Weighted Average Grant Date Fair Value Per Share
Unvested restricted stock units at December 31, 2023		1,031,545		$	18.27
Granted		1,584,280		$	14.38
Vested		(526,047	)	$	16.52
Forfeiture		(202,532	)	$	16.14
Unvested restricted stock units at September 30, 2024		1,887,246		$	15.72

Summary of Share/Stock-based Compensation Expense Recorded in The Accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss

Share-based compensation expense recorded in the accompanying condensed statements of operations is as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development expense	$	3,816	$	3,312	$	13,178	$	10,102
Selling, general and administrative expense		7,738		6,294		24,050		18,428
Total share-based compensation expense	$	11,554	$	9,606	$	37,228	$	28,530

Summary of The Unvested Common Stock

The following table provides a summary of the unvested common stock awards activity during the nine months ended September 30, 2024.


	Number of Shares			Weighted Average Grant Date Fair Value Per Share
Unvested common stock as of December 31, 2023		747,679		$	16.00
Vested		(556,424	)	$	16.00
Forfeiture		(25,415	)	$	16.00
Unvested common stock as of September 30, 2024		165,840		$	16.00

Schedule of fair value of our common stock to be issued under the ESPP

The fair value of our common stock to be issued under the ESPP is estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions:


	Nine Months Ended September 30,
	2024	2023
Expected term (in years)	0.5	0.5
Expected volatility	63.45%	63.57%
Risk-free interest rate	5.40%	5.24%
Expected dividend yield	—	—

Summary of The Black-Scholes Option Pricing Model to Estimate The Fair Value of Stock Option Granted

The Company used the Black-Scholes option pricing model to estimate the fair value of stock option awards granted with the following assumptions:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Expected term (in years)	6.06 - 6.11	5.65 - 6.14	5.27 - 6.74	5.27 - 6.25
Expected volatility	68.46% - 68.72%	68.82% - 71.43%	68.27% - 70.57%	68.82% - 81.98%
Risk-free interest rate	3.43% - 4.40%	4.02% - 4.56%	3.43% - 4.47%	3.47% - 4.56%
Expected dividend yield	—	—	—	—

2021 Equity Incentive Plan

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Summary of Stock Option Activity

The following table provides a summary of stock option activity during the nine months ended September 30, 2024.


	Options			Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Term		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2023		10,211,758		$	17.10
Granted		2,830,362		$	14.31
Exercised		(94,553	)	$	14.26			$	134
Forfeiture		(1,021,246	)	$	16.62
Outstanding at September 30, 2024		11,926,321		$	16.51		7.9	$	2,367
Vested and expected to vest at September 30, 2024		11,926,321		$	16.51		7.9	$	2,367
Exercisable at September 30, 2024		6,722,507		$	16.66		7.4	$	1,224

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ 37,037	$ (4,407)	$ (62,412)	$ (46,150)	$ (45,863)	$ (42,393)	$ (29,782)	$ (134,406)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Share-based Compensation - Summary of The Black-Scholes Option Pricing Model to Estimate The Fair Value of Stock Option Granted (Detail)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Two Thousand And Twenty One Equity Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Two Thousand And Twenty One Equity Incentive Plan [Member] \| Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	6 years 1 month 9 days	6 years 1 month 20 days	6 years 8 months 26 days	6 years 3 months
Expected volatility	68.72%	71.43%	70.57%	81.98%
Risk-free interest rate	4.40%	4.56%	4.47%	4.56%
Two Thousand And Twenty One Equity Incentive Plan [Member] \| Minimum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	6 years 21 days	5 years 7 months 24 days	5 years 3 months 7 days	5 years 3 months 7 days
Expected volatility	68.46%	68.82%	68.27%	68.82%
Risk-free interest rate	3.43%	4.02%	3.43%	3.47%
Two Thousand Twenty One Employee Stock Purchase Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)			6 months	6 months
Expected dividend yield			0.00%	0.00%

Balance Sheet Items - Summary of Accrued expenses and other current liabilities (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued license agreement upfront payment	$ 16,299	$ 12,643
Accrued payroll related expenses	11,502	9,165
Accrued professional service expenses	2,893	3,675
Other	4,495	1,041
Total accrued expenses and other current liabilities	$ 35,189	$ 26,524

Share-based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended						9 Months Ended
	May 31, 2021	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Oct. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, Amount		$ 977	$ 324	$ 48	$ 115	$ 39	$ 1,184
Common stock shares reserved for future issuance		20,111,278						20,111,278
Allocated share based compensation expense		$ 11,554			9,606			$ 37,228	$ 28,530
Restricted Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Unamortized stock-based compensation for stock options		27,900						$ 27,900
Weighted-average period expected to be recognized								2 years 9 months 18 days
2021 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Issuance of common stock upon exercise of stock options, Amount								$ 100	600
Total fair value of options		$ 25,700			$ 19,800			$ 25,700	$ 19,800
Share based compensation by share based payment award fair value assumptions dividend yield		0.00%			0.00%			0.00%	0.00%
Number of shares issued upon conversion	4,719,605
Common stock shares reserved for future issuance	6,369,000
Share based compensation by share based payment arrangement non vested options granted during the period								2,830,362
Weighted-average period expected to be recognized								7 years 10 months 24 days
Granted								2,830,362
2021 Equity Incentive Plan \| PSOs
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share based compensation by share based payment arrangement non vested options granted during the period weighted average grant date fair value								$ 9.24	$ 13.37
Unamortized stock-based compensation for stock options		$ 53,300						$ 53,300
Weighted-average period expected to be recognized								2 years 3 months 18 days
2021 Equity Incentive Plan \| Incremental Shares Reserved for Future Issuance [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-Based Compensation Arrangement by Share-Based Payment Award, Percentage of Outstanding Stock Maximum	5.00%
2021 Employee Stock Purchase Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock shares reserved for future issuance	603,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Percentage of Outstanding Stock Maximum	1.00%
Allocated share based compensation expense		200			$ 100			$ 600	$ 600
Stock Issued During Period, Shares, Employee Stock Ownership Plan								331,014
2022 Equity Inducement Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock shares reserved for future issuance										1,000,000
Unvested Common Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Unamortized stock-based compensation for stock options		$ 1,100						$ 1,100
Weighted-average period expected to be recognized								6 months

Net Income (Loss) Per Share (Tables)

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Summary of Basic and Diluted Net Loss Per Share Attributable to Common Shareholders/Stockholders

Basic and diluted net income (loss) per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts):


	Three Months Ended September 30,					Nine Months Ended September 30,
	2024		2023			2024			2023
Net income (loss) - basic and diluted	$	37,037	$	(46,150	)	$	(29,782	)	$	(134,406	)
Weighted average shares outstanding - basic		96,623,123		85,952,501			90,164,895			77,682,237
Effect of dilutive securities:
Stock options		57,455		—			—			—
Restricted stock units		107,935		—			—			—
Restricted stock awards		149,246		—			—			—
Weighted average shares outstanding - diluted		96,937,759		85,952,501			90,164,895			77,682,237
Net income (loss) per share - basic	$	0.38	$	(0.54	)	$	(0.33	)	$	(1.73	)
Net income (loss) per share - diluted	$	0.38	$	(0.54	)	$	(0.33	)	$	(1.73	)

Summary of Outstanding Potentially Dilutive Securities Have Been Excluded From Calculation of Diluted Net Loss Per Share

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net income (loss) per share, as their effect is anti-dilutive:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Stock options		11,454,704		10,039,940		11,926,321		10,039,940
Unvested common shares		—		956,719		165,840		956,719
Restricted stock units		406,092		1,001,313		1,887,246		1,001,313
Shares committed under ESPP		88,832		69,578		88,832		69,578
Total		11,949,628		12,067,550		14,068,239		12,067,550

Summary Of Significant Accounting Policies	9 Months Ended
Summary Of Significant Accounting Policies	Sep. 30, 2024
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Basis of Presentation The Company’s unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024. The condensed financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB. Use of Estimates The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses during the reporting period. Estimates and assumptions made in the accompanying condensed financial statements include, but are not limited to, accruals for research and development expenses, variable consideration and other relevant inputs impacting the gross and net revenue recognition, the valuation of share-based awards, and the valuation of deferred tax assets. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions. Segments The Company has determined that its chief executive officer is the chief operating decision maker, or CODM. The Company operates and manages the business as one reporting and one operating segment, which is the business of developing and commercializing targeted therapies for people of all ages with genomically-defined cancers. The Company’s CODM reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s assets are located in the United States. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments, and accounts receivable. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and short-term investments that are recorded on its balance sheet. Per policy, the Company mitigates its risk by investing in high-grade instruments and limiting the concentration in any one non-United States government or government backed issuer, which limits its exposure. The Company has not experienced any losses on its cash, cash equivalents and short-term investments. For the three months ended September 30, 2024, three individual customers accounted for 100.0% of total net product revenue, with these individual customers representing 69.0%, 23.0%, and 8.0% of the Company's total net product revenue. For the nine months ended September 30, 2024, three individual customers accounted for 100.0% of total net product revenue, with these individual customers representing 66.6%, 27.0%, and 6.4% of the Company's total net product revenue. As of September 30, 2024, three customers accounted for 100.0% of the accounts receivable balance, with these individual customers representing 55.0%, 25.7%, and 19.3% of the accounts receivable balance. No other individual customers account for more than 10.0% of net product sales or accounts receivable. The Company monitors the financial condition of its customers so that it can appropriately respond to changes in their creditworthiness. To date, the Company has not experienced any losses with respect to the collection of its accounts receivable. The Company is subject to certain risks and uncertainties and believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of its operations: ability to obtain future financing; regulatory requirements for approval and market acceptance of, and reimbursement for, product candidates; performance of third-party clinical research organizations and manufacturers upon which the Company relies; development of sales channels; protection of the Company’s intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; changes to the market landscape; and the Company’s ability to attract and retain employees necessary to support its growth. The Company is dependent on third-party manufacturers to supply products for commercial and research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs. Accounts Receivable, Net Accounts receivable, net consists of trade receivables which are amounts due from the Company's specialty pharmacy and specialty distributor customers related to product sales. The Company records trade receivables net of discounts, chargebacks, and any allowances for potential credit losses. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. For the three and nine months ended September 30, 2024, the Company did not record any expected credit losses related to outstanding accounts receivable. Inventory The Company began capitalizing inventory for OJEMDA upon approval by the U.S. Food and Drug Administration, or FDA, in April 2024. OJEMDA is approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma, or pLGG, harboring a BRAF fusion rearrangement, or BRAF V600 mutation. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. Raw and intermediate materials that may be used for either research and development or commercial purposes where the intended use is not yet known are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used or otherwise allocated for research and development, it is expensed as research and development in the period that determination is made. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenue. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product revenue in the statements of operations. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2024. Intangible Assets, Net Upon FDA approval and commercial launch of OJEMDA in April 2024, the Company capitalized the $9.0 million milestone payment to Viracta Therapeutics, Inc. (f/k/a Sunesis Pharmaceuticals, Inc.), or Viracta, for a specified regulatory milestone as a finite-lived intangible asset. Upon the sale of the Priority Review Voucher, or PRV, in May 2024 to fully satisfy PRV-related obligations of the Company's license agreement with Viracta, dated December 16, 2019, as amended, the Company capitalized the $8.1 million payment to Viracta as a finite-lived intangible asset. The intangible assets will be amortized on a straight-line basis over each of the estimated useful life of the underlying intellectual property of 7.3 years. Amortization expense will be recorded as cost of product revenue. Revenue Recognition The Company recognizes net product and license revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which outlines a five-step process for recognizing revenue from contracts with customers: (i) identify the contract with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied. Product Revenue, Net The Company recognizes net product revenue from OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion rearrangement, or BRAF V600 mutation, which it began selling in May 2024 through contractual arrangements with its specialty pharmacy and specialty distributor customers. The Company has determined that the delivery of OJEMDA to its customers constitutes a single performance obligation. There are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Net product revenue is recognized at the transaction price when the customer obtains control of the Company’s product, which occurs at a point in time upon delivery of the product to the customer. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with the Company’s customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Net product revenues from the sale of OJEMDA are recorded at the transaction price, which include adjustments for discounts and allowances, including estimated cash discounts, government chargebacks, government rebates, specialty distributor fees, copay assistance, and returns. These adjustments represent variable consideration under ASC 606 and are estimated using the expected value method or most likely amount method and are recorded when revenue is recognized on the sale of the product. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price, only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Cash Discounts — The Company estimates cash discounts based on contractual terms and expectations regarding future customer payment patterns. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Government Chargebacks — Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S. Department of Veterans Affairs hospitals and 340B entities at prices lower than the list prices charged to customers who directly purchase the product from the Company. The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of chargebacks that customers have claimed, but for which the Company has not yet issued a credit and credits that the Company expects to issue for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Specialty Distributor Fees — The Company pays fees to our specialty distributor customers for distribution services provided in connection with the sales of OJEMDA. These specialty distributor fees are based on a contractually determined fixed percentage of sales. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Copay Assistance — The Company offers a co-pay assistance program, which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as accrued expenses and other current liabilities. Product Returns — Consistent with industry practice, the Company’s contracts with customers for OJEMDA generally provide for returns only if the product is damaged or defective upon delivery, if there is a shipment error, and for certain customers, if the product is within an eligible expiry window. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company believes the returns of OJEMDA will be minimal because our customers often carry limited inventory given the price of our products, and the limited number of patients. These reserves are established in the same period that the related revenue is recognized. License Revenue The Company generates license revenue from the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen Pharma SAS, or Ipsen, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $70.8 million and (ii) Ipsen Biopharmaceuticals, Inc., or the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $40.0 million, at a price per share representing a 17.0% premium to the volume weighted average price, or VWAP, of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Company’s public release of U.S. GAAP revenue for the quarter ended June 30, 2024 on July 30, 2024, or the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company is also eligible to receive up to approximately $350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties are recognized as revenue when the related sales occur as the license of intellectual property is deemed to be the predominant item to which the commercial launch milestones, sales-based milestones and royalties relate. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $78.2 million, representing the aggregate of the upfront license fee of $70.8 million and the premium paid by Ipsen on its equity investment in the Company of $7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue against each performance obligation as or when the performance obligations under the contract are satisfied. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. Cost of Product Revenue Our cost of product revenue includes the cost of inventory sold, amortization expense of intangible assets and third-party royalties payable on our net product revenue. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company is currently evaluating the effect of this update on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures, which enhances the transparency and decision usefulness of income tax disclosures by requiring disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its financial statement disclosures.

Recurring Fair Value Measurement - Schedule of cash equivalents, marketable securities, and unrealized gains and losses (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Cash and Cash Equivalents [Line Items]
Cash equivalents, amortized cost	$ 422,765	$ 230,784
Marketable securities
Cash and Cash Equivalents [Line Items]
Debt securities, available-for-sale, amortized cost	135,623	135,554
Debt securities, available-for-sale, unrealized gain	31	9
Debt securities, available-for-sale, unrealized loss	(36)	0
Debt securities, available-for-sale, estimated fair value	135,618	135,563
Cash equivalents
Cash and Cash Equivalents [Line Items]
Cash equivalents, amortized cost	399,632	220,850
Cash equivalents, unrealized gains	0	0
Cash equivalents, unrealized losses	0	0
Cash and cash equivalents, fair value disclosure	399,632	220,850
Money market funds
Cash and Cash Equivalents [Line Items]
Cash equivalents, amortized cost	249,276	47,003
Cash equivalents, unrealized gains	0	0
Cash equivalents, unrealized losses	0	0
Cash and cash equivalents, fair value disclosure	249,276	47,003
U.S. government agency securities
Cash and Cash Equivalents [Line Items]
Cash equivalents, amortized cost	81,762	63,202
Cash equivalents, unrealized gains	0	0
Cash equivalents, unrealized losses	0	0
Cash and cash equivalents, fair value disclosure	81,762	63,202
Debt securities, available-for-sale, amortized cost	9,733
Debt securities, available-for-sale, unrealized gain	4
Debt securities, available-for-sale, unrealized loss	(1)
Debt securities, available-for-sale, estimated fair value	9,736
U.S. treasury securities
Cash and Cash Equivalents [Line Items]
Cash equivalents, amortized cost	68,594	110,645
Cash equivalents, unrealized gains	0	0
Cash equivalents, unrealized losses	0	0
Cash and cash equivalents, fair value disclosure	68,594	110,645
Debt securities, available-for-sale, amortized cost	125,890	135,554
Debt securities, available-for-sale, unrealized gain	27	9
Debt securities, available-for-sale, unrealized loss	(35)	0
Debt securities, available-for-sale, estimated fair value	$ 125,882	$ 135,563

Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income tax expense	$ (882)	$ 0	$ 670	$ 0
Recognized income tax benefit	$ 900
Effective income tax rate	2.40%		2.30%
Federal statutory rate	21.00%		21.00%

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (ee)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 4: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.7)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-10

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(9))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477250/944-220-S99-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Subparagraph (a)
-SubTopic 20
-Topic 740
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482659/740-20-45-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h))
-SubTopic 10
-Topic 235
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

+ Details

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The Company’s unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024. The condensed financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB.
Use of Estimates	Use of Estimates The preparation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses during the reporting period. Estimates and assumptions made in the accompanying condensed financial statements include, but are not limited to, accruals for research and development expenses, variable consideration and other relevant inputs impacting the gross and net revenue recognition, the valuation of share-based awards, and the valuation of deferred tax assets. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results may differ from those estimates or assumptions.
Segments	Segments The Company has determined that its chief executive officer is the chief operating decision maker, or CODM. The Company operates and manages the business as one reporting and one operating segment, which is the business of developing and commercializing targeted therapies for people of all ages with genomically-defined cancers. The Company’s CODM reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company’s assets are located in the United States.
Concentration of credit risk and other risks and uncertainties	Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments, and accounts receivable. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and short-term investments that are recorded on its balance sheet. Per policy, the Company mitigates its risk by investing in high-grade instruments and limiting the concentration in any one non-United States government or government backed issuer, which limits its exposure. The Company has not experienced any losses on its cash, cash equivalents and short-term investments. For the three months ended September 30, 2024, three individual customers accounted for 100.0% of total net product revenue, with these individual customers representing 69.0%, 23.0%, and 8.0% of the Company's total net product revenue. For the nine months ended September 30, 2024, three individual customers accounted for 100.0% of total net product revenue, with these individual customers representing 66.6%, 27.0%, and 6.4% of the Company's total net product revenue. As of September 30, 2024, three customers accounted for 100.0% of the accounts receivable balance, with these individual customers representing 55.0%, 25.7%, and 19.3% of the accounts receivable balance. No other individual customers account for more than 10.0% of net product sales or accounts receivable. The Company monitors the financial condition of its customers so that it can appropriately respond to changes in their creditworthiness. To date, the Company has not experienced any losses with respect to the collection of its accounts receivable. The Company is subject to certain risks and uncertainties and believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position or results of its operations: ability to obtain future financing; regulatory requirements for approval and market acceptance of, and reimbursement for, product candidates; performance of third-party clinical research organizations and manufacturers upon which the Company relies; development of sales channels; protection of the Company’s intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; changes to the market landscape; and the Company’s ability to attract and retain employees necessary to support its growth. The Company is dependent on third-party manufacturers to supply products for commercial and research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.
Accounts Receivable, Net	Accounts Receivable, Net Accounts receivable, net consists of trade receivables which are amounts due from the Company's specialty pharmacy and specialty distributor customers related to product sales. The Company records trade receivables net of discounts, chargebacks, and any allowances for potential credit losses. An allowance for credit losses is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. For the three and nine months ended September 30, 2024, the Company did not record any expected credit losses related to outstanding accounts receivable.
Inventory	Inventory The Company began capitalizing inventory for OJEMDA upon approval by the U.S. Food and Drug Administration, or FDA, in April 2024. OJEMDA is approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma, or pLGG, harboring a BRAF fusion rearrangement, or BRAF V600 mutation. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. Raw and intermediate materials that may be used for either research and development or commercial purposes where the intended use is not yet known are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is used or otherwise allocated for research and development, it is expensed as research and development in the period that determination is made. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenue. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product revenue in the statements of operations. There were no expenses recorded for excess inventory or other impairments during the three and nine months ended September 30, 2024.
Intangible Assets, Net	Intangible Assets, Net Upon FDA approval and commercial launch of OJEMDA in April 2024, the Company capitalized the $9.0 million milestone payment to Viracta Therapeutics, Inc. (f/k/a Sunesis Pharmaceuticals, Inc.), or Viracta, for a specified regulatory milestone as a finite-lived intangible asset. Upon the sale of the Priority Review Voucher, or PRV, in May 2024 to fully satisfy PRV-related obligations of the Company's license agreement with Viracta, dated December 16, 2019, as amended, the Company capitalized the $8.1 million payment to Viracta as a finite-lived intangible asset. The intangible assets will be amortized on a straight-line basis over each of the estimated useful life of the underlying intellectual property of 7.3 years. Amortization expense will be recorded as cost of product revenue.
Revenue Recognition	Revenue Recognition The Company recognizes net product and license revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which outlines a five-step process for recognizing revenue from contracts with customers: (i) identify the contract with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied. Product Revenue, Net The Company recognizes net product revenue from OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion rearrangement, or BRAF V600 mutation, which it began selling in May 2024 through contractual arrangements with its specialty pharmacy and specialty distributor customers. The Company has determined that the delivery of OJEMDA to its customers constitutes a single performance obligation. There are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Net product revenue is recognized at the transaction price when the customer obtains control of the Company’s product, which occurs at a point in time upon delivery of the product to the customer. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with the Company’s customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Net product revenues from the sale of OJEMDA are recorded at the transaction price, which include adjustments for discounts and allowances, including estimated cash discounts, government chargebacks, government rebates, specialty distributor fees, copay assistance, and returns. These adjustments represent variable consideration under ASC 606 and are estimated using the expected value method or most likely amount method and are recorded when revenue is recognized on the sale of the product. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price, only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Cash Discounts — The Company estimates cash discounts based on contractual terms and expectations regarding future customer payment patterns. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Government Chargebacks — Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S. Department of Veterans Affairs hospitals and 340B entities at prices lower than the list prices charged to customers who directly purchase the product from the Company. The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of chargebacks that customers have claimed, but for which the Company has not yet issued a credit and credits that the Company expects to issue for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Specialty Distributor Fees — The Company pays fees to our specialty distributor customers for distribution services provided in connection with the sales of OJEMDA. These specialty distributor fees are based on a contractually determined fixed percentage of sales. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Copay Assistance — The Company offers a co-pay assistance program, which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as accrued expenses and other current liabilities. Product Returns — Consistent with industry practice, the Company’s contracts with customers for OJEMDA generally provide for returns only if the product is damaged or defective upon delivery, if there is a shipment error, and for certain customers, if the product is within an eligible expiry window. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company believes the returns of OJEMDA will be minimal because our customers often carry limited inventory given the price of our products, and the limited number of patients. These reserves are established in the same period that the related revenue is recognized. License Revenue The Company generates license revenue from the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen Pharma SAS, or Ipsen, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $70.8 million and (ii) Ipsen Biopharmaceuticals, Inc., or the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $40.0 million, at a price per share representing a 17.0% premium to the volume weighted average price, or VWAP, of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Company’s public release of U.S. GAAP revenue for the quarter ended June 30, 2024 on July 30, 2024, or the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company is also eligible to receive up to approximately $350.0 million in additional commercial launch and sales-based milestone payments, as well as tiered, double-digit royalty payments starting at mid-teens percentage of annual net sales of tovorafenib, subject to customary adjustments specified in the Ipsen License Agreement. The commercial launch milestones related to first commercial sale(s) in certain territories, sales-based milestones and royalties are recognized as revenue when the related sales occur as the license of intellectual property is deemed to be the predominant item to which the commercial launch milestones, sales-based milestones and royalties relate. Upon execution of the Ipsen License Agreement, the transaction price was determined to be $78.2 million, representing the aggregate of the upfront license fee of $70.8 million and the premium paid by Ipsen on its equity investment in the Company of $7.4 million (the excess of the value of the shares of the Company issued to Ipsen), representing additional consideration from Ipsen for the rights under the Ipsen License Agreement. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue against each performance obligation as or when the performance obligations under the contract are satisfied. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met.
Cost of Product Revenue	Cost of Product Revenue Our cost of product revenue includes the cost of inventory sold, amortization expense of intangible assets and third-party royalties payable on our net product revenue. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company is currently evaluating the effect of this update on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures, which enhances the transparency and decision usefulness of income tax disclosures by requiring disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its financial statement disclosures.

Condensed Balance Sheets (unaudited) (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Common Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Common Stock, Shares Authorized	500,000,000	500,000,000
Common Stock, Shares Issued	100,810,357	87,227,132
Common Stock, Shares Outstanding	100,810,357	87,227,132

Defined Contribution Plan (Additional Information) (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Retirement Benefits [Abstract]
Matching Contribution	$ 0.4	$ 0.2	$ 1.4	$ 1.0

Condensed Statements of Operations (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue:
Total revenues	$ 93,761	$ 0	$ 101,953	$ 0
Cost and operating expenses:
Cost of product revenue	1,590	0	2,297	0
Research and development	33,563	33,163	165,879	93,173
Selling, general and administrative	28,972	18,275	85,715	53,374
Total cost and operating expenses	64,125	51,438	253,891	146,547
Income (loss) from operations	29,636	(51,438)	(151,938)	(146,547)
Non-operating income:
Gain from sale of priority review voucher	0	0	108,000	0
Investment income, net	5,322	5,291	13,649	12,163
Other income (expense), net	1,197	(3)	1,177	(22)
Total non-operating income, net	6,519	5,288	122,826	12,141
Income (loss) before income taxes	36,155	(46,150)	(29,112)	(134,406)
Income tax benefit (expense)	882	0	(670)	0
Net income (loss)	$ 37,037	$ (46,150)	$ (29,782)	$ (134,406)
Net income (loss) per share - basic	$ 0.38	$ (0.54)	$ (0.33)	$ (1.73)
Net income (loss) per share - diluted	$ 0.38	$ (0.54)	$ (0.33)	$ (1.73)
Weighted-average number of common shares used in net income (loss) per share - basic	96,623,123	85,952,501	90,164,895	77,682,237
Weighted-average number of common shares used in net income (loss) per share - diluted	96,937,759	85,952,501	90,164,895	77,682,237
Product revenue, net [Member]
Revenue:
Total revenues	$ 20,070	$ 0	$ 28,262	$ 0
License revenue [Member]
Revenue:
Total revenues	$ 73,691	$ 0	$ 73,691	$ 0

Share-based Compensation - Fair value of our common stock to be issued under the ESPP (Details) - 2021 Employee Stock Purchase Plan [Member]	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Expected term (in years)	6 months	6 months
Expected volatility	63.45%	63.57%
Risk-free interest rate	5.40%	5.24%
Expected dividend yield	0.00%	0.00%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Recurring Fair Value Measurement - Schedule of maturities of available-for-sale marketable securities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Cash and Cash Equivalents [Line Items]
Amortized cost, mature in one year or less	$ 535,255	$ 356,404
Amortized cost, total	535,255	356,404
Fair value, mature in one year or less	535,250	356,413
Fair value, total	$ 535,250	$ 356,413

Commitments and Contingencies - Summary of Future Lease Obligations (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]
2024 (Remaining)	$ 147
2025	352
2026	435
2027	448
2028	461
Thereafter	2,613
Total future minimum lease payments	4,456
Less: Imputed interest	(1,841)
Present value of operating lease liabilities	2,615
Less: current portion of operating lease liabilities	(77)	$ (408)
Operating lease liabilities	$ 2,538	$ 0

Net Income (Loss) Per Share - Summary of Outstanding Potentially Dilutive Securities Have Been Excluded From Calculation of Diluted Net Loss Per Share (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock options	11,949,628	12,067,550	14,068,239	12,067,550
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock options	11,454,704	10,039,940	11,926,321	10,039,940
Unvested common shares
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock options	0	956,719	165,840	956,719
Restricted Stock Units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock options	406,092	1,001,313	1,887,246	1,001,313
Shares committed under ESPP
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Stock options	88,832	69,578	88,832	69,578

Cover Page - shares	9 Months Ended
Cover Page - shares	Sep. 30, 2024	Oct. 24, 2024
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Entity Registrant Name	DAY ONE BIOPHARMACEUTICALS, INC.
Entity Central Index Key	0001845337
Securities Act File Number	001-40431
Entity Tax Identification Number	83-2415215
Entity Incorporation, State or Country Code	DE
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Shell Company	false
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Address, Address Line One	2000 Sierra Point Parkway
Entity Address, Address Line Two	Suite 501
Entity Address, City or Town	Brisbane
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94005
City Area Code	650
Local Phone Number	484-0899
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	DAWN
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		100,846,294

Net Income (Loss) Per Share

9 Months Ended

Sep. 30, 2024

Earnings Per Share [Abstract]

Net Income (Loss) Per Share

10.

Net Income (Loss) Per Share

Basic and diluted net income (loss) per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts):


	Three Months Ended September 30,					Nine Months Ended September 30,
	2024		2023			2024			2023
Net income (loss) - basic and diluted	$	37,037	$	(46,150	)	$	(29,782	)	$	(134,406	)
Weighted average shares outstanding - basic		96,623,123		85,952,501			90,164,895			77,682,237
Effect of dilutive securities:
Stock options		57,455		—			—			—
Restricted stock units		107,935		—			—			—
Restricted stock awards		149,246		—			—			—
Weighted average shares outstanding - diluted		96,937,759		85,952,501			90,164,895			77,682,237
Net income (loss) per share - basic	$	0.38	$	(0.54	)	$	(0.33	)	$	(1.73	)
Net income (loss) per share - diluted	$	0.38	$	(0.54	)	$	(0.33	)	$	(1.73	)

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net income (loss) per share, as their effect is anti-dilutive:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Stock options		11,454,704		10,039,940		11,926,321		10,039,940
Unvested common shares		—		956,719		165,840		956,719
Restricted stock units		406,092		1,001,313		1,887,246		1,001,313
Shares committed under ESPP		88,832		69,578		88,832		69,578
Total		11,949,628		12,067,550		14,068,239		12,067,550

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Leases

In April 2022, the Company entered into a lease agreement for approximately 12,000 square feet of general use office space in Brisbane, California. Such agreement was determined to be a lease since the right to control the use of the identified asset was conveyed to the Company for a period of time in exchange for consideration. The term of the lease is 31 months and commenced in May 2022. There is no option to extend the lease term nor is there an option to terminate the lease term prior to its expiration. The Company is obligated to pay monthly rent expense and its pro rata share of the landlord's operating expenses which include utilities, common area maintenance expenses, and property taxes. Such expenses are a non-lease component and a variable consideration and included in the Company's operating expenses as incurred. The Company concluded that this lease is also an operating lease. The total payments for base rent over the term of the lease is approximately $1.1 million. Upon execution of the agreement, the Company paid a security deposit of approximately $40,000 classified as deposits and other long-term assets on the condensed balance sheet.

In June 2024, the Company entered into a lease agreement for approximately 19,000 square feet of general use office space in Brisbane, California. Such agreement was determined to be a lease since the right to control the use of the identified asset was conveyed to the Company for a period of time in exchange for consideration. The term of the lease is approximately 7.4 years and commenced in August 2024. There is no option to extend the lease term nor is there an option to terminate the lease term prior to its expiration. The Company is obligated to pay monthly rent expense and its pro rata share of the landlord's operating expenses which include utilities, common area maintenance expenses, and property taxes. Such expenses are a non-lease component and a variable consideration and included in the Company's operating expenses as incurred. The Company concluded that this lease is also an operating lease. The total payments for base rent over the term of the lease is approximately $4.4 million. Upon execution of the agreement, the Company paid a security deposit of approximately $86,000 classified as deposits and other long-term assets on the condensed balance sheet.

The Company determined the lease incremental borrowing rate, or IBR, based on the information available at the applicable lease commencement date as the Company’s leases do not provide an implicit rate. The IBR is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment where the asset is located. As of September 30, 2024, the weighted-average remaining lease term and weighted-average discount rate were 7.0 years and 12.7%, respectively.

The Company’s lease does not require any contingent rental payments, impose financial restrictions, or contain any residual value guarantees.

Lease expense of right-of-use assets is recognized on a straight-line basis over the applicable lease term. Lease expense was $0.2 million and $0.1 million for the three months ended September 30, 2024 and 2023, respectively, and was $0.4 million and $0.3 million for the nine months ended September 30, 2024 and 2023, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $0.4 million and $0.3 million for the nine months ended September 30, 2024 and 2023, respectively. Variable payments expensed during the three and nine months ended September 30, 2024 and 2023 were immaterial.

As of September 30, 2024, the future lease obligations were as follows (in thousands):


Year Ending December 31,
2024 (Remaining)	$	147
2025		352
2026		435
2027		448
2028		461
Thereafter		2,613
Total future minimum lease payments		4,456
Less: imputed interest		(1,841	)
Present value of operating lease liabilities		2,615
Less: current portion of operating lease liabilities		(77	)
Operating lease liabilities	$	2,538

Research and Development Agreements

The Company enters into contracts in the normal course of business with clinical research organizations, contract manufacturing organizations, and other third-party vendors for clinical trial, manufacturing, testing, and other research and development activities. These contracts generally provide for termination on notice, with the exception of one vendor where

certain costs are non-cancellable after the approval of the project. As of September 30, 2024 and December 31, 2023, there were no amounts accrued related to termination and cancellation charges as these are not probable.

License Agreements

The Company entered into license agreements, as disclosed in Note 5, with various parties under which it is obligated to make contingent and non-contingent payments.

Purchase Commitments

To support product needs for OJEMDA, the Company has entered into a manufacturing and supply agreement with Quotient Sciences - Philadelphia, LLC in July 2023 that requires the Company to meet minimum purchase obligations on an annual basis. The amount of future minimum purchase obligations under the manufacturing and supply agreement over the next five years is approximately $15.2 million, in aggregate, as of September 30, 2024. For the nine months ended September 30, 2024, the Company made purchases of $2.0 million under the purchase obligation.

Legal Proceedings

The Company, from time to time, may be party to litigation, claims and assessments arising in the ordinary course of business. The Company accrues liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. The Company is not subject to any material legal proceedings, and to the best of its knowledge, no material legal proceedings are currently pending or threatened.

Indemnification Agreements

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against it in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at its request in such capacities. There have been no claims to date, and the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company had not recorded any liabilities for these agreements as of September 30, 2024 and December 31, 2023.

Recurring Fair Value Measurement (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of fair value, assets and liabilities measured on recurring basis

The following table sets forth the Company’s financial instruments as of September 30, 2024 and December 31, 2023, which are measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):


	September 30, 2024
	Level 1		Level 2		Level 3		Total
Financial assets:
Money market funds	$	249,276	$	—	$	—	$	249,276
U.S. treasury securities		—		194,476		—		194,476
U.S. government agency securities		—		91,498		—		91,498
Total assets measured at fair value	$	249,276	$	285,974	$	—	$	535,250


	December 31, 2023
	Level 1		Level 2		Level 3		Total
Financial assets:
Money market funds	$	47,003	$	—	$	—	$	47,003
U.S. treasury securities		—		246,208		—		246,208
U.S. government agency securities		—		63,202		—		63,202
Total assets measured at fair value	$	47,003	$	309,410	$	—	$	356,413

Schedule of cash equivalents, marketable securities, and unrealized gains and losses

The following tables summarize the estimated fair value of the Company's cash equivalents, available-for-sale securities classified as short-term investments, and associated unrealized gains and losses (in thousands):


	September 30, 2024
	Amortized Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
Cash equivalents:
Money market funds	$	249,276	$	—	$	—		$	249,276
U.S. government agency securities		81,762		—		—			81,762
U.S. treasury securities		68,594		—		—			68,594
Total cash equivalents		399,632		—		—			399,632

Short-term investments
U.S. government agency securities		9,733		4		(1	)		9,736
U.S. treasury securities		125,890		27		(35	)		125,882
Total short-term investments	$	135,623	$	31	$	(36	)	$	135,618


	December 31, 2023
	Amortized Cost		Unrealized Gains		Unrealized Losses		Estimated Fair Value
Cash equivalents:
Money market funds	$	47,003	$	—	$	—	$	47,003
U.S. government agency securities		63,202		—		—		63,202
U.S. treasury securities		110,645		—		—		110,645
Total cash equivalents		220,850		—		—		220,850

Short-term investments
U.S. treasury securities		135,554		9		—		135,563
Total short-term investments	$	135,554	$	9	$	—	$	135,563

Schedule of maturities of available-for-sale marketable securities

The following table summarizes the maturities of our cash equivalents and available-for-sale securities (in thousands):


	September 30, 2024
	Amortized Cost		Fair Value
Mature in one year or less	$	535,255	$	535,250
Total	$	535,255	$	535,250


	December 31, 2023
	Amortized Cost		Fair Value
Mature in one year or less	$	356,404	$	356,413
Total	$	356,404	$	356,413

Condensed Statements of Stockholders' Equity (unaudited) (Parenthetical) $ in Thousands	3 Months Ended
	Jun. 30, 2023 USD ($)
Common Stock
Stock issuance costs	$ 10,827

Net Income (Loss) Per Share - Summary of Basic and Diluted Net Loss Per Share Attributable to Common Shareholders/Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Net income (loss) - basic and diluted	$ 37,037	$ (4,407)	$ (62,412)	$ (46,150)	$ (45,863)	$ (42,393)	$ (29,782)	$ (134,406)
Weighted average shares outstanding - basic	96,623,123			85,952,501			90,164,895	77,682,237
Weighted average shares outstanding - diluted	96,937,759			85,952,501			90,164,895	77,682,237
Net income (loss) per share - basic	$ 0.38			$ (0.54)			$ (0.33)	$ (1.73)
Net income (loss) per share - diluted	$ 0.38			$ (0.54)			$ (0.33)	$ (1.73)
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Effect of dilutive securities:	57,455			0			0	0
Restricted Stock Units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Effect of dilutive securities:	107,935			0			0	0
Restricted stock awards
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Effect of dilutive securities:	149,246

Share-based Compensation - Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units - 2021 Equity Incentive Plan	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Unvested restricted stock, beginning balance \| shares	1,031,545
Granted \| shares	1,584,280
Vested \| shares	(526,047)
Forfeiture \| shares	(202,532)
Unvested restricted stock, ending balance \| shares	1,887,246
Weighted Average Grant Date Fair Value Per Share, Beginning Balance \| $ / shares	$ 18.27
Grant date fair value \| $ / shares	14.38
Vested \| $ / shares	16.52
Weighted Average Grant Date Fair Value, Forfeited \| $ / shares	16.14
Weighted Average Grant Date Fair Value Per Share, Ending Balance \| $ / shares	$ 15.72

Significant Agreements - Additional Information (Detail) - USD ($) $ in Thousands							1 Months Ended	3 Months Ended	9 Months Ended
	Jul. 23, 2024	May 29, 2024	Apr. 23, 2024	Mar. 04, 2024	May 26, 2021	Dec. 16, 2019	Jul. 31, 2024	Sep. 30, 2024	Sep. 30, 2024	Sep. 30, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds From sale of PRV									$ 108,000	$ 0
Proceeds from issuance of private placement									178,177	0
Deferred revenue									4,523	$ 0
Takeda Asset Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront of cash payment						$ 1,000
Takeda Asset Agreement [Member] \| Common Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Issuance of Series B redeemable convertible preferred shares for cash, net of issuance costs, shares					6,470,382
Takeda Asset Agreement [Member] \| Series A Redeemable Convertible Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Share Issuance						9,857,143
Common stock issued, share issuance costs						$ 9,900
Issuance of Series B redeemable convertible preferred shares for cash, net of issuance costs, shares					9,857,143
Merck License Agreement [Member] \| Research And Development Expense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment									8,000
Merck License Agreement [Member] \| Research And Development Expense \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments not yet paid									364,500
Viracta License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment of Milestones			$ 9,000
Viracta License Agreement [Member] \| Other Intangible Assets [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment of Milestones									9,000
Viracta License Agreement [Member] \| PRV
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment of Milestones									8,100
Proceeds From sale of PRV		$ 108,000							108,000
Payment of PRV related obligations		$ 8,100
Viracta License Agreement [Member] \| Research And Development Expense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment				$ 5,000
Upfront of cash payment									2,000
Sprint Bioscience Agreement [Member] \| Research And Development Expense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment									3,000
Payment of Milestones									40,000
Sprint Bioscience Agreement [Member] \| Research And Development Expense \| Maximum [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments not yet paid									309,000
MabCare License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment							$ 55,000
MabCare License Agreement [Member] \| Research And Development Expense
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments not yet paid									1,152,000
License agreement with Ipsen Pharma SAS [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment of Milestones									350,000
Proceeds from issuance of private placement	$ 40,000
Transaction Price	78,200
Equity Investment	7,400
Deferred revenue								$ 200	200
License agreement with Ipsen Pharma SAS [Member] \| Current Member
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Deferred revenue								1,400	1,400
License agreement with Ipsen Pharma SAS [Member] \| Noncurrent Member
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Deferred revenue								$ 3,100	3,100
License agreement with Ipsen Pharma SAS [Member] \| Obligations
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Frontline Payment									4,700
License agreement with Ipsen Pharma SAS [Member] \| License revenue [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront payment	$ 70,800
Aggregate Of Upfront License Fee Received									$ 73,500
License agreement with Ipsen Pharma SAS [Member] \| Common Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Share Issuance	2,341,495
Volume weighted average price	17.00%

Recurring Fair Value Measurement - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Fair value, measurement recurring basis, asset, transfers, net		$ 0		$ 0
Unrealized losses twelve months or greater		$ 0		$ 0
Realized gains and losses	$ 0		$ 0

Condensed Balance Sheets (unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 422,765	$ 230,784
Short-term investments	135,618	135,563
Accounts receivable, net	8,695	0
Inventory	2,735	0
Prepaid expenses and other current assets	11,183	8,927
Total current assets	580,996	375,274
Property and equipment, net	904	208
Operating lease right-of-use asset	2,574	352
Intangible assets, net	16,216	0
Deposits and other long-term assets	117	214
Total assets	600,807	376,048
Current Liabilities:
Accounts payable	3,017	2,576
Accrued expenses and other current liabilities	35,189	26,524
Current portion of deferred revenue	1,462
Current portion of operating lease liabilities	77	408
Total current liabilities	39,745	29,508
Long-term portion of deferred revenue	3,061	0
Long-term portion of operating lease liabilities	2,538	0
Total liabilities	45,344	29,508
Commitments and contingencies (Note 6)
Stockholders' equity
Common stock, $0.0001 par value; 500,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 100,810,357 and 87,227,132 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.	10	9
Additional paid-in-capital	1,043,826	805,107
Accumulated other comprehensive (loss) income	(6)	9
Accumulated deficit	(488,367)	(458,585)
Total stockholders' equity	555,463	346,540
Total liabilities and stockholders' equity	$ 600,807	$ 376,048

Share-based Compensation - Summary of Stock Option Activity (Detail) - 2021 Equity Incentive Plan - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Shares, Beginning Balance	10,211,758
Granted	2,830,362
Exercised	(94,553)
Forfeiture	(1,021,246)
Outstanding at September 30, 2024	11,926,321
Vested and expected to vest at September 30, 2024	11,926,321
Exercisable at September 30, 2024	6,722,507
Weighted Average Exercise Price Per Share, Beginning Balance	$ 17.1
Granted	14.31
Exercised	14.26
Forfeiture	16.62
Weighted Average Exercise Price Per Share, Ending Balance	16.51
Weighted Average Exercise Price Per Share, Vested and expected to vest at September 30, 2024	16.51
Exercisable at September 30, 2024	$ 16.66
Weighted-Average Remaining Contractual Term, Outstanding at September 30, 2024	7 years 10 months 24 days
Weighted-Average Remaining Contractual Term, Vested and expected to vest at September 30, 2024	7 years 10 months 24 days
Weighted-Average Remaining Contractual Term, Exercisable at September 30, 2024	7 years 4 months 24 days
Exercised	$ 134
Outstanding at September 30, 2024 Aggregate Intrinsic Value	2,367
Vested and expected to vest at September 30, 2024, Aggregate Intrinsic Value	2,367
Exercisable at September 30, 2024	$ 1,224

Commitments and Contingencies - Additional Information (Detail)	1 Months Ended	3 Months Ended		9 Months Ended
	Apr. 30, 2022 USD ($) ft²	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Aug. 31, 2024	Jun. 30, 2024 USD ($) ft²	Dec. 31, 2023 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease term	31 months					7 years 4 months 24 days
Amortization of operating right-of-use assets				$ 332,000	$ 257,000
Operating lease payments	$ 1,100,000			$ 4,400,000
Weighted average remaining lease term		7 years		7 years
Weighted average discount rate percent		12.70%		12.70%
Research And Development Agreements
Lessee, Lease, Description [Line Items]
Termination and cancellation charges payable		$ 0		$ 0				$ 0
Indemnification Agreement
Lessee, Lease, Description [Line Items]
Termination and cancellation charges payable		0		0				$ 0
Purchase Commitments
Lessee, Lease, Description [Line Items]
Aggregate amount of future minimum purchase obligations		15,200,000		15,200,000
Purchases under the purchase obligation				2,000,000
Brisbane, California
Lessee, Lease, Description [Line Items]
Sublease agreement area \| ft²	12,000						19,000
Security deposit	$ 40,000						$ 86,000
Lease For Corporate Office Facility
Lessee, Lease, Description [Line Items]
Amortization of operating right-of-use assets		$ 200,000	$ 100,000	400,000	300,000
Operating lease payments				$ 400,000	$ 300,000

Share-based Compensation - Summary of The Unvested Common Stock (Detail) - Unvested Common Stock [Member]	9 Months Ended
	Sep. 30, 2024 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Shares, Unvested Common Stock, Beginning balance \| shares	747,679
Vested \| shares	(556,424)
Number of Shares, Forfeited \| shares	(25,415)
Number of Shares, Unvested Common Stock, Ending balance \| shares	165,840
Weighted Average Grant Date Fair Value Per Share, Beginning Balance \| $ / shares	$ 16
Vested \| $ / shares	16
Forfeiture \| $ / shares	16
Weighted Average Grant Date Fair Value Per Share, Ending Balance \| $ / shares	$ 16

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Recurring Fair Value Measurements

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Recurring Fair Value Measurements


	September 30, 2024
	Level 1		Level 2		Level 3		Total
Financial assets:
Money market funds	$	249,276	$	—	$	—	$	249,276
U.S. treasury securities		—		194,476		—		194,476
U.S. government agency securities		—		91,498		—		91,498
Total assets measured at fair value	$	249,276	$	285,974	$	—	$	535,250


	December 31, 2023
	Level 1		Level 2		Level 3		Total
Financial assets:
Money market funds	$	47,003	$	—	$	—	$	47,003
U.S. treasury securities		—		246,208		—		246,208
U.S. government agency securities		—		63,202		—		63,202
Total assets measured at fair value	$	47,003	$	309,410	$	—	$	356,413

The Company's money market funds are classified as Level 1 because they are measured using observable inputs from active markets for identical assets.

The Company's U.S. treasury securities and U.S. government agency securities are classified as Level 2 because they are measured with inputs that are either directly or indirectly observable for the asset which include quoted prices for similar assets in active markets and quoted prices for identical or similar assets in markets that are not active.

There were no assets or liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023.

There were no transfers between Level 1, Level 2 or Level 3 categories during the periods presented.


	September 30, 2024
	Amortized Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
Cash equivalents:
Money market funds	$	249,276	$	—	$	—		$	249,276
U.S. government agency securities		81,762		—		—			81,762
U.S. treasury securities		68,594		—		—			68,594
Total cash equivalents		399,632		—		—			399,632

Short-term investments
U.S. government agency securities		9,733		4		(1	)		9,736
U.S. treasury securities		125,890		27		(35	)		125,882
Total short-term investments	$	135,623	$	31	$	(36	)	$	135,618


	December 31, 2023
	Amortized Cost		Unrealized Gains		Unrealized Losses		Estimated Fair Value
Cash equivalents:
Money market funds	$	47,003	$	—	$	—	$	47,003
U.S. government agency securities		63,202		—		—		63,202
U.S. treasury securities		110,645		—		—		110,645
Total cash equivalents		220,850		—		—		220,850

Short-term investments
U.S. treasury securities		135,554		9		—		135,563
Total short-term investments	$	135,554	$	9	$	—	$	135,563

The following table summarizes the maturities of our cash equivalents and available-for-sale securities (in thousands):


	September 30, 2024
	Amortized Cost		Fair Value
Mature in one year or less	$	535,255	$	535,250
Total	$	535,255	$	535,250


	December 31, 2023
	Amortized Cost		Fair Value
Mature in one year or less	$	356,404	$	356,413
Total	$	356,404	$	356,413

The Company regularly reviews the changes to the rating of its securities and monitors the surrounding economic conditions to assess the risk of expected credit losses. As of September 30, 2024 and December 31, 2023, there were no securities that were in an unrealized loss position for more than 12 months. As of September 30, 2024, the unrealized losses, if any, on the Company’s short-term investments were primarily caused by interest rate increases. The Company does not expect the issuers to settle any security at a price less than the amortized cost basis of the investment with the contractual cash flows of these investments guaranteed by the issuer. No allowance for credit losses has been recorded since it is not more-likely-than-not that the Company will be required to sell the investments before recovery of their amortized cost basis. Realized gains and losses were immaterial for the three and nine months ended September 30, 2024. There were no realized gains and losses for the three and nine months ended September 30, 2023.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
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+ Details

Subsequent Event (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Jul. 31, 2024	Dec. 31, 2023
Subsequent Event [Line Items]
Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs	$ 178,177	$ 0
Common stock par value per share	$ 0.0001			$ 0.0001
Common Stock [Member]
Subsequent Event [Line Items]
Common stock par value per share			$ 0.0001

Common Stock (Tables)

9 Months Ended

Sep. 30, 2024

Stockholders' Equity Note [Abstract]

Schedule of Common Stock Shares Reserved for Future Issuance

The Company has reserved shares of common stock for future issuances as follows:


	September 30, 2024
Common stock options issued and outstanding		11,926,321
Common stock available for future grants		3,799,351
Common stock available for ESPP		2,498,360
Restricted stock units issued and outstanding		1,887,246
Total		20,111,278

Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		6 Months Ended	9 Months Ended
	Aug. 01, 2024	Jun. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Jul. 31, 2024	Dec. 31, 2023
Class of Stock [Line Items]
Common Stock, Shares Authorized			500,000,000			500,000,000
Common Stock, Par or Stated Value Per Share			$ 0.0001			$ 0.0001
Common Stock, Shares Issued			100,810,357			87,227,132
Common Stock, Shares Outstanding			100,810,357			87,227,132
Common stock shares reserved for future issuance			20,111,278
Proceeds from the issuance of common stock, net			$ 0	$ 161,409
Proceeds from issuance of private placement			178,177	0
Common Stock Value			10			$ 9
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs			$ 20,941	$ 0
2024 Private Placement [Member]
Class of Stock [Line Items]
Common Stock, Shares Issued					10,551,718
Proceeds from issuance of private placement	$ 166,500
2024 Private Placement [Member] \| Pre-Funded Warrant [Member]
Class of Stock [Line Items]
Ownership percentage			9.99%
Investment Agreement [Member]
Class of Stock [Line Items]
Upfront license fee					$ 70,800
Number of Common Stock Shares Purchased					2,341,495
Common Stock Value					$ 32,600
Weighted Average Price of Company's common Stock					17.00%
Common Shares Purchase Agreement
Class of Stock [Line Items]
Common Stock, Shares Authorized			500,000,000
Common Stock, Par or Stated Value Per Share			$ 0.0001
Sales Agreement with Piper Sandler and Jones Services LLC
Class of Stock [Line Items]
Common Stock, Par or Stated Value Per Share		$ 13
Common Stock, Shares Issued		13,269,231
Common stock shares reserved for future issuance		1,730,769
Proceeds from the issuance of common stock, net		$ 161,400	$ 250,000
Pre-Funded Warrants [Member]
Class of Stock [Line Items]
Purchase Price of Common Stock Per Share					$ 14.4999
Number of Pre-funded warrants purchased					1,517,241
Excersise price of pre-funded warrants					$ 0.0001
Pre-Funded Warrants [Member] \| 2024 Private Placement [Member]
Class of Stock [Line Items]
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs	20,900
Common Stock [Member]
Class of Stock [Line Items]
Common Stock, Par or Stated Value Per Share					0.0001
Common stock shares reserved for future issuance			11,926,321
Purchase Price of Common Stock Per Share					$ 14.5
Number of Pre-funded warrants purchased					1,517,241
Common Stock [Member] \| 2024 Private Placement [Member]
Class of Stock [Line Items]
Proceeds from the issuance of common stock, net	$ 145,600
Common Stock [Member] \| Investment Agreement [Member]
Class of Stock [Line Items]
Common Stock Value					$ 40,000

Common Stock - Schedule of Common Stock Shares Reserved for Future Issuance (Details) (Details)	Sep. 30, 2024 shares
Class of Stock [Line Items]
Common stock shares reserved for future issuance	20,111,278
Employee Stock Option
Class of Stock [Line Items]
Common stock shares reserved for future issuance	3,799,351
Restricted Stock Units (RSUs)
Class of Stock [Line Items]
Common stock shares reserved for future issuance	1,887,246
Employee Stock Purchase Plan
Class of Stock [Line Items]
Common stock shares reserved for future issuance	2,498,360
Common Stock
Class of Stock [Line Items]
Common stock shares reserved for future issuance	11,926,321

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
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Reference 2: http://www.xbrl.org/2003/role/recommendedDisclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Condensed Statements of Cash Flows (unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities
Net Income (Loss)	$ (29,782)	$ (134,406)
Adjustments to reconcile net loss to net cash used in operating activities:
Acquired in-process research and development assets	55,000	3,000
Share-based compensation expense	37,228	28,530
Depreciation expense	54	23
Accretion of discounts on short-term investments, net	(3,566)	(8,502)
Amortization of intangible assets	884	0
Amortization of operating right-of-use asset	332	257
Gain from sale of priority review voucher	(108,000)	0
Changes in operating assets and liabilities:
Accounts receivable, net	(8,695)	0
Inventory	(2,683)	0
Prepaid expenses and other current assets	(2,326)	(2,148)
Deposits and other long-term assets	97	236
Accounts payable	441	3,131
Accrued expenses and other current liabilities	8,665	4,697
Deferred revenue	4,523	0
Operating lease liability	(277)	(299)
Net cash used in operating activities	(48,105)	(105,481)
Cash flows from investing activities
Cash paid for purchase of short-term investments	(383,395)	(344,701)
Proceeds from maturity of short-term investments	307,482	445,915
Proceeds from sale of short-term investments	79,409	0
Cash paid for acquired intangible assets	(17,100)	0
Proceeds from sale of priority review voucher	108,000	0
Cash paid for acquired in-process research and development assets	(55,000)	(3,000)
Cash paid for purchase of property and equipment	(750)	(216)
Net cash provided by investing activities	38,646	97,998
Cash flows from financing activities
Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs	178,177	0
Proceeds from issuance of prefunded warrants to purchase common stock, net of issuance costs	20,941	0
Proceeds from the issuance of common stock, net	0	161,409
Proceeds from issuance of common stock upon stock option exercises	1,349	1,338
Proceeds from issuance of common stock upon Employee Stock Purchase Plan purchase	973	653
Cash provided by financing activities	201,440	163,400
Net increase in cash and cash equivalents	191,981	155,917
Cash and cash equivalents, beginning of period	230,784	85,262
Cash and cash equivalents, end of period	422,765	241,179
Supplemental disclosure of cash flow information:
IncomeTaxesPaid	883	0
Cash Flow, Noncash Investing and Financing Activities Disclosure [Abstract]
Right-of-use asset obtained in exchange for new operating lease liabilities	2,554	0
Deferred offering costs not yet paid	66	0
Purchases of property and equipment included in accrued expenses and other current liabilities	$ 0	$ 41

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Summary of Future Lease Obligations

As of September 30, 2024, the future lease obligations were as follows (in thousands):


Year Ending December 31,
2024 (Remaining)	$	147
2025		352
2026		435
2027		448
2028		461
Thereafter		2,613
Total future minimum lease payments		4,456
Less: imputed interest		(1,841	)
Present value of operating lease liabilities		2,615
Less: current portion of operating lease liabilities		(77	)
Operating lease liabilities	$	2,538

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Tax Disclosure [Abstract]

Income Taxes

For the three months ended September 30, 2024, the Company recognized an income tax benefit of $0.9 million on pre-tax book income for the period, resulting in an effective tax rate of (2.4)%. For the nine months ended September 30, 2024, the Company recognized income tax expense of $0.7 million on a pre-tax book loss for the period, resulting in an effective tax rate of (2.3)%. The primary reconciling items between the federal statutory rate of 21.0% for the three and nine months ended

September 30, 2024 and the Company’s overall effective tax rate of (2.4)% and (2.3)%, respectively, was the effect of equity compensation, generation of tax credits, deferred state income taxes and the valuation allowance recorded against the full amount of its net deferred tax assets. The Company did not record an income tax provision for the three and nine months ended September 30, 2023 as it generated tax losses during each of the periods.

A valuation allowance is established when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company continues to establish a valuation allowance against the full amount of its net deferred tax assets since it is more likely than not that benefits will not be realized, including those benefits created in the current year. This assessment is based on the Company's historical cumulative losses, which provide strong objective evidence that cannot be overcome with projections of income, as well as the fact the Company expects continuing losses in the future.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands		3 Months Ended	9 Months Ended
	Apr. 23, 2024	Sep. 30, 2024	Sep. 30, 2024	Dec. 31, 2023
Accounting Policies [Line Items]
Accounts receivable, credit losses		$ 0	$ 0
Other expenses		$ 0	0
Milestone payment, capitalized			$ 9,000
Intangible asset useful life		7 years 3 months 18 days	7 years 3 months 18 days
Share Purchased		100,810,357	100,810,357	87,227,132
Viracta License Agreement
Accounting Policies [Line Items]
Milestone payment, capitalized			$ 8,100
Payment of Milestones	$ 9,000
Ipsen License Agreement
Accounting Policies [Line Items]
Premium Received On License Agreement			7,400
Aggregate Of Upfront License Fee Received			$ 70,800
Share Purchased		2,341,495	2,341,495
Payment to private placement			$ 40,000
Volume weighted average price			17.00%
Payment of Milestones			$ 350,000
Transaction Price			$ 78,200
One Customer [Member] \| Revenue Benchmark [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable		69.00%	66.60%
One Customer [Member] \| Accounts Receivable [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable			55.00%
Two Customer [Member] \| Revenue Benchmark [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable		23.00%	27.00%
Two Customer [Member] \| Accounts Receivable [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable			25.70%
Three Customer [Member] \| Revenue Benchmark [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable		8.00%	6.40%
Three Customer [Member] \| Accounts Receivable [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable			19.30%
Other Individual Customer [Member] \| Net Product Revenue and Accounts Receivable [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member] \| Maximum [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable			10.00%
Individual Customer [Member] \| Revenue Benchmark [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable		100.00%	100.00%
Individual Customer [Member] \| Accounts Receivable [Member] \| Concentration of Credit Risk and Other Risks and Uncertainties [Member]
Accounting Policies [Line Items]
Concentration risk percentage of net product revenue and accounts receivable			100.00%

Condensed Statements of Comprehensive Loss (unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Net Income (Loss)	$ 37,037	$ (46,150)	$ (29,782)	$ (134,406)
Other comprehensive income:
Unrealized gain (loss) on available-for-sale securities	16	2	(15)	64
Total comprehensive income (loss)	$ 37,053	$ (46,148)	$ (29,797)	$ (134,342)

- Definition

Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.

+ References + Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Common Stock

9 Months Ended

Sep. 30, 2024

Stockholders' Equity Note [Abstract]

Common Stock

Pursuant to its certificate of incorporation, the Company is authorized to issue 500.0 million shares of common stock at a par value of $0.0001 per share. As of September 30, 2024, 100,810,357 shares of common stock were issued and outstanding.

The Company has reserved shares of common stock for future issuances as follows:


	September 30, 2024
Common stock options issued and outstanding		11,926,321
Common stock available for future grants		3,799,351
Common stock available for ESPP		2,498,360
Restricted stock units issued and outstanding		1,887,246
Total		20,111,278

2024 Private Placement

In July 2024, the Company entered into a securities purchase agreement with certain institutional and accredited investors, or the Investors, pursuant to which the Company agreed to sell and issue to the Investors in a private placement, or the Private Placement, an aggregate of (i) 10,551,718 shares, or the Shares, of the Company’s common stock, par value $0.0001 per share, or the Common Stock, at a purchase price of $14.50 per share and (ii) 1,517,241 pre-funded warrants, or the Pre-Funded Warrants, to purchase up to an aggregate of 1,517,241 shares of Common Stock, or the Warrant Shares, at a purchase price of $14.4999 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of $0.0001 per Warrant Share.

The Pre-Funded Warrants are exercisable at any time after their original issuance at the option of each holder, in such holder’s discretion, by (i) payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise or (ii) a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the Pre-Funded Warrant. A holder will not be entitled to exercise any portion of any Pre-Funded Warrant if the holder’s ownership of the Company’s common stock would exceed 9.99% following such exercise.

In the event of certain fundamental transactions, the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind of amounts of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental transaction without regard to any limitations on exercise contained in the Pre-Funded Warrants.

The Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in capital and were recorded at the issuance date using a relative fair value allocation method. The Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such Pre-Funded Warrants do not provide any guarantee of value or return. The Company valued the Pre-Funded Warrants at issuance, concluding that their sales price approximated their fair value, and allocated net proceeds from the Private Placement proportionately to the Common Stock and Pre-Funded Warrants.

The Private Placement closed on August 1, 2024 and the Company received net proceeds of $166.5 million, after deducting underwriting discounts, commissions, and offering costs, of which $145.6 million was allocated to the Common Stock and $20.9 million was allocated to the Pre-Funded Warrants. The net proceeds were recorded as a component of additional paid-in capital.

Investment agreement with Ipsen Biopharmaceuticals, Inc.

In July 2024, the Company entered into the Ipsen License Agreement, pursuant to which, the Company licensed to Ipsen, on an exclusive basis, the right to commercialize tovorafenib in all territories outside the United States and agreed to provide certain research and development and manufacturing services. Under the terms of the Ipsen License Agreement, (i) Ipsen paid the Company an upfront license fee in the amount of $70.8 million and (ii) the Investor, a fully-owned United States affiliate of Ipsen, purchased 2,341,495 shares of the Company’s common stock in a private placement for $40.0 million, at a price per share representing a 17.0% premium to the VWAP of the Company’s common stock as traded on The Nasdaq Stock Market LLC for the ten consecutive trading days prior to and including the date of the Revenue Release, and the ten consecutive trading days following the Revenue Release, in accordance with the terms set forth in an investment agreement by and between the Company and the Investor dated July 23, 2024. The Company valued the shares at issuance at $32.6 million, concluding that the Company's common stock price as traded on The Nasdaq Stock Market LLC on the close date of the transaction approximated fair value, which was recorded as a component of additional paid-in capital.

June 2023 Follow-On Offering

In June 2023, the Company completed a follow-on offering and issued and sold 13,269,231 shares of common stock (including the exercise by the underwriters of their option to purchase an additional 1,730,769 shares of common stock) at a price to the public of $13.00 per share for net proceeds of approximately $161.4 million, after deducting underwriting discounts, commissions, and offering costs.

At-The-Market Offering

The Company has entered into an equity distribution agreement, or the Equity Distribution Agreement, with Piper Sandler & Co. and JonesTrading Institutional Services LLC, as sales agents, relating to the issuance and sale of shares of the Company’s common stock for an aggregate offering price of up to $250.0 million under an at-the-market offering program, or the ATM. The Company has no obligation to sell any shares and could at any time suspend solicitations and offers under the ATM. No shares of the Company’s common stock have been sold under the ATM as of September 30, 2024.

- Definition

The entire disclosure for equity.

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+ Details

Description of Business and Organization

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business and Organization

Organization and Business

Day One Biopharmaceuticals, Inc., or the Company, is a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted cancer therapies for people of all ages with life-threatening diseases. The Company was founded in November 2018 and is headquartered in Brisbane, CA.