RCUS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• •In June 2026, we announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb ("BMS"). Under the agreement, we will supply casdatifan, our investigational small-molecule HIF-2α inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical tria…

• •In July 2026, we announced a clinical trial collaboration with Summit Therapeutics. Under the agreement, a new cohort in the ARC-20 platform study will evaluate casdatifan with ivonescimab, an investigational PD-1/VEGF bispecific antibody, in first-line clear cell renal cell carcinoma ("ccRCC").

• •In July 2026, we announced a clinical supply agreement with AVEO Oncology, an LG Chem company. Under the agreement, AVEO will supply its vascular endothelial growth factor receptor ("VEGFR") tyrosine kinase inhibitor ("TKI") tivozanib (FOTIVDA®) to be evaluated in combination with casdatifan as par…

• •In April 2026, we announced the discontinuation of the Phase 3 STAR-121 study due to futility, and in August 2026, we announced the discontinuation of the Phase 3 PACIFIC-8 study. STAR-121 evaluated domvanalimab plus the anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus che…

• The decrease in Total revenues for the three months ended June 30, 2026 was primarily driven by the cumulative catch-up from license and development services revenue of $143 million in 2025 due to Gilead's return of its license to the etrumadenant program, partially offset by: (i) an increase in acc…

Text removed vs the prior filing · source: 10-Q · 2026-05-05

• •In March 2026, we and AstraZeneca agreed not to re-open enrollment in eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan in combination with volrustomig, AstraZeneca's investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line, advanced/met…

• •In April 2026, we announced the discontinuation of the Phase 3 STAR-121 study due to futility. STAR-121 evaluated domvanalimab plus the anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic NSCLC.

• The decrease in Total revenues for the three months ended March 31, 2026 was primarily driven by lower development services revenue from the Gilead Collaboration.

• R&D expenses were flat for the three months ended March 31, 2026, with (i) late-stage development programs increasing due to our investment in casdatifan and our Phase 3 PRISM-1 study for quemliclustat, partially offset by the wind-down of studies related to domvanalimab, (ii) early-stage developmen…

• The increase in G&A expenses for the three months ended March 31, 2026, was primarily due to a $2 million increase in non-cash stock-based compensation, which was primarily attributable to a separation agreement with an officer.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• Patent rights are of limited duration. Given the amount of time required for the development, testing and regulatory review of new investigational products, patents protecting such candidates might expire before or shortly after

• such investigational products are commercialized. Even if patents covering our investigational products are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products. A patent term extension based on regulatory delay may be available …

• We are highly dependent on the services of our founders, Terry Rosen, Ph.D., who serves as our Chief Executive Officer, and Juan Jaen, Ph.D., who serves as our President. Although we have entered into employment agreements with

• them, they are not for a specific term, and each of them may terminate their employment with us at any time, though we are not aware of any present intention of either of these individuals to leave us.

• Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited. For example, California recently enacted a franchise tax law limiting the usa…

Text removed vs the prior filing · source: 10-Q · 2026-05-05

• Patent rights are of limited duration. Given the amount of time required for the development, testing and regulatory review of new investigational products, patents protecting such candidates might expire before or shortly after such investigational products are commercialized. Even if patents cover…

• We are highly dependent on the services of our founders, Terry Rosen, Ph.D., who serves as our Chief Executive Officer, and Juan Jaen, Ph.D., who serves as our President. Although we have entered into employment agreements with them, they are not for a specific term, and each of them may terminate t…

• related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such an award. In addition, supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party p…

• there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.

• approval of our investigational products and ultimately commercialize our investigational products in foreign markets, we would be subject to additional risks and uncertainties, including:

Text added vs the prior filing · source: 10-Q · 2026-08-05

• On August 5, 2026, the Company and Gilead entered into an Amended and Restated Investor Rights Agreement (2026 Amended and Restated IRA), which amends and restates in its entirety the Amended & Restated Investor Rights Agreement entered into on January 29, 2024. Pursuant to the 2026 Amended and Rest…

• The adoption, modification or termination of contracts, instructions or written plans for the purchase or sale of our securities by our Section 16 officers and directors for the three months ended June 30, 2026, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under…

Text removed vs the prior filing · source: 10-Q · 2026-05-05

• The adoption, modification or termination of contracts, instructions or written plans for the purchase or sale of our securities by our Section 16 officers and directors for the three months ended March 31, 2026, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) unde…