Arcus Biosciences Retains Casdatifan Rights and Announces $150M Stock Offering
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage global biopharmaceutical company specializing in cancer treatments, announced today that Gilead’s exclusive option rights to its potential best-in-class HIF-2α inhibitor, casdatifan, have expired. In addition, Arcus revealed the pricing of a $150 million common stock offering, which will be subject to customary closing conditions.
This offering includes participation from both new and existing institutional healthcare investors, as well as Gilead. The funds raised will support Arcus through the expected data readout for PEAK-1, the Phase 3 trial of casdatifan in immuno-oncology (IO)-experienced clear cell renal cell carcinoma (ccRCC). This financing, along with the development and regulatory expertise Arcus has cultivated, will help accelerate the progress of casdatifan and sustain the momentum the company has built independently to date.
Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage biopharmaceutical company focused on developing innovative cancer treatments, is excited to announce the retention of full ownership of casdatifan, a promising HIF-2α inhibitor. Casdatifan, which has the potential to address a substantial unmet medical need, represents an estimated $5 billion market opportunity in treating patients with clear cell renal cell carcinoma (ccRCC). The company believes this development marks a transformative shift for Arcus, providing significant strategic flexibility and opportunities for future growth.
Terry Rosen, Ph.D., the CEO of Arcus, expressed the company’s enthusiasm about retaining the rights to casdatifan. He emphasized, “Owning the rights to casdatifan represents a transformational change for Arcus, providing us with significant future strategic optionality.” He further elaborated on the potential of casdatifan, citing recent data shared at the ASCO Genitourinary (GU) Cancers Symposium. The data demonstrated that casdatifan could become the best-in-class HIF-2α inhibitor in a competitive space, positioning it to meet the anticipated demand for HIF-2α inhibitors in ccRCC treatment.
Dr. Rosen also noted that Arcus’s development plan is specifically designed to make casdatifan the preferred HIF-2α inhibitor. Key milestones in this plan include the initiation of the Phase 3 PEAK-1 study, which will assess casdatifan combined with cabozantinib in IO-experienced metastatic ccRCC patients. Additionally, Arcus is advancing its collaboration with AstraZeneca, with the eVOLVE study aiming to combine casdatifan with AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody in IO-naive ccRCC patients.
The new data on casdatifan, presented by Dr. Toni Choueiri of Dana-Farber Cancer Institute at the 2025 ASCO GU Cancers Symposium, provided significant insights into its potential in treating ccRCC. The ARC-20 Phase 1/1b study explored casdatifan in patients who had progressed on at least two prior therapies, including an anti-PD-1 agent and a VEGFR tyrosine kinase inhibitor (TKI). The oral presentation highlighted the objective response rates (ORR) for the 50mg twice-daily (BID) cohort, the 50mg once-daily (QD) cohort, and the 100mg QD cohort. The study also included the first median progression-free survival (PFS) data for the 50mg BID cohort.
Looking ahead, Arcus has outlined several key milestones for 2025 and 2026. In Q2 2025, the company plans to initiate the PEAK-1 Phase 3 trial, which will compare casdatifan plus cabozantinib against cabozantinib alone in the IO-experienced metastatic ccRCC setting. The primary endpoint of this study will be PFS. Mid-2025 will see the presentation of initial safety and efficacy data from the casdatifan plus cabozantinib cohort of ARC-20. Later in the year, Arcus will share more mature results from the casdatifan monotherapy cohorts of ARC-20.
In addition to the PEAK-1 trial, Arcus intends to start a Phase 1b study in the eVOLVE portfolio in 2025, evaluating casdatifan in combination with volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, in IO-naive ccRCC patients. This collaboration with AstraZeneca allows Arcus to explore the IO-naive setting with capital and resource efficiency while retaining full rights to casdatifan.
In 2026, Arcus expects to share initial data from newly added ARC-20 cohorts evaluating casdatifan monotherapy in favorable risk first-line (1L) ccRCC, casdatifan plus zimberelimab in 1L ccRCC, and casdatifan monotherapy in IO-experienced/TKI-naive ccRCC.
As Arcus progresses with these trials and collaborations, it is expected to provide updates and insights into the development of casdatifan. Investors are invited to join the conference call on Tuesday, February 18, 2025, at 5:00 AM PT / 8:00 AM ET to learn more about these updates and other important developments. The live webcast and accompanying slide presentation will be available on the Arcus Biosciences website. A replay will also be accessible following the live event.
With promising data and a clear roadmap for clinical trials and collaborations, Arcus Biosciences is poised to further advance casdatifan as a leading treatment for ccRCC, with the potential to address a significant unmet medical need and bring substantial benefits to patients.
