Arcus Biosciences Retains Rights to Casdatifan, a Potential Best-in-Class HIF-2a Inhibitor, and Announces Pricing of $150 Million Common Stock Offering
Arcus Biosciences (NYSE:RCUS) has retained full rights to casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma (ccRCC), following the expiration of Gilead Sciences' option window. The company has also priced a $150 million common stock offering with participation from new and existing investors, including Gilead.
New data from the ARC-20 study showed improvements in progression rates, overall response rate (ORR), and progression-free survival (PFS) for casdatifan monotherapy. The company estimates a $5 billion market opportunity for this treatment. Key upcoming milestones include the initiation of the Phase 3 PEAK-1 trial in Q2 2025 and a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with their anti-PD-1/CTLA-4 bispecific antibody.
Arcus Biosciences (NYSE:RCUS) ha mantenuto i diritti completi su casdatifan, un inibitore di HIF-2a per il carcinoma a cellule renali a cellule chiare (ccRCC), dopo la scadenza della finestra di opzione di Gilead Sciences. L'azienda ha anche fissato un offerta di azioni ordinarie da 150 milioni di dollari con la partecipazione di investitori nuovi ed esistenti, inclusa Gilead.
Nuovi dati dallo studio ARC-20 hanno mostrato miglioramenti nei tassi di progressione, nel tasso di risposta globale (ORR) e nella sopravvivenza libera da progressione (PFS) per la monoterapia con casdatifan. L'azienda stima un opportunità di mercato da 5 miliardi di dollari per questo trattamento. I principali traguardi futuri includono l'avvio della sperimentazione di Fase 3 PEAK-1 nel secondo trimestre del 2025 e una collaborazione clinica con AstraZeneca per valutare casdatifan in combinazione con il loro anticorpo bispecifico anti-PD-1/CTLA-4.
Arcus Biosciences (NYSE:RCUS) ha mantenido todos los derechos sobre casdatifan, un inhibidor de HIF-2a para el carcinoma de células renales de células claras (ccRCC), tras la expiración de la ventana de opción de Gilead Sciences. La compañía también ha fijado una oferta de acciones comunes de 150 millones de dólares con la participación de nuevos e inversores existentes, incluyendo a Gilead.
Nuevos datos del estudio ARC-20 mostraron mejoras en las tasas de progresión, la tasa de respuesta global (ORR) y la supervivencia libre de progresión (PFS) para la monoterapia con casdatifan. La compañía estima una oportunidad de mercado de 5 mil millones de dólares para este tratamiento. Los hitos clave que se avecinan incluyen el inicio del ensayo de fase 3 PEAK-1 en el segundo trimestre de 2025 y una colaboración clínica con AstraZeneca para evaluar casdatifan en combinación con su anticuerpo bispecífico anti-PD-1/CTLA-4.
Arcus Biosciences (NYSE:RCUS)는 Gilead Sciences의 옵션 기간 만료 이후 ccRCC(투명 세포 신장 세포 암종)를 위한 HIF-2a 억제제인 casdatifan에 대한 모든 권리를 유지했습니다. 또한, 회사는 Gilead을 포함한 신규 및 기존 투자자들의 참여로 1억 5천만 달러 규모의 보통주 공모를 가격 책정했습니다.
ARC-20 연구의 새로운 데이터는 casdatifan 단독 요법의 진행률, 전체 반응률(ORR), 진행 없는 생존(PFS)에서 개선을 보여주었습니다. 회사는 이 치료법에 대해 50억 달러의 시장 기회를 추정하고 있습니다. 주요 다가오는 이정표로는 2025년 2분기에 PEAK-1 3상 시험을 시작하고, AstraZeneca와의 임상 협력을 통해 그들의 항-PD-1/CTLA-4 이중 특이성 항체와 함께 casdatifan을 평가하는 것이 포함됩니다.
Arcus Biosciences (NYSE:RCUS) a conservé tous les droits sur casdatifan, un inhibiteur de HIF-2a pour le carcinome à cellules rénales claires (ccRCC), suite à l'expiration de la fenêtre d'option de Gilead Sciences. L'entreprise a également fixé une offre d'actions ordinaires de 150 millions de dollars avec la participation de nouveaux investisseurs et d'investisseurs existants, y compris Gilead.
De nouvelles données de l'étude ARC-20 ont montré des améliorations des taux de progression, du taux de réponse global (ORR) et de la survie sans progression (PFS) pour la monothérapie avec casdatifan. L'entreprise estime une opportunité de marché de 5 milliards de dollars pour ce traitement. Les principales étapes à venir incluent le lancement de l'essai de Phase 3 PEAK-1 au deuxième trimestre de 2025 et une collaboration clinique avec AstraZeneca pour évaluer casdatifan en combinaison avec leur anticorps bispécifique anti-PD-1/CTLA-4.
Arcus Biosciences (NYSE:RCUS) hat nach dem Ablauf des Optionsfensters von Gilead Sciences alle Rechte an casdatifan, einem HIF-2a-Inhibitor für das klare Zell-Nierenzellkarzinom (ccRCC), behalten. Das Unternehmen hat auch ein Aktienangebot über 150 Millionen US-Dollar mit der Beteiligung neuer und bestehender Investoren, einschließlich Gilead, festgelegt.
Neue Daten aus der ARC-20-Studie zeigten Verbesserungen der Progressionsraten, der Gesamtansprechrate (ORR) und des progressionsfreien Überlebens (PFS) bei der Monotherapie mit casdatifan. Das Unternehmen schätzt eine Marktchance von 5 Milliarden US-Dollar für diese Behandlung. Wichtige bevorstehende Meilensteine umfassen den Beginn der Phase-3-PEAK-1-Studie im 2. Quartal 2025 und eine klinische Zusammenarbeit mit AstraZeneca zur Bewertung von casdatifan in Kombination mit ihrem anti-PD-1/CTLA-4 bispezifischen Antikörper.
- Retained full rights to casdatifan, potentially worth $5 billion in market opportunity
- Secured $150 million in financing through common stock offering
- Positive clinical data from ARC-20 study showing improvements in progression rates, ORR, and PFS
- Strategic collaboration with AstraZeneca for combination therapy development
- Stock dilution through $150 million common stock offering
- Loss of potential partnership with Gilead for casdatifan development
Insights
The expiration of Gilead's option rights to casdatifan represents a pivotal moment for Arcus Biosciences, fundamentally altering its strategic position in the oncology space. This development, coupled with the
The financing structure is particularly noteworthy, featuring participation from both new institutional healthcare investors and Gilead - suggesting continued confidence in the program despite not exercising their option. This funding provides runway through the PEAK-1 trial readout, a critical value-inflection point for the company.
The clinical data from the ARC-20 study demonstrates casdatifan's potential competitive advantages in the HIF-2α inhibitor space. The improvement in progression rates, ORR, and PFS positions the drug favorably in what management describes as a "two-horse race." The
The development strategy is well-crafted, targeting both IO-experienced and IO-naive patient populations through the PEAK-1 trial and AstraZeneca collaboration respectively. This dual-track approach maximizes market potential while managing development costs effectively. The AstraZeneca collaboration for the eVOLVE study is particularly strategic, allowing Arcus to explore first-line treatment opportunities while preserving resources and maintaining full rights to casdatifan.
Multiple catalysts are scheduled throughout 2025-2026, including:
- PEAK-1 trial initiation (Q2 2025)
- Initial combination therapy data (Mid-2025)
- Mature monotherapy results (Fall 2025)
- First-line treatment data (2026)
These milestones provide clear value-creation opportunities and demonstrate a well-structured clinical development pathway.
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Gilead Sciences’ window to exercise its option to casdatifan has expired;
$150 million - New data from the ARC-20 study in patients with clear cell renal cell carcinoma (ccRCC) showed that casdatifan monotherapy demonstrated improvements in the rate of primary progression, overall response rate (ORR) and progression-free survival (PFS) and reinforced its differentiation relative to published data from studies with HIF-2a inhibitors to date
- Arcus will host a conference call today to discuss the ARC-20 results and casdatifan development plans at 5:00 AM PT / 8:00 AM ET
“We are thrilled to retain ownership of casdatifan, which has the potential to address a significant unmet need for patients with an estimated
The new data from ARC-20, a Phase 1/1b study of the HIF-2a inhibitor casdatifan in ccRCC, were presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium by Dr. Toni Choueiri, Dana-Farber Cancer Institute. The presentation included ORR for the 50mg twice-daily (BID) cohort, 50mg once-daily (QD) cohort and 100mg QD (tablet) cohort in patients who had progressed on at least two prior therapies, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor (TKI) therapy. Arcus also reported the first median PFS data for the 50mg BID cohort.
Expected milestones for casdatifan in 2025 and 2026 are:
- Q2 2025: To initiate PEAK-1, which will evaluate casdatifan plus cabozantinib versus cabozantinib in the IO-experienced metastatic ccRCC setting. The primary endpoint will be PFS.
- Mid-2025: To present initial safety and efficacy data from the casdatifan plus cabozantinib cohort of ARC-20.
- Fall 2025: To share more mature results for the casdatifan monotherapy cohorts of ARC-20.
- 2025: To initiate a Phase 1b study, part of the eVOLVE portfolio, which AstraZeneca will operationalize, to evaluate casdatifan plus volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, in ccRCC patients who are IO-naive. This clinical collaboration enables Arcus to pursue the IO-naive setting in a capital and resource efficient manner while retaining all rights to casdatifan.
- 2026: To share initial data from newly added cohorts of ARC-20 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.
Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 331780 today, Tuesday, February 18, 2025 at 5:00 AM PT / 8:00 AM ET. Participants may also register for the call online using the following link: https://events.q4inc.com/attendee/364282703. To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.
About RCC
According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the
About Casdatifan (AB521)
Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2⍺, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.
Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.
About the Gilead Collaboration
In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing four investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 and May 2023 to include research directed to two targets for oncology and two targets for inflammatory diseases.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39, and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements regarding the initiation, design of and associated timing for future studies, including statements about PEAK-1 and the eVOLVE study; the potential market opportunity for casdatifan; plans to disclose or present study analyses or data, including any analyses or data from ARC-20; whether data and results from studies validate our pipeline or support further development of a program; the potency, efficacy or safety of Arcus’s investigational products, including their potential for a best-in-class profile; the expected closing of the common stock offering and the expected participation in the offering from certain investors; and Arcus’s expectation that the common stock offering positions Arcus to fund its operations through the anticipated data readout for PEAK-1. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; unfavorable global economic, political and trade conditions; Arcus’s dependence on the collaboration with third parties such as Gilead and Taiho for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the
The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
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Investor Inquiries:
Pia Eaves
VP of Investor Relations & Strategy
(617) 459-2006
peaves@arcusbio.com
Media Inquiries:
Holli Kolkey
VP of Corporate Affairs
(650) 922-1269
hkolkey@arcusbio.com
Maryam Bassiri
AD, Corporate Communications
(510) 406-8520
mbassiri@arcusbio.com
Source: Arcus Biosciences
FAQ
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