Arcus Biosciences, Inc., a global biopharmaceutical company in the clinical stage, has reported its financial outcomes for Q2 ending June 30, 2024, and provided updates on its investigational molecules targeting multiple cancer types. The company highlighted advancements in its pipeline, focusing on molecules like TIGIT, CD73, A2a/A2b receptors, HIF-2a, AXL, and PD-1, each aimed at treating various common cancers.
CEO Terry Rosen emphasized the potential of casdatifan, a HIF-2a inhibitor, to become a best-in-class treatment for clear cell renal cell carcinoma (ccRCC). Arcus is exploring this molecule in both first- and second-line treatments and various combinations. Rosen also pointed out the promising safety profile of their Fc-silent anti-TIGIT antibody, domvanalimab, especially when combined with chemotherapy, which could offer an efficacy advantage.
In July 2024, Taiho Pharmaceutical exercised its option for quemliclustat, a CD73 inhibitor, in Japan and parts of Asia. This move will see Taiho operationalize a Phase 3 study (PRISM-1) of quemliclustat in pancreatic cancer within these regions while Arcus benefits from opt-in and milestone payments.
Key highlights from Arcus's pipeline include:
Casdatifan (HIF-2a Inhibitor):
- Multiple cohorts are evaluating casdatifan in ccRCC, with presentations expected over the next 18 months.
- The ARC-20 Phase 1/1b study is assessing casdatifan alone and in combination therapy, with data presentations scheduled for late 2024 and 2025.
- Plans for a Phase 3 study (PEAK-1) combining casdatifan with cabozantinib in metastatic ccRCC will begin in the first half of 2025.
Domvanalimab and Zimberelimab (Anti-TIGIT and Anti-PD-1 Antibodies):
- Data from the Phase 2 EDGE-Gastric study showed promising results for domvanalimab-zimberelimab combined with chemotherapy in upper GI adenocarcinomas.
- The Phase 3 STAR-221 and STAR-121 studies are evaluating the combination in upper GI adenocarcinomas and non-small cell lung cancer (NSCLC), respectively.
- Upcoming milestones include overall survival data from the Phase 3 ARC-10 study in NSCLC by the end of 2024 and further data from EDGE-Gastric in 2025.
CD73-Adenosine Axis:
- Etrumadenant, an A2a/A2b receptor antagonist, showed significant survival benefits in a Phase 1b/2 study (ARC-9) for metastatic colorectal cancer.
- Quemliclustat will enter a Phase 3 trial (PRISM-1) combined with gemcitabine/nab-paclitaxel for pancreatic cancer by early 2025.
Financial Performance:
- Arcus reported cash, cash equivalents, and marketable securities of $1.0 billion as of June 30, 2024, up from $866 million at the end of 2023. This increase was driven by a $320 million equity investment from Gilead, offset by research and development expenditures.
- Revenues for Q2 2024 totaled $39 million, compared to $29 million in Q2 2023. This includes $28 million from license and development services and $11 million from collaboration revenue, primarily related to Gilead.
- Research and development expenses rose to $115 million in Q2 2024 from $84 million in Q2 2023, due to increased clinical trial costs and headcount.
- General and administrative expenses were $30 million, up from $28 million in the same period last year, attributed to higher headcount and agreement-related costs.
- The net loss for Q2 2024 was $93 million, compared to $75 million in Q2 2023.
These updates underscore Arcus Biosciences' commitment to developing innovative cancer treatments through strategic collaborations and extensive clinical trials, aiming to bring first- or best-in-class therapies to patients globally.
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