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- Four Phase 3 and two Phase 2 trials are now enrolling to evaluate domvanalimab-based combinations in lung and gastrointestinal cancers.<\/i><\/li>\n<\/ul>\n
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- The third dose-escalation cohort (100mg) of ARC-20 for AB521, a potential best-in-class HIF-2a inhibitor, is enrolling; the dose-expansion stage of ARC-20 and a Phase 2 combination study in clear-cell renal cell carcinoma (ccRCC) patients are expected to begin in the third quarter.<\/i><\/li>\n<\/ul>\n
- \n
- Three new drug candidates are expected to advance into the clinic in 2023 and early 2024.<\/i><\/li>\n<\/ul>\n
- \n
- With $1.0 billion in cash, cash equivalents and marketable securities and funding into 2026, Arcus is well-positioned to advance its pipeline.<\/i><\/li>\n<\/ul>\n
HAYWARD, Calif.–(BUSINESS WIRE<\/a>)–
\nArcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today reported financial results for the first quarter ended March 31, 2023, and provided a pipeline update on its clinical-stage investigational molecules \u2013 targeting TIGIT, the adenosine axis (CD73 and A2a\/A2b receptors), HIF-2a and PD-1 \u2013 across multiple common cancers.<\/p>\n\n\u201cTogether with our partner Gilead, we continue to execute on our four Phase 3 studies evaluating domvanalimab-based combinations versus standard of care in lung and gastrointestinal cancers. We are also making great progress on our earlier-stage pipeline. Specifically, we plan to initiate a Phase 2 combination study for AB521, our potential best-in-class HIF-2a inhibitor, in the second half of this year, while also advancing two additional molecules into the clinic in 2023,\u201d said Terry Rosen, Ph.D., chief executive officer of Arcus. \u201cMeanwhile, we are leveraging our deep immunology and small-molecule expertise to diversify our portfolio into inflammatory disease with the advancement of our KIT inhibitor program. With $1.0 billion in cash and investments and runway into 2026, we are in an extremely strong position to advance our diverse portfolio of innovative therapies.\u201d<\/p>\n
Pipeline Highlights:<\/b><\/p>\n
Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody)<\/span><\/b><\/p>\n
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- \nData from the ARC-7 study will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023, which will include updated data for all 150 patients in the trial.<\/p>\n<\/li>\n
- \nInitial ORR data from the ongoing EDGE-Gastric (ARC-21) Phase 2 study of domvanalimab plus zimberelimab in first- and second-line upper GI cancers are expected in the second half of 2023. These data will be from the cohort that reflects the same patient population and dosing regimen as the ongoing Phase 3 study, STAR-221.<\/p>\n<\/li>\n<\/ul>\n
AB521 <\/span>(HIF-2a<\/span> inhibitor)<\/span><\/b><\/p>\n
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- \nArcus is enrolling the third dose-escalation cohort of ARC-20, a Phase 1\/1b study of AB521 in cancer patients, evaluating a 100-mg daily dose, which Arcus believes has the potential to achieve at least 3 times greater HIF-2a inhibition than that of the approved dose of the marketed competitor.<\/p>\n
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- \nUpon completion of this cohort, Arcus expects to advance ARC-20 into the dose-expansion stage of the study.<\/p>\n<\/li>\n
- \nInitial pharmacokinetic (PK), pharmacodynamic (PD) and safety data, along with any preliminary signs of anti-tumor activity from the dose-escalation phase of ARC-20, are anticipated in late 2023 or early 2024.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nA Phase 2 study evaluating AB521 in combination with other agents is anticipated to begin in the third quarter of 2023.<\/p>\n<\/li>\n<\/ul>\n
Quemliclustat (small-molecule CD73 inhibitor)<\/span><\/b><\/p>\n
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- \nArcus and Gilead expect mature overall survival (OS) data from the ongoing Phase 1\/1b ARC-8 trial evaluating quemliclustat plus chemotherapy with or without zimberelimab in first-line pancreatic cancer in the second half of 2023; these data will inform next steps for quemliclustat in pancreatic cancer.<\/p>\n<\/li>\n<\/ul>\n
Etrumadenant (A2a\/A2b adenosine receptor antagonist)<\/span><\/b><\/p>\n
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- \nUpdated analysis from the ARC-7 study will be presented at the ASCO Annual Meeting in June 2023, including more mature data for the etrumadenant plus domvanalimab plus zimberelimab arm.<\/p>\n<\/li>\n
- \nData from the randomized cohort of ARC-6, a Phase 1b\/2 study evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in metastatic castrate-resistant prostate cancer (mCRPCs), are expected in the second half of 2023.<\/p>\n<\/li>\n
- \nData from ARC-9, a Phase 1b\/2 study evaluating etrumadenant plus zimberelimab plus chemotherapy in second-line and third-line metastatic colorectal cancer (mCRC), are expected in the second half of 2023.<\/p>\n<\/li>\n<\/ul>\n
Preclinical Programs<\/span><\/b><\/p>\n
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- \nThe IND for AB598, Arcus\u2019s anti-CD39 antibody, has been cleared by the FDA, and Arcus is on track to initiate a Phase 1 trial in cancer patients in the second quarter of 2023.<\/p>\n<\/li>\n
- \nArcus expects to initiate a Phase 1 study for AB801, a potent and highly selective Axl inhibitor, in the second half of 2023.<\/p>\n
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- \nArcus presented data at the American Association for Cancer Research (AACR) Annual Meeting in April 2023 demonstrating high potency and selectivity of AB801 for Axl over other kinases in multiple assays; the data also showed that AB801 significantly decreased tumor volume and increased survival in mouse tumor models.<\/p>\n<\/li>\n
- \nThe early development plan is expected to focus on treatment-resistant tumor types, such as STK11-mutant NSCLC.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nArcus expects to advance its first candidate against an inflammation target, AB375, a highly selective KIT inhibitor, into the clinic in early 2024.<\/p>\n<\/li>\n<\/ul>\n
Financial Results for First Quarter 2023:<\/b><\/p>\n
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- Cash, cash equivalents and marketable securities <\/b>were $1.0 billion as of March 31, 2023, compared to $1.1 billion as of December 31, 2022. The decrease during the period is primarily due to the use of cash in research and development activities. Cash, cash equivalents and marketable securities on-hand are expected to be sufficient to fund operations into 2026.\n<\/li>\n<\/ul>\n
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- Revenues <\/b>were $25 million for first quarter 2023, compared to $18 million for the same period in 2022. In first quarter 2023, Arcus recognized $17 million in license and development service revenues for programs optioned by Gilead. Arcus further recognized $8 million in collaboration revenue related to Gilead\u2019s ongoing rights to access Arcus\u2019s research and development pipeline in accordance with the Gilead collaboration agreement.\n<\/li>\n<\/ul>\n
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- Research and Development (R&D) Expenses<\/b> were $81 million for first quarter 2023, compared to $61 million for the same period in 2022. Arcus\u2019s expanding clinical and development activities increased costs by $31 million, partially offset by $11 million in higher reimbursements for shared expenses from Arcus’s collaborations, primarily the Gilead collaboration, which was expanded in December 2021. The $20 million increase in R&D costs net of reimbursements was driven by Arcus’s expanding clinical and development activities as Arcus enrolled more patients in its existing and new studies. Non-cash stock-based compensation expense was $9 million for both periods. For first-quarter 2023 and 2022, Arcus recognized reimbursements of $42 million and $31 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration.\n<\/li>\n<\/ul>\n
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- General and Administrative (G&A) Expenses<\/b> were $30 million for first quarter 2023, compared to $24 million for the same period in 2022. The increase was driven by the increased complexity of supporting Arcus’s expanding clinical pipeline and partnership obligations. Non-cash stock-based compensation expense was $10 million for first quarter 2023, compared to $8 million for the same period in 2022.\n<\/li>\n<\/ul>\n
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- Net Loss<\/b> was $80 million for first quarter 2023, compared to $68 million for the same period in 2022.\n<\/li>\n<\/ul>\n
Arcus Ongoing and Announced Clinical Studies<\/b><\/p>\n
- Net Loss<\/b> was $80 million for first quarter 2023, compared to $68 million for the same period in 2022.\n<\/li>\n<\/ul>\n
- General and Administrative (G&A) Expenses<\/b> were $30 million for first quarter 2023, compared to $24 million for the same period in 2022. The increase was driven by the increased complexity of supporting Arcus’s expanding clinical pipeline and partnership obligations. Non-cash stock-based compensation expense was $10 million for first quarter 2023, compared to $8 million for the same period in 2022.\n<\/li>\n<\/ul>\n
- Research and Development (R&D) Expenses<\/b> were $81 million for first quarter 2023, compared to $61 million for the same period in 2022. Arcus\u2019s expanding clinical and development activities increased costs by $31 million, partially offset by $11 million in higher reimbursements for shared expenses from Arcus’s collaborations, primarily the Gilead collaboration, which was expanded in December 2021. The $20 million increase in R&D costs net of reimbursements was driven by Arcus’s expanding clinical and development activities as Arcus enrolled more patients in its existing and new studies. Non-cash stock-based compensation expense was $9 million for both periods. For first-quarter 2023 and 2022, Arcus recognized reimbursements of $42 million and $31 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration.\n<\/li>\n<\/ul>\n
- Revenues <\/b>were $25 million for first quarter 2023, compared to $18 million for the same period in 2022. In first quarter 2023, Arcus recognized $17 million in license and development service revenues for programs optioned by Gilead. Arcus further recognized $8 million in collaboration revenue related to Gilead\u2019s ongoing rights to access Arcus\u2019s research and development pipeline in accordance with the Gilead collaboration agreement.\n<\/li>\n<\/ul>\n
- Cash, cash equivalents and marketable securities <\/b>were $1.0 billion as of March 31, 2023, compared to $1.1 billion as of December 31, 2022. The decrease during the period is primarily due to the use of cash in research and development activities. Cash, cash equivalents and marketable securities on-hand are expected to be sufficient to fund operations into 2026.\n<\/li>\n<\/ul>\n
- \nArcus and Gilead expect mature overall survival (OS) data from the ongoing Phase 1\/1b ARC-8 trial evaluating quemliclustat plus chemotherapy with or without zimberelimab in first-line pancreatic cancer in the second half of 2023; these data will inform next steps for quemliclustat in pancreatic cancer.<\/p>\n<\/li>\n<\/ul>\n
- \nArcus is enrolling the third dose-escalation cohort of ARC-20, a Phase 1\/1b study of AB521 in cancer patients, evaluating a 100-mg daily dose, which Arcus believes has the potential to achieve at least 3 times greater HIF-2a inhibition than that of the approved dose of the marketed competitor.<\/p>\n
- With $1.0 billion in cash, cash equivalents and marketable securities and funding into 2026, Arcus is well-positioned to advance its pipeline.<\/i><\/li>\n<\/ul>\n
- Three new drug candidates are expected to advance into the clinic in 2023 and early 2024.<\/i><\/li>\n<\/ul>\n
- The third dose-escalation cohort (100mg) of ARC-20 for AB521, a potential best-in-class HIF-2a inhibitor, is enrolling; the dose-expansion stage of ARC-20 and a Phase 2 combination study in clear-cell renal cell carcinoma (ccRCC) patients are expected to begin in the third quarter.<\/i><\/li>\n<\/ul>\n