Arcus Biosciences Reports Second Quarter 2022 Financial Results and Provides a Pipeline Update
Arcus Biosciences (NYSE: RCUS) reported its second-quarter financial results, revealing collaboration and license revenues of $26.8 million, up from $9.5 million year-over-year. The company's cash position stands strong at $1.3 billion, sufficient to fund operations into 2026. Notable updates include ongoing Phase 3 trials for domvanalimab-based therapies in NSCLC and gastrointestinal cancers. The interim analysis of the ARC-8 trial for quemliclustat indicates no significant safety issues, but final data on progression-free and overall survival are awaited in 2023.
- Collaboration and license revenues increased to $26.8 million, a significant jump from $9.5 million YoY.
- Strong cash position of $1.3 billion, providing operational funding through 2026.
- Ongoing and planned Phase 3 trials for domvanalimab indicate strategic growth.
- Net loss of $66.6 million for Q2 2022, though improved from $76 million YoY.
- Interim results from ARC-8 show no significant improvement over historical benchmarks for chemotherapy in PDAC.
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Four registrational Phase 3 trials evaluating domvanalimab-based combinations are ongoing or expected to start by year-end; Arcus and Gilead Sciences continue to expand their late-stage clinical program for domvanalimab with the goal of establishing a best-in-class anti-TIGIT antibody regimen in multiple cancers.
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An interim analysis was conducted for the ongoing Phase 1/1b ARC-8 trial of quemliclustat plus chemotherapy, with or without zimberelimab, in pancreatic ductal adenocarcinoma (PDAC); based on the results, Arcus and Gilead plan to wait for mature progression-free survival (PFS) and overall survival (OS) data, expected in 2023, to inform next steps for the PDAC program.
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On track to initiate ARC-20, a Phase 1/1b study to evaluate AB521, Arcus’s HIF-2a inhibitor, in cancer patients in Q3 2022; data from the ongoing healthy volunteer study enable Arcus to start dose escalation in patients at a pharmacologically relevant dose level.
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Arcus nominated a new development candidate, AB801 (an AXL inhibitor), in the second quarter; and at least two new molecules are expected to advance into the clinic in 2023.
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Arcus is well positioned to advance its expanding programs and portfolio, with
in cash, and cash equivalents and funding into 2026.$1.3 billion
“This is a transformational year in the evolution of Arcus, as we expand the scope of our global clinical programs to include four registrational Phase 3 trials with domvanalimab-based combinations,” said
Anti-TIGIT program (domvanalimab and AB308)
Update on Domvanalimab:
-
Arcus is on track to complete enrollment in Q3 2022 of 150 patients for ARC-7, a randomized Phase 2 study evaluating the safety and efficacy of zimberelimab alone vs. domvanalimab plus zimberelimab vs. domvanalimab plus zimberelimab and etrumadenant in first-line PD-L1≥
50% metastatic NSCLC. -
Arcus and Gilead are pursuing a broad development program for domvanalimab-based combinations in NSCLC, with three ongoing or soon-to-be initiated registrational Phase 3 trials:
- STAR-121, evaluating the combination of domvanalimab plus zimberelimab and chemotherapy versus pembrolizumab with chemotherapy in first-line NSCLC PD-L1 all-comers, is expected to achieve first site initiation in the third quarter and is being operationalized by Gilead.
-
ARC-10 is evaluating domvanalimab plus zimberelimab vs. zimberelimab alone vs. chemotherapy in first-line PD-L1≥
50% locally advanced or metastatic NSCLC. - PACIFIC-8, operationalized by AstraZeneca, is evaluating domvanalimab plus durvalumab, an anti-PD-L1 antibody, in unresectable Stage III NSCLC.
-
The companies are also advancing the study of domvanalimab plus zimberelimab-based combinations with two new studies in GI cancers, which are on track to start by year-end:
- ARC-21, a Phase 2 trial evaluating domvanalimab plus zimberelimab-based combinations in upper GI cancers, is open for enrollment and is intended to support the registrational Phase 3 trial STAR-221.
- STAR-221, a randomized Phase 3 study, will evaluate a domvanalimab plus zimberelimab-based combination in upper GI cancers.
Upcoming Anti-TIGIT Milestones:
- Topline disclosure from the Phase 2 ARC-7 study is expected in the second half of 2022 with a planned presentation of the data at a medical conference in 2023.
- Arcus and Gilead expect to initiate two Phase 2 platform lung studies evaluating novel domvanalimab-based combinations, including domvanalimab plus zimberelimab-based triplet combinations with etrumadenant, Trodelvy® (sacituzumab govitecan-hziy), and/or quemliclustat, by year-end.
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Upcoming Etrumadenant Milestones:
- Topline disclosure from the Phase 2 ARC-7 study is expected in the second half of 2022 with a planned presentation of the data at a medical conference in 2023.
- Data from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line metastatic castrate-resistant prostate cancer (CRPC) are anticipated in-house in the second half of 2022 with a presentation of results expected in 2023.
- Data from ARC-9, a Phase 1b/2 study evaluating etrumadenant-based combinations in second-line and third-line metastatic colorectal cancer (mCRC), are expected in the first half of 2023.
Quemliclustat (small-molecule CD73 inhibitor)
Update on ARC-8:
- The ARC-8 study includes two stages: the first stage is a dose-escalation and dose-expansion stage evaluating quemliclustat plus a chemotherapy doublet and zimberelimab (the quad) followed by the second stage, a randomized cohort comparing the quad versus quemliclustat plus a chemotherapy doublet in first-line PDAC.
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Arcus conducted an interim analysis for ARC-8, which included patients from the first stage of the trial and the initial two-thirds of patients from the second stage.
- At this interim analysis, we continued to observe encouraging data from patients treated in the first stage of ARC-8. However, data from patients treated in the randomized portion were similar to historical benchmarks for chemotherapy alone.
- At the time of data cut off, no unexpected safety signals were observed.
- The companies plan to wait for more mature PFS and overall survival data from all 90 patients in the randomized cohort to inform next steps for the PDAC program. These data are expected in the first half of 2023.
Upcoming Quemliclustat Milestones:
- As mentioned above, Arcus and Gilead expect to initiate a Phase 2 platform study to evaluate domvanalimab and quemliclustat combinations in NSCLC by year-end. We also expect to explore quemliclustat-based combinations in GI cancers in the ARC-21 study.
AB521 (HIF-2a inhibitor)
AB521 Update:
- Arcus is on track to initiate ARC-20, a Phase 1/1b study to explore the safety and clinical activity of AB521 in cancer patients in Q3 2022. Data from the ongoing healthy volunteer study enable Arcus to start dose escalation in patients at a pharmacologically relevant dose level. Pharmacokinetic (PK)/pharmacodynamic (PD) data for AB521 in healthy volunteers demonstrate its potential to have an improved clinical profile compared to the approved HIF-2a inhibitor.
Discovery Programs:
- AB598 (anti-CD39 antibody) continues to progress through preclinical development, and we expect to file an Investigational New Drug (IND) application and initiate a Phase 1 trial in cancer patients in the first half of 2023.
- Arcus nominated a new small molecule development candidate, AB801, a potent and selective AXL inhibitor, which has the potential to address various treatment-resistant tumor types, such as STK11-mutant NSCLC.
- Arcus expects to nominate a potential first-in-class small molecule candidate designed to treat a wide range of inflammatory conditions in the second half of 2022.
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As part of Arcus’s and Gilead’s research collaboration, the companies have now selected targets for the two drug discovery programs in oncology. Upon completion of certain IND-enabling activities, Gilead has the right to exercise its option for a payment of
for each program.$60 million
Financial Results for the Second Quarter 2022
-
Cash, cash equivalents and investments: were
as of$1,271.1 million June 30, 2022 , compared to as of$681.3 million December 31, 2021 . The increase was primarily due to the receipt of from Gilead in$725 million January 2022 . Arcus expects cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations into 2026.
-
Revenues: Collaboration and license revenues were
for the three months ended$26.8 million June 30, 2022 , compared to for the same period in 2021. In the three months ended$9.5 million June 30, 2022 , Arcus recognized in license and development service revenues for all programs optioned by Gilead, based on estimates of progress made toward satisfying the related performance obligations,$16.7 million in collaboration revenue related to Gilead’s ongoing rights to access Arcus's research and development pipeline in accordance with the Gilead collaboration agreement, as well as$8.3 million related to the collaboration agreement with Taiho. In the three months ended$1.8 million June 30, 2021 , Arcus recognized in other collaboration revenue related to Gilead's access to Arcus's research and development pipeline, as well as$7.7 million related to the Taiho collaboration agreement. Collaboration and license revenues were$1.8 million for the six months ended$44.8 million June 30, 2022 , compared to for the same period in 2021.$18.9 million
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R&D Expenses: Research and development expenses were
for the three months ended$69.9 million June 30, 2022 , compared to for the same period in 2021. Arcus’s expanding clinical and development activities for domvanalimab and zimberelimab drove increases in manufacturing and clinical costs. Arcus’s growing employee base and 2022 stock awards drove an increase in employee compensation costs, including a$68.8 million increase in non-cash stock-based compensation to approximately$0.7 million . The above increases in research and development costs were mostly offset by increased cost-sharing reimbursements compared to the same quarter in the prior year. The increase in cost-sharing reimbursements was driven by the four programs optioned by Gilead in the current quarter, compared to a single program in the same quarter of the prior year. Research and development expenses were$7.7 million for the six months ended$131.1 million June 30, 2022 , compared to for the same period in 2021.$135.2 million
-
G&A Expenses: General and administrative expenses were
for the three months ended$25.8 million June 30, 2022 , compared to for the same period in 2021. The increase was driven by the increased administrative costs to support the growing size and complexity of Arcus's clinical development organization associated with Arcus's expanding clinical pipeline and collaboration obligations. Arcus's growing employee base and 2022 stock awards drove increases in employee compensation costs and facilities expense, including a$16.8 million increase in non-cash stock-based compensation to approximately$1.6 million for the three months ended$8.0 million June 30, 2022 compared to the prior year period. General and administrative expenses were for the six months ended$49.8 million June 30, 2022 , compared to for the same period in 2021.$32.6 million
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Net Loss: Net loss was
for the three months ended$66.6 million June 30, 2022 , compared to a net loss of for the same period in the prior year. Net loss was$76.0 million for the six months ended$134.6 million June 30, 2022 , compared to a net loss of for the same period in the prior year.$148.6 million
Arcus Ongoing and Announced Clinical Studies
Trial |
Arms |
Setting |
Status |
NCT No. |
|
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ARC-7 |
zim vs. dom + zim vs. etruma + dom + zim |
1L NSCLC (PD-L1 ≥ |
Ongoing Randomized Phase 2 |
|
PACIFIC-8 (AZ) |
dom + durva vs. durva |
Curative-Intent Stage 3 NSCLC |
Ongoing Registrational Phase 3 |
|
ARC-10 |
dom + zim vs. zim vs. chemo |
1L NSCLC (PD-L1 ≥ |
Ongoing Registrational Phase 3 |
|
STAR-121 (GILD) |
dom + zim + chemo vs pembro + chemo |
1L NSCLC (PD-L1 all-comers) |
Planned Registrational Phase 3 |
TBD |
EDGE-Lung |
dom + zim +/- quemli |
1L/2L NSCLC (lung cancer platform study) |
In Planning Phase 2 |
TBD |
Lung Platform (GILD) |
dom + zim +/- etruma or sacituzumab govitecan (Trodelvy) or other combos |
1L/2L NSCLC (lung cancer platform study) |
In Planning Phase 2 |
TBD |
Gastrointestinal Cancers |
||||
ARC-9 |
etruma + zim + mFOLFOX vs. SOC |
2L/3L/3L+ CRC |
Ongoing Randomized Phase 2 |
|
ARC-21 |
dom + zim ± chemo |
1L/2L Upper GI Malignancies |
Ongoing Phase 2 |
|
STAR-221 |
dom + zim + chemo vs. nivo + chemo |
GI Malignancies |
Planned Registrational Phase 3 |
TBD |
Pancreatic Cancer |
||||
ARC-8 |
quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac |
1L, 2L PDAC |
Ongoing Randomized Phase 1/1b |
|
Prostate Cancer |
||||
ARC-6 |
etruma + zim + SOC vs. SOC (Adding sacituzumab govitecan (Trodelvy) combination cohorts) |
2L/3L CRPC |
Ongoing Randomized Phase 2 |
|
Various |
||||
ARC-12 |
AB308 + zim |
Advanced Malignancies |
Ongoing Phase 1/1b |
|
ARC-14 |
AB521 |
|
Ongoing |
|
ARC-20 |
AB521 |
Cancer Patients / ccRCC |
Planned Phase 1/1b |
TBD |
dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear-cell renal cell carcinoma
CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma
About the Gilead Collaboration
In
Gilead and Arcus are co-developing and equally share global development costs for five clinical candidates, including domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, quemliclustat, a small molecule inhibitor of CD73, and zimberelimab, an anti-PD1 antibody.
About
Forward-Looking Statements
This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, the statements in Dr. Rosen’s quote, Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into 2026, future data disclosures and presentations, the projected achievement of clinical study milestones and their associated timing (including under the captions “Upcoming Anti-TIGIT Milestones,” “Upcoming Etrumadenant Milestones,” “Upcoming Quemliclustat Milestones,” “AB521 Update,” and “Discovery Programs”), and additional clinical studies in planning or expected to be initiated this year 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. 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; 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, all of which may be exacerbated by the COVID-19 pandemic; Arcus’s dependence on the collaboration with Gilead 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 its Quarterly Report on Form 10-Q for the quarter ended
The Arcus name and logo are trademarks of
Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts) |
||||||||||||||||
|
|
Three Months Ended |
|
|
Six Months Ended |
|
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|
|
|
|
|
|
|
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|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
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Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
License and development service revenue |
|
$ |
16,693 |
|
|
$ |
- |
|
|
$ |
24,632 |
|
|
$ |
- |
|
Other collaboration revenue |
|
|
10,066 |
|
|
|
9,461 |
|
|
|
20,132 |
|
|
|
18,922 |
|
Total revenues |
|
|
26,759 |
|
|
|
9,461 |
|
|
|
44,764 |
|
|
|
18,922 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
69,905 |
|
|
|
68,771 |
|
|
|
131,116 |
|
|
|
135,158 |
|
General and administrative |
|
|
25,836 |
|
|
|
16,826 |
|
|
|
49,810 |
|
|
|
32,647 |
|
Total operating expenses |
|
|
95,741 |
|
|
|
85,597 |
|
|
|
180,926 |
|
|
|
167,805 |
|
Loss from operations |
|
|
(68,982 |
) |
|
|
(76,136 |
) |
|
|
(136,162 |
) |
|
|
(148,883 |
) |
Non-operating income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
2,861 |
|
|
|
166 |
|
|
|
3,443 |
|
|
|
320 |
|
Effective interest on liability for sale of future royalties |
|
|
(511 |
) |
|
|
- |
|
|
|
(902 |
) |
|
|
- |
|
Total non-operating income, net |
|
|
2,350 |
|
|
|
166 |
|
|
|
2,541 |
|
|
|
320 |
|
Net loss before income taxes |
|
|
(66,632 |
) |
|
|
(75,970 |
) |
|
|
(133,621 |
) |
|
|
(148,563 |
) |
Income tax expense |
|
|
- |
|
|
|
- |
|
|
|
(1,004 |
) |
|
|
- |
|
Net loss |
|
|
(66,632 |
) |
|
|
(75,970 |
) |
|
|
(134,625 |
) |
|
|
(148,563 |
) |
Other comprehensive loss |
|
|
(2,584 |
) |
|
|
(44 |
) |
|
|
(5,983 |
) |
|
|
(90 |
) |
Comprehensive loss |
|
$ |
(69,216 |
) |
|
$ |
(76,014 |
) |
|
$ |
(140,608 |
) |
|
$ |
(148,653 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.93 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.88 |
) |
|
$ |
(2.17 |
) |
Weighted-average number of shares used to compute basic and diluted net loss per share |
|
|
71,814,232 |
|
|
|
69,745,297 |
|
|
|
71,506,216 |
|
|
|
68,421,086 |
|
Selected Consolidated Balance Sheet Data (unaudited) (In thousands) |
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|
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||
|
|
2022 |
|
|
2021(1) |
|
||
Cash, cash equivalents and investments in marketable securities |
|
$ |
1,271,105 |
|
|
$ |
681,298 |
|
Total assets |
|
|
1,476,773 |
|
|
|
1,591,898 |
|
Total liabilities |
|
|
729,387 |
|
|
|
750,448 |
|
Total stockholders’ equity |
|
|
747,386 |
|
|
|
841,450 |
|
(1) Derived from the audited financial statements for the year ended
View source version on businesswire.com: https://www.businesswire.com/news/home/20220803005357/en/
Investor Inquiries:
Pia Banerjee
Head of Investor Relations & Strategy
(617) 459-2006
pbanerjee@arcusbio.com
Media Inquiries:
VP of Corporate Communications
(650) 922-1269
hkolkey@arcusbio.com
Source:
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