Full Press Release Details
Arcus Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Operational Highlights
HAYWARD, Calif. - (BUSINESS WIRE) - February 24, 2021 - Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided operational highlights.
"With $735 million in cash at the end of the year, plus $220 million from Gilead's recent equity investment, we are extremely well-positioned to accelerate the advancement of our pipeline, initiate our first registrational trials for domvanalimab, and deliver multiple readouts from the randomized portions of our ongoing clinical studies." said Terry Rosen, Ph.D., CEO. "These readouts include the interim analysis for ARC-7, our Phase 2 randomized study evaluating domvanalimab and zimberelimab in first-line, PD-L1 high, non-small cell lung cancer, in the second quarter of 2021, as well as initial data from our randomized studies evaluating our A2a/A2b adenosine receptor antagonist, etrumadenant. In 2021, we also expect to continue to advance AB680, our CD73 inhibitor, in pancreatic cancer and to expand the clinical program for this first-in-class small molecule to other tumor types. We are also pleased to announce that we received IND clearance for AB308 in January, allowing us to achieve a new milestone with five molecules now in clinical development, and we expect to advance at least one new small molecule program into clinical development in the second half of 2021."
Corporate and Partnership Updates
Domvanalimab (FcR-silent TIGIT antibody)
Upcoming Milestones:
AB680 (CD73 inhibitor)
Upcoming Milestones:
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Upcoming Milestones:
Financial Results for the Fourth Quarter and Full Year Ended December 31, 2020
Arcus Clinical Trials Referenced Above
| Trial Name | Arms | Setting | Status | NCT No. |
| ARC-3 | Etruma + mFOLFOX | CRC | Initial Study | NCT03720678 |
| ARC-4 | Etruma + Zim + Carbo/Pem vs. Zim + Carbo/Pem | TKI R/R EGFRmut NSCLC | Ongoing Randomized Phase 1/2 | NCT03846310 |
| ARC-6 | Etruma + Zim + SOC vs. SOC | 2L/3L CRPC | Ongoing Randomized Phase 2 | NCT04381832 |
| ARC-7 | Zim vs. Zim + Dom vs. Zim + Dom + Etruma | 1L NSCLC (PD-L1 50%) | Ongoing Randomized Phase 2 | NCT04262856 |
| ARC-8 | AB680 + Zim + Gem/NP vs. AB680 + Gem/NP* | 1L PDAC | Ongoing Randomized Phase 1/1b | NCT04104672 |
| ARC-9 | Etruma + Zim + mFOLFOX vs. SOC | 2L/3L/3L+ CRC | Initiated Randomized Phase 2 | NCT04660812 |
| ARC-10 | Chemo vs. Zim mono vs. Zim + Dom | 1L NSCLC (PD-L1 50%) | Initiated Registrational | NCT04736173 |
| PACIFIC-8 | Durva Dom | Curative-Intent Stage 3 NSCLC | Expected initiation 2H21 Registrational | NA |
CRC: colorectal cancer, NSCLC: non-small cell lung carcinoma, CRPC: castrate-resistant prostate cancer, PDAC: pancreatic ductal adenocarcinoma
*Randomization is expected to open by end of 1Q21.
1. Von Hoff DD, et al., N Eng J Med. 2013; 369(18):1691.
3. Weiss GJ, et al., Invest New Drugs. 2018; 36(1):96.
4. Zev A., et al., Clin Cancer Res. 2020; 26(18): 4814.
About Arcus Biosciences
Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1 50% metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus etrumadenant with zimberelimab. In addition, domvanalimab has advanced into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab + domvanalimab and a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting. AB308, an anti-TIGIT antibody that is FcR-enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, was in-licensed to enable the development of Arcus's combination regimens and is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, 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, including, but not limited to, Arcus's expectations for the company and its ability to advance, expand and accelerate the progress of its pipeline and clinical development programs, anticipated milestones and associated timelines and Arcus's expectation that cash, cash equivalents and investments on-hand to be sufficient to fund operations through at least 2023 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, uncertainties and other important factors that may cause Arcus's actual results, performance or achievements
to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: the inherent uncertainty associated with the COVID-19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products; the inherent uncertainty associated with pharmaceutical product development and clinical trials; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; the emergence of adverse events or other undesirable side effects; risks associated with preliminary and interim data; and changes in the competitive landscape for our programs. Risks and uncertainties facing Arcus are described more fully in Arcus's annual report on Form 10-K for the year ended December 31, 2020 filed on February 24, 2021 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
The Arcus name and logo are trademarks of Arcus. All other trademarks belong to their respective owners.
Source: Arcus Biosciences
VP Investor Relations & Corporate Strategy
ARCUS BIOSCIENCES, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | - | $ | 8,000 | $ | 55,096 | $ | 8,000 | ||||||||
| Collaboration revenue | 9,487 | 1,750 | 22,421 | 7,000 | ||||||||||||
| Collaboration and license revenue | 9,487 | 9,750 | 77,517 | 15,000 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 48,712 | 20,686 | 159,348 | 78,481 | ||||||||||||
| General and administrative | 12,787 | 6,591 | 42,404 | 25,228 | ||||||||||||
| Total operating expenses | 61,499 | 27,277 | 201,752 | 103,709 | ||||||||||||
| Income (loss) from operations | (52,012 | ) | (17,527 | ) | (124,235 | ) | (88,709 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest and other income, net | 159 | 929 | 1,377 | 5,201 | ||||||||||||
| Gain on deemed sale from equity method investee | - | - | 613 | - | ||||||||||||
| Share of loss from equity method investee | - | - | (613 | ) | (1,202 | ) | ||||||||||
| Total non-operating income, net | 159 | 929 | 1,377 | 3,999 | ||||||||||||
| Net income (loss) | (51,853 | ) | (16,598 | ) | (122,858 | ) | (84,710 | ) | ||||||||
| Other comprehensive income (loss) | (37 | ) | 11 | (20 | ) | 171 | ||||||||||
| Comprehensive loss | $ | (51,890 | ) | $ | (16,587 | ) | $ | (122,878 | ) | $ | (84,539 | ) | ||||
| Net income loss per share, basic and diluted | $ | (0.82 | ) | $ | (0.38 | ) | $ | (2.24 | ) | $ | (1.93 | ) | ||||
| Weighted-average number of shares used to compute basic and diluted net loss per share | 63,527,932 | 44,056,407 | 54,787,118 | 43,825,991 |
Selected Consolidated Balance Sheet Data
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Cash, cash equivalents and investments in marketable securities | $ | 735,086 | $ | 188,270 | ||||
| Total assets | 772,292 | 203,110 | ||||||
| Total liabilities | 269,988 | 39,268 | ||||||
| Total stockholders' equity | 502,304 | 163,842 |