Full Press Release Details
Arcus Biosciences Reports First Quarter 2021 Financial Results and Provides Operational Highlights
HAYWARD, Calif. - (BUSINESS WIRE) - May 5, 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 first quarter ended March 31, 2021 and provided operational highlights.
"Our ongoing clinical trials include six randomized studies with several that are expected to provide meaningful readouts over the next 12 months," said Terry Rosen, Ph.D., CEO. "We expect the next milestone in our anti-TIGIT program, the ARC-7 interim analysis, later this quarter. We also continue to generate substantial clinical evidence to support our first-in-class therapies targeting the ATP-adenosine axis having recently presented data from ARC-3 which showed a doubling of progression-free survival and overall survival for etrumadenant and chemotherapy in late-line colorectal cancer compared to those reported for current standard-of-care therapies, and promising results for AB680 in first-line pancreatic cancer. We will present initial data from ARC-6, evaluating etrumadenant plus zimberelimab and chemotherapy in metastatic castrate-resistant prostate cancer, at the upcoming ASCO Annual Meeting."
Domvanalimab (FcR-silent anti-TIGIT antibody)
Upcoming Milestones:
AB308 (FcR-enabled anti-TIGIT antibody)
AB680 (CD73 inhibitor)
Upcoming Milestones:
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Upcoming Milestones:
HIF-2 inhibitor Program
Financial Results for the First Quarter 2021 Ended March 31, 2021
Arcus Clinical Study Overview
| 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 |
| ARC-12 | AB308 + Zim | Advanced Malignancies | Initiated Phase 1/1b | NCT04772989 |
| PACIFIC-8 | Durva Dom | Curative-Intent Stage 3 NSCLC | Expected initiation 2H21 Registrational | NA |
CRC: colorectal cancer, NSCLC: non-small cell lung cancer, CRPC: castrate-resistant prostate cancer, PDAC: pancreatic ductal adenocarcinoma, Durva: durvalumab
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% locally advanced or metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab + zimberelimab and domvanalimab + etrumadenant + 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 is expected to advance into a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting later this year. AB308, an anti-TIGIT antibody that is FcR-enabled, advanced 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 meaningful readouts and ability to generate substantial clinical evidence as set forth in Dr. Rosen's quote, the potential for the ARC-7 interim analysis to inform a potential opt-in decision by Gilead, Arcus's anticipated milestones and associated timelines described herein and Arcus's expectation that its cash, cash equivalents and marketable securities on-hand will 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; the inherent uncertainty associated with pharmaceutical product development and clinical trials; our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products; 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 unexpected 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 quarterly report on Form 10-Q for the quarter ended March 31, 2021 filed on May 5, 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)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenues: | ||||||||
| Collaboration revenue | $ | 9,461 | $ | 1,750 | ||||
| Total collaboration and license revenues | 9,461 | 1,750 | ||||||
| Operating expenses: | ||||||||
| Research and development | 66,387 | 23,142 | ||||||
| General and administrative | 15,821 | 7,008 | ||||||
| Total operating expenses | 82,208 | 30,150 | ||||||
| Loss from operations | (72,747 | ) | (28,400 | ) | ||||
| Non-operating income (expense): | ||||||||
| Interest and other income, net | 154 | 647 | ||||||
| Gain on deemed sale from equity method investee | - | 482 | ||||||
| Share of loss from equity method investee | - | (482 | ) | |||||
| Total non-operating income, net | 154 | 647 | ||||||
| Net loss | (72,593 | ) | (27,753 | ) | ||||
| Other comprehensive income (loss) | (46 | ) | 224 | |||||
| Comprehensive loss | $ | (72,639 | ) | $ | (27,529 | ) | ||
| Net loss per share, basic and diluted | $ | (1.08 | ) | $ | (0.63 | ) | ||
| Weighted-average number of shares used to compute basic and diluted net loss per share | 67,082,161 | 44,282,607 |
Selected Consolidated Balance Sheet Data
| March 31, | December 31, | |||||||
| 2021 | 2020 (1) | |||||||
| Cash, cash equivalents and investments in marketable securities | $ | 884,912 | $ | 735,086 | ||||
| Total assets | 935,119 | 772,292 | ||||||
| Total liabilities | 270,329 | 269,988 | ||||||
| Total stockholders' equity | 664,790 | 502,304 |
(1) Derived from the audited financial statements for the year ended December 31, 2020, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2021.