Full Press Release Details
Arcus Biosciences Reports Second Quarter 2021 Financial Results and Provides Operational Highlights
HAYWARD, Calif. - (BUSINESS WIRE) - August 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 second quarter ended June 30, 2021 and provided operational highlights. Management will host a conference call today, August 5, 2021 beginning at 1:30 pm PT/ 4:30 pm ET.
"We have made significant progress advancing our portfolio and partnerships in the first half of 2021," said Terry Rosen, Ph.D., CEO. "We generated additional clinical data for four of our clinical-stage molecules, across trials in lung, colon, prostate, and pancreatic cancers, that continue to support our ongoing randomized studies. We also advanced our Fc-enabled anti-TIGIT antibody into a Phase 1 study and selected our HIF-2 small molecule to be our sixth clinical-stage molecule, anticipated to enter the clinic by the end of the year. With over $800 million of cash and investments as of the end of the second quarter, and our partnership with Gilead, we are confident we can address and pursue the immense need in these patient populations and the corresponding magnitude of the market opportunities."
Domvanalimab (Fc-silent anti-TIGIT antibody)
Upcoming Milestones:
AB308 (Fc-enabled anti-TIGIT antibody)
Upcoming Milestones:
Quemliclustat (also referred to as AB680; CD73 inhibitor)
Upcoming Milestones:
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Upcoming Milestones:
HIF-2 inhibitor Program
Upcoming Milestones:
Upcoming Milestones:
Financial Results for the Second Quarter 2021
Management will host a conference call today, August 5, 2021 to discuss second quarter 2021 financial results and recent corporate highlights. The call will begin at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the conference call may do so by dialing (844) 200-6205 in the U.S. or +44 208 0682 558 internationally, using Conference ID: 152804. In addition, the live webcast and any accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company's website for at least two weeks following the live event.
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 | Quemli + Zim + Gem/NP vs. Quemli + 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, and non-small cell lung. Quemliclustat (AB680), the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development in combination with zimberelimab and gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic cancer. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study evaluating zimberelimab monotherapy, domvanalimab plus zimberelimab and domvanalimab plus etrumadenant plus zimberelimab for first-line treatment of PD-L1 50% metastatic non-small cell lung cancer (NSCLC). In addition, domvanalimab has advanced into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab plus 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, is in clinical development, with a potential focus on hematological
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, statements under the captions "Upcoming Milestones" above, Arcus's expectations including as to timing to advance its investigational products 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 and 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 pandemic 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 June 30, 2021 filed on August 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 of Investor Relations & Corporate Strategy
VP of Corporate Communications
ARCUS BIOSCIENCES, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Collaboration revenue | $ | 9,461 | $ | 1,750 | 18,922 | $ | 3,500 | |||||||||
| Total collaboration and license revenues | 9,461 | 1,750 | 18,922 | 3,500 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 68,771 | 35,693 | 135,158 | 58,835 | ||||||||||||
| General and administrative | 16,826 | 11,432 | 32,647 | 18,440 | ||||||||||||
| Total operating expenses | 85,597 | 47,125 | 167,805 | 77,275 | ||||||||||||
| Loss from operations | (76,136 | ) | (45,375 | ) | (148,883 | ) | (73,775 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest and other income, net | 166 | 301 | 320 | 948 | ||||||||||||
| Gain on deemed sale from equity method investee | - | 131 | - | 613 | ||||||||||||
| Share of loss from equity method investee | - | (131 | ) | - | (613 | ) | ||||||||||
| Total non-operating income, net | 166 | 301 | 320 | 948 | ||||||||||||
| Net loss | (75,970 | ) | (45,074 | ) | (148,563 | ) | (72,827 | ) | ||||||||
| Other comprehensive income (loss) | (44 | ) | (144 | ) | (90 | ) | 80 | |||||||||
| Comprehensive loss | $ | (76,014 | ) | $ | (45,218 | ) | $ | (148,653 | ) | $ | (72,747 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.09 | ) | $ | (0.93 | ) | $ | (2.17 | ) | $ | (1.57 | ) | ||||
| Weighted-average number of shares used to compute basic and diluted net loss per share | 69,745,297 | 48,556,843 | 68,421,086 | 46,419,724 |
Selected Consolidated Balance Sheet Data
| June 30 | December 31, | |||||||
| 2021 | 2020 (1) | |||||||
| Cash, cash equivalents and investments in marketable securities | $ | 805,108 | $ | 735,086 | ||||
| Total assets | 898,773 | 772,292 | ||||||
| Total liabilities | 294,218 | 269,988 | ||||||
| Total stockholders' equity | 604,555 | 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.