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Arcus Biosciences Announces Third Quarter 2020 Financial Results and Corporate Updates

Commenced 10-year highly strategic partnership with Gilead to deliver next-generation cancer therapies

Recently announced collaboration with AstraZeneca for registrational trial, PACIFIC-8, further validates domvanalimab’s therapeutic potential

Significant readouts from multiple studies expected in 2021

Approximately $785 million of cash and funding into at least 2023

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced financial results for the third quarter ended September 30, 2020 and provided corporate updates.

“Our progress in 2020 has significantly de-risked the viability of Arcus’s ambitions to become a long-term independent biopharmaceutical company,” said Terry Rosen, Ph.D., CEO. “With the continued advancement of our four clinical-stage molecules, a landmark all-in collaboration with Gilead, a recently announced collaboration with AstraZeneca and approximately $785 million of cash on our balance sheet, we are well positioned to capitalize on the opportunities afforded by our pipeline. We expect 2021 to be a pivotal year for the company, with meaningful clinical readouts for all four of our clinical-stage molecules that should provide clear evidence of clinical benefit, as well as the start of a registrational trial that is designed to support the potential approval of both zimberelimab monotherapy and domvanalimab in combination with zimberelimab. In 2021, we also expect to further expand our clinical pipeline with IND filings in the second half of the year for our first two small molecules active against cancer cell-intrinsic targets.”

Key Corporate Highlights

Anticipated Corporate Milestones

Fourth Quarter of 2020

Full Year 2021

Financial Results for the Third Quarter 2020 Ended September 30, 2020

About Arcus Biosciences

Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to create highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first and only dual A2a/A2b adenosine receptor antagonist in the clinic, is being evaluated in multiple Phase 1b/2 studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor in the clinic, is in Phase 1 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-high metastatic non-small cell lung cancer evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus AB928 with zimberelimab. Zimberelimab (AB122), Arcus’s anti-PD-1 monoclonal antibody, is also being evaluated in a Phase 1b study as monotherapy for cancers with no approved anti-PD-1 treatment options, and 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 other than statements of historical facts contained herein, including, but not limited to, Arcus’s expectations for 2021 as set forth in Dr. Rosen’s quote, anticipated milestones and expectations with respect to future events under the caption “Anticipated Corporate Milestones,” and Arcus’s expectation that cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations into 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 quarterly report on Form 10-Q for the quarter ended September 30, 2020 filed on November 5, 2020 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

ARCUS BIOSCIENCES, INC.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Collaboration and license revenue

 

$

64,530

 

 

$

1,750

 

 

$

68,030

 

 

$

5,250

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

51,801

 

 

 

17,241

 

 

 

110,636

 

 

 

57,795

 

General and administrative

 

 

11,177

 

 

 

7,758

 

 

 

29,617

 

 

 

18,637

 

Total operating expenses

 

 

62,978

 

 

 

24,999

 

 

 

140,253

 

 

 

76,432

 

Income (loss) from operations

 

 

1,552

 

 

 

(23,249

)

 

 

(72,223

)

 

 

(71,182

)

Non-operating income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

270

 

 

 

1,254

 

 

 

1,218

 

 

 

4,272

 

Gain on deemed sale from equity method investee

 

 

 

 

 

 

 

 

613

 

 

 

 

Share of loss from equity method investee

 

 

 

 

 

(357

)

 

 

(613

)

 

 

(1,202

)

Total non-operating income, net

 

 

270

 

 

 

897

 

 

 

1,218

 

 

 

3,070

 

Net income (loss)

 

 

1,822

 

 

 

(22,352

)

 

 

(71,005

)

 

 

(68,112

)

Other comprehensive income (loss)

 

 

(63

)

 

 

(59

)

 

 

17

 

 

 

160

 

Comprehensive income (loss)

 

$

1,759

 

 

$

(22,411

)

 

$

(70,988

)

 

$

(67,952

)

Net income (loss) per share, basic

 

$

0.03

 

 

$

(0.51

)

 

$

(1.37

)

 

$

(1.56

)

Weighted-average number of shares used to compute basic net income (loss) per share

 

 

62,599,193

 

 

 

43,939,281

 

 

 

51,852,247

 

 

 

43,750,154

 

Net income (loss) per share, diluted

 

$

0.03

 

 

$

(0.51

)

 

$

(1.37

)

 

$

(1.56

)

Weighted-average number of shares used to compute diluted net income (loss) per share

 

 

65,145,707

 

 

 

43,939,281

 

 

 

51,852,247

 

 

 

43,750,154

 

Selected Consolidated Balance Sheet Data

(In thousands)

(unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019(1)

 

Cash, cash equivalents and investments in marketable securities

 

$

785,132

 

 

$

188,270

 

Total assets

 

 

811,075

 

 

 

203,110

 

Total liabilities

 

 

266,658

 

 

 

39,268

 

Total stockholders’ equity

 

 

544,417

 

 

 

163,842

 

(1) Derived from the audited financial statements for the year ended December 31, 2019, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2020.

Contacts

Katherine Bock

VP Investor Relations & Corporate Strategy

(510) 694-6231

kbock@arcusbio.com

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