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Arcus Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Operational Highlights

Multiple key data read-outs expected for 2021, including the ARC-7 interim analysis in 2Q21

Domvanalimab’s advancement into a registrational study coupled with recent IND clearance for AB308, Arcus’s FcR-enabled anti-TIGIT antibody, reinforces Arcus’s position as a leader in the anti-TIGIT field

Promising early data in first-line metastatic pancreatic cancer for AB680, the first small-molecule CD73 inhibitor to enter clinical development, were presented at ASCO GI in 1Q21

Gilead’s recent increased investment in Arcus demonstrates the strength of our ongoing collaboration and Gilead’s confidence in Arcus’s clinical-stage pipeline and R&D capabilities

HAYWARD, Calif.–(BUSINESS WIRE)–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)

Recent Highlights:

Upcoming Milestones:

AB680 (CD73 inhibitor)

Recent Highlights:

Upcoming Milestones:

Etrumadenant (A2a/A2b adenosine receptor antagonist)

Recent Highlights:

Upcoming Milestones:

Other Programs

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.

2. https://packageinserts.bms.com/pi/pi_abraxane.pdf
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

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

(In thousands)

 

 

 

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

 

 

Contacts

Katherine Bock

VP Investor Relations & Corporate Strategy

(510) 694-6231

kbock@arcusbio.com

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