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Arcus Biosciences Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides a Pipeline Update

 

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a pipeline update on its clinical-stage investigational molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b receptors), HIF-2a, AXL and PD-1 – across multiple common cancers.

“By the beginning of next year, we expect to have six ongoing Phase 3 trials for three distinct programs: domvanalimab plus zimberelimab, our Fc-silent anti-TIGIT antibody and anti-PD-1 antibody combination; casdatifan (AB521), our HIF-2a inhibitor; and quemliclustat, our CD73 inhibitor. Two of our Phase 3 trials (STAR-121 and STAR-221) for domvanalimab plus zimberelimab are expected to complete enrollment this year, and we are beginning preparations for regulatory filings,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “We now have cash runway into 2027, enabling us to accelerate our multiple late-clinical stage studies and support our highly productive discovery engine.”

Corporate Update:

Pipeline Highlights:

Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody) plus Zimberelimab (anti-PD-1 antibody)

Domvanalimab-zimberelimab Updates:

Upcoming Domvanalimab-Zimberelimab Milestones:

Casdatifan, also known as AB521 (HIF-2a inhibitor)

Casdatifan (AB521) Updates:

Upcoming Casdatifan (AB521) Milestones:

Quemliclustat (small-molecule CD73 inhibitor)

Etrumadenant (A2a/A2b adenosine receptor antagonist)

Early Clinical and Preclinical Programs

Financial Results for Fourth Quarter and Full Year 2023:

Conference Call Information:

Arcus will host a conference call and webcast today, February 21, at 2:00 PM PT / 5:00 PM ET to discuss its fourth-quarter and full-year 2023 financial results and pipeline updates. To access the call, please dial (404) 975-4839 (local) or (833) 470-1428 (toll-free), using Access Code: 235272. To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

Arcus Ongoing and Announced Clinical Studies:

Trial Name

Arms

Setting

Status

NCT No.

Lung Cancer

PACIFIC-8

 

dom + durva vs. durva

Unresectable Stage 3 NSCLC

Ongoing Registrational Phase 3

NCT05211895

STAR-121

 

dom + zim + chemo vs. pembro + chemo

1L NSCLC (PD-L1 all-comers)

Ongoing Registrational Phase 3

NCT05502237

STAR-131

dom + zim + chemo; dom + zim

Perioperative NSCLC

Planned Registrational Phase 3

TBD

EDGE-Lung

dom +/- zim +/- quemli +/- chemo

1L/2L NSCLC (lung cancer platform study)

Ongoing Randomized Phase 2

NCT05676931

VELOCITY-Lung

 

dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos

1L/2L NSCLC (lung cancer platform study)

Ongoing Randomized Phase 2

NCT05633667

Gastrointestinal Cancers

ARC-9

etruma + zim + mFOLFOX vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized Phase 2

NCT04660812

EDGE-Gastric (ARC-21)

dom +/- zim +/- quemli +/- chemo

1L/2L Upper GI Malignancies

Ongoing

Randomized Phase 2

NCT05329766

STAR-221

dom + zim + chemo vs. nivo + chemo

1L Gastric, Gastroesophageal Junction (GEJ) and Esophageal Adenocarcinoma (EAC)

Ongoing Registrational Phase 3

NCT05568095

Pancreatic Cancer

ARC-8

quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac

1L, 2L PDAC

Ongoing Randomized Phase 1/1b

NCT04104672

Prostate Cancer

ARC-6

etruma + zim + SOC vs. SOC

2L/3L CRPC

Ongoing Randomized Phase 2

NCT04381832

Kidney Cancer

ARC-20

cas

Cancer Patients / ccRCC

Ongoing Phase 1/1b

NCT05536141

STELLAR-009

cas + zanza

ccRCC

Ongoing Phase 1b/2

NCT06191796

Other

ARC-25

AB598

Advanced Malignancies

Ongoing

NCT05891171

ARC-26

AB801

Healthy Volunteers

Ongoing

NCT06004921

ARC-27

AB801

Advanced Malignancies

Ongoing

NCT06120075

cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zanza: zanzalintinib; zim: zimberelimab; ccRCC: clear-cell renal cell carcinoma; CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

About the Gilead Collaboration

In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing four investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 to include research directed to two targets for oncology, which research collaboration was further expanded in May 2023 to add up to four targets for inflammatory diseases.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73, dual A2a/A2b receptor and CD39), AXL and HIF-2a. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit www.arcusbio.com or follow us on Twitter.

Domvanalimab, etrumadenant, quemliclustat, and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan, AB598 and AB801 are also investigational molecules, and Arcus has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

Forward-Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein 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, including, but not limited to, the statements in Dr. Rosen’s quote and statements regarding: Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into 2027 and support Phase 3 trials for 3 different molecules and launch preparations; the timing and scope of analyses, data disclosures and presentations; whether data and results from current studies support further development of a program; expected timing of clinical milestones, including the completion of enrollment; our ability to accelerate the development of our clinical pipeline; the potential of casdatifan to achieve substantially greater HIF-2a inhibition than the approved dose of the marketed competitor; the potency, efficacy or safety of Arcus’s investigational products; and the initiation of and associated timing for future studies, including STAR-131 and the Phase 3 studies in ccRCC and pancreatic cancer. 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 by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. 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 except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

ARCUS BIOSCIENCES, INC.

Consolidated Statements of Operations

(unaudited)

(In millions, except per share amounts)

 

 

Three Months Ended
December 31,

 

Years Ended
December 31,

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Revenues:

 

 

 

 

 

 

 

License and development service revenue

$

22

 

 

$

26

 

 

$

80

 

 

$

74

 

Other collaboration revenue

 

9

 

 

 

8

 

 

 

37

 

 

 

38

 

Total revenues

 

31

 

 

 

34

 

 

 

117

 

 

 

112

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

93

 

 

 

80

 

 

 

340

 

 

 

288

 

General and administrative

 

29

 

 

 

28

 

 

 

117

 

 

 

104

 

Total operating expenses

 

122

 

 

 

108

 

 

 

457

 

 

 

392

 

 

 

 

 

 

 

 

 

Loss from operations

 

(91

)

 

 

(74

)

 

 

(340

)

 

 

(280

)

 

 

 

 

 

 

 

 

Non-operating income (expense):

 

 

 

 

 

 

 

Interest and other income, net

 

11

 

 

 

8

 

 

 

41

 

 

 

16

 

Effective interest on liability for sale of future royalties

 

 

 

 

(1

)

 

 

(2

)

 

 

(2

)

Total non-operating income, net

 

11

 

 

 

7

 

 

 

39

 

 

 

14

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(80

)

 

 

(67

)

 

 

(301

)

 

 

(266

)

 

 

 

 

 

 

 

 

Income tax expense

 

(1

)

 

 

 

 

 

(6

)

 

 

(1

)

 

 

 

 

 

 

 

 

Net loss

$

(81

)

 

$

(67

)

 

$

(307

)

 

$

(267

)

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

Basic and diluted

$

(1.08

)

 

$

(0.93

)

 

$

(4.15

)

 

$

(3.71

)

 

 

 

 

 

 

 

 

Shares used to compute net loss per share:

 

 

 

 

 

 

 

Basic and diluted

 

75.0

 

 

 

72.6

 

 

 

74.0

 

 

 

72.0

 

Selected Consolidated Balance Sheet Data

(unaudited)

(In millions)

 

 

December 31,
2023

 

December 31,
2022

Cash, cash equivalents and marketable securities

$

866

 

$

1,138

Total assets

 

1,095

 

 

1,345

Total liabilities

 

633

 

 

688

Total stockholders’ equity

 

462

 

 

657

 

Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 21, 2024.

 

Contacts

Investor Inquiries:
Pia Eaves

Head of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Communications

(650) 922-1269

hkolkey@arcusbio.com

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