Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast

Arcus Biosciences Reports First-Quarter 2024 Financial Results and Provides a Pipeline Update


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 first quarter ended March 31, 2024, 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.

"Arcus has evolved to become a late-stage oncology company with multiple programs targeting lung, gastrointestinal and kidney cancers that address extremely large patient populations with high unmet need," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With two oral presentations at ASCO in GI cancers and a third dataset for our HIF-2a inhibitor expected later this year, we have several near-term catalysts that will further validate our deep pipeline of potentially first- and best-in-class molecules, which will be in at least 5 different Phase 3 studies by the first half of 2025."

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

Casdatifan (HIF-2a inhibitor)

CD73-Adenosine Axis: Etrumadenant (A2a/A2b receptor antagonist) and Quemliclustat (small-molecule CD73 inhibitor)

Early Clinical Programs

Financial Results for First Quarter 2024:

Conference Call Information:

Arcus will host a conference call and webcast today, May 8, at 1:30 PM PT / 4:30 PM ET to discuss its first-quarter 2024 financial results and pipeline updates. To access the call, please dial (404) 975-4839 (local) or (833) 470-1428 (toll-free), using Access Code: 034427. 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

STAR-121

 

dom + zim + chemo vs. pembro + chemo

1L NSCLC (PD-L1 all-comers)

Ongoing Registrational Phase 3

NCT05502237

PACIFIC-8

 

dom + durva vs. durva

Unresectable Stage 3 NSCLC

Ongoing Registrational Phase 3

NCT05211895

STAR-131

dom + zim + chemo; dom + zim

Perioperative NSCLC

Registrational Phase 3 In Planning

TBD

ARC-7

zim vs. dom + zim vs. etruma + dom + zim

1L NSCLC (PD-L1 ? 50%)

 

Ongoing Randomized Phase 2

NCT04262856

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

Upper Gastrointestinal Cancers

STAR-221

dom + zim + chemo vs. nivo + chemo

1L Gastric, GEJ and EAC

Ongoing Registrational Phase 3

NCT05568095

EDGE-Gastric (ARC-21)

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

1L/2L Upper GI Malignancies

Ongoing

Randomized Phase 2

NCT05329766

Colorectal Cancer

ARC-9

etruma + zim + mFOLFOX vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized Phase 2

NCT04660812

Pancreatic Cancer

PRISM-1

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

1L PDAC

Planned Phase 3

TBD

ARC-8

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

1L, 2L PDAC

Ongoing Randomized Phase 1/1b

NCT04104672

Kidney Cancer

STELLAR-009

cas + zanza

ccRCC

Ongoing Phase 1b/2

NCT06191796

ARC-20

cas, cas + cabo

Cancer Patients / ccRCC

Ongoing Phase 1/1b

NCT05536141

Other

ARC-25

AB598

Advanced Malignancies

Ongoing

NCT05891171

ARC-27

AB801

Advanced Malignancies

Ongoing

NCT06120075

cabo: cabozantinib; 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; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; 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 and May 2023 to include research directed to two targets for oncology and two 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 collaborators, 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 and dual A2a/A2b receptor), HIF-2a, CD39, and AXL. For more information about Arcus Biosciences' clinical and preclinical programs, please visit www.arcusbio.com.

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; the timing and scope of analyses, data disclosures and presentations; whether data and results from studies validate our pipeline or support further development of a program; expected timing of clinical milestones, including the completion of enrollment; the potency, efficacy or safety of Arcus's investigational products; and the initiation of and associated timing for future studies, including statements about the number of Phase 3 studies that Arcus's investigational products will be in by the end of the year and Arcus's intention to initiate its first Phase 3 study evaluating casdatifan. 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 in Arcus's investigational products; 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; unfavorable global economic, political and trade conditions; 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
March 31,

 

 

2024

 

 

 

2023

 

Revenues:

 

 

 

License and development services revenue

$

135

 

 

$

17

 

Other collaboration revenue

 

10

 

 

 

8

 

Total revenues

 

145

 

 

 

25

 

 

 

 

 

Operating expenses:

 

 

 

Research and development

 

109

 

 

 

81

 

General and administrative

 

32

 

 

 

30

 

Impairment of long-lived assets

 

20

 

 

 

?

 

Total operating expenses

 

161

 

 

 

111

 

 

 

 

 

Loss from operations

 

(16

)

 

 

(86

)

 

 

 

 

Non-operating income (expense):

 

 

 

Interest and other income, net

 

13

 

 

 

9

 

Effective interest on liability for sale of future royalties

 

(1

)

 

 

(1

)

Total non-operating income, net

 

12

 

 

 

8

 

 

 

 

 

Loss before income taxes

 

(4

)

 

 

(78

)

 

 

 

 

Income tax expense

 

?

 

 

 

(2

)

 

 

 

 

Net loss

$

(4

)

 

$

(80

)

 

 

 

 

Net loss per share:

 

 

 

Basic and diluted

$

(0.05

)

 

$

(1.09

)

 

 

 

 

Shares used to compute net loss per share:

 

 

 

Basic and diluted

 

86.2

 

 

 

73.0

 

Selected Consolidated Balance Sheet Data

(unaudited)

(In millions)

 

 

March 31,
2024

 

December 31,
2023 (1)

Cash, cash equivalents and marketable securities

$

1,095

 

$

866

Total assets

 

1,293

 

 

1,095

Total liabilities

 

586

 

 

633

Total stockholders' equity

 

707

 

 

462

(1)

Derived from the audited financial statements for the quarter ended December 31, 2023, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 21, 2024.

 


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