Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

________________________________________________________

FORM 8-K

________________________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 23, 2024

________________________________________________________

Arcus Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

________________________________________________________

Delaware

001-38419

47-3898435

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

3928 Point Eden Way

Hayward, California

94545

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (510) 694-6200

(Former Name or Former Address, if Changed Since Last Report)

________________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.0001 Per Share

RCUS

The New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 Other Events.

On May 23, 2024, an abstract providing data from an interim analysis from Cohort B of Arcus Biosciences, Inc.’s (the “Company”) Phase 1b/2 clinical trial ARC-9 was published on the American Society of Clinical Oncology (“ASCO”) website. Cohort B of ARC-9 is evaluating etrumadenant and zimberelimab in combination with FOLFOX and bevacizumab vs. regorafenib in third-line metastatic colorectal cancer. The abstract has been selected for an oral presentation at the upcoming 2024 ASCO Annual Meeting, which presentation will occur on Sunday, June 2, 2024. The Company plans to issue a press release on June 2, 2024 to announce the full results of the interim analysis presented at the ASCO Annual Meeting.

A copy of the abstract is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.


Exhibit No.						Description
99.1						Abstract
104						Cover Page Interactive Data File (embedded within the Inline XBRL Document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	ARCUS BIOSCIENCES, INC.

Date: May 23, 2024	By:	/s/ Terry Rosen, Ph. D.
		Terry Rosen, Ph.D.
		Chief Executive Officer (Principal Executive Officer)

Exhibit 99.1

ARC-9: A Randomized Study to Evaluate Etrumadenant Based Treatment Combinations in Previously Treated Metastatic Colorectal Cancer (mCRC)

Authors: Zev A. Wainberg1, Sae-Won Han2, Soohyeon Lee3, Keun-Wook Lee4, Scott Kopetz5, Jonathan Mizrahi6, Yong Sang Hong7, Francois Ghiringhelli8, Antoine Italiano9, David Tougeron10, Brandon Beagle11, Mathew Boakye11, Tingting Zhao11, Joon Rhee12, Dimitry S.A. Nuyten11, Michael Cecchini13

Affiliations: 1David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA; 2Seoul National University Hospital, Seoul, South Korea; 3Korea University Anam Hospital, Seoul, South Korea; 4Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; 5The University of Texas MD Anderson Cancer Center, Houston, TX; 6Ochsner Medical Center, New Orleans, LA; 7Asan Medical Center, Seoul, South Korea; 8Centre Georges Francois Leclerc, Dijon, France; 9Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, France; 10Centre Hospitalier Universitaire de Poitiers, Poitiers, France; 11Arcus Biosciences, Inc., Hayward, CA; 12Gilead Sciences, Inc., Foster City, CA; 13Yale University School of Medicine, New Haven, CT

Background: Adenosine mediated signaling via A2a and A2b receptors impairs activation, proliferation, and cytotoxic activity of effector T cells resulting in inhibition of antitumor activity. Adenosine receptor blockade may therefore enhance therapeutic efficacy of chemo/immunotherapy regimens. Etrumadenant (E) is an orally bioavailable, selective, A2a and A2b receptor antagonist that has demonstrated safety and clinical activity in solid tumors when combined with chemo/immunotherapy.

ARC-9 (NCT04660812), a Phase Ib/II trial evaluating the safety and efficacy of E combined with zimberelimab (Z) (anti-PD-1 antibody), and FOLFOX/bevacizumab (bev) regimens or novel therapies in 3 cohorts of patients (pts) with mCRC. While FOLFOX rechallenge is frequently used in the management of mCRC, no prospective trials have been performed to date.

Methods: Cohort B enrolled pts who previously progressed on both oxaliplatin and irinotecan containing regimens. Pts were randomized 2:1 to EZFB: E (150 mg orally [PO] once daily [QD]) + Z (240 mg intravenous [IV] once every 2 weeks [Q2W]) + mFOLFOX-6 + bev (5 mg/kg IV Q2W), or regorafenib (rego) (160 mg PO QD [days 1-21 every 4 weeks]). Pts who progressed on rego were allowed to crossover to EZFB. The primary endpoint is progression-free survival (PFS) per RECIST 1.1 and overall survival (OS) is a key secondary endpoint.

Results: In Cohort B, 112 pts were randomized. Baseline characteristics are comparable between arms. As of 13 Nov 2023, with median follow up of 20.4 months (mo), EZFB demonstrated statistically significant improvement in PFS (HR 0.27, 95% CI 0.17-0.43, p<0.0001) and OS (HR 0.37, 95% CI 0.22-0.63, p=0.0003) vs rego (Table). EZFB had an acceptable safety profile, consistent with the known FOLFOX/bev toxicity profile with no deaths related to study treatment in either arm.

Conclusions: In this randomized phase II clinical trial, EZFB significantly improved efficacy outcomes compared to rego in refractory mCRC pts previously treated with 5-FU, oxaliplatin and irinotecan regimens with no unexpected toxicities. Further investigation of this promising regimen is warranted given the clinically meaningful PFS and OS improvement.

Table


Efficacy Population	EZFB: E + Z + mFOLFOX-6 ± beva (n=75)	Rego (n=37)
Confirmed ORR n (%) [90% CI]	13 (17.3) [10.6, 26.1]	1 (2.7) [0.1, 12.2]
Median PFS (mo) [95% CI]	6.2 [5.5, 7.5]	2.1 [1.8, 3.0]
PFS HR [95% CI]	0.27 [0.17, 0.43]	-
Median OS (mo) [95% CI]	19.7 (14.7, 20.6)	9.5 (8.0, 12.5)
OS HR [95% CI]	0.37 (0.22, 0.63)	-
Safety Population	n=74	n=35
Grade ≥3 TEAEs n (%)	61 (82.4)	17 (48.6)
Grade ≥3 related to E or Z or rego n (%)	17 (23.0)	9 (25.7)
TEAEs leading to discontinuation of all study drugs n (%)	4 (5.4)	6 (17.1)

aAdministered if bevacizumab is not contraindicated. HR, hazard ratio; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TEAE, treatment emergent adverse event

Cover	May 23, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	May 23, 2024
Entity Registrant Name	Arcus Biosciences, Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-38419
Entity Tax Identification Number	47-3898435
Entity Address, Address Line One	3928 Point Eden Way
Entity Address, City or Town	Hayward
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94545
City Area Code	510
Local Phone Number	694-6200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.0001 Per Share
Trading Symbol	RCUS
Security Exchange Name	NYSE
Entity Emerging Growth Company	false
Amendment Flag	false
Entity Central Index Key	0001724521