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Arcus Biosciences Reports First Quarter 2021 Financial Results and Provides Operational Highlights

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 first quarter ended March 31, 2021 and provided operational highlights.

“Our ongoing clinical trials include six randomized studies with several that are expected to provide meaningful readouts over the next 12 months,” said Terry Rosen, Ph.D., CEO. “We expect the next milestone in our anti-TIGIT program, the ARC-7 interim analysis, later this quarter. We also continue to generate substantial clinical evidence to support our first-in-class therapies targeting the ATP-adenosine axis having recently presented data from ARC-3 which showed a doubling of progression-free survival and overall survival for etrumadenant and chemotherapy in late-line colorectal cancer compared to those reported for current standard-of-care therapies, and promising results for AB680 in first-line pancreatic cancer. We will present initial data from ARC-6, evaluating etrumadenant plus zimberelimab and chemotherapy in metastatic castrate-resistant prostate cancer, at the upcoming ASCO Annual Meeting.”

Anti-TIGIT Program

Domvanalimab (FcR-silent anti-TIGIT antibody)

Recent Highlights:

Upcoming Milestones:

AB308 (FcR-enabled anti-TIGIT antibody)

AB680 (CD73 inhibitor)

Recent Highlights:

Upcoming Milestones:

Etrumadenant (A2a/A2b adenosine receptor antagonist)

Recent Highlights:

Upcoming Milestones:

HIF-2α inhibitor Program

Financial Results for the First Quarter 2021 Ended March 31, 2021

Arcus Clinical Study Overview

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

ARC-12

AB308 + Zim

Advanced Malignancies

Initiated Phase 1/1b

NCT04772989

PACIFIC-8

Durva ± Dom

Curative-Intent Stage 3 NSCLC

Expected initiation 2H21 Registrational

NA

CRC: colorectal cancer, NSCLC: non-small cell lung cancer, CRPC: castrate-resistant prostate cancer, PDAC: pancreatic ductal adenocarcinoma, Durva: durvalumab

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% locally advanced or metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab + zimberelimab and domvanalimab + etrumadenant + 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 is expected to advance into a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting later this year. AB308, an anti-TIGIT antibody that is FcR-enabled, advanced 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 meaningful readouts and ability to generate substantial clinical evidence as set forth in Dr. Rosen’s quote, the potential for the ARC-7 interim analysis to inform a potential opt-in decision by Gilead, Arcus’s anticipated milestones and associated timelines described herein and Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand will 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; the inherent uncertainty associated with pharmaceutical product development and clinical trials; our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products; 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 unexpected 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 March 31, 2021 filed on May 5, 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

(unaudited)

(In thousands, except share and per share amounts)

 

 

 

 

 

Three Months Ended

 

 

March 31,

 

 

2021

 

2020

Revenues:

 

 

 

 

 

 

Collaboration revenue

 

$

9,461

 

 

$

1,750

 

Total collaboration and license revenues

 

 

9,461

 

 

 

1,750

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

66,387

 

 

 

23,142

 

General and administrative

 

 

15,821

 

 

 

7,008

 

Total operating expenses

 

 

82,208

 

 

 

30,150

 

Loss from operations

 

 

(72,747

)

 

 

(28,400

)

Non-operating income (expense):

 

 

 

 

 

 

Interest and other income, net

 

 

154

 

 

 

647

 

Gain on deemed sale from equity method investee

 

 

 

 

 

482

 

Share of loss from equity method investee

 

 

 

 

 

(482

)

Total non-operating income, net

 

 

154

 

 

 

647

 

Net loss

 

 

(72,593

)

 

 

(27,753

)

Other comprehensive income (loss)

 

 

(46

)

 

 

224

 

Comprehensive loss

 

$

(72,639

)

 

$

(27,529

)

Net loss per share, basic and diluted

 

$

(1.08

)

 

$

(0.63

)

Weighted-average number of shares used to compute basic and diluted net loss per share

 

 

67,082,161

 

 

 

44,282,607

 

Selected Consolidated Balance Sheet Data

(unaudited)

(In thousands)

 

 

 

March 31,

 

December 31,

 

 

2021

 

2020(1)

Cash, cash equivalents and investments in marketable securities

 

$

884,912

 

$

735,086

Total assets

 

 

935,119

 

 

772,292

Total liabilities

 

 

270,329

 

 

269,988

Total stockholders’ equity

 

 

664,790

 

 

502,304

(1) Derived from the audited financial statements for the year ended December 31, 2020, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2021.

Contacts

Arcus Contact:
Katherine Bock

VP Investor Relations & Corporate Strategy

(510) 694-6231

kbock@arcusbio.com

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