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Arcus Biosciences Announces Second Quarter 2020 Financial Results and Corporate Updates

Established a 10-year global partnership with Gilead to co-develop and co-commercialize next-generation cancer immunotherapies

Strengthened balance sheet by raising approximately $348 million in gross proceeds from a public offering of Arcus’s common stock

Presented early clinical activity of etrumadenant (AB928) in late-line metastatic colorectal cancer patients

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced financial results for the second quarter ended June 30, 2020 and provided corporate updates.

“The multitude and quality of accomplishments from the Arcus team over the course of these dynamic few months have illustrated Arcus’s extraordinary commitment to its vision to consistently create, develop and deliver life-changing therapies to patients,” said Terry Rosen, Ph.D., Chief Executive Officer. “In this short period of time, Arcus and Gilead executed a partnership framework that enables Arcus to expand and accelerate the opportunities inherent in Arcus’s broad pipeline and discovery organization and expedite Arcus’s evolution into a sustainable, fully-integrated biopharmaceutical company. Arcus’s concurrent public offering raised additional funding to support aggressive advancement of four clinical molecules in highly pursued immuno-oncology pathways – TIGIT, the Adenosine Axis, and PD-1, including its near-term goals to expand its development programs and begin potential registrational studies in 2021. In addition, Arcus reported early clinical activity of etrumadenant (AB928) plus mFOLFOX-6 in late-line metastatic colorectal cancer during this year’s AACR conference, further enhancing the growing confidence in etrumadenant and its unique biological mechanism and providing basis for expanded future studies in the metastatic colorectal cancer setting. We are excited for this momentum to continue building in the second half of 2020 as we advance our mission to serve patients.”

As we continue to navigate through these unique and unprecedented times for the biotechnology industry and the world as a whole, the Arcus team has demonstrated their ability to be nimble and quickly adapt to shifting environments. We would like to acknowledge our staff for their extraordinary commitment to our mission, as well as the patients, caregivers and investigators that enabled our ongoing and new clinical trials and our shareholders for their ongoing support, particularly with respect to our May financing. We would also like to express our gratitude to Gilead for their collaborative efforts in designing, executing and closing an alliance that enables and cements Arcus’s trajectory toward becoming an independent biopharmaceutical company and to our colleagues at Taiho for their highly-regarded long-term support of Arcus since our early days and continued partnership in Japan. We enter the second half of 2020 in a stronger position than ever.

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Recent Key Highlights

Anticipated Near-Term Corporate Milestones

Through most of the second quarter, Arcus’s employees had been working remotely due to shelter-in-place orders, but in late June, Arcus began to transition its laboratory-based personnel back into its facilities. Arcus instituted a regular testing/monitoring program for COVID-19 in order to minimize the risks to Arcus’s employees as they return to work. Arcus continues to actively monitor the COVID-19 pandemic and its effects on our clinical trial operations, research and development programs, key vendors and employees. While we do not anticipate modifications to the timelines above, this will depend on future developments which are currently unknown, including any new information that may emerge concerning the duration and/or severity of the outbreak and any resurgences, any new actions by government authorities to contain the spread of the virus, and when and to what extent normal economic and operating conditions can resume.

Financial Results for the Second Quarter 2020 and Six Months Ended June 30, 2020

About Arcus Biosciences

Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to create highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first and only dual A2a/A2b adenosine receptor antagonist in the clinic, is being evaluated in multiple Phase 1b/2 studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor in the clinic, is in Phase 1 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-high metastatic non-small cell lung cancer evaluating zimberelimab monotherapy, AB154 with zimberelimab and AB154 plus AB928 with zimberelimab. Zimberelimab (AB122), Arcus’s anti-PD-1 monoclonal antibody, is also being evaluated in a Phase 1b study as monotherapy for cancers with no approved anti-PD-1 treatment options, and 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 other than statements of historical facts contained herein, including, but not limited to, Arcus’s expectations regarding the impact of COVID-19 on our operations, including ongoing and upcoming clinical trials, and financial condition; benefits associated with the Gilead partnership; and anticipated trials, milestones and timelines, 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 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 quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed on August 6, 2020 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.

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

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Collaboration and license revenue

 

$

1,750

 

 

$

1,750

 

 

$

3,500

 

 

$

3,500

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

35,693

 

 

 

24,999

 

 

 

58,835

 

 

 

40,553

 

General and administrative

 

 

11,432

 

 

 

5,911

 

 

 

18,440

 

 

 

10,879

 

Total operating expenses

 

 

47,125

 

 

 

30,910

 

 

 

77,275

 

 

 

51,432

 

Loss from operations

 

 

(45,375

)

 

 

(29,160

)

 

 

(73,775

)

 

 

(47,932

)

Non-operating income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

301

 

 

 

1,482

 

 

 

948

 

 

 

3,016

 

Gain on deemed sale from equity method investee

 

 

131

 

 

 

 

 

 

613

 

 

 

 

Share of loss from equity method investee

 

 

(131

)

 

 

(412

)

 

 

(613

)

 

 

(844

)

Total non-operating income, net

 

 

301

 

 

 

1,070

 

 

 

948

 

 

 

2,172

 

Net loss

 

 

(45,074

)

 

 

(28,090

)

 

 

(72,827

)

 

 

(45,760

)

Other comprehensive income

 

 

(144

)

 

 

84

 

 

 

80

 

 

 

220

 

Comprehensive loss

 

$

(45,218

)

 

$

(28,006

)

 

$

(72,747

)

 

$

(45,540

)

Net loss per share, basic and diluted

 

$

(0.93

)

 

$

(0.64

)

 

$

(1.57

)

 

$

(1.05

)

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

 

 

48,556,843

 

 

 

43,797,718

 

 

 

46,419,724

 

 

 

43,653,325

 

Selected Consolidated Balance Sheet Data

(In thousands)

(unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019(1)

 

Cash, cash equivalents and investments in marketable securities

 

$

462,473

 

 

$

188,270

 

Total assets

 

 

481,389

 

 

 

203,110

 

Total liabilities

 

 

52,679

 

 

 

39,268

 

Total stockholders’ equity

 

 

428,710

 

 

 

163,842

 

(1) Derived from the audited financial statements for the year ended December 31, 2019, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, dated March 5, 2020.

Contacts

Katherine Bock

(510) 694-6231

kbock@arcusbio.com

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