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- Three dose-escalation trials evaluating AB928, the Company’s dual adenosine receptor antagonist, in combination with other agents are now enrolling patients; Initial data from the dose-escalation trials expected in the second quarter of 2019 -
- Initiated dosing in patients for the Company’s third clinical candidate, AB154, an anti-TIGIT antibody -
- Ended the quarter with $265.6 million in cash and investments and funding into 2021 -
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, today announced financial results for the third quarter ended September 30, 2018 and provided updates on its clinical and preclinical programs.
“This was another productive quarter for Arcus as we began dosing patients with our third product candidate, AB154, and made significant progress advancing our initial combination trials for AB928,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. “The starting dose for the dose-escalation portion of our AB928 combination trials is 75 mg once-daily, a dose that demonstrated significant inhibition of the adenosine 2a receptor pathway in our healthy volunteer study. We have incorporated extensive biomarker analysis into the design of our AB928 combination trials to determine if clinical responses observed in the trials can be attributed to the mechanism of action of AB928. We look forward to reporting initial clinical data for both AB928 and AB154, as well as data from our healthy volunteer study of AB680, our small-molecule CD73 inhibitor, in 2019.”
Pipeline Updates and Poster Presentations
AB928 (dual A2aR/A2bR antagonist)
The Company also expects the following AB928 dose-escalation trial to be open for enrollment shortly:
In the above NSCLC trial, the Company also plans to explore AB928 combinations in the relapsed/refractory setting, including in patients previously treated with anti-PD-1 therapy.
AB122 (anti-PD-1 antibody)
AB154 (anti-TIGIT antibody)
AB680 (small molecule CD73 inhibitor)
In the first half of 2019, the Company expects to:
In the middle of 2019, the Company expects to:
In the second half of 2019, the Company expects to:
Third Quarter and Year-to-Date 2018 Financial Results
Based on its current operating plan, the Company expects that its cash and investments as of September 30, 2018 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into 2021.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies. Arcus has several programs targeting important immuno-oncology pathways, including a dual adenosine receptor antagonist, AB928, which is in a Phase 1/1b program to evaluate AB928 in combination with other agents in multiple tumor types, and an anti-PD-1 antibody, AB122, which is being evaluated in a Phase 1 trial and is being tested in combination with Arcus’s other product candidates. Arcus’s other programs include AB154, an anti-TIGIT antibody, which is in a Phase 1 trial to evaluate AB154 as monotherapy and in combination with AB122, and AB680, a small molecule inhibitor of CD73, which has entered clinical development. Arcus has extensive in-house expertise in medicinal chemistry, immunology, biochemistry, pharmacology and structural biology. For more information about Arcus Biosciences, please visit www.arcusbio.com.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including, but not limited to, Arcus’s clinical development plans, biomarker activities, milestones and timelines, and anticipated operating expenses and capital expenditure requirements 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 pharmaceutical product development and clinical trials, difficulties or delays in developing and validating biomarkers and related assays, 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, and the emergence of adverse events or other undesirable side effects. Risks and uncertainties facing Arcus are described more fully in Arcus’s quarterly report on Form 10-Q for the quarter ended September 30, 2018 filed on November 8, 2018 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.
Doxil® is a registered trademark of Alza Corporation.
|ARCUS BIOSCIENCES, INC.|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)|
|September 30,||December 31,|
|Cash and cash equivalents||$||74,889||$||98,426|
|Receivable from collaboration partners||5,000||—|
|Prepaid expenses and other current assets||2,329||1,141|
|Amounts owed by a related party||114||25|
|Total current assets||265,280||176,869|
|Property and equipment, net||11,762||11,230|
|Equity investment in related party||1,525||682|
|Other long-term assets||205||1,502|
|Deferred revenue, current||6,250||5,000|
|Other current liabilities||1,585||769|
|Total current liabilities||16,611||12,726|
|Deferred revenue, noncurrent||18,546||18,587|
|Other long-term liabilities||2,047||565|
|Convertible preferred stock||—||226,196|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||355,758||948|
|Accumulated other comprehensive loss||(108||)||(42||)|
|Total stockholders’ equity (deficit)||245,121||(72,328||)|
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
(1) Derived from the audited financial statements for the year ended December 31, 2017, included in the Company's Prospectus filed with the Securities and Exchange Commission, dated March 14, 2018.
|ARCUS BIOSCIENCES, INC.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration and license revenue||$||4,291||$||163||$||6,791||$||163|
|Research and development||12,859||21,435||38,210||35,072|
|General and administrative||3,577||1,862||9,956||5,188|
|Total operating expenses||16,436||23,297||48,166||40,260|
|Loss from operations||(12,145||)||(23,134||)||(41,375||)||(40,097||)|
|Interest and other income, net||1,333||12||4,076||225|
|Other comprehensive gain (loss)||(25||)||14||(66||)||17|
|Net loss per share, basic and diluted||$||(0.25||)||$||(11.86||)||$||(1.16||)||$||(23.47||)|
Weighted-average number of shares used to compute basic and diluted net loss per share
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