On March 10, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the fourth quarter and year ended December 31, 2016, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 10, 2017, View Source [SID1234518064]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2016, Corvus made the successful transition to becoming a public company, initiated clinical investigation of our lead program, CPI-444, and reported promising results, and continued to advance our additional pipeline candidates," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Preliminary data from our Phase 1/1b study has shown single agent activity, particularly in patients who are resistant or refractory to prior PD-1/PD-L1 therapy. We believe these findings place us in a unique position in the immuno-oncology field and we look forward to reporting updated data at the meeting of the American Association of Cancer Research in April."

RECENT ACHIEVEMENTS AND UPCOMING MILESTONES
Clinical & Preclinical Development

Initiated enrollment of the disease-specific expansion part of the Phase 1/1b clinical study of the Company’s lead oral checkpoint inhibitor, CPI-444, as a single agent and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. This second stage of the study utilizes an optimal oral dose of 100 mg twice daily for 28 days, which was identified in the initial dose-selection part of the study.
Expanded the cohort of renal cell carcinoma patients treated with single-agent CPI-444 from 14 to 26 patients in the Phase 1/1b clinical study, per predefined protocol criteria.
Reported evidence of single agent CPI-444 activity in patients in other disease-specific cohorts, including lung cancer and melanoma. Overall, in 33 patients receiving single agent CPI-444, two patients achieved partial responses and 12 patients had stable disease.
Presented preliminary safety and efficacy data from the dose-selection phase of the Phase 1/1b clinical study at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting.
Continued to progress anti-CD73 antibody and ITK inhibitor programs toward Phase 1 study initiation in 2018.
Plan to present clinical updates from the Phase 1/1b study of CPI-444 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2017 and at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017.
Plan to initiate a registration trial for CPI-444 in renal cell carcinoma patients, if the data warrant.
Anticipate expanding additional disease-specific cohorts in the Phase 1/1b clinical trial, if the data warrant.
Corporate

Appointed Ian T. Clark, former Genentech chief executive officer, to the Board of Directors.
Hold first R&D Day on March 14, 2017 to highlight the emerging role of the adenosine axis in immuno-oncology and provide additional updates on the CPI-444 program. Webcast information for the presentation will be provided closer to the date.
FINANCIAL RESULTS
At December 31, 2016, Corvus had cash, cash equivalents and marketable securities totaling $134.9 million. This compared to cash, cash equivalents and marketable securities of $94.4 million at December 31, 2015. The Company expects net cash utilization of $55 million to $60 million in 2017.

Research and development expenses for the three months and full year ended December 31, 2016 totaled $9.1 million and $29.4 million, respectively, compared to $4.9 million and $11.4 million for the same periods in 2015. In the fourth quarter of 2016, the increase of $4.2 million was primarily due to an increase of $0.6 million in personnel and related costs associated with higher headcount, an increase of $2.4 million in outside costs for the Phase 1/1b clinical trial for CPI-444, and an increase of $1.2 million in outside costs associated with other clinical development programs. For the full year 2016, the increase of $18.0 million was primarily due to an increase of $7.6 million in outside costs for the Phase 1/1b clinical trial for CPI-444, an increase of $4.5 million in personnel and related costs associated with higher headcount, and an increase of $3.7 million in outside costs associated with other clinical development programs.

General and administrative expenses for the three months and full year ended December 31, 2016 totaled $2.1 million and $7.6 million, respectively, compared to $1.2 million and $2.4 million for the same periods in 2015. In the fourth quarter of 2016, the increase of $0.9 million was primarily due to an increase of $0.9 in other personnel and associated costs, primarily due to an increase of $0.6 million in stock compensation costs. For the full year 2016, the increase of $5.2 million was primarily due to an increase of $3.1 million in personnel and associated costs, $0.9 million in costs associated with operating as a public company and an increase of $0.6 million in patent and related costs.

The net loss for the three months and full year ended December 31, 2016 was $11.1 million and $36.4 million, respectively, compared to $6.0 million and $31.3 million for the same periods in 2015. The net loss of $31.3 million in 2015 included a loss of $17.6 million associated with the change in fair value of a convertible preferred stock liability. Total stock compensation expense for the three months and full year ended December 31, 2016 was $1.0 million and $3.8 million, respectively, compared to $0.3 million and $0.4 million for the same periods in 2015.