On March 1, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the fourth quarter and year ended December 31, 2017, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335772 [SID1234524299]).
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"In 2017, Corvus continued to make progress in expanding its pipeline of product candidates. We have enrolled more than 235 patients on our Phase 1/1b trial with CPI-444 and met the objectives of the trial, which were to optimize dose and schedule, establish safety and identify efficacy signals in renal cell cancer and non-small cell lung cancer (NSCLC)," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This now positions us to expand studies in both renal cell cancer and NSCLC using patient selection criteria determined from our initial studies. These studies will focus on patients who have failed prior therapy with anti-PD-(L)1 antibodies, a situation ideally suited for our drug and representing an unmet need in oncology. We also plan to begin enrolling patients in our Phase 1/1b trial with our anti-CD73 antibody (CPI-006) in the first quarter of 2018."
RECENT ACHIEVEMENTS
Clinical & Preclinical Development
Continued enrollment in the Phase 1/1b clinical study of the Company’s lead oral checkpoint inhibitor, CPI-444, with over 235 patients enrolled to date. This study is investigating CPI-444 as a single agent and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody, with expansion cohorts in renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC).
Presented updated clinical response data in 30 patients from the single agent and combination RCC cohorts of the Phase 1/1b clinical study at an oral session at the meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) annual meeting. Biomarker data from the trial showed an association between adenosine pathway gene expression and response to therapy, and resistance to prior anti-PD-(L)1 treatment.
Initiated patient enrollment in a randomized, controlled Phase 1b/2 clinical trial, being conducted by Genentech as part of their MORPHEUS platform, to evaluate CPI-444 in combination with Tecentriq as second- or third-line therapy in patients with NSCLC who are resistant or refractory to prior anti-PD-(L)1 antibody therapy.
Reported preliminary data from an ongoing study with our ITK inhibitor at the T-Cell Lymphoma Forum. In the preclinical study, two dogs were treated — one with peripheral T cell lymphoma (PTCL) and one with cutaneous T cell lymphoma (CTCL). Results showed evidence of antitumor activity in both animals. A complete response was achieved in the PTCL animal after 28 days of daily dosing, and a partial response was achieved in the CTCL animal within 14 days of the initiation of treatment. The compound was well tolerated in both dogs, with no clinical signs or laboratory findings of toxicity.
UPCOMING MILESTONES
Amend ongoing Phase 1/1b clinical trial of CPI-444 in combination with Tecentriq, to enroll patients in a Phase 1b/2 trial in RCC patients that have failed anti-PD-(L)1 and a tyrosine kinase inhibitor.
Initiate enrollment in a Phase 1/1b clinical trial with CPI-006 in patients with advanced cancers in the first quarter of 2018.
Select development candidates for two additional programs, an adenosine small molecule antagonist of the A2B receptor and an antibody to an undisclosed target that was in-licensed in 2017.
FINANCIAL RESULTS
At December 31, 2017, Corvus had cash, cash equivalents and marketable securities totaling $90.1 million. This compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016. The Company expects net cash utilization of $43 million to $47 million in 2018.
Research and development expenses for the three months and full year ended December 31, 2017 totaled $9.7 million and $46.3 million, respectively, compared to $9.1 million and $29.4 million for the same periods in 2016. In the fourth quarter of 2017, the increase of $0.6 million was primarily due to an increase of $0.8 million in personnel and related costs associated with higher headcount. This increase was partially offset by a decrease of $0.2 million in outside costs for the Phase 1/1b clinical trial for CPI-444. For the full year 2017, the increase of $16.9 million was primarily due to an increase of $11.0 million in outside costs for the Phase 1/1b clinical trial for CPI-444, an increase of $3.2 million in outside costs associated with the development of CPI-006 and an increase of $2.1 million in personnel and related costs associated with higher headcount.
General and administrative expenses for the three months and full year ended December 31, 2017 totaled $2.5 million and $10.2 million, respectively, compared to $2.1 million and $7.6 million for the same periods in 2016. In the fourth quarter of 2017, the increase of $0.4 million was primarily due to an increase of $0.3 in personnel and associated costs. For the full year 2017, the increase of $2.6 million was primarily due to an increase of $2.0 million in personnel and associated costs and $0.6 million in costs associated with operating as a public company.
The net loss for the three months and full year ended December 31, 2017 was $11.9 million and $55.7 million, compared to $11.1 million and $36.4 million for the same periods in 2016. Total stock compensation expense for the three months and full year ended December 31, 2017 was $1.7 million and $6.2 million, compared to $1.0 million and $3.8 million for the same periods in 2016.