On November 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 third quarter ended September 30, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, NOV 1, 2018, View Source [SID1234530625]).
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"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are encouraged by ongoing presentation of data related to both programs at medical meetings and in peer-reviewed journals. This includes biomarker data for CPI-444 that our team presented at the ESMO (Free ESMO Whitepaper) 2018 Congress on October 22, 2018. We also are looking forward to presenting additional new clinical and biomarker data for both programs at the SITC (Free SITC Whitepaper) annual meeting on November 9 and 10, 2018. Our progress continues to demonstrate that we are a leader in designing and developing medicines that modulate the adenosine pathway and that have demonstrated efficacy as monotherapies and in combination with other agents. We are also advancing our ITK inhibitor, CPI-818, toward the clinic and expect to initiate a clinical trial in early 2019."
Recent Achievements
CPI-444: A2A Receptor Antagonist of Adenosine
Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1/1b clinical trial evaluating CPI-444, the Company’s lead product candidate, administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. Patients in the study have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor, compared to having failed up to five (median three) prior treatment regimens in prior CPI-444 studies.
Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Presented new data on the "adenosine gene signature," a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress.
CPI-006: Anti-CD73 Antibody
Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with CPI-444, and in combination with an anti-PD-1. The trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with NSCLC, RCC, and other cancers who have failed standard therapies.
CPI-818: A small molecule ITK inhibitor
Plan to submit an Investigational New Drug (IND) filing for CPI-818, the Company’s interleukin-2-inducible kinase (ITK) inhibitor, in early 2019.
Preclinical data on CPI-818 to be presented by Douglas H. Thamm, VMD, DACVIM (Oncology) at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, November 13 through 16, 2018 in Dublin, Ireland.
Financial Results
As of September 30, 2018, Corvus had cash, cash equivalents and marketable securities totaling $122.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017.
Research and development expenses for the three months ended September 30, 2018 totaled $8.4 million compared to $10.7 million for the same period in 2017. The decrease of $2.3 million was primarily due to a decrease in CPI-444 clinical trial expenses.
General and administrative expenses for the three months ended June 30, 2018 totaled $2.8 million compared to $2.2 million for the same period in 2017. The increase of $0.6 million was primarily due to an increase of $0.3 million in patent and public company expenses, and an increase of $0.2 million in personnel costs.
The net loss for the three months ended September 30, 2018 was $10.5 million compared to $12.7 million for the same period in 2017. Total stock compensation expense for the three months ended September 30, 2018 was $1.8 million compared to $1.5 million for the same period in 2017.