Corvus Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Business Update
“We made important progress in advancing our clinical programs and building our pipeline, with several notable developments in the first quarter that reinforce our continued leadership in the development of therapies targeting the adenosine pathway,” said
CPI-444: A2A Receptor Antagonist of Adenosine
- Amended the clinical trial protocol for the ongoing 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, in up to 50 patients with renal cell cancer (RCC) who have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor. Prior to this amendment, RCC patients were eligible and enrolled with up to five (median three) prior treatments regimens.
- Continued enrolling patients in the Phase 1b/2 trial, being conducted by Genentech as part of their MORPHEUS platform, which is evaluating CPI-444 and Tecentriq in up to 60 patients with non-small cell lung cancer (NSCLC) who have failed no more than two prior regimens.
CPI-006: Anti-CD73 Antibody
- As recently announced, initiated the Phase 1/1b clinical trial evaluating CPI-006, the Company’s anti-CD73 antibody, as a single agent and in combination with CPI-444, and in combination with pembrolizumab. The trial is anticipated to enroll up to 350 patients and 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.
- Advanced Investigational New Drug (IND) enabling studies and additional preclinical trials in spontaneous canine T-cell lymphoma for the Company’s interleukin-2–inducible kinase (ITK) inhibitor and progressed scale-up manufacturing activities in preparation for an anticipated IND filing in late 2018.
$64.9 millionin net proceeds in March 2018through an underwritten public offering, broadening our investor base.
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
The net loss for the three months ended
Tecentriq® is a registered trademark of Genentech.
Keytruda® is a registered trademark of Merck.
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.
About CD73 and Adenosine
CD73 is a cell surface enzyme whose function is to convert adenosine monophosphate (AMP) to adenosine by removing phosphate from AMP. CD73 is expressed on cells of the immune system, including T-cells and B-cells. CD73 is also present on many tumors, including lung, renal, melanoma, colon, prostate, breast and others. In the tumor microenvironment, CD73 produces adenosine, which binds to the adenosine A2A receptor on immune cells and inhibits various immune responses including those directed against the tumor. Tumors utilize this immunosuppressive mechanism to escape attack by the immune system.
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-144 and CPI-006, the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of CPI-444, the Company’s Phase 1/1b clinical trial of CPI-006 and the Company’s IND-enabling studies of its ITK inhibitor, the basis for and the timing of any future clinical trials of the Company’s ITK inhibitor and the utility of biomarker data collected and the suitability of dosing regimen selected for clinical trials. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended
Director, Business Development
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||$||12,103||$||13,497|
|General and administrative||2,541||2,720|
|Total operating expenses||14,644||16,217|
|Loss from operations||(14,644||)||(16,217||)|
|Net loss per share, basic and diluted||$||(0.63||)||$||(0.79||)|
|Shares used to compute net loss per share, basic and diluted||22,580,620||20,349,391|
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|March 31,||December 31,|
|Cash, cash equivalents and marktable securities||$||143,933||$||90,055|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||11,461||$||9,940|
|Total liabilities and stockholders' equity||$||148,689||$||94,775|
Source: Corvus Pharmaceuticals, Inc.