UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2016
CORVUS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-37719 |
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46-4670809 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
863 Mitten Road, Suite 102
Burlingame, CA 94010
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (650) 900-4520
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On May 5, 2016, Corvus Pharmaceuticals, Inc. issued a press release regarding, among other matters, its unaudited financial results for the three months ended March 31, 2016 and its unaudited financial position as of March 31, 2016. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
Reference is made to the Exhibit Index attached hereto.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CORVUS PHARMACEUTICALS, INC. | |
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Date: May 5, 2016 |
By: |
/s/ Leiv Lea |
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Leiv Lea |
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Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
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Description |
99.1 |
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Press release titled, Corvus Pharmaceuticals Announces First Quarter 2016 Financial Results dated May 5, 2016. |
Exhibit 99.1
For Immediate Release
Corvus Pharmaceuticals Announces First Quarter 2016 Financial Results
Burlingame, Calif., May 5, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, today announced financial results for the three months ended March 31, 2016.
Since commencing operations in November 2014, weve made substantial progress and today, we have four product candidates in our pipeline focused on immuno-oncology therapies, said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus.
In the first quarter of 2016, our achievements were particularly noteworthy as we commenced enrollment in an expansion cohort designed Phase 1/1b clinical trial to evaluate our novel oral checkpoint inhibitor, CPI-444, alone and in combination with atezolizumab, an investigational anti-PD-L1 antibody from Genentech in patients with solid tumors. We also successfully completed our IPO, raising $63.7 million in net proceeds before the partial exercise of the underwriters over-allotment option, said Miller.
First Quarter 2016 Financial Results Compared To First Quarter 2015 Financial Results
At March 31, 2016, Corvus had cash and cash equivalents and marketable securities totaling $152.3 million, compared to $94.4 million at December 31, 2015.
Research and development costs for the three months ended March 31, 2016 totaled $5.4 million, compared with $1.9 million, for the prior period. The increase was primarily due to costs associated with commencing the Phase 1/1b clinical trial for the Companys lead product candidate, CPI-444.
General and administrative costs for the three months ended March 31, 2016 totaled $1.0 million, compared to $0.3 million for the prior period, due to increased headcount and professional fees associated with the Companys preparation for being a public company.
The net loss for the three months ended March 31, 2016 was $6.3 million compared to a net loss for the three months ended March 31, 2015 of $1.9 million.
Additionally, in April 2016, the underwriters of the Companys IPO exercised their over-allotment option and purchased 502,618 shares of Corvuss common stock resulting in net proceeds to the Company of $7.0 million.
About Adenosine A2A Receptor Antagonists
Over the last several years, significant progress has been made in developing immunotherapies for the treatment of cancer, in part due to the development of checkpoint inhibitors antibodies that block immuno-suppressive mechanisms.
Tumors evade immune attack by usurping pathways that negatively regulate immune responses. Adenosine in the tumor microenvironment leads to the activation of the A2A receptor and has been shown to represent one such negative immune regulatory mechanism. Because the tumor microenvironment produces relatively high concentrations of adenosine, blocking A2A receptor activation has the potential to enhance anti-tumor immunity. Data have demonstrated the ability of A2A receptor blockade to enhance anti-tumor immunity, checkpoint blockade and adoptive T-cell therapy. Studies to date support the development of A2A receptor antagonists as novel immunotherapy treatments.
About CPI-444
CPI-444, Corvuss lead checkpoint inhibitor, is an adenosine A2A receptor antagonist. It is designed to disable a tumors ability to subvert attack by the immune system by inhibiting adenosine in the tumor microenvironment. CPI-444 is a small molecule that is taken orally. It is in development as an immuno-oncology therapy for the treatment of patients with solid tumors.
Corvus is currently evaluating CPI-444 in a multicenter Phase 1/1b clinical trial in patients with various solid tumors. This successive expansion cohort trial is examining the activity of CPI-444 both as a single agent and in combination with atezolizumab (MPDL3280A), Genentechs investigational cancer immunotherapy. Atezolizumab is a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1). Corvus is conducting the trial with Genentech, a member of the Roche Group, under a clinical trial collaboration the two companies entered into in October 2015.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals (NASDAQ: CRVS) is a clinical-stage biopharmaceutical company focused on the development and commercialization of small molecule and antibody agents that target the immune system to treat patients with cancer. These agents block or modify crucial immune checkpoints and reprogram immune T-cells. For more information, visit www.corvuspharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential efficacy of CPI-444, both as a single agent and in combination with anti-PD-1 or anti-PD-L1, the Companys ability to identify assets that can be in-licensed and further developed internally. 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 Corvuss control. Corvuss 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 Companys registration statement on Form S-1 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Companys ability to demonstrate evidence of efficacy and safety for CPI-444 during its Phase 1/1b clinical trial; the accuracy of the Companys estimates relating to its ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such
statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
# # #
Investor Contact:
Leiv Lea
Chief Financial Officer
LLea@corvuspharma.com
650-900-4522
Media Contact:
Julie Normart, W2O Group
415-946-1087
jnormart@w2ogroup.com
CORVUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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2016 |
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2015 |
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Operating expenses: |
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Research and development |
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$ |
5,397 |
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$ |
1,924 |
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General and administrative |
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1,029 |
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290 |
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Total operating expenses |
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6,426 |
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2,214 |
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Loss from operations |
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(6,426 |
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(2,214 |
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Change in fair value of convertible preferred stock liability |
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300 |
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Interest income |
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79 |
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1 |
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Net loss |
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$ |
(6,347 |
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$ |
(1,913 |
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Net loss per share, basic and diluted |
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$ |
(5.39 |
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$ |
(6.44 |
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Shares used to compute net loss per share, basic and diluted |
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1,176,546 |
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297,123 |
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CORVUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2016 |
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2015 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
152,300 |
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$ |
94,386 |
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Other Assets |
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4,924 |
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4,073 |
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Total assets |
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$ |
157,224 |
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$ |
98,459 |
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Liabilities, Convertible Preferred Stock and Stockholders Equity (Deficit) |
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Accounts payable and accrued liabilities and other liabilities |
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$ |
4,674 |
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$ |
3,780 |
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Convertible preferred stock |
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125,780 |
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Stockholders equity (deficit) |
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152,550 |
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(31,101 |
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Total liabilities, convertible preferred stock and stockholders equity |
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$ |
157,224 |
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$ |
98,459 |
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