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): November 3, 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 November 3, 2016, Corvus Pharmaceuticals, Inc. issued a press release regarding, among other matters, its unaudited financial results for the three and nine months ended September 30, 2016 and its unaudited financial position as of September 30, 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: November 3, 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 |
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99.1 |
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Press release titled, Corvus Pharmaceuticals Announces Third Quarter 2016 Financial Results and Provides Business Update dated November 3, 2016. |
Exhibit 99.1
Corvus Pharmaceuticals Announces Third Quarter Financial Results
and Provides Business Update
Burlingame, Calif., November 3, 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 third quarter and nine months ended September 30, 2016 and provided a business update.
We continue to make good progress on the development of our lead product candidate, CPI-444, said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. Enrollment in the dose-selection stage of our Phase 1/1b trial with CPI-444 is complete and we are now enrolling patients in the expansion cohort stage of the trial, which is open in 35 sites in the U.S., Canada and Australia. In addition, we reported data on CPI-444 at two recent scientific meetings.
Recent Business Progress
CPI-444 Program
· Completed enrollment of 48 patients in four cohorts in the dose-selection part of the Phase 1/1b trial for the Companys lead oral checkpoint inhibitor, CPI-444, as a single agent and in combination with Genentechs TECENTRIQ® (atezolizumab), an anti-PD-L1 antibody.
· Selected an oral dose of 100 mg twice daily for 28 days for both the single agent and combination arms of the disease-specific expansion cohort stage of the trial, which is now enrolling.
· Presented preclinical and preliminary biomarker data at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in September, which showed that CPI-444 is well tolerated and that single agent treatment is associated with activation of T-cells detected in the blood. Corvus believes this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist.
· Presented additional biomarker data from the Phase 1/1b study showing continued evidence of treatment-related immune activation at the European Society for Medical Oncology (ESMO) Congress in October. CPI-444 continued to be generally well tolerated, with one patient experiencing a possibly drug related serious adverse event.
Other Product Candidates
· Demonstrated in preclinical studies that Corvus anti-CD73 antibody directly inhibited catalytic activity of CD73 and was differentiated from other competitive CD73 antibodies. Large scale manufacturing of anti-CD73 is in progress and IND enabling studies have been initiated.
· Selected a lead compound for Corvus interleukin-2 (IL-2)-inducible T-cell kinase (ITK) inhibitor program and initiated IND enabling studies.
Upcoming Milestone
· The Company expects to present preliminary efficacy data from the dose-selection part of the Phase 1/1b trial for CPI-444 in the fourth quarter of 2016.
Third Quarter 2016 Financial Results
At September 30, 2016, Corvus had cash, cash equivalents and marketable securities totaling $145.1 million. This compared to cash, cash equivalents and marketable securities of $94.4 million at December 31, 2015.
Research and development expenses for the three months ended September 30, 2016 totaled $7.7 million, an increase of $5.2 million from $2.5 million in the prior year period, primarily due to an increase of $1.2 million in personnel and related costs associated with higher headcount, an increase of $2.2 million in outside costs for the Phase 1/1b clinical trial for CPI-444, and an increase of $1.4 million in outside costs associated with other clinical development programs.
General and administrative expenses for the three months ended September 30, 2016 totaled $2.8 million, an increase of $2.2 million from $0.6 million in the prior year period, primarily due to an increase of $1.0 million in personnel and associated costs, an increase of $0.7 million in patent and related costs and $0.2 million in costs associated with operating as a public company.
The net loss for the three months ended September 30, 2016 was $10.3 million, compared with a net loss of $3.2 million, for same period in 2015. Total stock compensation expense for the three months ended September 30, 2016 was $1.3 million, compared to $0.1 million in the prior year period.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals 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. Corvus lead product, CPI-444, is a checkpoint inhibitor that 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. CPI-444 is currently being evaluated 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 Genentechs TECENTRIQ (atezolizumab), an anti-PD-L1 antibody. 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. 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 develop and advance product candidates into and successfully complete clinical trials, including the Companys Phase 1/1b clinical trial for CPI-444, the timing of regulatory filings and Phase I clinical trials for the Companys anti-CD73 antibody and ITK inhibitor, the utility of biomarker data collected and the suitability of the dosing regimen selected for the Companys Phase 1/1b clinical trial for CPI-444. 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 Companys control. The Companys 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 utilize biomarker data, select a suitable dosing regimen and 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 IND enabling studies and/or 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:
Jason Coloma, Ph.D.
SVP and Chief Business Officer
650-900-4511
JColoma@corvuspharma.com
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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Nine Months Ended |
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September 30, |
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September 30, |
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2016 |
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2015 |
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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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$ |
7,707 |
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$ |
2,514 |
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$ |
20,224 |
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$ |
6,443 |
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General and administrative |
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2,769 |
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606 |
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5,502 |
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1,223 |
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Total operating expenses |
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10,476 |
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3,120 |
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25,726 |
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7,666 |
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Loss from operations |
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(10,476 |
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(3,120 |
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(25,726 |
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(7,666 |
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Change in fair value of convertible preferred stock liability |
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(17,600 |
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Interest income and other expenses, net |
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179 |
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(31 |
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437 |
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(30 |
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Net loss |
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$ |
(10,297 |
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$ |
(3,151 |
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$ |
(25,289 |
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$ |
(25,296 |
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Net loss per share, basic and diluted |
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$ |
(0.51 |
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$ |
(7.97 |
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$ |
(1.83 |
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$ |
(72.98 |
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Shares used to compute net loss per share, basic and diluted |
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20,183,497 |
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395,320 |
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13,797,927 |
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346,621 |
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CORVUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
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September 30, |
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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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$ |
145,123 |
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$ |
94,386 |
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Other assets |
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4,640 |
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4,073 |
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Total assets |
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$ |
149,763 |
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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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$ |
6,853 |
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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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142,910 |
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(31,101 |
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Total liabilities, convertible preferred stock and stockholders equity |
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$ |
149,763 |
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$ |
98,459 |
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