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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): April 30, 2020  

CORVUS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware001-3771946-4670809
(State or other jurisdiction
of incorporation)		(Commission
File Number)		(IRS Employer
Identification Number)

 

863 Mitten Road, Suite 102
Burlingame, CA 94010
(Address of principal executive offices, including Zip Code)

Registrant's 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:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, Par Value $0.0001 per shareCRVSNasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ X ]

 

Item 2.02. Results of Operations and Financial Condition.

          On April 30, 2020, Corvus Pharmaceuticals, Inc. issued a press release regarding, among other matters, its financial results for the first quarter ended March 31, 2020 and its financial position as of March 31, 2020, and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

          The 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.

Exhibit No. Description
   
99.1 Press release of Corvus Pharmaceuticals, Inc. dated April 30, 2020.

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.

 CORVUS PHARMACEUTICALS, INC.
   
  
Date: April 30, 2020By: /s/ Leiv Lea        
  Leiv Lea
  Chief Financial Officer
  

EdgarFiling

EXHIBIT 99.1

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2020 Financial Results

Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT

BURLINGAME, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, today provided a business update and announced financial results for the first quarter ended March 31, 2020.

“In the first quarter, we continued enrolling patients across our three clinical stage programs and reported positive data updates for ciforadenant, the Adenosine Gene Signature, and CPI-818,” said Richard A. Miller, M.D.,  president and chief executive officer of Corvus. “With ciforadenant, CPI-006 and the Adenosine Gene Signature, we have a leadership position in the development of targeted medicines addressing the adenosine pathway. We look forward to providing another important update for ciforadenant at ASCO, where we will present new data in renal cell cancer, including data confirming the utility of the Adenosine Gene Signature as a predictive biomarker to identify patients most likely to respond to treatment with ciforadenant.”

“We also worked closely with our clinical trial sites to quickly adapt and update our study protocols to ensure patient and healthcare provider safety in light of the COVID-19 pandemic. We are pleased that this enabled enrollment and follow-up activities for patients in our studies to continue with minimal disruption. Fortunately, we have had strong enrollment in our clinical studies up to this point, allowing us to collect important clinical data as the studies mature.”

Recent Achievements

Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine             

CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity

CPI-818: A small molecule ITK inhibitor

Anticipated Events in 2020

Financial Results

At March 31, 2020, Corvus had cash, cash equivalents and marketable securities totaling $68.7 million, as compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019.  Corvus has revised its financial forecast for 2020 and now expects full year 2020 net cash used in operating activities to be between $29 million and $31 million, versus prior expectations in the range of $39 million to $42 million. The decrease is primarily related to reduced levels of both drug manufacturing and new patient enrollment in the Company’s clinical trials for the remainder of 2020 due to the impact of the COVID-19 pandemic.

Research and development expenses for the three months ended March 31, 2020 totaled $10.2 million compared to $9.4 million for the same period in 2019. The increase of $0.8 million was primarily due to a $1.3 million increase in CPI-006 clinical trial expenses, partially offset by a $0.9 million reduction in CPI-818 drug manufacturing costs. 

The net loss for the three months ended March 31, 2020 was $12.9 million, compared to a net loss of $11.6 million for the same period in 2019. Total stock compensation expense for the three months ended March 31, 2020 was $1.8 million compared to $2.0 million of total stock compensation expense for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, April 30, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2020 financial results. The conference call can be accessed by dialing 1-800-479-1004 (toll-free domestic) or 1-720-543-0206 (international) and using the conference ID 6494327. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These product candidates are being studied in ongoing Phase 1/1b and Phase 1b/2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (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.

Adenosine Gene Signature
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor.  These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated macrophages, which are thought to mediate resistance to anti-PD(L)1 treatment. To date, in our clinical trial of  renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant.

About CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. This antibody also possesses immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking, which are independent of adenosine.  In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.

About CPI-818
CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company’s ability to identify and utilize the adenosine gene signature for purposes of its clinical trials, including the Company’s Phase 1b/2 clinical trial of ciforadenant, the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1b/2 clinical trial of ciforadenant, the Company’s Phase 1/1b clinical trial of CPI-006,  the Company’s Phase 1/1b clinical trial of CPI-818, the suitability of dosing regimen selected for clinical trials, and the impact of COVID-19 and related “shelter in place” orders and other public health guidance measures on our clinical programs and business operations. 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 March 31, 2020, filed with the Securities and Exchange Commission on April 30, 2020, 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 Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ciforadenant, CPI-006 and CPI-818; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the Company’s ability to utilize biomarker data and select a suitable dosing regimen; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; and the effects of COVID-19 on the Company’s clinical programs and business operations. 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
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
W2O pure
+1 213-262-9390
sseapy@purecommunications.com


CORVUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)

    
 Three Months Ended
March 31,
  2020   2019 
        
 (unaudited)
Operating expenses:   
Research and development$10,163  $9,419 
General and administrative 3,106   2,886 
Total operating expenses 13,269   12,305 
Loss from operations (13,269)  (12,305)
Interest income and other expense, net 334   662 
Net loss$(12,935) $(11,643)
Net loss per share, basic and diluted$(0.44) $(0.40)
Shares used to compute net loss per share, basic and diluted 29,411,233   29,292,135 
    



CORVUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands)

    
 March 31, December 31,
  2020   2019 
 (unaudited)  
Assets   
Cash, cash equivalents and marketable securities$68,707  $77,982 
Operating lease right-of-use asset 2,163   2,327 
Other assets 2,927   3,337 
Total assets$73,797  $83,646 
Liabilities and stockholders' equity   
Accounts payable and accrued liabilities and other liabilities$10,785  $9,347 
Operating lease liability 2,977   3,188 
Stockholders' equity 60,035   71,111 
Total liabilities and stockholders' equity$73,797  $83,646