Item 1. Financial Statements
Item 1.
Financial Statements (unaudited)
3
Condensed Consolidated Balance Sheets
3
Condensed Consolidated Statements of Operations and Comprehensive Loss
4
Condensed Consolidated Statements of Change in Stockholders’ Equity
5
Condensed Consolidated Statements of Cash Flows
6
Notes to Condensed Consolidated Financial Statements
7
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
33
Item 4
Controls and Procedures
33
PART II — OTHER INFORMATION
Item 1.
Legal Proceedings
35
Item 1A.
Risk Factors
35
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
82
Item 3.
Defaults Upon Senior Securities
82
Item 4.
Mine Safety Disclosures
82
Item 5.
Other Information
82
Item 6.
Exhibits
83
SIGNATURES
84
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PART I - FINANCIAL INFORMATION
Item 1. Unaudited Condensed Financial Statements
CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
(unaudited)
September 30,
December 31,
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
22,976
$
5,154
Marketable securities
28,385
72,828
Prepaid and other current assets
1,148
1,362
Total current assets
52,509
79,344
Property and equipment, net
1,048
1,462
Operating lease right-of-use asset
1,825
2,327
Other assets
480
513
Total assets
$
55,862
$
83,646
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
2,571
$
2,448
Operating lease liability
1,026
878
Accrued and other liabilities
8,404
6,899
Total current liabilities
12,001
10,225
Operating lease liability
1,511
2,310
Total liabilities
13,512
12,535
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock: $ 0.0001 par value; 10,000,000 shares authorized at September 30, 2020 and December 31, 2019; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019
—
—
Common stock: $ 0.0001 par value; 290,000,000 shares authorized at September 30, 2020 and December 31, 2019; 28,059,900 and 27,953,233 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
3
3
Additional paid-in capital
292,822
288,224
Accumulated other comprehensive income
12
29
Accumulated deficit
( 250,487 )
( 217,145 )
Total stockholders’ equity
42,350
71,111
Total liabilities and stockholders’ equity
$
55,862
$
83,646
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
6,619
$
8,996
$
24,639
$
29,055
General and administrative
3,226
2,517
9,242
8,359
Total operating expenses
9,845
11,513
33,881
37,414
Loss from operations
( 9,845 )
( 11,513 )
( 33,881 )
( 37,414 )
Interest income and other expense, net
49
509
539
1,789
Net loss
$
( 9,796 )
$
( 11,004 )
$
( 33,342 )
$
( 35,625 )
Net loss per share, basic and diluted
$
( 0.33 )
$
( 0.37 )
$
( 1.13 )
$
( 1.21 )
Shares used to compute net loss per share, basic and diluted
29,500,318
29,389,003
29,419,431
29,331,290
Other comprehensive loss:
Unrealized gain (loss) on marketable securities
( 41 )
( 5 )
( 17 )
68
Comprehensive loss
$
( 9,837 )
$
( 11,009 )
$
( 33,359 )
$
( 35,557 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share data)
(unaudited)
Nine Months Ended September 30, 2020
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Equity
Balance at December 31, 2019
27,953,233
$
3
$
288,224
$
29
$
( 217,145 )
$
71,111
Stock-based compensation expense
—
—
1,845
—
—
1,845
Unrealized gain on marketable securities
—
—
—
14
—
14
Net loss
—
—
—
—
( 12,935 )
( 12,935 )
Balance at March 31, 2020
27,953,233
$
3
$
290,069
$
43
$
( 230,080 )
$
60,035
Common stock issued on exercise of stock options
81,500
—
23
—
—
23
Stock-based compensation expense
—
—
1,383
—
—
1,383
Unrealized gain on marketable securities
—
—
—
10
—
10
Net loss
—
—
—
—
( 10,611 )
( 10,611 )
Balance at June 30, 2020
28,034,733
$
3
$
291,475
$
53
$
( 240,691 )
$
50,840
Common stock issued on exercise of stock options
25,167
—
64
—
—
64
Vesting of restricted stock for early exercise of stock options
—
—
—
—
—
—
Stock-based compensation expense
—
—
1,283
—
—
1,283
Unrealized loss on marketable securities
—
—
—
( 41 )
—
( 41 )
Net loss
—
—
—
—
( 9,796 )
( 9,796 )
Balance at September 30, 2020
28,059,900
$
3
$
292,822
$
12
$
( 250,487 )
$
42,350
Nine Months Ended September 30, 2019
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Equity
Balance at December 31, 2018
29,323,930
$
3
$
280,840
$
( 34 )
$
( 170,473 )
$
110,336
Common stock issued on exercise of stock options
2,970
—
1
—
—
1
Vesting of restricted stock for early exercise of stock options
—
—
5
—
—
5
Stock-based compensation expense
—
—
1,953
—
—
1,953
Unrealized gain on marketable securities
—
—
—
45
—
45
Net loss
—
—
—
—
( 11,643 )
( 11,643 )
Balance at March 31, 2019
29,326,900
$
3
$
282,799
$
11
$
( 182,116 )
$
100,697
Common stock issued on exercise of stock options
21,500
—
5
—
—
5
Vesting of restricted stock for early exercise of stock options
—
—
4
—
—
4
Stock-based compensation expense
—
—
1,898
—
—
1,898
Unrealized gain on marketable securities
—
—
—
28
—
28
Net loss
—
—
—
—
( 12,978 )
( 12,978 )
Balance at June 30, 2019
29,348,400
$
3
$
284,706
$
39
$
( 195,094 )
$
89,654
Common stock issued on exercise of stock options
57,000
—
16
—
—
16
Vesting of restricted stock for early exercise of stock options
—
—
3
—
—
3
Stock-based compensation expense
—
—
1,749
—
—
1,749
Unrealized loss on marketable securities
—
—
—
( 5 )
—
( 5 )
Net loss
—
—
—
—
( 11,004 )
( 11,004 )
Balance at September 30, 2019
29,405,400
$
3
$
286,474
$
34
$
( 206,098 )
$
80,413
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Nine Months Ended
September 30,
2020
2019
Cash flows from operating activities
Net loss
$
( 33,342 )
$
( 35,625 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
490
558
Accretion related to marketable securities
44
( 565 )
Stock-based compensation
4,511
5,600
Changes in operating assets and liabilities:
Prepaid and other current assets
214
( 419 )
Operating lease right-of-use asset
502
443
Other assets
33
( 50 )
Accounts payable
123
( 88 )
Accrued and other liabilities
1,505
1,903
Operating lease liability
( 651 )
( 568 )
Net cash used in operating activities
( 26,571 )
( 28,811 )
Cash flows from investing activities
Purchases of marketable securities
( 35,464 )
( 114,873 )
Sales of marketable securities
1,009
—
Maturities of marketable securities
78,837
113,553
Purchases of property and equipment
( 76 )
( 20 )
Net cash provided by investing activities
44,306
( 1,340 )
Cash flows from financing activities
Proceeds from exercise of common stock options
87
22
Net cash provided by financing activities
87
22
Net increase (decrease) in cash and cash equivalents
17,822
( 30,129 )
Cash and cash equivalents at beginning of the period
5,154
39,196
Cash and cash equivalents at end of the period
$
22,976
$
9,067
The accompanying notes are an integral part of these condensed consolidated financial statements.
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CORVUS PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
1. Organization
Corvus Pharmaceuticals, Inc. (“Corvus” or the “Company”) was incorporated in Delaware on January 27, 2014 and commenced operations in November 2014. Corvus is a clinical-stage biopharmaceutical company. The Company’s operations are located in Burlingame, California. The Company has three insignificant subsidiaries.
Initial Public Offering
On March 22, 2016, the Company’s registration statement on Form S-1 (File No. 333-208850) relating to its initial public offering (“IPO”) of its common stock was declared effective by the Securities and Exchange Commission (“SEC”) and the shares of its common stock began trading on the Nasdaq Global Market on March 23, 2016. The public offering price of the shares sold in the IPO was $ 15.00 per share. The IPO closed on March 29, 2016, pursuant to which the Company sold 4,700,000 shares of its common stock. On April 26, 2016, the Company sold an additional 502,618 shares of its common stock to the underwriters upon partial exercise of their over-allotment option, at the initial offering price of $ 15.00 per share. The Company received aggregate net proceeds of approximately $ 70.6 million, after underwriting discounts, commissions and offering expenses. Immediately prior to the consummation of the IPO, all outstanding shares of convertible preferred stock were converted into common stock.
Follow-on Public Offering
In March 2018, the Company completed a follow-on public offering in which the Company sold 8,117,647 shares of common stock at a price of $ 8.50 per share, which included 1,058,823 shares issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock. The aggregate net proceeds received by the Company from the offering were approximately $ 64.9 million, net of underwriting discounts and commissions and offering expenses payable by the Company.
Liquidity
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations, compliance with government regulations and the need to obtain additional financing to fund operations. Since commencing operations in 2014, the majority of the Company’s efforts have been focused on the research and development of ciforadenant, CPI-006 and CPI-818. The Company believes that it will continue to expend substantial resources for the foreseeable future as it continues clinical development of, seek regulatory approval for and, if approved, prepare for the commercialization of ciforadenant, CPI-006, and CPI-818, as well as product candidates under the Company’s other development programs. These expenditures will include costs associated with research and development, conducting preclinical studies and clinical trials, obtaining regulatory approvals, manufacturing and supply, sales and marketing and general operations. In addition, other unanticipated costs may arise. Because the outcome of any clinical trial and/or regulatory approval process is highly uncertain, the Company may not be able to accurately estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of ciforadenant, CPI-006, CPI-818 or any other product candidates. The Company does not expect its existing capital resources to be sufficient to enable it to fund the completion of all of its ongoing or planned clinical trials and remaining development program of ciforadenant, CPI-006 or CPI-818 through commercialization. In addition, its operating plan may change as a result of many factors, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 9, 2020.
The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $ 250.5 million as of September 30, 2020. The Company has historically financed its operations primarily through the sale of redeemable convertible preferred stock and common stock. While
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the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending would have a material adverse effect on the Company’s ability to achieve its intended business objectives.
As of September 30, 2020, the Company had cash, cash equivalents and short-term marketable securities of $ 51.4 million. Management believes that the Company’s current cash, cash equivalents and short-term marketable securities will be sufficient to fund its planned operations for at least 12 months from the date of the issuance of these financial statements.
The current COVID-19 (coronavirus) pandemic, which is impacting worldwide economic activity, poses risks that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities. The extent to which COVID-19 impacts the Company’s business, including its clinical trials and financial condition, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. As COVID-19 continues to spread around the globe, we will likely experience disruptions, including delays or difficulties in enrolling patients in our clinical trials, delays or difficulties in clinical site initiation, interruption of key clinical trial activities, delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials and delays in necessary interactions with local regulatory authorities. COVID-19 may also impact the Company’s ability to raise additional capital on a timely basis or at all, which could negatively impact short-term and long-term liquidity.
Exchange Warrants
On November 8, 2019, the Company entered into an exchange agreement (the “Exchange Agreement”) with an Investor and its affiliates (the “Exchanging Stockholders”), pursuant to which the Company exchanged an aggregate of 1,458,000 shares of the Company’s common stock, par value $ 0.0001 per share, owned by the Exchanging Stockholders for pre-funded warrants (the “Exchange Warrants”) to purchase an aggregate of 1,458,000 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Exchange Warrants), with an exercise price of $ 0.0001 per share. The Exchange Warrants will expire ten years from the date of issuance. The Exchange Warrants are exercisable at any time prior to expiration except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99 % of the Company’s common stock, subject to certain exceptions. In accordance with Accounting Standards Codification Topic 505, Equity, and Accounting Research Bulletin 43, the Company recorded the retirement of the common stock exchanged as a reduction of common shares outstanding and elected to record the excess over par value as a debit to additional paid-in-capital at the fair value of the Exchange Warrants on the issuance date. The Exchange Warrants are classified as equity in accordance with Accounting Standards Codification Topic 480, Distinguishing Liabilities from Equity, and Accounting Standards Codification Topic 815, Derivatives and Hedging, and the fair value of the Exchange Warrants was recorded as a credit to additional paid-in capital and is not subject to remeasurement. The Company determined that the fair value of the Exchange Warrants is substantially similar to the fair value of the retired shares on the issuance date due to the negligible exercise price for the Exchange Warrants. As of September 30, 2020, none of the Exchange Warrants have been exercised.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s functional and reporting currency is the U.S. dollar. The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and discharge of liabilities in the normal
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course of business. Since its inception, the Company has incurred significant losses and negative cash flows from operations. As of September 30, 2020, the Company had an accumulated deficit of $ 250.5 million and cash, cash equivalents and marketable securities of $ 51.4 million. The Company has financed its operations primarily with the proceeds from the sale of stock. The Company will need to raise additional capital to meet its business objectives. The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its planned expenditures and meet its obligations through at least the next twelve months from the issuance of these financial statements.
Unaudited Interim Financial Information
The accompanying interim condensed consolidated financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented.
The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed consolidated results of operations for the nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2020.
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from such estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company’s marketable securities consist of investments in U.S. Treasury securities, U.S. government agency securities and corporate debt obligations, which can be subject to certain credit risks. However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities.
The Company is subject to a number of risks similar to other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, and protection of proprietary technology. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability.
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, that of the development of and commercialization of precisely targeted oncology therapies.
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Significant Accounting Policies
The Company’s significant accounting policies are described in Note 2 to its consolidated financial statements for the year ended December 31, 2019, included in its Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2020.
Recent Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board issued ASU No. 2016-02, Leases (Topic 842), which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize an ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019 and has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. Upon adoption of ASU 2016-02, the Company recognized an operating lease, right-of-use asset of $ 2.8 million and a corresponding liability of $ 3.8 million and eliminated $ 1.0 million of deferred rent in the Company’s condensed balance sheet. The adoption of ASU 2016-02 did not have any impact on the Company’s condensed statements of operations and comprehensive loss. See also Note 11.
3. Net Loss per Share
The following table shows the calculation of net loss per share (in thousands, except share and per share data):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Numerator:
Net loss - basic and diluted
$
( 9,796 )
$
( 11,004 )
$
( 33,342 )
$
( 35,625 )
Denominator:
Weighted average common shares outstanding
29,500,318
29,394,639
29,419,431
29,350,507
Less: weighted average common shares subject to repurchase
—
( 5,636 )
—
( 19,217 )
Weighted average common shares outstanding used to compute basic and diluted net loss per share
29,500,318
29,389,003
29,419,431
29,331,290
Net loss per share, basic and diluted
$
( 0.33 )
$
( 0.37 )
$
( 1.13 )
$
( 1.21 )
Weighted average common shares outstanding for the three and nine months ended September 30, 2020 include 1,458,000 shares of common stock issuable on the conversion of pre-funded warrants described in Note 1.
The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Outstanding options
5,387,868
4,091,919
5,387,868
4,091,919
Total shares of common stock equivalents
5,387,868
4,091,919
5,387,868
4,091,919
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4. Fair Value Measurements
Financial assets and liabilities are measured and recorded at fair value. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
● Level 1—Quoted prices in active markets for identical assets or liabilities
● Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly
● Level 3 —Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability
There have been no transfers of assets and liabilities between levels of hierarchy.
The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs.
The following tables present information as of September 30, 2020 and December 31, 2019 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands):
September 30, 2020
Fair Value Measured Using
Total
(Level 1)
(Level 2)
(Level 3)
Balance
Assets
Cash equivalents
$
22,314
$
—
$
—
$
22,314
Marketable securities
2,035
26,350
—
28,385
$
24,349
$
26,350
$
—
$
50,699
December 31, 2019
Fair Value Measured Using
Total
(Level 1)
(Level 2)
(Level 3)
Balance
Assets
Cash equivalents
$
4,252
$
—
$
—
$
4,252
Marketable securities
7,023
65,805
—
72,828
$
11,275
$
65,805
$
—
$
77,080
As of September 30, 2020, marketable securities had a maximum remaining maturity of eleven months .
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As of September 30, 2020 and December 31, 2019, the fair value of available for sale marketable securities by type of security were as follows (in thousands):
September 30, 2020
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
U.S. Treasury securities
$
2,034
$
1
$
—
$
2,035
U.S. Government agency securities
22,085
9
( 2 )
22,092
Corporate debt obligations
4,254
4
—
4,258
$
28,373
$
14
$
( 2 )
$
28,385
December 31, 2019
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
U.S. Treasury securities
$
7,019
$
4
$
—
$
7,023
U.S. Government agency securities
17,701
16
—
17,717
Corporate debt obligations
48,079
17
( 8 )
48,088
$
72,799
$
37
$
( 8 )
$
72,828
5. License and Collaboration Agreements
Scripps Licensing Agreement
In December 2014, the Company entered into a license agreement with The Scripps Research Institute (“Scripps”), pursuant to which it was granted a non-exclusive, world-wide license for all fields of use under Scripps’ rights in certain know-how and technology related to a mouse hybridoma clone expressing an anti-human CD73 antibody, and to progeny, mutants or unmodified derivatives of such hybridoma and any antibodies expressed by such hybridoma, from which we developed CPI-006. Scripps also granted the Company the right to grant sublicenses in conjunction with other proprietary rights the Company holds, or to others collaborating with or performing services for the Company. Under this license agreement, Scripps has agreed not to grant any additional commercial licenses with respect to such materials, other than march-in rights granted to the U.S. government.
Upon execution of the agreement, the Company made a one-time cash payment to Scripps of $ 10,000 in 2015 and is also obligated to pay a minimum annual fee to Scripps of $ 25,000 . The one-time cash payment was recorded as research and development expense as technological feasibility of the asset had not been established and there was no alternative future use. A minimum annual fee payment is due on each anniversary of the effective date of the agreement for the term of the agreement. The Company is also required to make performance-based cash payments upon successful completion of clinical and sales milestones. The aggregate potential milestone payments are $ 2.6 million. The Company is also required to pay royalties on net sales of licensed products (including CPI-006) sold by it, its affiliates and its sublicensees at a rate in the low-single digits. In addition, should the Company sublicense the rights licensed under the agreement, it has agreed to pay a percentage of sublicense revenue received at specified rates that start at double digit percentages and decrease to single digit percentages based on the elapsed time from the effective date of the agreement and the time of entry into such sublicense. To date, no milestone payments have been made.
The Company’s license agreement with Scripps will terminate upon expiration of its obligation to pay royalties to Scripps under the license agreement. The Company’s license agreement with Scripps is terminable by the consent of the parties, at will by the Company upon providing 90 days written notice to Scripps, or by Scripps for certain material breaches, or if the Company undergoes a bankruptcy event. In addition, Scripps may terminate the license on a product-by-product basis, or the entire agreement, if the Company fails to meet specified diligence obligations related to the development and commercialization of licensed products. Scripps may also terminate the agreement after the third anniversary of the effective date of the agreement if it reasonably believes, based on reports the Company provides to Scripps, that the Company has not used commercially reasonable efforts as required under the agreement, subject to a specified notice and cure period.
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Vernalis Licensing Agreement
In February 2015, the Company entered into a license agreement with Vernalis (R&D) Limited (“Vernalis”), which was subsequently amended as of November 5, 2015, and, pursuant to which the Company was granted an exclusive, worldwide license under certain patent rights and know-how, including a limited right to grant sublicenses, for all fields of use to develop, manufacture and commercialize products containing certain adenosine receptor antagonists, including ciforadenant (formerly CPI-444). Pursuant to this agreement, the Company made a one-time cash payment to Vernalis in the amount of $ 1.0 million, which was recorded as research and development expense as technological feasibility of the asset had not been established and there was no alternative future use. The Company is also required to make cash milestone payments to Vernalis upon the successful completion of clinical and regulatory milestones for licensed products depending on the indications for which such licensed products are developed and upon achievement of certain sales milestones. In February 2017, the Company made a milestone payment of $ 3.0 million to Vernalis following the expansion of a cohort of patients with renal cell cancer treated with single agent ciforadenant in the Company’s Phase 1/1b clinical trial. The aggregate potential milestone payments are approximately $ 220 million for all indications.
The Company has also agreed to pay Vernalis tiered incremental royalties based on the annual net sales of licensed products containing ciforadenant on a product-by-product and country-by-country basis, subject to certain offsets and reductions. The tiered royalty rates for products containing ciforadenant range from the mid-single digits up to the low-double digits on a country-by-country net sales basis. The royalties on other licensed products that do not include ciforadenant also increase with the amount of net sales on a product-by-product and country-by-country basis and range from the low-single digits up to the mid-single digits on a country-by-country net sales basis. The Company is also obligated to pay to Vernalis certain sales milestones as indicated above when worldwide net sales reach specified levels over an agreed upon time period.
The agreement will expire on a product-by-product and country-by-country basis upon the expiration of the Company’s payment obligations to Vernalis in respect of a particular product and country. Both parties have the right to terminate the agreement for an uncured material breach by the other party. The Company may also terminate the agreement at its convenience by providing 90 days written notice, provided that the Company has not received notice of its own default under the agreement at the time the Company exercises such termination right. Vernalis may also terminate the agreement if the Company challenges a licensed patent or undergoes a bankruptcy event.
Genentech Collaboration Agreements
In October 2015, the Company entered into a clinical trial collaboration agreement with Genentech to evaluate the safety, tolerability and preliminary efficacy of ciforadenant combined with Genentech’s investigational cancer immunotherapy, Tecentriq (atezolizumab), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1(“PD-L1”), in a variety of solid tumors in a Phase 1/1b clinical trial. Pursuant to this agreement, the Company will be responsible for the conduct and cost of the relevant studies, under the supervision of a joint development committee made up of representatives of the Company and representatives of Genentech. Genentech will supply Tecentriq. As part of the agreement, the Company granted Genentech certain rights of first negotiation to participate in future clinical trials that the Company may conduct evaluating the administration of ciforadenant in combination with an anti-PD-1 or anti-PD-L1 antibody. If the Company and Genentech do not reach agreement on the terms of any such participation by Genentech within a specified time period, the Company retains the right to collaborate with third parties in such activities. The Company also granted Genentech certain rights of first negotiation should it decide to license development and commercialization rights to ciforadenant. Should the Company and Genentech not reach agreement on the terms of such a license within a specified time period, it retains the right to enter into a license with another third party.
The Company and Genentech each have the right to terminate the agreement for material breach by the other party. In addition, the agreement may be terminated by either party due to safety considerations, if directed by a regulatory authority or if development of ciforadenant or Tecentriq is discontinued. Further, the agreement will expire after a set period of time following the provision by the Company of the final clinical study report to Genentech.
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In May 2017, the Company signed a second clinical trial collaboration agreement with Genentech. Under the second agreement, ciforadenant administered in combination with Tecentriq is being evaluated in a Phase 1b/2 randomized, controlled clinical study, known as Morpheus, as second-line therapy in patients with non-small cell lung cancer who are resistant and/or refractory to prior therapy with an anti-PD-(L)1 antibody. The patients in the Morpheus trial are currently in the follow-up phase of the trial. Genentech is responsible for the conduct of the study and the parties share the cost of the Morpheus trial, which began enrolling patients in the fourth quarter of 2017. The Company is responsible for supplying ciforadenant and retains global development and commercialization rights to ciforadenant. The Company and Genentech each have the right to terminate the agreement for material breach by the other party. In addition, the agreement may be terminated by either party due to safety considerations, if directed by a regulatory authority or if development of ciforadenant or Tecentriq is discontinued.
Monash License Agreement
In April 2017, the Company entered into a license agreement with Monash University (Monash), pursuant to which the Company was granted an exclusive, sublicensable worldwide license under certain know-how, patent rights and other intellectual property rights controlled by Monash to research, develop, and commercialize certain antibodies directed to CXCR2 for the treatment of human diseases.
Upon execution of the agreement, the Company made a one-time cash payment to Monash of $ 275,000 and reimbursed Monash for certain patent prosecution costs incurred prior to execution of the agreement. The Company us also obligated to pay an annual license maintenance fee to Monash of $ 25,000 until a certain development milestone is met with respect to the licensed product, after which no further maintenance fee will be due. The Company is also required to make development and sales milestone payments to Monash with respect to the licensed products in the aggregate of up to $ 45.1 million. The Company is also required to pay to Monash tiered royalties on net sales of licensed products sold by it, its affiliates and its sublicensees at a rate ranging in the low-single digits. In addition, should the Company sublicense its rights under the agreement, the Company has agreed to pay a percentage of sublicense revenue received at specified rates that are currently at low double digit percentages and decrease to single digit percentages based on the achievement of development milestones.
The term of the Company’s agreement with Monash continues until the expiration of its obligation to pay royalties to Monash thereunder. The license agreement is terminable at will by the Company upon providing 30 days written notice to Monash, or by either party for material breaches by the other party. In addition, Monash may terminate the entire agreement or convert the license to a non-exclusive license if the Company has materially breached our obligation to use commercially reasonable efforts to develop and commercialize a licensed product, subject to a specified notice and cure mechanism.
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6. Balance Sheet Components (in thousands)
September 30,
December 31,
2020
2019
Prepaid and Other Current Assets
Interest receivable
$
139
$
329
Prepaid research and development manufacturing expenses
44
240
Prepaid facility expenses
160
157
Prepaid insurance
357
150
Other
448
486
$
1,148
$
1,362
Property and Equipment
Laboratory equipment
$
2,472
$
2,396
Computer equipment and purchased software
142
142
Leasehold improvements
2,084
2,084
4,698
4,622
Less: accumulated depreciation and amortization
( 3,650 )
( 3,160 )
$
1,048
$
1,462
Accrued and Other Liabilities
Accrued clinical trial related
$
4,516
$
4,300
Accrued manufacturing expense
623
696
Personnel related
2,293
1,624
Other
972
279
$
8,404
$
6,899
7. Common Stock
As of September 30, 2020, the amended and restated certificate of incorporation authorizes the Company to issue 290 million shares of common stock and 10 million shares of preferred stock.
Each share of common stock is entitled to one vote. Common stockholders are entitled to dividends if and when declared by the board of directors. As of September 30, 2020, no dividends on common stock had been declared.
In March 2020, the Company entered into an open market sale agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, from time to time, with aggregate gross sales proceeds of up to $ 50,000,000 , through an at-the-market equity offering program under which Jefferies will act as its sales agent. The issuance and sale of shares of common stock by the Company pursuant to the Sales Agreement are deemed an “at-the-market” offering under the Securities Act of 1933, as amended. Jefferies is entitled to compensation for its services equal to up to 3.0 % of the gross proceeds of any shares of common stock sold through Jefferies under the Sales Agreement. As of September 30, 2020, the Company had received no proceeds from the sale of shares of common stock pursuant to the Sales Agreement.
The Company has reserved shares of common stock for issuance as follows:
September 30,
December 31,
2020
2019
Exchange warrants
1,458,000
1,458,000
Shares available for future option grants
2,971,058
1,704,183
Outstanding options
5,387,868
5,643,410
Shares reserved for employee stock purchase plan
400,000
400,000
Total
10,216,926
9,205,593
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8. Stock Option Plans
In February 2014, the Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”), which was subsequently amended in November 2014, July 2015 and September 2015, under which it granted incentive stock options (“ISOs”) or non-qualified stock options (“NSOs”). Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2014 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years . The 2014 Plan provides that grants must be at an exercise price of 100 % of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant.
In connection with the consummation of the IPO in March 2016, the 2016 Equity Incentive Award Plan (the “2016 Plan”), became effective. Under the 2016 Plan, incentive stock options, non-statutory stock options, stock purchase rights and other stock-based awards may be granted. Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2016 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years . The 2016 Plan provides that grants must be at an exercise price of 100 % of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant. In conjunction with adopting the 2016 Plan, the 2014 Plan was terminated and no further awards will be granted under the 2014 Plan. Options outstanding under the 2014 Plan as of the effective date of the 2016 Plan that are forfeited or lapse unexercised may be re-issued under the 2016 Plan, up to a maximum of 1,136,229 shares.
Activity under the Company’s stock option plans is set forth below:
Options Outstanding
Weighted ‑
Shares
Average
Available
Number of
Exercise
for Grant
Options
Price
Balance at December 31, 2019
1,704,183
5,643,410
$
8.05
Additional shares authorized
1,118,000
—
—
Options granted
( 220,000 )
220,000
2.68
Options exercised
—
( 106,667 )
0.82
Options forfeited
368,875
( 368,875 )
6.39
Balance at September 30, 2020
2,971,058
5,387,868
$
8.01
9. Stock-Based Compensation
The Company’s results of operations include expenses relating to employee and non-employee stock-based awards as follows (in thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Research and development
$
622
$
752
$
2,206
$
2,350
General and administrative
661
997
2,305
3,250
Total
$
1,283
$
1,749
$
4,511
$
5,600
10. Income Taxes
During the three and nine months ended September 30, 2020 and 2019, the Company recorded no income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items. The Company continues to maintain a full valuation allowance against its net deferred tax assets.
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11. Facility Lease
In January 2015, the Company signed an initial operating lease, effective February 1, 2015 for 8,138 square feet of office and laboratory space with a one year term. Between January 2015 and October 2018, the Company entered into a series of lease amendments to increase the amount of leased space to 27,280 square feet and extend the expiration of the lease to February 2023. The lease agreement includes annual rent escalations. Under the lease and subsequent amendments, the landlord provided approximately $ 1.9 million in free rent and lease incentives. The Company records rent expense on a straight-line basis over the effective term of the lease, including any free rent periods and incentives. As the interest rate implicit in lease arrangements is typically not readily available, in calculating the present value of the lease payments, the Company has utilized its incremental borrowing rate, which is determined based on the prevailing market rates for collateralized debt with maturity dates commensurate with the term of its lease . The Company’s facility lease is a net lease, as the non-lease components (i.e. common area maintenance) are paid separately from rent based on actual costs incurred. Therefore, the non-lease components were not included in the right-of-use asset and liability and are reflected as an expense in the period incurred.
As of September 30, 2020 and December 31, 2019, the right-of-use asset under operating lease was $ 1.8 million and $ 2.3 million, respectively. The elements of lease expense for the three and nine months ended September 30, 2020 and 2019 were as follows (in thousands):
Three Months Ended
Nine Months Ended
Statements of operations and
September 30,
September 30,
comprehensive loss location
2020
2019
2020
2019
Costs of operating lease
Operating lease costs
Research and development,
General and administrative
$
239
$
239
$
718
$
720
Costs of non-lease components (previously common area maintenance)
Research and development,
General and administrative
87
81
263
243
Total operating lease cost
$
326
$
320
$
981
$
963
Other Information
Operating cash flows used for operating lease
$
377
$
363
$
1,132
$
1,084
Remaining lease term
2.3 years
3.3 years
2.3 years
3.3 years
Discount rate
10.0 %
10.0 %
10.0 %
10.0 %
As of September 30, 2020, minimum rental commitments under this lease were as follows (in thousands):
Year Ended December 31 (in thousands)
2020*
$
290
2021
1,260
2022
1,299
Total lease payments
2,849
Less: imputed interest
( 312 )
Total
$
2,537
* Remainder of the year
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As of December 31, 2019, minimum rental commitments under this lease were as follows (in thousands):
Year Ended December 31 (in thousands)
2020
$
1,159
2021
1,260
2022
1,299
Total lease payments
3,718
Less: imputed interest
( 530 )
Total
$
3,188
12. Commitments and Contingencies
In August 2015, the Company entered into an agreement for a line of credit of $ 0.1 million for the purpose of issuing its landlord a letter of credit of $ 0.1 million as a security deposit under its facility lease. The Company pledged money market funds and marketable securities as collateral for the line of credit. For further discussion of the Company’s facility lease agreement, see Note 11.
Pursuant to the Company’s license agreements with each of Vernalis, Scripps and Monash, it has obligations to make future milestone and royalty payments to these parties, respectively. However, because these amounts are contingent, they have not been included on the Company’s balance sheet. For further discussion of the Vernalis, Scripps and Monash licensing agreements, see Note 5.
Indemnifications
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. There have been no claims to date and the Company has a directors and officers insurance policy that may enable it to recover a portion of any amounts paid for future claims.
Legal Proceedings
The Company is not a party to any material legal proceedings.
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13. Subsequent Events
In October 2020, the Company announced the formation and launch of Angel Pharmaceuticals Co., Ltd. (“Angel Pharmaceuticals”), a new China based biopharmaceutical. The Company formed Angel Pharmaceuticals as a wholly-owned subsidiary and it launched with a post-money valuation of approximately $ 106.0 million, based on an approximate $ 41.0 million cash investment from a Chinese investor group that includes funds associated with Tigermed and Betta Pharmaceuticals, Hisun Pharmaceuticals and Zhejiang Puissance Capital, $ 6.6 million of such investments are subject to the satisfaction of certain customary conditions. Such cash is not available for Corvus’ use. Contemporaneously with the financing, Angel Pharmaceuticals obtained the rights to develop and commercialize the Company’s three clinical-stage candidates – ciforadenant, CPI-006 and CPI-818 – in greater China and obtained global rights to the Company’s BTK inhibitor preclinical programs. Under the collaboration, the Company will initially retain a 49.7 % equity stake in Angel Pharmaceuticals and will be entitled to designate three individuals on Angel’s five -person Board of Directors. The Company is currently in the process of finalizing the related accounting treatment of this transaction.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.