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
31
Item 4 .
Controls and Procedures
31
PART II — OTHER INFORMATION
Item 1.
Legal Proceedings
31
Item 1A.
Risk Factors
32
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
78
Item 3.
Defaults Upon Senior Securities
78
Item 4.
Mine Safety Disclosures
78
Item 5.
Other Information
78
Item 6.
Exhibits
79
SIGNATURES
80
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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,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
20,105
$
13,159
Marketable securities
12,063
29,144
Accounts receivable - related party
11
588
Prepaid and other current assets
915
773
Total current assets
33,094
43,664
Property and equipment, net
264
353
Operating lease right-of-use asset
1,423
2,217
Investment in Angel Pharmaceuticals
17,072
21,877
Other assets
89
129
Total assets
$
51,942
$
68,240
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
1,404
$
1,976
Operating lease liability
1,336
1,228
Accrued and other liabilities
4,559
7,548
Total current liabilities
7,299
10,752
Operating lease liability
354
1,373
Total liabilities
7,653
12,125
Commitments and contingencies (Note 13)
Stockholders’ equity:
Preferred stock: $ 0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; 0 shares issued and outstanding at September 30, 2023 and December 31, 2022
—
—
Common stock: $ 0.0001 par value; 290,000,000 shares authorized at September 30, 2023 and December 31, 2022; 49,038,582 and 46,553,511 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
5
5
Additional paid-in capital
373,791
364,361
Accumulated other comprehensive loss
( 1,443 )
( 563 )
Accumulated deficit
( 328,064 )
( 307,688 )
Total stockholders’ equity
44,289
56,115
Total liabilities and stockholders’ equity
$
51,942
$
68,240
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,
2023
2022
2023
2022
Operating expenses:
Research and development
$
3,965
$
10,365
$
12,527
$
20,388
General and administrative
1,595
2,108
5,229
6,511
Total operating expenses
5,560
12,473
17,756
26,899
Loss from operations
( 5,560 )
( 12,473 )
( 17,756 )
( 26,899 )
Interest income and other expense, net
425
225
1,204
336
Sublease income - related party
—
147
56
439
Loss from equity method investment
( 865 )
( 2,730 )
( 3,880 )
( 5,367 )
Net loss
$
( 6,000 )
$
( 14,831 )
$
( 20,376 )
$
( 31,491 )
Net loss per share, basic and diluted
$
( 0.12 )
$
( 0.32 )
$
( 0.43 )
$
( 0.68 )
Shares used to compute net loss per share, basic and diluted
48,971,246
46,553,511
47,683,792
46,553,511
Other comprehensive loss:
Unrealized gain (loss) on marketable securities
5
5
45
( 77 )
Cumulative foreign currency translation adjustment
( 80 )
( 1,537 )
( 925 )
( 2,985 )
Comprehensive loss
$
( 6,075 )
$
( 16,363 )
$
( 21,256 )
$
( 34,553 )
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, 2023
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Equity
Balance at December 31, 2022
46,553,511
$
5
$
364,361
$
( 563 )
$
( 307,688 )
$
56,115
Common stock issued on exercise of stock options
15,000
—
4
—
—
4
Stock-based compensation expense
—
—
492
—
—
492
Unrealized gain on marketable securities
—
—
—
41
—
41
Foreign currency translation adjustment
—
—
—
88
—
88
Net loss
—
—
—
—
( 7,873 )
( 7,873 )
Balance at March 31, 2023
46,568,511
$
5
$
364,857
$
( 434 )
$
( 315,561 )
$
48,867
Stock-based compensation expense
—
—
537
—
—
537
Unrealized loss on marketable securities
—
—
—
( 1 )
—
( 1 )
Foreign currency translation adjustment
—
—
—
( 933 )
—
( 933 )
Issuance of common stock in connection with at-the-market offering, net
2,329,851
—
7,516
—
—
7,516
Net loss
—
—
—
—
( 6,503 )
( 6,503 )
Balance at June 30, 2023
48,898,362
$
5
$
372,910
$
( 1,368 )
$
( 322,064 )
$
49,483
Common stock issued on exercise of stock options
8,168
—
8
—
—
8
Stock-based compensation expense
—
—
546
—
—
546
Unrealized gain on marketable securities
—
—
—
5
—
5
Foreign currency translation adjustment
—
—
—
( 80 )
—
( 80 )
Issuance of common stock in connection with at-the-market offering, net
132,052
—
327
—
—
327
Net loss
—
—
—
—
( 6,000 )
( 6,000 )
Balance at September 30, 2023
49,038,582
$
5
$
373,791
$
( 1,443 )
$
( 328,064 )
$
44,289
Nine Months Ended September 30, 2022
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income
Deficit
Equity
Balance at December 31, 2021
46,553,511
$
5
$
361,669
$
1,869
$
( 266,381 )
$
97,162
Stock-based compensation expense
—
—
739
—
—
739
Unrealized loss on marketable securities
—
—
—
( 28 )
—
( 28 )
Foreign currency translation adjustment
—
—
—
146
—
146
Net loss
—
—
—
—
( 8,297 )
( 8,297 )
Balance at March 31, 2022
46,553,511
$
5
$
362,408
$
1,987
$
( 274,678 )
$
89,722
Stock-based compensation expense
—
—
675
—
—
675
Unrealized loss on marketable securities
—
—
—
( 54 )
—
( 54 )
Foreign currency translation adjustment
—
—
—
( 1,594 )
—
( 1,594 )
Net loss
—
—
—
—
( 8,363 )
( 8,363 )
Balance at June 30, 2022
46,553,511
$
5
$
363,083
$
339
$
( 283,041 )
$
80,386
Stock-based compensation expense
—
—
658
—
—
658
Unrealized loss on marketable securities
—
—
—
5
—
5
Foreign currency translation adjustment
—
—
—
( 1,537 )
—
( 1,537 )
Net loss
—
—
—
—
( 14,831 )
( 14,831 )
Balance at September 30, 2022
46,553,511
$
5
$
363,741
$
( 1,193 )
$
( 297,872 )
$
64,681
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,
2023
2022
Cash flows from operating activities
Net loss
$
( 20,376 )
$
( 31,491 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
123
273
Accretion related to marketable securities
( 767 )
12
Stock-based compensation
1,575
2,072
Loss from equity method investment
3,880
5,367
Changes in operating assets and liabilities:
Accounts receivable - related party
577
4
Prepaid and other current assets
( 142 )
202
Operating lease right-of-use asset
794
723
Other assets
40
( 12 )
Accounts payable
( 572 )
2,662
Accrued and other liabilities
( 2,989 )
1,489
Operating lease liability
( 911 )
( 777 )
Net cash used in operating activities
( 18,768 )
( 19,476 )
Cash flows from investing activities
Purchases of marketable securities
( 35,623 )
( 46,890 )
Maturities of marketable securities
53,516
27,765
Purchases of property and equipment
( 34 )
( 269 )
Net cash (used in) provided by investing activities
17,859
( 19,394 )
Cash flows from financing activities
Proceeds from issuance of common stock in connection with at-the-market offering, net
7,843
—
Proceeds from exercise of common stock options
12
—
Net cash provided by financing activities
7,855
—
Net increase (decrease) in cash and cash equivalents
6,946
( 38,870 )
Cash and cash equivalents at beginning of the period
13,159
63,458
Cash and cash equivalents at end of the period
$
20,105
$
24,588
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.
Presentation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Corvus Biopharmaceuticals, Ltd. and Corvus Hong Kong Limited. All intercompany accounts and transactions have been eliminated from the consolidated financial statements.
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 Offerings
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.
In February 2021, the Company completed a follow-on public offering in which the Company sold 9,783,660 shares of common stock at a price of $ 3.50 per share, which included 1,212,231 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 $ 32.0 million, net of underwriting discounts and commissions and offering expenses.
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 soquelitinib (CPI-818), ciforadenant and mupadolimab. 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 soquelitinib, ciforadenant and mupadolimab, 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,
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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 soquelitinib, ciforadenant and mupadolimab 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 its clinical trials and remaining development program of soquelitinib, ciforadenant and mupadolimab 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, 2022 filed on March 28, 2023 and this Quarterly Report on Form 10-Q.
The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $ 328.1 million as of September 30, 2023. The Company has historically financed its operations primarily through the sale of common stock and redeemable convertible preferred stock. While 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, 2023, the Company had cash, cash equivalents and short-term marketable securities of $ 32.2 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.
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, except for its investment in its equity method investee which is the Chinese renminbi (RMB). 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 course of business.
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 three and nine months ended September 30, 2023 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2023.
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.
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Investments in Equity Securities
The Company uses the equity method of accounting for its equity investment if the investment provides the ability to exercise significant influence, but not control, over operating and financial policies of the investee.
The Company’s proportionate share of the net income (loss) resulting from the equity method investment is reported under the line item captioned “loss from equity method investment” in the Consolidated Statements of Operations and Comprehensive Loss and the carrying value of the equity method investments is reported under the line captioned “Investment in Angel” in the Consolidated Balance Sheets. The Company’s equity method investments are reported at cost and adjusted each period for the Company’s share of the investee’s income or loss and the foreign currency translation adjustment as applicable.
For equity method investees with a functional currency different than the Company’s reporting currency, the Company follows the guidance under ASC 830-10-15-5, pursuant to which, the foreign currency financial statements of a foreign investee accounted for by the equity method should be translated to the reporting entity's reporting currency.
The Company evaluates equity method investments for impairment whenever events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable. Factors considered by the Company when reviewing an equity method investment for impairment include the length of time (duration) and the extent (severity) to which the fair value of the equity method investment has been less than cost, the investee’s financial condition and near-term prospects and the intent and ability to hold the investment for a period of time sufficient to allow for anticipated recovery. An impairment that is other-than-temporary is recognized in the period identified.
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 and U.S. government agency securities, 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, 2022, 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, 2023.
Recent Accounting Pronouncements
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 is effective in 2021 and interim periods within that year and permits for an early adoption. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of the guidance did not have a material impact on its financial statements and related disclosures.
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective in the first quarter of 2023 for calendar-year SEC filers that are smaller reporting companies as of the one-time determination date. The Company has adopted the new guidance as of January 1, 2023, and it did not have a material impact on its financial statements and related disclosures.
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,
2023
2022
2023
2022
Numerator:
Net loss - basic and diluted
$
( 6,000 )
$
( 14,831 )
$
( 20,376 )
$
( 31,491 )
Denominator:
Weighted average common shares outstanding used to compute basic and diluted net loss per share
48,971,246
46,553,511
47,683,792
46,553,511
Net loss per share, basic and diluted
$
( 0.12 )
$
( 0.32 )
$
( 0.43 )
$
( 0.68 )
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,
2023
2022
2023
2022
Outstanding options
7,762,672
7,069,868
7,762,672
7,069,868
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
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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, 2023 and December 31, 2022 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, 2023
Fair Value Measured Using
Total
(Level 1)
(Level 2)
(Level 3)
Balance
Assets
Cash equivalents
$
19,840
$
—
$
—
$
19,840
Marketable securities
6,933
5,130
—
12,063
$
26,773
$
5,130
$
—
$
31,903
December 31, 2022
Fair Value Measured Using
Total
(Level 1)
(Level 2)
(Level 3)
Balance
Assets
Cash equivalents
$
11,942
$
—
$
—
$
11,942
Marketable securities
22,001
7,143
—
29,144
$
33,943
$
7,143
$
—
$
41,086
As of September 30, 2023 marketable securities had a maximum remaining maturity of nine months .
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As of September 30, 2023 and December 31, 2022, the fair value of available for sale marketable securities by type of security were as follows (in thousands):
September 30, 2023
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
U.S. Treasury securities
$
6,936
$
—
$
( 3 )
$
6,933
U.S. Government agency securities
5,133
—
( 3 )
5,130
$
12,069
$
—
$
( 6 )
$
12,063
December 31, 2022
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
U.S. Treasury securities
$
22,020
$
4
$
( 23 )
$
22,001
U.S. Government agency securities
7,175
—
( 32 )
7,143
$
29,195
$
4
$
( 55 )
$
29,144
5. Equity Method Investment
As of September 30, 2023 and December 31, 2022, the Company’s ownership interest in Angel was approximately 49.7 %, excluding 7 % of Angel’s equity reserved for issuance under the Angel ESOP. The Company recognized its share of losses in Angel for the total amount of $ 0.9 million and $ 3.9 million as loss from equity method investment on the consolidated statement of operations for the three and nine months ended September 30, 2023, respectively.
Summary Financial Information
Summary financial information for Angel Pharmaceuticals is as follows:
As of
As of
Balance Sheet Data
September 30, 2023
December 31, 2022
(in thousands)
Current assets
$
18,765
$
29,062
Non-current assets
1,329
1,652
Current liabilities
1,613
6,293
Non-current liabilities
686
985
Stockholders' equity
17,795
23,436
Three Months Ended
Nine Months Ended
September 30,
September 30,
Statement of Operations Data
2023
2022
2023
2022
(in thousands)
Revenue
$
—
$
—
$
—
$
—
Gross Profit
—
—
—
—
Net loss
( 1,016 )
( 3,204 )
( 4,565 )
( 6,402 )
Share of loss from investments accounted for using the equity method
( 865 )
( 2,730 )
( 3,880 )
( 5,367 )
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6. 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 mupadolimab. 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 and is also obligated to pay a minimum annual fee to Scripps of $ 25,000 . The first minimum annual fee payment is due on each anniversary of the effective date of the agreement and will be due on each subsequent anniversary of the effective date 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 mupadolimab) 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.
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. 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. During the nine months ended September 30, 2023, no clinical or regulatory milestones were completed or paid to Vernalis and the aggregate potential milestone payments were approximately $ 220 million for all indications as of September 30, 2023. 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
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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 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.
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 recorded these payments as research and development expenses for the year ended December 31, 2017. The Company is 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. During the nine months ended September 30, 2023, no development or sales milestones were completed or paid to Monash and the aggregate potential milestones were $ 45.1 million as of September 30, 2023. 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 its 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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7. Balance Sheet Components (in thousands)
September 30,
December 31,
2023
2022
Prepaid and Other Current Assets
Interest receivable
$
39
$
45
Prepaid research and development manufacturing expenses
149
192
Prepaid facility expenses
196
182
Prepaid insurance
317
252
Other
214
102
$
915
$
773
Property and Equipment
Laboratory equipment
$
2,678
$
2,673
Computer equipment and purchased software
171
142
Leasehold improvements
2,084
2,084
4,933
4,899
Less: accumulated depreciation and amortization
( 4,669 )
( 4,546 )
$
264
$
353
Accrued and Other Liabilities
Accrued clinical trial expense
$
2,603
$
2,934
Accrued manufacturing expense
592
3,254
Personnel related
751
1,113
Accrued legal and accounting
351
89
Other
262
158
$
4,559
$
7,548
During the three months ended September 30, 2023 and 2022, the Company recorded approximately $ 30,000 and $ 94,000 in depreciation expense, respectively, and during the nine months ended September 30, 2023 and 2022, the Company recorded approximately $ 123,000 and $ 273,000 in depreciation expense, respectively.
8. Common Stock
As of September 30, 2023, 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, 2023, no dividends on common stock had been declared.
In March 2020, the Company entered into an open market sale agreement (the “2020 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. In November 2021, the Company entered into another Sale Agreement (“2021 Sales Agreement”) with Jefferies to sell shares of its common stock from time-to-time, with aggregate gross sales proceeds of up to $ 40,000,000 .
On March 28, 2023, the Company terminated both the 2020 Sales Agreement and the 2021 Sales Agreement and concurrently entered into a new open market sale agreement (the “2023 Sales Agreement”) with Jefferies to sell shares of the Company’s common stock, from time-to-time, with aggregate gross sales proceeds of up to $ 90,000,000 , 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 2023 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 3.0 % of the gross proceeds of any shares of common stock sold through Jefferies under the 2023 Sales Agreement.
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During the nine months ended September 30, 2023, the Company sold 2,461,903 shares of common stock under its at-the-market offering program resulting in net proceeds of $ 7.8 million. As of September 30, 2023, $ 81.9 million remained available for sale under the 2023 Sales Agreement.
The Company has reserved shares of common stock for issuance as follows:
September 30,
December 31,
2023
2022
Shares available for future option grants
5,099,421
4,017,011
Outstanding options
7,762,672
7,006,250
Shares reserved for employee stock purchase plan
400,000
400,000
Total
13,262,093
11,423,261
9. 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, 2022
4,017,011
7,006,250
$
5.25
Additional shares authorized
1,862,000
—
—
Options granted
( 1,002,000 )
1,002,000
1.10
Options exercised
—
( 23,168 )
0.52
Options forfeited
222,410
( 222,410 )
5.98
Balance at September 30, 2023
5,099,421
7,762,672
$
4.71
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10. 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,
2023
2022
2023
2022
Research and development
$
179
$
244
$
555
$
800
General and administrative
367
414
1,020
1,272
Total
$
546
$
658
$
1,575
$
2,072
11. Income Taxes
During the nine months ended September 30, 2023 and 2022, 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.
12. 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 September 2021, 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 2025. 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 was 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, 2023 and December 31, 2022, the right-of-use asset under operating lease was $ 1.4 million and $ 2.2 million, respectively. The elements of lease expense for the three and nine months ended September 30, 2023 and 2022 were as follows (in thousands):
Three Months Ended
Nine Months Ended
Statements of operations and
September 30,
September 30,
comprehensive loss location
2023
2022
2023
2022
Costs of operating lease
Operating lease costs
Research and development,
General and administrative
$
306
$
306
$
918
$
746
Costs of non-lease components (previously common area maintenance)
Research and development,
General and administrative
112
108
308
241
Total operating lease cost
$
418
$
414
$
1,226
$
987
Other Information
Operating cash flows used for operating lease
$
459
$
433
$
1,378
$
1,265
Remaining lease term
1.3 years
2.3 years
1.3 years
2.3 years
Discount rate
8.0 %
8.0 %
8.0 %
8.0 %
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As of September 30, 2023, minimum rental commitments under this lease were as follows (in thousands):
Year Ended December 31 (in thousands)
2023*
$
348
2024
1,434
Total lease payments
1,782
Less: imputed interest
( 92 )
Total
$
1,690
* Remainder of the year
As of December 31, 2022, minimum rental commitments under this lease were as follows (in thousands):
Year Ended December 31 (in thousands)
2023
$
1,391
2024
1,434
Total lease payments
2,825
Less: imputed interest
( 224 )
Total
$
2,601
In August 2021, the Company entered into an agreement to sublease 7,585 square feet of its office and laboratory space in Burlingame, California to Angel Pharmaceuticals. Pursuant to the sublease, rent is due monthly and is subject to scheduled annual increases and Angel Pharmaceuticals is responsible for certain operating expenses and taxes throughout the life of the sublease. The sublease expired in January 2023. Sublease income is recognized on a straight-line basis as other income in our consolidated statements of operations. For the three and nine months ended September 30, 2023, the Company recognized $ 0.0 million and $ 0.1 million of sublease income, respectively.
13. 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 12.
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 6.
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.
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Legal Proceedings
The Company is not a party to any material legal proceedings.
14. Related Party Transactions
As more fully described in Note 5 to the Company’s consolidated financial statements for the year ended December 31, 2022, included in the Annual Report on Form 10-K, the Company holds a 49.7 % ownership in Angel Pharmaceuticals and, in connection with intellectual property licensing agreements between the Company and Angel Pharmaceuticals, the Company provides operational support and clinical drug supplies to Angel Pharmaceuticals. Third-party and internal personnel costs incurred by the Company are billed to Angel Pharmaceuticals in the period incurred and recorded as an offset to expenses. During the nine months ended September 30, 2023 and 2022, the Company billed Angel for $ 0.0 million and approximately $ 140,000 , respectively, in internal personnel costs and approximately $ 59,000 and $ 631,000 , respectively, in third-party party costs.
In addition to the provision of clinical supplies to Angel Pharmaceuticals, Angel Pharmaceuticals may provide clinical supplies or research services to the Company on an as needed basis. These costs are recorded as research and development expense. During the three and nine months ended September 30, 2023, Angel Pharmaceuticals billed the Company for approximately $ 9,000 and $ 225,000 million in research services, respectively.
In August 2021, the Company entered into an agreement to sublease 7,585 square feet of its office and laboratory space in Burlingame, California to Angel Pharmaceuticals. Pursuant to the sublease, rent is due monthly and is subject to scheduled annual increases and Angel Pharmaceuticals is responsible for certain operating expenses and taxes throughout the life of the sublease. The sublease expired in January 2023. Sublease income is recognized on a straight-line basis as other income in our consolidated statements of operations. During the nine months ended September 30, 2023 and 2022, the Company recognized approximately $ 0.1 million and $ 0.3 million of sublease income, respectively.
In July 2021, Linda S. Grais, M.D., J.D., a member of the Company’s Board of Directors, was appointed as a non-executive member of the Board of Directors of ICON plc (“ICON”), effective upon completion of ICON’s acquisition of PRA Health Sciences, Inc. ICON is a clinical research organization and provides services to support the Company’s clinical trials. During the nine months ended September 30, 2023 and 2022, the Company recorded approximately $ 0.2 million and $ 0.2 million, respectively, in clinical trial expenses under its agreements with ICON.
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