Corvus Pharmaceuticals Inc
For the period ended Dec 31, 2023. Filed Mar 19, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 19, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
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 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.
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, 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,
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 has incurred significant losses and negative cash flows from operations in all periods since inception. The Company had net losses of $27.0 million, $41.3 million, and $43.2 million for the years ended December 31, 2023, 2022, and 2021, respectively. The Company used net cash of $23.9 million, $27.0 million, and $36.7 million through its operating activities for the years ended December 31, 2023, 2022, and 2021, respectively. The Company had an accumulated deficit of $334.7 million and $307.7 million as of December 31, 2023 and 2022, respectively. To date, none of the Company’s product candidates have been approved for sale and therefore the Company has not generated any revenue from sales of commercial products. Management expects operating losses to continue for the foreseeable future. The Company has funded its operations to date primarily through the sale of redeemable convertible preferred stock and common stock. As of December 31, 2023, the Company had cash, cash equivalents and marketable securities of $27.1 million. The Company’s cash, cash equivalents and marketable securities are not sufficient to fund the Company’s planned operations for a period of 12 months from the date these consolidated financial statements are issued. To fund the Company's planned operations, the Company will need to raise additional capital. The Company intends to raise additional capital through private and public equity offerings, including its “at-the-market” offering program, debt financings, and potential future collaboration, license and development agreements. However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms acceptable to the Company or at all. If the Company is unsuccessful in its efforts to raise additional capital or if sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate one or more of its development programs, out-license intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above, any of which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its obligations on a timely basis or at all. Failure to manage discretionary spending or raise additional capital, as needed, may adversely impact the Company’s ability to achieve its intended business objectives. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these consolidated financial statements. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern.
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 were exercisable at any time prior to expiration except that the Exchange Warrants could not be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would have beneficially owned 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 were 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 was substantially similar to the fair value of the retired shares on the issuance date due to the negligible exercise price for the Exchange
Warrants.
In September 2021, the Exchange Warrants were fully exercised, resulting in the issuance of 1,457,947 shares of common stock on a net exercise basis.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying 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 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. Since its inception, the Company has incurred significant losses and negative cash flows from operations. As of December 31, 2023, the Company had an accumulated deficit of $334.7 million and cash, cash equivalents and marketable securities of $27.1 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.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the 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 withtwo 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 inone operating segment, that of the development of and commercialization of drugs and antibodies that target critical elements of the immune system.
Cash, Cash Equivalents and Marketable Securities
The Company considers all highly liquid investment securities with remaining maturities at the date of purchase of three months or less to be cash equivalents.
Investments with remaining maturities, at the date of purchase, greater than three months are classified as “available-for-sale” and are carried at fair value with unrealized gains and losses, if any, included as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Interest and realized gains and losses are included in interest income. Realized gains and losses are recognized based on the specific identification model.
Fair Value Measurements
Fair value accounting is applied for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). The carrying amount of the Company’s financial instruments, including cash equivalents, accounts payable and accrued liabilities, approximate fair value due to their short-term maturities.
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.
See Note 5 Equity Method Investment, for further information.
Property and Equipment, Net
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the respective assets:
| | | | |
|---|---|---|---|
| Laboratory equipment | 5 | years | |
| Computer equipment and purchased software | | 3 | years |
| Leasehold improvements | | Shorter of asset's useful life or remaining term of lease |
Maintenance and repairs that do not extend the life or improve the asset are expensed when incurred. When assets are retired or otherwise disposed of, the cost and accumulated depreciation or amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations.
Impairment of Long-Lived Assets
The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment, to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to future undiscounted net cash flows expected to be generated by the asset or asset group. Should impairment exist, the impairment loss to be recognized is measured by the amount by which the carrying amount of the asset exceeds the projected discounted future net cash flows arising from the asset. All long-lived assets are maintained in the United States of America.
Clinical Trial Accruals
Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks. The Company applies significant judgment in developing estimates for clinical trial accruals based on assumptions related to vendors’ progress towards completion. In developing these estimates, management estimates vendors’ progress towards completion using data such as clinical site activations, patient enrollment or information provided to the Company by its vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion, or the services completed. The Company’s estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time.
Stock-Based Compensation
The Company maintains incentive plans under which incentive stock options and nonqualified stock options may be granted to employees and non-employee service providers.
The Company accounts for stock-based employee compensation arrangements in accordance with the provisions of ASC 718, “Compensation—Stock Compensation.” For stock options granted to employees, the Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair values. The value of the award is recognized as an expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. Forfeitures are accounted for when they occur.
Stock-based compensation expense related to stock options granted to non-employees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model. The awards generally vest over the time period the Company expects to receive service from the non-employee.
Income Taxes
The Company accounts for income taxes under the asset and liability method. The Company estimates actual current tax exposure together with assessing temporary differences resulting from differences in accounting for reporting purposes and tax purposes for certain items, such as accruals and allowances not currently deductible for tax purposes. These temporary differences result in deferred tax assets and liabilities, which are included in the Company’s balance sheets. In general, deferred tax assets represent future tax benefits to be received when certain expenses previously recognized in the Company’s statements of operations and comprehensive loss become deductible expenses, under applicable income tax laws or when net operating loss or credit carryforwards are utilized. Accordingly, realization of the Company’s deferred tax assets is dependent on future taxable income against which these deductions, losses and credits can be utilized.
The Company must assess the likelihood that the Company’s deferred tax assets will be recovered from future taxable income and a valuation allowance is recorded when it is more likely than not that the deferred tax asset will not be recovered. The Company applies judgment in the determination of the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Based on the available evidence, the
Company is unable, at this time, to support the determination that it is more likely than not that its deferred tax assets will be utilized in the future. Accordingly, the Company recorded a full valuation allowance for all periods presented. The Company intends to maintain a valuation allowance until sufficient evidence exists to support its reversal.
The Company recognizes benefits of uncertain tax positions if it is more likely than not such positions will be sustained upon examination based solely on their technical merits as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. The Company recognizes any material interest and penalties related to unrecognized tax benefits in income tax expense. The Company is required to file income tax returns in the U.S. federal jurisdiction. The Company currently is not under examination by the Internal Revenue Service or other jurisdictions for any tax years.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s elements of other comprehensive loss in any period presented were unrealized gains and losses on available-for-sale marketable securities and cumulative foreign currency translation adjustments.
Net Loss per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding and Exchange Warrants outstanding during the period, without consideration of potentially dilutive securities. In accordance with Accounting Standards Codification Topic 260,Earnings Per Share, the Exchange Warrants are included in the computation of basic net loss per share because the exercise price is negligible and they are fully vested and exercisable at any time after the original issuance date. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares, Exchange Warrants, and potentially dilutive securities outstanding for the period. Diluted net loss per share is the same as basic net loss per share for all periods presented since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company.
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 October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K is effective. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the Codification and will not become effective for any entities. We are currently evaluating the effect of adopting this ASU.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Entities are permitted to early adopt the standard “for annual financial statements that have not yet been issued or made available for issuance.” As adoption is either prospectively or retrospectively, the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the impact of this ASU but does not expect any material impacts upon adoption.
3. Net Loss per Share
The following table shows the calculation of net loss per share (in thousands, except share and per share data):
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · · · · · · · · | ||||||
| · · Year Ended December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Numerator: · · · · | ||||||
| Net loss - basic and diluted | | $(27,029) | | $(41,307) | | $(43,241) |
| Denominator: | | | | | ||
| Weighted average common shares outstanding | | 48,025,274 | | 46,553,511 | | 41,854,110 |
| Less: weighted average common shares subject to repurchase | | — | | — | | — |
| Weighted average common shares outstanding used to compute basic and diluted net loss per share | | 48,025,274 | | 46,553,511 | | 41,854,110 |
| Net loss per share, basic and diluted | | $(0.56) | | $(0.89) | | $(1.03) |
The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect:
| · · · · · · | ||||
|---|---|---|---|---|
| · · · · · · | ||||
| · · Year Ended December 31, | ||||
| · 2023 · 2022 · 2021 | ||||
| Outstanding options | | 9,244,150 | 7,006,250 | 6,354,308 |
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 December 31, 2023 and 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):
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||
| · · Fair Value Measured Using · · Total | ||||||||
| · (Level 1) · (Level 2) · (Level 3) · Balance | ||||||||
| Assets · · · · | ||||||||
| Cash equivalents | | $12,280 | | $— | | $— | | $12,280 |
| Marketable securities | | 10,356 | | 4,173 | | — | | 14,529 |
| | | $22,636 | | $4,173 | | $— | | $26,809 |
| · · · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| · · 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 December 31, 2023, marketable securities had a maximum remaining maturity ofeleven months.
As of December 31, 2023 and 2022, the fair value of available for sale marketable securities by type of security were as follows (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||||||
| · · · Gross · Gross · · | ||||||||||||
| · · Amortized · · Unrealized · · Unrealized · · Fair | ||||||||||||
| · · Cost · · Gains · · Losses · · Value | ||||||||||||
| U.S. Treasury securities | | $10,348 | | $8 | | $— | | $10,356 | ||||
| U.S. Government agency securities | | | 4,166 | | | 7 | | | — | | | 4,173 |
| | | $14,514 | | $15 | | $— | | $14,529 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · 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
In August 2020, the Company established Angel Pharmaceuticals Co. Ltd. (“Angel”), a wholly-owned corporate venture in the People’s Republic of China (“China”) designed to develop, manufacture, and commercialize soquelitinib, ciforadenant and mupadolimab compounds for distribution within the countries of China, Taiwan, Macao, and Hong Kong (collectively, the “Territories”) based on intellectual property licenses to be contributed to Angel by the Company.
In October 2020, Angel raised financing from third-party investors, the licenses were entered into and the Company’s ownership interest was reduced to 53.2%. Under the license agreements, the Company is required to provide manufacturing supply services for future supply of drug products for use in clinical trials, research and development, operational support, and participate in the joint steering committee which oversees the development and commercialization of the compounds. Angel is not required to make any payments to the Company regarding the licensed compounds or the additional services outlined in the agreement. Pursuant to the terms of the agreement, during the Exclusive Grant Back Period, Angel grants to Corvus an exclusive, fully paid-up and sublicensable license for sole and jointly owned IP. After the 7 year Exclusive Grant Back Period, the licenses for sole and jointly owned IP that Angel grants to the company will be non-exclusive, fully paid, and sublicensable.
As a result of the financing, the Company reassessed its interest in Angel and determined that while Angel is a VIE, the Company is not considered the primary beneficiary of such VIE since Corvus does not have the power, through voting or similar rights and the license agreements, to direct the activities of Angel that most significantly impact Angel’s economic performance. Further, the Company determined that as it has a significant influence over Angel, and, therefore, it shall account for its investment in Angel using the equity method starting in October 2020, the date it lost control over Angel. At the date of loss of control, the Company derecognized all of Angel’s assets and liabilities from its balance sheet, recognized the retained equity interest at its fair value of $37.5 million, and recognized a gain of $37.5 million, which is included in gain on deconsolidation of Angel Pharmaceuticals on the consolidated statement of operations for the year ended December 31, 2020.
As of December 31, 2023, 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 $5.3 million, $10.0 million and $4.8 million as loss from equity method investment on the consolidated statement of operations for the years ended December 31, 2023, 2022 and 2021, respectively. Since inception through December 31, 2023, Angel has not recorded any revenue.
The Company evaluates its equity method investment in Angel for impairment whenever events or changes in circumstances indicate that the carrying amount of the investment might not be recoverable. For further discussion of the
Company’s impairment policy, see Note 2.
Summary Financial Information
Summary financial information for Angel Pharmaceuticals is as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| | | | As of | | | As of |
| Balance Sheet Data · December 31, 2023 · · December 31, 2022 | ||||||
| · (in thousands) | ||||||
| Current assets | | $17,628 | | $29,062 | ||
| Non-current assets | | 1,427 | | 1,652 | ||
| Current liabilities | | 1,725 | | 6,293 | ||
| Non-current liabilities | | 648 | | 985 | ||
| Stockholders' equity | | | 16,682 | | | 23,436 |
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · | |||||||||
| · · Year Ended December 31, | |||||||||
| Statement of Operations Data · 2023 · · 2022 · · 2021 | |||||||||
| · (in thousands) | |||||||||
| Revenue | | $— | | $— | | $— | |||
| Gross Profit | | — | | — | | — | |||
| Net loss | | | 6,213 | | | (11,846) | | | (5,697) |
| Share of loss from investments accounted for using the equity method | | (5,284) | | (10,005) | | (4,831) | |||
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 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 $2.5 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.
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 year ended December 31, 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 December 31, 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-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 year ended December 31, 2023, no development or sales milestones were completed or paid to Monash and the aggregate potential milestones were $45.1 million as of December 31, 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.
**7.**Balance Sheet Components (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| | 2023 | 2022 | ||||
| Prepaid and Other Current Assets | | | | | | |
| Interest receivable | | $37 | | $45 | ||
| Prepaid research and development manufacturing expenses | | | 149 | | | 192 |
| Prepaid facility expenses | | | 196 | | | 182 |
| Prepaid insurance | | | 179 | | | 252 |
| Other | | 220 | | 102 | ||
| | | $781 | | $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 | | (4,697) | | (4,546) | ||
| | | $236 | | $353 | ||
| Accrued and Other Liabilities | | | | | | |
| Accrued clinical trial expense | | $2,302 | | $2,934 | ||
| Accrued manufacturing expense | | 675 | | 3,254 | ||
| Personnel related | | 684 | | 1,113 | ||
| Accrued legal and accounting | | | 64 | | | 89 |
| Other | | 245 | | 158 | ||
| | | $3,970 | | $7,548 | ||
During the years ended December 31, 2023, 2022, and 2021, the Company recorded $0.2 million, $0.4 million and $0.5 million in depreciation expense, respectively.
8. Common Stock
As of December 31, 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 toone vote. Common stockholders are entitled to dividends if and when declared by the board of directors. As of December 31, 2023, no dividends on common stock had been declared.
On March 28, 2023, the Company entered into an 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.
During the year ended December 31, 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 December 31, 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:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Shares available for future option grants | | 3,617,943 | | 4,017,011 | | 2,806,953 |
| Outstanding options | 9,244,150 | | 7,006,250 | | 6,354,308 | |
| Shares reserved for employee stock purchase plan | 400,000 | | 400,000 | | 400,000 | |
| Total | 13,262,093 | | 11,423,261 | | 9,561,261 | |
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 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 andno 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 | (2,543,500) | 2,543,500 | | 1.43 |
| Options exercised | — | (23,168) | | 0.52 |
| Options forfeited | 282,432 | (282,432) | | 6.67 |
| Balance at December 31, 2023 | 3,617,943 | 9,244,150 | | $4.17 |
The weighted average grant date fair value of options granted for the years ended December 31, 2023, 2022 and 2021, was $1.12, $0.69 and $1.93, respectively.
Options outstanding that had vested or were expected to vest at December 31, 2023 were as follows:
| · · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | | | | Weighted | | |
| · · · · · · · Average · · Aggregate | ||||||
| · · · · Weighted · · Remaining · · Intrinsic | ||||||
| · · Number · · Average · · Contractual · · Value | ||||||
| · · of shares · · Exercise Price · · Life (years) · · (in thousands) | ||||||
| Vested | 5,368,174 | | $6.01 | 5.86 | | $736 |
| Expected to vest | 3,875,976 | | $1.62 | 9.08 | | $1,451 |
In the table above, aggregate intrinsic value represents the difference between the exercise price of the options to purchase common stock and the fair value of the Company’s common stock of $1.76 per share as of December 31, 2023.
The aggregate intrinsic value of stock options exercised in the years ended December 31, 2023, 2022 and 2021, was less than $0.1 million, $0.0 million and $1.0 million, respectively.
The total fair value of options that vested in the year ended December 31, 2023, 2022 and 2021, was $2.1 million, $2.8 million, and $4.5 million, respectively.
10. Stock-Based Compensation
The Company’s results of operations include expenses relating to stock-based awards as follows (in thousands):
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · · · · · · · · | ||||||
| · · Year Ended December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Research and development | | $755 | | $1,039 | | $2,161 |
| General and administrative | | 1,392 | | 1,653 | | 2,071 |
| Total | | $2,147 | | $2,692 | | $4,232 |
Valuation Assumptions
The Company estimated the fair value of employee stock options using the Black-Scholes valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value of employee stock options were estimated using the following assumptions for the years ended December 31, 2023, 2022 and 2021:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · Year Ended December 31, · | ||||||
| · 2023 · 2022 · 2021 · | ||||||
| Risk-free interest rate | | 3.9% | 3.0% | 0.9% | ||
| Expected volatility | | 97.1% | 83.8% | 86.7% | ||
| Expected term (in years) | | 5.7 | | 5.5 | | 6.0 |
| Expected dividend yield | | 0% | 0% | 0% | ||
**Risk-free Interest Rate:**The risk-free interest rate is estimated based on the U.S. Treasury securities with maturity dates commensurate with the expected term of the equity award.
Volatility: The expected volatility in 2023 was determined based on the Company’s historical stock price volatility. In 2022 and 2021, the Company utilized the average historical stock price volatility of a peer group of publicly traded companies to represent its expected future stock price volatility, due to the insufficient trading history of the Company’s common stock. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. For each grant, the Company measured historical volatility over a period equivalent to the expected term.
Expected Term: The Company uses the simplified method prescribed in the ASC 718, Compensation—Stock Compensation, to calculate the expected term of options granted to employees and directors.
Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future.
At December 31, 2023, 2022 and 2021, the unrecognized compensation expense associated with respect to options granted to employees was $4.5 million, $3.9 million and $5.9 million, respectively, and is expected to be recognized on a straight-line basis over 2.27,2.44, and 2.69 years, respectively.
11. Income Taxes
The components of loss before income tax is as follows (in thousands):
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Domestic | | $(27,029) | | $(41,307) | | $(43,241) |
| Foreign | | — | | — | | — |
| | | $(27,029) | | $(41,307) | | $(43,241) |
During the years ended December 31, 2023, 2022 and 2021, the Company recordedno income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items.
A reconciliation of the Company’s effective tax rate to the U.S. Federal statutory rate is as follows:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Federal tax benefit at statutory rate | | 21% | 21% | 21% | ||
| State tax, net of Federal benefit | | 8% | 8% | 9% | ||
| Change in valuation allowance | | (25)% | (22)% | (26)% | ||
| Research and development tax credits | | 3% | 2% | 3% | ||
| Share based Compensation | | (1)% | (1)% | (1)% | ||
| FIN48 Reserve | | (1)% | —% | (1)% | ||
| Investment in Angel | | (5)% | (7)% | (3) | | |
| Prior year federal true-up | | —% | —% | (1)% | ||
| Other | | —% | (1) | | (1) | |
| Effective income tax rate | | 0% | 0% | 0% | ||
The effective tax rate is different from the federal statutory tax rate primarily due to a foreign rate differential and a valuation allowance against deferred tax assets as a result of the Company’s history of losses.
The principal components of the Company’s net deferred tax assets are as follows (in thousands)
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · December 31, | |||||||||
| | 2023 | 2022 | 2021 | ||||||
| Deferred tax assets | | | | | | | | | |
| Net operating loss carryforwards | | $59,314 | | $56,030 | | $52,539 | |||
| Tax credit carryforwards | | 10,752 | | 9,888 | | 9,181 | |||
| Capitalized tax assets | | 138 | | 155 | | 125 | |||
| Accruals | | 116 | | 124 | | 137 | |||
| Stock compensation | | | 5,883 | | | 5,487 | | | 5,006 |
| Operating lease liability | | | 384 | | | 728 | | | 1,021 |
| IRC 174 capitalization | | | 6,713 | | | 4,518 | | | — |
| Other | | — | | 21 | | 12 | |||
| Total deferred tax assets | | $83,300 | | $76,951 | | $68,021 | |||
| Deferred tax liabilities | | | | | | | | | |
| Operating lease right-of-use asset | | $(322) | | $(620) | | $(893) | |||
| Valuation allowance | | (82,978) | | (76,331) | | (67,128) | |||
| Net deferred tax assets | | $— | | $— | | $— | |||
The Company recorded a valuation allowance against its deferred tax assets at December 31, 2023 and 2022 because Company management believed that it was more likely than not that these assets would not be fully realized in the future. The valuation allowance increased by approximately $6.6 million and $9.2 million for the years ended December 31, 2023 and 2022, respectively. Changes in the valuation allowance for deferred tax assets relate primarily to the increase in the Company’s net operating loss carryforward.
As of December 31, 2023, the Company had federal NOL carryforwards of approximately $228.7 million and state NOL carryforwards of approximately $294.8 million which are available to reduce future taxable income. The NOLs will begin to expire in 2034, if not utilized. Utilization of the net operating loss carryforwards are subject to various limitations due to the ownership change limitations provided by Internal Revenue Code (IRC) Section 382 and similar state provisions.
As of December 31, 2023, the Company also had $9.4 million of federal and $5.1 million of state research and development tax credit carryforwards available to reduce future income taxes. The federal research and development tax credits will begin to expire 2035, if not utilized. The state research and development tax credits have no expiration date.
U.S. income and foreign withholding taxes have not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries that are essentially permanent in duration. This excess totaled approximately $16.1 million as of December 31, 2023, which will be indefinitely reinvested; deferred income taxes have not been provided on such foreign earnings.
As of December 31, 2023, the Company had unrecognized tax benefits (“UTBs”) of approximately $12.8 million. All of the deferred tax assets associated with these UTBs are fully offset by a valuation allowance. The following table summarizes the activity related to UTBs:
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · December 31, | ||||||
| · 2023 · 2022 · 2021 | ||||||
| Unrecognized tax benefits beginning of the period | | $12,720 | | $12,504 | | $12,157 |
| Decrease related to the prior year | | (119) | | — | | — |
| Increased related to the current year | | 222 | | 216 | | 347 |
| Unrecognized tax benefits, end of the period | | $12,823 | | $12,720 | | $12,504 |
The Company follows the provisions of ASC 740, Accounting for Income Taxes, and the accounting guidance related to accounting for uncertainty in income taxes. The Company determines its uncertain tax positions based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more
likely than not to be sustained upon examination by the relevant income tax authorities. None of the Company’s unrecognized tax benefits that, if recognized, would affect its effective tax rate. The Company does not anticipate the total amounts of unrecognized tax benefits will significantly increase or decrease in the next 12 months. The Company will recognize both accrued interest and penalties related to unrecognized benefits in income tax expense. Management determined thatno accrual forinterest or penalties was required as of December 31, 2023, 2022 and 2021.
The Company currently hasno federal orstate tax examinations in progress nor has it had any federal or state examinations since inception. As a result of the Company’s net operating loss carryforwards, all of its tax years are subject to federal, state and foreign tax examinations.
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 aone 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 January 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 isdetermined 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 December 31, 2023 and 2022, the right-of-use asset under operating lease was $1.1 million and $2.2 million, respectively. The elements of lease expense were as follows (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Year Ended | ||||||||||||
| · Statements of operations and · · December 31, | ||||||||||||
| | | comprehensive loss location | 2023 | 2022 | 2021 | | ||||||
| Costs of operating lease | | | | | | | | | | | | |
| Operating lease costs | | Research and development,General and administrative | | $1,224 | | $1,051 | | $1,046 | | |||
| Costs of non-lease components (previously common area maintenance) | | Research and development,General and administrative | | | 420 | | | 351 | | | 396 | |
| Total operating lease cost | | | | $1,644 | | $1,402 | | $1,442 | | |||
| Other Information | | | | | | | | | | | | |
| Operating cash flows used for operating lease | | | | $1,839 | | $1,695 | | $1,645 | | |||
| Remaining lease term | | | | 1.1 years | | 2.1 years | | 3.1 years | | |||
| Discount rate | | | | 8.0% | | 8.0% | | 8.0% | | |||
As of December 31, 2023, minimum rental commitments under this lease were as follows (in thousands)
| | | | |
|---|---|---|---|
| Year Ended December 31 (in thousands) · · | |||
| 2024 | | | 1,434 |
| Total lease payments | | 1,434 | |
| Less: imputed interest | | | (60) |
| Total | $1,374 | ||
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 years ended December 31, 2023 and 2022, the Company recognized $0.1 million and $0.6 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.
Legal Proceedings
The Company is not a party to any material legal proceedings.
14. Related Party Transactions
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.
The following aggregate number of shares of common stock were sold to the Company’s owners of more than 10% of our common stock, directors, or executive officers during the February 2021 underwritten public offering:
| | | | | | | |
|---|---|---|---|---|---|---|
| · Number of · · Aggregate | ||||||
| · · · Shares of · · Purchase | ||||||
| | Common Stock | Price | ||||
| Owners of More Than 10% of Our Common Stock | | | | | | |
| OrbiMed Advisors LLC (1) | | | 1,285,714 | | $4,499,999 | |
| Board of Directors | | | | | | |
| Richard A. Miller, M.D. | | | 100,000 | | | 350,000 |
| (1) | Peter Thompson, M.D., a member of our Board of Directors since November 2014, is a Member of OrbiMed Advisors, LLC. |
As more fully described in Note 5, 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 years ended December 31, 2023 and 2022, the Company billed Angel for approximately $0.0 million and $0.1 million in internal personnel costs, respectively, and $0.1 million and $1.3 million in third-party costs, respectively. Of the third-party costs billed to Angel in the year ending December 31, 2022, approximately $0.5 million were associated with clinical drug supply manufactured and expensed in prior years. The remaining $0.1 million and $0.8 million in third-party costs were primarily associated with clinical drug supply passthrough costs incurred during the years ended December 31, 2023 and 2022, respectively, and did not have an impact on the Company’s consolidated statements of operations.
In addition to the provision of clinical supplies to Angel Pharmaceuticals, Angel Pharmaceuticals may provide clinical supplies and research services to the Company on an as needed basis. These transactions are recorded as research and development expense. During the years ended December 31, 2023 and 2022, Angel Pharmaceuticals billed the Company for approximately $0.2 million and $0.2 million, respectively, associated with clinical drug supply and research services provided to the Company.
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 years ended December 31, 2023 and 2022, the Company recognized $0.1 million and $0.6 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 years ended December 31, 2023 and 2022, the Company recorded approximately $254,000 and $429,000, respectively, in clinical trial expenses under its agreements with ICON.
15. Subsequent Events
The Company has evaluated subsequent events through the filing of this Annual Report on Form 10-K and determined that there have been no events that have occurred that would require adjustments to its disclosures in the consolidated financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.