Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 06, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CALA | |
Entity Registrant Name | CALITHERA BIOSCIENCES, INC. | |
Entity Central Index Key | 0001496671 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 97,237,262 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36644 | |
Entity Tax Identification Number | 27-2366329 | |
Entity Address, Address Line One | 343 Oyster Point Blvd. | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 870-1000 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, 0.0001 par value | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 44,664 | $ 59,537 |
Receivable related to asset purchase agreement | 127 | |
Prepaid expenses and other current assets | 2,478 | 1,915 |
Total current assets | 47,269 | 61,452 |
Restricted cash | 270 | 270 |
Property and equipment, net | 492 | 556 |
Operating lease right-of-use asset | 2,205 | 2,478 |
Total assets | 50,236 | 64,756 |
Current liabilities: | ||
Accounts payable | 2,124 | 3,650 |
Accrued and other liabilities | 9,251 | 10,356 |
Total current liabilities | 11,375 | 14,006 |
Noncurrent operating lease liability | 1,295 | 1,666 |
Total liabilities | 12,670 | 15,672 |
Commitments and contingencies | ||
Convertible preferred stock; $0.0001 par value; 10,000 shares authorized as of March 31, 2022 and December 31, 2021; 1,000 shares issued and outstanding as of March 31, 2022 and December 31, 2021; $35,000 liquidation preference as of March 31, 2022 and December 31, 2021 (Note 7) | 40,702 | 40,702 |
Stockholders' (deficit) equity: | ||
Common stock, $0.0001 par value, 200,000 shares authorized as of March 31, 2022, and December 31, 2021; 78,718 and 77,144 shares issued and outstanding as of March 31, 2022, and December 31, 2021, respectively | 8 | 8 |
Additional paid-in capital | 502,017 | 499,700 |
Accumulated deficit | (505,161) | (491,326) |
Total stockholders' (deficit) equity | (3,136) | 8,382 |
Total liabilities, convertible preferred stock and stockholders' (deficit) equity | $ 50,236 | $ 64,756 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Temporary equity, par value | $ 0.0001 | $ 0.0001 |
Temporary equity, shares authorized | 10,000,000 | 10,000,000 |
Temporary equity, shares issued | 1,000,000 | 1,000,000 |
Temporary equity, shares outstanding | 1,000,000 | 1,000,000 |
Temporary equity, liquidation preference | $ 35,000 | $ 35,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 78,718,000 | 77,144,000 |
Common stock, shares outstanding | 78,718,000 | 77,144,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 9,566 | $ 15,339 |
General and administrative | 4,260 | 5,428 |
Total operating expenses | 13,826 | 20,767 |
Loss from operations | (13,826) | (20,767) |
Interest and other income (expense), net | (9) | 372 |
Net loss | $ (13,835) | $ (20,395) |
Net loss per share, basic and diluted | $ (0.18) | $ (0.28) |
Weighted average common shares used to compute net loss per share, basic and diluted | 78,468 | 72,247 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Consolidated Statements of Comprehensive Loss [Abstract] | ||
Net loss | $ (13,835) | $ (20,395) |
Other comprehensive loss: | ||
Net unrealized loss on available-for-sale securities | (3) | |
Total comprehensive loss | $ (13,835) | $ (20,398) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) shares in Thousands, $ in Thousands | Total | Convertible Preferred Stock | At-the-Market Offering | Common Stock | Common StockAt-the-Market Offering | Additional Paid-In Capital | Additional Paid-In CapitalAt-the-Market Offering | Accumulated Deficit | Accumulated Other Comprehensive Income |
Balance at Dec. 31, 2020 | $ 102,371 | $ 7 | $ 478,599 | $ (376,238) | $ 3 | ||||
Balance, shares at Dec. 31, 2020 | 70,686 | ||||||||
Issuance of common stock | $ 9,488 | $ 9,488 | |||||||
Issuance of common stock, shares | 3,197 | ||||||||
Exercise of stock options | 2 | 2 | |||||||
Exercise of stock options, shares | 1 | ||||||||
Stock-based compensation expense | 2,695 | 2,695 | |||||||
Net loss | (20,395) | (20,395) | |||||||
Unrealized gain (loss) on available-for-sale securities | (3) | (3) | |||||||
Balance at Mar. 31, 2021 | 94,158 | $ 7 | 490,784 | (396,633) | |||||
Balance, shares at Mar. 31, 2021 | 73,884 | ||||||||
Balance at Dec. 31, 2020 | 102,371 | $ 7 | 478,599 | (376,238) | $ 3 | ||||
Balance, shares at Dec. 31, 2020 | 70,686 | ||||||||
Net loss | (115,100) | ||||||||
Balance at Dec. 31, 2021 | 8,382 | $ 8 | 499,700 | (491,326) | |||||
Balance, shares at Dec. 31, 2021 | 77,144 | ||||||||
Temporary equity, Balance at Dec. 31, 2021 | $ 40,702 | $ 40,702 | |||||||
Temporary equity, Balance, shares at Dec. 31, 2021 | 1,000 | 1,000 | |||||||
Issuance of common stock | $ 1,137 | $ 1,137 | |||||||
Issuance of common stock, shares | 1,234 | ||||||||
Issuance of common stock pursuant to equity incentive plans, Shares | 340 | ||||||||
Stock-based compensation expense | $ 1,180 | 1,180 | |||||||
Net loss | (13,835) | (13,835) | |||||||
Balance at Mar. 31, 2022 | (3,136) | $ 8 | $ 502,017 | $ (505,161) | |||||
Balance, shares at Mar. 31, 2022 | 78,718 | ||||||||
Temporary equity, Balance at Mar. 31, 2022 | $ 40,702 | $ 40,702 | |||||||
Temporary equity, Balance, shares at Mar. 31, 2022 | 1,000 | 1,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Cash Flows Used in Operating Activities | |||
Net loss | $ (13,835) | $ (20,395) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 64 | 73 | |
Accretion of discounts on investments | 3 | ||
Stock-based compensation | 1,180 | 2,695 | |
Gain on remeasurement of the lease liability | (362) | ||
Non-cash lease expense | 273 | 351 | |
Changes in operating assets and liabilities: | |||
Receivables | (127) | 513 | |
Prepaid expenses and other current assets | (146) | (619) | |
Accounts payable | (1,526) | (390) | |
Accrued liabilities | (1,560) | (3,402) | |
Lease liability | (333) | (469) | |
Net cash used in operating activities | (16,010) | (22,002) | $ (66,300) |
Cash Flows Provided by Investing Activities | |||
Proceeds from sale and maturity of investments | 6,500 | ||
Net cash provided by investing activities | 6,500 | ||
Cash Flows Provided by Financing Activities | |||
Proceeds from issuance of common stock through an at-the-market offering, net | 1,137 | 9,535 | |
Proceeds from stock options exercises | 2 | ||
Net cash provided by financing activities | 1,137 | 9,537 | |
Net decrease in cash, cash equivalents, and restricted cash | (14,873) | (5,965) | |
Cash, cash equivalents, and restricted cash at beginning of period | 59,807 | 107,586 | 107,586 |
Cash, cash equivalents, and restricted cash at end of period | 44,934 | 101,621 | $ 59,807 |
Supplemental Disclosure of Non-Cash Activities: | |||
Unpaid amounts related to stock issuance and deferred financing costs | $ 417 | $ 47 |
Organization and Basis of Prese
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Organization Calithera Biosciences, Inc., or the Company, was incorporated in the State of Delaware on March 9, 2010 . The Company is a clinical-stage precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of investigational, small molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. The Company’s principal operations are based in South San Francisco, California, and it operates in one segment. Presentation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Calithera Biosciences UK Limited and Calithera Biosciences Ireland Limited. All significant intercompany accounts and transactions have been eliminated from the condensed consolidated financial statements. The Company's Ability to Continue as a Going Concern As of March 31, 2022, the Company had cash and cash equivalents of $ 44.7 million. On April 1, 2022, the Company received $ 8.5 million in net proceeds from its public offering of shares of its common stock and warrants, after deducting underwriting discounts, commissions and offering costs. The Company has incurred losses since inception and to date has financed its operations primarily through the sale of shares of its capital stock and payments from the Company’s collaboration and licensing agreements. As of March 31, 2022, the Company had an accumulated deficit of $ 505.2 million. During the year ended December 31, 2021 and three months ended March 31, 2022, the Company incurred a loss from continuing operations of $ 115.1 million and $ 13.8 million, respectively, and used $ 66.3 million and $ 16.0 million of cash in operations, respectively. The Company expects to continue to generate operating losses and negative operating cash flows for the foreseeable future and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of its existing product candidates, including sapanisertib and mivavotinib, and the achievement of a level of revenues adequate to support its cost structure. In accordance with Accounting Standards Codification, or ASC, 205-40, Going Concern , the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued on May 10, 2022. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity or debt issuances cannot be considered probable at this time because these plans are not entirely within the Company’s control and have not been approved by the board of directors as of the date of these condensed consolidated financial statements. The Company's expectation to generate operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these condensed consolidated financial statements are issued on May 10, 2022. Management's plans to alleviate the conditions that raise substantial doubt include the pursuit of additional cash resources through sales of shares of its capital stock, reduced 2022 spending, and potentially through strategic collaboration or licensing agreements. Management has concluded the likelihood that its plan to successfully obtain sufficient funding from one or more of these sources, or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these condensed consolidated financial statements. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The interim condensed consolidated balance sheet as of March 31, 2022, the statements of operations, comprehensive loss, and stockholders’ (deficit) equity, for the three months ended March 31, 2022 and 2021, and the statement of cash flows for the three months ended March 31, 2022 and 2021 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three-month period are also unaudited. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other future annual or interim period. The balance sheet as of December 31, 2021 included herein was derived from the audited consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Form 10-K as filed with the Securities and Exchange Commission, or SEC. Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contract assets and contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accrued liabilities, revenue recognition, fair value of marketable securities, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents, which consist primarily of amounts invested in money market accounts, are stated at fair value. Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. As of each balance sheet date, the Company classifies available-for-sale securities with remaining contractual maturities of more than one year as long-term investments, and those with remaining contractual maturities of one year or less as short-term investments. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. Restricted Cash Restricted cash consists of money market funds held by the Company’s financial institution as collateral for the Company’s obligations under its facility lease for the Company’s corporate headquarters in South San Francisco, California. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents, investments and restricted cash. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, investments and restricted cash are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit may at times exceed federally insured limits. Revenue Recognition The Company records revenue in accordance with Accounting Standards Codification, or ASC No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company has a collaboration and license agreement with Incyte, the Incyte Collaboration Agreement, and a license agreement with Antengene, the Antengene License Agreement, that are within the scope of ASC 606, under which the Company licenses certain rights to its product candidates. The terms of these arrangements include payment to the Company of non-refundable, upfront license fees, and potential development, regulatory and sales milestones, and sales royalties. Each of these payments results in collaboration or license revenue, except for revenues from royalties on net sales of licensed products, which would be classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreement, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Licenses of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promised goods or services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received or the underlying activity has been completed. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Contract Balances Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company had no contract assets or liabilities as of March 31, 2022 and December 31, 2021. For the three months ended March 31, 2022 and 2021, the Company did no t recognize any revenue from performance obligations satisfied in previous periods. Awards The Company assesses at the inception of award agreements whether the agreement is a liability. If the Company is obligated to repay funds received regardless of the outcome of the related research and development activities, then the Company is required to estimate and recognize a liability for this obligation. Alternatively, if the Company is not required to repay the funds, then payments received are recorded as contra research and development expense in the consolidated statement of operations as expenses are incurred. If payment criteria has been met and allowable expenses have been incurred, but not received at the balance sheet date, the amount of the receivable is included in receivables from collaborations in the consolidated balance sheet. Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and includes these costs in accrued and other liabilities in the consolidated balance sheets and within research and development expense in the consolidated statements of operations. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. Leases The Company accounts for its leases under ASC No. 2016-02, Leases (Topic 842), or ASC 842. Operating lease right-of-use, or ROU, assets and lease liabilities are recognized at commencement and are recorded for leases with durations greater than 12 months. ROU assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company estimates an incremental borrowing rate based on the information available at commencement date, in determining the present value of lease payments. The operating lease ROU asset also includes lease incentives. Lease expense is recognized on a straight-line basis over the lease term. The Company elected to not separate lease components and non-lease components for its long-term facility lease. Variable lease payments include lease operating expenses. Stock-Based Compensation The Company maintains various stock incentive plans under which stock options and restricted stock awards are granted to employees, non-employee directors of the board, and non-employees. The Company also has an employee stock purchase plan for all eligible employees. Stock options and stock purchased under the employee stock purchase plan, are recorded at fair value as of the grant date using the Black-Scholes option-pricing model. Restricted stock awards are measured at grant date fair value, at the market price of the Company’s common stock on the grant date. The Company has elected to account for forfeitures as they occur. The Company records stock-based compensation expense related to the service-based instruments ratably over the employee, director, or non-employees’ respective requisite service period (generally the vesting period). For performance-based stock awards with vesting conditioned on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If the assessment of the probability of the performance condition being met changes, the impact of the change in estimate would be recognized in the period of the change. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. Accounting Pronouncement Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, or ASU 2016-13 . The updated accounting guidance requires changes to the recognition of credit losses on financial instruments not accounted for at fair value through net income. In May 2019, the FASB issued ASU No. 2019-05, Targeted Transition Relief , which provides transition guidance to entities that elect the fair value option for eligible instruments. In November 2019, the FASB issued ASU 2019-10 which extends the effective date of the standards for smaller reporting companies to interim and annual periods beginning after December 15, 2022. These standards require using a modified retrospective approach with the cumulative effect recognized as an adjustment to retained earnings. A prospective transition approach is required for debt securities that have recognized an other-than-temporary impairment prior to the effective date. For the Company’s receivables from collaborations and other agreements and certain other financial instruments, the Company will be required to use a forward-looking “expected” credit loss model instead of the existing “incurred” credit loss model, which will generally result in earlier recognition of allowances for credit losses. The Company plans to adopt this standard effective January 1, 2023. The Company is currently evaluating the effect the guidance will have on its financial statements or disclosures. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the condensed consolidated financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, investments, receivables, accounts payable, and accrued liabilities that approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds as Level 1. When quoted market prices are not available for the specific security, then the Company estimates fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and market reference data. The Company classifies its corporate notes and U.S. government agency securities as Level 2. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset or liability. The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that were measured on a recurring basis (in thousands): March 31, 2022 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 43,944 $ — $ — $ 43,944 Total financial assets $ 43,944 $ — $ — $ 43,944 December 31, 2021 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 56,337 $ — $ — $ 56,337 Total financial assets $ 56,337 $ — $ — $ 56,337 |
Financial Instruments
Financial Instruments | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Financial Instruments | 4. Financial Instruments Cash equivalents and investments, all of which are classified as available-for-sale securities and restricted cash, consisted of the following (in thousands): March 31, 2022 December 31, 2021 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 43,944 $ — $ — $ 43,944 $ 56,337 $ — $ — $ 56,337 $ 43,944 $ — $ — $ 43,944 $ 56,337 $ — $ — $ 56,337 Classified as: Cash equivalents $ 43,674 $ 56,067 Restricted cash 270 270 Total cash equivalents, $ 43,944 $ 56,337 There have been no significant realized gains or losses on available-for-sale securities for the periods presented. As of March 31, 2022 and December 31, 2021, there were no unrealized losses on cash equivalents. As of March 31, 2022 , the Company had a total of $ 44.9 million in cash, cash equivalents and restricted cash, which includes approximately $ 1 million in cash and $ 43.9 million in cash equivale nts and restricted cash. |
Accrued and Other Liabilities
Accrued and Other Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued and Other Liabilities | 5. Accrued and Other Liabilities Accrued and other liabilities consist of the following (in thousands): March 31, 2022 December 31, 2021 Accrued clinical and manufacturing expenses $ 4,202 $ 5,086 Accrued payroll and related expenses 2,146 3,283 Current portion of lease liability 1,412 1,374 Accrued professional and consulting expenses 977 155 Other 514 458 Total accrued and other liabilities $ 9,251 $ 10,356 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | 6. Leases The Company has a non-cancelable facility lease agreement, or the Lease, for office and laboratory facilities in South San Francisco, California, with a remaining lease term of 1.8 years, through January 2024, and a two-year renewal option prior to expiration. The renewal option to extend the Lease was not considered in the determination of the right-of-use asset or the lease liability for the Lease as the Company did not consider it reasonably certain that it would exercise any such option. The Lease provides that the Company is obligated to pay certain variable costs, including taxes and operating expenses. The Lease is classified as an operating lease. From inception, the Company measured the present value of its lease liability using an estimated incremental borrowing rate of 9 %. On March 8, 2021, the Company amended its lease to reduce its rentable area from approximately 54,000 square feet to approximately 34,000 square feet. The related reduction in rent was effective January 1, 2021. In connection with the amendment, the Company also reduced its existing letter of credit from $ 440,000 to $ 270,000 as a security deposit to the lease. Subsequent to the amendment, which was determined to be a modification of the lease, the Company remeasured the present value of its lease liability using an estimated incremental borrowing rate of 7.5 %. The Company recognized a gain of $ 0.4 million, which is included in interest and other income (expense), net in its unaudited condensed consolidated statement of operations for the three months ended March 31, 2021, which represents the difference between the reduced lease liability and the reduction in the operating lease right of use asset. The components of net operating lease costs included in the condensed consolidated statement of operations for the three months ended March 31, 2022 and 2021, were as follows (in thousands): Three Months Ended March 31, Operating Lease Costs: 2022 2021 Straight-line rent expense related to $ 326 $ 484 Variable rent expense related to 229 244 Net operating lease costs $ 555 $ 728 Cash paid for amounts included in the measurement of the lease liabilities for both the three months ended March 31, 2022 and 2021 , was $ 0.4 million and $ 0.6 million, respectively, was included in net cash used in operating activities in the Company’s unaudited condensed consolidated statements of cash flows. The balance sheet classification of the Company’s operating lease liability was as follows (in thousands): Operating Lease Liability: March 31, 2022 December 31, 2021 Current portion included in accrued and other liabilities $ 1,412 $ 1,374 Noncurrent operating lease liability 1,295 1,666 Total operating lease liability $ 2,707 $ 3,040 The maturities of the Company’s lease liability as of March 31, 2022, was as follows (in thousands): Year ending December 31: 2022 (excluding the three months ended March 31, 2022) $ 1,161 2023 1,593 2024 136 Total lease payments 2,890 Less: interest ( 183 ) Present value of lease liability $ 2,707 |
Takeda Asset Purchase and Stock
Takeda Asset Purchase and Stock Purchase Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Business Combinations [Abstract] | |
Takeda Asset Purchase and Stock Purchase Agreement | 7. Takeda Asset Purchase and Stock Purchase Agreements Takeda Asset Purchase Agreement On October 18, 2021, the Company entered into an Asset Purchase Agreement, or APA, with Millennium Pharmaceuticals, Inc. or Millennium, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, or Takeda, pursuant to which the Company acquired and licensed from Millennium certain technology, intellectual property and other assets related to Takeda’s small molecule programs sapanisertib (CB-228, formerly known as TAK-228) and mivavotinib (CB-659, formerly known as TAK-659), or the Takeda Programs. Under the APA, Millennium assigned or caused to be assigned to the Company certain patents and know-how solely related to the Takeda Programs and necessary for the exploitation of products containing the CB-228 and CB-659 compounds, as well as specified regulatory materials, agreements, materials and inventory related to the Takeda Programs. Takeda also granted to the Company a license under certain other intellectual property necessary for the exploitation of such products. The Company granted to Millennium a license under the intellectual property assigned by Takeda to the Company (including intellectual property controlled by the Company via the assigned contracts) in order for Millennium to perform its obligations under the APA, ancillary agreements executed in connection with the APA and other retained agreements and for Millennium’s internal research use. The Company must use commercially reasonable efforts to develop and commercialize at least one CB-228 product and one CB-659 product in each of the United States, Japan and certain European countries. Pursuant to the APA, in October 2021, the Company paid Millennium an upfront payment of $ 10 million in cash and issued to Millennium 1,000,000 shares of its Series A convertible preferred stock as referenced below. In determining the total purchase consideration paid to Millennium, the Series A convertible preferred stock shares were classified as level 3 in the valuation hierarchy due to the presence of significant unobservable inputs, and were valued upon issuance at $ 40.9 million using the Black-Scholes option-pricing model and the following assumptions: Description Credit spread 12.4 % Allowance for counterparty credit risk of the Company given the liquidation preference and obligation to issue more shares as the stock price decreases Probability of a Qualified 75 % As determined upon issuance date Expected timing of a 0.5 years As determined upon issuance date Expected term 0.7 years Weighted average of time to a Qualified Financing and time to the Mandatory Pricing Date, as determined upon issuance date Volatility 55 % Based on the Company’s trading history for its common stock over the estimated term to the mandatory pricing date Risk-free interest rate 0.08 % Based on the U.S. constant maturity treasury yield curve at the time of issuance over the expected term Common stock price $ 2.04 The Company's closing common stock price on October 15, 2021 Total consideration transferred was $ 50.9 million and was comprised of the $ 10 million cash payment and the estimated fair value of the shares of the Company’s Series A convertible preferred stock of $ 40.9 million. The Company recorded a charge of $ 50.9 million related to the assets acquired to “research and development related to asset acquisition” in the consolidated statements of operations as the assets acquired had no alternative future use at the time of the acquisition. There were no material direct transaction costs related to the transaction. The Company will make tiered earn-out payments of high single-digits to low teens on net sales of CB-228 products and CB-659 products, subject to certain customary reductions. Millennium will be eligible to receive up to an aggregate of $ 470 million in clinical development, regulatory and sales milestone payments across both Takeda Programs. The term of the APA will continue until the expiration of the Company's obligations to make earn-out payments, unless earlier terminated. Either party may terminate the APA in the event of an uncured material breach of the other party or in the case of insolvency of the other party. Preferred Stock Purchase Agreement On October 18, 2021, in accordance with the APA, the Company entered into a Preferred Stock Purchase Agreement, or the Purchase Agreement, with Millennium, pursuant to which it agreed to issue 1,000,000 shares of its Series A convertible preferred stock, or the Series A preferred stock. Each share of Series A preferred stock is initially convertible at the option of the holder into approximately 17.2 shares of common stock, based on the Company’s $ 2.04 per share closing stock price on October 15, 2021. The conversion rate of the Series A preferred stock is subject to anti-dilution adjustments that if triggered would result in the issuance of additional shares of common stock upon conversion. The holder of the Series A preferred stock has the following rights, preferences and privileges: Voting Rights The holder of Series A preferred stock will be entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series A preferred stock are convertible on any matter presented to the stockholders of the Company or at any meeting of stockholders, subject to certain beneficial ownership limitations. Additionally, certain matters require the approval of the Series A preferred stock, voting as a separate class, including to (i) amend the Company’s organizational documents in a way that has an adverse effect on the Series A preferred stock, (ii) create or authorize the creation of any new security, or reclassify or amend any existing security, of the Company that are senior to, or equal in priority with, the Series A preferred stock, including any shares of Series A preferred stock, with respect to the distribution of assets on the liquidation, dissolution or winding up of the Company, the payment of dividends and rights of redemption or (iii) purchase or redeem, or pay or declare, any dividend or make any distribution on, any shares of capital stock of the Company, subject to certain exceptions. Mandatory Conversion The Series A preferred stock will automatically convert, subject to certain beneficial ownership limitations, on the earlier of (i) the 18-month anniversary of the date of issuance, or the Mandatory Pricing Date, into 17,156,863 shares of common stock, subject to adjustment into additional shares of common stock if the volume weighted-average price of common stock on the thirty ( 30 ) trading days prior to the Mandatory Pricing Date is lower than $ 2.04 and (ii) a qualified financing that results in net proceeds to the Company of at least $ 40 million, excluding the conversion of the Series A preferred stock into 17,156,863 shares of common stock, subject to adjustment into additional shares of common stock if the weighted-average price paid by investors in the Qualified Financing is lower than $ 2.04 per share. Optional Conversion The Series A preferred stock is convertible, subject to certain beneficial ownership limitations, at the option of the holder thereof, at any time prior to the Mandatory Pricing Date or a Qualified Financing into 17,156,863 shares of common stock, subject to adjustment into additional shares of common stock if the volume weighted-average sales price per share of certain shares of common stock sold from the issuance date of the Series A preferred stock through the date of the election to convert is lower than $ 2.04 per share. Dividends The Series A preferred stock will be entitled to dividends or distributions on shares of Series A preferred stock equal to and in the same form as dividends or distributions actually paid on shares of the common stock when, as and if such dividends or distributions are paid. No dividends had been declared by the Board of Directors as of March 31, 2022. Liquidation Preference The Series A preferred stock will have preference over the common stock with respect to distribution of assets or available proceeds, as applicable, in the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or any other deemed liquidation event, and will be entitled to a liquidation preference equal to the greater of the original issuance price of the Series A preferred stock and the payment such holder would have received had the Series A preferred stock been converted into shares of common stock immediately prior to such liquidation event. Redemption Rights The holders of the Series A preferred stock have no redemption rights. However, if the Company is unable to obtain stockholder approval, and as a result the Series A preferred stockholders are unable to convert all the shares into common stock, then the parties shall promptly negotiate in good faith the timing and amount per share to be paid to compensate the holder for such inability (“Redemption Event”); provided, however that the Company shall not be required to make any cash redemption payment until at least three years after the Closing Date without the Company’s consent. The Company has recorded the Series A preferred stock at an estimated fair value at the time of issuance of $ 40.9 million, net of issuance costs of approximately $ 0.2 million. The Company has classified the Series A preferred stock as temporary equity due to the uncertainty of having sufficient authorized common stock reserved for issuance to cover the potential conversion of the Series A preferred stock into common stock if any of the conversion features (optional or automatic) are triggered. If the Company does not receive the Requisite Stockholder Approval, then the Company may be required to compensate the holder, upon occurrence of a Redemption Event. At the end of each reporting period, the Company adjusts the Series A preferred stock carrying value to the greater of the issuance date fair value of $ 40.9 million or the current redemption amount in accordance with ASC 480-10-S99-3A, Distinguishing Liabilities from Equit y. As March 31, 2022, the Series A preferred stock was recorded at $ 40.9 million. |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders' (Deficit) Equity | 8. Stockholders’ (Deficit) Equity At-the-Market Offering In August 2020, the Company entered into a sales agreement with Jefferies as sales agent and underwriter, pursuant to which the Company could issue and sell shares of its common stock with an aggregate maximum offering price of $ 75 million under an at-the-market offering program, or the ATM program. The Company will pay Jefferies up to 3 % of gross proceeds for any common stock sold through the sales agreement. During the three months ended March 31, 2022 , the Company sold 1,233,875 shares under the ATM program at an average price per share of $ 0.57 , for net proceeds of $ 0.7 million, and received $ 0.4 million upon the settlement of trades outstanding at December 31, 2021. As of March 31, 2022 , a total of 6,479,285 shares had been sold under the ATM program. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation Stock Options A summary of stock option activity was as follows (in thousands, except weighted-average exercise price and contractual term amounts): Options Outstanding Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2021 8,324 $ 6.18 Options granted 2,294 $ 0.44 Options cancelled ( 901 ) $ 6.63 Outstanding — March 31, 2022 9,717 $ 4.78 6.73 $ — Exercisable — March 31, 2022 5,339 $ 6.77 5.40 $ — Stock Awards During the three months ended March 31, 2022 , the Company issued 9,200 restricted stock units, or RSUs, to its employees. The RSUs vest 25 % annually over 4 years commencing on the date of grant. The RSUs are measured at grant date fair value, at the market price of the Company’s common stock on the grant date. The Company records stock-based compensation expense related to the RSUs ratably over the employee respective requisite service period. On January 20, 2021, the Company granted 1,607,812 performance-based restricted stock units, or PSUs, to employees. The PSUs vested 20 % on January 3, 2022 and 80 % upon the achievement of two goals that were achieved by January 3, 2022. The PSUs were measured at grant date fair value, using the market price of the Company’s common stock on the grant date of $ 2.98 . The Company estimated that all vesting conditions were probable of being achieved and elected to recognize compensation expense for the PSUs as one aggregate award using the straight-line method over the estimated implicit service period from the grant date to January 3, 2022. The Company monitored the probability of achievement of the goals each reporting period and adjusted its estimates accordingly. During the three months ended March 31, 2022 and 2021, the Company recorded $ 6,000 and $ 0.9 million of expense, respectively, related to the PSUs. A summary of restricted stock unit activity was as follows (in thousands, except weighted-average grant-date fair value and contractual term amounts): Stock Awards (PSUs and RSUs) Shares Weighted- Weighted- Aggregate Outstanding — December 31, 2021 716 $ 2.86 RSUs — Awarded 9 $ 0.65 PSUs and RSUs — Vested ( 340 ) $ 2.98 PSUs and RSUs — Cancelled ( 15 ) $ 2.85 Outstanding — March 31, 2022 370 $ 2.70 1.84 $ 150 Total stock-based compensation expense related to the Company’s 2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan, and the 2014 Employee Stock Purchase Plan was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 498 $ 1,280 General and administrative 682 1,415 Total stock-based compensation $ 1,180 $ 2,695 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | . Net Loss per Share Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. Potentially dilutive securities that were not included in the diluted net loss per share calculations because they would be anti-dilutive were as follows (in thousands): March 31, 2022 2021 Options to purchase common stock 9,717 9,436 Employee stock plan purchases 137 42 Restricted stock units subject to future vesting 370 2,048 Conversion of Series A preferred 17,157 — Total 27,381 11,526 |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Licensing Agreements [Abstract] | |
Collaboration and Licensing Agreements | 11. Collaboration and Licensing Agreements Incyte Collaboration and License Agreement On January 27, 2017, the Company entered into a collaboration and license agreement with Incyte, or the Incyte Collaboration Agreement. Under the terms of the Incyte Collaboration Agreement, the Company granted Incyte an exclusive, worldwide license to develop and commercialize its small molecule arginase inhibitors for hematology and oncology indications. Through September 30, 2020, the parties collaborated on and co-funded the development of the licensed products, with Incyte bearing 70 % and the Company bearing 30 % of global development costs. The parties would share profits and losses in the United States, with 60 % to Incyte and 40 % to the Company. The Company would have the right to co-detail the licensed products in the United States, and Incyte would pay the Company tiered royalties ranging from the low to mid-double digits on net sales of licensed products outside the United States. The Incyte Collaboration Agreement also provides that the Company may choose to opt out of its co-funding obligations at any time. On August 28, 2020, the Company delivered written notice to Incyte of its decision to opt out of its co-development rights effective September 30, 2020. As a result of the Company’s decision to opt out, Incyte will pay all costs to develop INCB001158 or any other licensed products. In addition, the Company’s rights to U.S. profit sharing will no longer be in effect, and instead Incyte will pay Calithera tiered royalties ranging from the low double digits to mid-teens on net sales of licensed products in the U.S., an incremental 3 % royalty on annual net sales in the United States of such licensed product until such incremental royalty equals 120 % of previous development expenditures incurred by the Company. Under the Incyte Collaboration Agreement, the Company received an upfront payment of $ 45 million in February 2017. In March 2017, the Company achieved a development milestone of $ 12 million, for which the Company received payment in May of 2017. In April 2020, the Company filed a complaint against Incyte in the Superior Court of California, San Francisco County, asserting claims for breach of contract arising out of Incyte’s failure to pay two milestone payments totaling $ 18 million the Company believed were due under the Incyte Collaboration Agreement. In September 2021, the Company entered into a Settlement Agreement and Release with Incyte. Concurrently, the parties also filed a dismissal of the complaint in the Superior Court of California. Under the terms of the Settlement Agreement and Release, which resolves all claims in the complaint without any admission of liability or fault, Incyte was to pay the Company a negotiated settlement amount of $ 6.75 million and the parties have exchanged mutual releases. In September 2021, the Company received and recognized the $ 6.75 million as milestone revenues. Total remaining potential development, regulatory and commercialization milestones as of March 31, 2022 were $ 720 million. The Incyte Collaboration Agreement is considered to be under the scope of ASC Topic 808, Collaborative Arrangements . The Company has concluded that the research and development co-funding activities were not representative of a customer relationship and this unit of account is accounted for as an increase to or reduction of research and development expenses, rather than as revenue. In addition, the Company has analogized to ASC 606 for other aspects of the arrangement. The performance obligations under the Incyte Collaboration Agreement consist of intellectual property licenses and the performance of certain manufacturing and manufacturing technology transfer services. The Company determined that the license is not distinct from the associated manufacturing and technology transfer services to be performed under the agreement. Specifically, the Company believes the license is not capable of being distinct, as Incyte did not have the know-how to manufacture the collaboration product without Calithera’s assistance until completion of the manufacturing technology transfer process, and no other third parties could perform such assistance due to the early stage nature of the licensed intellectual property as well as Calithera’s propriety knowledge with respect to the licensed intellectual property. Net costs associated with co-development activities performed under the Incyte Collaboration Agreement are included in research and development expenses in the accompanying consolidated statements of operations, with any reimbursement of costs by Incyte reflected as a reduction of such expenses. For the three months ended March 31, 2022 and 2021, net costs payable to Incyte were approximately $ 29,000 and $ 0.7 million, respectively. As of March 31, 2022, net amounts payable to Incyte were $ 0.7 million. Antengene License Agreement On May 16, 2021, the Company entered into a license agreement, or the Antengene License Agreement, with Antengene Investment, Ltd., a wholly-owned subsidiary of Antengene Corporation. Under the terms of the Antengene License Agreement, the Company granted Antengene an exclusive, worldwide license to develop and commercialize CB-708, the Company’s small molecule inhibitor of CD73. The Company received an upfront payment of $ 3 million in May 2021 and may receive potential development, regulatory and sales milestones of up to $ 252 million, as well as tiered royalties on sales of the licensed product up to low double-digits. The Antengene License Agreement is considered to be under the scope of ASC 606. In accordance with ASC 606, the Company determined the transaction price to be the $ 3.0 million upfront payment. The performance obligations consist of the intellectual property license, inventory, and manufacturing technical support services. The transaction price was allocated to the performance obligations on a relative selling price basis, with the value of the manufacturing technical support services considered to be de minimis. The Company determined that it had satisfied the intellectual property license and inventory performance obligations in the second quarter of 2021 and accordingly recognized license revenue of $ 3 million during the three months ended June 30, 2021. No additional revenue was recognized in subsequent periods related to the Antengene License Agreement. Symbioscience License Agreement In December 2014, the Company entered into an exclusive license agreement with Mars, Inc., by and through its Mars Symbioscience division, or Symbioscience, under which the Company has been granted the exclusive, worldwide license to develop and commercialize Symbioscience’s portfolio of arginase inhibitors for use in human healthcare, or the Symbioscience License Agreement. There were no expenses related to its licensing arrangement with Mars Symbioscience recorded in the three months ended March 31, 2022 or 2021. The Company may make future payments of up to $ 23.6 million contingent upon attainment of various development and regulatory milestones and $ 95.0 million contingent upon attainment of various sales milestones. Additionally, the Company will pay royalties on sales of the licensed product, if such product sales are ever achieved. If the Company develops additional licensed products, after achieving regulatory approval of the first licensed product, the Company would owe additional regulatory milestone payments and additional royalty payments based on sales of such additional licensed products. |
Cystic Fibrosis Foundation Deve
Cystic Fibrosis Foundation Development Award | 3 Months Ended |
Mar. 31, 2022 | |
Research and Development [Abstract] | |
Cystic Fibrosis Foundation Development Award | 12. Cystic Fibrosis Foundation Development Award In October 2020, the Company was awarded $ 2.4 million from the Cystic Fibrosis Foundation, or CFF, to support the clinical development of CB-280 in cystic fibrosis. The award will be paid in installments upon the achievement of certain milestones. The Company recognizes the CFF milestones awards as a reduction to research and development expenses in the accompanying unaudited consolidated statements of operations in the period the milestone is achieved and expenses have been incurred. For the three months ended March 31, 2022 and 2021, no amounts from the CFF were recognized as a reduction of research and development expenses. The award contains provisions where the Company must repay up to two times the award if it ceases to use commercially reasonable efforts to develop CB-280. Upon commercialization, the Company will owe certain royalty payments to the CFF up to a royalty cap. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses a product in the cystic fibrosis field, or if the Company enters into a change of control transaction. In May 2022, the Company made the decision to no longer pursue further development of CB-280 in cystic fibrosis at this time. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | 13. Subsequent Event Public Offering On April 1, 2022, the Company closed an underwritten public offering of 18,518,519 shares of its common stock at a combined price to the public of $ 0.54 per share and accompanying common warrants, or $ 10 million in gross proceeds, resulting in $ 8.5 million of net proceeds after deducting underwriting discounts, commissions and offering costs. Each share of common stock is accompanied by a warrant to purchase one share of common stock at an exercise price of $ 0.54 per share, which is immediately exercisable and will expire 18 months from the date of issuance, or a short-term warrant, and a warrant to purchase one share of common stock at an exercise price of $ 0.54 per share, which is immediately exercisable and will expire 5 years from the date of issuance, or a long-term warrant. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The interim condensed consolidated balance sheet as of March 31, 2022, the statements of operations, comprehensive loss, and stockholders’ (deficit) equity, for the three months ended March 31, 2022 and 2021, and the statement of cash flows for the three months ended March 31, 2022 and 2021 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three-month period are also unaudited. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other future annual or interim period. The balance sheet as of December 31, 2021 included herein was derived from the audited consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Form 10-K as filed with the Securities and Exchange Commission, or SEC. |
Use of Estimates | Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contract assets and contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accrued liabilities, revenue recognition, fair value of marketable securities, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents, which consist primarily of amounts invested in money market accounts, are stated at fair value. |
Investments | Investments All investments have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. As of each balance sheet date, the Company classifies available-for-sale securities with remaining contractual maturities of more than one year as long-term investments, and those with remaining contractual maturities of one year or less as short-term investments. Unrealized gains and losses are excluded from earnings and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest and other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest on marketable securities is included in interest and other income (expense), net. |
Restricted Cash | Restricted Cash Restricted cash consists of money market funds held by the Company’s financial institution as collateral for the Company’s obligations under its facility lease for the Company’s corporate headquarters in South San Francisco, California. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents, investments and restricted cash. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, investments and restricted cash are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit may at times exceed federally insured limits. |
Revenue Recognition | Revenue Recognition The Company records revenue in accordance with Accounting Standards Codification, or ASC No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company has a collaboration and license agreement with Incyte, the Incyte Collaboration Agreement, and a license agreement with Antengene, the Antengene License Agreement, that are within the scope of ASC 606, under which the Company licenses certain rights to its product candidates. The terms of these arrangements include payment to the Company of non-refundable, upfront license fees, and potential development, regulatory and sales milestones, and sales royalties. Each of these payments results in collaboration or license revenue, except for revenues from royalties on net sales of licensed products, which would be classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreement, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Licenses of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promised goods or services, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received or the underlying activity has been completed. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Contract Balances Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company had no contract assets or liabilities as of March 31, 2022 and December 31, 2021. For the three months ended March 31, 2022 and 2021, the Company did no t recognize any revenue from performance obligations satisfied in previous periods. |
Awards | Awards The Company assesses at the inception of award agreements whether the agreement is a liability. If the Company is obligated to repay funds received regardless of the outcome of the related research and development activities, then the Company is required to estimate and recognize a liability for this obligation. Alternatively, if the Company is not required to repay the funds, then payments received are recorded as contra research and development expense in the consolidated statement of operations as expenses are incurred. If payment criteria has been met and allowable expenses have been incurred, but not received at the balance sheet date, the amount of the receivable is included in receivables from collaborations in the consolidated balance sheet. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and includes these costs in accrued and other liabilities in the consolidated balance sheets and within research and development expense in the consolidated statements of operations. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled, and the rate of patient enrollments may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. |
Leases | Leases The Company accounts for its leases under ASC No. 2016-02, Leases (Topic 842), or ASC 842. Operating lease right-of-use, or ROU, assets and lease liabilities are recognized at commencement and are recorded for leases with durations greater than 12 months. ROU assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise that option. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company estimates an incremental borrowing rate based on the information available at commencement date, in determining the present value of lease payments. The operating lease ROU asset also includes lease incentives. Lease expense is recognized on a straight-line basis over the lease term. The Company elected to not separate lease components and non-lease components for its long-term facility lease. Variable lease payments include lease operating expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company maintains various stock incentive plans under which stock options and restricted stock awards are granted to employees, non-employee directors of the board, and non-employees. The Company also has an employee stock purchase plan for all eligible employees. Stock options and stock purchased under the employee stock purchase plan, are recorded at fair value as of the grant date using the Black-Scholes option-pricing model. Restricted stock awards are measured at grant date fair value, at the market price of the Company’s common stock on the grant date. The Company has elected to account for forfeitures as they occur. The Company records stock-based compensation expense related to the service-based instruments ratably over the employee, director, or non-employees’ respective requisite service period (generally the vesting period). For performance-based stock awards with vesting conditioned on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If the assessment of the probability of the performance condition being met changes, the impact of the change in estimate would be recognized in the period of the change. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. |
Accounting Pronouncement Not Yet Adopted | Accounting Pronouncement Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, or ASU 2016-13 . The updated accounting guidance requires changes to the recognition of credit losses on financial instruments not accounted for at fair value through net income. In May 2019, the FASB issued ASU No. 2019-05, Targeted Transition Relief , which provides transition guidance to entities that elect the fair value option for eligible instruments. In November 2019, the FASB issued ASU 2019-10 which extends the effective date of the standards for smaller reporting companies to interim and annual periods beginning after December 15, 2022. These standards require using a modified retrospective approach with the cumulative effect recognized as an adjustment to retained earnings. A prospective transition approach is required for debt securities that have recognized an other-than-temporary impairment prior to the effective date. For the Company’s receivables from collaborations and other agreements and certain other financial instruments, the Company will be required to use a forward-looking “expected” credit loss model instead of the existing “incurred” credit loss model, which will generally result in earlier recognition of allowances for credit losses. The Company plans to adopt this standard effective January 1, 2023. The Company is currently evaluating the effect the guidance will have on its financial statements or disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | The following table sets forth the fair value of our financial assets and liabilities, allocated into Level 1, Level 2 and Level 3, that were measured on a recurring basis (in thousands): March 31, 2022 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 43,944 $ — $ — $ 43,944 Total financial assets $ 43,944 $ — $ — $ 43,944 December 31, 2021 Level 1 Level 2 Level 3 Total Financial Assets: Money market funds $ 56,337 $ — $ — $ 56,337 Total financial assets $ 56,337 $ — $ — $ 56,337 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Securities | Cash equivalents and investments, all of which are classified as available-for-sale securities and restricted cash, consisted of the following (in thousands): March 31, 2022 December 31, 2021 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 43,944 $ — $ — $ 43,944 $ 56,337 $ — $ — $ 56,337 $ 43,944 $ — $ — $ 43,944 $ 56,337 $ — $ — $ 56,337 Classified as: Cash equivalents $ 43,674 $ 56,067 Restricted cash 270 270 Total cash equivalents, $ 43,944 $ 56,337 |
Accrued and Other Liabilities (
Accrued and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued and Other Liabilities | Accrued and other liabilities consist of the following (in thousands): March 31, 2022 December 31, 2021 Accrued clinical and manufacturing expenses $ 4,202 $ 5,086 Accrued payroll and related expenses 2,146 3,283 Current portion of lease liability 1,412 1,374 Accrued professional and consulting expenses 977 155 Other 514 458 Total accrued and other liabilities $ 9,251 $ 10,356 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Schedule of Components of Net Operating Lease Costs Included in Condensed Consolidated Statement of Operations | The components of net operating lease costs included in the condensed consolidated statement of operations for the three months ended March 31, 2022 and 2021, were as follows (in thousands): Three Months Ended March 31, Operating Lease Costs: 2022 2021 Straight-line rent expense related to $ 326 $ 484 Variable rent expense related to 229 244 Net operating lease costs $ 555 $ 728 |
Balance Sheet Classification of Company's Operating Lease Liability | The balance sheet classification of the Company’s operating lease liability was as follows (in thousands): Operating Lease Liability: March 31, 2022 December 31, 2021 Current portion included in accrued and other liabilities $ 1,412 $ 1,374 Noncurrent operating lease liability 1,295 1,666 Total operating lease liability $ 2,707 $ 3,040 |
Summary of Maturities of the Company's Lease Liability | The maturities of the Company’s lease liability as of March 31, 2022, was as follows (in thousands): Year ending December 31: 2022 (excluding the three months ended March 31, 2022) $ 1,161 2023 1,593 2024 136 Total lease payments 2,890 Less: interest ( 183 ) Present value of lease liability $ 2,707 |
Takeda Asset Purchase and Sto_2
Takeda Asset Purchase and Stock Purchase Agreements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Series A Convertible Preferred Stock | |
Business Acquisition [Line Items] | |
Summary of Fair Value of Series A Convertible Preferred Stock Using Black-Scholes Option-pricing Model | Pursuant to the APA, in October 2021, the Company paid Millennium an upfront payment of $ 10 million in cash and issued to Millennium 1,000,000 shares of its Series A convertible preferred stock as referenced below. In determining the total purchase consideration paid to Millennium, the Series A convertible preferred stock shares were classified as level 3 in the valuation hierarchy due to the presence of significant unobservable inputs, and were valued upon issuance at $ 40.9 million using the Black-Scholes option-pricing model and the following assumptions: Description Credit spread 12.4 % Allowance for counterparty credit risk of the Company given the liquidation preference and obligation to issue more shares as the stock price decreases Probability of a Qualified 75 % As determined upon issuance date Expected timing of a 0.5 years As determined upon issuance date Expected term 0.7 years Weighted average of time to a Qualified Financing and time to the Mandatory Pricing Date, as determined upon issuance date Volatility 55 % Based on the Company’s trading history for its common stock over the estimated term to the mandatory pricing date Risk-free interest rate 0.08 % Based on the U.S. constant maturity treasury yield curve at the time of issuance over the expected term Common stock price $ 2.04 The Company's closing common stock price on October 15, 2021 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Option Activity | A summary of stock option activity was as follows (in thousands, except weighted-average exercise price and contractual term amounts): Options Outstanding Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2021 8,324 $ 6.18 Options granted 2,294 $ 0.44 Options cancelled ( 901 ) $ 6.63 Outstanding — March 31, 2022 9,717 $ 4.78 6.73 $ — Exercisable — March 31, 2022 5,339 $ 6.77 5.40 $ — |
Summary of Restricted Stock Unit Activity | A summary of restricted stock unit activity was as follows (in thousands, except weighted-average grant-date fair value and contractual term amounts): Stock Awards (PSUs and RSUs) Shares Weighted- Weighted- Aggregate Outstanding — December 31, 2021 716 $ 2.86 RSUs — Awarded 9 $ 0.65 PSUs and RSUs — Vested ( 340 ) $ 2.98 PSUs and RSUs — Cancelled ( 15 ) $ 2.85 Outstanding — March 31, 2022 370 $ 2.70 1.84 $ 150 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan and 2014 Employee Stock Purchase Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Summary of Stock Based Compensation Expense | Total stock-based compensation expense related to the Company’s 2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan, and the 2014 Employee Stock Purchase Plan was as follows (in thousands): Three Months Ended March 31, 2022 2021 Research and development $ 498 $ 1,280 General and administrative 682 1,415 Total stock-based compensation $ 1,180 $ 2,695 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Common Stock Excluded from Calculation of Diluted Net Loss Per Share | Potentially dilutive securities that were not included in the diluted net loss per share calculations because they would be anti-dilutive were as follows (in thousands): March 31, 2022 2021 Options to purchase common stock 9,717 9,436 Employee stock plan purchases 137 42 Restricted stock units subject to future vesting 370 2,048 Conversion of Series A preferred 17,157 — Total 27,381 11,526 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Thousands | Apr. 01, 2022USD ($) | Mar. 31, 2022USD ($)Segment | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
State of incorporation | DE | |||
Date of incorporation | Mar. 9, 2010 | |||
Number of operating segments | Segment | 1 | |||
Cash and cash equivalents | $ 44,664 | $ 59,537 | ||
Net proceeds from public offering | $ 8,500 | |||
Accumulated deficit | 505,161 | 491,326 | ||
Loss from continuing operations | (13,835) | $ (20,395) | (115,100) | |
Cash used in operations | $ (16,010) | $ (22,002) | $ (66,300) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Contract assets | $ 0 | $ 0 | |
Contract liabilities | 0 | $ 0 | |
Revenue recognized from performance obligations satisfied in previous periods | $ 0 | $ 0 | |
Long-term Investments | Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Remaining contractual maturities of available-for-sale-securities | more than one year | ||
Short-term Investments | Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Remaining contractual maturities of available-for-sale-securities | one year or less |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets and Liabilities (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 43,944 | $ 56,337 |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 43,944 | 56,337 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 43,944 | 56,337 |
Level 1 | Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 43,944 | $ 56,337 |
Financial Instruments - Summary
Financial Instruments - Summary of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | $ 43,944 | $ 56,337 |
Estimated Fair Value | 43,944 | 56,337 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cost | 43,944 | 56,337 |
Estimated Fair Value | 43,944 | 56,337 |
Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | 43,674 | 56,067 |
Restricted Cash | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Estimated Fair Value | $ 270 | $ 270 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||
Realized gains (losses) on available-for-sale securities | $ 0 | |
Unrealized losses on cash equivalents | 0 | $ 0 |
Cash, cash equivalents, and restricted cash | 44,900,000 | |
Cash portion included in cash, cash equivalents and restricted cash | 1,000,000 | |
Cash equivalents and restricted cash | $ 43,900,000 |
Accrued and Other Liabilities -
Accrued and Other Liabilities - Summary of Accrued and Other Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued clinical and manufacturing expenses | $ 4,202 | $ 5,086 |
Accrued payroll and related expenses | 2,146 | 3,283 |
Current portion of lease liability | 1,412 | 1,374 |
Accrued professional and consulting expenses | 977 | 155 |
Other | 514 | 458 |
Total accrued and other liabilities | $ 9,251 | $ 10,356 |
Leases - Additional Information
Leases - Additional Information (Details) | Jan. 03, 2022 | Mar. 09, 2021 | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2022 | Mar. 08, 2021USD ($)ft² | Mar. 07, 2021USD ($)ft² |
Operating Leased Assets [Line Items] | |||||||
Operating lease, description | The Company has a non-cancelable facility lease agreement, or the Lease, for office and laboratory facilities in South San Francisco, California, with a remaining lease term of 1.8 years, through January 2024, and a two-year renewal option prior to expiration. | ||||||
Remaining lease term | 1 year 9 months 18 days | 1 year 9 months 18 days | |||||
Operating lease, renewal term | 2 years | 2 years | |||||
Incremental borrowing rate | 7.50% | 9.00% | |||||
Rentable area | ft² | 34,000 | 54,000 | |||||
Lease security deposit available in existing letter of credit | $ 270,000 | $ 440,000 | |||||
Cash paid for amounts included in the measurement of the lease liabilities | $ 400,000 | $ 600,000 | |||||
Interest and Other Income (Expense) Net | |||||||
Operating Leased Assets [Line Items] | |||||||
Gain recognized due to difference between reduced lease liability and reduction in operating lease right of use asset | $ 400,000 |
Leases - Schedule of Components
Leases - Schedule of Components of Net Operating Lease Costs Included in Condensed Consolidated Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating Lease Costs: | ||
Straight-line rent expense related to facility operating lease | $ 326 | $ 484 |
Variable rent expense related to facility operating lease | 229 | 244 |
Net operating lease costs | $ 555 | $ 728 |
Leases - Balance Sheet Classifi
Leases - Balance Sheet Classification of Company's Operating Lease Liability (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Operating Lease Liability: | ||
Current portion included in accrued and other liabilities | $ 1,412 | $ 1,374 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued and other liabilities | Accrued and other liabilities |
Noncurrent operating lease liability | $ 1,295 | $ 1,666 |
Total operating lease liability | $ 2,707 | $ 3,040 |
Leases - Summary of Maturities
Leases - Summary of Maturities of the Company's Lease Liability (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2022 (excluding the three months ended March 31, 2022) | $ 1,161 | |
2023 | 1,593 | |
2024 | 136 | |
Total lease payments | 2,890 | |
Less: interest | (183) | |
Present value of lease liability | $ 2,707 | $ 3,040 |
Takeda Asset Purchase and Sto_3
Takeda Asset Purchase and Stock Purchase Agreements - Additional Information (Details) - USD ($) | Oct. 18, 2021 | Oct. 31, 2021 | Mar. 31, 2022 |
Business Acquisition [Line Items] | |||
Research and development related to asset acquisition | $ 50,900,000 | ||
Dividends | $ 0 | ||
Mandatory Conversion | |||
Business Acquisition [Line Items] | |||
Qualified financing amount for conversion of preferred stock | $ 40,000,000 | ||
Maximum weighted average price per share | $ 2.04 | ||
Qualified financing mandatory conversion maximum number of shares | $ 17,156,863 | ||
Series A Convertible Preferred Stock | |||
Business Acquisition [Line Items] | |||
Preferred stock, value, issued | $ 40,900,000 | ||
Issuance costs | $ 200,000 | ||
Redemption rights | 0 | ||
Issuance of fair value | $ 40,900,000 | ||
Series A Convertible Preferred Stock | ASC 480-10-S99-3A | |||
Business Acquisition [Line Items] | |||
Issuance of fair value | $ 40,900,000 | ||
Series A Convertible Preferred Stock | Mandatory Conversion | |||
Business Acquisition [Line Items] | |||
Maximum weighted average price per share | $ 2.04 | ||
Convertible Preferred Stock, initially convertible into approximately 17.2 shares of Common Stock | 17,156,863 | ||
Number of trading days | 30 days | ||
Series A Convertible Preferred Stock | Optional Conversion | |||
Business Acquisition [Line Items] | |||
Maximum weighted average price per share | $ 2.04 | ||
Qualified financing mandatory conversion maximum number of shares | $ 17,156,863 | ||
Millennium | Millennium Asset Purchase Agreement | |||
Business Acquisition [Line Items] | |||
Upfront Payment Paid | $ 10,000,000 | ||
Clinical development, regulatory and sales milestone payments | 470,000,000 | ||
Asset acquisition, total consideration transferred | 50,900,000 | ||
Asset acquisition, cash payment | $ 10,000,000 | ||
Millennium | Series A Convertible Preferred Stock | Millennium Asset Purchase Agreement | |||
Business Acquisition [Line Items] | |||
Preferred stock, shares issued | 1,000,000 | ||
Asset acquisition, consideration transferred, estimated fair value of shares | $ 40,900,000 | ||
Millennium | Series A Convertible Preferred Stock | Millennium Asset Purchase Agreement | Level 3 | |||
Business Acquisition [Line Items] | |||
Preferred stock, value, issued | $ 40,900,000 | ||
Millennium | Series A Convertible Preferred Stock | Preferred Stock Purchase Agreement | |||
Business Acquisition [Line Items] | |||
Preferred stock, shares issued | 1,000,000 | ||
Preferred stock value per share | $ 2.04 | ||
Convertible Preferred Stock, initially convertible into approximately 17.2 shares of Common Stock | 17.2 |
Takeda Asset Purchase and Sto_4
Takeda Asset Purchase and Stock Purchase Agreements - Summary of Fair Value of Series A Convertible Preferred Stock Using Black-Scholes Option-pricing Model (Details) - Millennium Asset Purchase Agreement - Millennium - Series A Convertible Preferred Stock | 1 Months Ended |
Oct. 31, 2021$ / shares | |
Credit Spread | |
Business Acquisition [Line Items] | |
Measurement input | 0.124 |
Probability of a Qualified Financing | |
Business Acquisition [Line Items] | |
Measurement input | 0.75 |
Expected Timing of a Qualified Financing | |
Business Acquisition [Line Items] | |
Expected term | 6 months |
Expected Term | |
Business Acquisition [Line Items] | |
Expected term | 8 months 12 days |
Volatility | |
Business Acquisition [Line Items] | |
Measurement input | 0.55 |
Risk-free Interest Rate | |
Business Acquisition [Line Items] | |
Measurement input | 0.0008 |
Common Stock Price | |
Business Acquisition [Line Items] | |
Common stock price | $ 2.04 |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 20 Months Ended | |
Aug. 31, 2020 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | |
Class Of Stock [Line Items] | ||||
Proceeds from the issuance of common stock, net | $ 1,137 | $ 9,535 | ||
At-the-Market Offering | Common Stock | ||||
Class Of Stock [Line Items] | ||||
Number of shares issued and sold | 1,234,000 | 3,197,000 | ||
At-the-Market Offering | Common Stock | Jefferies LLC | ||||
Class Of Stock [Line Items] | ||||
Aggregate maximum offering price | $ 75,000 | |||
Number of shares issued and sold | 1,233,875 | 6,479,285 | ||
Proceeds received from settlement of trades | $ 400 | |||
Shares sold, average price per share | $ 0.57 | $ 0.57 | ||
Proceeds from the issuance of common stock, net | $ 700 | |||
At-the-Market Offering | Common Stock | Jefferies LLC | Maximum | ||||
Class Of Stock [Line Items] | ||||
Percentage of sales commission on gross proceeds for common stock sold through sales agreement | 3.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) shares in Thousands | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
Number of Shares Underlying Outstanding Options | |
Outstanding at Beginning balance | shares | 8,324 |
Options granted | shares | 2,294 |
Options cancelled | shares | (901) |
Outstanding at Ending balance | shares | 9,717 |
Exercisable at End of Period | shares | 5,339 |
Weighted-Average Exercise Price | |
Outstanding at Beginning balance | $ / shares | $ 6.18 |
Options granted | $ / shares | 0.44 |
Options cancelled | $ / shares | 6.63 |
Outstanding at Ending balance | $ / shares | 4.78 |
Exercisable at End of Period | $ / shares | $ 6.77 |
Weighted Average Remaining Contractual Term (Years) | |
Outstanding at Ending balance | 6 years 8 months 23 days |
Exercisable at End of Period | 5 years 4 months 24 days |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | Jan. 03, 2022 | Jan. 20, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of stock awards issued | 9,000 | |||
Grant date fair value of stock awards | $ 0.65 | |||
RSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of stock awards issued | 9,200 | |||
Stock awards vesting period (total) | 4 years | |||
Annual stock awards vesting percentage | 25.00% | |||
PSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of stock awards issued | 1,607,812 | |||
Annual stock awards vesting percentage | 20.00% | |||
Stock awards vesting percentage upon achievement of two goals | 80.00% | |||
Grant date fair value of stock awards | $ 2.98 | |||
Expense related to PSUs | $ 6,000 | $ 900,000 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Unit Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Shares | |
Outstanding at Beginning balance | shares | 716 |
RSUs - Awarded | shares | 9 |
PSUs and RSUs - Vested | shares | (340) |
PSUs and RSUs — Cancelled | shares | (15) |
Outstanding at Ending balance | shares | 370 |
Weighted-Average Grant-Date Fair Value | |
Outstanding at Beginning balance | $ / shares | $ 2.86 |
RSUs - Awarded | $ / shares | 0.65 |
PSUs and RSUs - Vested | $ / shares | 2.98 |
PSUs and RSUs — Cancelled | $ / shares | 2.85 |
Outstanding at Ending balance | $ / shares | $ 2.70 |
Weighted-Average Remaining Contractual Term (Years) | |
Outstanding | 1 year 10 months 2 days |
Aggregate Intrinsic Value | |
Outstanding | $ | $ 150 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 1,180 | $ 2,695 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan and 2014 Employee Stock Purchase Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | 1,180 | 2,695 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan and 2014 Employee Stock Purchase Plan | Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | 498 | 1,280 |
2010 Equity Incentive Plan, 2014 Equity Incentive Plan, 2018 Inducement Plan and 2014 Employee Stock Purchase Plan | General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation | $ 682 | $ 1,415 |
Net Loss Per Share - Common Sto
Net Loss Per Share - Common Stock Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 27,381 | 11,526 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 9,717 | 9,436 |
Employee Stock Plan Purchases | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 137 | 42 |
Restricted Stock Units Subject to Future Vesting | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 370 | 2,048 |
Conversion of Series A Preferred Stock into Shares of Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 17,157 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements - Additional Information (Details) - USD ($) | Jan. 27, 2017 | Sep. 30, 2021 | May 31, 2021 | May 31, 2017 | Feb. 28, 2017 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Apr. 30, 2020 |
Mars, Inc. | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Potential license agreement fee | $ 23,600,000 | |||||||||
Additional potential payments based on sale of first licensed product | 95,000,000 | |||||||||
Mars, Inc. | Research and Development | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
License fee | 0 | $ 0 | ||||||||
Incyte Collaboration Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Percentage of sharing in global development cost | 30.00% | |||||||||
Future profits and losses share percentage | 40.00% | |||||||||
Upfront payment received | $ 45,000,000 | |||||||||
Development milestone received | $ 12,000,000 | |||||||||
Milestone payments the Company believed were due | $ 18,000,000 | |||||||||
Net costs payable to Incyte | 29,000 | $ 700,000 | ||||||||
Net amounts payable under collaboration agreement | 700,000 | |||||||||
Incyte Collaboration Agreement | Opt Out of Co-Funding Obligations | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Incremental royalty percentage on annual net sales | 3.00% | |||||||||
Maximum incremental royalty, percentage of previous development expenditure | 120.00% | |||||||||
Additional potential development, regulatory and commercialization milestones receivable | 720,000,000 | |||||||||
Incyte Collaboration Agreement | Incyte | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Percentage of sharing in global development cost | 70.00% | |||||||||
Future profits and losses share percentage | 60.00% | |||||||||
Incyte Settlement Agreement and Release | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone payments receivable upon dispute settlement | $ 6,750,000 | |||||||||
License revenue | $ 6,750,000 | |||||||||
Antengene License Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront payment received | $ 3,000,000 | |||||||||
License revenue | 0 | $ 3,000,000 | ||||||||
Antengene License Agreement | Maximum | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Additional potential development, regulatory and sales milestones receivable | 252,000,000 | |||||||||
Antengene License Agreement | ASC 606 | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Upfront consideration allocated to combined unit of accounting | $ 3,000,000 |
Cystic Fibrosis Foundation De_2
Cystic Fibrosis Foundation Development Award - Additional Information (Details) - Cystic Fibrosis Foundation - USD ($) | 1 Months Ended | 3 Months Ended | |
Oct. 31, 2020 | Mar. 31, 2022 | Mar. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Award received for clinical development | $ 2,400,000 | ||
Reduction of research and development expenses | $ 0 | $ 0 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Subsequent Event - Underwriting Agreement $ / shares in Units, $ in Millions | Apr. 01, 2022USD ($)$ / sharesshares |
Subsequent Event [Line Items] | |
Public offering price per share | $ / shares | $ 0.54 |
Gross proceeds from issuance of public offering before underwriting discounts and commissions and estimated offering expenses | $ | $ 10 |
Net proceeds from issuance of public offering after underwriting discounts and commissions and estimated offering expenses | $ | $ 8.5 |
Common Stock | |
Subsequent Event [Line Items] | |
Number of shares issued and sold | shares | 18,518,519 |
Short-term Warrants | |
Subsequent Event [Line Items] | |
Number of warrants issued | shares | 18,518,519 |
Public offering price per share | $ / shares | $ 0.54 |
Warrants term | 18 months |
Long-term Warrants | |
Subsequent Event [Line Items] | |
Number of warrants issued | shares | 18,518,519 |
Public offering price per share | $ / shares | $ 0.54 |
Warrants term | 5 years |