Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | STRO | |
Entity Registrant Name | SUTRO BIOPHARMA, INC. | |
Entity Central Index Key | 0001382101 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38662 | |
Entity Tax Identification Number | 47-0926186 | |
Entity Address, Address Line One | 111 Oyster Point Blvd | |
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 | 881-6500 | |
Entity Common Stock, Shares Outstanding | 60,527,043 | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common stock, $0.001 par value | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 235,095 | $ 47,254 |
Marketable securities | 123,198 | 255,090 |
Investment in equity securities | 33,349 | 32,020 |
Accounts receivable | 9,999 | 7,122 |
Prepaid expenses and other current assets | 10,344 | 11,667 |
Total current assets | 411,985 | 353,153 |
Property and equipment, net | 23,636 | 24,621 |
Operating lease right-of-use assets | 25,138 | 26,443 |
Other non-current assets | 3,268 | 1,855 |
Restricted cash | 872 | 872 |
Total assets | 464,899 | 406,944 |
Current liabilities: | ||
Accounts payable | 3,856 | 4,797 |
Accrued compensation | 9,509 | 13,142 |
Deferred revenue—current | 18,036 | 16,759 |
Operating lease liability - current | 5,934 | 4,585 |
Debt—current | 10,197 | 12,500 |
Accrued expenses and other current liabilities | 19,593 | 14,764 |
Total current liabilities | 67,125 | 66,547 |
Deferred revenue - non-current | 79,880 | 89,885 |
Operating lease liability - non-current | 26,526 | 29,574 |
Debt—non-current | 3,771 | |
Deferred royalty obligation related to the sale of future royalties | 136,653 | |
Other non-current liabilities | 119 | |
Total liabilities | 310,184 | 189,896 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value - 10,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | ||
Common stock, $0.001 par value - 300,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 60,471,041 and 57,499,541 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 60 | 58 |
Additional paid-in-capital | 695,828 | 670,223 |
Accumulated other comprehensive loss | 16 | (618) |
Accumulated deficit | (541,189) | (452,615) |
Total stockholders’ equity | 154,715 | 217,048 |
Total Liabilities and Stockholders’ Equity | $ 464,899 | $ 406,944 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 60,471,041 | 57,499,541 |
Common stock, shares outstanding | 60,471,041 | 57,499,541 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenues | $ 10,412 | $ 28,096 | $ 23,086 | $ 33,993 |
Operating expenses | ||||
Research and development | 41,592 | 32,332 | 80,991 | 62,322 |
General and administrative | 14,999 | 15,143 | 30,511 | 30,182 |
Total operating expenses | 56,591 | 47,475 | 111,502 | 92,504 |
Loss from operations | (46,179) | (19,379) | (88,416) | (58,511) |
Interest income | 2,842 | 197 | 5,402 | 313 |
Unrealized gain (loss) on equity securities | 8,321 | (3,736) | 1,329 | (3,173) |
Non-cash interest expense related to the sale of future royalties | (442) | (442) | ||
Interest and other income (expense), net | (2,915) | (594) | (5,901) | (1,251) |
Loss before provision for income taxes | (38,373) | (23,512) | (88,028) | (62,622) |
Provision for income taxes | 200 | 2,500 | 546 | 2,500 |
Net loss | $ (38,524) | $ (26,012) | $ (88,574) | $ (65,122) |
Net loss per share, basic | $ (0.64) | $ (0.55) | $ (1.49) | $ (1.39) |
Net loss per share, diluted | $ (0.64) | $ (0.55) | $ (1.49) | $ (1.39) |
Weighted-average shares used in computing basic loss per share | 60,339,475 | 46,957,196 | 59,535,918 | 46,729,663 |
Weighted-average shares used in computing diluted loss per share | 60,339,475 | 46,957,196 | 59,535,918 | 46,729,663 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (38,524) | $ (26,012) | $ (88,574) | $ (65,122) |
Other comprehensive income (loss): | ||||
Net unrealized income (loss) on available-for-sale securities | 123 | (204) | 634 | (1,042) |
Comprehensive loss | $ (38,401) | $ (26,216) | $ (87,940) | $ (66,164) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balances at Dec. 31, 2021 | $ 252,564 | $ 46 | $ 586,243 | $ (314) | $ (333,411) |
Common Stock Balance, Shares at Dec. 31, 2021 | 46,327,131 | ||||
Exercise of common stock options | 180 | 180 | |||
Exercise of common stock options, Shares | 32,497 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 1,006 | 1,006 | |||
Issuance of common stock under Employee Stock Purchase Plan, Shares | 146,165 | ||||
Vesting of restricted stock units | $ 1 | (1) | |||
Vesting of restricted stock units, Shares | 465,731 | ||||
Stock transaction associated with taxes withheld on restricted stock units | (404) | (404) | |||
Stock transaction associated with taxes withheld on restricted stock units,Shares | (44,665) | ||||
Stock-based compensation expense | 6,974 | 6,974 | |||
Net unrealized gain (loss) on available-for-sale securities | (838) | (838) | |||
Net loss | (39,110) | (39,110) | |||
Balances at Mar. 31, 2022 | 220,372 | $ 47 | 593,998 | (1,152) | (372,521) |
Common Stock Balance, Shares at Mar. 31, 2022 | 46,926,859 | ||||
Balances at Dec. 31, 2021 | 252,564 | $ 46 | 586,243 | (314) | (333,411) |
Common Stock Balance, Shares at Dec. 31, 2021 | 46,327,131 | ||||
Net unrealized gain (loss) on available-for-sale securities | (1,042) | ||||
Net loss | (65,122) | ||||
Balances at Jun. 30, 2022 | 209,058 | $ 49 | 608,898 | (1,356) | (398,533) |
Common Stock Balance, Shares at Jun. 30, 2022 | 48,674,232 | ||||
Balances at Mar. 31, 2022 | 220,372 | $ 47 | 593,998 | (1,152) | (372,521) |
Common Stock Balance, Shares at Mar. 31, 2022 | 46,926,859 | ||||
Exercise of common stock options | 2 | 2 | |||
Exercise of common stock options, Shares | 298 | ||||
Vesting of restricted stock units, Shares | 31,375 | ||||
Stock transaction associated with taxes withheld on restricted stock units | (9) | (9) | |||
Stock transaction associated with taxes withheld on restricted stock units,Shares | (1,296) | ||||
Stock-based compensation expense | 6,696 | 6,696 | |||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs | 8,213 | $ 2 | 8,211 | ||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs, Shares | 1,716,996 | ||||
Net unrealized gain (loss) on available-for-sale securities | (204) | (204) | |||
Net loss | (26,012) | (26,012) | |||
Balances at Jun. 30, 2022 | 209,058 | $ 49 | 608,898 | (1,356) | (398,533) |
Common Stock Balance, Shares at Jun. 30, 2022 | 48,674,232 | ||||
Balances at Dec. 31, 2022 | 217,048 | $ 58 | 670,223 | (618) | (452,615) |
Common Stock Balance, Shares at Dec. 31, 2022 | 57,499,541 | ||||
Exercise of common stock options | 314 | 314 | |||
Exercise of common stock options, Shares | 53,060 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 1,097 | 1,097 | |||
Issuance of common stock under Employee Stock Purchase Plan, Shares | 239,060 | ||||
Vesting of restricted stock units, Shares | 801,769 | ||||
Stock transaction associated with taxes withheld on restricted stock units | (451) | (451) | |||
Stock transaction associated with taxes withheld on restricted stock units,Shares | (73,003) | ||||
Stock-based compensation expense | 6,021 | 6,021 | |||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs | 10,923 | $ 2 | 10,921 | ||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs, Shares | 1,641,374 | ||||
Net unrealized gain (loss) on available-for-sale securities | 511 | 511 | |||
Net loss | (50,050) | (50,050) | |||
Balances at Mar. 31, 2023 | 185,413 | $ 60 | 688,125 | (107) | (502,665) |
Common Stock Balance, Shares at Mar. 31, 2023 | 60,161,801 | ||||
Balances at Dec. 31, 2022 | 217,048 | $ 58 | 670,223 | (618) | (452,615) |
Common Stock Balance, Shares at Dec. 31, 2022 | 57,499,541 | ||||
Net unrealized gain (loss) on available-for-sale securities | 634 | ||||
Net loss | (88,574) | ||||
Balances at Jun. 30, 2023 | 154,715 | $ 60 | 695,828 | 16 | (541,189) |
Common Stock Balance, Shares at Jun. 30, 2023 | 60,471,041 | ||||
Balances at Mar. 31, 2023 | 185,413 | $ 60 | 688,125 | (107) | (502,665) |
Common Stock Balance, Shares at Mar. 31, 2023 | 60,161,801 | ||||
Vesting of restricted stock units, Shares | 94,500 | ||||
Stock transaction associated with taxes withheld on restricted stock units | (6) | (6) | |||
Stock transaction associated with taxes withheld on restricted stock units,Shares | (1,296) | ||||
Stock-based compensation expense | 6,661 | 6,661 | |||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs | 1,048 | 1,048 | |||
Issuance of common stock in connection with At-The-Market sale, net of issuance costs, Shares | 216,036 | ||||
Net unrealized gain (loss) on available-for-sale securities | 123 | 123 | |||
Net loss | (38,524) | (38,524) | |||
Balances at Jun. 30, 2023 | $ 154,715 | $ 60 | $ 695,828 | $ 16 | $ (541,189) |
Common Stock Balance, Shares at Jun. 30, 2023 | 60,471,041 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | ||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | |
ATM | |||
Common stock, issuance costs | $ 151 | $ 308 | $ 690 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities | ||
Net loss | $ (88,574) | $ (65,122) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,346 | 2,724 |
(Accretion of discount) amortization of premium on marketable securities | (3,628) | 913 |
Stock-based compensation | 12,682 | 13,670 |
Non-cash lease expenses | 1,305 | 1,325 |
Unrealized (gain) / loss on equity securities | (1,329) | 3,173 |
Non-cash interest expense on deferred royalty obligation | 442 | |
Other | 106 | 13 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,877) | (85,217) |
Prepaid expenses and other assets | (90) | (81) |
Accounts payable | (659) | 836 |
Accrued compensation | (3,633) | (3,669) |
Accrued expenses and other liabilities | 1,150 | 1,072 |
Deferred revenue | (8,728) | 90,994 |
Change in operating lease liability | (1,699) | 928 |
Net cash used in operating activities | (92,186) | (38,441) |
Investing activities | ||
Purchases of marketable securities | (141,361) | (14,938) |
Maturities of marketable securities | 268,460 | 70,409 |
Sales of marketable securities | 9,055 | 29,179 |
Purchases of equipment and leasehold improvements | (2,546) | (3,753) |
Net cash provided by investing activities | 133,608 | 80,897 |
Financing activities | ||
Proceeds from sales of common stock, net of issuance costs | 11,971 | 8,595 |
Payment of debt | (6,250) | (3,125) |
Proceeds from the sale of future royalties, net of issuance costs | 139,744 | |
Proceeds from exercise of common stock options | 314 | 182 |
Taxes paid related to net shares settlement of restricted stock units | (457) | (413) |
Proceeds from employee stock purchase plan | 1,097 | 1,006 |
Net cash provided by financing activities | 146,419 | 6,245 |
Net increase in cash, cash equivalents and restricted cash | 187,841 | 48,701 |
Cash, cash equivalents and restricted cash at beginning of period | 48,126 | 31,286 |
Cash, cash equivalents and restricted cash at end of period | 235,967 | 79,987 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 722 | 998 |
Supplemental disclosure of non-cash investing and financing information: | ||
Purchases of equipment included in accounts payable and accrued expense | 141 | 392 |
Financing component associated with program fees | 5,075 | |
Issuance costs related to deferred royalty obligation in accrued expenses | $ 3,536 | |
Issuance costs included in accounts payable | $ 382 |
Organization and Principal Acti
Organization and Principal Activities | 6 Months Ended |
Jun. 30, 2023 | |
Disclosure Text Block [Abstract] | |
Organization and Principal Activities | 1. Organization and Principal Activities Description of Business Sutro Biopharma, Inc. (the “Company”), is a clinical-stage oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs. The Company was incorporated on April 21, 2003 and is headquartered in South San Francisco , California . The Company operates in one business segment, the development of biopharmaceutical products. At-The-Market Sales During the three and six months ended June 30, 2023, the Company sold an aggregate of 216,036 shares and 1,857,410 shares, respectively, of its common stock through its At-the-Market Facility (“ATM Facility”) pursuant to its Open Market Sales Agreement SM dated April 2, 2021 with Jefferies LLC (“Jefferies”), as sales agent (the “Sales Agreement”). During the three and six months ended June 30, 2023, the gross proceeds from these sales were approximately $ 1.2 million and $ 12.4 million, respectively, before deducting fees of approximately $ 0.2 million and $ 0.4 million, respectively, resulting in net proceeds of approximately $ 1.0 million and $ 12.0 million, respectively, to the Company. Liquidity The Company has incurred significant losses and has negative cash flows from operations. As of June 30, 2023, the Company had an accumulated deficit of $ 541.2 million. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development and other operational activities. As of June 30, 2023, the Company had unrestricted cash, cash equivalents and marketable securities of $ 358.3 million and equity securities of $ 33.3 million, consisting solely of common stock of Vaxcyte, which are available to fund future operations. The Company will need to raise additional capital to support the completion of its research and development activities and to support its operations. The Company believes that its unrestricted cash, cash equivalents, marketable securities and equity securities as of June 30, 2023 will enable the Company to maintain its operations for a period of at least 12 months following the filing date of its condensed financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying interim condensed financial statements of the Company are unaudited. These interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The December 31, 2022 condensed balance sheet was derived from the audited financial statements as of that date, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported on the Company’s condensed Balance Sheets and the amounts of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining research and development periods under collaboration arrangements, stock-based compensation expense, valuation of marketable securities, impairment of long-lived assets, income taxes, deferred royalty obligation related to the sale of future royalties and related non-cash interest expense, and certain accrued liabilities. Actual results could differ from such estimates or assumptions. The accompanying unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to state fairly the Company’s financial position, results of operations, comprehensive loss, and cash flows for the interim periods. The interim results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or for any other future annual or interim period. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s audited financial statements included in the Annual Report on Form 10-K pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, for the year ended December 31, 2022. Deferred Royalty Obligation related to the Sale of Future Royalties and Non-cash Interest Expense In June 2023, the Company entered into a purchase and sale agreement (the “Purchase Agreement”) with Blackstone, pursuant to which the Company sold to Blackstone its 4 % royalty, or revenue interest, in the potential future net sales of Vaxcyte products, including VAX-24 (the “Purchased Interest”) under that certain Amended and Restated SutroVax Agreement, dated October 12, 2015, by and between the Company and Vaxcyte, as amended (the “2015 License Agreement”). In June 2023, Blackstone made an upfront payment of $ 140.0 million to the Company and will also pay up to an additional $ 250.0 million upon the achievement of various return thresholds as set forth in the Purchase Agreement. The net proceeds from the upfront payment received by the Company from the sale of future royalties from Vaxcyte are recorded as deferred royalty obligation related to the sale of future royalties on the Company's condensed Balance Sheets. As royalties are earned and remitted pursuant to the 2015 License Agreement, the balance of the deferred royalty obligation will be amortized over the estimated life of the royalty term arrangement, and non-cash interest expense related to the sale of future royalties is recorded using the effective interest method. To determine the amortization of our deferred royalty obligation, the Company is required to estimate the total amount of future royalties to be earned under the 2015 License Agreement. There are a number of factors that could materially affect the amount and timing of royalty payments earned, most of which are not within the Company's control. The Company will periodically assess the amount of royalty payments expected to be earned which are subject to the Purchase Agreement and, to the extent that the amount or timing of such earned royalties is materially different than the Company's original estimates, the Company will prospectively adjust the imputed interest rate and the related amortization of the deferred royalty obligation. Issuance fees and costs directly related to the Purchase Agreement were offset against the initial carrying value of the deferred royalty obligation and were amortized using the effective interest method over the estimated life of the royalty term arrangement. Recent Accounting Pronouncements Not Yet Adopted There were no new accounting pronouncements issued since the Company's filing of the Annual Report on Form 10-K for the year ended December 31, 2022, which could have a significant effect on the Company's condensed financial statements. Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company's condensed Balance Sheets that sum to the total of the same amounts shown in the Company's condensed Statements of Cash Flows. June 30, 2023 2022 (in thousands) Cash and cash equivalents $ 235,095 $ 79,115 Restricted cash 872 872 Total cash, cash equivalents, and restricted cash shown in the $ 235,967 $ 79,987 Investments in Equity Securities Vaxcyte common stock held by the Company is measured at fair value at each reporting period based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any realized or unrealized gains and losses recorded in the Company’s condensed Statements of Operations. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows: Level 1—Quoted prices in active markets for identical assets and liabilities; Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices 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 assets or liabilities; and Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amounts of accounts receivable, prepaid expenses, accounts payable, accrued liabilities and accrued compensation and benefits approximate fair value due to the short-term nature of these items. The fair value of the Company’s outstanding loan (See Note 6) is estimated using the net present value of the payments, discounted at an interest rate that is consistent with the market interest rate, which is a Level 2 input. The estimated fair value of the Company’s outstanding loan approximates the carrying amount, as the loan bears a floating rate that approximates the market interest rate. The carrying value of the deferred royalty obligation related to the sale of future royalties under the 2015 License Agreement with Vaxcyte approximates its fair value as of June 30, 2023, and is based on our current estimates of future royalties expected to be earned over the estimated life of the royalty term arrangement. See Note 9. Deferred Royalty Obligation Related to the Sale of Future Royalties for a description of the Level 3 inputs used to estimate the fair value of the liability. Revenue Recognition When the Company enters into collaboration agreements, it assesses whether the arrangements fall within the scope of ASC 808, Collaborative Arrangements ("ASC 808") based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the Company and its collaboration partner fall within the scope of other accounting literature. If it concludes that payments from the collaboration partner to the Company represent consideration from a customer, such as license fees and contract research and development activities, the Company accounts for those payments within the scope of Accounting Standards Update (ASU) No. 2014-09 (Topic 606), Revenue from Contracts with Customers (“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 Company satisfies a performance obligation. However, if the Company concludes that its collaboration partner is not a customer for certain activities and associated payments, such as for certain collaborative research, development, manufacturing and commercial activities, the Company presents such payments as a reduction of research and development expense or general and administrative expense, based on where the Company presents the underlying expense. The Company has no products approved for commercial sale and has not generated any revenue from commercial product sales. The total revenue to date has been generated principally from collaboration and license agreements and to a lesser extent, from manufacturing, supply and services, and materials the Company provides to its collaboration partners. Collaboration Revenue: The Company derives revenue from collaboration arrangements, under which the Company may grant licenses to its collaboration partners to further develop and commercialize its proprietary product candidates. The Company may also perform research and development activities under the collaboration agreements. Consideration under these contracts generally includes a nonrefundable upfront payment, development, regulatory and commercial milestones and other contingent payments, and royalties based on net sales of approved products. Additionally, the collaborations may provide options for the customer to acquire from the Company materials and reagents, clinical product supply or additional research and development services under separate agreements. The Company assesses which activities in the collaboration agreements are considered distinct performance obligations that should be accounted for separately. The Company develops assumptions that require judgement to determine whether the license to the Company’s intellectual property is distinct from the research and development services or participation in activities under the collaboration agreements. At the inception of each agreement, the Company determines the arrangement transaction price, which includes variable consideration, based on the assessment of the probability of achievement of future milestones and contingent payments and other potential consideration. The Company recognizes revenue over time by measuring its progress towards the complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. For arrangements that include multiple performance obligations, the Company allocates the transaction price to the identified performance obligations based on the standalone selling price, or SSP, of each distinct performance obligation. In instances where SSP is not directly observable, the Company develops assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. These key assumptions may include full-time equivalent, or FTE, personnel effort, estimated costs, discount rates and probabilities of clinical development and regulatory success. Upfront Payments : For collaboration arrangements that include a nonrefundable upfront payment, if the license fee and research and development services cannot be accounted for as separate performance obligations, the transaction price is deferred and recognized as revenue over the expected period of performance using a cost-based input methodology. The Company uses judgement to assess the pattern of delivery of the performance obligation. In addition, amounts paid in advance of services being rendered may result in an associated financing component to the upfront payment. Accordingly, the interest on such borrowing cost component will be recorded as interest expense and revenue, based on an appropriate borrowing rate applied to the value of services to be performed by the Company over the estimated service performance period. License Grants: For collaboration arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. Milestone and Contingent Payments : At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s collaborators generally pay milestones and contingent payments subsequent to achievement of the triggering event. Research and Development Services : For amounts allocated to the Company’s research and development obligations in a collaboration arrangement, the Company recognizes revenue over time using a cost-based input methodology, representing the transfer of goods or services as activities are performed over the term of the agreement. Materials Supply: The Company provides materials and reagents, clinical materials and services to certain of its collaborators under separate agreements. The consideration for such services is generally based on FTE personnel effort used to manufacture those materials, reimbursed at an agreed upon rate in addition to agreed-upon pricing for the provided materials. The amounts billed are recognized as revenue as the performance obligations are met by the Company. Revenue subject to governmental withholding taxes is recognized on a gross basis with the withholding taxes recorded as a component of income tax expense. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis by level within the fair value hierarchy: June 30, 2023 Total Level 1 Level 2 Level 3 (in thousands) Assets: Money market funds $ 204,698 $ 204,698 $ - $ - Commercial paper 49,254 - 49,254 - Corporate debt securities 2,984 - 2,984 - Equity securities 33,349 33,349 - - Asset-backed securities 1,591 - 1,591 - U.S. government securities 84,434 84,434 - - U.S. agency securities 14,845 - 14,845 - Total $ 391,155 $ 322,481 $ 68,674 $ - December 31, 2022 Total Level 1 Level 2 Level 3 (in thousands) Assets: Money market funds $ 36,486 $ 36,486 $ - $ - Commercial paper 87,140 - 87,140 - Corporate debt securities 36,429 - 36,429 - Equity securities 32,020 32,020 - - Asset-backed securities 14,016 - 14,016 - U.S. government securities 91,251 91,251 - - U.S. agency securities 16,607 - 16,607 - Supranational debt securities 16,481 - 16,481 - Total $ 330,430 $ 159,757 $ 170,673 $ - Where applicable, the Company uses quoted market prices in active markets for identical assets to determine fair value. This pricing methodology applies to Level 1 investments, which are comprised of money market funds, U.S. government securities and the shares of Vaxcyte common stock held by the Company. If quoted prices in active markets for identical assets are not available, then the Company uses quoted prices for similar assets or inputs other than quoted prices that are observable, either directly or indirectly. These investments are included in Level 2 and consist of commercial paper, corporate debt securities, asset-backed securities, U.S. agency securities and supranational debt securities. These assets are valued using market prices when available, adjusting for accretion of the purchase price to face value at maturity. 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. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3 within the valuation hierarchy. As of June 30, 2023, the deferred royalty obligation related to the sale of future Vaxcyte royalties was classified as Level 3 within the valuation hierarchy. As of December 31, 2022, the Company did not hold any securities that were classified as Level 3 within the valuation hierarchy. Investments in Equity Securities As of June 30, 2023 and December 31, 2022, the Company held 667,780 shares of Vaxcyte common stock with an estimated fair value of $ 33.3 million and $ 32.0 million, respectively. The Company recognized an unrealized gain of $ 8.3 million and an unrealized loss of ($ 3.7 ) million for the three months ended June 30, 2023 and 2022, respectively, and an unrealized gain of $ 1.3 million and an unrealized loss of ($ 3.2 ) million for the six months ended June 30, 2023 and 2022, respectively. |
Cash Equivalents and Marketable
Cash Equivalents and Marketable Securities | 6 Months Ended |
Jun. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash Equivalents and Marketable Securities | 4. Cash Equivalents and Marketable Securities Cash equivalents and marketable securities consisted of the following: June 30, 2023 Amortized Unrealized Unrealized Fair (in thousands) Money market funds $ 204,698 $ - $ - $ 204,698 Commercial paper 49,254 - - 49,254 Corporate debt securities 2,984 - - 2,984 Asset-based securities 1,591 - - 1,591 U.S. government securities 84,425 14 ( 5 ) 84,434 U.S. agency securities 14,838 7 - 14,845 Total 357,790 21 ( 5 ) 357,806 Less amounts classified as cash equivalents ( 234,605 ) ( 3 ) - ( 234,608 ) Total marketable securities $ 123,185 $ 18 $ ( 5 ) $ 123,198 December 31, 2022 Amortized Unrealized Unrealized Fair (in thousands) Money market funds $ 36,486 $ - $ - $ 36,486 Commercial paper 87,140 - - 87,140 Corporate debt securities 36,554 2 ( 127 ) 36,429 Asset-based securities 14,026 - ( 10 ) 14,016 U.S. government securities 91,619 8 ( 376 ) 91,251 U.S. agency securities 16,646 - ( 39 ) 16,607 Supranational debt securities 16,555 - ( 74 ) 16,481 Total 299,026 10 ( 626 ) 298,410 Less amounts classified as cash equivalents ( 43,318 ) ( 2 ) - ( 43,320 ) Total marketable securities $ 255,708 $ 8 $ ( 626 ) $ 255,090 There were $ 26.4 million and $ 139.5 million of investments in an unrealized loss position of $ 5 thousand and $ 0.6 million as of June 30, 2023 and December 31, 2022, respectively. During the three and six months ended June 30, 2023 and 2022, the Company did no t record any other-than-temporary impairment charges on its available-for-sale securities. Based on the Company’s procedures under the expected credit loss model, including an assessment of unrealized losses on the portfolio after June 30, 2023 and 2022, the Company concluded that the unrealized losses for its marketable securities were not attributable to credit and therefore an allowance for credit losses for these securities has not been recorded as of June 30, 2023 and 2022. Also, based on the scheduled maturities of the investments, the Company was more likely than not to hold these investments for a period of time sufficient for a recovery of the Company’s cost basis. The Company recognized no material gains or losses on its cash equivalents and current and non-current marketable securities as of June 30, 2023 and December 31, 2022 and as a result, the Company did not reclassify any amounts out of accumulated other comprehensive income (loss) for the period then ended. |
Collaboration and License Agree
Collaboration and License Agreements and Supply Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Collaboration And License Agreements And Supply Agreements [Abstract] | |
Collaboration and License Agreements and Supply Agreements | 5. Collaboration and License Agreements and Supply Agreements The Company has entered into collaboration and license agreements and supply agreements with various pharmaceutical and biotechnology companies. See “Note 5. Collaboration and License Agreements and Supply Agreements” to the Company’s financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2022, or as further described below, for additional information on each of its collaboration agreements. The Company’s accounts receivable balances may contain billed and unbilled amounts from milestones and other contingent payments, as well as reimbursable costs from collaboration and license agreements and supply agreements. The Company performs a regular review of its customers’ credit risk and payment histories, including payments made after the period end. Historically, the Company has not experienced credit loss from its accounts receivable and, therefore, has no t recorded a reserve for estimated credit losses as of June 30, 2023 and December 31, 2022. In accordance with the collaboration agreements, the Company recognized revenue as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Bristol Myers Squibb Company (“BMS”) $ 2,236 $ 2,266 $ 5,402 $ 4,431 Merck Sharp & Dohme Corporation (“Merck”) 140 146 2,693 1,210 Merck KGaA, Darmstadt, Germany (operating in the United - 137 8 2,034 Astellas Pharma Inc. (“Astellas”) 7,333 - 13,605 - Vaxcyte 703 547 1,378 1,318 Tasly Biopharmaceuticals Co., Ltd. (“Tasly”) - 25,000 - 25,000 Total revenue $ 10,412 $ 28,096 $ 23,086 $ 33,993 The following table presents the changes in the Company’s deferred revenue balance from collaboration agreements during the six months ended June 30, 2023: Six Months Ended June 30, 2023 (in thousands) Deferred revenue—December 31, 2022 $ 106,644 Additions to deferred revenue 1,018 Recognition of revenue in current period ( 9,746 ) Deferred revenue—June 30, 2023 $ 97,916 The Company’s balance of deferred revenue contains upfront payments and an advance payment for an obligation from one of our supply agreements which remains partially unsatisfied. The Company expects to recognize approximately $ 18.0 million of the deferred revenue over the next twelve months . Collaboration with BMS BMS Agreement and 2018 BMS Master Services Agreement In September 2014, the Company signed a Collaboration and License Agreement (the “BMS Agreement”) with BMS to discover and develop bispecific antibodies and/or antibody-drug conjugates (“ADCs”), focused primarily on the field of immuno-oncology, using the Company’s proprietary integrated cell-free protein synthesis platform, XpressCF ® . In August 2017, the Company entered into an amended and restated collaboration and license agreement with BMS to refocus the collaboration on four programs that were advancing through preclinical development, including an ADC program targeting B cell maturation antigen (“BCMA ADC” or “CC-99712”). In May 2019, the U.S. Food and Drug Administration cleared the investigational new drug (“IND”) application for the BCMA ADC, which was discovered and manufactured by the Company and is the first collaboration program IND. In March 2018, the Company entered into a Master Development and Clinical Manufacturing Services Agreement (the “2018 BMS Master Services Agreement”) with BMS, wherein BMS requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. In June 2023, the Company received a notice of termination from BMS indicating that it was stopping development of CC-99712 due to a portfolio prioritization decision. The termination of the BMS Agreement is effective as of October 7, 2023 (the "Termination Date"). From and after the Termination Date, the Company will have sole worldwide rights to CC-99712. As of June 30, 2023 and December 31, 2022, there was no deferred revenue related to payments received by the Company under the BMS Agreement. As of June 30, 2023 and December 31, 2022, there was $ 0.2 million and $ 3.1 million, respectively, of deferred revenue under the 2018 BMS Master Services Agreement. Revenues under the BMS Agreement and the 2018 BMS Master Services Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ 192 $ 240 $ 413 $ 484 Materials supply 2,044 2,026 4,989 3,947 Total revenue $ 2,236 $ 2,266 $ 5,402 $ 4,431 Collaboration with Merck 2018 Merck Agreement In July 2018, the Company e ntered into an agreement (the “2018 Merck Agreement”) with Merck for access to the Company’s technology and the identification and preclinical research and development of two target programs, with an option for Merck to engage the Company to continue these activities for a third program, upon the payment of an additional amount, focusing on cytokine derivatives for cancer and autoimmune disorders, with an initial transaction price of $ 60.0 million. The option to expand activities to a third program expired in January 2021. In March 2020, Merck exercised its option to extend the research term of the collaboration’s first cytokine-derivative program by one year , which, pursuant to the terms of the 2018 Merck Agreement, triggered a payment of $ 5.0 million. In April 2021, the Company earned a $ 15.0 million contingent payment for the initiation by Merck of the first IND-enabling toxicology study under the first cytokine-derivative program in the collaboration. In September 2021, the Company entered into an amendment to the 2018 Merck Agreement (the “2021 Amendment”) to extend the research term for the first program in the 2018 Merck Agreement . Under the terms of the 2021 Amendment, the Company received a payment of $ 2.5 million with an additional $ 7.5 million to be received upon the achievement of certain developmental milestones by Merck on a second molecule under the first cytokine-derivative program of the collaboration . Merck decided not to pursue further development of a second molecule under the first cytokine-derivative program of the collaboration and, therefore, allowed the option to extend the period for nomination of additional clinical candidates under the 2021 Amendment to expire in June 2022. In December 2021, Merck did not extend the research term for the second research program of the collaboration, which research program reverted to the Company. The first research program of the collaboration is focuse d on one distinct cytokine derivative molecule for the treatment of cancer. The Company is eligible to receive aggregate contingent payments of up to approximately $ 0.5 billion for the target program selected by Merck, assuming the develo pment and sale of the therapeutic candidate and all possible indications identified under the collaboration. If one or more products from the target program is developed for non-oncology or a single indication, the Company will be eligible for reduced aggregate contingent payments. In addition, the Company is eligible to receive tiered royalties ranging from mid-single digit to low teen percentages on the worldwide sales of any commercial products that may result from the collaboration. In July 2022, the first patient was dosed in a Phase 1 study of an investigational candidate resulting from the 2018 Merck Agreement for the development of a novel cytokine derivative therapeutic for the treatment of cancer. As a result of this achievement, the Company earned and received a $ 10.0 million contingent payment from Merck during the year ended December 31, 2022. As of both June 30, 2023 and December 31, 2022, there was no deferred revenue related to the 2018 Merck Agreement and 2021 Amendment. 2020 Merck Master Services Agreement In August 2020, the Company entered into a Pre-Clinical and Clinical Supply Agreement (the “2020 Merck Master Services Agreement”) with Merck, wherein Merck requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply, upon completion of the research programs under the 2018 Merck Agreement. As of both June 30, 2023 and December 31, 2022, there was no deferred revenue under the 2020 Merck Master Services Agreement. Revenues under the 2018 Merck Agreement and the 2020 Merck Master Services Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Ongoing performance related to $ - $ - $ – $ 862 Research and development services 79 93 204 266 Materials supply 61 53 2,489 82 Total revenue $ 140 $ 146 $ 2,693 $ 1,210 Collaboration with EMD Serono MDA Agreement and 2019 EMD Serono Supply Agreement The Company signed a Collaboration Agreement and a License Agreement with EMD Serono in May 2014 and September 2014, respectively, which were entered into in contemplation of each other and, therefore, treated as a single agreement for accounting purposes. The Collaboration Agreement was subsumed into the License Agreement (the “MDA Agreement”), which agreement is to develop ADCs for multiple cancer targets. In April 2019, the Company entered into an ADC Product Preclinical and Phase I Clinical Supply Agreement (the “2019 EMD Serono Supply Agreement”) with EMD Serono, wherein EMD Serono requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. In March 2023, EMD Serono disclosed its decision to close the Phase 1a trial of M1231 in patients with solid tumors and not initiate a previously planned expansion study. EMD Serono stated that the decision was based on strategic portfolio considerations. As of both June 30, 2023 and December 31, 2022, there was no deferred revenue related to payments received by the Company under the MDA Agreement or the 2019 EMD Serono Supply Agreement. Revenues under the EMD Serono agreements were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ - $ 132 $ 6 $ 416 Materials supply - 5 2 1,618 Total revenue $ - $ 137 $ 8 $ 2,034 Astellas License and Collaboration Agreement In June 2022, the Company entered into a License and Collaboration Agreement (the “Astellas Agreement”) with Astellas for the development of immunost imulatory antibody-drug conjugates for up to three biological targets, to be identified by Astellas. The Company will conduct research and pre-clinical development of any compound (as designated by Astellas) in each of the three programs in accor dance with the terms of a research plan between the Company and Astellas. Astellas will have an exclusive worldwide license to develop and commercialize any such designated compound, subject to the Company’s rights to participate in cost and profit sharing in the United States, as described below. Pursuant to the Astellas Agreement, the Company received from Astellas a one-time, nonrefundable, non-creditable, upfront payment of $ 90.0 million during the year ended December 31, 2022. Under ASC 808 and ASC 606, the Company determined that both parties are active participants in the activities and are exposed to significant risks and rewards dependent on the success of the development program, and identified four performance obligations under the Astellas Agreement as: (1) performance of services related to the first target program; (2) performance of services related to the second target program; (3) performance of services related to the third target program; and (4) the Company’s estimated future services on the collaboration JSC. The transaction price of $ 90.0 million was allocated among the performance obligations using the Company’s best estimate of the standalone selling price, or SSP, for each of the associated performance obligations. Revenue allocated to the three target programs, which totaled $ 89.1 million, is being recognized on a proportion of performance basis, using FTE cost as the basis of measurement, with such performance expected to occur over an estimated service period of four years for each target program. As it pertains to the JSC performance obligation, the revenue allocated to such performance obligation was $ 0.9 million, and is being recognized on a proportion of performance basis using FTE cost as the basis of measurement, and such effort is expected to be incurred on a relatively consistent basis throughout the term of the Astellas Agreement. Additionally, under ASC 606, the Company determined a financing component associated with the $ 90.0 million upfront payment and has calculated $ 32.3 million as of June 30, 2023, on the unearned revenue portion beyond one year from the effective date of the agreement, which amount is being recognized as interest expense and revenue over the estimated service period for the three target programs. The Company is also eligible to receive up to $ 422.5 million in develo pment, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teen percentages on worldwide sales of any commercial products that may result from the collaboration, subject to customary deductions under certain circumstances. The Company can also elect to convert any product candidate into a cost and profit-sharing arrangement, for the United States only. In the event the Company makes such election, it will share commercialization costs and profits relating to such product candidate equally with Astellas in the United States, and no royalties will be due from Astellas for net sales of such product candidates in the United States. Revenues under the Astellas Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Ongoing performance related to $ 3,239 $ - $ 5,811 $ - Research and development services 1,562 - 2,719 - Financing component on unearned revenue 2,532 - 5,075 - Total revenue $ 7,333 $ - $ 13,605 $ - As of June 30, 2023 and December 31, 2022, there was $ 80.2 million and $ 86.1 million of deferred revenue, respectively, related to the upfront payment received by the Company under the Astellas Agreement. Agreements with Vaxcyte Vaxcyte Supply Agreement In May 2018, the Company entered into a Supply Agreement (the “Supply Agreement”) with Vaxcyte, wherein Vaxcyte engaged the Company to provide research and development services and to supply extracts and custom reagents, as requested by Vaxcyte. The pricing is based on an agreed upon cost-plus arrangement. During 2020, upon Vaxcyte’s request and their agreement to reimburse the related costs, the Company entered into agreements with third-party contract manufacturing organizations, or CMOs, to conduct process transfers to allow for such CMOs to manufacture and supply extract and custom reagents for Vaxcyte. As part of the agreement with Vaxcyte, should the Company decide to purchase extract from the extract CMO, the Company would be required to reimburse Vaxcyte for a portion of all incurred process transfer costs. As of June 30, 2023 and December 31, 2022, there was $ 5.4 million and $ 4.8 million, respectively, in such accruals related to the Vaxcyte Supply Agreement. For the three and six months ended June 30, 2023, the agreed-upon reimbursements by Vaxcyte of the costs associated with such arrangements, principally for pass-through costs from the CMOs, were $0 .9 million and $ 2.8 million, respectively, and were accounted for by the Company as a reduction to research and development expense based on the Company’s conclusion that Vaxcyte was not a customer for such activities and associated payments. For the three and six months ended June 30, 2022, the agreed-upon reimbursements by Vaxcyte of the costs associated with such arrangements, principally for pass-through costs from the CMOs, were $ 3.8 million and $ 6.2 million, respectively. Revenues under the Vaxcyte Supply Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ 567 $ 542 $ 1,071 $ 1,143 Materials supply 136 5 307 175 Total revenue $ 703 $ 547 $ 1,378 $ 1,318 Vaxcyte Agreement In December 2022, the Company entered into a letter agreement (the “Vaxcyte Agreement”) with Vaxcyte under which the Company granted to Vaxcyte (i) authorization to enter into an agreement with an independent alternate CMO to source cell-free extract solely for the products it licensed from the Company, allowing Vaxcyte to have direct oversight over financial and operational aspects of the relationship with the CMO (“CMO Relationship Rights”), and (ii) a right, but not an obligation, to obtain certain exclusive rights to internally manufacture and/or source extract from certain CMOs and the right to independently develop and make improvements to extract for use in connection with the exploitation of certain vaccine compositions (the “Option”). The Option is exercisable for five years following the effective date of the Vaxcyte Agreement (the “Option Period”), subject to potential acceleration in the event of a change of control of Vaxcyte. Pursuant to the Vaxcyte Agreement, the Company received a one-time, nonrefundable, non-creditable, upfront payment of $ 10.0 million in cash, and 167,780 shares of Vaxcyte common stock with a fair value of $ 7.5 million in December 2022. The Company will receive an additional nonrefundable, non-creditable payment of $ 5.0 million after the Company and Vaxcyte mutually agree in writing upon the Form Definitive Agreement that will become effective upon Vaxcyte’s exercise of the Option. In the event Vaxcyte elects to exercise the Option, Vaxcyte will pay the Company $ 75.0 million in cash in two installments, and upon the occurrence of certain regulatory milestones, certain additional payments totaling up to $ 60.0 million. In the event that Vaxcyte undergoes a change of control, and subsequently exercises the Option, a substantial majority of the milestone payments will be accelerated. The Company evaluated the terms of the Vaxcyte Agreement and concluded that the Vaxcyte Agreement is considered a new standalone contract and distinct from the previously existing agreements with Vaxcyte. Under ASC 606, the Company determined that Vaxcyte is a customer for this arrangement and identified the promised goods and services under the Vaxcyte Agreement as: (1) the Option; (2) the Form Definitive Agreement; (3) CMO Relationship Rights; and (4) Joint steering committee participation. The Company concluded that the promises within the contract are interrelated and interdependent of one another. As such, these are not considered distinct but are combined as a single performance obligation. This single performance obligation is considered a material right as it provides Vaxcyte with the right to acquire additional goods at a price it would not have received without having entered into the Vaxcyte Agreement. Other than the upfront cash and stock payments received, all other payment provisions in the Vaxcyte Agreement were considered constrained variable consideration or otherwise not eligible for revenue recognition at inception and as of June 30, 2023. Revenue for the single performance obligation was deferred and will be eligible to begin to be recognized at the earlier of when the Option is exercised or expires. As of each of June 30, 2023 and December 31, 2022, there was $ 17.5 million of deferred revenue, related to the upfront cash and stock payments received by the Company under the Vaxcyte Agreement. Refer to Note 9 below for information relating to the Purchase Agreement between the Company and Blackstone, pursuant to which the Company sold to Blackstone its 4 % royalty, or revenue interest, in potential future net sales of Vaxcyte products, including VAX-24. |
Loan and Security Agreement
Loan and Security Agreement | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | 6. Loan and Security Agreement The Company entered into a Loan and Security Agreement with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) in February 2020 (the “LSA”). See “Note 7. Loan and Security Agreement” to the Company’s Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2022, or as further described below, for additional information. In June 2022, the Company entered into an amendment to the LSA with Oxford and SVB (the “LSA Amendment”). The LSA Amendment added a financial covenant that requires the Company to maintain a minimum unrestricted cash balance of $ 10.0 million. The Company was in compliance with the financial covenant under the LSA Amendment as of June 30, 2023. The Loan and Security Agreement previously included a covenant requiring the Company to keep substantially all of its cash and investments with SVB, the substantial majority of which was held in a custodial account with another institution, for which SVB Asset Management was the advisor. In March and April 2023, the Loan and Security Agreement was amended to allow the Company to hold cash and investments at multiple financial institutions. In June 2023, the Company entered into an amendment to the LSA with Oxford and SVB (the “5th LSA Amendment”). Under the 5th LSA Amendment, effective July 1, 2023, the loan will bear interest at the floating per annum rate of interest equal to the greater of (i) 8.07 % and (ii) the sum of (a) a specific published 1-month secured overnight financing rate (SOFR) reported on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 0.10 %, plus (c) 6.40 %. There was an immaterial impact of the 5th LSA Amendment on the financial statements of the Company. As of June 30, 2023 and December 31, 2022, the Company has classified $ 10.2 million and $ 12.5 million, respectively, of the outstanding debt balance as a current liability, and zero and $ 3.8 million, respectively, as a non-current liability, which reflects the scheduled repayment terms under the February 2020 LSA. As of both June 30, 2023 and December 31, 2022, accrued interest expense was $ 0.1 million. During the three and six months ended June 30, 2023, the Company recorded interest expense related to loans outstanding of $ 0.4 million and $ 0.8 million, respectively, with average interest rates of 11.44 % and 11.19 %, respectively, which includes interest related to the accretion of debt discount of $ 0.1 million and $ 0.2 million, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Leases The Company leases certain office, labo ratory and manufacturing facilities in South San Francisco, California and San Carlos, California. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease for an additional 5 years . These renewal options have not been considered in the determination of the right-of-use assets and lease liabilities associated with these leases as the Company has determined it is not reasonably certain it will exercise such options. The Company recognizes rent expense for these operating leases on a straight-line basis over the lease period. The components of lease costs, which the Company includes in operating expenses in the Company's condensed Statements of Operations, were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Operating lease cost $ 1,538 $ 1,538 $ 3,076 $ 3,076 Short-term lease cost 19 20 43 41 Variable lease cost 441 430 851 854 Total lease costs $ 1,998 $ 1,988 $ 3,970 $ 3,971 During the three and six months ended June 30, 2023, the Company recorded operating lease expense of $ 1.5 million and $ 3.1 million, respectively. As of June 30, 2023, the Company paid $ 3.5 million of operating lease payments related to the lease liabilities, which the Company includes in net cash used in operating activities in the Company's condensed Statements of Cash Flows. During the three and six months ended June 30, 2022, the Company recorded operating lease expense of $ 1.5 million and $ 3.1 million, respectively. As of June 30, 2022, the Company paid $ 0.8 million of operating lease payments related to the lease liabilities, which the Company includes in net cash used in operating activities in the Company's condensed Statements of Cash Flows. As of June 30, 2023 and December 31, 2022, the weighted-average remaining lease term was 4.3 years and 4.8 years, respectively, and the weighted-average discount rate used to determine the operating lease liability was 10.8 % for both periods. As of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Year Ending December 31, Amount (in thousands) Remaining in 2023 $ 4,530 2024 9,219 2025 9,533 2026 8,994 2027 8,289 Total lease payments 40,565 Less: imputed interest ( 8,105 ) Operating lease liabilities 32,460 Less: current portion ( 5,934 ) Total lease liabilities, non-current $ 26,526 Indemnification & Other In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s condensed Balance Sheets, condensed Statements of Operations, or condensed Statements of Cash Flows. The Company currently has directors’ and officers’ liability insurance. In addition, the Company enters into agreements in the normal course of business, including with contract research organizations for clinical trials, contract manufacturing organizations for certain manufacturing services, and vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 8. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: June 30, December 31, 2023 2022 (in thousands) Vaxcyte-related accrual under Vaxcyte Supply Agreement $ 5,449 $ 4,830 CMO-related accrual 3,484 3,900 Clinical trials-related accrual 3,335 2,954 Other 7,325 3,080 Total accrued expenses and other current liabilities $ 19,593 $ 14,764 |
Deferred Royalty Obligation rel
Deferred Royalty Obligation related to the Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2023 | |
Deferred Royalty Obligation [Abstract] | |
Deferred Royalty Obligation related to the Sale of Future Royalties | 9. Deferred Royalty Obligation related to the Sale of Future Royalties In June 2023, the Company entered into the Purchase Agreement with Blackstone, pursuant to which the Company sold to Blackstone its 4 % royalty, or revenue interest, in the potential future net sales of Vaxcyte products, including the Purchased Interest under the 2015 License Agreement. The Company retains the right to discover and develop vaccines for the treatment or prophylaxis of any disease that is not caused by an infectious pathogen, including cancer. In June 2023, Blackstone made an upfront payment of $ 140.0 million to the Company and will also pay up to an additional $ 250.0 million upon the achievement of various return thresholds as set forth in the Purchase Agreement. Under the Purchase Agreement, and in connection with its sale of the Purchased Interest, the Company has agreed to certain covenants with respect to the exercise of its rights under the 2015 License Agreement, including with respect to the Company’s right to amend, assign and terminate the 2015 License Agreement. The Purchase Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party. The Company recorded the $ 140.0 million upfront payment from Blackstone as a deferred royalty obligation related to the sale of future royalties on the Company's condensed Balance Sheets. Due to the Company's ongoing manufacturing obligations under the 2015 License Agreement, the Company accounted for the proceeds as imputed debt and, therefore, will recognize future non-cash royalty revenues. Non-cash interest expense will be recognized over the estimated life of the royalty term arrangement using the effective interest method based on the imputed interest rate derived from estimated amounts and timing of future royalty payments to be received from Vaxcyte. As part of the sale, the Company incurred approximately $ 3.8 million in transaction costs, which are being amortized over the estimated life of the royalty term arrangement using the effective interest method. As future royalties are earned from Vaxcyte by Blackstone, the balance of the deferred royalty obligation will be amortized over the estimated life of the royalty term arrangement. There are a number of factors that could materially affect the fair value of the deferred royalty obligation. Such factors include, but are not limited to, the amount and timing of potential future royalty payments to be earned and received by Blackstone from Vaxcyte under the 2015 License Agreement, changing standards of care, the introduction of competing products, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of the vaccine products, and other events or circumstances that could result in reduced royalty payments from Vaxcyte to Blackstone, which are not within our control, and all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the estimated life of the royalty term arrangement. The Company will periodically assess the estimated royalty payments to be earned by Blackstone from Vaxcyte and, to the extent that the amount or timing of such payments is materially different than our original estimates, the Company will prospectively adjust the imputed interest rate and the related amortization of the deferred royalty obligation. As of June 30, 2023, our effective interest rate used to amortize the liability is 16.3 %. During the three months ended June 30, 2023, the Company recognized approximately $ 0.4 million of non-cash interest expense on the deferred royalty obligation, which amount will increase such balance. As of June 30, 2023, Blackstone has not received any royalty payment from Vaxcyte and, therefore, the deferred royalty obligation has not begun to be amortized. The following table shows the activity of the deferred royalty obligation since transaction inception through June 30, 2023: June 30, 2023 (in thousands) Proceeds from the sale of future Vaxcyte royalties $ 140,000 Issuance costs ( 3,792 ) Non-cash interest expense associated with the sale of future Vaxcyte royalties 442 Amortization of issuance costs 3 Deferred royalty obligation related to the sale of future Vaxcyte royalties, net $ 136,653 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | . Stockholders’ Equity Common Stock Holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders of the Company. The Company has reserved common stock, on an if-converted basis, for issuance as follows: June 30, December 31, 2023 2022 Common stock options issued and outstanding 8,351,659 7,310,611 Common stock awards issued and outstanding 5,212,174 3,958,478 Remaining shares reserved for issuance under 2018 Equity 1,737,524 1,541,706 Shares reserved for issuance under 2018 Employee 1,201,930 865,995 Warrants to purchase common stock 127,616 127,616 Total 16,630,903 13,804,406 Preferred Stock As of June 30, 2023 and December 31, 2022, the Company had 10,000,000 shares of preferred stock authorized with a par value of $ 0.001 per share. No shares of preferred stock were outstanding as of June 30, 2023 and December 31, 2022. |
Equity Incentive Plans, Equity
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation | . Equity Incentive Plans , Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation 2004 Equity Incentive Plan, 2018 Equity Incentive Plan, 2021 Equity Inducement Plan, and Amended and Restated 2021 Equity Inducement Plan In September 2018, the Company adopted the 2018 Equit y Incentive Plan (“2018 Plan”), which became effective on September 25, 2018. As a result, the Company will not grant any additional awards under the 2004 Equity Incentive Plan (“2004 Plan”). The terms of the 2004 Plan and applicable award agreements will continue to govern any outstanding awards thereunder. In addition to the shares of common stock reserved for future issuance under the 2004 Plan that were added to the 2018 Plan upon its effective date, the Company initially reserved 2,300,000 shares of common stock for issuance under the 2018 Plan. In addition, the number of shares of common stock reserved for issuance under the 2018 Plan will automatically increase on the first day of January for a period of up to ten years , commencing on January 1, 2019, in an amount equal to 5 % of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year (rounded to the nearest whole share), or a lesser number of shares determined by the Company’s board of directors. As a result, common stock reserved for issuance under the 2018 Plan was increased by 2,874,977 shares on January 1, 2023. In August 2021, the Company adopted the 2021 Equity Inducement Plan (“2021 Plan”), which became effective on August 4, 2021. Upon its effective date, the Company initially reserved 750,000 shares of common stock for issuance pursuant to non-qualified stock options and restricted stock units (“RSUs”) under the 2021 Plan. In accordance with Rule 5635(c)(4) of the Nasdaq listing rules, equity awards under the 2021 Plan may only be made to an employee if he or she is granted such equity awards in connection with his or her commencement of employment with the Company and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. In addition, awards under the 2021 Plan may only be made to employees who have not previously been an employee or member of the Board (or any parent or subsidiary of the Company) or following a bona fide period of non-employment of the employee by the Company (or a parent or subsidiary of the Company). At all times, the Company will reserve and keep available a sufficient number of shares as will be required to satisfy the requirements of all outstanding awards granted under the 2021 Plan. In August 2022, the Company amended and restated the 2021 Plan (the “Amended and Restated 2021 Plan”) and reserved an additional 750,000 shares of common stock available for issuance under the Amended and Restated 2021 Plan to be granted by the Company to certain employees as a material inducement to their acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Additionally, in February 2023, the Company amended and restated the 2021 Plan and reserved an additional 500,000 shares of common stock available for issuance under the Amended and Restated 2021 Plan to be granted by the Company to certain employees as a material inducement to their acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The total number of shares reserved for issuance pursuant to the Amended and Restated 2021 Plan is 2,000,000 shares. As of June 30, 2023, the Company had a total of 1,737,524 shares available for grant under the 2018 Plan and the 2021 Plan. The following table summarizes option activity under the Company’s 2004 Plan, 2018 Plan and 2021 Plan: Shares Weighted- Stock options outstanding at December 31, 2022 7,310,611 $ 12.68 Granted 1,368,000 5.66 Exercised ( 53,060 ) 5.92 Canceled and forfeited ( 273,892 ) 11.24 Stock options outstanding at June 30, 2023 8,351,659 11.62 Stock options exercisable at June 30, 2023 5,735,042 $ 12.83 Restricted Stock Units During the six months ended June 30 , 2023, the Company granted 2,305,225 shares of restricted common stock units (“RSUs”) to certain employees. These RSUs vest annually, and generally, will become fully vested over four years . A summary of the status and activity of non-vested RSUs during the six months ended June 30, 2023 is as follows: Number of Weighted Non-vested December 31, 2022 3,958,478 $ 11.70 Granted 2,305,225 5.80 Vested and released ( 896,269 ) 12.52 Canceled and forfeited ( 155,260 ) 10.72 Non-vested June 30, 2023 5,212,174 $ 8.98 2018 Employee Stock Purchase Plan In September 2018, the Company adopted the 201 8 Employee Stock Purchase Plan (“ESPP”), which became effective on September 26, 2018, in order to enable eligible employees to purchase shares of the Company’s common stock. The Company initially reserved 230,000 shares of common stock for sale under the ESPP. The aggregate number of shares reserved for sale under the ESPP will automatically increase on the first day of January for a period of up to ten years , commencing on January 1, 2019, in an amount equal to 1 % of the total number of shares of the Company’s capital stock outstanding on the last day of the preceding year (rounded to the nearest whole share), or a lesser number of shares determined by the Company’s board of directors. As a result, common stock reserved for issuance under the ESPP was increased by 574,995 shares on January 1, 2023. The aggregate number of shares issued over the term of the Company’s ESPP, subject to stock-splits, recapitalizations or similar events, may not exceed 2,300,000 shares of the Company’s common stock. As of June 30, 20 23, 983,316 shares had been purchased and 1,201,930 shares were available for future issuance under the ESPP. Stock-Based Compensation Expense The Company believes that the fair value of the stock options, RSUs and ESPP shares is more reliably measurable than the fair value of services received. Total stock-based compensation expense recognized was as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development expense: $ 3,127 $ 2,271 $ 5,948 $ 4,884 General and administrative expense: 3,534 4,425 6,734 8,786 Total $ 6,661 $ 6,696 $ 12,682 $ 13,670 As of June 30, 2023, unrecogni zed stock-based compensation expense related to the unvested stock options and RSUs granted was $ 15.3 million and $ 38.1 million, respectively. The remaining unrecognized compensation cost related to the unvested stock options and RSUs is expected to be recognized over a weighted-average period of 2.2 years and 2.6 years, respectively. As of June 30, 2023, there was $ 0.2 million of unrecognized stock-based compensation expense related to the ESPP. As of June 30, 2022, unrecognized stock-based compensation expense related to the unvested stock options and RSUs granted was $ 22.1 million and $ 42.1 million, respectively. The remaining unrecognized compensation cost related to the unvested stock options and RSUs is expected to be recognized over a weighted-average period of 2.5 years and 3.0 years, respectively. As of June 30, 2022, there is $ 0.2 million of unrecognized stock-based compensation expense related to the ESPP. |
Provision For Income Taxes
Provision For Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Provision For Income Taxes | 12. Provision for Income Taxes For the three and six months ended June 30, 2023, the Company recognized an income tax expense of $ 0.2 million and $ 0.5 million, respectively, resulting in an effective tax rate of ( 0.3 )%. The Company recorded a foreign income tax charge of $ 2.5 million during the three and six months ended June 30, 2022, due to a withholding tax in China on its license revenue from Tasly. The Company has established a full valuation allowance against its net deferred tax assets due to the uncertainty surrounding the realization of such assets. All losses to date have been incurred domestically. The income tax charge for the three and six months ended June 30, 2023, was primarily due to unfavorable book-tax differences related to capitalizing and amortizing research and development expenditures under Internal Revenue Code, or IRC, Section 174, the upfront payment from the sale of future royalties, and IRC Section 382 limitations imposed on the utilization of the Company's historical tax attributes as a result of cumulative ownership changes that the Company more likely than not experienced in prior years. The effective tax rates for the three and six months ended June 30, 2023 vary from the U.S. federal statutory tax rate of 21 % primarily due to the Company’s inability to recognize the benefit from its net deferred tax assets, which are offset by a valuation allowance. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss Per Share The following table sets forth the computation of the Company’s basic and diluted net loss per share. Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except share and per share amounts) Numerator: Net loss $ ( 38,524 ) $ ( 26,012 ) $ ( 88,574 ) $ ( 65,122 ) Denominator: Shares used in computing net loss per share 60,339,475 46,957,196 59,535,918 46,729,663 Net loss per share, basic and diluted $ ( 0.64 ) $ ( 0.55 ) $ ( 1.49 ) $ ( 1.39 ) The following common stock equivalents were excluded from the computation of diluted net loss per share for the period ended June 30, 2023 and 2022, because including them would have been antidilutive: As of June 30, 2023 2022 Common stock options issued and outstanding 8,351,659 7,507,431 Restricted stock units issued and outstanding 5,212,174 3,737,945 Warrants to purchase common stock 127,616 127,616 Shares to be issued under employee stock purchase plan 203,206 158,299 Total 13,894,655 11,531,291 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying interim condensed financial statements of the Company are unaudited. These interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and the applicable rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The December 31, 2022 condensed balance sheet was derived from the audited financial statements as of that date, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported on the Company’s condensed Balance Sheets and the amounts of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining research and development periods under collaboration arrangements, stock-based compensation expense, valuation of marketable securities, impairment of long-lived assets, income taxes, deferred royalty obligation related to the sale of future royalties and related non-cash interest expense, and certain accrued liabilities. Actual results could differ from such estimates or assumptions. The accompanying unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to state fairly the Company’s financial position, results of operations, comprehensive loss, and cash flows for the interim periods. The interim results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, or for any other future annual or interim period. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s audited financial statements included in the Annual Report on Form 10-K pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, for the year ended December 31, 2022. |
Deferred Royalty Obligation related to the Sale of Future Royalties and Non-cash Interest Expense | Deferred Royalty Obligation related to the Sale of Future Royalties and Non-cash Interest Expense In June 2023, the Company entered into a purchase and sale agreement (the “Purchase Agreement”) with Blackstone, pursuant to which the Company sold to Blackstone its 4 % royalty, or revenue interest, in the potential future net sales of Vaxcyte products, including VAX-24 (the “Purchased Interest”) under that certain Amended and Restated SutroVax Agreement, dated October 12, 2015, by and between the Company and Vaxcyte, as amended (the “2015 License Agreement”). In June 2023, Blackstone made an upfront payment of $ 140.0 million to the Company and will also pay up to an additional $ 250.0 million upon the achievement of various return thresholds as set forth in the Purchase Agreement. The net proceeds from the upfront payment received by the Company from the sale of future royalties from Vaxcyte are recorded as deferred royalty obligation related to the sale of future royalties on the Company's condensed Balance Sheets. As royalties are earned and remitted pursuant to the 2015 License Agreement, the balance of the deferred royalty obligation will be amortized over the estimated life of the royalty term arrangement, and non-cash interest expense related to the sale of future royalties is recorded using the effective interest method. To determine the amortization of our deferred royalty obligation, the Company is required to estimate the total amount of future royalties to be earned under the 2015 License Agreement. There are a number of factors that could materially affect the amount and timing of royalty payments earned, most of which are not within the Company's control. The Company will periodically assess the amount of royalty payments expected to be earned which are subject to the Purchase Agreement and, to the extent that the amount or timing of such earned royalties is materially different than the Company's original estimates, the Company will prospectively adjust the imputed interest rate and the related amortization of the deferred royalty obligation. Issuance fees and costs directly related to the Purchase Agreement were offset against the initial carrying value of the deferred royalty obligation and were amortized using the effective interest method over the estimated life of the royalty term arrangement. |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted There were no new accounting pronouncements issued since the Company's filing of the Annual Report on Form 10-K for the year ended December 31, 2022, which could have a significant effect on the Company's condensed financial statements. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company's condensed Balance Sheets that sum to the total of the same amounts shown in the Company's condensed Statements of Cash Flows. June 30, 2023 2022 (in thousands) Cash and cash equivalents $ 235,095 $ 79,115 Restricted cash 872 872 Total cash, cash equivalents, and restricted cash shown in the $ 235,967 $ 79,987 |
Investments in Equity Securities | Investments in Equity Securities Vaxcyte common stock held by the Company is measured at fair value at each reporting period based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any realized or unrealized gains and losses recorded in the Company’s condensed Statements of Operations. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value. The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows: Level 1—Quoted prices in active markets for identical assets and liabilities; Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices 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 assets or liabilities; and Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amounts of accounts receivable, prepaid expenses, accounts payable, accrued liabilities and accrued compensation and benefits approximate fair value due to the short-term nature of these items. The fair value of the Company’s outstanding loan (See Note 6) is estimated using the net present value of the payments, discounted at an interest rate that is consistent with the market interest rate, which is a Level 2 input. The estimated fair value of the Company’s outstanding loan approximates the carrying amount, as the loan bears a floating rate that approximates the market interest rate. The carrying value of the deferred royalty obligation related to the sale of future royalties under the 2015 License Agreement with Vaxcyte approximates its fair value as of June 30, 2023, and is based on our current estimates of future royalties expected to be earned over the estimated life of the royalty term arrangement. See Note 9. Deferred Royalty Obligation Related to the Sale of Future Royalties for a description of the Level 3 inputs used to estimate the fair value of the liability. |
Revenue Recognition | Revenue Recognition When the Company enters into collaboration agreements, it assesses whether the arrangements fall within the scope of ASC 808, Collaborative Arrangements ("ASC 808") based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the Company and its collaboration partner fall within the scope of other accounting literature. If it concludes that payments from the collaboration partner to the Company represent consideration from a customer, such as license fees and contract research and development activities, the Company accounts for those payments within the scope of Accounting Standards Update (ASU) No. 2014-09 (Topic 606), Revenue from Contracts with Customers (“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 Company satisfies a performance obligation. However, if the Company concludes that its collaboration partner is not a customer for certain activities and associated payments, such as for certain collaborative research, development, manufacturing and commercial activities, the Company presents such payments as a reduction of research and development expense or general and administrative expense, based on where the Company presents the underlying expense. The Company has no products approved for commercial sale and has not generated any revenue from commercial product sales. The total revenue to date has been generated principally from collaboration and license agreements and to a lesser extent, from manufacturing, supply and services, and materials the Company provides to its collaboration partners. Collaboration Revenue: The Company derives revenue from collaboration arrangements, under which the Company may grant licenses to its collaboration partners to further develop and commercialize its proprietary product candidates. The Company may also perform research and development activities under the collaboration agreements. Consideration under these contracts generally includes a nonrefundable upfront payment, development, regulatory and commercial milestones and other contingent payments, and royalties based on net sales of approved products. Additionally, the collaborations may provide options for the customer to acquire from the Company materials and reagents, clinical product supply or additional research and development services under separate agreements. The Company assesses which activities in the collaboration agreements are considered distinct performance obligations that should be accounted for separately. The Company develops assumptions that require judgement to determine whether the license to the Company’s intellectual property is distinct from the research and development services or participation in activities under the collaboration agreements. At the inception of each agreement, the Company determines the arrangement transaction price, which includes variable consideration, based on the assessment of the probability of achievement of future milestones and contingent payments and other potential consideration. The Company recognizes revenue over time by measuring its progress towards the complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. For arrangements that include multiple performance obligations, the Company allocates the transaction price to the identified performance obligations based on the standalone selling price, or SSP, of each distinct performance obligation. In instances where SSP is not directly observable, the Company develops assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. These key assumptions may include full-time equivalent, or FTE, personnel effort, estimated costs, discount rates and probabilities of clinical development and regulatory success. Upfront Payments : For collaboration arrangements that include a nonrefundable upfront payment, if the license fee and research and development services cannot be accounted for as separate performance obligations, the transaction price is deferred and recognized as revenue over the expected period of performance using a cost-based input methodology. The Company uses judgement to assess the pattern of delivery of the performance obligation. In addition, amounts paid in advance of services being rendered may result in an associated financing component to the upfront payment. Accordingly, the interest on such borrowing cost component will be recorded as interest expense and revenue, based on an appropriate borrowing rate applied to the value of services to be performed by the Company over the estimated service performance period. License Grants: For collaboration arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. Milestone and Contingent Payments : At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s collaborators generally pay milestones and contingent payments subsequent to achievement of the triggering event. Research and Development Services : For amounts allocated to the Company’s research and development obligations in a collaboration arrangement, the Company recognizes revenue over time using a cost-based input methodology, representing the transfer of goods or services as activities are performed over the term of the agreement. Materials Supply: The Company provides materials and reagents, clinical materials and services to certain of its collaborators under separate agreements. The consideration for such services is generally based on FTE personnel effort used to manufacture those materials, reimbursed at an agreed upon rate in addition to agreed-upon pricing for the provided materials. The amounts billed are recognized as revenue as the performance obligations are met by the Company. Revenue subject to governmental withholding taxes is recognized on a gross basis with the withholding taxes recorded as a component of income tax expense. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the Company's condensed Balance Sheets that sum to the total of the same amounts shown in the Company's condensed Statements of Cash Flows. June 30, 2023 2022 (in thousands) Cash and cash equivalents $ 235,095 $ 79,115 Restricted cash 872 872 Total cash, cash equivalents, and restricted cash shown in the $ 235,967 $ 79,987 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets Measured on Recurring Basis | The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis by level within the fair value hierarchy: June 30, 2023 Total Level 1 Level 2 Level 3 (in thousands) Assets: Money market funds $ 204,698 $ 204,698 $ - $ - Commercial paper 49,254 - 49,254 - Corporate debt securities 2,984 - 2,984 - Equity securities 33,349 33,349 - - Asset-backed securities 1,591 - 1,591 - U.S. government securities 84,434 84,434 - - U.S. agency securities 14,845 - 14,845 - Total $ 391,155 $ 322,481 $ 68,674 $ - December 31, 2022 Total Level 1 Level 2 Level 3 (in thousands) Assets: Money market funds $ 36,486 $ 36,486 $ - $ - Commercial paper 87,140 - 87,140 - Corporate debt securities 36,429 - 36,429 - Equity securities 32,020 32,020 - - Asset-backed securities 14,016 - 14,016 - U.S. government securities 91,251 91,251 - - U.S. agency securities 16,607 - 16,607 - Supranational debt securities 16,481 - 16,481 - Total $ 330,430 $ 159,757 $ 170,673 $ - |
Cash Equivalents and Marketab_2
Cash Equivalents and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash Equivalents and Marketable Securities | Cash equivalents and marketable securities consisted of the following: June 30, 2023 Amortized Unrealized Unrealized Fair (in thousands) Money market funds $ 204,698 $ - $ - $ 204,698 Commercial paper 49,254 - - 49,254 Corporate debt securities 2,984 - - 2,984 Asset-based securities 1,591 - - 1,591 U.S. government securities 84,425 14 ( 5 ) 84,434 U.S. agency securities 14,838 7 - 14,845 Total 357,790 21 ( 5 ) 357,806 Less amounts classified as cash equivalents ( 234,605 ) ( 3 ) - ( 234,608 ) Total marketable securities $ 123,185 $ 18 $ ( 5 ) $ 123,198 December 31, 2022 Amortized Unrealized Unrealized Fair (in thousands) Money market funds $ 36,486 $ - $ - $ 36,486 Commercial paper 87,140 - - 87,140 Corporate debt securities 36,554 2 ( 127 ) 36,429 Asset-based securities 14,026 - ( 10 ) 14,016 U.S. government securities 91,619 8 ( 376 ) 91,251 U.S. agency securities 16,646 - ( 39 ) 16,607 Supranational debt securities 16,555 - ( 74 ) 16,481 Total 299,026 10 ( 626 ) 298,410 Less amounts classified as cash equivalents ( 43,318 ) ( 2 ) - ( 43,320 ) Total marketable securities $ 255,708 $ 8 $ ( 626 ) $ 255,090 |
Collaboration and License Agr_2
Collaboration and License Agreements and Supply Agreements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | In accordance with the collaboration agreements, the Company recognized revenue as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Bristol Myers Squibb Company (“BMS”) $ 2,236 $ 2,266 $ 5,402 $ 4,431 Merck Sharp & Dohme Corporation (“Merck”) 140 146 2,693 1,210 Merck KGaA, Darmstadt, Germany (operating in the United - 137 8 2,034 Astellas Pharma Inc. (“Astellas”) 7,333 - 13,605 - Vaxcyte 703 547 1,378 1,318 Tasly Biopharmaceuticals Co., Ltd. (“Tasly”) - 25,000 - 25,000 Total revenue $ 10,412 $ 28,096 $ 23,086 $ 33,993 |
Summary of Deferred Revenue Balance | The following table presents the changes in the Company’s deferred revenue balance from collaboration agreements during the six months ended June 30, 2023: Six Months Ended June 30, 2023 (in thousands) Deferred revenue—December 31, 2022 $ 106,644 Additions to deferred revenue 1,018 Recognition of revenue in current period ( 9,746 ) Deferred revenue—June 30, 2023 $ 97,916 |
2018 BMS Master Services Agreement | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | Revenues under the BMS Agreement and the 2018 BMS Master Services Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ 192 $ 240 $ 413 $ 484 Materials supply 2,044 2,026 4,989 3,947 Total revenue $ 2,236 $ 2,266 $ 5,402 $ 4,431 |
2020 Merck Master Services Agreement | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | Revenues under the 2018 Merck Agreement and the 2020 Merck Master Services Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Ongoing performance related to $ - $ - $ – $ 862 Research and development services 79 93 204 266 Materials supply 61 53 2,489 82 Total revenue $ 140 $ 146 $ 2,693 $ 1,210 |
2019 EMD Serono Supply Agreement | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | Revenues under the EMD Serono agreements were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ - $ 132 $ 6 $ 416 Materials supply - 5 2 1,618 Total revenue $ - $ 137 $ 8 $ 2,034 |
Supply Agreement | Vaxcyte, Inc. | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | Revenues under the Vaxcyte Supply Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development services $ 567 $ 542 $ 1,071 $ 1,143 Materials supply 136 5 307 175 Total revenue $ 703 $ 547 $ 1,378 $ 1,318 |
Astellas License and Collaboration Agreement | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Summary of Recognized Revenue | Revenues under the Astellas Agreement were as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Ongoing performance related to $ 3,239 $ - $ 5,811 $ - Research and development services 1,562 - 2,719 - Financing component on unearned revenue 2,532 - 5,075 - Total revenue $ 7,333 $ - $ 13,605 $ - |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Costs | The components of lease costs, which the Company includes in operating expenses in the Company's condensed Statements of Operations, were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Operating lease cost $ 1,538 $ 1,538 $ 3,076 $ 3,076 Short-term lease cost 19 20 43 41 Variable lease cost 441 430 851 854 Total lease costs $ 1,998 $ 1,988 $ 3,970 $ 3,971 |
Schedule of Maturities of Operating Lease Liabilities | As of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Year Ending December 31, Amount (in thousands) Remaining in 2023 $ 4,530 2024 9,219 2025 9,533 2026 8,994 2027 8,289 Total lease payments 40,565 Less: imputed interest ( 8,105 ) Operating lease liabilities 32,460 Less: current portion ( 5,934 ) Total lease liabilities, non-current $ 26,526 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: June 30, December 31, 2023 2022 (in thousands) Vaxcyte-related accrual under Vaxcyte Supply Agreement $ 5,449 $ 4,830 CMO-related accrual 3,484 3,900 Clinical trials-related accrual 3,335 2,954 Other 7,325 3,080 Total accrued expenses and other current liabilities $ 19,593 $ 14,764 |
Deferred Royalty Obligation r_2
Deferred Royalty Obligation related to the Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Deferred Royalty Obligation [Abstract] | |
Schedule of Royalty Obligation transaction | The following table shows the activity of the deferred royalty obligation since transaction inception through June 30, 2023: June 30, 2023 (in thousands) Proceeds from the sale of future Vaxcyte royalties $ 140,000 Issuance costs ( 3,792 ) Non-cash interest expense associated with the sale of future Vaxcyte royalties 442 Amortization of issuance costs 3 Deferred royalty obligation related to the sale of future Vaxcyte royalties, net $ 136,653 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | The Company has reserved common stock, on an if-converted basis, for issuance as follows: June 30, December 31, 2023 2022 Common stock options issued and outstanding 8,351,659 7,310,611 Common stock awards issued and outstanding 5,212,174 3,958,478 Remaining shares reserved for issuance under 2018 Equity 1,737,524 1,541,706 Shares reserved for issuance under 2018 Employee 1,201,930 865,995 Warrants to purchase common stock 127,616 127,616 Total 16,630,903 13,804,406 |
Equity Incentive Plans, Equit_2
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Option Activity | The following table summarizes option activity under the Company’s 2004 Plan, 2018 Plan and 2021 Plan: Shares Weighted- Stock options outstanding at December 31, 2022 7,310,611 $ 12.68 Granted 1,368,000 5.66 Exercised ( 53,060 ) 5.92 Canceled and forfeited ( 273,892 ) 11.24 Stock options outstanding at June 30, 2023 8,351,659 11.62 Stock options exercisable at June 30, 2023 5,735,042 $ 12.83 |
Summary of Status and Activity of Non-vested RSUs | A summary of the status and activity of non-vested RSUs during the six months ended June 30, 2023 is as follows: Number of Weighted Non-vested December 31, 2022 3,958,478 $ 11.70 Granted 2,305,225 5.80 Vested and released ( 896,269 ) 12.52 Canceled and forfeited ( 155,260 ) 10.72 Non-vested June 30, 2023 5,212,174 $ 8.98 |
Schedule of Stock-Based Compensation Expense Recognized | Total stock-based compensation expense recognized was as follows: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands) (in thousands) Research and development expense: $ 3,127 $ 2,271 $ 5,948 $ 4,884 General and administrative expense: 3,534 4,425 6,734 8,786 Total $ 6,661 $ 6,696 $ 12,682 $ 13,670 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Computation of Company's Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the Company’s basic and diluted net loss per share. Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (in thousands, except share and per share amounts) Numerator: Net loss $ ( 38,524 ) $ ( 26,012 ) $ ( 88,574 ) $ ( 65,122 ) Denominator: Shares used in computing net loss per share 60,339,475 46,957,196 59,535,918 46,729,663 Net loss per share, basic and diluted $ ( 0.64 ) $ ( 0.55 ) $ ( 1.49 ) $ ( 1.39 ) |
Summary of Common Stock Equivalents of Antidilutive Securities Excluded from Computation of Diluted Net Loss per Share | The following common stock equivalents were excluded from the computation of diluted net loss per share for the period ended June 30, 2023 and 2022, because including them would have been antidilutive: As of June 30, 2023 2022 Common stock options issued and outstanding 8,351,659 7,507,431 Restricted stock units issued and outstanding 5,212,174 3,737,945 Warrants to purchase common stock 127,616 127,616 Shares to be issued under employee stock purchase plan 203,206 158,299 Total 13,894,655 11,531,291 |
Organization and Principal Ac_2
Organization and Principal Activities - Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2023 USD ($) shares | Jun. 30, 2023 USD ($) Segment shares | Dec. 31, 2022 USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Date of incorporation | Apr. 21, 2003 | ||
Headquartered in | South San Francisco | ||
Headquartered in state | CA | ||
Number of operating segments | Segment | 1 | ||
Accumulated deficit | $ 541,189 | $ 541,189 | $ 452,615 |
Unrestricted cash, cash equivalents and marketable securities | 358,300 | $ 358,300 | |
Substantial doubt about going concern, within one year | false | ||
Vaxcyte | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Unrestricted cash, cash equivalents and equity securities at carrying value | $ 33,300 | $ 33,300 | |
At-the-Market (“ATM") | Common Stock | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Shares of common stock | shares | 216,036 | 1,857,410 | |
Gross proceeds from issuance of common stock | $ 1,200 | $ 12,400 | |
Underwriting discounts and commissions and other offering expenses | 200 | 400 | |
Net proceeds from issuance of common stock | $ 1,000 | $ 12,000 | |
Minimum | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Period from issuance date of unaudited interim condensed financial statements | 12 months |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - Blackstone Life Sciences $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |
Upfront payment received | $ 140 |
Maximum | |
Summary Of Significant Accounting Policies [Line Items] | |
Milestone payment receivable | $ 250 |
Royalty | 2015 License Agreement | |
Summary Of Significant Accounting Policies [Line Items] | |
Revenue interest percentage | 4% |
Upfront payment received | $ 140 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 235,095 | $ 47,254 | $ 79,115 |
Restricted cash | 872 | $ 872 | 872 |
Total cash, cash equivalents, and restricted cash shown in the condensed Statements of Cash Flows | $ 235,967 | $ 79,987 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Financial Assets Measured on Recurring Basis (Details) - Fair Value Measurements Recurring - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Total | $ 391,155 | $ 330,430 |
Level 1 | ||
Assets: | ||
Total | 322,481 | 159,757 |
Level 2 | ||
Assets: | ||
Total | 68,674 | 170,673 |
Money Market Funds | ||
Assets: | ||
Total | 204,698 | 36,486 |
Money Market Funds | Level 1 | ||
Assets: | ||
Total | 204,698 | 36,486 |
Commercial Paper | ||
Assets: | ||
Total | 49,254 | 87,140 |
Commercial Paper | Level 2 | ||
Assets: | ||
Total | 49,254 | 87,140 |
Corporate Debt Securities | ||
Assets: | ||
Total | 2,984 | 36,429 |
Corporate Debt Securities | Level 2 | ||
Assets: | ||
Total | 2,984 | 36,429 |
Equity Securities | ||
Assets: | ||
Total | 33,349 | 32,020 |
Equity Securities | Level 1 | ||
Assets: | ||
Total | 33,349 | 32,020 |
Asset-backed Securities | ||
Assets: | ||
Total | 1,591 | 14,016 |
Asset-backed Securities | Level 2 | ||
Assets: | ||
Total | 1,591 | 14,016 |
U.S. Government Securities | ||
Assets: | ||
Total | 84,434 | 91,251 |
U.S. Government Securities | Level 1 | ||
Assets: | ||
Total | 84,434 | 91,251 |
U.S. Agency Securities | ||
Assets: | ||
Total | 14,845 | 16,607 |
U.S. Agency Securities | Level 2 | ||
Assets: | ||
Total | $ 14,845 | 16,607 |
Supranational Debt Securities | ||
Assets: | ||
Total | 16,481 | |
Supranational Debt Securities | Level 2 | ||
Assets: | ||
Total | $ 16,481 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Estimated fair value of equity securities | $ 33,349 | $ 33,349 | $ 32,020 | ||
Unrealized gain (loss) on equity securities | 8,321 | $ (3,736) | 1,329 | $ (3,173) | |
Vaxcyte, Inc. | Vaxcyte Common Stock | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Estimated fair value of equity securities | 33,300 | 33,300 | $ 32,000 | ||
Unrealized gain (loss) on equity securities | $ 8,300 | $ (3,700) | $ 1,300 | $ (3,200) | |
Vaxcyte, Inc. | Equity Securities | Vaxcyte Common Stock | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Number of shares held | 667,780 | 667,780 | 667,780 | ||
Fair Value Measurements Recurring | |||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||||
Securities held | $ 391,155 | $ 391,155 | $ 330,430 |
Cash Equivalents and Marketab_3
Cash Equivalents and Marketable Securities - Schedule of Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 |
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | $ 357,790 | $ 299,026 | |
Unrealized Gains | 21 | 10 | |
Unrealized Losses | (5) | (626) | |
Fair Value | 357,806 | 298,410 | |
Less amounts classified as cash equivalents, Amortized Cost Basis | (235,095) | (47,254) | $ (79,115) |
Marketable Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 123,185 | 255,708 | |
Unrealized Gains | 18 | 8 | |
Unrealized Losses | (5) | (626) | |
Fair Value | 123,198 | 255,090 | |
Cash Equivalents | |||
Cash And Cash Equivalents [Line Items] | |||
Less amounts classified as cash equivalents, Amortized Cost Basis | (234,605) | (43,318) | |
Less amounts classified as cash equivalents, Unrealized Gains | (3) | (2) | |
Less amounts classified as cash equivalents, Fair Value | (234,608) | (43,320) | |
Money Market Funds | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 204,698 | 36,486 | |
Fair Value | 204,698 | 36,486 | |
Commercial Paper | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 49,254 | 87,140 | |
Fair Value | 49,254 | 87,140 | |
Corporate Debt Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 2,984 | 36,554 | |
Unrealized Gains | 2 | ||
Unrealized Losses | (127) | ||
Fair Value | 2,984 | 36,429 | |
Asset-backed Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 1,591 | 14,026 | |
Unrealized Losses | (10) | ||
Fair Value | 1,591 | 14,016 | |
U.S. Government Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 84,425 | 91,619 | |
Unrealized Gains | 14 | 8 | |
Unrealized Losses | (5) | (376) | |
Fair Value | 84,434 | 91,251 | |
U.S. Agency Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 14,838 | 16,646 | |
Unrealized Gains | 7 | ||
Unrealized Losses | (39) | ||
Fair Value | $ 14,845 | 16,607 | |
Supranational Debt Securities | |||
Cash And Cash Equivalents [Line Items] | |||
Amortized Cost Basis | 16,555 | ||
Unrealized Losses | (74) | ||
Fair Value | $ 16,481 |
Cash Equivalents and Marketab_4
Cash Equivalents and Marketable Securities - Additional Information (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Cash And Cash Equivalents [Line Items] | |||
Investments in an unrealized loss position | $ 26,400,000 | $ 139,500,000 | |
Unrealized losses | 5,000 | $ 626,000 | |
Recognition of other-than-temporary impairment | $ 0 | $ 0 |
Collaboration and License Agr_3
Collaboration and License Agreements and Supply Agreements - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2022 USD ($) PerformanceObligation Program | Mar. 31, 2020 USD ($) | Jul. 31, 2018 USD ($) Program | Aug. 31, 2017 Program | Jun. 30, 2023 USD ($) Installment | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) Installment | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Apr. 30, 2021 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Accounts receivable, reserve for credit losses | $ 0 | $ 0 | $ 0 | ||||||||
Vaxcyte, Inc. | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 17,500,000 | 17,500,000 | 17,500,000 | ||||||||
Nonrefundable, non-creditable upfront payment receivable | $ 10,000,000 | ||||||||||
Shares received | shares | 167,780 | ||||||||||
Common stock fair value | $ 7,500,000 | ||||||||||
Additional nonrefundable and noncreditable payment | 5,000,000 | 5,000,000 | |||||||||
Regulatory milestones cash in payment | $ 75,000,000 | $ 75,000,000 | |||||||||
Number of installments | Installment | 2 | 2 | |||||||||
Additional milestone payment | $ 60,000,000 | $ 60,000,000 | |||||||||
Blackstone Life Sciences | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront payment received | 140,000,000 | ||||||||||
BMS Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Number of programs advancing through preclinical development | Program | 4 | ||||||||||
Deferred revenue | 0 | 0 | 0 | ||||||||
2018 BMS Master Services Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 200,000 | 200,000 | 3,100,000 | ||||||||
2015 License Agreement | Blackstone Life Sciences | Royalty | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront payment received | $ 140,000,000 | ||||||||||
Revenue interest percentage | 4% | ||||||||||
2018 Merck Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 0 | $ 0 | 0 | ||||||||
Milestone payment receivable upon initiation of IND enabling toxicology study | $ 15,000,000 | ||||||||||
2018 Merck Agreement | Merck Sharp & Dohme Corp | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Number of target programs | Program | 2 | ||||||||||
Initial transaction price | $ 60,000,000 | ||||||||||
Contingent payment received | 10,000,000 | ||||||||||
Milestone payment received | 2,500,000 | ||||||||||
Additional milestone payment received | 7,500,000 | ||||||||||
Revenue recognition aggregate contingent payments eligible to receive | $ 500,000,000 | ||||||||||
Milestone method revenue recognition description | If one or more products from the target program is developed for non-oncology or a single indication, the Company will be eligible for reduced aggregate contingent payments. In addition, the Company is eligible to receive tiered royalties ranging from mid-single digit to low teen percentages on the worldwide sales of any commercial products that may result from the collaboration. | ||||||||||
First Cytokine-Derivative Program | Merck Sharp & Dohme Corp | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront payment received | $ 5,000,000 | ||||||||||
Extended research term | 1 year | ||||||||||
2020 Merck Master Services Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 0 | $ 0 | 0 | ||||||||
MDA Agreement | EMD Serono | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 0 | 0 | 0 | ||||||||
Supply Agreement | Vaxcyte, Inc. | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Reimbursements expenses accruals | 5,400,000 | 5,400,000 | 4,800,000 | ||||||||
Reimbursements expenses | 900,000 | $ 3,800,000 | 2,800,000 | $ 6,200,000 | |||||||
Astellas License and Collaboration Agreement | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Deferred revenue | 80,200,000 | 80,200,000 | 86,100,000 | ||||||||
Number of target programs | Program | 3 | ||||||||||
Upfront payment received | 90,000,000 | ||||||||||
Transaction price | $ 90,000,000 | ||||||||||
Estimated service period | 4 years | ||||||||||
Recognition of up front payment | $ 89,100,000 | 89,100,000 | 89,100,000 | ||||||||
Upfront payment revenue not recognized | 32,300,000 | ||||||||||
Nonrefundable, non-creditable upfront payment receivable | $ 90,000,000 | ||||||||||
Number of performance obligations | PerformanceObligation | 4 | ||||||||||
Maximum amount eligible to receive for development, regulatory and commercial milestones for each product candidate | $ 422,500,000 | $ 422,500,000 | |||||||||
Astellas License and Collaboration Agreement | Future Services on Collaboration Joint Steering Committee ("JSC") | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Recognition of up front payment | $ 900,000 | $ 900,000 | $ 900,000 |
Collaboration and License Agr_4
Collaboration and License Agreements and Supply Agreements - Summary of Recognized Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | $ 10,412 | $ 28,096 | $ 23,086 | $ 33,993 |
Collaboration and License Agreements and Supply Agreements | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 10,412 | 28,096 | 23,086 | 33,993 |
Collaboration and License Agreements and Supply Agreements | Bristol-Myers Squibb Company ("BMS") | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 2,236 | 2,266 | 5,402 | 4,431 |
Collaboration and License Agreements and Supply Agreements | Merck Sharp & Dohme Corporation ("Merck") | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 140 | 146 | 2,693 | 1,210 |
Collaboration and License Agreements and Supply Agreements | Merck KGaA, Darmstadt, Germany (operating in the United States and Canada under the name ''EMD Serono'') | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 137 | 8 | 2,034 | |
Collaboration and License Agreements and Supply Agreements | Astellas Pharma Inc. ("Astellas") | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 7,333 | 13,605 | ||
Collaboration and License Agreements and Supply Agreements | Vaxcyte | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 703 | 547 | 1,378 | 1,318 |
Collaboration and License Agreements and Supply Agreements | Tasly Biopharmaceuticals Co., Ltd. ("Tasly") | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 25,000 | 25,000 | ||
BMS Agreement and the 2018 BMS Master Services Agreement | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Revenues | 2,236 | 2,266 | 5,402 | 4,431 |
BMS Agreement and the 2018 BMS Master Services Agreement | Research and Development Services | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Revenues | 192 | 240 | 413 | 484 |
BMS Agreement and the 2018 BMS Master Services Agreement | Materials Supply | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Revenues | 2,044 | 2,026 | 4,989 | 3,947 |
2020 Merck Master Services Agreement | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 140 | 146 | 2,693 | 1,210 |
2020 Merck Master Services Agreement | Ongoing Performance Related to Unsatisfied Performance Obligations | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 862 | |||
2020 Merck Master Services Agreement | Research and Development Services | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 79 | 93 | 204 | 266 |
2020 Merck Master Services Agreement | Materials Supply | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 61 | 53 | 2,489 | 82 |
2019 EMD Serono Supply Agreement | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 137 | 8 | 2,034 | |
2019 EMD Serono Supply Agreement | Research and Development Services | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 132 | 6 | 416 | |
2019 EMD Serono Supply Agreement | Materials Supply | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 5 | 2 | 1,618 | |
Supply Agreement | Vaxcyte | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 703 | 547 | 1,378 | 1,318 |
Supply Agreement | Vaxcyte | Research and Development Services | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 567 | 542 | 1,071 | 1,143 |
Supply Agreement | Vaxcyte | Materials Supply | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 136 | $ 5 | 307 | $ 175 |
Astellas License and Collaboration Agreement | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 7,333 | 13,605 | ||
Astellas License and Collaboration Agreement | Ongoing Performance Related to Unsatisfied Performance Obligations | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 3,239 | 5,811 | ||
Astellas License and Collaboration Agreement | Research and Development Services | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | 1,562 | 2,719 | ||
Astellas License and Collaboration Agreement | Financing Component on Unearned Revenue | ||||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||||
Total revenue | $ 2,532 | $ 5,075 |
Collaboration and License Agr_5
Collaboration and License Agreements and Supply Agreements - Performance Obligations - Additional Information (Details) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2023-07-01 $ in Millions | Jun. 30, 2023 USD ($) |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation, amount | $ 18 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 12 months |
Collaboration and License Agr_6
Collaboration and License Agreements and Supply Agreements - Summary of Deferred Revenue Balance (Details) - Collaboration and License Agreements and Supply Agreements $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | |
Deferred revenue | $ 106,644 |
Additions to deferred revenue | 1,018 |
Recognition of revenue in current period | (9,746) |
Deferred revenue | $ 97,916 |
Loan and Security Agreement - A
Loan and Security Agreement - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||||
Debt, non-current | $ 3,771 | ||||
Interest payable | $ 100 | $ 100 | 100 | ||
Loan and accretion of debt discount | 100 | $ 100 | 200 | $ 300 | |
Interest expense, debt | $ 400 | $ 600 | $ 800 | $ 1,300 | |
Average interest rate | 11.44% | 8.07% | 11.19% | 8.07% | |
Loan and Security Agreement | SOFR | |||||
Debt Instrument [Line Items] | |||||
Long term debt percentage rate of interest accrued | 0.10% | 0.10% | |||
Loan and Security Agreement | Oxford Finance LLC and Silicon Valley Bank | |||||
Debt Instrument [Line Items] | |||||
Unrestricted cash balance | $ 10,000 | $ 10,000 | |||
Debt, current | $ 10,200 | $ 10,200 | 12,500 | ||
Debt, non-current | $ 0 | $ 0 | $ 3,800 | ||
Term loan floating per annum rate of interest | 8.07% | 8.07% | |||
Description of interest charges on loan | loan will bear interest at the floating per annum rate of interest equal to the greater of (i) 8.07% and (ii) the sum of (a) a specific published 1-month secured overnight financing rate (SOFR) reported on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 0.10%, plus (c) 6.40%. | ||||
Loan and Security Agreement | Oxford Finance LLC and Silicon Valley Bank | SOFR | |||||
Debt Instrument [Line Items] | |||||
Long term debt percentage rate of interest accrued | 6.40% | 6.40% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Loss Contingencies [Line Items] | |||||
Aggregate estimated base rent payments due | $ 40,565 | $ 40,565 | |||
Operating lease expense | $ 1,500 | $ 1,500 | 3,100 | $ 3,100 | |
Operating lease payments | $ 3,500 | $ 800 | |||
Operating lease, weighted average remaining lease term | 4 years 3 months 18 days | 4 years 3 months 18 days | 4 years 9 months 18 days | ||
Operating lease, weighted average discount rate, percent | 10.80% | 10.80% | 10.80% | ||
San Carlos Lease | California | |||||
Loss Contingencies [Line Items] | |||||
Lease extension period | 5 years | ||||
Lease renewal term | 5 years | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 1,538 | $ 1,538 | $ 3,076 | $ 3,076 |
Short-term lease cost | 19 | 20 | 43 | 41 |
Variable lease cost | 441 | 430 | 851 | 854 |
Total lease costs | $ 1,998 | $ 1,988 | $ 3,970 | $ 3,971 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remaining in 2023 | $ 4,530 | |
2024 | 9,219 | |
2025 | 9,533 | |
2026 | 8,994 | |
2027 | 8,289 | |
Total lease payments | 40,565 | |
Less: imputed interest | (8,105) | |
Operating lease liabilities | 32,460 | |
Less: current portion | (5,934) | $ (4,585) |
Total lease liabilities, non-current | $ 26,526 | $ 29,574 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Other | $ 7,325 | $ 3,080 |
Total accrued expenses and other current liabilities | 19,593 | 14,764 |
Supply Agreement | Vaxcyte | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration and license agreements and supply agreement accruals | 5,449 | 4,830 |
CMO | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration and license agreements and supply agreement accruals | 3,484 | 3,900 |
Clinical Trials | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration and license agreements and supply agreement accruals | $ 3,335 | $ 2,954 |
Deferred Royalty Obligation r_3
Deferred Royalty Obligation related to the Sale of Future Royalties Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | |
Deferred Royalty Obligation [Line Items] | ||
Non-cash interest expense on deferred royalty obligation | $ 400 | $ 442 |
Percentage of interest rate amortize liability | 16.30% | 16.30% |
Blackstone Life Sciences | ||
Deferred Royalty Obligation [Line Items] | ||
Upfront payment received | $ 140,000 | |
Blackstone Life Sciences | Maximum | ||
Deferred Royalty Obligation [Line Items] | ||
Milestone payment receivable | 250,000 | |
2015 License Agreement | Blackstone Life Sciences | ||
Deferred Royalty Obligation [Line Items] | ||
Transaction costs incurred | 3,800 | |
2015 License Agreement | Blackstone Life Sciences | Royalty | ||
Deferred Royalty Obligation [Line Items] | ||
Upfront payment received | $ 140,000 | |
Revenue interest percentage | 4% |
Deferred Royalty Obligation r_4
Deferred Royalty Obligation related to the Sale of Future Royalties - Schedule of Royalty Obligation transaction (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Deferred Royalty Obligation [Line Items] | |
Deferred royalty obligation related to the sale of future Vaxcyte royalties, net | $ 136,653 |
Vaxcyte, Inc. | |
Deferred Royalty Obligation [Line Items] | |
Proceeds from sale of future Vaxcyte royalties | 140,000 |
Issuance costs | (3,792) |
Non-cash interest expense associated with the sale of future Vaxcyte royalties | 442 |
Amortization of issuance costs | 3 |
Deferred royalty obligation related to the sale of future Vaxcyte royalties, net | $ 136,653 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | |
Stockholders Equity [Line Items] | ||
Voting rights per share | one vote per share | |
Preferred stock shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, outstanding | 0 | 0 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2023 | Dec. 31, 2022 |
Stockholders Equity [Line Items] | ||
Reserved common stock | 16,630,903 | 13,804,406 |
Common Stock Options Issued and Outstanding | ||
Stockholders Equity [Line Items] | ||
Reserved common stock | 8,351,659 | 7,310,611 |
Common Stock Awards Issued and Outstanding | ||
Stockholders Equity [Line Items] | ||
Reserved common stock | 5,212,174 | 3,958,478 |
Remaining Shares Reserved for Issuance under 2018 Equity Incentive Plan and 2021 Equity Inducement Plan | ||
Stockholders Equity [Line Items] | ||
Reserved common stock | 1,737,524 | 1,541,706 |
Shares Reserved for Issuance Under 2018 Employee Stock Purchase Plan | ||
Stockholders Equity [Line Items] | ||
Reserved common stock | 1,201,930 | 865,995 |
Warrants to Purchase Common Stock | ||
Stockholders Equity [Line Items] | ||
Reserved common stock | 127,616 | 127,616 |
Equity Incentive Plans, Equit_3
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||
Sep. 26, 2018 | Sep. 25, 2018 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Feb. 28, 2023 | Jan. 01, 2023 | Dec. 31, 2022 | Aug. 31, 2022 | Aug. 04, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reserved common stock | 16,630,903 | 16,630,903 | 13,804,406 | ||||||||
Stock-based compensation expense | $ 6,661 | $ 6,696 | $ 12,682 | $ 13,670 | |||||||
Restricted Stock Units | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Restricted common stock granted | 2,305,225 | ||||||||||
Shares vesting period | 4 years | ||||||||||
2018 Equity Incentive Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reserved common stock | 2,300,000 | ||||||||||
Annual increase period of common stock reserved for issuance | 10 years | ||||||||||
Maximum number of shares issuable | 2,874,977 | ||||||||||
2018 Equity Incentive Plan | Restricted Stock Units | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total unrecognized compensation cost related to unvested granted | 38,100 | 42,100 | $ 38,100 | $ 42,100 | |||||||
Remaining unrecognized compensation cost expected to be recognized over weighted-average period | 2 years 7 months 6 days | 3 years | |||||||||
2018 Equity Incentive Plan | Employee Stock Options | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total unrecognized compensation cost related to unvested granted | 15,300 | 22,100 | $ 15,300 | $ 22,100 | |||||||
Remaining unrecognized compensation cost expected to be recognized over weighted-average period | 2 years 2 months 12 days | 2 years 6 months | |||||||||
2018 Equity Incentive Plan | Employee Stock Purchase Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Unrecognized stock-based compensation expense | $ 200 | $ 200 | $ 200 | $ 200 | |||||||
2018 Equity Incentive Plan | Maximum | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Increase in stock reserved for issuance as percentage of capital stock outstanding on last day of preceding year | 5% | ||||||||||
2021 Equity Inducement Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reserved common stock | 750,000 | ||||||||||
Amended and Restated 2021 Equity Inducement Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reserved common stock | 2,000,000 | 2,000,000 | 500,000 | 750,000 | |||||||
2018 Equity Incentive Plan and 2021 Equity Inducement Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares available for grant | 1,737,524 | 1,737,524 | |||||||||
2018 Employee Stock Purchase Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Reserved common stock | 230,000 | ||||||||||
Annual increase period of common stock reserved for issuance | 10 years | ||||||||||
Increase in stock reserved for issuance as percentage of capital stock outstanding on last day of preceding year | 1% | ||||||||||
Maximum number of shares issuable | 2,300,000 | 983,316 | 983,316 | ||||||||
Shares available for grant | 1,201,930 | 1,201,930 | |||||||||
Shares available for grant, increase | 574,995 |
Equity Incentive Plans, Equit_4
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation - Summary of Option Activity (Details) - 2004 Plan, 2018 Plan and 2021 Plan | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Stock options outstanding, Beginning Balance, Shares | shares | 7,310,611 |
Granted, Shares | shares | 1,368,000 |
Exercised, Shares | shares | (53,060) |
Canceled and forfeited, Shares | shares | (273,892) |
Stock options outstanding, Ending Balance, Shares | shares | 8,351,659 |
Stock options exercisable, Shares | shares | 5,735,042 |
Stock options outstanding, Weighted - Average Exercise Price, Beginning Balance | $ / shares | $ 12.68 |
Weighted - Average Exercise Price, Granted | $ / shares | 5.66 |
Weighted - Average Exercise Price, Exercised | $ / shares | 5.92 |
Weighted - Average Exercise Price, Canceled and forfeited | $ / shares | 11.24 |
Stock options outstanding, Weighted - Average Exercise Price, Ending Balance | $ / shares | 11.62 |
Stock options exercisable, Weighted - Average Exercise Price, Exercisable | $ / shares | $ 12.83 |
Equity Incentive Plans, Equit_5
Equity Incentive Plans, Equity Inducement Plans, Employee Stock Purchase Plan and Stock-Based Compensation - Summary of Status and Activity of Non-vested RSUs (Details) - Restricted Stock Units | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Number of shares | |
Non-vested, Beginning Balance | shares | 3,958,478 |
Granted | shares | 2,305,225 |
Vested and released | shares | (896,269) |
Canceled and forfeited | shares | (155,260) |
Non-vested, Ending balance | shares | 5,212,174 |
Weighted Average Grant-Date Fair Value | |
Non-vested, Beginning Balance | $ / shares | $ 11.70 |
Granted | $ / shares | 5.80 |
Vested and released | $ / shares | 12.52 |
Canceled and forfeited | $ / shares | 10.72 |
Non-vested, Ending balance | $ / shares | $ 8.98 |
Equity Incentive Plans, Employe
Equity Incentive Plans, Employee Stock Purchase Plan and Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 6,661 | $ 6,696 | $ 12,682 | $ 13,670 |
Research and Development Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 3,127 | 2,271 | 5,948 | 4,884 |
General and Administrative Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 3,534 | $ 4,425 | $ 6,734 | $ 8,786 |
Provision For Income Taxes - Ad
Provision For Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense | $ 200 | $ 2,500 | $ 546 | $ 2,500 |
Effective tax rates | (0.30%) | |||
U.S. federal statutory tax rate | 21% | 21% | ||
Foreign income tax charge | $ 2,500 | $ 2,500 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Computation of Company's Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Numerator: | ||||||
Net loss | $ (38,524) | $ (50,050) | $ (26,012) | $ (39,110) | $ (88,574) | $ (65,122) |
Denominator: | ||||||
Weighted-average shares used in computing basic loss per share | 60,339,475 | 46,957,196 | 59,535,918 | 46,729,663 | ||
Weighted-average shares used in computing diluted loss per share | 60,339,475 | 46,957,196 | 59,535,918 | 46,729,663 | ||
Net loss per share, basic | $ (0.64) | $ (0.55) | $ (1.49) | $ (1.39) | ||
Net loss per share, diluted | $ (0.64) | $ (0.55) | $ (1.49) | $ (1.39) |
Net Loss Per Share - Summary _2
Net Loss Per Share - Summary of Common Stock Equivalents of Antidilutive Securities Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share | 13,894,655 | 11,531,291 |
Common Stock Options Issued and Outstanding | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share | 8,351,659 | 7,507,431 |
Restricted Stock Units Issued and Outstanding | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share | 5,212,174 | 3,737,945 |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share | 127,616 | 127,616 |
Shares to be Issued Under Employee Stock Purchase Plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share | 203,206 | 158,299 |