Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Registrant Name | ARCELLX, INC. | |
Entity Central Index Key | 0001786205 | |
Entity File Number | 001-41259 | |
Entity Tax Identification Number | 47-2855917 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | ACLX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 25 West Watkins Mill Road | |
Entity Address, Address Line Two | Suite A | |
Entity Address, City or Town | Gaithersburg | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20878 | |
City Area Code | 240 | |
Local Phone Number | 327-0603 | |
Entity Common Stock, Shares Outstanding | 43,853,893 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets, Current [Abstract] | ||
Cash and cash equivalents | $ 56,763 | $ 30,833 |
Marketable securities | 224,018 | 73,784 |
Prepaid expenses and other current assets | 9,524 | 8,192 |
Total current assets | 290,305 | 112,809 |
Restricted cash | 2,501 | 199 |
Property and equipment, net | 10,034 | 10,318 |
Operating lease right-of-use assets | 28,969 | |
Deferred offering costs | 3,172 | |
Prepaid research and development expenses and other long-term assets | 5,518 | 2,284 |
Total assets | 337,327 | 128,782 |
Current liabilities: | ||
Accounts payable | 2,962 | 1,333 |
Accrued liabilities | 11,212 | 13,180 |
Operating lease liabilities, current portion | 2,874 | |
Finance lease liabilities, current portion | 27,729 | |
Deferred rent, current portion | 183 | |
Other current liabilities | 149 | |
Total current liabilities | 44,777 | 14,845 |
Operating lease liabilities, net of current portion | 29,212 | |
Finance lease liabilities, net of current portion | 27,054 | |
Deferred Rent Credit, Noncurrent | 1,895 | |
Other long-term liabilities | 178 | |
Total liabilities | 101,043 | 16,918 |
Redeemable convertible preferred stock: | ||
Redeemable convertible preferred stock | 233,379 | |
Stockholders' equity (deficit): | ||
Preferred stock, par value of $0.001 per share; 200,000,000 shares authorized and no shares issued and outstanding as of September 30, 2022; no shares authorized, issued or outstanding as of December 31, 2021 | ||
Common stock, par value of $0.001 per share; 1,000,000,000 shares authorized and 43,846,393 shares issued and outstanding as of September 30, 2022; 185,000,000 shares authorized and 544,210 shares issued and outstanding as of December 31, 2021 | 44 | 1 |
Additional paid-in capital | 516,437 | 8,615 |
Accumulated other comprehensive loss | (399) | (20) |
Accumulated Deficit | (279,798) | (130,111) |
Total stockholders' equity (deficit) | 236,284 | (121,515) |
Total liabilities, redeemable convertible preferred stock, and stockholders' equity | 337,327 | 128,782 |
Series A Redeemable Convertible Preferred Stock | ||
Redeemable convertible preferred stock: | ||
Redeemable convertible preferred stock | 28,894 | |
Series B Redeemable Convertible Preferred Stock | ||
Redeemable convertible preferred stock: | ||
Redeemable convertible preferred stock | 85,367 | |
Series C Redeemable Convertible Preferred Stock | ||
Redeemable convertible preferred stock: | ||
Redeemable convertible preferred stock | $ 119,118 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 200,000,000 | 0 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par or stated value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,000,000,000 | 185,000,000 |
Common stock, shares, issued | 43,846,393 | 544,210 |
Common stock, shares, outstanding | 43,846,393 | 544,210 |
Series A Redeemable Convertible Preferred Stock | ||
Temporary equity, par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity, shares authorized | 0 | 29,795,227 |
Temporary equity, shares issued | 0 | 5,413,272 |
Temporary equity, shares outstanding | 0 | 5,413,272 |
Temporary Equity, Liquidation Preference | $ 0 | $ 29,795 |
Series B Redeemable Convertible Preferred Stock | ||
Temporary equity, par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity, shares authorized | 0 | 49,402,623 |
Temporary equity, shares issued | 0 | 8,975,585 |
Temporary equity, shares outstanding | 0 | 8,975,585 |
Temporary Equity, Liquidation Preference | $ 0 | $ 85,681 |
Series C Redeemable Convertible Preferred Stock | ||
Temporary equity, par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity, shares authorized | 0 | 57,224,618 |
Temporary equity, shares issued | 0 | 10,396,707 |
Temporary equity, shares outstanding | 0 | 10,396,707 |
Temporary Equity, Liquidation Preference | $ 0 | $ 120,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues [Abstract] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 83,473 | 12,325 | 123,612 | 33,489 |
General and administrative | 10,402 | 4,785 | 27,643 | 10,831 |
Total operating expenses | 93,875 | 17,110 | 151,255 | 44,320 |
Loss from operations | (93,875) | (17,110) | (151,255) | (44,320) |
Other income, net | 1,001 | 19 | 1,568 | 21 |
Net loss | (92,874) | (17,091) | (149,687) | (44,299) |
Other comprehensive loss: | ||||
Unrealized loss on marketable securities | 137 | 5 | 379 | 5 |
Comprehensive loss | $ (93,011) | $ (17,096) | $ (150,066) | $ (44,304) |
Net loss per share attributable to common stockholders - basic | $ (2.12) | $ (34.72) | $ (4.43) | $ (104.77) |
Net loss per share attributable to common stockholders - diluted | $ (2.12) | $ (34.72) | $ (4.43) | $ (104.77) |
Weighted-average common shares outstanding - basic | 43,819,365 | 492,199 | 33,814,418 | 422,825 |
Weighted-average common shares outstanding - diluted | 43,819,365 | 492,199 | 33,814,418 | 422,825 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (unaudited) - USD ($) $ in Thousands | Total | Series A | Series B | Series C | IPO | Private Placement | Follow-on offering | Common Stock | Common Stock IPO | Common Stock Private Placement | Common Stock Follow-on offering | Additional Paid In Capital | Additional Paid In Capital IPO | Additional Paid In Capital Private Placement | Additional Paid In Capital Follow-on offering | Retained Earnings | Accumulated Other Comprehensive Income |
Beginning Balance at Dec. 31, 2020 | $ (63,720) | $ 1 | $ 1,421 | $ (65,142) | |||||||||||||
Beginning Balance, Shares at Dec. 31, 2020 | 333,658 | ||||||||||||||||
Temporary Equity, Beginning Balance at Dec. 31, 2020 | $ 28,894 | $ 85,367 | |||||||||||||||
Temporary Equity, Beginning balance, shares at Dec. 31, 2020 | 5,413,272 | 8,975,585 | |||||||||||||||
Issuance of Series C redeemable convertible preferred stock, Value, net of transaction costs | $ 91,186 | ||||||||||||||||
Issuance of Series C redeemable convertible preferred stock, shares, net of transaction costs | 7,970,812 | ||||||||||||||||
Issuance of Series C redeemable convertible preferred stock, subscriptions | $ (10,000) | ||||||||||||||||
Issuance of common stock from vesting of restricted stock, value | 5 | 5 | |||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 7,173 | ||||||||||||||||
Exercise of stock options, value | 7 | 7 | |||||||||||||||
Exercise of stock options, shares | 7,522 | ||||||||||||||||
Share-based compensation | 757 | 757 | |||||||||||||||
Net loss | (11,281) | (11,281) | |||||||||||||||
Ending Balance at Mar. 31, 2021 | (74,232) | $ 1 | 2,190 | (76,423) | |||||||||||||
Ending Balance, shares at Mar. 31, 2021 | 348,353 | ||||||||||||||||
Temporary Equity, Ending Balance at Mar. 31, 2021 | $ 28,894 | $ 85,367 | $ 91,186 | ||||||||||||||
Temporary Equity, Ending balance, Shares at Mar. 31, 2021 | 5,413,272 | 8,975,585 | 7,970,812 | ||||||||||||||
Issuance of Series C redeemable convertible preferred stock for cash, subscriptions receivable, ending balance at Mar. 31, 2021 | $ (10,000) | ||||||||||||||||
Beginning Balance at Dec. 31, 2020 | (63,720) | $ 1 | 1,421 | (65,142) | |||||||||||||
Beginning Balance, Shares at Dec. 31, 2020 | 333,658 | ||||||||||||||||
Temporary Equity, Beginning Balance at Dec. 31, 2020 | $ 28,894 | $ 85,367 | |||||||||||||||
Temporary Equity, Beginning balance, shares at Dec. 31, 2020 | 5,413,272 | 8,975,585 | |||||||||||||||
Net loss | (44,299) | ||||||||||||||||
Ending Balance at Sep. 30, 2021 | (103,795) | $ 1 | 5,650 | (109,441) | $ (5) | ||||||||||||
Ending Balance, shares at Sep. 30, 2021 | 507,970 | ||||||||||||||||
Temporary Equity, Ending Balance at Sep. 30, 2021 | $ 28,894 | $ 85,367 | $ 119,118 | ||||||||||||||
Temporary Equity, Ending balance, Shares at Sep. 30, 2021 | 5,413,272 | 8,975,585 | 10,396,707 | ||||||||||||||
Beginning Balance at Mar. 31, 2021 | (74,232) | $ 1 | 2,190 | (76,423) | |||||||||||||
Beginning Balance, Shares at Mar. 31, 2021 | 348,353 | ||||||||||||||||
Temporary Equity, Beginning Balance at Mar. 31, 2021 | $ 28,894 | $ 85,367 | $ 91,186 | ||||||||||||||
Temporary Equity, Beginning balance, shares at Mar. 31, 2021 | 5,413,272 | 8,975,585 | 7,970,812 | ||||||||||||||
Issuance of Series C redeemable convertible preferred stock, Value, net of transaction costs | $ 27,932 | ||||||||||||||||
Issuance of Series C redeemable convertible preferred stock, shares, net of transaction costs | 2,425,895 | ||||||||||||||||
Issuance of Series C redeemable convertible preferred stock, subscriptions | $ 10,000 | ||||||||||||||||
Issuance of common stock from vesting of restricted stock, value | 2 | 2 | |||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 3,264 | ||||||||||||||||
Exercise of stock options, value | 175 | 175 | |||||||||||||||
Exercise of stock options, shares | 101,573 | ||||||||||||||||
Share-based compensation | 1,235 | 1,235 | |||||||||||||||
Net loss | (15,927) | (15,927) | |||||||||||||||
Ending Balance at Jun. 30, 2021 | (88,747) | $ 1 | 3,602 | (92,350) | |||||||||||||
Ending Balance, shares at Jun. 30, 2021 | 453,190 | ||||||||||||||||
Temporary Equity, Ending Balance at Jun. 30, 2021 | $ 28,894 | $ 85,367 | $ 119,118 | ||||||||||||||
Temporary Equity, Ending balance, Shares at Jun. 30, 2021 | 5,413,272 | 8,975,585 | 10,396,707 | ||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 5 | ||||||||||||||||
Exercise of stock options, value | 188 | 188 | |||||||||||||||
Exercise of stock options, shares | 54,775 | ||||||||||||||||
Share-based compensation | 1,860 | 1,860 | |||||||||||||||
Unrealized loss on investment | (5) | (5) | |||||||||||||||
Net loss | (17,091) | (17,091) | |||||||||||||||
Ending Balance at Sep. 30, 2021 | (103,795) | $ 1 | 5,650 | (109,441) | (5) | ||||||||||||
Ending Balance, shares at Sep. 30, 2021 | 507,970 | ||||||||||||||||
Temporary Equity, Ending Balance at Sep. 30, 2021 | $ 28,894 | $ 85,367 | $ 119,118 | ||||||||||||||
Temporary Equity, Ending balance, Shares at Sep. 30, 2021 | 5,413,272 | 8,975,585 | 10,396,707 | ||||||||||||||
Beginning Balance at Dec. 31, 2021 | (121,515) | $ 1 | 8,615 | (130,111) | (20) | ||||||||||||
Beginning Balance, Shares at Dec. 31, 2021 | 544,210 | ||||||||||||||||
Temporary Equity, Beginning Balance at Dec. 31, 2021 | 233,379 | $ 28,894 | $ 85,367 | $ 119,118 | |||||||||||||
Temporary Equity, Beginning balance, shares at Dec. 31, 2021 | 5,413,272 | 8,975,585 | 10,396,707 | ||||||||||||||
Issuance of common stock, net of transaction costs, value | $ 127,283 | $ 9,958 | $ 9 | $ 1 | $ 127,274 | $ 9,957 | |||||||||||
Issuance of common stock , net of transaction costs, shares | 9,487,500 | 590,318 | |||||||||||||||
Conversion of preferred stock to common stock, value | 233,379 | $ 25 | 233,354 | ||||||||||||||
Conversion of preferred stock to common stock, shares | 24,785,564 | ||||||||||||||||
Temporary Equity, Conversion of stock, value | $ (28,894) | $ (85,367) | $ (119,118) | ||||||||||||||
Temporary Equity, Conversion of stock, shares | (5,413,272) | (8,975,585) | (10,396,707) | ||||||||||||||
Issuance of common stock from vesting of restricted stock, value | 107 | 107 | |||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 24,889 | ||||||||||||||||
Exercise of stock options, value | 307 | 307 | |||||||||||||||
Exercise of stock options, shares | 286,283 | ||||||||||||||||
Share-based compensation | 4,481 | 4,481 | |||||||||||||||
Unrealized loss on investment | (24) | (24) | |||||||||||||||
Net loss | (26,041) | (26,041) | |||||||||||||||
Ending Balance at Mar. 31, 2022 | 227,935 | $ 36 | 384,095 | (156,152) | (44) | ||||||||||||
Ending Balance, shares at Mar. 31, 2022 | 35,718,764 | ||||||||||||||||
Beginning Balance at Dec. 31, 2021 | (121,515) | $ 1 | 8,615 | (130,111) | (20) | ||||||||||||
Beginning Balance, Shares at Dec. 31, 2021 | 544,210 | ||||||||||||||||
Temporary Equity, Beginning Balance at Dec. 31, 2021 | 233,379 | $ 28,894 | $ 85,367 | $ 119,118 | |||||||||||||
Temporary Equity, Beginning balance, shares at Dec. 31, 2021 | 5,413,272 | 8,975,585 | 10,396,707 | ||||||||||||||
Net loss | (149,687) | ||||||||||||||||
Ending Balance at Sep. 30, 2022 | 236,284 | $ 44 | 516,437 | (279,798) | (399) | ||||||||||||
Ending Balance, shares at Sep. 30, 2022 | 43,846,393 | ||||||||||||||||
Temporary Equity, Ending Balance at Sep. 30, 2022 | |||||||||||||||||
Temporary Equity, Ending balance, Shares at Sep. 30, 2022 | 0 | 0 | 0 | ||||||||||||||
Beginning Balance at Mar. 31, 2022 | 227,935 | $ 36 | 384,095 | (156,152) | (44) | ||||||||||||
Beginning Balance, Shares at Mar. 31, 2022 | 35,718,764 | ||||||||||||||||
Issuance of common stock, net of transaction costs, value | $ 120,719 | $ 8 | $ 120,711 | ||||||||||||||
Issuance of common stock , net of transaction costs, shares | 8,050,000 | ||||||||||||||||
Issuance of common stock from vesting of restricted stock, value | 11 | 11 | |||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 13,294 | ||||||||||||||||
Share-based compensation | 5,944 | 5,944 | |||||||||||||||
Unrealized loss on investment | (218) | (218) | |||||||||||||||
Net loss | (30,772) | (30,772) | |||||||||||||||
Ending Balance at Jun. 30, 2022 | 323,619 | $ 44 | 510,761 | (186,924) | (262) | ||||||||||||
Ending Balance, shares at Jun. 30, 2022 | 43,782,058 | ||||||||||||||||
Issuance of common stock from vesting of restricted stock, value | 4 | 4 | |||||||||||||||
Issuance of common stock from vesting of restricted stock, shares | 4,526 | ||||||||||||||||
Exercise of stock options, value | 343 | 343 | |||||||||||||||
Exercise of stock options, shares | 59,809 | ||||||||||||||||
Share-based compensation | 5,329 | 5,329 | |||||||||||||||
Unrealized loss on investment | (137) | (137) | |||||||||||||||
Net loss | (92,874) | (92,874) | |||||||||||||||
Ending Balance at Sep. 30, 2022 | 236,284 | $ 44 | $ 516,437 | $ (279,798) | $ (399) | ||||||||||||
Ending Balance, shares at Sep. 30, 2022 | 43,846,393 | ||||||||||||||||
Temporary Equity, Ending Balance at Sep. 30, 2022 | |||||||||||||||||
Temporary Equity, Ending balance, Shares at Sep. 30, 2022 | 0 | 0 | 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | ||
Jun. 30, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | |
Series C Redeemable Convertible Preferred Stock | |||
Transaction costs | $ 814 | ||
Common Stock | IPO [Member] | |||
Transaction costs | $ 15,029 | ||
Common Stock | Private Placement [Member] | |||
Transaction costs | $ 42 | ||
Common Stock | Follow-on offering [Member] | |||
Transaction costs | $ 8,081 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (149,687) | $ (44,299) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 904 | 710 |
Interest expense | 595 | |
Loss on disposal of property and equipment | 1 | 3 |
Noncash operating lease expense | 593 | |
Right of use asset expensed | 63,148 | |
Amortization of premiums and discounts on marketable securities | (768) | 60 |
Share-based compensation | 15,754 | 3,852 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current and non-current assets | (4,150) | (649) |
Accounts payable and other current liabilities | 1,494 | 1,079 |
Accrued liabilities | (677) | 6,494 |
Operating lease liabilities | 1,010 | |
Deferred rent | 58 | |
Net cash used in operating activities | (71,783) | (32,692) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,001) | (1,030) |
Purchases of marketable securities | (247,980) | (61,283) |
Proceeds from maturities of marketable securities | 97,685 | |
Net cash used in investing activities | (151,296) | (62,313) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock (initial public offering), net of transactions costs | 129,156 | |
Proceeds from issuance of common stock (private placement), net of transactions costs | 9,958 | |
Proceeds from issuance of common stock (follow-on offering), net of transactions costs | 120,719 | |
Proceeds from issuance of Series C redeemable convertible preferred stock, net of transaction costs | 119,118 | |
Proceeds from exercise of stock options | 773 | 369 |
Payments for repurchase of restricted stock | (24) | |
Payments under finance lease | (9,295) | |
Payments under capital leases | (359) | |
Payments of deferred offering costs | (668) | |
Net cash provided by financing activities | 251,311 | 118,436 |
Net increase in cash and cash equivalents and restricted cash | 28,232 | 23,431 |
Cash and cash equivalents and restricted cash, beginning of the year | 31,032 | 46,795 |
Cash and cash equivalents and restricted cash, end of the period | 59,264 | 70,226 |
Supplemental disclosures of noncash investing and financing activities: | ||
Purchase of property and equipment included in accounts payable and accrued liabilities | $ 430 | $ 850 |
Nature of the Business
Nature of the Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of The Business | 1. Nature of the Business Organization Arcellx, Inc. (Arcellx or the Company) was incorporated in Delaware in December 2014 and is headquartered in Gaithersburg, Maryland. The Company is a clinical-stage biopharmaceutical company reimagining cell therapy through the development of innovative therapies for patients with cancer and other incurable diseases. On February 8, 2022, the Company closed its initial public offering (IPO) of 9,487,500 shares of its common stock, including the exercise in full by the underwriters of their option to purchase 1,237,500 additional shares of its common stock, at a public offering price of $ 15.00 per share. The Company received net proceeds of $ 127.3 million, after deducting underwriting discounts and commissions of and other offering expenses paid by the Company of approximately $ 15.0 million. The Company’s common stock began trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol “ACLX.” On June 21, 2022, the Company closed its follow-on public offering of 8,050,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase 1,050,000 additional shares of its common stock, at a public offering price of $ 16.00 per share. The Company received net proceeds of $ 120.7 million after deducting underwriting discounts and commissions and other offering expenses paid by the Company of approximately $ 8.1 million. Liquidity The Company has not commercialized any of its drug candidates and planned commercial operations have not commenced. The Company expects to incur additional operating losses and negative operating cash flows for the foreseeable future as it continues development of drug candidates, including preclinical and clinical testing and regulatory approval prior to commercialization. The Company has not generated any revenue to date from product sales and does not expect to generate any revenues from product sales in the foreseeable future. Even if drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales or generate operating income or cash flows. The Company expects that its cash and cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next twelve months. The Company has funded its operations primarily with proceeds from public and private offerings of its common and preferred stock. The Company plans to seek additional funding through public or private equity offerings, debt financings, marketing and distribution arrangements, other collaborations, strategic alliances, and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information required by U.S. generally accepted accounting principles for complete financial statements. These condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and the accompanying notes to our consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 24, 2022. In our management’s opinion, the accompanying condensed consolidated financial statements contain all adjustments, including normal, recurring adjustments, necessary to fairly present our financial position as of September 30, 2022 and December 31, 2021, our condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021, our condensed consolidated statements of redeemable convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2022 and 2021, and our statements of condensed consolidated cash flows for the nine months ended September 30, 2022 and 2021 . Interim results are not necessarily indicative of results for an entire year. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies There have been no material changes to the significant accounting policies disclosed in the Company’s Annual Report on Form 10-K during the nine months ended September 30, 2022, except for the adoption of the new lease accounting standard effective January 1, 2022, as discussed below. Leases In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update ( ASU) 2016-02 , Leases (Topic 842) . Topic 842 increases transparency and comparability among organizations by requiring the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The Company adopted the new standard effective January 1, 2022 , electing to use the package of practical expedients permitted under the transition guidance which allows for the carry forward of historical lease classification for existing leases on the adoption date and does not require the assessment of existing lease contracts to determine whether the contracts contain a lease or initial direct costs. The Company also elected the practical expedient to not separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with that lease component as a single lease component for leases associated with office and laboratory space, manufacturing facilities, and equipment. Prior periods were not retrospectively adjusted. The adoption of this standard resulted in the recognition of operating lease right-of-use (ROU) assets in the amount of $ 3.3 million and operating lease liabilities in the amount of $ 5.4 million on the consolidated balance sheet, with a $ 2.1 million reclassification of deferred rent and tenant improvement allowances. There was no cumulative effect adjustment to the opening balance of accumulated deficit as of January 1, 2022. The adoption of this standard did not have an impact on the consolidated statements of operations or cash flows on the effective date. The Company leases office and laboratory space and equipment. In addition, the Company enters into manufacturing supply agreements with contract manufacturing organizations (CMO) and contract development and manufacturing organizations (CDMO) to manufacture clinical product candidate materials. Such agreements may include an embedded lease due to the exclusive use of identified manufacturing facilities and equipment that are controlled by the Company and for which the Company obtains substantially all the output. The evaluation of leases that are embedded in the Company’s CMO and CDMO agreements is complex and requires judgment. If a lease arrangement is determined to exist with a lease term of more than 12 months at the lease commencement date, an ROU asset and corresponding lease liability are recorded on the consolidated balance sheet at the lease commencement date based on the present value of fixed lease payments over the lease term. The lease commencement date, defined as the date on which the lessor makes the underlying asset available for use by the lessee and the date from which the Company is required to recognize lease expenses, may be different from the inception date of the contract. An ROU asset represents the right to control the use of an identified asset over the lease term and a lease liability represents the obligation to make lease payments arising from the lease. The Company uses the discount rate implicit in the lease, if available, or its incremental borrowing rate on the lease commencement date to determine the present value of lease payments. The lease terms used to calculate the ROU assets and related lease liabilities include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company expenses ROU assets acquired for research and development activities under Accounting Standards Codification (ASC) Topic 730, Research and Development , if they do not have alternative future use, in research and development projects or otherwise. Leases are classified as either operating or finance leases based on the economic substance of the agreement. For operating leases, the Company recognizes lease expense related to fixed payments on a straight-line basis over the lease term. For finance leases, the Company recognizes the amortization of the ROU asset over the shorter of the lease term or useful life of the underlying asset. Interest accretion on the finance lease liabilities is recorded as interest expense. For both operating and finance leases, lease expense related to variable payments is recognized as incurred based on performance or usage in accordance with the contractual agreements. For short-term lease arrangements with a term of one year or less, the Company has elected to recognize the related lease payments on a straight-line basis over the lease term without recording related ROU assets and lease liabilities. The Company uses significant assumptions and judgment in evaluating its lease contracts and other agreements, including the determination of whether an agreement is or contains a lease, whether a change in the terms and conditions of a lease contract represent a new or modified lease, whether a lease represents an operating or finance lease, the discount rate used to determine the present value of lease obligations, and the term of a lease embedded in its manufacturing supply agreements. Pre-Launch Inventory Prior to FDA approval, the Company's policy is to recognize the cost associated with acquiring raw materials and production for clinical trials and pre-launch inventory, including third-party CMO and CDMO, as research and development expense in its consolidated statements of operations, in the period in which the costs are incurred. |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Restricted Cash | 3. Restricted Cash The Company is required to maintain cash collateral on deposit in segregated money market bank accounts, as a condition of its lease agreements. The bank may restrict withdrawals or transfers by, or on behalf of, the Company. The required restricted cash reserve totaled $ 2.5 mi llion and $ 0.2 million as of September 30, 2022 and December 31, 2021, respectively. This amount is presented as restricted cash on the accompanying consolidated balance sheets. The following table reconciles cash and cash equivalents and restricted cash per the balance sheets to the statements of cash flows (in thousands): September 30, September 30, Cash and cash equivalents $ 56,763 $ 70,027 Restricted cash 2,501 199 Total $ 59,264 $ 70,226 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments The fair value of the Company’s financial assets by level within the fair value hierarchy were as follows (in thousands): September 30, 2022 Level 1 Level 2 Level 3 Money market fund (cash equivalent) $ 46,204 $ — $ — Money market fund (long-term restricted cash) 2,501 — — Marketable securities: Commercial paper — 133,194 — Corporate debt — 17,953 — Government agency — 72,871 — Total assets measured at fair value $ 48,705 $ 224,018 $ — December 31, 2021 Level 1 Level 2 Level 3 Money market fund (cash equivalent) $ 26,472 $ — $ — Money market fund (long-term restricted cash) 199 — — Marketable securities: (1) Commercial paper — 43,969 — Corporate debt — 17,072 — U.S. government agency — 5,053 — Asset-backed securities — 7,690 — Total assets measured at fair value $ 26,671 $ 73,784 $ — (1) These items have been reclassified to conform to current period presentation. The fair value of financial assets categorized within Level 1 of the fair value hierarchy is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. The fair value of financial assets categorized within Level 2 of the fair value hierarchy is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. The Company did not transfer any assets measured at fair value on a recurring basis between levels during the nine months ended September 30, 2022 or the year ended December 31, 2021 . |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities [Abstract] | |
Marketable Securities | 5. Marketable Securities Available-for-sale marketable securities were as follows (in thousands): September 30, 2022 Amortized Unrealized Unrealized Fair Value Commercial paper $ 133,194 $ — $ — $ 133,194 Corporate debt 18,052 — ( 99 ) 17,953 Government agency 73,171 — ( 300 ) 72,871 Total $ 224,417 $ — $ ( 399 ) $ 224,018 December 31, 2021 (1) Amortized Unrealized Unrealized Fair Value Commercial paper $ 43,969 $ — $ — $ 43,969 Corporate debt 17,084 — ( 12 ) 17,072 U.S. government agency 5,056 — ( 3 ) 5,053 Asset-backed securities 7,695 — ( 5 ) 7,690 Total $ 73,804 $ — $ ( 20 ) $ 73,784 (1) These items have been reclassified to conform to current period presentation. All of the Company’s available-for-sale debt marketable securities held as of September 30, 2022 had contractual matu rities of less than one year . The Company had 17 securities in an unrealized loss position with an aggregate related fair value of $ 88.8 million as of September 30, 2022. All securities in an unrealized loss position as of September 30, 2022 had been in a loss position for less than 12 months. Unrealized losses on available-for-sale marketable securities as of September 30, 2022 were not significant and were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. Accordingly, no allowance for credit losses related to the Company’s available-for-sale marketable securities was recorded for the nine months ended September 30, 2022. The Company does not intend to sell these securities or expect to be required to sell the investments before recov ery of their amortized cost bases, which may be at maturity. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Prepaid research and development costs $ 6,909 $ 6,143 Other prepaid expense and current assets 2,615 2,049 Total prepaid expenses and other current assets $ 9,524 $ 8,192 |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2022 | |
Commitments [Abstract] | |
Commitments | 7. Commitments Pursuant to the manufacturing services agreement with Lonza Houston, Inc. (Lonza) in connection with the development and manufacture of autologous drug product CART-ddBCMA (Lonza Agreement), the Company entered into a statement of work with Lonza (Lonza SOW) in February 2022, for the technology transfer and cGMP manufacturing of CART-ddBCMA and potentially other pipeline products. The Lonza SOW contains an embedded lease as the Company has exclusive use of, and control over, a portion of manufacturing facilities during the contractual term. The Lonza SOW also contains an agreement to purchase inventory that is accounted for separately. The term of the Lonza SOW expires December 31, 2024, unless earlier terminated by either party or unless extended due to certain delays or suspensions or by mutual agreement. The Lonza SOW was non-cancellable for the first six months of the term and carried minimum non-cancellable costs including upfront payments, milestone fees, and fixed monthly payments during the related period. Subsequent to the non-cancellable period, the Company may terminate the arrangement for any reason upon 12 months prior notification to Lonza. As of September 30, 2022 , the Company’s minimum non-cancellable costs payable to Lonza was approximately $ 47.7 million, of which $ 27.7 million is reflected in the current finance lease liabilities (see Note 9). Variable costs under this arrangement include materials, external testing, and other services. The Company paid $ 2.8 million and $ 13.7 million under this arrangement during the three and nine months ended September 30, 2022 . |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | 8. Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, Research and development accrued expenses $ 6,521 $ 6,626 Accrued offering costs — 1,301 Accrued bonus 2,856 3,429 Other liabilities 1,835 1,824 Total accrued liabilities $ 11,212 $ 13,180 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | 9. Leases Operating Leases In July 2022, the Company entered into a new operating lease agreement for 57,902 square feet of office and laboratory space in Rockville, Maryland for a term of appr oximately 12.9 years with total undiscounted minimum lease payments of approximately $ 31.0 million. The Rockville lease contains annual rent escalation and rent abatement clauses as well as an allowance of approximately $ 12.1 million for tenant improv ements. The Rockville lease provides for optional two five-year extensions. The optional period is not included in the lease term used to determine the ROU asset or lease liability associated with this lease as the Company did not consider it reasonably certain it would exercise the option. The Company consulted a qualified third-party valuation specialist and determined an incremental borrowing rate of 12.0 % to be used as the discount rate of for measuring the related operating lease liabilities. In May 2022, the Company entered into a new operating lease agreement for 51,822 square feet of office and laboratory space in Redwood City, California for a term of approximately 11.7 years with total undiscounted minimum lease payments of approximately $ 56.5 million. The Redwood City lease contains annual rent escalation and rent abatement clauses as well as an allowance of approximately $ 9.8 million for tenant improvements. The Redwood City lease provides for an optional five-year extension. The optional period is not included in the lease term used to determine the ROU asset or lease liability associated with this lease as the Company did not consider it reasonably certain it would exercise the option. The Company consulted a qualified third-party valuation specialist and determined an incremental borrowing rate of 8.5 % to be used as the discount rate of for measuring the related operating lease liabilities. The Company also leases office and laboratory space in Gaithersburg, Maryland that has a term that expires in 2030 unless renewed. This operating lease agreement contains rent escalation, rent abatement clauses, tenant improvement allowances, and optional renewal clauses. All three operating leases include variable lease payments, which are primarily related to common area maintenance, taxes and utility charges. The Company also has short-term operating leases with a term of one year or less. Finance Leases The Lonza SOW contains an embedded lease as the Company has the exclusive use of, and control over, a portion of the manufacturing facility and equipment of the supplier during the contractual term of the manufacturing arrangement. Lease commencement occurred during the three months ended September 30, 2022 when the applicable manufacturing facility and equipment became available for cGMP manufacturing under the Company's exclusive use and control. The Company elected the practical expedient to combine the lease component and the non-lease components associated with the lease component as a single lease component, except as related to the non-lease component associated with purchase of inventory. As the Company acquired ROU assets that represented assets acquired for research and development activities that did not have an alternative future use, the Company recorded $ 63.1 million of research and development expense and $ 0.6 million of interest expense (included in other income, net in the accompanying condensed consolidated statements of operations) on its finance lease liabilities during the three months ended September 30, 2022 . The Company had $ 27.7 million and $ 27.1 million of current and non-current finance lease liabilities, respectively, for this lease arrangement as of September 30, 2022. The Company's total lease costs were as follows (in thousands): Three Months Ended Nine Months Ended September 30, 2022 Finance lease costs: Right-of-use assets with no alternative future use $ 63,147 $ 63,147 Amortization of right-of-use assets 25 77 Interest on lease liabilities 598 604 Operating lease costs 1,472 2,299 Short-term lease costs 7 750 Variable lease costs 675 953 Total lease costs $ 65,924 $ 67,830 Future minimum lease payments were as follows (in thousands) as of September 30, 2022: Operating Leases Finance Leases Through December 31, 2022 $ 685 $ 8,314 2023 3,083 27,699 2024 6,045 23,866 2025 8,161 — 2026 8,412 — 2027 8,672 — Thereafter 58,873 — Total lease payments 93,931 59,879 Less: Tenant improvement incentive ( 21,936 ) — Imputed interest ( 39,909 ) ( 5,096 ) Present value of total lease liabilities $ 32,086 $ 54,783 Supplemental cash flow information related to leases is as follows (in thousands): Nine Months Ended September 30, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,191 Financing cash flows from finance leases 9,295 Right-of-use assets obtained in exchange for new operating lease liabilities 29,562 Weighted-average remaining lease terms and discount rates were as follows as of September 30, 2022: Weighted-average remaining lease term — finance leases 2.3 years Weighted-average remaining lease term — operating leases 11.5 years Weighted-average discount rate — finance leases 9.5 % Weighted-average discount rate — operating leases 9.6 % |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | 10. Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) Redeemable Convertible Preferred Stock In connection with the Company's IPO, all outstanding shares of the Company’s redeemable convertible preferred stock automatically converted into shares of common stock at the applicable conversion ratio then in effect. The Company's outstanding shares of preferred stock were converted into 24,785,564 shares of common stock. Preferred Stock Subsequent to the IPO, the Company's board of directors has the authority, without further action by the stockholders, to issue shares of preferred stock in one or more series and to fix the rights, preferences, privileges, and restrictions thereof. These rights, preferences, and privileges could include dividend rights, conversion rights, voting rights, redemption rights, liquidation preferences, sinking fund terms, and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing change in our control or other corporate action. Common Stock In addition to the shares of common stock issued and outstanding in connection with the IPO, the subsequent private placement, and the follow-on public offering, total shares of common stock issued and outstanding includes shares issued to employees pursuant to the exercise of vested stock options as well as the vesting of early exercised stock options. In order to execute the early exercises, the employees signed a Restricted Stock Purchase Agreement (RSPA) granting the Company, in the case of termination of employment, the rights to repurchase all of the unvested shares at the price paid by the employee for such shares. Based on the share repurchase rights outlined in the RSPA, the Company recorded the proceeds from the early exercises as a liability on the balance sheet. All shares that were early exercised by the employees of the Company are considered legally issued. However, for accounting purposes, only vested shares are considered issued. Below is a reconciliation of shares issued and outstanding: September 30, December 31, Total shares of common stock legally issued and outstanding 43,846,393 544,967 Less: unvested early exercised shares of common stock — ( 757 ) Total shares issued and outstanding 43,846,393 544,210 Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any. No dividends have been declared or paid by the Company through September 30, 2022. In the event of any liquidation or dissolution of the Company, the holders of common stock are entitled to the assets of the Company legally available for distribution. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | 11. Share-Based Compensation The Company’s 2017 Equity Incentive Plan (the 2017 Plan) provided for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, and restricted stock awards to the Company's employees, directors, and consultants. The 2017 Plan terminated one business day prior to effectiveness of the 2022 Equity Incentive Plan (the 2022 Plan) with respect to the grant of future awards. The 2022 Plan became effective on February 3, 2022 and provides for the grant of incentive stock options to the Company's employees and for the grant of non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units (RSUs), and performance awards to the Company's employees, directors, and consultants. The aggregate n umber of shares of common stock that may be issued pursuant to equity awards under the 2022 Plan is 4,296,875 shares, plus shares subject to awards granted under the 2017 Plan that expire or otherwise terminate without having been exercised in full or are forfeited to or repurchased by the Company (provided that the maximum number of shares that may be added to the 2022 Plan pursuant to awards under the 2017 Plan is 6,269,300 shares). The number of shares of common stock reserved for issuance under the 2022 Plan shall be cumulatively increased on the first day of each fiscal year, beginning with the Company’s 2023 fiscal year and ending on the ten year anniversary of the date the Company’s board of directors approves the 2022 Plan equal to the least of 4,296,875 shares, 5 % of the total number of shares of common stock outstanding as of the last day of the immediately preceding fiscal year, or a lesser number of shares determined by the administrator of the 2022 Plan. Share-based compensation expense by type of award was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 3,569 $ 1,860 $ 10,997 $ 3,852 Restricted stock units 1,162 — 2,807 — Restricted stock units - executive officer 598 — 1,950 — Total share-based compensation expense $ 5,329 $ 1,860 $ 15,754 $ 3,852 The Company recognized $ 5.3 million in share-based compensation expense during the three months ended September 30, 2022 , of which $ 1.6 million was included in research and development expense and $ 3.7 million was included in general and administrative expense in the accompanying condensed consolidated statements of operations. The Company recognized $ 1.9 million in share-based compensation expense during the three months ended September 30, 2021 , of which $ 0.5 million was included in research and development expense and $ 1.4 million was included in general and administrative expense in the accompanying condensed consolidated statements of operations. The Company recognizeld $ 15.8 million in share-based compensation expense during the nine months ended September 30, 2022 , of which $ 5.3 million was included in research and development expense and $ 10.5 million was included in general and administrative expense in the accompanying condensed consolidated statements of operations. The Company recognized $ 3.9 million in share-based compensation expense during the nine months ended September 30, 2021 , of which $ 1.0 million was included in research and development expense and $ 2.9 million was included in general and administrative expense in the accompanying condensed consolidated statements of operations. Stock Options Stock options granted under the 2017 Plan and the 2022 Plan vest over three or four years and expire after 10 years . The Company uses the Black Scholes option pricing model to determine the grant date fair value of stock options. A summary of stock option activity for awards under the 2017 Plan and the 2022 Plan is presented below: Options Outstanding and Exercisable Number of Weighted Weighted Aggregate (1) Outstanding as of January 1, 2022 5,598,830 $ 5.36 8.9 $ 7,349 Granted 3,448,158 14.59 Forfeited ( 217,803 ) 10.02 Exercised ( 388,802 ) 2.00 Outstanding as of September 30, 2022 8,440,383 $ 9.34 Exercisable as of September 30, 2022 2,876,912 $ 6.29 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money as of September 30, 2022 . Restricted Stock Units RSUs granted under the 2022 Plan generally vest annually over three or four years . The Company uses the market price of the Company’s common shares on the date of grant to determine the fair value of RSUs. A summary of RSU activity for awards under the 2022 Plan is presented below: Number of Weighted Average Grant Date Fair Value Outstanding as of January 1, 2022 — $ — Granted 911,452 17.06 Vested — — Forfeited ( 29,828 ) 17.84 Outstanding as of September 30, 2022 881,624 $ 17.03 Restricted Stock Units - Executive Officer In June 2021, the Company granted 952,804 RSUs to an executive officer subject to service, performance, and market conditions. In December 2021, the Company added alternative performance conditions for vesting of the same RSUs (the RSU Award). These additional performance conditions provided alternative paths to vesting and the original award from June 2021 and its vesting conditions remained the same, i.e., the original award was not modified. Each RSU granted in the RSU Award entitles the recipient to one share of common stock upon vesting subject to the service, performance, and market conditions. All 952,804 RSUs were outstanding as of September 30, 2022 and December 31, 2021 and no RSUs were vested as of September 30, 2022 and December 31, 2021. Service Condition The service condition to vesting of the RSU Award requires the executive officer’s continued employment with the Company through the achievement of any of the performance conditions and the market condition. Performance Condition The performance conditions to vesting of the RSU Award include (i) the consummation of a change in control event as defined in the 2017 Plan (Change in Control), (ii) the consummation of the first firm commitment underwritten public offering covering the offer and sale of Company shares, the consummation of the direct listing or direct placement of Company shares on a publicly traded exchange, or the completion of a merger or consolidation with a special purpose acquisition company in which the shares of the surviving or parent entity are listed on a national securities exchange (IPO), or (iii) a Change in Control following an IPO. Market Condition The market condition to vesting of the RSU Award involves Company value thresholds depending upon which of the three performance condition scenarios is applicable at the time of measurement. The Company value on a C hange in Control is measured on the date of the Change in Control and is the aggregate amount of deal consideration paid at the closing of a Change in Control by an acquirer for the Company shares of common stock in connection with such Change in Control (Change in Control Market Capitalization). Upon a Change in Control, (i) one-sixth of the RSU Award will vest if a minimum Change in Control Market Capitalization of $2.5 billion is achieved, (ii) all of the RSU Award will vest if a $5.0 billion Change in Control Market Capitalization is achieved, and (iii) a portion of the RSU Award will vest based on a straight-line interpolation if a Change in Control Market Capitalization of between $2.5 billion and $5.0 billion is achieved based on a straight-line interpolation. The Company value in the event of an IPO is measured each June 30 and December 31 following an IPO (subject to applicable lock-up period) and represents the Company's Enterprise Value. The Company's Enterprise Value is determined using the total market capitalization of the Company based the average closing trading price of one share of the Company over the 60-day period ending on the day prior to the applicable IPO measurement date, less cash. Upon an IPO, (i) one-sixth of the RSU Award will vest if a minimum Enterprise Value of $2.5 billion is achieved, (ii) all the RSU Award will vest if a $5.0 billion Enterprise Value is achieved, and (iii) a portion of the RSU Award will vest based on a straight-line interpolation if an Enterprise Value of between $2.5 billion and $5.0 billion is achieved. The Company utilized Monte Carlo simulation models to estimate the fair value of the RSU Award on the date of grant in each of the three performance condition scenarios. Upon completion of the IPO in February 2022, the performance condition of the RSU Award was satisfied and the Company began recognizing share-based compensation expense on an accelerated attribution basis over the anticipated service period ( 10 years ) and based on the fair value (aggregate $ 10.3 million) according to the IPO scenario as no other performance condition was deemed probable at the time of the IPO. The Company recogniz e d $ 0.6 million and $ 2.0 million in share-based compensation expense related to this RSU Award during the three and nine months ended September 30, 2022 . |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | 12. Net Loss Per Share Attributable to Common Stockholders The Company’s potentially dilutive securities include options to purchase common stock, unvested shares of restricted common stock redeemable convertible preferred stock, restricted stock units, and restricted stock units - executive officer. The Company's potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders for the period indicated because including them would have had an anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Redeemable convertible preferred stock — 24,785,564 — 24,785,564 Options to purchase common stock 8,440,383 5,231,618 8,440,383 5,231,618 Unvested shares of restricted common stock from early exercises — — - — Restricted stock units 881,624 — 881,624 — Restricted stock units - executive officer 952,804 952,804 952,804 952,804 Total 10,274,811 30,969,986 10,274,811 30,969,986 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Leases | Leases In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update ( ASU) 2016-02 , Leases (Topic 842) . Topic 842 increases transparency and comparability among organizations by requiring the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The Company adopted the new standard effective January 1, 2022 , electing to use the package of practical expedients permitted under the transition guidance which allows for the carry forward of historical lease classification for existing leases on the adoption date and does not require the assessment of existing lease contracts to determine whether the contracts contain a lease or initial direct costs. The Company also elected the practical expedient to not separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with that lease component as a single lease component for leases associated with office and laboratory space, manufacturing facilities, and equipment. Prior periods were not retrospectively adjusted. The adoption of this standard resulted in the recognition of operating lease right-of-use (ROU) assets in the amount of $ 3.3 million and operating lease liabilities in the amount of $ 5.4 million on the consolidated balance sheet, with a $ 2.1 million reclassification of deferred rent and tenant improvement allowances. There was no cumulative effect adjustment to the opening balance of accumulated deficit as of January 1, 2022. The adoption of this standard did not have an impact on the consolidated statements of operations or cash flows on the effective date. The Company leases office and laboratory space and equipment. In addition, the Company enters into manufacturing supply agreements with contract manufacturing organizations (CMO) and contract development and manufacturing organizations (CDMO) to manufacture clinical product candidate materials. Such agreements may include an embedded lease due to the exclusive use of identified manufacturing facilities and equipment that are controlled by the Company and for which the Company obtains substantially all the output. The evaluation of leases that are embedded in the Company’s CMO and CDMO agreements is complex and requires judgment. If a lease arrangement is determined to exist with a lease term of more than 12 months at the lease commencement date, an ROU asset and corresponding lease liability are recorded on the consolidated balance sheet at the lease commencement date based on the present value of fixed lease payments over the lease term. The lease commencement date, defined as the date on which the lessor makes the underlying asset available for use by the lessee and the date from which the Company is required to recognize lease expenses, may be different from the inception date of the contract. An ROU asset represents the right to control the use of an identified asset over the lease term and a lease liability represents the obligation to make lease payments arising from the lease. The Company uses the discount rate implicit in the lease, if available, or its incremental borrowing rate on the lease commencement date to determine the present value of lease payments. The lease terms used to calculate the ROU assets and related lease liabilities include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company expenses ROU assets acquired for research and development activities under Accounting Standards Codification (ASC) Topic 730, Research and Development , if they do not have alternative future use, in research and development projects or otherwise. Leases are classified as either operating or finance leases based on the economic substance of the agreement. For operating leases, the Company recognizes lease expense related to fixed payments on a straight-line basis over the lease term. For finance leases, the Company recognizes the amortization of the ROU asset over the shorter of the lease term or useful life of the underlying asset. Interest accretion on the finance lease liabilities is recorded as interest expense. For both operating and finance leases, lease expense related to variable payments is recognized as incurred based on performance or usage in accordance with the contractual agreements. For short-term lease arrangements with a term of one year or less, the Company has elected to recognize the related lease payments on a straight-line basis over the lease term without recording related ROU assets and lease liabilities. The Company uses significant assumptions and judgment in evaluating its lease contracts and other agreements, including the determination of whether an agreement is or contains a lease, whether a change in the terms and conditions of a lease contract represent a new or modified lease, whether a lease represents an operating or finance lease, the discount rate used to determine the present value of lease obligations, and the term of a lease embedded in its manufacturing supply agreements. |
Pre-Launch Inventory | Pre-Launch Inventory Prior to FDA approval, the Company's policy is to recognize the cost associated with acquiring raw materials and production for clinical trials and pre-launch inventory, including third-party CMO and CDMO, as research and development expense in its consolidated statements of operations, in the period in which the costs are incurred. |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents and Restricted Cash | The following table reconciles cash and cash equivalents and restricted cash per the balance sheets to the statements of cash flows (in thousands): September 30, September 30, Cash and cash equivalents $ 56,763 $ 70,027 Restricted cash 2,501 199 Total $ 59,264 $ 70,226 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Company's Financial Assets | September 30, 2022 Level 1 Level 2 Level 3 Money market fund (cash equivalent) $ 46,204 $ — $ — Money market fund (long-term restricted cash) 2,501 — — Marketable securities: Commercial paper — 133,194 — Corporate debt — 17,953 — Government agency — 72,871 — Total assets measured at fair value $ 48,705 $ 224,018 $ — December 31, 2021 Level 1 Level 2 Level 3 Money market fund (cash equivalent) $ 26,472 $ — $ — Money market fund (long-term restricted cash) 199 — — Marketable securities: (1) Commercial paper — 43,969 — Corporate debt — 17,072 — U.S. government agency — 5,053 — Asset-backed securities — 7,690 — Total assets measured at fair value $ 26,671 $ 73,784 $ — (1) These items have been reclassified to conform to current period presentation. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Marketable Securities [Abstract] | |
Schedule of Available-for-sale Marketable Securities | Available-for-sale marketable securities were as follows (in thousands): September 30, 2022 Amortized Unrealized Unrealized Fair Value Commercial paper $ 133,194 $ — $ — $ 133,194 Corporate debt 18,052 — ( 99 ) 17,953 Government agency 73,171 — ( 300 ) 72,871 Total $ 224,417 $ — $ ( 399 ) $ 224,018 December 31, 2021 (1) Amortized Unrealized Unrealized Fair Value Commercial paper $ 43,969 $ — $ — $ 43,969 Corporate debt 17,084 — ( 12 ) 17,072 U.S. government agency 5,056 — ( 3 ) 5,053 Asset-backed securities 7,695 — ( 5 ) 7,690 Total $ 73,804 $ — $ ( 20 ) $ 73,784 (1) These items have been reclassified to conform to current period presentation. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Prepaid research and development costs $ 6,909 $ 6,143 Other prepaid expense and current assets 2,615 2,049 Total prepaid expenses and other current assets $ 9,524 $ 8,192 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, December 31, Research and development accrued expenses $ 6,521 $ 6,626 Accrued offering costs — 1,301 Accrued bonus 2,856 3,429 Other liabilities 1,835 1,824 Total accrued liabilities $ 11,212 $ 13,180 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Summary of Total Lease Costs | The Company's total lease costs were as follows (in thousands): Three Months Ended Nine Months Ended September 30, 2022 Finance lease costs: Right-of-use assets with no alternative future use $ 63,147 $ 63,147 Amortization of right-of-use assets 25 77 Interest on lease liabilities 598 604 Operating lease costs 1,472 2,299 Short-term lease costs 7 750 Variable lease costs 675 953 Total lease costs $ 65,924 $ 67,830 |
Summary of Future Minimum Lease Payments | Future minimum lease payments were as follows (in thousands) as of September 30, 2022: Operating Leases Finance Leases Through December 31, 2022 $ 685 $ 8,314 2023 3,083 27,699 2024 6,045 23,866 2025 8,161 — 2026 8,412 — 2027 8,672 — Thereafter 58,873 — Total lease payments 93,931 59,879 Less: Tenant improvement incentive ( 21,936 ) — Imputed interest ( 39,909 ) ( 5,096 ) Present value of total lease liabilities $ 32,086 $ 54,783 |
Summary of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases is as follows (in thousands): Nine Months Ended September 30, 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 1,191 Financing cash flows from finance leases 9,295 Right-of-use assets obtained in exchange for new operating lease liabilities 29,562 |
Summary of Weighted-Average Remaining Lease Terms and Discount Rates | Weighted-average remaining lease terms and discount rates were as follows as of September 30, 2022: Weighted-average remaining lease term — finance leases 2.3 years Weighted-average remaining lease term — operating leases 11.5 years Weighted-average discount rate — finance leases 9.5 % Weighted-average discount rate — operating leases 9.6 % |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Reconciliation of Shares Issued and Outstanding | Below is a reconciliation of shares issued and outstanding: September 30, December 31, Total shares of common stock legally issued and outstanding 43,846,393 544,967 Less: unvested early exercised shares of common stock — ( 757 ) Total shares issued and outstanding 43,846,393 544,210 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Expense | Share-based compensation expense by type of award was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Stock options $ 3,569 $ 1,860 $ 10,997 $ 3,852 Restricted stock units 1,162 — 2,807 — Restricted stock units - executive officer 598 — 1,950 — Total share-based compensation expense $ 5,329 $ 1,860 $ 15,754 $ 3,852 |
Summary of Stock Option Activity | A summary of stock option activity for awards under the 2017 Plan and the 2022 Plan is presented below: Options Outstanding and Exercisable Number of Weighted Weighted Aggregate (1) Outstanding as of January 1, 2022 5,598,830 $ 5.36 8.9 $ 7,349 Granted 3,448,158 14.59 Forfeited ( 217,803 ) 10.02 Exercised ( 388,802 ) 2.00 Outstanding as of September 30, 2022 8,440,383 $ 9.34 Exercisable as of September 30, 2022 2,876,912 $ 6.29 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money as of September 30, 2022 . |
Summary of Restricted Stock Units Activity | A summary of RSU activity for awards under the 2022 Plan is presented below: Number of Weighted Average Grant Date Fair Value Outstanding as of January 1, 2022 — $ — Granted 911,452 17.06 Vested — — Forfeited ( 29,828 ) 17.84 Outstanding as of September 30, 2022 881,624 $ 17.03 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded From Computation of Earnings Per Share | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Redeemable convertible preferred stock — 24,785,564 — 24,785,564 Options to purchase common stock 8,440,383 5,231,618 8,440,383 5,231,618 Unvested shares of restricted common stock from early exercises — — - — Restricted stock units 881,624 — 881,624 — Restricted stock units - executive officer 952,804 952,804 952,804 952,804 Total 10,274,811 30,969,986 10,274,811 30,969,986 |
Nature of The Business - Additi
Nature of The Business - Additional Information (Details) - Common Stock - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||
Jun. 21, 2022 | Feb. 08, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
IPO | ||||
Class of Stock [Line Items] | ||||
Number of shares issued | 9,487,500 | 9,487,500 | ||
Additional stock issued during period shares exercised by underwriters with option to purchase | 1,237,500 | |||
Public offering price per share | $ 15 | |||
Net proceeds from initial public offering | $ 127.3 | |||
Cash paid for underwriting discounts and commissions and other offering expenses | $ 15 | |||
Follow-on offering | ||||
Class of Stock [Line Items] | ||||
Number of shares issued | 8,050,000 | 8,050,000 | ||
Additional stock issued during period shares exercised by underwriters with option to purchase | 1,050,000 | |||
Public offering price per share | $ 16 | |||
Net proceeds from initial public offering | $ 120.7 | |||
Cash paid for underwriting discounts and commissions and other offering expenses | $ 8.1 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Jan. 01, 2022 | Sep. 30, 2022 | |
Accounting Policies [Abstract] | ||
Accounting standards update [Extensible Enumeration] | us-gaap:AccountingStandardsUpdate201602Member | |
Change in accounting principle, accounting standards update, adopted date | Jan. 01, 2022 | |
Change in accounting principle, accounting standards update, adopted [true false] | true | |
Operating lease right-of-use assets | $ 3,300 | $ 28,969 |
Operating lease liabilities | 5,400 | $ 32,086 |
Reclassification of deferred rent and tenant improvement allowances | $ 2,100 |
Restricted Cash (Additional Inf
Restricted Cash (Additional Information) (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] | ||
Restricted cash reserve | $ 2.5 | $ 0.2 |
Restricted Cash - Schedule of C
Restricted Cash - Schedule of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 56,763 | $ 30,833 | $ 70,027 | |
Restricted cash | 2,501 | 199 | ||
Cash, cash equivalents and restricted cash | $ 59,264 | $ 31,032 | $ 70,226 | $ 46,795 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Fair Value of Company's Financial Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | ||
Assets | ||||
Marketable securities | $ 224,018 | $ 73,784 | [1] | |
Level 1 | Recurring | ||||
Assets | ||||
Money market fund (cash equivalent) | 46,204 | 26,472 | ||
Money market fund (long-term restricted cash) | 2,501 | 199 | ||
Total assets measured at fair value | 48,705 | 26,671 | [2] | |
Level 2 | Recurring | ||||
Assets | ||||
Total assets measured at fair value | 224,018 | 73,784 | [2] | |
Level 2 | Recurring | Commercial Paper | ||||
Assets | ||||
Marketable securities | 133,194 | 43,969 | [2] | |
Level 2 | Recurring | Corporate Debt | ||||
Assets | ||||
Marketable securities | 17,953 | |||
Level 2 | Recurring | U.S. Government Agency | ||||
Assets | ||||
Marketable securities | $ 72,871 | 17,072 | [2] | |
Level 2 | Recurring | Asset-Backed Securities | ||||
Assets | ||||
Marketable securities | [2] | 5,053 | ||
Total assets measured at fair value | [2] | $ 7,690 | ||
[1] These items have been reclassified to conform to current period presentation. These items have been reclassified to conform to current period presentation. |
Marketable Securities - Schedul
Marketable Securities - Schedule of Available-for-sale Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | ||
Marketable Securities [Line Items] | ||||
Amortized costs | $ 224,417 | $ 73,804 | [1] | |
Gross Unrealized Loss | (399) | (20) | [1] | |
Fair Value | 224,018 | 73,784 | [1] | |
Commercial Paper | ||||
Marketable Securities [Line Items] | ||||
Amortized costs | 133,194 | 43,969 | [1] | |
Fair Value | 133,194 | 43,969 | [1] | |
Corporate Debt | ||||
Marketable Securities [Line Items] | ||||
Amortized costs | 18,052 | 17,084 | [1] | |
Gross Unrealized Loss | (99) | (12) | [1] | |
Fair Value | 17,953 | 17,072 | [1] | |
U.S. Government Agency | ||||
Marketable Securities [Line Items] | ||||
Amortized costs | 73,171 | 5,056 | [1] | |
Gross Unrealized Loss | (300) | (3) | [1] | |
Fair Value | $ 72,871 | 5,053 | [1] | |
Asset-Backed Securities | ||||
Marketable Securities [Line Items] | ||||
Amortized costs | [1] | 7,695 | ||
Gross Unrealized Loss | [1] | (5) | ||
Fair Value | [1] | $ 7,690 | ||
[1] These items have been reclassified to conform to current period presentation. |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) Condition | |
Marketable Securities [Abstract] | |
Available-for-sale debt marketable securities contractual maturities | less than one year |
Number of securities in an unrealized loss position | Condition | 17 |
Aggregate fair value an unrealized loss position | $ 88.8 |
Allowance for credit losses | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development costs | $ 6,909 | $ 6,143 |
Other prepaid expense and current assets | 2,615 | 2,049 |
Total prepaid expenses and other current assets | $ 9,524 | $ 8,192 |
Commitments - Additional Inform
Commitments - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Related Party Transaction [Line Items] | ||
Finance lease liabilities, current | $ 27,729 | $ 27,729 |
Lonza | ||
Related Party Transaction [Line Items] | ||
Prior notification period to terminate arrangement | 12 months | |
Minimum non-cancellable costs | 47,700 | $ 47,700 |
Finance lease liabilities, current | 27,700 | 27,700 |
Payments for non-cancellable costs | $ 2,800 | $ 13,700 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Research and development accrued expenses | $ 6,521 | $ 6,626 |
Accrued offering costs | 1,301 | |
Accrued bonus | 2,856 | 3,429 |
Other liabilities | 1,835 | 1,824 |
Total accrued liabilities | $ 11,212 | $ 13,180 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jul. 31, 2022 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | May 31, 2022 USD ($) ft² | |
Lessee, Lease, Description [Line Items] | ||||||
Undiscounted minimum lease payments | $ 93,931 | $ 93,931 | ||||
Research and development expense on finance lease liabilities | 83,473 | $ 12,325 | 123,612 | $ 33,489 | ||
Interest expense on finance lease liabilities | 595 | |||||
Finance lease liabilities, current | 27,729 | 27,729 | ||||
Finance lease liabilities, non-current | 27,054 | 27,054 | ||||
Lonza | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Research and development expense on finance lease liabilities | 63,100 | |||||
Finance lease liabilities, current | 27,700 | 27,700 | ||||
Finance lease liabilities, non-current | 27,100 | $ 27,100 | ||||
Lonza | Other Income, Net | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Interest expense on finance lease liabilities | $ 600 | |||||
Redwood, California | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Square feet of space | ft² | 51,822 | |||||
Lease term | 11 years 8 months 12 days | |||||
Undiscounted minimum lease payments | $ 56,500 | |||||
Option to extend lease | The Redwood City lease provides for an optional five-year extension. | |||||
Option to extend lease term | 5 years | |||||
Lease includes allowance for tenant improvements | $ 9,800 | |||||
Operating lease, discount rate | 8.50% | 8.50% | ||||
Rockville, Maryland | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Square feet of space | ft² | 57,902 | |||||
Lease term | 12 years 10 months 24 days | |||||
Undiscounted minimum lease payments | $ 31,000 | |||||
Option to extend lease | The Rockville lease provides for optional two five-year extensions. | |||||
Option to extend lease term | 5 years | |||||
Lease includes allowance for tenant improvements | $ 12,100 | |||||
Operating lease, discount rate | 12% | |||||
Office and Laboratory Space | Rockville, Maryland | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Lease expiration year | 2030 |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Right-Of-Use Assets With No Alternative Future Use | $ 63,147 | $ 63,147 |
Amortization of right-of-use assets | 25 | 77 |
Interest on lease liabilities | 598 | 604 |
Operating lease costs | 1,472 | 2,299 |
Short-term lease costs | 7 | 750 |
Variable lease costs | 675 | 953 |
Total lease costs | $ 65,924 | $ 67,830 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 |
Leases [Abstract] | ||
Operating Leases, Through December 31, 2022 | $ 685 | |
Operating Leases, 2023 | 3,083 | |
Operating Leases, 2024 | 6,045 | |
Operating Leases, 2025 | 8,161 | |
Operating Leases, 2026 | 8,412 | |
Operating Leases, 2027 | 8,672 | |
Operating Leases, Thereafter | 58,873 | |
Total operating lease payments | 93,931 | |
Less: Tenant improvement incentive | (21,936) | |
Less: Operating Leases, imputed interest | (39,909) | |
Present value of total operating lease liabilities | 32,086 | $ 5,400 |
Finance Leases, Through December 31, 2022 | 8,314 | |
Finance Leases, 2023 | 27,699 | |
Finance Leases, 2024 | 23,866 | |
Total finance lease payments | 59,879 | |
Less: Finance Leases, imputed interest | (5,096) | |
Present value of total finance lease liabilities | $ 54,783 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Finance Leases (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Lessee Disclosure [Abstract] | |
Operating cash flows from operating leases | $ 1,191 |
Financing cash flows from finance leases | 9,295 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 29,562 |
Leases - Summary of Weighted-Av
Leases - Summary of Weighted-Average Remaining Lease Terms And Discount Rates (Details) | Sep. 30, 2022 |
Leases [Abstract] | |
Weighted-average remaining lease term - finance leases | 2 years 3 months 18 days |
Weighted-average remaining lease term - finance leases | 11 years 6 months |
Weighted-average discount rate - finance leases | 9.50% |
Weighted-average discount rate - operating leases | 9.60% |
Redeemable Convertible Prefer_3
Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - Additional Information (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) shares | |
Class of Stock [Line Items] | |
Common stock voting rights | one vote |
Common Stock | |
Class of Stock [Line Items] | |
Dividends declared or paid | $ | $ 0 |
IPO | Redeemable Convertible Preferred Stock | |
Class of Stock [Line Items] | |
Shares issued upon conversion of preferred stock | shares | 24,785,564 |
Redeemable Convertible Prefer_4
Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - Schedule of Reconciliation of Shares Issued and Outstanding (Details) - Common Stock - shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Total shares of common stock legally issued and outstanding | 43,846,393 | 544,967 |
Less: unvested early exercised shares of common stock | (757) | |
Total shares issued and outstanding | 43,846,393 | 544,210 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Condition shares | Sep. 30, 2021 USD ($) | Dec. 31, 2021 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | $ 5,329 | $ 1,860 | $ 15,754 | $ 3,852 | ||
2022 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units, granted | shares | 4,296,875 | |||||
2022 Equity Incentive Plan | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
2022 Equity Incentive Plan | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
2017 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units, outstanding | shares | 6,269,300 | 6,269,300 | ||||
Board of Directors | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Anniversary period | 10 years | |||||
Board of Directors | 2022 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units, granted | shares | 4,296,875 | |||||
Percentage increase in common stock reserve for future issuance | 5% | |||||
Research and Development Expense | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | $ 1,600 | 500 | $ 5,300 | 1,000 | ||
General and Administrative Expense | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | 3,700 | 1,400 | 10,500 | 2,900 | ||
Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | 3,569 | $ 1,860 | $ 10,997 | $ 3,852 | ||
Stock Options | 2017 and 2022 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expiration period | 10 years | |||||
Stock Options | 2017 and 2022 Equity Incentive Plan | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
Stock Options | 2017 and 2022 Equity Incentive Plan | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Restricted Stock Units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | $ 1,162 | $ 2,807 | ||||
Restricted Stock Units | 2022 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units, granted | shares | 911,452 | |||||
Restricted stock units, outstanding | shares | 881,624 | 881,624 | ||||
Restricted Stock Units | Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | $ 598 | $ 1,950 | ||||
Restricted stock units, granted | shares | 952,804 | |||||
Vesting description | Each RSU granted in the RSU Award entitles the recipient to one share of common stock upon vesting subject to the service, performance, and market conditions. | |||||
Restricted stock units, outstanding | shares | 952,804 | 952,804 | 952,804 | |||
Restricted stock units, vested | shares | 0 | 0 | ||||
Number of performance condition scenarios | Condition | 3 | |||||
Restricted Stock Units | IPO | Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting description | Upon an IPO, (i) one-sixth of the RSU Award will vest if a minimum Enterprise Value of $2.5 billion is achieved, (ii) all the RSU Award will vest if a $5.0 billion Enterprise Value is achieved, and (iii) a portion of the RSU Award will vest based on a straight-line interpolation if an Enterprise Value of between $2.5 billion and $5.0 billion is achieved. | |||||
Anticipated service period | 10 years | |||||
Fair value of the RSU award | $ | $ 10,300 | |||||
Restricted Stock Units | Change in Control | Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting description | Upon a Change in Control, (i) one-sixth of the RSU Award will vest if a minimum Change in Control Market Capitalization of $2.5 billion is achieved, (ii) all of the RSU Award will vest if a $5.0 billion Change in Control Market Capitalization is achieved, and (iii) a portion of the RSU Award will vest based on a straight-line interpolation if a Change in Control Market Capitalization of between $2.5 billion and $5.0 billion is achieved based on a straight-line interpolation. | |||||
Restricted Stock Units | General and Administrative Expense | Executive Officer | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ | $ 600 | $ 2,000 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 5,329 | $ 1,860 | $ 15,754 | $ 3,852 |
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | 3,569 | $ 1,860 | 10,997 | $ 3,852 |
Restricted Stock Units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | 1,162 | 2,807 | ||
Restricted Stock Units | Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 598 | $ 1,950 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Stock Option Activity (Details) - Stock Options - 2017 and 2022 Equity Incentive Plan $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Outstanding, Beginning balance | shares | 5,598,830 | ||
Number of Shares, Granted | shares | 3,448,158 | ||
Number of Shares, Forfeited | shares | (217,803) | ||
Number of Shares, Exercised | shares | (388,802) | ||
Number of Shares, Outstanding, Ending balance | shares | 8,440,383 | 5,598,830 | |
Number of Shares, Exercisable | shares | 2,876,912 | ||
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | $ 5.36 | ||
Weighted Average Exercise Price, Granted | $ / shares | 14.59 | ||
Weighted Average Exercise Price, Forfeited | $ / shares | 10.02 | ||
Weighted Average Exercise Price, Exercised | $ / shares | 2 | ||
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | 9.34 | $ 5.36 | |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 6.29 | ||
Weighted Average Remaining Contractual Life (Years), Outstanding | 8 years 10 months 24 days | ||
Aggregate Intrinsic Value, Outstanding | $ | $ 7,349 | [1] | |
[1] The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money as of September 30, 2022 . |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Restricted Stock Units Activity (Details) - 2022 Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 4,296,875 |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 911,452 |
Number of Shares, Forfeited | (29,828) |
Number of Shares, Outstanding, Ending balance | 881,624 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | $ 17.06 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 17.84 |
Weighted Average Grant Date Fair Value, Outstanding, Ending Balance | $ / shares | $ 17.03 |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Summary of Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 10,274,811 | 30,969,986 | 10,274,811 | 30,969,986 |
Redeemable Convertible Preferred Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 24,785,564 | 24,785,564 | ||
Options to Purchase Common Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 8,440,383 | 5,231,618 | 8,440,383 | 5,231,618 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 881,624 | 881,624 | ||
Restricted stock units - executive officer | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 952,804 | 952,804 | 952,804 | 952,804 |