Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 02, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | TENAYA THERAPEUTICS, INC. | |
Entity Central Index Key | 0001858848 | |
Entity File Number | 001-40656 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-3789973 | |
Entity Address, Address Line One | 171 Oyster Point Boulevard | |
Entity Address, Address Line Two | 5th Floor | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 825-6990 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | TNYA | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 41,374,508 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 34,494 | $ 38,129 |
Investments in marketable securities | 114,956 | 213,171 |
Prepaid expenses and other current assets | 7,617 | 4,058 |
Total current assets | 157,067 | 255,358 |
Property and equipment, net | 52,194 | 43,020 |
Operating lease right-of-use assets | 12,399 | 11,685 |
Other noncurrent assets | 4,650 | 4,126 |
Total assets | 226,310 | 314,189 |
Current liabilities: | ||
Accounts payable | 5,312 | 10,721 |
Accrued and other current liabilities | 8,388 | 9,059 |
Operating lease liabilities, current | 4,016 | 1,994 |
Total current liabilities | 17,716 | 21,774 |
Operating lease liabilities, noncurrent | 12,043 | 13,707 |
Other noncurrent liabilities | 223 | 182 |
Total liabilities | 29,982 | 35,663 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Common stock | 4 | 4 |
Additional paid-in capital | 442,773 | 434,196 |
Accumulated other comprehensive loss | (767) | (141) |
Accumulated deficit | (245,682) | (155,533) |
Total stockholders' equity | 196,328 | 278,526 |
Total liabilities and stockholders' equity | $ 226,310 | $ 314,189 |
Condensed Statements of Operati
Condensed 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 | |
Operating expenses: | ||||
Research and development | $ 23,758 | $ 12,944 | $ 68,789 | $ 33,440 |
General and administrative | 7,540 | 5,356 | 22,282 | 13,202 |
Total operating expenses | 31,298 | 18,300 | 91,071 | 46,642 |
Loss from operations | (31,298) | (18,300) | (91,071) | (46,642) |
Other income (expense), net: | ||||
Interest income | 596 | 23 | 917 | 41 |
Other income (expense), net | 6 | 15 | 5 | 31 |
Total other income (expense), net | 602 | 38 | 922 | 72 |
Net loss before income tax expense | (30,696) | (18,262) | (90,149) | (46,570) |
Net loss | (30,696) | (18,262) | (90,149) | (46,570) |
Other comprehensive loss: | ||||
Net unrealized loss on marketable securities | (28) | (23) | (626) | (23) |
Comprehensive loss | $ (30,724) | $ (18,285) | $ (90,775) | $ (46,593) |
Net loss per share, basic | $ (0.74) | $ (0.68) | $ (2.18) | $ (4.75) |
Net loss per share, diluted | $ (0.74) | $ (0.68) | $ (2.18) | $ (4.75) |
Weighted-average shares used in computing net loss per share, basic | 41,358,296 | 26,895,716 | 41,309,812 | 9,808,162 |
Weighted-average shares used in computing net loss per share, diluted | 41,358,296 | 26,895,716 | 41,309,812 | 9,808,162 |
Condensed Statements of Convert
Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Initial Public Offering | Convertible Preferred Stock | Convertible Preferred Stock Initial Public Offering | Series C Convertible Preferred Stock | Common Stock | Common Stock Initial Public Offering | Additional Paid-In Capital | Additional Paid-In Capital Initial Public Offering | Notes Receivable from Stockholders | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Temporary equity balance, shares at Dec. 31, 2020 | 24,493,528 | |||||||||||
Temporary equity, balance at Dec. 31, 2020 | $ 220,754 | |||||||||||
Balance at Dec. 31, 2020 | $ (81,315) | $ 1,584 | $ (87) | $ (82,812) | ||||||||
Balance, shares at Dec. 31, 2020 | 1,210,306 | |||||||||||
Issuance of convertible preferred stock, net of issuance costs | $ 19,981 | |||||||||||
Issuance of convertible preferred stock, net of issuance costs, shares | 1,608,750 | |||||||||||
Issuance of common stock upon exercise of stock options | 29 | 29 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 12,508 | |||||||||||
Repurchase of common stock related to early exercise of options, shares | (365) | |||||||||||
Vesting of early exercised stock options | 9 | 9 | ||||||||||
Stock-based compensation | 432 | 432 | ||||||||||
Net loss | (13,098) | (13,098) | ||||||||||
Balance at Mar. 31, 2021 | (93,943) | 2,054 | (87) | (95,910) | ||||||||
Temporary equity balance, shares at Mar. 31, 2021 | 26,102,278 | |||||||||||
Temporary equity, balance at Mar. 31, 2021 | $ 240,735 | |||||||||||
Balance, shares at Mar. 31, 2021 | 1,222,449 | |||||||||||
Temporary equity balance, shares at Dec. 31, 2020 | 24,493,528 | |||||||||||
Temporary equity, balance at Dec. 31, 2020 | $ 220,754 | |||||||||||
Balance at Dec. 31, 2020 | (81,315) | 1,584 | (87) | (82,812) | ||||||||
Balance, shares at Dec. 31, 2020 | 1,210,306 | |||||||||||
Net loss | (46,570) | |||||||||||
Balance at Sep. 30, 2021 | 303,699 | $ 4 | 433,112 | (12) | $ (23) | (129,382) | ||||||
Balance, shares at Sep. 30, 2021 | 41,280,402 | |||||||||||
Temporary equity balance, shares at Mar. 31, 2021 | 26,102,278 | |||||||||||
Temporary equity, balance at Mar. 31, 2021 | $ 240,735 | |||||||||||
Balance at Mar. 31, 2021 | (93,943) | 2,054 | (87) | (95,910) | ||||||||
Balance, shares at Mar. 31, 2021 | 1,222,449 | |||||||||||
Issuance of common stock upon exercise of stock options | 31 | 31 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 12,173 | |||||||||||
Repurchase of common stock related to early exercise of options, shares | (11,980) | |||||||||||
Vesting of early exercised stock options | 9 | 9 | ||||||||||
Notes receivable from stockholders | 75 | 75 | ||||||||||
Stock-based compensation | 502 | 502 | ||||||||||
Net loss | (15,210) | (15,210) | ||||||||||
Balance at Jun. 30, 2021 | (108,536) | 2,596 | (12) | (111,120) | ||||||||
Temporary equity balance, shares at Jun. 30, 2021 | 26,102,278 | |||||||||||
Temporary equity, balance at Jun. 30, 2021 | $ 240,735 | |||||||||||
Balance, shares at Jun. 30, 2021 | 1,222,642 | |||||||||||
Conversion of convertible preferred stock to common stock upon completion of initial public offering | $ 240,735 | $ (240,735) | $ 3 | $ 240,732 | ||||||||
Conversion of convertible preferred stock to common stock upon completion of initial public offering, shares | (26,102,278) | 26,102,278 | ||||||||||
Issuance of common stock upon initial public offering, net of issuance costs | $ 188,541 | $ 1 | $ 188,540 | |||||||||
Issuance of common stock upon initial public offering, net of issuance costs, shares | 13,800,000 | |||||||||||
Issuance of common stock upon exercise of stock options | 268 | 268 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 160,096 | |||||||||||
Repurchase of common stock related to early exercise of options, shares | 4,614 | |||||||||||
Vesting of early exercised stock options | 8 | 8 | ||||||||||
Stock-based compensation | 968 | 968 | ||||||||||
Other comprehensive loss | (23) | (23) | ||||||||||
Net loss | (18,262) | (18,262) | ||||||||||
Balance at Sep. 30, 2021 | 303,699 | $ 4 | 433,112 | $ (12) | (23) | (129,382) | ||||||
Balance, shares at Sep. 30, 2021 | 41,280,402 | |||||||||||
Balance at Dec. 31, 2021 | 278,526 | $ 4 | 434,196 | (141) | (155,533) | |||||||
Balance, shares at Dec. 31, 2021 | 41,291,374 | |||||||||||
Issuance of common stock upon exercise of stock options | 17 | 17 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 7,652 | |||||||||||
Vesting of early exercised stock options | 6 | 6 | ||||||||||
Stock-based compensation | 2,094 | 2,094 | ||||||||||
Other comprehensive loss | (490) | (490) | ||||||||||
Net loss | (31,056) | (31,056) | ||||||||||
Balance at Mar. 31, 2022 | 249,097 | $ 4 | 436,313 | (631) | (186,589) | |||||||
Balance, shares at Mar. 31, 2022 | 41,299,026 | |||||||||||
Balance at Dec. 31, 2021 | 278,526 | $ 4 | 434,196 | (141) | (155,533) | |||||||
Balance, shares at Dec. 31, 2021 | 41,291,374 | |||||||||||
Net loss | (90,149) | |||||||||||
Balance at Sep. 30, 2022 | 196,328 | $ 4 | 442,773 | (767) | (245,682) | |||||||
Balance, shares at Sep. 30, 2022 | 41,374,689 | |||||||||||
Balance at Mar. 31, 2022 | 249,097 | $ 4 | 436,313 | (631) | (186,589) | |||||||
Balance, shares at Mar. 31, 2022 | 41,299,026 | |||||||||||
Issuance of common stock upon exercise of stock options | 28 | 28 | ||||||||||
Issuance of common stock upon exercise of stock options, shares | 13,186 | |||||||||||
Issuance of common stock pursuant to employee stock purchase plan | 230 | 230 | ||||||||||
Issuance of common stock pursuant to employee stock purchase plan, shares | 51,608 | |||||||||||
Vesting of early exercised stock options | 5 | 5 | ||||||||||
Stock-based compensation | 3,012 | 3,012 | ||||||||||
Other comprehensive loss | (108) | (108) | ||||||||||
Net loss | (28,397) | (28,397) | ||||||||||
Balance at Jun. 30, 2022 | 223,867 | $ 4 | 439,588 | (739) | (214,986) | |||||||
Balance, shares at Jun. 30, 2022 | 41,363,820 | |||||||||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units | 6 | 6 | ||||||||||
Issuance of common stock upon exercise of stock options and vesting of restricted stock units, shares | 10,869 | |||||||||||
Vesting of early exercised stock options | 5 | 5 | ||||||||||
Stock-based compensation | 3,174 | 3,174 | ||||||||||
Other comprehensive loss | (28) | (28) | ||||||||||
Net loss | (30,696) | (30,696) | ||||||||||
Balance at Sep. 30, 2022 | $ 196,328 | $ 4 | $ 442,773 | $ (767) | $ (245,682) | |||||||
Balance, shares at Sep. 30, 2022 | 41,374,689 |
Condensed Statements of Conve_2
Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) (Unaudited) $ in Thousands | 3 Months Ended |
Sep. 30, 2021 USD ($) | |
Initial Public Offering | |
Stock issuance costs | $ 18,459 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Cash flows from operating activities: | ||
Net loss | $ (90,149) | $ (46,570) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4,350 | 2,170 |
Amortization of premium on marketable securities | 76 | 6 |
Stock-based compensation | 8,280 | 1,902 |
Loss on write-offs and disposal of property and equipment | 27 | 4 |
Non-cash operating lease expense | 1,510 | 743 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (3,278) | (3,029) |
Other noncurrent assets | (672) | (3,063) |
Accounts payable | (1,803) | 2,518 |
Accrued and other current liabilities | 2,051 | 1,729 |
Operating lease liabilities | (2,147) | (952) |
Other noncurrent liabilities | 13 | 77 |
Net cash used in operating activities | (81,742) | (44,465) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (19,835) | (12,567) |
Purchases of marketable securities | (108,737) | (163,417) |
Proceeds from maturities of marketable securities | 206,250 | |
Net cash provided by (used in) investing activities | 77,678 | (175,984) |
Cash flows from financing activities: | ||
Proceeds from initial public offering, net of issuance costs | 188,605 | |
Proceeds from exercise of stock options and employee stock purchase plan | 281 | 343 |
Repurchase of common stock | (13) | |
Proceeds from repayments on notes receivable from stockholders | 75 | |
Net cash provided by financing activities | 281 | 208,991 |
Net change in cash, cash equivalents and restricted cash | (3,783) | (11,458) |
Cash and cash equivalents and restricted cash at beginning of period | 38,676 | 129,082 |
Cash and cash equivalents and restricted cash at end of period | 34,893 | 117,624 |
Components of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 34,494 | 117,077 |
Restricted cash included in other noncurrent assets | 399 | 547 |
Cash, cash equivalents and restricted cash | 34,893 | 117,624 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Conversion of convertible preferred stock to common stock upon completion of initial public offering | 220,754 | |
Offering costs related to initial public offering included in accounts payable and accrued and other current liabilities | 64 | |
Property and equipment included in accounts payable and accrued and other current liabilities | $ 263 | 3,677 |
Series C Convertible Preferred Stock | ||
Cash flows from financing activities: | ||
Proceeds from issuance of convertible preferred stock, net of issuance costs | $ 19,981 |
Organization and Description of
Organization and Description of the Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of the Business | 1. Organization and Description of the Business Description of the Business Tenaya Therapeutics, Inc. (Company) was incorporated in the state of Delaware in August 2016 and is headquartered in South San Francisco, California. The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease. The Company is advancing product candidates from three distinct but interrelated product platforms: gene therapy, cellular regeneration and precision medicine. Liquidity The Company has incurred net losses since inception and expects such losses to continue in the future as it conducts research and development activities. As of September 30, 2022, the Company had an accumulated deficit of $ 245.7 million. The Company incurred a net loss of $ 90.1 million and $ 46.6 million during the nine months ended September 30, 2022 and 2021, respectively. The Company had $ 149.5 million of cash, cash equivalents and investments in marketable securities as of September 30, 2022. Management recognizes the need to raise additional capital to fully implement its business plan. The Company may seek to raise capital through equity financings, debt financings, license agreements, collaborative agreements or other sources of financing. Management believes that its existing cash, cash equivalents and investments in marketable securities as of September 30, 2022 will be sufficient to fund the Company’s operations for at least the next twelve months following the date these condensed financial statements are filed with the Securities and Exchange Commission (SEC). In August 2022, the Company entered into a sales agreement with a sales agent to establish an at-the-market (ATM) offering program under the Securities Act. Pursuant to the sales agreement, the Company is permitted to offer and sell, from time to time, shares of its common stock having a maximum aggregate offering price of up to $ 75.0 million. As of September 30, 2022, no shares have been sold pursuant to the ATM program. |
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 Basis of Presentation The accompanying condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. The interim condensed balance sheet as of September 30, 2022, the interim condensed statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) and cash flows for the nine months ended September 30, 2022 and 2021 are unaudited. These unaudited interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2021 included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the related notes thereto for the year ended December 31, 2021, included in Company's Annual Report on Form 10-K, filed with the SEC on March 23, 2022. Reclassification Certain prior year balances have been reclassified in order to conform to current year presentation for the condensed balance sheets. These reclassifications have no effect on the previously reported financial position. Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accrued liabilities, income tax valuation allowance and stock-based compensation. Management bases its estimates on historical experience, the current economic environment, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Significant Accounting Policies There have been no material revisions in the Company's significant accounting policies described in Note 2 to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Recently Adopted Accounting Standards In December 2019, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which is intended to simplify the accounting for income taxes. This standard eliminates certain exceptions to the approach for intra period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. As an emerging growth company, ASU 2019-12 became effective for the Company beginning January 1, 2022 . The adoption of this standard did not have any impact on its financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance (ASU 2021-10), which requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model. The required annual disclosures include the nature of the transaction, the entity’s related accounting policy, the financial statement line items affected and the amounts reflected in the current period financial statements, and any significant terms and conditions. ASU 2021-10 became effective for the Company beginning January 1, 2022 . The adoption of this standard did no t have a material impact on its financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which replaces the existing incurred loss impairment model with an expected credit loss model . This standard will require companies to recognize an allowance for credit losses on available-for-sale debt securities rather than the current approach of recording a reduction to the carrying value of the asset. As an emerging growth company, ASU 2016-13 will become effective for the Company beginning January 1, 2023. The Company is evaluating the impact of this standard on its financial statements. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 - Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2022 Valuation Amortized Unrealized Unrealized Fair Value (In thousands) Assets: Cash equivalents: Money market funds Level 1 $ 23,376 $ — $ — $ 23,376 Commercial paper Level 2 9,966 — — 9,966 Marketable securities: U.S. treasuries Level 1 50,048 1 ( 445 ) 49,604 Commercial paper Level 2 44,510 — ( 164 ) 44,346 Corporate bonds Level 2 2,675 — ( 25 ) 2,650 Government agencies bonds Level 2 18,490 — ( 134 ) 18,356 Total financial assets $ 149,065 $ 1 $ ( 768 ) $ 148,298 December 31, 2021 Valuation Amortized Unrealized Unrealized Fair Value (In thousands) Assets: Cash equivalents: Money market funds Level 1 $ 37,129 $ — $ — $ 37,129 Marketable securities: U.S. treasuries Level 1 78,097 — ( 85 ) 78,012 Commercial paper Level 2 121,634 — ( 50 ) 121,584 Corporate bonds Level 2 8,979 — ( 3 ) 8,976 Government agencies bonds Level 2 4,602 — ( 3 ) 4,599 Total financial assets $ 250,441 $ — $ ( 141 ) $ 250,300 Money market funds are classified as Level 1 because they are valued using quoted market prices in active markets for identical assets. Financial instruments classified within Level 2 of the fair value hierarchy are valued based on observable inputs or can be derived from non-binding quotes from the Company’s investment managers, which are based on proprietary valuation models of independent pricing services. These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers. To validate the fair value determination provided by its investment managers, the Company reviews the pricing movement in the context of overall market trends and trading information from its investment managers. In addition, the Company considers the inputs and methods used in determining the fair value in order to determine the classification of securities in the fair value hierarchy. The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has no t recorded any impairment charges on marketable securities related to other-than-temporary declines in market value. As of September 30, 2022, all available-for-sale marketable securities had remaining maturities of less than one year. The carrying amount of the Company's remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following: September 30, December 31, (In thousands) Leasehold improvements $ 23,605 $ 7,241 Laboratory equipment 19,957 11,891 Manufacturing equipment 17,468 — Construction in progress 2,933 32,561 Computer equipment and software 904 218 Furniture and fixtures 902 534 Total property and equipment $ 65,769 $ 52,445 Less: accumulated depreciation and amortization ( 13,575 ) ( 9,425 ) Total property and equipment, net $ 52,194 $ 43,020 Depreciation and amortization expense for the three months ended September 30, 2022 and 2021 was $ 2.1 million and $ 0.7 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2022 and 2021 was $ 4.3 million and $ 2.2 million, respectively. Leasehold improvements as of September 30, 2022 include certain enhancements made to the Company’s leased manufacturing and office space located in Union City, California (Union City Facility). During the second quarter of 2022, the Company completed the build out and operational launch of the Union City Facility. As a result, the Company reclassified the related capitalized machinery and equipment from construction in progress to manufacturing and laboratory equipment in that period. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following: September 30, December 31, (In thousands) Accrued compensation and related expenses $ 4,607 $ 3,667 Accrued research and development expenses 2,567 2,023 Accrued professional services 574 344 Accrued property and equipment 155 2,863 Other current liabilities 485 162 Total accrued and other current liabilities $ 8,388 $ 9,059 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets include a receivable of approximately $ 2 million relating to the employee retention credit (ERC) under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The ERC is a refundable tax credit, which was provided to encourage businesses to keep employees on the payroll during the COVID-19 pandemic. During the second quarter of 2022, the Company filed a claim for the ERC and recorded the receivable with the offsetting benefit included in operating expenses. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2022 | |
License Agreements [Abstract] | |
License Agreements | 5. License Agreements Gladstone License Agreement In October 2016, the Company entered into a license agreement with the J. David Gladstone Institute (Gladstone), pursuant to which Gladstone granted the Company a worldwide, royalty-bearing exclusive patent license and a non-exclusive technology license to develop and commercialize certain products for certain diseases (Gladstone License Agreement). Pursuant to the Gladstone License Agreement, the Company is obligated, among other things, to pay Gladstone (i) annual license maintenance fees ranging from $ 25,000 up to $ 100,000 per year, which will be creditable against royalties paid in the following twelve month period, (ii) milestone payments up to $ 4.1 million for royalty-bearing products directed to a particular target, which are contingent upon achieving specific clinical and commercialization milestone events, and (iii) tiered low-single digit royalties on future net sales of each royalty-bearing product. Under the agreement, the Company is subject to diligence requirements to develop and commercialize at least one royalty-bearing product. The Company may pay $ 50,000 to $ 100,000 to extend the deadline for its diligence milestone obligations for up to four additional one-year terms. As of September 30, 2022, the Company has no t recognized any milestone and royalty payments under the Gladstone License Agreement. During the nine months ended September 30, 2022 and 2021, there were no material amounts recorded related to annual license fees payable pursuant to the Gladstone License Agreement. University of Texas Southwestern License Agreement In January 2020, the Company entered into a license agreement with the University of Texas Southwestern (UTSW License), pursuant to which UTSW granted the Company a royalty-bearing exclusive and sublicensable patent license and a non-exclusive, non-sublicensable license for mutually agreed upon development activities. Under the UTSW License, the Company is obligated to pay UTSW (i) a non-refundable upfront license fee of $ 0.1 million, (ii) milestone payments up to a total of $ 14.8 million in aggregate, which are contingent upon achieving specific development and commercialization milestone events, and (iii) royalties on future net sales of each royalty-bearing product ranging in the low-single digits. As of September 30, 2022, the Company has no t recognized any milestone and royalty payments under the UTSW License. Other License Agreements In addition to the agreements described above, the Company also previously entered into other license agreements with various institutions and business entities, none of which are material individually or in the aggregate. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Facility Leases In December 2016, the Company entered into a lease agreement for office and laboratory space in South San Francisco, California. The lease expires in May 2025 and the Company may renew the lease term for two additional five-year periods. In February 2021, the Company entered into a lease agreement for the Union City Facility. The lease commenced in May 2021 and has a ten-year term with one five-year renewal option. Upon the execution of the lease agreement, the Company provided the landlord with a refundable security deposit of $ 3.3 million, which was included in other noncurrent assets on the balance sheets. In November 2021, the Company entered into a short-term sublease agreement for additional office and laboratory space in South San Francisco, California with a lease term that was initially set to expire on June 30, 2022 . In May 2022, the Company entered into an amendment to extend the term for the existing sublease premise through December 31, 2022 . The amendment also included an additional term whereby the Company subleases additional office and laboratory space at the same sublease premise through November 30, 2023. Information related to operating lease activity during the three and nine months ended September 30, 2022 was as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Operating lease cost $ 1,090 $ 702 $ 2,624 $ 1,662 Variable lease cost 319 $ 306 910 $ 796 Short-term lease cost 244 585 709 1,755 Total lease cost $ 1,653 $ 1,593 $ 4,243 $ 4,213 Operating lease-right-of-use assets obtained in exchange for lease obligations $ 2,224 $ 8,558 Cash paid for leases included in operating cash outflows $ 4,597 $ 4,423 Cash paid for amounts included in the measurement of lease liabilities $ 2,978 $ 1,872 As of September 30, 2022, the Company's operating leases had a weighted average remaining lease term of 5.7 years and a weighted average discount rate of 9.2 %. Future minimum lease payments under the Company’s operating leases as of September 30, 2022 were as follows: Amount (In thousands) 2022 (remaining 3 months) $ 1,315 2023 5,223 2024 3,910 2025 2,445 2026 1,386 Thereafter 6,905 Total undiscounted future minimum lease payments $ 21,184 Imputed interest ( 5,125 ) Total operating lease liabilities $ 16,059 Asset Retirement Obligation Under the lease agreement for the manufacturing and office facility in Union City, the Company is contractually obligated to remove constructed leasehold improvements related to capitalized machinery and equipment (see Note 4) and to restore the leased space to its original condition upon termination of the lease agreement. As of September 30, 2022, the balance of the asset retirement obligation liability was not material. Purchase Commitments The Company enters into contractual agreements with various suppliers in the normal course of its business, including vendors that provide machinery and equipment. All contracts are terminable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would only be obligated for the products or services that the Company had received through the time of termination. Litigation and Indemnification From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the consolidated financial statements and (ii) the range of loss can be reasonably estimated. The Company was not involved in any material litigation as of September 30, 2022. In the normal course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amounts of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. As of September 30, 2022 and December 31, 2021, the Company did not have any material indemnification claims that were probable or reasonably possible and, consequently, has not recorded any related liabilities. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation 2021 Equity Incentive Plan In July 2021, the Company adopted the 2021 Equity Incentive Plan (2021 Plan), which became effective in connection with the initial public offering (IPO). Under the 2021 Plan, 4,000,000 shares of the Company's common stock were initially reserved for issuance of equity awards to employees, directors, and consultants, under terms and provisions established by the Board of Directors. The number of shares of common stock available for issuance under the 2021 Plan automatically increases on the first day of January for a period of ten years , commencing on January 1, 2022, in an amount equal to the lesser of: 4,000,000 shares; 4 % of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the Company’s Board of Directors may determine. In addition, the Company’s 2016 Equity Incentive Plan (2016 Plan) was terminated in connection with the IPO. Shares subject to awards granted under the 2016 Plan that are repurchased by or forfeited to the Company will be reserved for issuance under the 2021 Plan. Total shares reserved and available for grant under the 2021 Plan as of September 30, 2022 are 2,720,107 . Stock Option Activity The following table summarizes stock option activity: Shares Weighted- (in dollars) Outstanding as of December 31, 2021 2,772,154 $ 7.90 Options granted 2,532,602 $ 12.97 Options exercised ( 22,775 ) $ 2.19 Options cancelled ( 77,366 ) $ 13.21 Outstanding as of September 30, 2022 5,204,615 $ 10.32 Stock option awards granted to employees generally vest over a four-year period. The contractual term of stock option awards is generally 10 years from the grant date. Stock Option Valuation The fair value of the Company’s stock option awards is estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Expected term (in years) 5.5 – 6.1 6.0 – 6.1 5.5 – 6.1 5.0 – 6.1 Expected volatility 96 % – 97 % 95 % – 96 % 96 % – 97 % 95 % – 103 % Risk-free interest rate 2.9 % – 3.6 % 0.9 % – 1.2 % 1.6 % – 3.6 % 0.6 % – 1.2 % Expected dividend yield —% —% —% —% Restricted Stock Units The Company began granting restricted stock units (RSUs) in the first quarter of 2022. RSUs are awards that entitle the holder to receive freely tradable shares of the Company's common stock upon the completion of a specific period of continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. RSUs are valued at the market price of the underlying common stock on the date of grant. The Company recognizes noncash compensation expense for the fair value of RSUs on a straight-line basis over the requisite service period of the awards. The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2021 Plan. Shares Weighted (in dollars) Unvested as of December 31, 2021 — $ — Granted 76,156 $ 15.19 Vested ( 8,932 ) $ 15.19 Forfeited ( 5,687 ) $ 15.19 Unvested as of September 30, 2022 61,537 $ 15.19 2021 Employee Stock Purchase Plan In July 2021, the Company adopted the 2021 Employee Stock Purchase Plan (ESPP), which became effective in connection with the IPO. The Company initially reserved 800,000 shares for future issuance under the ESPP. The number of shares of common stock available for issuance under the ESPP automatically increases on the first day of each fiscal year beginning with 2022 in an amount equal to the lesser of: 800,000 shares; 1 % of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the board of directors may determine. As of September 30, 2022, 1,161,305 shares were reserved for future issuance under the ESPP. Under Company's ESPP, employees are generally eligible to participate and can purchase shares on each purchase date established semi-annually through payroll deductions at the lower of 85 % of the fair market value of the Company's stock at the commencement of the offering period or each purchase date of the offering period. Each offering period spans 6 months . The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 15 % of qualified compensation, up to an annual limit of $ 25,000 per the Internal Revenue Service. The first offering period commenced in January 2022. For the nine months ended September 30, 2022, the stock-based compensation expense for ESPP was no t material. Stock-Based Compensation The following table summarizes stock-based compensation recognized in the Company’s condensed statements of operations and comprehensive loss: Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Research and development $ 1,344 $ 326 $ 3,777 $ 654 General and administrative 1,830 642 4,503 1,248 Total stock-based compensation $ 3,174 $ 968 $ 8,280 $ 1,902 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes For the nine months ended September 30, 2022 and 2021, the Company did no t record any income tax expense or benefit. The Company has recorded a full valuation allowance against its U.S. federal and state deferred tax assets as the Company believes it is not more likely than not that the benefit will be realized. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9. Net Loss Per Share Basic and diluted loss per share are computed by dividing net loss by the weighted-average number of common shares outstanding during the reporting period. The following potentially dilutive securities were not included in the calculation of diluted net loss per share as of the periods presented because the effect would have been anti-dilutive: September 30, 2022 2021 Outstanding stock options and awards 5,266,152 2,530,121 Restricted stock subject to future vesting 7,773 40,915 Total 5,273,925 2,571,036 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. The interim condensed balance sheet as of September 30, 2022, the interim condensed statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) and cash flows for the nine months ended September 30, 2022 and 2021 are unaudited. These unaudited interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2021 included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the related notes thereto for the year ended December 31, 2021, included in Company's Annual Report on Form 10-K, filed with the SEC on March 23, 2022. |
Reclassification | Reclassification Certain prior year balances have been reclassified in order to conform to current year presentation for the condensed balance sheets. These reclassifications have no effect on the previously reported financial position. |
Use of Estimates | Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accrued liabilities, income tax valuation allowance and stock-based compensation. Management bases its estimates on historical experience, the current economic environment, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Recently Adopted Accounting Standards and Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Standards In December 2019, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which is intended to simplify the accounting for income taxes. This standard eliminates certain exceptions to the approach for intra period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. As an emerging growth company, ASU 2019-12 became effective for the Company beginning January 1, 2022 . The adoption of this standard did not have any impact on its financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance (ASU 2021-10), which requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model. The required annual disclosures include the nature of the transaction, the entity’s related accounting policy, the financial statement line items affected and the amounts reflected in the current period financial statements, and any significant terms and conditions. ASU 2021-10 became effective for the Company beginning January 1, 2022 . The adoption of this standard did no t have a material impact on its financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which replaces the existing incurred loss impairment model with an expected credit loss model . This standard will require companies to recognize an allowance for credit losses on available-for-sale debt securities rather than the current approach of recording a reduction to the carrying value of the asset. As an emerging growth company, ASU 2016-13 will become effective for the Company beginning January 1, 2023. The Company is evaluating the impact of this standard on its financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Assets Measured at Fair Value on Recurring Basis | The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2022 Valuation Amortized Unrealized Unrealized Fair Value (In thousands) Assets: Cash equivalents: Money market funds Level 1 $ 23,376 $ — $ — $ 23,376 Commercial paper Level 2 9,966 — — 9,966 Marketable securities: U.S. treasuries Level 1 50,048 1 ( 445 ) 49,604 Commercial paper Level 2 44,510 — ( 164 ) 44,346 Corporate bonds Level 2 2,675 — ( 25 ) 2,650 Government agencies bonds Level 2 18,490 — ( 134 ) 18,356 Total financial assets $ 149,065 $ 1 $ ( 768 ) $ 148,298 December 31, 2021 Valuation Amortized Unrealized Unrealized Fair Value (In thousands) Assets: Cash equivalents: Money market funds Level 1 $ 37,129 $ — $ — $ 37,129 Marketable securities: U.S. treasuries Level 1 78,097 — ( 85 ) 78,012 Commercial paper Level 2 121,634 — ( 50 ) 121,584 Corporate bonds Level 2 8,979 — ( 3 ) 8,976 Government agencies bonds Level 2 4,602 — ( 3 ) 4,599 Total financial assets $ 250,441 $ — $ ( 141 ) $ 250,300 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Property and Equipment, Net | Property and equipment, net consists of the following: September 30, December 31, (In thousands) Leasehold improvements $ 23,605 $ 7,241 Laboratory equipment 19,957 11,891 Manufacturing equipment 17,468 — Construction in progress 2,933 32,561 Computer equipment and software 904 218 Furniture and fixtures 902 534 Total property and equipment $ 65,769 $ 52,445 Less: accumulated depreciation and amortization ( 13,575 ) ( 9,425 ) Total property and equipment, net $ 52,194 $ 43,020 |
Summary of Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following: September 30, December 31, (In thousands) Accrued compensation and related expenses $ 4,607 $ 3,667 Accrued research and development expenses 2,567 2,023 Accrued professional services 574 344 Accrued property and equipment 155 2,863 Other current liabilities 485 162 Total accrued and other current liabilities $ 8,388 $ 9,059 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Activity | Information related to operating lease activity during the three and nine months ended September 30, 2022 was as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Operating lease cost $ 1,090 $ 702 $ 2,624 $ 1,662 Variable lease cost 319 $ 306 910 $ 796 Short-term lease cost 244 585 709 1,755 Total lease cost $ 1,653 $ 1,593 $ 4,243 $ 4,213 Operating lease-right-of-use assets obtained in exchange for lease obligations $ 2,224 $ 8,558 Cash paid for leases included in operating cash outflows $ 4,597 $ 4,423 Cash paid for amounts included in the measurement of lease liabilities $ 2,978 $ 1,872 |
Summary of Future Minimum Lease Payments Under Operating Lease | Future minimum lease payments under the Company’s operating leases as of September 30, 2022 were as follows: Amount (In thousands) 2022 (remaining 3 months) $ 1,315 2023 5,223 2024 3,910 2025 2,445 2026 1,386 Thereafter 6,905 Total undiscounted future minimum lease payments $ 21,184 Imputed interest ( 5,125 ) Total operating lease liabilities $ 16,059 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity: Shares Weighted- (in dollars) Outstanding as of December 31, 2021 2,772,154 $ 7.90 Options granted 2,532,602 $ 12.97 Options exercised ( 22,775 ) $ 2.19 Options cancelled ( 77,366 ) $ 13.21 Outstanding as of September 30, 2022 5,204,615 $ 10.32 |
Summary of Fair Value of Stock Option Awards | The fair value of the Company’s stock option awards is estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Expected term (in years) 5.5 – 6.1 6.0 – 6.1 5.5 – 6.1 5.0 – 6.1 Expected volatility 96 % – 97 % 95 % – 96 % 96 % – 97 % 95 % – 103 % Risk-free interest rate 2.9 % – 3.6 % 0.9 % – 1.2 % 1.6 % – 3.6 % 0.6 % – 1.2 % Expected dividend yield —% —% —% —% |
Summary of Restricted Stock Activity | The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2021 Plan. Shares Weighted (in dollars) Unvested as of December 31, 2021 — $ — Granted 76,156 $ 15.19 Vested ( 8,932 ) $ 15.19 Forfeited ( 5,687 ) $ 15.19 Unvested as of September 30, 2022 61,537 $ 15.19 |
Summary of Stock-based Compensation | The following table summarizes stock-based compensation recognized in the Company’s condensed statements of operations and comprehensive loss: Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Research and development $ 1,344 $ 326 $ 3,777 $ 654 General and administrative 1,830 642 4,503 1,248 Total stock-based compensation $ 3,174 $ 968 $ 8,280 $ 1,902 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share | The following potentially dilutive securities were not included in the calculation of diluted net loss per share as of the periods presented because the effect would have been anti-dilutive: September 30, 2022 2021 Outstanding stock options and awards 5,266,152 2,530,121 Restricted stock subject to future vesting 7,773 40,915 Total 5,273,925 2,571,036 |
Organization and Description _2
Organization and Description of the Business - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Aug. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Organization And Description Of Business [Line Items] | ||||||||||
Accumulated deficit | $ (245,682) | $ (245,682) | $ (155,533) | |||||||
Net loss | (30,696) | $ (28,397) | $ (31,056) | $ (18,262) | $ (15,210) | $ (13,098) | (90,149) | $ (46,570) | ||
Cash, cash equivalents and investments in marketable securities | $ 149,500 | $ 149,500 | ||||||||
ATM Offering | ||||||||||
Organization And Description Of Business [Line Items] | ||||||||||
Maximum aggregate offering price | $ 75,000 | |||||||||
Shares sold | 0 | 0 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | Sep. 30, 2022 |
ASU 2019-12 | |
Significant Accounting Policies [Line Items] | |
Accounting standards update, adopted [true false] | true |
Accounting standards update, immaterial effect [true false] | true |
Accounting standards update, adoption date | Jan. 01, 2022 |
ASU 2021-10 | |
Significant Accounting Policies [Line Items] | |
Accounting standards update, adopted [true false] | true |
Accounting standards update, immaterial effect [true false] | true |
Accounting standards update, adoption date | Jan. 01, 2022 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | $ 34,494 | $ 38,129 | $ 117,077 |
Fair Value, Measurements, Recurring | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 149,065 | 250,441 | |
Unrealized Gain | 1 | ||
Unrealized Loss | (768) | (141) | |
Fair Value | 148,298 | 250,300 | |
Money Market Funds | Fair Value, Measurements, Recurring | Level 1 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 23,376 | 37,129 | |
Fair Value | 23,376 | 37,129 | |
Commercial Paper | Fair Value, Measurements, Recurring | Level 2 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 9,966 | ||
Fair Value | 9,966 | ||
Commercial Paper | Fair Value, Measurements, Recurring | Level 2 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 44,510 | 121,634 | |
Unrealized Loss | (164) | (50) | |
Fair Value | 44,346 | 121,584 | |
U.S. Treasuries | Fair Value, Measurements, Recurring | Level 1 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 50,048 | 78,097 | |
Unrealized Gain | 1 | ||
Unrealized Loss | (445) | (85) | |
Fair Value | 49,604 | 78,012 | |
Government Agencies Bonds | Fair Value, Measurements, Recurring | Level 2 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 18,490 | 4,602 | |
Unrealized Loss | (134) | (3) | |
Fair Value | 18,356 | 4,599 | |
Corporate Bonds | Fair Value, Measurements, Recurring | Level 2 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Amortized Cost | 2,675 | 8,979 | |
Unrealized Loss | (25) | (3) | |
Fair Value | $ 2,650 | $ 8,976 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Impairment charges on marketable securities related to other-than-temporary | $ 0 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 65,769 | $ 52,445 |
Less: accumulated depreciation and amortization | (13,575) | (9,425) |
Total property and equipment, net | 52,194 | 43,020 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 23,605 | 7,241 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 19,957 | 11,891 |
Manufacturing equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 17,468 | |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 2,933 | 32,561 |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 904 | 218 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 902 | $ 534 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2022 | |
Depreciation and amortization expense | $ 2.1 | $ 0.7 | $ 4.3 | $ 2.2 | |
Prepaid Expenses and Other Current Assets | |||||
Employee retention credit receivable CARES Act | $ 2 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued compensation and related expenses | $ 4,607 | $ 3,667 |
Accrued property and equipment | 155 | 2,863 |
Accrued research and development expenses | 2,567 | 2,023 |
Other liabilities, current | 485 | 162 |
Accrued professional services | 574 | 344 |
Total accrued and other current liabilities | $ 8,388 | $ 9,059 |
License Agreements (Details)
License Agreements (Details) | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2020 USD ($) | Oct. 31, 2016 USD ($) Option | Sep. 30, 2022 USD ($) | |
University of Texas Southwestern License Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Milestone and royalty payments recognized | $ 0 | ||
Non-refundable upfront license fee | $ 100,000 | ||
University of Texas Southwestern License Agreement | Maximum | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Milestone payments contingent upon achieving specific development and commercialization milestone events | $ 14,800,000 | ||
Gladstone | Gladstone License Agreement | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Milestone and royalty payments recognized | $ 0 | ||
Number of additional option to extend milestone payment | Option | 4 | ||
Milestone obligation additional extended payment terms | 1 year | ||
Gladstone | Gladstone License Agreement | Minimum | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Annual license maintenance fees | $ 25,000 | ||
Milestone obligation amount | 50,000 | ||
Gladstone | Gladstone License Agreement | Maximum | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Annual license maintenance fees | 100,000 | ||
Milestone payments for royalty-bearing products contingent upon achieving specific clinical and commercialization milestone events | 4,100,000 | ||
Milestone obligation amount | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
May 31, 2022 | Nov. 30, 2021 | Feb. 28, 2021 USD ($) RenewalOption | Dec. 31, 2016 RenewalOption | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Commitments And Contingencies [Line Items] | ||||||||
Weighted-average remaining lease term | 5 years 8 months 12 days | 5 years 8 months 12 days | ||||||
Weighted-average discount rate | 9.20% | 9.20% | ||||||
Short-term lease | $ 244 | $ 585 | $ 709 | $ 1,755 | ||||
Variable lease payments | $ 319 | $ 306 | $ 910 | $ 796 | ||||
Union City Facility | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Number of lease renewal term | RenewalOption | 1 | |||||||
Lease renewal term | 5 years | |||||||
Lease commenced month and year | 2021-05 | |||||||
Term of lease | 10 years | |||||||
Union City Facility | Other Noncurrent Assets | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Security deposit | $ 3,300 | |||||||
Office and Laboratory Space | South San Francisco, California | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Lease expiration month and year | 2025-05 | |||||||
Number of lease renewal term | RenewalOption | 2 | |||||||
Lease renewal term | 5 years | |||||||
Additional Office and Laboratory Space | South San Francisco, California | ||||||||
Commitments And Contingencies [Line Items] | ||||||||
Lease Expiration Date | Dec. 31, 2022 | Jun. 30, 2022 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Activity (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 1,090 | $ 702 | $ 2,624 | $ 1,662 |
Variable lease cost | 319 | 306 | 910 | 796 |
Short-term lease cost | 244 | 585 | 709 | 1,755 |
Total lease cost | $ 1,653 | $ 1,593 | 4,243 | 4,213 |
Operating lease-right-of-use assets obtained in exchange for lease obligations | 2,224 | 8,558 | ||
Cash paid for leases included in operating cash outflows | 4,597 | 4,423 | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 2,978 | $ 1,872 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Future Minimum Lease Payments Under Operating Leases (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 (remaining 6 months) | $ 1,315 |
2023 | 5,223 |
2024 | 3,910 |
2025 | 2,445 |
2026 | 1,386 |
Thereafter | 6,905 |
Total undiscounted future minimum lease payments | 21,184 |
Imputed interest | (5,125) |
Total operating lease liabilities | $ 16,059 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Contractual term of stock option awards | 10 years | ||||
Vesting period | 4 years | ||||
Stock-based compensation | $ 3,174 | $ 968 | $ 8,280 | $ 1,902 | |
2021 Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for issuance | 800,000 | 1,161,305 | 1,161,305 | ||
Participants to purchase common stock through payroll deduction maximum percentage of eligible compensation | 15% | ||||
Participants to purchase shares through payroll deduction at lower percentage of fair market value | 85% | ||||
Number of shares of common stock that may be issued in accordance with the plan | 800,000 | ||||
Percentage of shares of common stock outstanding on last day of immediately preceding year | 1% | ||||
Stock-based compensation | $ 0 | ||||
Participants to purchase common stock through payroll deduction annual limit of eligible compensation | $ 25,000 | ||||
Offering period | 6 months | ||||
2021 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for issuance | 4,000,000 | ||||
Common stock shares available for issuance period | 10 years | ||||
Number of shares of common stock that may be issued in accordance with the plan | 4,000,000 | ||||
Percentage of shares of common stock outstanding on last day of immediately preceding year | 4% | ||||
Shares reserved and available for grant | 2,720,107 | 2,720,107 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - 2021 Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Shares, Outstanding Beginning Balance | shares | 2,772,154 |
Shares, Options granted | shares | 2,532,602 |
Shares, Options exercised | shares | (22,775) |
Shares, Options cancelled | shares | (77,366) |
Shares, Outstanding Ending Balance | shares | 5,204,615 |
Weighted-Average Exercise Price Per Share, Outstanding Beginning Balance | $ / shares | $ 7.90 |
Weighted-Average Exercise Price Per Share, Options granted | $ / shares | 12.97 |
Weighted-Average Exercise Price Per Share, Options exercised | $ / shares | 2.19 |
Weighted-Average Exercise Price Per Share, Options cancelled | $ / shares | 13.21 |
Weighted-Average Exercise Price Per Share, Outstanding Ending Balance | $ / shares | $ 10.32 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Fair Value of Stock Option Awards (Details) | 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] | ||||
Expected volatility, minimum | 96% | 95% | 96% | 95% |
Expected volatility, maximum | 97% | 96% | 97% | 103% |
Risk-free interest rate, minimum | 2.90% | 0.90% | 1.60% | 0.60% |
Risk free interest rate, maximum | 3.60% | 1.20% | 3.60% | 1.20% |
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 6 months | 6 years | 5 years 6 months | 5 years |
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Activity (Details) - 2021 Equity Incentive Plan - Restricted Stock | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of Shares | |
Granted | shares | 76,156 |
Vested | shares | (8,932) |
Forfeited | shares | (5,687) |
Unvested as of September 30, 2022 | shares | 61,537 |
Weighted Average Grant Date Fair Value per Share | |
Granted | $ / shares | $ 15.19 |
Vested | $ / shares | 15.19 |
Forfeited | $ / shares | 15.19 |
Unvested as of September 30, 2022 | $ / shares | $ 15.19 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-based Compensation (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 stock-based compensation | $ 3,174 | $ 968 | $ 8,280 | $ 1,902 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | 1,344 | 326 | 3,777 | 654 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation | $ 1,830 | $ 642 | $ 4,503 | $ 1,248 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 0 | $ 0 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities were not included in the calculation of diluted net loss per share | 5,273,925 | 2,571,036 |
Outstanding Stock Options and Awards | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities were not included in the calculation of diluted net loss per share | 5,266,152 | 2,530,121 |
Restricted Stock Subject to Future Vesting | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities were not included in the calculation of diluted net loss per share | 7,773 | 40,915 |