Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 01, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | TALS | ||
Entity Registrant Name | TALARIS THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001827506 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Common Stock, Shares Outstanding | 42,015,166 | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Entity File Number | 001-40384 | ||
Entity Tax Identification Number | 83-2377352 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 93 Worcester St. | ||
Entity Address, City or Town | Wellesley | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02481 | ||
City Area Code | 502 | ||
Local Phone Number | 398-9250 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | false | ||
Entity Public Float | $ 139,064,898 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 34 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s proxy statement for the 2023 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year ended December 31, 2022 , are incorporated by reference in Part III of this Form 10-K. |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 13,670 | $ 18,614 |
Marketable securities | 167,612 | 225,357 |
Prepaid and other current assets | 4,331 | 2,543 |
Total current assets | 185,613 | 246,514 |
Property and equipment, net | 5,348 | 4,804 |
Right-of-use assets | 2,643 | |
Other assets | 111 | 104 |
Total assets | 193,715 | 251,422 |
Current liabilities: | ||
Accounts payable | 3,887 | 2,556 |
Accrued expenses | 6,665 | 5,431 |
Lease liability, current | 910 | |
Total current liabilities | 11,462 | 7,987 |
Share repurchase liability | 208 | 593 |
Other liabilities | 16 | 33 |
Lease liability, net of current | 1,974 | |
Total liabilities | 13,660 | 8,613 |
Stockholders' equity | ||
Common stock, $0.0001 par value, 140,000,000 shares authorized and 41,629,426 issued and outstanding and 10,000,000 non-voting shares authorized as of December 31, 2022 and 140,000,000 shares authorized and 39,763,049 issued and outstanding and 10,000,000 non-voting shares authorized and 1,150,000 issued and outstanding as of December 31, 2021 | 4 | 4 |
Additional paid-in-capital | 345,513 | 333,730 |
Accumulated deficit | (164,741) | (90,847) |
Accumulated other comprehensive loss | (721) | (78) |
Total stockholders' equity | 180,055 | 242,809 |
Total liabilities and stockholders' equity | $ 193,715 | $ 251,422 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 140,000,000 | 140,000,000 |
Common stock, shares issued | 41,629,426 | 39,763,049 |
Common stock, shares outstanding | 41,629,426 | 39,763,049 |
Non-voting Shares | ||
Common stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, shares issued | 1,150,000 | |
Common stock, shares outstanding | 1,150,000 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses | ||
Research and development | $ 57,005 | $ 34,245 |
General and administrative | 19,472 | 13,262 |
Total operating expenses | 76,477 | 47,507 |
Loss from operations | (76,477) | (47,507) |
Interest and other income (expense), net | 2,583 | (326) |
Net loss | (73,894) | (47,833) |
Unrealized loss on marketable securities | (643) | (65) |
Total other comprehensive loss | (643) | (65) |
Total comprehensive loss | (74,537) | (47,898) |
Net loss attributable to common stockholders | $ (73,894) | $ (47,833) |
Net loss per common share, basic | $ (1.79) | $ (1.64) |
Net loss per common share, diluted | $ (1.79) | $ (1.64) |
Weighted average number of common shares outstanding used in computation of net loss per common share, basic | 41,248,392 | 29,126,373 |
Weighted average number of common shares outstanding used in computation of net loss per common share, diluted | 41,248,392 | 29,126,373 |
Statements of Convertible Prefe
Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series A Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Beginning balance at Dec. 31, 2020 | $ (38,147) | $ 1 | $ 4,879 | $ (43,014) | $ (13) | |||
Beginning balance, shares at Dec. 31, 2020 | 40,000,000 | 28,000,000 | 62,499,993 | |||||
Beginning balance at Dec. 31, 2020 | $ 37,383 | $ 34,272 | $ 114,496 | |||||
Beginning balance, shares at Dec. 31, 2020 | 7,087,130 | |||||||
Issuance of common stock, net of underwriting discounts and issuance costs | 137,166 | $ 1 | 137,165 | |||||
Issuance of common stock, net of underwriting discounts and issuance costs, shares | 8,825,000 | |||||||
Conversion of convertible preferred stock to common stock, value | $ (37,383) | $ (37,272) | $ (114,496) | |||||
Conversion of convertible preferred stock to common stock, shares | (40,000,000) | (28,000,000) | (62,499,993) | |||||
Conversion of convertible preferred stock to common stock, value | 186,151 | $ 2 | 186,149 | |||||
Conversion of convertible preferred stock to common stock, shares | 24,392,498 | |||||||
Issuance of contingent common stock, value | 831 | 831 | ||||||
Issuance of contingent common stock, shares | 48,889 | |||||||
Issuance of common stock upon exercise of stock options | $ 721 | 721 | ||||||
Issuance of common stock upon exercise of stock options, shares | 149,707 | 543,649 | ||||||
Issuance of common stock under 2021 employee stock purchase plan | $ 207 | 207 | ||||||
Issuance of common stock under 2021 employee stock purchase plan, shares | 15,883 | |||||||
Stock-based compensation expense | 3,778 | 3,778 | ||||||
Net loss | (47,833) | (47,833) | ||||||
Unrealized loss on marketable securities | (65) | (65) | ||||||
Ending balance at Dec. 31, 2021 | $ 242,809 | $ 4 | 333,730 | (90,847) | (78) | |||
Ending balance, shares at Dec. 31, 2021 | 39,763,049 | 40,913,049 | ||||||
Issuance of common stock upon exercise of stock options | $ 493 | 493 | ||||||
Issuance of common stock upon exercise of stock options, shares | 96,646 | 476,832 | ||||||
Issuance of common stock under 2021 employee stock purchase plan | $ 134 | 134 | ||||||
Issuance of common stock under 2021 employee stock purchase plan, shares | 85,157 | |||||||
Vesting of restricted stock units | 154,388 | |||||||
Stock-based compensation expense | 11,156 | 11,156 | ||||||
Net loss | (73,894) | (73,894) | ||||||
Unrealized loss on marketable securities | (643) | (643) | ||||||
Ending balance at Dec. 31, 2022 | $ 180,055 | $ 4 | $ 345,513 | $ (164,741) | $ (721) | |||
Ending balance, shares at Dec. 31, 2022 | 41,629,426 | 41,629,426 |
Statements of Convertible Pre_2
Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Net of underwriting discounts and issuance costs | $ 12,858,764 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (73,894) | $ (47,833) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,383 | 623 |
Amortization of right-of-use assets | 779 | |
Accretion and amortization of marketable securities, net | (1,613) | 427 |
Stock-based compensation expense | 11,156 | 3,778 |
Fair value adjustment of contingent stock liability | 735 | |
Gain on disposal of property and equipment | (33) | |
Asset impairment | 235 | |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (1,788) | (1,280) |
Other assets | (7) | (90) |
Accounts payable | 1,664 | 1,323 |
Accrued expenses | 1,784 | 2,329 |
Operating lease liability | (644) | |
Other liabilities | 88 | 33 |
Net cash used in operating activities | (60,857) | (39,988) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (3,043) | (2,437) |
Purchases of marketable securities | (191,579) | (275,879) |
Maturities of marketable securities | 250,293 | 181,929 |
Net cash provided by (used in) investing activities | 55,671 | (96,387) |
Cash flows from financing activities: | ||
Proceeds from isuance of common stock | 139,523 | |
Common stock issuance costs | (12,858,764) | |
Payment of partial settlement of contingent stock liability | (277) | |
Proceeds from exercise of stock options | 108 | 317 |
Net cash provided by financing activities | 242 | 137,400 |
Net (decrease) increase in cash and cash equivalents | (4,944) | 1,025 |
Cash and cash equivalents at beginning of period | 18,614 | 17,589 |
Cash and cash equivalents at end of period | 13,670 | 18,614 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Property and equipment additions included in accounts payable and accrued expenses | 147 | 1,028 |
2021 Employee Stock Purchase Plan | ||
Cash flows from financing activities: | ||
Proceeds from isuance of common stock | $ 134 | 206 |
Common Stock | ||
Cash flows from financing activities: | ||
Common stock issuance costs | $ (2,369) |
Nature of Business and Liquidit
Nature of Business and Liquidity | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Liquidity | 1. Nature of Business and Liquidity Talaris Therapeutics, Inc. (“Talaris” or the “Company”) is a late-clinical stage, cell therapy company developing an innovative method of allogeneic hematopoietic stem cell transplantation ("allo-HSCT"), called "Facilitated Allo-HSCT Therapy", that the Company believes has the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases and certain severe blood, immune and metabolic disorders. The Company believes that these indications, individually and collectively, represent a significant unmet need and commercial opportunity. The Company maintains corporate offices in Boston, Massachusetts, a laboratory in Houston, Texas and its cell processing facility in Louisville, Kentucky. In February 2023, the Company announced the discontinuation of our FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipient. This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones. In February 2023, the Company also announced a comprehensive review of strategic alternatives focused on maximizing shareholder value, including, but not limited to, an acquisition, merger, possible business combinations and/or a divestiture of the Company's cell therapy chemistry, manufacturing and controls capabilities. In March 2023, pending the outcome of the Company's review of strategic alternatives, the Company voluntarily paused enrollment in the FREEDOM-3 Phase 2 clinical trial evaluating FCR001's ability to induce tolerance in diffuse systemic sclerosis, a severe autoimmune disease, while continuing to evaluate patients for potential future enrollment. We expect to devote substantial time and resources to exploring strategic alternatives that our board of directors believes will maximize stockholder value. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a timetable for completion of this strategic review process, and our board of directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value, or that we will make any additional cash distributions to our stockholders. Initial Public Offering The Company completed an initial public offering (“IPO”) on May 11, 2021 in which the Company issued and sold 8,825,000 shares of its common stock at a public offering price of $ 17.00 per share. The Company’s aggregate gross proceeds from the sale of shares in the IPO was $ 150.0 million before underwriting discounts and commissions and other expenses of approximately $ 12.9 million. Upon completion of the offering, the Company’s outstanding convertible preferred stock was automatically converted into shares of common stock and non-voting common stock. Following the IPO, there were no shares of preferred stock outstanding. Prior to the IPO, on April 30, 2021, the Company’s board of directors and shareholders approved a one-for-5.35 reverse share split of issued and outstanding common shares and incentive shares and a proportional adjustment to the existing conversion ratios for the Company’s convertible preferred stock. Liquidity The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. Management has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Since its inception, the Company has incurred net losses and negative cash flows from operations. During the years ended December 31, 2022 and 2021, the Company incurred a net loss of $ 73.9 million and $ 47.8 million , respectively, and used $ 60.9 million and $ 40.0 million in cash for operations, respectively. In addition, as of December 31, 2022, the Company had an accumulated deficit of $ 164.7 million . The Company expects to continue to generate operating losses and negative cash flows for the foreseeable future. The Company currently expects the cash and cash equivalents of $ 13.7 million and marketable securities of $ 167.6 million as of December 31, 2022, will be sufficient to fund its operating expenses and capital requirements for more than twelve months from the date the financial statements are available to be issued. Risks and Uncertainties Additional funding will be needed to finance future clinical, pre-clinical, manufacturing and commercial activities. There is no assurance the Company will be successful in obtaining such additional financing on terms acceptable to it, if at all, and it may not be able to enter into other arrangements. If the Company is unable to obtain funding, it could be forced to delay, reduce or eliminate our research and development programs, portfolio expansion or commercialization efforts, which could adversely affect its business prospects and ability to continue operations. The Company is subject to risks common to companies in the biopharmaceutical industry. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for its intellectual property will be maintained, that any products developed will obtain required regulatory approval, or that any approved products will be commercially viable. Even if the development efforts are successful, it is uncertain when, if ever, the Company will generate significant product sales and ultimately net income. Coronavirus Pandemic In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. The worldwide COVID-19 pandemic has affected and may affect in the future the Company’s ability to initiate and complete preclinical studies, delay the initiation and completion of its current and planned clinical trials, disrupt regulatory activities or have other adverse effects on its business, results of operations, financial condition and prospects. In addition, the pandemic has caused substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could adversely affect the Company’s business, operations and ability to raise funds to support its operations. The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business, and it has the potential to adversely affect its business, financial condition, results of operations and prospects. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("US GAAP"). Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make judgments, assumptions, and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of financial statements, and the reported amounts of income and expense during the reporting period. The most significant estimates relate to determination of the fair value of stock option grants and estimates related to the amount of accrued research and development expenses as of the balance sheet date. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors, including the current economic environment, and makes adjustments when the facts and circumstances dictate. These estimates are based on information available as of the date of the financial statements; therefore, actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. As of December 31, 2022 and 2021 , cash consists primarily of checking and savings deposits and money market fund holdings. Marketable Securities The Company classifies its marketable securities as available-for-sale securities, which are carried at their fair value based on the quoted market prices of the securities. Unrealized gains and losses are reported as accumulated other comprehensive loss, a separate component of stockholders’ deficit. Realized gains and losses on available-for-sale securities are included in net loss in the period earned or incurred. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Equipment and furniture and fixtures are depreciated over five or seven year lives. Leasehold improvements are amortized over the shorter of the lease term or the five-year estimated useful life of the asset . Computer equipment and computer software are depreciated over three years . Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are expensed as incurred. Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist primarily of property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. During the year ended December 31, 2022 , the Company recorded a $ 0.2 million non-cash impairment charge (see Note 6). No impairments were identified as of December 31, 2021 . Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company’s investment policy includes guidelines regarding the quality of the financial institutions and financial instruments and defines allowable investments that it believes minimizes the exposure to concentration of credit risk. The Company may invest in money market funds (minimum of $ 1 billion in assets), U.S. Treasury securities, corporate debt, bank debt, U.S. government-related agency securities, other sovereign debt, municipal debt and commercial paper. These deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts and believes that it is not exposed to significant credit risk as our deposits are held at financial institutions that management believes to be of high credit quality. Fair Value of Financial Instruments Fair value is defined as the price that the Company would receive to sell an investment in a timely transaction or pay to transfer a liability in a timely transaction with an independent buyer in the principal market, or in the absence of a principal market, the most advantageous market for the investment or liability. A framework is used for measuring fair value utilizing a three-tier hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 investments) and the lowest priority to unobservable inputs (Level 3 investments). The three levels of the fair value hierarchy are as follows: • Level 1 inputs: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; • Level 2 inputs: Quoted prices in markets that are not considered to be active or financial instrument valuations for which all significant inputs are observable, either directly or indirectly; and, • Level 3 inputs: Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. Financial instruments are categorized in their entirety based on the lowest level of input that is significant to the fair value measurement. The assessment of the significance of a particular input to the fair value measurement requires judgment and considers factors specific to the investment. The Company’s money market funds and marketable securities are carried at fair value determined according to the fair value hierarchy described above (Level 1 and Level 2, respectively). Research and Development Expenses Research and development expenses include (i) employee-related expenses, including salaries, benefits, travel and stock-based compensation expense; (ii) external research and development expenses incurred under arrangements with third parties, such as contract research organization agreements, investigational sites, and consultants; (iii) the cost of acquiring, developing, and manufacturing clinical study materials; (iv) costs associated with preclinical and clinical activities and regulatory operations; (v) costs incurred in development of intellectual property; and (vi) an allocated portion of facilities and other infrastructure costs associated with our research and development activities. Costs incurred in connection with research and development activities are expensed as incurred. The Company enters into consulting, research, and other agreements with commercial entities, researchers, universities, and others for the provision of goods and services. Such arrangements are generally cancelable upon reasonable notice and payment of costs incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided by the respective vendors, including the Company’s clinical sites. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved, and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly. Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees, nonemployees, and directors based on the fair value on the date of the grant and recognizes stock-based compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues stock option and restricted stock unit awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company’s policy is to account for forfeitures when they occur. The Company classifies stock-based compensation expense in its statement of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company recently completed its IPO and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the US Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is zero because the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Prior to the Company’s IPO, the Company considered the estimated fair value of the common stock as of the measurement date in determining the exercise price for options granted. The estimated fair value of the common stock was determined at each grant date based upon a variety of factors, including the illiquid nature of the common stock, arm’s-length sales of the Company’s capital stock (including convertible preferred stock), the effect of the rights and preferences of the preferred shareholders, and the prospects of a liquidity event. Among other factors are the Company’s financial position and historical financial performance, forecasted future operations of the Company, an evaluation or benchmark of the Company’s competition, and the current business climate in the marketplace. Significant changes to the key assumptions underlying the factors used could result in different fair values of common stock at each valuation date. The fair value for options granted since the Company’s IPO are based on the closing stock price on grant date . Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions. These reserves are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. Potential interest and penalties associated with such uncertain tax positions are recorded as a component of income tax expense. The Company had no significant uncertain tax positions as of December 31, 2022 and December 31, 2021 . Basic and Diluted Net Loss Per Share The Company calculates basic and diluted net loss per share using the two-class method. The two-class method requires income available to common stockholders for the period to be allocated between common stock and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Accordingly, basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the dilutive effects of potentially dilutive securities outstanding during the period. Potentially dilutive securities include vested and unexercised stock options, restricted stock issued upon early exercise of stock options, convertible preferred shares and contingent stock liabilities. The dilutive effect of stock options and contingent stock liabilities are computed using the treasury stock method and the dilutive effect of convertible preferred shares is calculated using the if-converted method. The Company has generated a net loss for all periods presented, therefore diluted net loss per share is the same as basic net loss per share since the inclusion of potentially dilutive securities would be anti-dilutive. Segments Operating segments are defined as components of an entity for which separate financial information is made available and is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company’s CODM is the chief executive officer and operations are managed as a single segment for the purposes of assessing performance and making operating decisions. Comprehensive Loss Comprehensive loss represents net loss for the period plus the results of certain other changes in stockholders’ equity. The Company’s comprehensive loss included unrealized gains related to marketable securities for the years ended December 31, 2022 and 2021 . Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , which requires lessees to recognize the right-of-use assets and related lease liabilities in the balance sheet. The new standard provides for a modified retrospective application. ASU 2016-02 is effective for interim and annual period beginning after December 15, 2021. The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term for those leases commencing prior to January 1, 2022 did not change with the adoption of the new leasing standards. The expected lease term for leases commencing after the adoption of the new leasing standards includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. As a result of the adoption of the new leasing standards, on January 1, 2022, the Company recorded right-of-use assets of $ 3.4 million and operating lease liabilities of $ 3.5 million. The adoption did not have a material impact on the statement of operations or the statement of cash flows. For additional information on the adoption of the new leasing standard, refer to Note 8. The following table presents the cumulative effect of adoption of ASC 842 on January 1, 2022 (in thousands) : January 1, 2022 Prior to adoption of new leasing standards Adjustment for adoption of new leasing standards As adjusted Right-of-use assets (1) $ — $ 3,422 $ 3,422 Deferred rent (2) $ 105 $ ( 105 ) $ — Operating lease liability (3) $ — $ 645 $ 645 Operating lease liability, net of current portion (3) $ — $ 2,882 $ 2,882 (1) Represents capitalization of operating right-of-use assets (2) Represents reclassification of deferred rent and incentives as a reduction of operating right-of-use assets (3) Represents recognition of operating right-of-use assets |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis and indicates the fair value hierarchy of the inputs the Company utilized to determine such fair value (in thousands) : December 31, 2022 Total Level 1 Level 2 Level 3 Financial assets: Money market funds (cash equivalents) $ 12,309 $ 12,309 $ — $ — Marketable securities 167,612 31,718 135,894 — Total financial assets measured at fair value $ 179,921 $ 44,027 $ 135,894 $ — December 31, 2021 Total Level 1 Level 2 Level 3 Financial assets: Money market funds (cash equivalents) $ 10,319 $ 10,319 $ — $ — Marketable securities 225,357 27,186 198,171 — Total financial assets measured at fair value $ 235,676 $ 37,505 $ 198,171 $ — The contingent stock liability in the table below represents the fair value of contingent equity consideration equal to 65,186 shares of common stock contingently issuable to the University of Louisville Research Foundation Inc. ("ULRF") in connection with its amended and restated exclusive license agreement with the Company (see Note 8). In conjunction with the Company's IPO, the Company issued 48,889 shares of common stock and paid the cash equivalent fair value of 16,297 shares, or $ 0.3 million, to ULRF in May 2021 (see Note 8). A rollforward of the contingent common stock liability, which is measured at fair value for the year ended December 31, 2021, is represented as follows (in thousands) : Fair value as of January 1, 2021 $ 373 Change in fair value 735 Share issuance in partial settlement of contingent stock ( 831 ) Cash payment in partial settlement of contingent stock ( 277 ) Fair value as of December 31, 2021 $ — Valuation techniques used to measure fair value maximize the use of relevant observable inputs and minimize the use of unobservable inputs. Prior to the Company’s IPO, the Company’s contingent stock liability was classified within Level 3 of the fair value hierarchy because its fair value measurement is based, in part, on significant inputs not observed in the market, which incorporates assumptions and estimates to value the Company’s common stock. As there was no public market for the Company’s common stock prior to May 2021, the estimated fair value was determined by the Company’s board of directors with input from management, considering the most recently available third-party valuations of common stock, and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of each valuation. Historically, these third-party valuations of the Company’s common stock were performed contemporaneously when events occurred which management believed would have an impact on the valuation of the Company. The Company’s common stock valuation was prepared using the option-pricing method, (“OPM”), which uses a market approach to estimate enterprise value. The fair value of the Company’s common stock used to value the contingent stock liability as of January 1, 2021 was $ 5.72 . T he Company's IPO price of $ 17.00 was used to determine the contingent stock value prior to settlement in cash and share issuance. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2022 | |
Marketable Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities The fair value of the Company’s marketable securities as of December 31, 2022 and 2021 is based on level 1 and level 2 inputs. The Company’s investments consist mainly of U.S. government and agency securities, government-sponsored bond obligations and certain other corporate debt securities. Fair value is determined by taking into consideration valuations obtained from third-party pricing services. The third-party pricing services utilize industry standard valuation models, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; and other observable inputs. There were no transfers between levels within the hierarchy during the years ended December 31, 2022 and 2021. The Company has assessed U.S. government treasuries as level 1 and all other marketable securities as level 2 within the fair value hierarchy of ASC 820. The Company classifies its entire investment portfolio as available-for-sale as defined in ASC 320, Debt Securities . Securities are carried at fair value with the unrealized gains (losses) reported in other comprehensive loss. As of December 31, 2022 and 2021, none of the Company’s investments were determined to be other than temporarily impaired. The following table summarizes the Company’s investments (in thousands) : December 31, 2022 Amortized Unrealized Unrealized Estimated Commercial paper $ 119,313 $ 19 $ ( 365 ) $ 118,967 Government and agency securities 43,016 — ( 368 ) 42,648 Corporate debt securities 6,004 — ( 7 ) 5,997 Total $ 168,333 $ 19 $ ( 740 ) $ 167,612 December 31, 2021 Amortized Unrealized Unrealized Estimated Commercial paper $ 179,151 $ 38 $ ( 47 ) $ 179,142 Corporate debt securities 31,244 — ( 58 ) 31,186 Government and agency securities 15,040 — ( 11 ) 15,029 Total $ 225,435 $ 38 $ ( 116 ) $ 225,357 The fair values of available-for-sale debt securities as of December 31, 2022, by contractual maturity, are summarized as follows (in thousands) : December 31, 2022 Due in one year or less $ 165,648 Due after one year through two years 1,964 $ 167,612 The aggregate fair value of available-for-sale securities in an unrealized loss position as of December 31, 2022 was $ 130.5 million. The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-loss related factors. As such, no allowance for credit losses was recorded as of December 31, 2022 . |
Prepaid and Other Current Asset
Prepaid and Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid and Other Current Assets | 5. Prepaid and Other Current Assets Prepaid and other current assets consisted of the following (in thousands) : December 31, 2022 2021 Prepaid insurance $ 1,037 $ 1,121 Prepaid research and development expenses 2,426 782 Other current assets 868 640 Total prepaid and other current assets $ 4,331 $ 2,543 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands) : December 31, 2022 2021 Equipment $ 6,562 $ 4,449 Leasehold improvements 1,191 821 Computer equipment 859 953 Furniture and fixtures 674 426 Construction in progress 242 952 Total property and equipment 9,528 7,601 Less accumulated depreciation ( 4,180 ) ( 2,797 ) Property and equipment, net $ 5,348 $ 4,804 Depreciation expense was $ 1.4 million and $ 0.6 million for the years ended December 31, 2022 and 2021, respectively. In July 2022, the Company received a notice from a third party vendor indicating the decommissioning of its software platform. As a result, the Company recorded a $ 0.2 million non-cash impairment expense in research and development operating expense in the accompanying statement of operations and comprehensive loss for the year ended December 31, 2022 . |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consisted of the following (in thousands) : December 31, 2022 2021 Compensation and benefit costs $ 3,566 $ 3,320 Research and development expenses 1,978 854 Professional fees, consulting and other 1,121 1,257 Total accrued expenses $ 6,665 $ 5,431 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases The Company currently has four active lease agreements for office and laboratory space and related equipment. The Company's cell processing facility lease is located on the University of Louisville campus in Louisville, Kentucky (the “Louisville Lease”). This lease has a termination date in November 2023 , with an option to extend for three additional years at the Company’s discretion. In May 2020, the Company added additional office and laboratory space to the Louisville Lease. In September 2021, the Company entered into a sublease agreement for separate office space in Louisville, Kentucky. This sublease has a termination date in November 2023 . The Company maintains a lease for office space in Wellesley, Massachusetts (the "Boston Lease"), that had an original termination date in March 2021 . In April 2021, the Company entered into an amended lease agreement providing for temporary space from April 2021 until an expansion of the Boston Lease was complete, from which the lease term extends 39 months from the expansion completion date. The expansion was completed in June 2022, resulting in the lease term extending to September 2025 . In July 2021, the Company entered into a lease agreement for laboratory space in Houston, Texas (the “Houston Lease”). The Houston Lease commenced in January 2022. The term of the lease is 36 months from the commencement date, terminating December 2024 . The future minimum rent payments relating to all four of the Company’s ongoing facility operating leases under the terms and conditions existing as of December 31, 2022, as well as amendments the Company has entered into between the date of these financial statements and the date they were available to be issued (as described in Note 16), are summarized as follows (in thousands) : Years Ending December 31, 2023 $ 1,064 2024 935 2025 756 2026 437 Total lease payments $ 3,192 Less: imputed interest ( 308 ) Present value of lease liabilities $ 2,884 The Company incurred rent expense of $ 1.0 million and $ 0.7 million for the years ended December 31, 2022 and 2021, respectively. The following table summarizes the operating lease term and discount rate as of December 31, 2022: As of December 31, 2022 Weighted-average remaining lease term (years) 3.3 Weighted-average discount rate 6.5 % Cash paid for amounts included in the measurement of the Company's operating lease liability wa s $ 0.9 million for the year ended December 31, 2022. License Agreement In October 2018, the Company entered an amended and restated exclusive license agreement with the ULRF related to certain licensed patent rights and know-how related to human facilitating cells for its Facilitated Allo-HSCT Therapy approach. Pursuant to the ULRF License Agreement, ULRF granted the Company an exclusive, worldwide license under such patents and a nonexclusive royalty-bearing, worldwide license for such know-how to research, develop, commercialize and manufacture FCR001 and products containing FCR001 in all fields, without limitation. ULRF also granted the Company the right to grant sublicenses in accordance with the ULRF License Agreement. Under the terms of the agreement, the Company is obligated to compensate ULRF three percent of net sales of all licensed products sold, one third of any non-royalty sublicensing income, and up to $ 1.625 million in regulatory and sales milestones on each licensed product upon the occurrence of specific events as outlined in the license agreement; and annual license maintenance fees. In addition, upon execution of the ULRF License Agreement, the Company granted contingent equity consideration equal to 65,186 shares of common stock to ULRF. On or prior to the Company’s first underwritten public offering or any transaction that is treated as a deemed liquidation event, the Company may either issue to ULRF the 65,186 shares in common stock or make a cash payment equal to the 65,186 shares of common stock multiplied by either the price per share of common stock in the underwritten public offering or by the price per share of common stock received in connection with such deemed liquidation event. Coincident with the completion of the Company’s IPO, the Company issued 48,889 shares of common stock to ULRF and provided a cash payment of approximately $ 0.3 million in lieu of issuing the remaining 16,297 shares of common stock. As of December 31, 2022 and 2021, the contingent stock liability was fully satisfied. The Company incurred $ 0.1 million in expense in February 2022 related to an annual maintenance fee pursuant to the license agreement for the year ended December 31, 2022. The Company also incurred $ 0.1 million in expense in February 2021 related to the annual maintenance fee for the year ended December 31, 2021. Legal Proceedings The Company is not currently a party to any material legal proceedings. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses the costs related to its legal proceedings as incurred. The Company may be involved in litigation arising in the ordinary course of conducting business. The Company reviews all litigation on an ongoing basis when making accrual and disclosure decisions. The Company, in accordance with current accounting standards for loss contingencies and based upon information currently known by the Company, will establish reserves for litigation when it is probable that a loss associated with a claim or proceeding has been incurred and the amount of the loss or range of loss can be reasonably estimated. When no amount within the range of loss is a better estimate than any other amount, we accrue the minimum amount of the estimable loss. To the extent that such litigation against the Company may have an exposure to a loss in excess of the amount accrued, the Company believes that such excess would not be material to our financial condition, results of operations, or cash flows. |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2022 | |
Convertible Preferred Stock [Abstract] | |
Convertible Preferred Stock | 9. Convertible Preferred Stock Upon closing of the Company's IPO on May 11, 2021, all 130,499,993 shares of convertible preferred stock that were outstanding immediately prior to the closing of the IPO automatically converted into 23,242,498 shares of common stock and 1,150,000 shares of non-voting common stock. Convertible preferred stock prior to conversion was as follows (in thousands, except share amounts) : Series A Series A-1 Series B Preferred shares authorized, issued and outstanding prior to conversion 40,000,000 28,000,000 62,499,993 Aggregate liquidation preference $ 40,000 $ 35,000 $ 114,994 Under the Third Amended and Restated Certificate of Incorporation, filed upon the Company's IPO, the Company authorized 10,000,000 shares of undesignated preferred stock, $ 0.0001 par value per share ("Preferred Stock"), of which no shares were outstanding at December 31, 2022 and 2021 . |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Common Stock | 10. Common Stock Common Stock On April 30, 2021, the Company’s stockholders approved the third amended and restated certificate of incorporation of the Company, which included the authorization of 10,000,000 shares of undesignated preferred stock with a par value of $ 0.0001 , authorization of 140,000,000 shares of voting common stock and 10,000,000 shares of non-voting common stock. As of December 31, 2022, no undesignated preferred stock was outstanding. Shelf Registration Statement On August 15, 2022, the Company filed a registration statement on Form S-3 (the "registration statement") pursuant to which the Company may issue and sell, from time to time, in one or more series or classes, up to $ 250.0 million in aggregate principal amount of common stock, preferred stock, debt securities, warrants and/or units, in any combination, together or separately, in one or more offerings in amounts and on such minimum prices and terms the Company will determine at the time of offering. Each time the Company sells securities pursuant to the registration statement, a supplemental prospectus specifying the terms of the securities being offered will be filed with the SEC. No shares have been sold under the registration statement as of December 31, 2022. Sales Agreement On August 15, 2022, the Company entered into an At-the-Market Sales Agreement (the "2022 Sales Agreement") with SVB Securities LLC ("SVB"), pursuant to which the Company may elect to issue and sell shares of common stock having an aggregate offering price of up to $ 75.0 million in such quantities and on such minimum price terms as the Company sets from time to time through SVB as the sales agent. The Company agreed to pay SVB an aggregate commission rate of up to 3.0 % of the gross proceeds of the sales price per share for common stock sold through SVB under the 2022 Sales Agreement. The registration statement filed by the Company on August 15, 2022 includes a prospectus pursuant to which the Company may offer and sell, from time to time, shares of common stock having an aggregate offering price of up to $ 75.0 million under the 2022 Sales Agreement. No shares have been sold under the 2022 Sales Agreement as of December 31, 2022. Common Stock Reserved The number of shares of common stock that have been reserved for the potential conversion of Preferred Stock, outstanding stock options granted and stock options available for grant under the Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) and the 2018 Equity Incentive Plan (the “2018 Plan”) and shares reserved for issuance under the Company’s 2021 Employee Stock Purchase Plan (the “2021 ESPP”) are as follows: December 31, 2022 2021 Restricted stock related to early exercise of common stock options 158,154 538,340 Restricted stock units outstanding 1,144,994 — Outstanding common stock options 6,264,898 3,643,796 Shares reserved for issuance under equity incentive plans 758,434 2,702,995 Shares reserved for issuance under the 2021 Employee Stock Purchase Plan 1,166,444 837,088 Total 9,492,924 7,722,219 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 11. Stock-Based Compensation 2021 Employee Stock Purchase Plan In April 2021, the Company’s board of directors and stockholders approved the 2021 ESPP. The 2021 ESPP became effective immediately prior to the effectiveness of the Company’s registration statement on Form S-1 for its IPO. The 2021 ESPP provides employees the opportunity to purchase shares at a 15 % discount at the lower of the share price at the beginning or end of six-month offering periods. 852,971 shares have been reserved and approved for this purpose for the 2021 plan year. The number of shares reserved and available for issuance under the plan will increase on January 1, 2022, and each January 1 thereafter through January 1, 2031, by the lesser of (A) 3,000,000 shares of common stock, (B) 1 % of the cumulative number of shares of common stock issued and outstanding on the immediately preceding December 31 st or (C) such lesser number of shares of common stock as determined by the Board. On January 1, 2022, an additional 414,513 shares were added to the 2021 ESPP, representing 1 % of total common shares outstanding at December 31, 2021. The expense incurred under this plan for the year ended December 31, 2022 was not material to the financial statements. The amounts have been included in the total stock-based compensation line items in the accompanying financial statements and disclosures. Equity Incentive Plans In April 2021, the Company’s board of directors and stockholders approved the 2021 Plan and terminated the 2018 Plan with respect to any unissued awards. The 2021 Plan became effective immediately prior to the effectiveness of the Company’s registration statement on Form S-1 for its IPO. The 2021 Plan provides for the issuance of up to 3,015,907 new share-based awards, as well as the 3,381,382 options to purchase common stock then outstanding under the 2018 Plan, for a total of 6,397,289 shares. To the extent outstanding options granted under the 2018 Plan are cancelled, forfeited, or otherwise terminated without being exercised and would otherwise have been returned to the share reserve under the 2018 Plan, the number of shares underlying such awards will be available for future grant under the 2021 Plan. Beginning on January 1, 2022, t he number of shares reserved and available for issuance under the 2021 Plan will increase on each January 1 through January 1, 2031 by the lesser of (A) 5 % percent of the number of shares of stock issued and outstanding on the immediately preceding December 31 st or (B) such lesser number of shares of common stock as determined by the Board. On January 1, 2022 an additional 2,072,569 shares were added to the 2021 Plan, representing 5 % of total common shares outstanding at December 31, 2021. As of December 31, 2022, 758,434 shares remained available for future grant under the 2021 Plan. 6,190,132 options were outstanding under the 2021 Plan and 2018 Plan as of December 31, 2022. The Company’s 2021 Plan provides for the Company to sell or issue common stock or restricted common stock or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, nonemployees and members of the board of directors of the Company. The 2021 Plan is administered by the board of directors or at the discretion of the board of directors by the compensation committee of the board. The exercise prices, vesting periods, and other restrictions are determined at the discretion of the compensation committee of the board of directors, except that the exercise price per share of stock options may not be less than 100 % of the fair market value of the share of common stock on the date of grant and the contractual term of stock option may not be greater than 10 years . Stock options granted to date typically vest over four years . Stock Option Valuation The assumptions used to determine the fair values of stock options granted to employees and directors are presented as follows: For the years ended December 31, 2022 2021 Fair value of common stock $ 1.53 - 16.56 $ 5.72 - 17.00 Dividend yield —% —% Volatility 82.29 %- 88.41 % 80.6 %- 91.25 % Risk-free interest rate 1.46 %- 4.23 % 0.50 %- 1.33 % Expected term (years) 5.38 - 6.25 6.25 Summary of Option Activity The Company’s stock option activity regarding employees, directors, and nonemployees is summarized as follows ( in thousands excepts share and per share amounts) : Shares Weighted- Weighted- Aggregate Options outstanding—January 1, 2021 2,745,185 $ 4.20 9.40 $ 4,183 Granted 1,076,022 9.19 Exercised ( 149,707 ) 2.12 Cancelled ( 7,605 ) 1.38 Forfeited ( 20,099 ) 5.79 Options outstanding—December 31, 2021 3,643,796 $ 5.75 8.69 $ 34,754 Granted 3,252,866 8.12 Exercised ( 96,646 ) 1.12 Cancelled ( 57,434 ) 5.25 Forfeited ( 477,684 ) 7.55 Options outstanding—December 31, 2022 6,264,898 $ 6.92 8.43 $ 42 Options exercisable—December 31, 2022 1,838,406 $ 5.23 7.56 Additional information with regard to stock option activity involving employees and directors is as follows ( in thousands except per share amounts) : For the years ended December 31, 2022 2021 Weighted-average grant-date fair value per option of total options granted $ 5.82 $ 6.69 Aggregate intrinsic value of stock options exercised 291 1,616 As of December 31, 2022 , total unrecognized compensation cost related to the unvested awards to employees, directors, and nonemployees is $ 20.0 million , which is expected to be recognized over a weighted-average period of 2.7 years. Summary of Restricted Stock Unit Activity The fair values of restricted stock units (“RSUs”) are based on the fair market value of the Company’s common stock on the date of grant. Each RSU represents a contingent right to receive one share of the Company’s common stock upon vesting. In general, RSUs vest (i) annually in four equal installments on the grant anniversary or (ii) incrementally over two years . The following table summarizes the Company’s RSU activity for the year ended December 31, 2022: Number of Restricted Weighted- Outstanding at January 1, 2022 — $ — Granted 1,391,906 7.17 Vested ( 154,388 ) 9.10 Forfeited ( 92,524 ) 8.98 Outstanding at December 31, 2022 1,144,994 $ 6.76 The total fair value of restricted stock units vested during the year ended December 31, 2022 was $ 0.7 million. As of December 31, 2022, total unrecognized compensation cost related to the unvested awards to employees i s $ 6.9 million, which is expected to be recognized over a weighted-average period of 1.7 years . Stock-Based Compensation The Company recorded stock-based compensation expense regarding its employees, directors, and nonemployees as follows (in thousands) : For the years ended December 31, 2022 2021 Research and development expense $ 6,558 $ 1,848 General and administrative expense 4,598 1,930 Total $ 11,156 $ 3,778 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes The Company recorded no income tax benefit for the net loss incurred for the years ended December 31, 2022 and 2021, due to its uncertainty of realizing a benefit from such losses. All of the Company’s operating losses since inception have been generated in the United States. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective tax rate is as follows: For the years ended December 31, 2022 2021 Federal statutory rate 21.0 % 21.0 % Federal research tax credit/orphan drug credit 0.3 % 2.4 % Permanent items, including stock compensation ( 0.9 )% ( 0.6 )% Change in valuation allowance ( 20.7 )% ( 22.0 )% Other 0.2 % ( 0.9 )% 0.0 % 0.0 % Significant components of the Company’s deferred tax assets are included in the table below (in thousands) : For the years ended December 31, 2022 2021 Deferred tax assets: Net operating loss and capital loss carryforwards $ 25,875 $ 20,815 Capitalized research and development expenses 14,500 — Research and development credit carryforwards 2,610 2,359 Accrued expenses 127 1,377 Stock-based compensation 2,894 876 Operating lease right-of-use assets 68 — Total deferred tax assets 46,074 25,427 Deferred tax liabilities: Depreciation ( 179 ) ( 80 ) Accretion ( 331 ) — Total deferred tax assets ( 510 ) ( 80 ) Less valuation allowance ( 45,564 ) ( 25,347 ) Net deferred tax assets $ — $ — The Company’s management has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are composed primarily of net operating loss ("NOL") carryforwards and research and development credit carryforwards. Management has considered the Company’s history of net losses incurred since inception and probability of future losses to conclude it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets. As a result, the Company has established a valuation allowance for the full amount of the net deferred tax assets as of December 31, 2022 and December 31, 2021 . The valuation allowance increased by $ 20.2 million and $ 13.2 million during the years ended December 31, 2022 and December 31, 2021, respectively. As of December 31, 2022 , the Company has $ 96.9 million of US federal NOLs and $ 97.1 million of Kentucky state NOL carryforwards that have no expiration dates. The Company does no t have any US federal or state capital loss carryforwards that expire in 2023 . In addition, the Company had a US federal research and development tax credit carryforward of $ 2.6 million, which may be available to reduce future tax liabilities which start to expire in 2039 . Through December 31, 2022, the Company has generated research and development tax credits but has not conducted a study to document the qualified activities. Such study may result in an adjustment to the Company’s research and development credit carryforwards. Since a full valuation allowance has been provided against the Company’s research and development credits, any reduction in the gross deferred tax asset established for the research and development credit carryforwards would not result in any net impact to the Company’s financial statements. Effective January 1, 2022, the 2017 Tax Cuts and Jobs Act ("TCJA") requires research and experimenatal ("R&E") expenses under Internal Revenue Code Section 174 to be capitalized. R&E expenses are required to be amortized over a five-year period for domestic expenses and over a fifteen-year period for foreign expenses. Prior to the TCJA being effective, businesses had the option of deducting Section 174 expenses in the year incurred or capitalizing and amortizing the costs over five years . The Company has reflected this change in treatment of R&E expenses in the current tax provision. Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the NOL carryforward period. Under the provisions of Sections 382 and 383 of the Internal Revenue Code ("IRC"), and corresponding provisions of state law, certain substantial changes in the Company’s ownership, including a sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of NOL carryforwards, which could be used annually to offset future taxable income. No study has been completed as of the date of these financial statements to determine whether a change in control, as defined by Section 382 of the IRC, has occurred. If it is determined the Company has experienced a change in control at any time since inception, realization of the NOL carryforwards or research and development tax credit carryforwards may be subject to an annual limitation. Any limitation may result in the expiration of a portion of NOL or research and development tax credit carryforwards before they are realized. The Company files US federal and state tax returns in the United States. All tax years since incorporation remain open to examination by the major taxing jurisdictions (state and federal) to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service ("IRS") or other authorities if they have or will be used in a future period. The Company is not currently under examination by the IRS or any other jurisdictions for any tax year. |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | 13. Defined Contribution Plan The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis. Current Company match contributions to the plan are made to employees who meet minimum service requirements in the amount of 100 % of the first 3 %, and 50 % of the next 2 % of employee contributions, subject to certain limitations. For the years ended December 31, 2022 and 2021, the Company made contributions in the amount of $ 0.6 m illion and $ 0.4 million, respectively. |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | 14. Net Loss Per Share Attributable to Common Stockholders Net Loss Per Share The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company (in thousands except share and per share amounts ). For the years ended December 31, 2022 2021 Net loss and net loss attributable to common stockholders $ ( 73,894 ) $ ( 47,833 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 1.79 ) $ ( 1.64 ) Weighted average number of common shares outstanding used in computation of 41,248,392 29,126,373 The Company’s potential dilutive securities, which include unvested RSUs, restricted stock related to early exercise of common stock options and common stock options, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. 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 following potential dilutive securities, presented on an as converted basis, were excluded from the calculation of net loss per share due to their anti-dilutive effect: For the years ended December 31, 2022 2021 Options to purchase common stock 6,264,898 3,643,796 Restricted stock units outstanding 1,144,994 — Restricted stock related to early exercise of options to purchase common stock 158,154 538,340 7,568,046 4,182,136 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions The Company engaged a firm managed by a former executive of the company for professional services related to accounting, finance and other administrative functions during the year ended December 31, 2021 . The costs incurred under this arrangement totaled $ 0.1 million, which were recorded as general and administrative expense in the accompanying statements of operations. No services were provided under this arrangement for the year ending December 31, 2022 and there are no amounts owed under this arrangement. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events The Company has evaluated subsequent events through March 31, 2023, the date the financial statements were available to be issued. The Company has concluded no subsequent events have occurred that require disclosure, except for those referenced below. Strategic Alternatives and Restructuring Plan In February 2023, the Company announced the discontinuation of its FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipients. This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones. The Company initiated a comprehensive review of strategic alternatives focused on maximizing shareholder value, including possible business combinations and/or a divestiture of the Company’s cell therapy CMC capabilities. In connection with the discontinuation of FREEDOM-1 and FREEDOM-2 noted above, the Company implemented a restructuring plan. As part of this plan, the Company approved a reduction in the Company’s workforce by approximately one-third across different areas and functions in the Company (the “Workforce Reduction”). The Workforce Reduction was substantially completed in the first quarter of 2023. Affected employees were offered separation benefits, including severance payments. The Company estimates that retention, severance, and termination-related costs will total approximatel y $ 2.9 million i n the aggregate and expects to record these charges in the first and second quarters of 2023. The Company expects that payments of these costs will be substantially complete through the end of the second quarter of 2023. The Company's estimates are subject to a number of assumptions, and actual costs may differ. Leases On March 1, 2023, the Company entered into an amended lease agreement for the Louisville Lease. The amendment increased the number of successive one-year renewal terms from three to five . The amendment also reduced the written renewal notice period for the successive one-year terms from six months in advance to three months in advance. The amendment is not expected to have a material impact on the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("US GAAP"). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make judgments, assumptions, and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of financial statements, and the reported amounts of income and expense during the reporting period. The most significant estimates relate to determination of the fair value of stock option grants and estimates related to the amount of accrued research and development expenses as of the balance sheet date. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors, including the current economic environment, and makes adjustments when the facts and circumstances dictate. These estimates are based on information available as of the date of the financial statements; therefore, actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. As of December 31, 2022 and 2021 , cash consists primarily of checking and savings deposits and money market fund holdings. |
Marketable Securities | Marketable Securities The Company classifies its marketable securities as available-for-sale securities, which are carried at their fair value based on the quoted market prices of the securities. Unrealized gains and losses are reported as accumulated other comprehensive loss, a separate component of stockholders’ deficit. Realized gains and losses on available-for-sale securities are included in net loss in the period earned or incurred. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Equipment and furniture and fixtures are depreciated over five or seven year lives. Leasehold improvements are amortized over the shorter of the lease term or the five-year estimated useful life of the asset . Computer equipment and computer software are depreciated over three years . Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist primarily of property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. During the year ended December 31, 2022 , the Company recorded a $ 0.2 million non-cash impairment charge (see Note 6). No impairments were identified as of December 31, 2021 . |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company’s investment policy includes guidelines regarding the quality of the financial institutions and financial instruments and defines allowable investments that it believes minimizes the exposure to concentration of credit risk. The Company may invest in money market funds (minimum of $ 1 billion in assets), U.S. Treasury securities, corporate debt, bank debt, U.S. government-related agency securities, other sovereign debt, municipal debt and commercial paper. These deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts and believes that it is not exposed to significant credit risk as our deposits are held at financial institutions that management believes to be of high credit quality. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that the Company would receive to sell an investment in a timely transaction or pay to transfer a liability in a timely transaction with an independent buyer in the principal market, or in the absence of a principal market, the most advantageous market for the investment or liability. A framework is used for measuring fair value utilizing a three-tier hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 investments) and the lowest priority to unobservable inputs (Level 3 investments). The three levels of the fair value hierarchy are as follows: • Level 1 inputs: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; • Level 2 inputs: Quoted prices in markets that are not considered to be active or financial instrument valuations for which all significant inputs are observable, either directly or indirectly; and, • Level 3 inputs: Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. Financial instruments are categorized in their entirety based on the lowest level of input that is significant to the fair value measurement. The assessment of the significance of a particular input to the fair value measurement requires judgment and considers factors specific to the investment. The Company’s money market funds and marketable securities are carried at fair value determined according to the fair value hierarchy described above (Level 1 and Level 2, respectively). |
Research and Development Expenses | Research and Development Expenses Research and development expenses include (i) employee-related expenses, including salaries, benefits, travel and stock-based compensation expense; (ii) external research and development expenses incurred under arrangements with third parties, such as contract research organization agreements, investigational sites, and consultants; (iii) the cost of acquiring, developing, and manufacturing clinical study materials; (iv) costs associated with preclinical and clinical activities and regulatory operations; (v) costs incurred in development of intellectual property; and (vi) an allocated portion of facilities and other infrastructure costs associated with our research and development activities. Costs incurred in connection with research and development activities are expensed as incurred. The Company enters into consulting, research, and other agreements with commercial entities, researchers, universities, and others for the provision of goods and services. Such arrangements are generally cancelable upon reasonable notice and payment of costs incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided by the respective vendors, including the Company’s clinical sites. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved, and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly. |
Stock-Based Compensation | Stock-Based Compensation The Company measures all stock options and other stock-based awards granted to employees, nonemployees, and directors based on the fair value on the date of the grant and recognizes stock-based compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues stock option and restricted stock unit awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company’s policy is to account for forfeitures when they occur. The Company classifies stock-based compensation expense in its statement of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company recently completed its IPO and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the US Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is zero because the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Prior to the Company’s IPO, the Company considered the estimated fair value of the common stock as of the measurement date in determining the exercise price for options granted. The estimated fair value of the common stock was determined at each grant date based upon a variety of factors, including the illiquid nature of the common stock, arm’s-length sales of the Company’s capital stock (including convertible preferred stock), the effect of the rights and preferences of the preferred shareholders, and the prospects of a liquidity event. Among other factors are the Company’s financial position and historical financial performance, forecasted future operations of the Company, an evaluation or benchmark of the Company’s competition, and the current business climate in the marketplace. Significant changes to the key assumptions underlying the factors used could result in different fair values of common stock at each valuation date. The fair value for options granted since the Company’s IPO are based on the closing stock price on grant date . |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more likely than not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions. These reserves are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. Potential interest and penalties associated with such uncertain tax positions are recorded as a component of income tax expense. The Company had no significant uncertain tax positions as of December 31, 2022 and December 31, 2021 . |
Basic and Diluted Net Loss Per Share | Basic and Diluted Net Loss Per Share The Company calculates basic and diluted net loss per share using the two-class method. The two-class method requires income available to common stockholders for the period to be allocated between common stock and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Accordingly, basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the dilutive effects of potentially dilutive securities outstanding during the period. Potentially dilutive securities include vested and unexercised stock options, restricted stock issued upon early exercise of stock options, convertible preferred shares and contingent stock liabilities. The dilutive effect of stock options and contingent stock liabilities are computed using the treasury stock method and the dilutive effect of convertible preferred shares is calculated using the if-converted method. The Company has generated a net loss for all periods presented, therefore diluted net loss per share is the same as basic net loss per share since the inclusion of potentially dilutive securities would be anti-dilutive. |
Segments | Segments Operating segments are defined as components of an entity for which separate financial information is made available and is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company’s CODM is the chief executive officer and operations are managed as a single segment for the purposes of assessing performance and making operating decisions. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss represents net loss for the period plus the results of certain other changes in stockholders’ equity. The Company’s comprehensive loss included unrealized gains related to marketable securities for the years ended December 31, 2022 and 2021 . |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , which requires lessees to recognize the right-of-use assets and related lease liabilities in the balance sheet. The new standard provides for a modified retrospective application. ASU 2016-02 is effective for interim and annual period beginning after December 15, 2021. The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term for those leases commencing prior to January 1, 2022 did not change with the adoption of the new leasing standards. The expected lease term for leases commencing after the adoption of the new leasing standards includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. As a result of the adoption of the new leasing standards, on January 1, 2022, the Company recorded right-of-use assets of $ 3.4 million and operating lease liabilities of $ 3.5 million. The adoption did not have a material impact on the statement of operations or the statement of cash flows. For additional information on the adoption of the new leasing standard, refer to Note 8. The following table presents the cumulative effect of adoption of ASC 842 on January 1, 2022 (in thousands) : January 1, 2022 Prior to adoption of new leasing standards Adjustment for adoption of new leasing standards As adjusted Right-of-use assets (1) $ — $ 3,422 $ 3,422 Deferred rent (2) $ 105 $ ( 105 ) $ — Operating lease liability (3) $ — $ 645 $ 645 Operating lease liability, net of current portion (3) $ — $ 2,882 $ 2,882 (1) Represents capitalization of operating right-of-use assets (2) Represents reclassification of deferred rent and incentives as a reduction of operating right-of-use assets (3) Represents recognition of operating right-of-use assets |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary of Cumulative Effect of Adoption of ASC 842 | The following table presents the cumulative effect of adoption of ASC 842 on January 1, 2022 (in thousands) : January 1, 2022 Prior to adoption of new leasing standards Adjustment for adoption of new leasing standards As adjusted Right-of-use assets (1) $ — $ 3,422 $ 3,422 Deferred rent (2) $ 105 $ ( 105 ) $ — Operating lease liability (3) $ — $ 645 $ 645 Operating lease liability, net of current portion (3) $ — $ 2,882 $ 2,882 (1) Represents capitalization of operating right-of-use assets (2) Represents reclassification of deferred rent and incentives as a reduction of operating right-of-use assets (3) Represents recognition of operating right-of-use assets |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments Measured at Fair Value on Recurring Basis | The following table presents information about the Company’s financial instruments that are measured at fair value on a recurring basis and indicates the fair value hierarchy of the inputs the Company utilized to determine such fair value (in thousands) : December 31, 2022 Total Level 1 Level 2 Level 3 Financial assets: Money market funds (cash equivalents) $ 12,309 $ 12,309 $ — $ — Marketable securities 167,612 31,718 135,894 — Total financial assets measured at fair value $ 179,921 $ 44,027 $ 135,894 $ — December 31, 2021 Total Level 1 Level 2 Level 3 Financial assets: Money market funds (cash equivalents) $ 10,319 $ 10,319 $ — $ — Marketable securities 225,357 27,186 198,171 — Total financial assets measured at fair value $ 235,676 $ 37,505 $ 198,171 $ — |
Schedule of Contingent Common Stock Liability Measured at Fair Value | A rollforward of the contingent common stock liability, which is measured at fair value for the year ended December 31, 2021, is represented as follows (in thousands) : Fair value as of January 1, 2021 $ 373 Change in fair value 735 Share issuance in partial settlement of contingent stock ( 831 ) Cash payment in partial settlement of contingent stock ( 277 ) Fair value as of December 31, 2021 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Marketable Securities [Abstract] | |
Summary of Company's Investments | The following table summarizes the Company’s investments (in thousands) : December 31, 2022 Amortized Unrealized Unrealized Estimated Commercial paper $ 119,313 $ 19 $ ( 365 ) $ 118,967 Government and agency securities 43,016 — ( 368 ) 42,648 Corporate debt securities 6,004 — ( 7 ) 5,997 Total $ 168,333 $ 19 $ ( 740 ) $ 167,612 December 31, 2021 Amortized Unrealized Unrealized Estimated Commercial paper $ 179,151 $ 38 $ ( 47 ) $ 179,142 Corporate debt securities 31,244 — ( 58 ) 31,186 Government and agency securities 15,040 — ( 11 ) 15,029 Total $ 225,435 $ 38 $ ( 116 ) $ 225,357 |
Schedule of Fair Values of Available-for-Sale Debt Securities By Contractual Maturity | The fair values of available-for-sale debt securities as of December 31, 2022, by contractual maturity, are summarized as follows (in thousands) : December 31, 2022 Due in one year or less $ 165,648 Due after one year through two years 1,964 $ 167,612 |
Prepaid and Other Current Ass_2
Prepaid and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Summary of Prepaid and Other Current Assets | Prepaid and other current assets consisted of the following (in thousands) : December 31, 2022 2021 Prepaid insurance $ 1,037 $ 1,121 Prepaid research and development expenses 2,426 782 Other current assets 868 640 Total prepaid and other current assets $ 4,331 $ 2,543 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands) : December 31, 2022 2021 Equipment $ 6,562 $ 4,449 Leasehold improvements 1,191 821 Computer equipment 859 953 Furniture and fixtures 674 426 Construction in progress 242 952 Total property and equipment 9,528 7,601 Less accumulated depreciation ( 4,180 ) ( 2,797 ) Property and equipment, net $ 5,348 $ 4,804 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands) : December 31, 2022 2021 Compensation and benefit costs $ 3,566 $ 3,320 Research and development expenses 1,978 854 Professional fees, consulting and other 1,121 1,257 Total accrued expenses $ 6,665 $ 5,431 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rent Payments | The future minimum rent payments relating to all four of the Company’s ongoing facility operating leases under the terms and conditions existing as of December 31, 2022, as well as amendments the Company has entered into between the date of these financial statements and the date they were available to be issued (as described in Note 16), are summarized as follows (in thousands) : Years Ending December 31, 2023 $ 1,064 2024 935 2025 756 2026 437 Total lease payments $ 3,192 Less: imputed interest ( 308 ) Present value of lease liabilities $ 2,884 |
Summary of Operating Lease Term and Discount Rate | The following table summarizes the operating lease term and discount rate as of December 31, 2022: As of December 31, 2022 Weighted-average remaining lease term (years) 3.3 Weighted-average discount rate 6.5 % |
Convertible Preferred Stock (Ta
Convertible Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Convertible Preferred Stock [Abstract] | |
Summary of Convertible Preferred Stock | Convertible preferred stock prior to conversion was as follows (in thousands, except share amounts) : Series A Series A-1 Series B Preferred shares authorized, issued and outstanding prior to conversion 40,000,000 28,000,000 62,499,993 Aggregate liquidation preference $ 40,000 $ 35,000 $ 114,994 |
Common Stock (Table)
Common Stock (Table) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Common Stock Reserved | The number of shares of common stock that have been reserved for the potential conversion of Preferred Stock, outstanding stock options granted and stock options available for grant under the Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) and the 2018 Equity Incentive Plan (the “2018 Plan”) and shares reserved for issuance under the Company’s 2021 Employee Stock Purchase Plan (the “2021 ESPP”) are as follows: December 31, 2022 2021 Restricted stock related to early exercise of common stock options 158,154 538,340 Restricted stock units outstanding 1,144,994 — Outstanding common stock options 6,264,898 3,643,796 Shares reserved for issuance under equity incentive plans 758,434 2,702,995 Shares reserved for issuance under the 2021 Employee Stock Purchase Plan 1,166,444 837,088 Total 9,492,924 7,722,219 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Assumptions Used to Determine the Fair Values of Stock Options Granted | The assumptions used to determine the fair values of stock options granted to employees and directors are presented as follows: For the years ended December 31, 2022 2021 Fair value of common stock $ 1.53 - 16.56 $ 5.72 - 17.00 Dividend yield —% —% Volatility 82.29 %- 88.41 % 80.6 %- 91.25 % Risk-free interest rate 1.46 %- 4.23 % 0.50 %- 1.33 % Expected term (years) 5.38 - 6.25 6.25 |
Summary of Option Activity | The Company’s stock option activity regarding employees, directors, and nonemployees is summarized as follows ( in thousands excepts share and per share amounts) : Shares Weighted- Weighted- Aggregate Options outstanding—January 1, 2021 2,745,185 $ 4.20 9.40 $ 4,183 Granted 1,076,022 9.19 Exercised ( 149,707 ) 2.12 Cancelled ( 7,605 ) 1.38 Forfeited ( 20,099 ) 5.79 Options outstanding—December 31, 2021 3,643,796 $ 5.75 8.69 $ 34,754 Granted 3,252,866 8.12 Exercised ( 96,646 ) 1.12 Cancelled ( 57,434 ) 5.25 Forfeited ( 477,684 ) 7.55 Options outstanding—December 31, 2022 6,264,898 $ 6.92 8.43 $ 42 Options exercisable—December 31, 2022 1,838,406 $ 5.23 7.56 |
Summary of Additional Information to Stock Option Activity Involving Employees and Directors | Additional information with regard to stock option activity involving employees and directors is as follows ( in thousands except per share amounts) : For the years ended December 31, 2022 2021 Weighted-average grant-date fair value per option of total options granted $ 5.82 $ 6.69 Aggregate intrinsic value of stock options exercised 291 1,616 |
Summary of RSU Activity | The following table summarizes the Company’s RSU activity for the year ended December 31, 2022: Number of Restricted Weighted- Outstanding at January 1, 2022 — $ — Granted 1,391,906 7.17 Vested ( 154,388 ) 9.10 Forfeited ( 92,524 ) 8.98 Outstanding at December 31, 2022 1,144,994 $ 6.76 |
Summary of Stock-based Compensation Expense | The Company recorded stock-based compensation expense regarding its employees, directors, and nonemployees as follows (in thousands) : For the years ended December 31, 2022 2021 Research and development expense $ 6,558 $ 1,848 General and administrative expense 4,598 1,930 Total $ 11,156 $ 3,778 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of Reconciliation of U.S. Federal Statutory Income Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective tax rate is as follows: For the years ended December 31, 2022 2021 Federal statutory rate 21.0 % 21.0 % Federal research tax credit/orphan drug credit 0.3 % 2.4 % Permanent items, including stock compensation ( 0.9 )% ( 0.6 )% Change in valuation allowance ( 20.7 )% ( 22.0 )% Other 0.2 % ( 0.9 )% 0.0 % 0.0 % |
Summary of Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are included in the table below (in thousands) : For the years ended December 31, 2022 2021 Deferred tax assets: Net operating loss and capital loss carryforwards $ 25,875 $ 20,815 Capitalized research and development expenses 14,500 — Research and development credit carryforwards 2,610 2,359 Accrued expenses 127 1,377 Stock-based compensation 2,894 876 Operating lease right-of-use assets 68 — Total deferred tax assets 46,074 25,427 Deferred tax liabilities: Depreciation ( 179 ) ( 80 ) Accretion ( 331 ) — Total deferred tax assets ( 510 ) ( 80 ) Less valuation allowance ( 45,564 ) ( 25,347 ) Net deferred tax assets $ — $ — |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Computation of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company (in thousands except share and per share amounts ). For the years ended December 31, 2022 2021 Net loss and net loss attributable to common stockholders $ ( 73,894 ) $ ( 47,833 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 1.79 ) $ ( 1.64 ) Weighted average number of common shares outstanding used in computation of 41,248,392 29,126,373 |
Summary of Potential Dilutive Securities Excluded From Calculation of Net Loss Per Share Due to Anti-dilutive Effect | The following potential dilutive securities, presented on an as converted basis, were excluded from the calculation of net loss per share due to their anti-dilutive effect: For the years ended December 31, 2022 2021 Options to purchase common stock 6,264,898 3,643,796 Restricted stock units outstanding 1,144,994 — Restricted stock related to early exercise of options to purchase common stock 158,154 538,340 7,568,046 4,182,136 |
Nature of Business and Liquid_2
Nature of Business and Liquidity - Additional Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
May 11, 2021 USD ($) $ / shares shares | Apr. 30, 2021 | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||
Underwriting discounts and commissions and other expenses | $ 12,858,764 | |||
Preferred stock outstanding | shares | 0 | 0 | 0 | |
Reverse stock split ratio | 0.1869 | |||
Net loss | $ 73,894 | $ 47,833 | ||
Cash used for operation | 60,857 | 39,988 | ||
Accumulated deficit | 164,741 | 90,847 | ||
Cash and cash equivalents | 13,670 | $ 18,614 | ||
Marketable securities | $ 167,600 | |||
Initial Public Offering | ||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||
Offering price | $ / shares | $ 17 | |||
Common Stock | ||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||
Number of shares issued and sold | shares | 8,825,000 | |||
Underwriting discounts and commissions and other expenses | $ 2,369 | |||
Common Stock | Initial Public Offering | ||||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | ||||
Number of shares issued and sold | shares | 8,825,000 | |||
Offering price | $ / shares | $ 17 | |||
Gross proceeds from sale of shares | $ 150,000 | |||
Underwriting discounts and commissions and other expenses | $ 12,900 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2022 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Impairments of long-lived assets | $ 200,000 | $ 0 | |
Expected dividend yield | 0% | ||
Non-cash impairment expense | $ 200,000 | $ 0 | |
Operating lease liability | 2,884,000 | $ 3,500,000 | |
Right-of-use assets | $ 2,643,000 | $ 3,400,000 | |
Leasehold Improvements | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, plant and equipment, useful life | 5 years | ||
Property, plant and equipment, useful life | amortized over the shorter of the lease term or the five-year estimated useful life of the asset | ||
Computer Equipment and Computer Software | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, plant and equipment, useful life | 3 years | ||
Minimum | Money Market Funds | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Investment in assets | $ 1,000,000,000 | ||
Minimum | Equipment and Furniture and Fixtures | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, plant and equipment, useful life | 5 years | ||
Maximum | Equipment and Furniture and Fixtures | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, plant and equipment, useful life | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Cumulative Effect of Adoption of ASC 842 (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Right-of-use assets | $ 2,643 | $ 3,400 |
Operating lease liability | 2,884 | 3,500 |
Operating lease liability, net of current portion | $ 910 | |
Adoption of ASC 842 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Right-of-use assets | 3,422 | |
Operating lease liability | 645 | |
Operating lease liability, net of current portion | 2,882 | |
Adoption of ASC 842 | Prior to adoption of new leasing standards | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Deferred rent | 105 | |
Adoption of ASC 842 | Adjustment for adoption of new leasing standards | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Right-of-use assets | 3,422 | |
Deferred rent | (105) | |
Operating lease liability | 645 | |
Operating lease liability, net of current portion | $ 2,882 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Summary of Financial Instruments Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Total financial assets measured at fair value | $ 179,921 | $ 235,676 |
Money Market Funds | Cash Equivalents | ||
Financial assets: | ||
Total financial assets measured at fair value | 12,309 | 10,319 |
Marketable Securities | ||
Financial assets: | ||
Total financial assets measured at fair value | 167,612 | 225,357 |
Level 1 | ||
Financial assets: | ||
Total financial assets measured at fair value | 44,027 | 37,505 |
Level 1 | Money Market Funds | Cash Equivalents | ||
Financial assets: | ||
Total financial assets measured at fair value | 12,309 | 10,319 |
Level 1 | Marketable Securities | ||
Financial assets: | ||
Total financial assets measured at fair value | 31,718 | 27,186 |
Level 2 | ||
Financial assets: | ||
Total financial assets measured at fair value | 135,894 | 198,171 |
Level 2 | Marketable Securities | ||
Financial assets: | ||
Total financial assets measured at fair value | $ 135,894 | $ 198,171 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2021 USD ($) shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 USD ($) shares | Jan. 01, 2021 UsdPerShares | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Number of shares equal to fair value of contingent equity consideration | 65,186 | |||
Common stock, shares issued | 41,629,426 | 39,763,049 | ||
Cash payment for contingent equity settlement | $ | $ 277 | |||
Measurement Input, Share Price | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Fair value of common stock used to value contingent stock liability | UsdPerShares | 5.72 | |||
IPO | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Shares issued, price per share | $ / shares | $ 17 | |||
ULRF | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Common stock, shares issued | 16,297 | |||
Cash payment for contingent equity settlement | $ | $ 300 | |||
ULRF | IPO | ||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||||
Common stock, shares issued | 48,889 | |||
Cash payment for contingent equity settlement | $ | $ 300 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Schedule of Contingent Common Stock Liability Measured at Fair Value (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value, Beginning balance | $ 373 |
Change in fair value | 735 |
Share issuance in partial settlement of contingent stock | (831) |
Cash payment in partial settlement of contingent stock | (277) |
Fair value, Ending balance | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Company's Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 168,333 | $ 225,435 |
Unrealized Gain | 19 | 38 |
Unrealized (Loss) | (740) | (116) |
Estimated Fair Value | 167,612 | 225,357 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 119,313 | 179,151 |
Unrealized Gain | 19 | 38 |
Unrealized (Loss) | (365) | (47) |
Estimated Fair Value | 118,967 | 179,142 |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 6,004 | 31,244 |
Unrealized (Loss) | (7) | (58) |
Estimated Fair Value | 5,997 | 31,186 |
Government and agency securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 43,016 | 15,040 |
Unrealized (Loss) | (368) | (11) |
Estimated Fair Value | $ 42,648 | $ 15,029 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Fair Values of Available-for-Sale Debt Securities By Contractual Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-Sale, Fair Value, Fiscal Year Maturity [Abstract] | ||
Due in one year or less | $ 165,648 | |
Due after one year through two years | 1,964 | |
Available-for-sale debt securities, Fair value | $ 167,612 | $ 225,357 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | Dec. 31, 2022 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale securities, unrealized loss position | $ 130,500,000 |
Available-for-sale securities, allowance for credit losses | $ 0 |
Prepaid and Other Current Ass_3
Prepaid and Other Current Assets - Summary of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid insurance | $ 1,037 | $ 1,121 |
Prepaid research and development expenses | 2,426 | 782 |
Other current assets | 868 | 640 |
Total prepaid and other current assets | $ 4,331 | $ 2,543 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 9,528 | $ 7,601 |
Less accumulated depreciation | (4,180) | (2,797) |
Property and equipment, net | 5,348 | 4,804 |
Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 6,562 | 4,449 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,191 | 821 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 859 | 953 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 674 | 426 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 242 | $ 952 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 1,400,000 | $ 600,000 |
Non-cash impairment expense | $ 200,000 | $ 0 |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Research and development |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Compensation and benefit costs | $ 3,566 | $ 3,320 |
Research and development expenses | 1,978 | 854 |
Professional fees, consulting and other | 1,121 | 1,257 |
Total accrued expenses | $ 6,665 | $ 5,431 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||
Jul. 31, 2021 | Sep. 30, 2021 | May 31, 2021 USD ($) shares | Feb. 28, 2021 USD ($) | Oct. 31, 2018 USD ($) shares | Dec. 31, 2022 USD ($) Leaseagreement shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | |
Loss Contingencies [Line Items] | ||||||||
Number of active lease agreements | Leaseagreement | 4 | |||||||
Lessee, operating lease, existence of option to extend | true | |||||||
Lease option to extend | three additional years | |||||||
Lease termination date | Nov. 30, 2023 | |||||||
Rent expense | $ 1,000,000 | $ 700,000 | ||||||
Common stock issued | shares | 41,629,426 | 39,763,049 | ||||||
Cash payment for contingent equity settlement | $ 277,000 | |||||||
Cash paid for measurement of operating lease liability | $ 900,000 | |||||||
Contingent stock liability | $ 0 | $ 373,000 | ||||||
Annual maintenance fee pursuant to license agreement | $ 100,000 | |||||||
ULRF | ||||||||
Loss Contingencies [Line Items] | ||||||||
Common stock issued | shares | 16,297 | |||||||
Cash payment for contingent equity settlement | $ 300,000 | |||||||
ULRF | IPO | ||||||||
Loss Contingencies [Line Items] | ||||||||
Common stock issued | shares | 48,889 | |||||||
Cash payment for contingent equity settlement | $ 300,000 | |||||||
ULRF License Agreement | ULRF | ||||||||
Loss Contingencies [Line Items] | ||||||||
Percentage of compensation on net sales of all licensed products sold | 3% | |||||||
Compensation on non-royalty sublicensing income | one third | |||||||
Common stock issued | shares | 65,186 | |||||||
ULRF License Agreement | ULRF | Contingent Equity Consideration | ||||||||
Loss Contingencies [Line Items] | ||||||||
Common stock issued | shares | 65,186 | |||||||
ULRF License Agreement | ULRF | Maximum | ||||||||
Loss Contingencies [Line Items] | ||||||||
Compensation on regulatory and sales milestones | $ 1,625,000 | |||||||
Kentucky | ||||||||
Loss Contingencies [Line Items] | ||||||||
Lease termination date | Nov. 30, 2023 | |||||||
Massachusetts | ||||||||
Loss Contingencies [Line Items] | ||||||||
Lease termination date | Mar. 31, 2021 | |||||||
Lease term extension date | 2025-09 | |||||||
Lease extension period | 39 months | |||||||
Houston, Texas | ||||||||
Loss Contingencies [Line Items] | ||||||||
Termination date | December 2024 | |||||||
Lease term period | 36 months |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Future Minimum Rent Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 |
Lessee, Operating Lease, Liability, to be Paid, Rolling Maturity [Abstract] | ||
2023 | $ 1,064 | |
2024 | 935 | |
2025 | 756 | |
2026 | 437 | |
Total lease payments | 3,192 | |
Less: imputed interest | (308) | |
Present value of lease liabilities | $ 2,884 | $ 3,500 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Operating Lease Term and Discount Rate (Details) | Dec. 31, 2022 |
Lessee, Operating Lease, Description [Abstract] | |
Weighted-average remaining lease term (years) | 3 years 3 months 18 days |
Weighted-average discount rate | 6.50% |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2022 | May 11, 2021 | Apr. 30, 2021 | Dec. 31, 2020 | |
Convertible Preferred Stock [Line Items] | |||||
Issuance costs, incurred | $ 12,858,764 | ||||
Preferred stock, shares outstanding | 130,499,993 | ||||
Authorization of undesignated preferred stock | 10,000,000 | ||||
Undesignated preferred stock, par value | $ 0.0001 | ||||
Undesignated preferred stock, outstanding | 0 | 0 | 0 | ||
Non-voting Common Stock | |||||
Convertible Preferred Stock [Line Items] | |||||
Conversion of preferred stock | 1,150,000 | ||||
Common Stock | |||||
Convertible Preferred Stock [Line Items] | |||||
Issuance costs, incurred | $ 2,369 | ||||
Conversion of preferred stock | 23,242,498 | ||||
Series A Convertible Preferred Stock | |||||
Convertible Preferred Stock [Line Items] | |||||
Preferred stock, shares outstanding | 40,000,000 | ||||
Series A-1 Convertible Preferred Stock | |||||
Convertible Preferred Stock [Line Items] | |||||
Preferred stock, shares outstanding | 28,000,000 | ||||
Series B Convertible Preferred Stock | |||||
Convertible Preferred Stock [Line Items] | |||||
Preferred stock, shares outstanding | 62,499,993 |
Convertible Preferred Stock - S
Convertible Preferred Stock - Summary of Convertible Preferred Stock (Details) $ in Thousands | May 10, 2021 USD ($) shares |
Series A | |
Convertible Preferred Stock [Line Items] | |
Preferred shares authorized, issued and outstanding prior to conversion | shares | 40,000,000 |
Aggregate liquidation preference | $ | $ 40,000 |
Series A-1 | |
Convertible Preferred Stock [Line Items] | |
Preferred shares authorized, issued and outstanding prior to conversion | shares | 28,000,000 |
Aggregate liquidation preference | $ | $ 35,000 |
Series B | |
Convertible Preferred Stock [Line Items] | |
Preferred shares authorized, issued and outstanding prior to conversion | shares | 62,499,993 |
Aggregate liquidation preference | $ | $ 114,994 |
Common Stock (Additional Inform
Common Stock (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Aug. 15, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | May 11, 2021 | Apr. 30, 2021 | |
Class of Stock [Line Items] | |||||
Authorization of undesignated preferred stock | 10,000,000 | ||||
Undesignated preferred stock, par value | $ 0.0001 | ||||
Undesignated preferred stock, outstanding | 0 | 0 | 0 | ||
Common stock, shares authorized | 140,000,000 | 140,000,000 | |||
2022 Sales Agreement | |||||
Class of Stock [Line Items] | |||||
Number of shares issued and sold | 0 | ||||
Registration Statement | |||||
Class of Stock [Line Items] | |||||
Number of shares issued and sold | 0 | ||||
Common Stock | |||||
Class of Stock [Line Items] | |||||
Number of shares issued and sold | 8,825,000 | ||||
Maximum | |||||
Class of Stock [Line Items] | |||||
Expected aggregate principal amount from issue and sales of equity, debt securities, warrants and units | $ 250 | ||||
Maximum | 2022 Sales Agreement | SVB Securities LLC | |||||
Class of Stock [Line Items] | |||||
Aggregate commission rate | 3% | ||||
Maximum | Common Stock | 2022 Sales Agreement | SVB Securities LLC | |||||
Class of Stock [Line Items] | |||||
Offering Price | $ 75 | ||||
Voting Shares | |||||
Class of Stock [Line Items] | |||||
Common stock, shares authorized | 140,000,000 | ||||
Non-voting Shares | |||||
Class of Stock [Line Items] | |||||
Common stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Reserved (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 | Apr. 30, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||||
Outstanding common stock options | 6,264,898 | 3,643,796 | 2,745,185 | |
2021 Employee Stock Purchase Plan | ||||
Class Of Stock [Line Items] | ||||
Shares reserved for issuance | 852,971 | |||
Common Stock | ||||
Class Of Stock [Line Items] | ||||
Restricted stock related to early exercise of common stock options | 158,154 | 538,340 | ||
Outstanding common stock options | 6,264,898 | 3,643,796 | ||
Total | 9,492,924 | 7,722,219 | ||
Common Stock | Restricted Stock Units | ||||
Class Of Stock [Line Items] | ||||
Total | 1,144,994 | |||
Common Stock | Equity Incentive Plans | ||||
Class Of Stock [Line Items] | ||||
Shares reserved for issuance | 758,434 | 2,702,995 | ||
Common Stock | 2021 Employee Stock Purchase Plan | ||||
Class Of Stock [Line Items] | ||||
Shares reserved for issuance | 1,166,444 | 837,088 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ in Millions | 12 Months Ended | ||||
Jan. 01, 2022 shares | Apr. 30, 2021 shares | Dec. 31, 2022 USD ($) Installment shares | Dec. 31, 2021 shares | Dec. 31, 2020 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options outstanding, shares | 6,264,898 | 3,643,796 | 2,745,185 | ||
Contractual term of stock option | 8 years 5 months 4 days | 8 years 8 months 8 days | 9 years 4 months 24 days | ||
Unrecognized compensation cost | $ | $ 20 | ||||
Unrecognized compensation cost, expected to be recognized period | 2 years 8 months 12 days | ||||
2021 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Increment in number of shares authorized possible | 2,072,569 | ||||
Number of shares remained available for future grant | 6,397,289 | 758,434 | |||
Percentage of shares issued and outstanding | 5% | ||||
Options outstanding, shares | 6,190,132 | ||||
Percentage of fair market value of common stock | 100% | ||||
Stock options vesting period | 4 years | ||||
2021 Equity Incentive Plan | Maximum | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of shares authorized under the plan | 3,015,907 | ||||
Contractual term of stock option | 10 years | ||||
2018 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Number of shares remained available for future grant | 3,381,382 | ||||
Options outstanding, shares | 6,190,132 | ||||
2021 Employee Stock Purchase Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Discount percentage to purchase shares | 15% | ||||
Offering periods | 6 months | ||||
Increment in number of shares authorized possible | 414,513 | 3,000,000 | |||
Percentage Of cumulative number of shares of common stock outstanding | 1% | ||||
Number of shares authorized under the plan | 852,971 | ||||
Percentage of cumulative number of shares of common stock issued and outstanding | 1% | ||||
Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Total fair value of restricted stock units vested | $ | $ 0.7 | ||||
Unrecognized compensation cost | $ | $ 6.9 | ||||
Unrecognized compensation cost, expected to be recognized period | 1 year 8 months 12 days | ||||
Number of installments, vested | Installment | 4 | ||||
Incremental period of vesting | 2 years |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Assumptions Used to Determine the Fair Values of Stock Options Granted (Details) - Stock Option - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Volatility, minimum | 82.29% | 80.60% |
Volatility, maximum | 88.41% | 91.25% |
Risk-free interest rate, minimum | 1.46% | 0.50% |
Risk-free interest rate, maximum | 4.23% | 1.33% |
Expected term (years) | 6 years 3 months | |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 5 years 4 months 17 days | |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 3 months | |
Common Stock | Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock | $ 1.53 | $ 5.72 |
Common Stock | Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Fair value of common stock | $ 16.56 | $ 17 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Additional General Disclosures [Abstract] | |||
Options outstanding, beginning balance, shares | 3,643,796 | 2,745,185 | |
Granted, shares | 3,252,866 | 1,076,022 | |
Exercised, shares | (96,646) | (149,707) | |
Cancelled, shares | (57,434) | (7,605) | |
Forfeited, shares | (477,684) | (20,099) | |
Options outstanding, ending balance, shares | 6,264,898 | 3,643,796 | 2,745,185 |
Options exercisable, shares | 1,838,406 | ||
Options outstanding, weighted- average exercise price | $ 5.75 | $ 4.20 | |
Granted, weighted- average exercise price | 8.12 | 9.19 | |
Exercised, weighted- average exercise price | 1.12 | 2.12 | |
Cancelled, weighted-average exercise price | 5.25 | 1.38 | |
Forfeited, weighted- average exercise price | 7.55 | 5.79 | |
Options outstanding, weighted- average exercise price | 6.92 | $ 5.75 | $ 4.20 |
Options exercisable, weighted- average exercise price | $ 5.23 | ||
Options outstanding, weighted- average remaining contractual life | 8 years 5 months 4 days | 8 years 8 months 8 days | 9 years 4 months 24 days |
Options exercisable, weighted- average remaining contractual life | 7 years 6 months 21 days | ||
Options outstanding, aggregate intrinsic value | $ 42 | $ 34,754 | $ 4,183 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Additional Information to Stock Option Activity Involving Employees and Directors (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted-average grant-date fair value per option of total options granted | $ 5.82 | $ 6.69 |
Aggregate intrinsic value of stock options exercised | $ 291 | $ 1,616 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of RSU Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Granted, Number of Restricted Stock Units | shares | 1,391,906 |
Vested, Number of Restricted Stock Units | shares | (154,388) |
Forfeited, Number of Restricted Stock Units | shares | (92,524) |
Outstanding, Number of Restricted Stock Units, ending balance | shares | 1,144,994 |
Granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 7.17 |
Vested, Weighted-Average Grant Date Fair Value | $ / shares | 9.10 |
Forfeited, Weighted-Average Grant Date Fair Value | $ / shares | 8.98 |
Outstanding, Weighted-Average Grant Date Fair Value, ending balance | $ / shares | $ 6.76 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 11,156 | $ 3,778 |
Research and Development Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 6,558 | 1,848 |
General and Administrative Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 4,598 | $ 1,930 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Jan. 01, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | |||
Income tax benefit | $ 0 | $ 0 | |
Valuation allowance of net deferred tax asset, Increase (Decrease) | 20,200,000 | $ 13,200,000 | |
Federal net operating loss carryforwards | 96,900,000 | ||
US federal and state capital loss carryforwards | $ 0 | ||
Operating loss carryforwards expiration date | Dec. 31, 2023 | ||
US federal research and development tax credit carryforward | $ 2,600,000 | ||
Tax credit carryforward expiration date | Dec. 31, 2039 | ||
Amortization period of research and experimental expenses | 5 years | ||
Domestic | |||
Income Tax Disclosure [Line Items] | |||
Amortization period of research and experimental expenses | 5 years | ||
Foreign | |||
Income Tax Disclosure [Line Items] | |||
Amortization period of research and experimental expenses | 15 years | ||
Kentucky | |||
Income Tax Disclosure [Line Items] | |||
Foreign net operating loss carryforwards | $ 97,100,000 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of U.S. Federal Statutory Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21% | 21% |
Federal research tax credit/orphan drug credit | 0.30% | 2.40% |
Permanent items, including stock compensation | (0.90%) | (0.60%) |
Change in valuation allowance | (20.70%) | (22.00%) |
Other | 0.20% | (0.90%) |
Effective income tax rate reconciliation, percent | 0% | 0% |
Income Taxes - Summary of Signi
Income Taxes - Summary of Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss and capital loss carryforwards | $ 25,875 | $ 20,815 |
Capitalized research and development expenses | 14,500 | |
Research and development credit carryforwards | 2,610 | 2,359 |
Accrued expenses | 127 | 1,377 |
Stock-based compensation | 2,894 | 876 |
Operating lease right-of-use assets | 68 | |
Total deferred tax assets | 46,074 | 25,427 |
Deferred tax liabilities: | ||
Depreciation | (179) | (80) |
Accretion | (331) | |
Total deferred tax assets | (510) | (80) |
Less valuation allowance | $ (45,564) | $ (25,347) |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Contribution amount | $ 0.6 | $ 0.4 |
First 3% of Employee Contributions | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Percentage of employee contributions | 3% | |
Next 2% of Employee Contributions | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Percentage of employee contributions | 2% | |
Minimum | First 3% of Employee Contributions | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan minimum service requirements percentage | 100% | |
Minimum | Next 2% of Employee Contributions | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan minimum service requirements percentage | 50% |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Summary of Computation of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss and net loss attributable to common stockholders | $ (73,894) | $ (47,833) |
Net loss per share attributable to common stockholders, basic | $ (1.79) | $ (1.64) |
Net loss per share attributable to common stockholders, diluted | $ (1.79) | $ (1.64) |
Weighted average number of common shares outstanding used in computation of net loss per common share, basic | 41,248,392 | 29,126,373 |
Weighted average number of common shares outstanding used in computation of net loss per common share, diluted | 41,248,392 | 29,126,373 |
Net Loss Per Share Attributab_4
Net Loss Per Share Attributable to Common Stockholders - Summary of Potential Dilutive Securities Excluded From Calculation of Net Loss Per Share Due to Anti-dilutive Effect (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share due to anti-dilutive effect | 7,568,046 | 4,182,136 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share due to anti-dilutive effect | 6,264,898 | 3,643,796 |
Restricted Stock Units Outstanding | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share due to anti-dilutive effect | 1,144,994 | |
Restricted Stock Related to Early Exercise of Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from calculation of net loss per share due to anti-dilutive effect | 158,154 | 538,340 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2022 | |
Related Party Transactions [Abstract] | ||
General and administrative expense | $ 100,000 | |
Amounts owed to related party | $ 0 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - USD ($) $ in Millions | Mar. 01, 2023 | Feb. 28, 2023 |
Severance and Termination | ||
Subsequent Event [Line Items] | ||
Estimated severance and termination-related costs | $ 2.9 | |
Kentucky | ||
Subsequent Event [Line Items] | ||
Lease term period | 5 years | 3 years |
Written renewal notice period in lease | 3 months | 6 months |