Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | HILLEVAX, INC. | |
Entity Central Index Key | 0001888012 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 48,437,001 | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity File Number | 001-41365 | |
Entity Tax Identification Number | 85-0545060 | |
Entity Address Address Line1 | 321 Harrison Avenue | |
Entity Address City Or Town | Boston | |
Entity Address State Or Province | MA | |
Entity Address Postal Zip Code | 02118 | |
Entity Incorporation State Country Code | DE | |
City Area Code | 617 | |
Local Phone Number | 213-5054 | |
Title of each class | Common Stock, $0.0001 par value per share | |
Trading Symbol | HLVX | |
Name of each exchange on which registered | NASDAQ | |
Document Annual Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 208,502 | $ 279,401 |
Marketable securities | 115,908 | |
Prepaid expenses and other current assets (includes related party amounts of $77 and $0, respectively) | 8,785 | 11,212 |
Total current assets | 333,195 | 290,613 |
Property and equipment, net | 13,744 | 5,586 |
Operating lease right-of-use assets | 18,377 | 19,359 |
Restricted cash | 1,631 | 1,631 |
Other assets | 22 | 22 |
Total assets | 366,969 | 317,211 |
Current liabilities: | ||
Accounts payable (includes related party amounts of $0 and $141, respectively) | 3,287 | 4,744 |
Accrued expenses (includes related party amounts of $0 and $140, respectively) | 12,889 | 8,210 |
Accrued interest | 128 | 55 |
Current portion of operating lease liability | 2,654 | 37 |
Total current liabilities | 18,958 | 13,046 |
Operating lease liability, net of current portion | 23,247 | 21,569 |
Long-term debt, net of debt discount | 25,038 | 14,792 |
Other long-term liabilities | 1,096 | 575 |
Total liabilities | 68,339 | 49,982 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; authorized shares-50,000,000 at September 30, 2023 and December 31, 2022; no shares issued and outstanding at September 30, 2023 and December 31, 2022 | ||
Common stock, $0.0001 par value; authorized shares-500,000,000 at September 30, 2023 and December 31, 2022; issued shares-48,417,931 and 39,240,746 at June 30, 2023 and December 31, 2022, respectively; outstanding shares-47,418,350 and 37,656,037 at September 30, 2023 and December 31, 2022, respectively | 5 | 4 |
Additional paid-in capital | 650,567 | 532,499 |
Accumulated other comprehensive loss | (343) | (281) |
Accumulated deficit | (351,599) | (264,993) |
Total stockholders' equity | 298,630 | 267,229 |
Total liabilities and stockholders' equity | $ 366,969 | $ 317,211 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid expenses and other current assets | $ 8,785 | $ 11,212 |
Accounts payable | 3,287 | 4,744 |
Accrued expenses | $ 12,889 | $ 8,210 |
Preferred stock par value | $ 0.0001 | $ 0.0001 |
Preferred stock shares authorized | 50,000,000 | 50,000,000 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common stock par value | $ 0.0001 | $ 0.0001 |
Common stock shares authorized | 500,000,000 | 500,000,000 |
Common stock shares issued | 48,417,931 | 39,240,746 |
Common stock shares outstanding | 47,418,350 | 37,656,037 |
Related party | ||
Prepaid expenses and other current assets | $ 77 | $ 0 |
Accounts payable | 0 | 141 |
Accrued expenses | $ 0 | $ 140 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development (includes related party amounts of $55, $719, $252, and $2,313, respectively) | $ 27,308 | $ 13,315 | $ 73,425 | $ 28,352 |
In-process research and development - related party | 2,500 | |||
General and administrative (includes related party amounts of $0, $3, $0, and $37, respectively) | 6,603 | 4,577 | 19,629 | 11,162 |
Total operating expenses | 33,911 | 17,892 | 93,054 | 42,014 |
Loss from operating ,Total | (33,911) | (17,892) | (93,054) | (42,014) |
Other income (expense): | ||||
Interest income | 1,690 | 1,317 | 6,717 | 1,657 |
Interest expense (includes related party amounts of $0, $0, $0, and $717, respectively) | (717) | (205) | (1,666) | (3,157) |
Change in fair value of convertible promissory notes (includes related party amounts of $0, $0, $0 and $13,196, respectively) | (51,469) | |||
Change in fair value of warrant liabilities - related party | (43,575) | |||
Other income (expense) | 1,123 | (25) | 1,397 | (63) |
Total other income (expense) | 2,096 | 1,087 | 6,448 | (96,607) |
Net loss | (31,815) | (16,805) | (86,606) | (138,621) |
Other comprehensive loss: | ||||
Unrealized loss on marketable securities | (28) | (65) | ||
Pension and other postemployment benefits | 7 | 3 | ||
Total comprehensive loss | $ (31,836) | $ (16,805) | $ (86,668) | $ (138,621) |
Net loss per share, basic | $ (0.81) | $ (0.45) | $ (2.26) | $ (5.86) |
Net loss per share, diluted | $ (0.81) | $ (0.45) | $ (2.26) | $ (5.86) |
Weighted-average shares of common stock outstanding, basic | 39,039,553 | 37,323,626 | 38,252,981 | 23,640,388 |
Weighted-average shares of common stock outstanding, diluted | 39,039,553 | 37,323,626 | 38,252,981 | 23,640,388 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Interest expense, related party | $ 717 | $ 205 | $ 1,666 | $ 3,157 |
Change in fair value of convertible promissory notes, related party | 0 | 0 | 0 | 13,196 |
Related party | ||||
Research and development expenses | 55 | 719 | 252 | 2,313 |
General and administrative, related party | 0 | 3 | 0 | 37 |
Interest expense, related party | $ 0 | $ 0 | $ 0 | $ 717 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands | Total | Underwritten Public Offering | Common Stock | Common Stock Underwritten Public Offering | Additional Paid-in Capital | Additional Paid-in Capital Underwritten Public Offering | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance at Dec. 31, 2021 | $ (100,757) | $ 1 | $ 4,426 | $ (105,184) | ||||
Beginning Balance, Shares at Dec. 31, 2021 | 6,599,886 | |||||||
Issuance of common stock | 209,515 | $ 1 | 209,514 | |||||
Issuance of common stock, Shares | 13,529,750 | |||||||
Conversion of August 2021 Notes and accrued interest into common shares | 215,364 | $ 1 | 215,363 | |||||
Conversion of August 2021 Notes and accrued interest into common shares, Shares | 10,672,138 | |||||||
Conversion of Takeda Warrant liability into equity | 100,020 | 100,020 | ||||||
Vesting of restricted shares, Shares | 761,612 | |||||||
Stock - based compensation | 1,672 | 1,672 | ||||||
Net loss | (138,621) | (138,621) | ||||||
Ending Balance at Sep. 30, 2022 | 287,193 | $ 3 | 530,995 | (243,805) | ||||
Ending Balance, Shares at Sep. 30, 2022 | 31,563,386 | |||||||
Beginning Balance at Jun. 30, 2022 | 303,154 | $ 3 | 530,151 | (227,000) | ||||
Beginning Balance, Shares at Jun. 30, 2022 | 31,311,387 | |||||||
Vesting of restricted shares, Shares | 251,999 | |||||||
Stock - based compensation | 844 | 844 | ||||||
Net loss | (16,805) | (16,805) | ||||||
Ending Balance at Sep. 30, 2022 | 287,193 | $ 3 | 530,995 | (243,805) | ||||
Ending Balance, Shares at Sep. 30, 2022 | 31,563,386 | |||||||
Beginning Balance at Dec. 31, 2022 | 267,229 | $ 4 | 532,499 | $ (281) | (264,993) | |||
Beginning Balance, Shares at Dec. 31, 2022 | 37,656,037 | |||||||
Issuance of common stock | $ 107,750 | $ 1 | $ 107,749 | |||||
Issuance of common stock, Shares | 9,200,000 | |||||||
Vesting of restricted shares, Shares | 513,036 | |||||||
Stock - based compensation | 9,834 | 9,834 | ||||||
Issuance of common stock under stock purchase plan | 318 | 318 | ||||||
Issuance of common stock under stock purchase plan, Shares | 26,895 | |||||||
Exercise of common stock options | 167 | 167 | ||||||
Exercise of common stock options, Shares | 22,382 | |||||||
Unrealized loss on marketable securities | (65) | (65) | ||||||
Pension and other postemployment benefits | 3 | 3 | ||||||
Net loss | (86,606) | (86,606) | ||||||
Ending Balance at Sep. 30, 2023 | 298,630 | $ 5 | 650,567 | (343) | (351,599) | |||
Ending Balance, Shares at Sep. 30, 2023 | 47,418,350 | |||||||
Beginning Balance at Jun. 30, 2023 | 218,763 | $ 4 | 538,865 | (322) | (319,784) | |||
Beginning Balance, Shares at Jun. 30, 2023 | 38,049,186 | |||||||
Issuance of common stock | $ 107,750 | $ 1 | $ 107,749 | |||||
Issuance of common stock, Shares | 9,200,000 | |||||||
Vesting of restricted shares, Shares | 168,164 | |||||||
Stock - based compensation | 3,946 | 3,946 | ||||||
Exercise of common stock options | 7 | 7 | ||||||
Exercise of common stock options, Shares | 1,000 | |||||||
Unrealized loss on marketable securities | (28) | (28) | ||||||
Pension and other postemployment benefits | 7 | 7 | ||||||
Net loss | (31,815) | (31,815) | ||||||
Ending Balance at Sep. 30, 2023 | $ 298,630 | $ 5 | $ 650,567 | $ (343) | $ (351,599) | |||
Ending Balance, Shares at Sep. 30, 2023 | 47,418,350 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Common Stock | |
Net of issuance costs | $ 20,491 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (86,606) | $ (138,621) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 450 | |
Stock-based compensation | 9,834 | 1,672 |
Change in fair value of convertible promissory notes (includes related party amounts of $0 and $13,196, respectively) | 51,469 | |
Change in fair value of warrant liabilities - related party | 43,575 | |
Amortization of operating lease right-of-use assets | 982 | 836 |
Amortization of debt discount | 410 | 182 |
Issuance of PIK interest debt | 375 | 48 |
Acquired in-process research and development - related party | 2,500 | |
Net amortization of premiums and discounts on marketable securities | (1,876) | |
Loss on disposal of property and equipment | 42 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets (includes related party amounts of $77 and $0 ,respectively) | 2,427 | (7,951) |
Accounts payable, accrued expenses and other long-term liabilities (includes related party amounts of $(281) and $(4,137), respectively) | 4,459 | (713) |
Accrued interest (includes related party amounts of $0 and $717, respectively) | 73 | 2,823 |
Operating lease right-of-use assets and liabilities | 4,295 | 666 |
Net cash used in operating activities | (65,177) | (43,472) |
Cash flows from investing activities | ||
Cash paid for purchased in-process research and development | (2,500) | |
Purchases of property and equipment | (10,010) | (185) |
Purchases of marketable securities | (129,097) | |
Proceeds from sales or maturities of marketable securities | 15,000 | |
Net cash used in investing activities | (124,107) | (2,685) |
Cash flows from financing activities | ||
Proceeds from issuances of stock under ESPP | 318 | |
Proceeds from issuance of common stock in initial public offering | 230,006 | |
Payment of initial public offering costs | (19,389) | |
Proceeds from issuance of common stock in underwritten public offering, net of issuance costs | 108,100 | |
Proceeds from issuance of long-term debt, net of issuance costs | 9,800 | 4,665 |
Proceeds from exercise of stock options | 167 | |
Net cash provided by financing activities | 118,385 | 215,282 |
Net increase (decrease) in cash, cash equivalents and restricted cash | (70,899) | 169,125 |
Cash, cash equivalents and restricted cash-beginning of period | 281,032 | 124,566 |
Cash, cash equivalents and restricted cash-end of period | 210,133 | 293,691 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 1,121 | 104 |
Supplemental disclosure of noncash investing and financing activities | ||
Operating lease | 20,317 | |
Unpaid initial public offering costs | 313 | |
Unpaid underwritten public offering costs | 350 | |
Unpaid property and equipment purchases | 171 | 415 |
Conversion of convertible promissory notes and interest into common stock | 215,364 | |
Conversion of warrant liability into equity | 100,020 | |
Accreted final interest payment fees | $ 339 | $ 158 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Change in fair value of convertible promissory notes, related party | $ 0 | $ 13,196 |
Related parties prepaid expenses and other assets current | 77 | 0 |
Related parties accounts payable, accrued expenses and other long-term liabilities | (281) | (4,137) |
Related parties accrued interest | $ 0 | $ 717 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Organization HilleVax, Inc. (the “Company” or “HilleVax”) was incorporated in the state of Delaware in March 2020 under the name MokshaCo, Inc. (“MokshaCo”). On February 8, 2021, MokshaCo changed its name to HilleVax and merged with North Bridge V, Inc. (“North Bridge V”) and YamadaCo III, Inc. (“YamadaCo III”), each a Delaware corporation formed in 2019, with HilleVax being the surviving entity (the “Merger”). The Company is a biopharmaceutical company focused on developing and commercializing novel vaccines. Forward Stock Split On April 22, 2022, the Company effected a 1.681 -for-1 forward split of shares of the Company’s common stock (the “Forward Stock Split”). The par value of the common stock was not adjusted as a result of the Forward Stock Split and the authorized shares were increased to 50,000,000 shares of common stock in connection with the Forward Stock Split. The accompanying financial statements and notes to the financial statements give retroactive effect to the Forward Stock Split for all periods presented, unless otherwise indicated. Liquidity and Capital Resources From inception to September 30, 2023, the Company has devoted substantially all of its efforts to organizing and staffing the Company, business planning, raising capital, in-licensing its initial vaccine candidate, HIL-214, preparing for and managing its clinical trials of HIL-214, and providing other general and administrative support for these operations. The Company has a limited operating history, has never generated any revenue, and the sales and income potential of its business is unproven. The Company has incurred net losses and negative cash flows from operating activities since its inception and expects to continue to incur net losses into the foreseeable future as it continues the development and potential commercialization of HIL-214. From inception to September 30, 2023 , the Company has funded its operations through the issuance of convertible promissory notes, commercial bank debt, the sale of 13,529,750 shares of common stock for net proceeds of approximately $ 209.5 million in its initial public offering ("IPO") which closed in May 2022, and the sale of 9,200,000 shares of common stock for net proceeds of approximately $ 107.8 million in its underwritten public offering which closed in September 2023 (see Note 10). The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. Management is required to perform a two-step analysis over the Company’s ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern (Step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (Step 2). Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these financial statements were issued. There can be no assurance that the Company will be successful in acquiring additional funding, if needed, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company's financial statements include the accounts of HilleVax Security Corporation, a wholly-owned subsidiary formed in Massachusetts, and HilleVax GmbH, a wholly-owned subsidiary formed in Zurich, Switzerland. The functional currency of the Company, HilleVax Security Corporation and HilleVax GmbH is the U.S. dollar. The Company’s assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the condensed consolidated statements of operations and were not material for the periods presented. All intercompany transactions have been eliminated in consolidation. Unaudited Interim Financial Information The unaudited condensed consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”), and with U.S. generally accepted accounting principles (“GAAP”) applicable to interim financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited financial statements and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year or future periods. The condensed consolidated balance sheet data as of December 31, 2022 was derived from the Company’s audited financial statements but does not include all disclosures required by GAAP. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 17, 2023. Use of Estimates The preparation of the Company’s unaudited condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s unaudited condensed consolidated financial statements relate to accruals for research and development expenses, and prior to the Company's IPO, the valuation of convertible promissory notes, warrant liabilities and various other equity instruments. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results could differ materially from those estimates and assumptions. Fair Value Option As permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments , (“ASC 825”), the Company has elected the fair value option to account for its convertible promissory notes issued through May 2022, when the convertible promissory notes converted into equity in connection with the Company's IPO. In accordance with ASC 825, the Company recorded these convertible promissory notes at fair value with changes in fair value recorded in the condensed consolidated statements of operations. As a result of applying the fair value option, direct costs and fees related to the convertible promissory notes were recognized in earnings as incurred and not deferred. Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts and money market funds. Restricted Cash Restricted cash consists of a money market account securing a standby letter of credit issued in connection with the Company’s Boston Lease (as defined and described in Note 6). Marketable Securities Marketable securities represent holdings of available-for-sale marketable debt securities in accordance with the Company’s investment policy. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit) until realized or until a determination is made that an other-than-temporary decline in market value has occurred. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, together with interest on securities sold, is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income (expense). Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and restricted cash. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. Property and Equipment, Net Property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets as follows: Estimated Useful Life Computer equipment 3 years Lab equipment 5 years Furniture and fixtures 5 years Leasehold improvements 3 – 10 years or term of lease Repairs and maintenance costs are charged to expense as incurred. Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. Lease terms are determined at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise. For its long-term operating leases, the Company recognizes a lease liability and a right-of-use (“ROU”) asset on its balance sheet and recognizes lease expense on a straight-line basis over the lease term. The lease liability is determined as the present value of future lease payments, reduced by any reimbursements for tenant improvements, using the discount rate implicit in the lease or, if the implicit rate is not readily determinable, an estimate of the Company’s incremental borrowing rate. The ROU asset is based on the lease liability, adjusted for any prepaid or deferred rent, and reduced by any reimbursements for tenant improvements. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component and variable charges for common area maintenance and other variable costs are recognized as expense as incurred. The Company has elected to not recognize a lease liability or ROU asset in connection with short-term operating leases and recognizes lease expense for short-term operating leases on a straight-line basis over the lease term. The Company does not have any financing leases. Impairment of Long-Lived Assets The Company reviews long-lived assets, such as property and equipment, for impairment whenever events or changes in circumstances indicate the carrying amount of an asset 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 as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Fair value would be assessed using discounted cash flows or other appropriate measures of fair value. The Company has not recognized any impairment losses through September 30, 2023 . Research and Development Expenses and Accruals All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, employee benefits, stock-based compensation charges for those individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s clinical trials of HIL-214. The Company has entered into various research and development contracts with clinical research organizations, clinical manufacturing organizations and other companies. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. In-Process Research and Development The Company evaluates whether acquired intangible assets are a business under applicable accounting standards. Additionally, the Company evaluates whether the acquired assets have a future alternative use. Intangible assets that do not have future alternative use are considered acquired in-process research and development. When the acquired in-process research and development assets are not part of a business combination, the value of the consideration paid is expensed on the acquisition date. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expenses and expensed as incurred since recoverability of such expenditures is uncertain. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of equity awards, primarily consisting of stock options, restricted common stock, and employee stock purchase rights, recognized on a straight-line basis over the requisite service period for stock options and restricted common stock, and over the respective offering period for employee stock purchase plan rights. The Company recognizes forfeitures as they occur. Benefit plans The Company has established a defined contribution savings plan for its employees in the United States under Section 401(k) of the Internal Revenue Code, and a defined benefits plan for its employees outside of the United States. The defined benefits plan is valued by an independent actuary using the projected unit credit method. The liabilities correspond to the projected benefit obligations of which the discounted net present value is calculated based on years of employment, expected salary increase, and pension adjustments. The Company reviews its actuarial assumptions on an annual basis and makes modifications to the assumptions based on current rates and trends. This plan is recognized under ASC 715, Compensation - Retirement Benefits . Income Taxes The Company accounts for income taxes under 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 included in the financial statements. Under this method, 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. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the condensed consolidated statements of operations in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense in the condensed consolidated statements of operations. Any accrued interest and penalties are included within the related tax liability in the condensed consolidated balance sheets. The Company did not recognize any interest or penalties during the periods presented. Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. For the three and nine months ended September 30, 2023, comprehensive loss included gains on the Company's pension benefit obligation and unrealized losses on marketable securities. For the three and nine months ended September 30, 2022 , the Company’s comprehensive loss was the same as its reported net loss. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. Net Loss Per Share Basic net loss per share is computed by dividing the consolidated net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company included 5,883,500 shares of common stock under the Takeda Warrant (as defined below) in the calculation of basic weighted-average common shares outstanding from the time the Takeda Warrant became exercisable upon the Company’s IPO because the Takeda Warrant was exercisable for minimal consideration. The Company has excluded weighted-average unvested shares of 1,149,612 shares, 1,954,126 shares, 1,318,737 shares, and 2,214,463 shares from the basic weighted-average number of common shares outstanding for the three months ended September 30, 2023 and 2022 and the nine months ended September 30, 2023 and 2022, respectively. Diluted net loss per share is computed by dividing the consolidated net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of unvested common stock, common stock options, contingently issuable shares under the Company's employee stock purchase plan, and common stock warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive common stock equivalents would be antidilutive. Potentially dilutive securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares): September 30, 2023 2022 Common stock options 3,770,701 1,795,989 Unvested common stock 1,742,090 1,781,874 ESPP shares 16,767 7,186 Total potentially dilutive shares 5,529,558 3,585,049 Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to avail itself of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments – Credit Losses (Topic 326), to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in Topic 326 replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. We adopted Topic 326 on January 1, 2023 . The adoption did no t have a material impact on our unaudited condensed consolidated financial statements’. Recently Issued Accounting Pronouncements The Company assesses the adoption impacts of recently issued accounting standards by the Financial Accounting Standards Board or other standard setting bodies on the Company's condensed consolidated financial statements as well as material updates to previous assessments, if any. Although there were several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company’s cash, cash equivalents, marketable securities, and restricted cash are carried at fair value, determined according to the fair value hierarchy discussed in Note 2. The carrying values of the Company's prepaid expenses and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities. The estimated fair value of the Company’s long-term debt approximated the carrying amount given its floating interest rate basis. Warrant liabilities and convertible promissory notes were recorded at fair value on a recurring basis until they converted to equity in connection with the Company's IPO, which closed in May 2022. The following tables present the Company’s fair value hierarchy for its assets that are measured at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands): Fair Value Measurements at Total Quoted Prices in Significant Significant Cash equivalents Money market funds $ 201,473 $ 201,473 $ — $ — Marketable securities: U.S. treasury notes 31,396 31,396 — — U.S government agency bonds 84,512 — 84,512 — Total $ 317,381 $ 232,869 $ 84,512 $ — Fair Value Measurements at Total Quoted Prices in Significant Significant Cash equivalents Money market funds $ 277,043 $ 277,043 $ — $ — Total $ 277,043 $ 277,043 $ — $ — U.S. government money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. As of September 30, 2023, the Company’s marketable securities consisted of U.S. Treasury notes which were valued based on Level 1 inputs and agency bonds which were valued based on Level 2 inputs. In determining the fair value of its agency bonds, the Company relied on quoted prices for similar securities in active markets or other inputs that are observable or can be corroborated by observable market data. No ne of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities As of September 30, 2023, the fair value of available-for-sale marketable debt securities by type of security was as follows (in thousands): September 30, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Marketable securities: U.S. treasury notes $ 31,417 $ - $ ( 21 ) $ 31,396 U.S. government agency bonds 84,556 3 ( 47 ) 84,512 Total $ 115,973 $ 3 $ ( 68 ) $ 115,908 At September 30, 2023 , all available-for-sale marketable securities had contractual maturities of less than one year. The Company did no t hold any marketable debt securities as of December 31, 2022. As of September 30, 2023 , the Company reviewed its investment portfolio to assess the unrealized losses on its available-for-sale investments. In making this assessment, the Company considered the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. The Company also evaluated whether it intended to sell the security and whether it was more likely than not that the Company would be required to sell the security before recovering its amortized cost basis. The Company determined no portion of the unrealized losses relate to a credit loss. There have been no impairments of the Company’s assets measured and carried at fair value during the three and nine months ended September 30, 2023 . |
Other Balance Sheet Details
Other Balance Sheet Details | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Other Balance Sheet Details | 5. Other Balance Sheet Details Property and Equipment Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2023 2022 Computer equipment $ 103 $ - Furniture and equipment 372 11 Leasehold improvements 11,870 378 Lab equipment 1,844 — Construction in progress 5 5,198 Total property and equipment, at cost 14,194 5,587 Less accumulated depreciation 450 1 Property and equipment, net $ 13,744 $ 5,586 Depreciation expense for the three and nine months ended September 30, 2023 was $ 0.4 and $ 0.5 million, respectively. Depreciation expense for the three and nine months ended September 30, 2022 was not material. Accrued Expenses Accrued expenses consisted of the following (in thousands): September 30, December 31, 2023 2022 Accrued external research and development costs $ 8,118 $ 3,510 Accrued payroll and payroll-related costs 3,729 4,018 Accrued professional costs 498 307 Other 544 375 Total accrued expenses $ 12,889 $ 8,210 Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash recorded within the accompanying condensed consolidated balance sheets that sum to the amounts shown in the condensed consolidated statements of cash flows (in thousands): September 30, December 31, 2023 2022 Cash and cash equivalents $ 208,502 $ 279,401 Restricted cash 1,631 1,631 Total cash, cash equivalents and restricted cash $ 210,133 $ 281,032 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 6. Leases Operating Leases In August 2021, the Company entered into a five-year noncancelable operating lease for a facility in Switzerland, which it determined was an operating lease at the inception of the lease contract. The lease commencement date occurred in September 2021 when the Company gained access to the facility. The Company is obligated to make monthly rental payments that periodically escalate during the lease term and is subject to additional charges for common area maintenance and other costs. The Company has an option to extend the lease for a period of five years which the Company is not reasonably certain to exercise. In March 2022, the Company entered into a lease for office and laboratory space located in Boston, Massachusetts (the “Boston Lease”), which it determined was an operating lease at the inception of the lease contract. The Boston Lease commenced in April 2022 with base rental payments beginning in January 2023. The Boston Lease includes certain tenant improvement allowances for the reimbursement of up to $ 6.3 million of costs incurred by the Company, and an optio n for the Company to extend the lease for a period of five years , which the Company is not reasonably certain to exercise. The Company determined that it owns the leasehold improvements related to the Boston Lease and, as such, reflected the $ 6.3 million lease incentive as a reduction of the rental payments used to measure the operating lease liability, and, in turn, the operating lease right-of-use asset as of the lease commencement date in April 2022. Between the lease commencement date and September 30, 2023, the Company recorded increases of $ 5.6 million to the operating lease liability as and when such leasehold improvements were paid for by the landlord. The Company expects to receive all tenant improvement reimbursements during the year ending December 31, 2023. Under the terms of the Boston Lease, the Company provided the lessor with an irrevocable standby letter of credit secured by restricted cash in the amount of $ 1.6 million. The following table summarizes operating lease expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Lease expense: Operating lease expense $ 780 $ 779 $ 2,339 $ 1,573 The Company incurred an immaterial amount of expense related to short-term leases and variable lease costs during the three and nine months ended September 30, 2023 and the three and nine months ended September 30, 2022. The following table summarizes the lease term and discount rate for operating leases: September 30, December 31, 2023 2022 Other information: Weighted-average remaining lease term 9.20 9.96 Weighted-average discount rate 7.4 % 7.4 % As there was not an implicit rate within the leases, management estimated the incremental borrowing rate 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 as well as by using a set of peer companies' incremental borrowing rates. The following table summarizes the cash paid for amounts included in the measurement of lease liabilities (in thousands): September 30, Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) $ 2,613 At September 30, 2023, the future minimum noncancelable operating lease payments were as follows (in thousands): September 30, Years ending December 31: 2023 $ 871 2024 3,584 2025 3,688 2026 3,784 2027 3,860 Thereafter 21,075 Total undiscounted operating lease payments 36,862 Present value adjustment ( 10,175 ) Tenant improvement reimbursements ( 786 ) Operating lease liability 25,901 Less current portion of operating lease liability 2,654 Operating lease liability, net of current portion $ 23,247 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions Frazier Life Sciences X, L.P. or its affiliates (“Frazier”) is a principal stockholder of the Company and is represented on the Company’s board of directors. From January 8, 2019 (inception) to September 30, 2023, the Company and Frazier reimbursed each other for various goods and services, including personnel related expenses, travel, insurance, facilities and other various overhead and administrative expenses. As of September 30, 2023 and December 31, 2022 , the Company had outstanding amounts due to Frazier of $ 0 and $ 6,000 , respectively, related to these shared operating expenses. For the three months ended September 30, 2023 and 2022 and the nine months ended September 30, 2023 and 2022 , the Company incurred $ 0 , $ 3,000 , $ 0 , and $ 37,000 , respectively, of shared operating expenses. As described in Note 9, the Company borrowed amounts from Frazier in connection with various convertible note financings. For the nine months ended September 30, 2022 , the Company recognized a $ 13.2 million change in fair value of convertible promissory notes in connection with convertible promissory notes issued to Frazier. For the nine months ended September 30, 2022 , the Company recognized $ 0.7 million of interest expense in connection with convertible promissory notes issued to Frazier. The convertible promissory notes automatically converted into 10,672,138 shares of the Company's common stock immediately prior to the completion of the IPO. In connection with the Takeda License (as defined and described in Note 8), Takeda became a related party stockholder with representation on the Company’s board of directors. The Company and Takeda are party to a TSA (as defined and described in Note 8) under which the Company is obligated to pay Takeda for certain services, including pass-through costs, related to research and development and regulatory assistance services, oversight and management of ongoing clinical and research studies, and maintenance of third-party vendor contracts. For the three months ended September 30, 2023 and 2022 and the nine months ended September 30, 2023 and 2022, the Company incurred $ 55,000 , $ 0.7 million, $ 0.3 million, and $ 2.3 million, respectively, of research and development expenses for Takeda’s services. As of September 30, 2023, the Company had a prepaid balance of $ 77,000 with Takeda. As of December 31, 2022 , the Company had $ 0.3 million of accounts payable and accrued expenses due to Takeda. See Note 8 for further information regarding the Company’s related party transactions with Takeda. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies License Agreement On July 2, 2021, the Company entered into a license agreement with Takeda pursuant to which it was granted an exclusive sublicensable, royalty-bearing license (the “Takeda License”) to develop and commercialize HIL-214 pharmaceutical products for all human uses on a worldwide basis outside of Japan (the “Territory”). The Company will be responsible, at its own cost, for the development, manufacture and commercialization of HIL-214 products in the Territory, and the Company will integrate certain Japan development activities into its development activities at its own cost. The Company is obligated to use commercially reasonable efforts to develop and commercialize HIL-214 products in the Territory, and to seek regulatory approval for such products throughout the world. In consideration of the Takeda License, the Company (i) paid Takeda $ 2.5 million in cash, (ii) issued Takeda 840,500 shares of its common stock at a fair value of $ 4.4 million, (iii) issued Takeda a warrant (the “Takeda Warrant”) to purchase 5,883,500 shares of its common stock at an exercise price of $ 0.0000595 per share, which was fully exercised in November 2022, and (iv) issued Takeda a warrant right (the “Takeda Warrant Right”) to receive an additional common stock warrant should Takeda’s fully-diluted ownership of the Company, including the Takeda Warrant, represent less than a certain specified percentage of the fully-diluted capitalization, including shares issuable upon conversion of outstanding convertible promissory notes, calculated immediately prior to the earlier of the closing of the Company’s IPO or a change of control transaction, at an initial fair value of $ 34,000 . In addition, the Company is obligated to pay Takeda an aggregate of $ 2.5 million upon the release of certain drug product and the completion of certain regulatory activities, which payment was made in March 2022, $ 7.5 million upon the achievement of a specified development milestone, up to an aggregate of $ 150.0 million in sales milestones upon the achievement of specified annual sales levels of HIL-214 products in the Territory, and tiered high single-digit to low-teen percentage royalties on net sales of HIL-214 products in the Territory, subject to specified offsets and reductions. Takeda has agreed to pay the Company tiered mid-single digit to low-double digit percentage royalties on net sales of HIL-214 products in Japan, subject to specified offsets and reductions. Royalties will be payable, on a product-by-product and country-by-country basis from the first commercial sale of such product in such country, until the latest of expiration of the licensed patents covering the applicable product, expiration of regulatory exclusivity in such country, or 20 years following first commercial sale of such product in such country. The obligations related to contingent payments are recognized in the accompanying condensed consolidated financial statements when the contingency is resolved and the consideration is paid or becomes payable. As of September 30, 2023, none of the remaining contingent payments were due or payable. Absent early termination, the Takeda License expires on a country-by-country and product-by-product basis upon the expiration of the applicable royalty term with respect to each product in each country, as applicable, or in its entirety upon the expiration of the royalty term with respect to the last product commercialized in the last country. The Company may terminate the Takeda License upon six months’ prior written notice. The Company and Takeda may terminate the Takeda License in the case of the other party’s insolvency, or upon prior written notice within a specified time period for the other party’s material uncured breach. Takeda may terminate the Takeda License if the Company challenges licensed patents, or assists any third-party in challenging such patents. The acquisition of the Takeda License has been accounted for as an asset acquisition as substantially all of the fair value is concentrated in a group of similar assets. In March 2022, the Company paid Takeda an aggregate $ 2.5 million contingent payment upon the release of certain drug products and the completion of certain regulatory activities, which have no alternative future use, and was recorded as in-process research and development in the Company’s condensed consolidated statement of operations for the nine months ended September 30, 2022 . The Company did no t make any milestone payments to Takeda during the three and nine months ended September 30, 2023. Transitional Services Agreement with Takeda As contemplated by the Takeda License, on December 17, 2021, the Company entered into a Transitional Services Agreement (“TSA”) with Takeda under which the Company will be obligated to pay Takeda for certain services, including pass-through costs, related to research and development and regulatory assistance services, oversight and management of ongoing clinical and research studies, and maintenance of third party vendor contracts. The TSA and related activities are considered related party transactions. Unless earlier terminated under its terms, the TSA will remain in effect until all transitional services are completed. The Company may terminate the provision of any or all services under the TSA upon certain written notice. The Company and Takeda may terminate the TSA in the case of the other party’s insolvency, or upon prior written notice within a specified time period for the other party’s material uncured breach. Takeda may terminate the TSA for non-payment and, in certain circumstances, upon a change of control of the Company. 401(k) Plan The Company established a defined-contribution plan under Section 401(k) of the Internal Revenue Code (the 401(k) Plan). The 401(k) Plan covers all eligible employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Beginning November 2022, the Company made matching contributions equal to 100 % of the employee’s contributions, subject to a maximum of 4 % of eligible compensation. The Company made matching contributions of $ 0.1 million and $ 0.5 million, respectively, during the three and nine months ended September 30, 2023 . The Company did no t make any matching contributions during the three and nine months ended September 30, 2022 . Contingencies In the event the Company becomes subject to claims or suits arising in the ordinary course of business, the Company would accrue a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. |
Convertible Promissory Notes an
Convertible Promissory Notes and Long-Term Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Convertible Promissory Notes and Long-Term Debt | 9. Convertible Promissory Notes and Long-Term Debt Frazier Convertible Note Financings During 2019, 2020 and 2021, the Company issued the Frazier Notes for an aggregate of $ 8.5 million bearing interest at per annum rates ranging from 0.12 % to 2.52 %. An aggregate of $ 0.9 million of the Frazier Notes were issued in April, May and September of 2019 (the “2019 Frazier Notes”), an aggregate of $ 1.3 million of the Frazier Notes were issued in March, August and October of 2020 (the “2020 Frazier Notes”) and an aggregate of $ 6.3 million of Frazier Notes were issued from April to July 2021 (the “2021 Frazier Notes”). The Frazier Notes were generally scheduled to mature 12 to 18 months from the date of issuance. The Company recorded changes in the fair value of the Frazier Notes in the condensed consolidated statements of operations. The Frazier Notes were exchanged for convertible promissory notes newly issued in connection with the August 2021 convertible note financing described below. August 2021 Convertible Note Financing On August 31, 2021, the Company entered into a note purchase agreement under which it issued the August 2021 Notes for an aggregate of $ 139.52 million. Of the August 2021 Notes, $ 103.75 million were issued to new investors, $ 25.0 million were issued to Frazier for cash and $ 10.77 million were issued to Frazier in exchange for the then outstanding principal and accrued interest on the Frazier Notes. The August 2021 Notes carried interest at a rate of 6 % per annum, compounded annually . The principal and accrued interest on the August 2021 Notes automatically converted into 10,672,138 shares of the Company's common stock immediately prior to the completion of the IPO. Of these shares, 2,736,234 were issued to Frazier. For the nine months ended September 30, 2022 , the Company recognized a $ 51.5 million change in fair value of convertible promissory notes and recognized $ 2.8 million of interest expense in connection with convertible promissory notes. Long-Term Debt The Company’s Term Loan consists of the following (in thousands): September 30, Long-term debt $ 25,000 Accumulated PIK interest 463 Total principal (including PIK interest) 25,463 Unamortized debt discount ( 425 ) Long-term debt, net of debt discount $ 25,038 On April 18, 2022, the Company entered into a Loan and Security Agreement (the “Existing Loan Agreement” and, as amended by the First Amendment (as defined below) the "Loan Agreement") with Hercules Capital, Inc., as administrative and collateral agent (in such capacity, "Hercules"), and the lenders from time to time party thereto (the "Lenders"), providing for term loans (“Term Loans”) of up to $ 75.0 million. Prior to June 16, 2023, the Company had borrowed $ 15.0 million in term loans under the Existing Loan Agreement and had the right thereunder to borrow (i) an additional $ 15.0 million of term loans until June 30, 2023 (“Term Loan Tranche 1”), (ii) an additional $ 20.0 million of term loans until June 30, 2023 (“Term Loan Tranche 2”), and (iii) subject to the achievement of certain clinical development milestones by the Company, an additional $ 25.0 million until March 31, 2024 ("Term Loan Tranche 3”). On June 16, 2023, the Company entered into a First Amendment to Loan and Security Agreement (the "First Amendment") with Hercules and the Lenders party thereto, which amended the Existing Loan Agreement. In connection with the First Amendment, the Company borrowed $ 10.0 million under Term Loan Tranche 1. Additionally, the First Amendment, among other things, amended the following: (i) with respect to the remaining $ 5.0 million under Term Loan Tranche 1, modified the period during which the Company may borrow thereunder to start on December 1, 2023 and end May 31, 2024 (or such earlier date if Lenders elect in their sole discretion), (ii) with respect to Term Loan Tranche 2, modified the period during which the Company may borrow thereunder to start on December 1, 2023 and end May 31, 2024 (or such earlier date if Lenders elect in their sole discretion) and (iii) with respect to Term Loan Tranche 3, (a) added as a new condition to borrow thereunder that (x) the Company’s Phase 2b clinical trial evaluating the safety, immunogenicity and efficacy of HIL-214 in infants ("NEST-IN1”) has achieved the protocol-specified primary efficacy endpoint and (y) HIL-214 has demonstrated acceptable safety results in the NEST-IN1 clinical trial, and, as a result, the Company supports the initiation of a Phase 3 registrational trial as the next immediate step in the development of HIL-214 (the “Tranche 3 Milestone”) and (b) modified the period during which the Company may borrow thereunder to start on the date the Company achieves the Tranche 3 Milestone and end on the earlier of (x) June 15, 2024 and (y) 30 days following the date the Company achieves the Tranche 3 Milestone. All Term Loans are subject to a minimum draw amount of $ 5.0 million and no event of default under the Loan Agreement having occurred and continuing. The borrowings under the Loan Agreement are collateralized by substantially all of the Company’s assets, including intellectual property and certain other assets. The First Amendment was accounted for as a debt modification; as such, the financing costs of $ 0.2 million were reflected as additional debt discount and is amortized as an adjustment to interest expense over the term of the First Amendment. The Term Loans bear (a) cash interest at a floating rate of the higher of (i) the Wall Street Journal prime rate (or 5.00 % if less) plus 1.05 %, or (ii) 4.55 % (interest rate of 6.05 % as of September 30, 2023 ), and (b) additional interest ("PIK Interest") at a per annum rate equal to 2.85 %, with such interest being added to the outstanding principal balance of the Term Loans on a monthly basis. The monthly payments consist of interest-only through June 1, 2025 or, if prior to April 30, 2025, the Company achieves the Tranche 3 Milestone, subject to reasonable verification by Hercules, through June 1, 2026. Subsequent to the interest-only period, the Term Loans will be payable in equal monthly installments of principal, plus accrued and unpaid interest, through the maturity date of May 1, 2027 . In addition, the Company is obligated to pay a final payment fee equal to the greater of (i) $ 2.145 million and (ii) 7.15 % of the original principal amount of the Term Loans (which is $ 2.1 million as of September 30, 2023 ). The final payment fee is recorded as a debt discount amortized over the life of the debt. The Company may elect to prepay all or a portion of the Term Loans prior to maturity, subject to a prepayment fee of up to 1.00 % of the then outstanding principal balance and the pro rata application of such payment to the final payment fee. After repayment, no Term Loan amounts may be borrowed again. The Loan Agreement contains certain customary affirmative and negative covenants and events of default. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding its operating accounts. The negative covenants include, among others, limitations on the Company’s ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies or businesses, make certain investments, pay dividends, transfer or dispose of assets, amend certain material agreements, including the Takeda License, or enter into various specified transactions. Upon the occurrence of an event of default, subject to any specified cure periods, all amounts owed by the Company would begin to bear interest at a rate that is 4.00 % above the rate effective immediately before the event of default and may be declared immediately due and payable by Hercules, as collateral agent. As of September 30, 2023 , the Company had borrowed $ 25.0 million pursuant to the Loan Agreement. During the three months ended September 30, 2023, the Company recognized interest expense of $ 1.0 million related to the Term Loans using the effective interest method. Included in such expense was $ 0.1 million, related to accretion of the final payment fee to other long-term liabilities, $ 0.2 million of PIK interest, $ 0.4 million of coupon interest, and an immaterial amount of debt discount amortization. During the nine months ended September 30, 2023, the Company recognized interest expense of $ 1.7 million related to the Term Loans using the effective interest method. Included in such expense was $ 0.3 million related to accretion of the final payment fee to other long-term liabilities, $ 0.4 million of PIK interest, $ 0.9 million of coupon interest, and an immaterial amount of debt discount amortization. Future minimum principal and interest payments, including the final payment fee, as of September 30, 2023 are as follows (in thousands): September 30, Years ending December 31: 2023 $ 390 2024 1,599 2025 8,433 2026 13,303 2027 10,645 Total principal payments, interest payments and final payment fee 34,370 Less: interest, PIK interest and final payment fee ( 8,907 ) Long-term debt $ 25,463 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 10. Stockholders’ Equity Initial Public Offering On May 3, 2022, the Company completed its IPO whereby it sold 13,529,750 shares of common stock at a public offering price of $ 17.00 per share, for net proceeds of approximately $ 209.5 million, after deducting underwriting discounts, commissions and offering costs of approximately $ 20.5 million. In connection with the Company's IPO, the Company increased the number of authorized shares of the Company's common stock and preferred stock to 500,000,000 shares and 50,000,000 shares, respectively. At-the-Market-Offering On May 12, 2023 , the Company entered into an At-the-Market Equity Offering Sales Agreement (the "Sales Agreement") with Stifel, Nicolaus & Company, Incorporated (the “Agent”), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $ 100.0 million from time to time, in “at the market” offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0 % of the gross proceeds of any shares of common stock sold under the Sales Agreement. The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. As of September 30, 2023, no sales have been made pursuant to the Sales Agreement. Underwritten Public Offering On September 22, 2023, the Company completed an underwritten public offering whereby it sold 9,200,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,200,000 shares, at a public offering price of $ 12.50 per share for total net proceeds of approximately $ 107.8 million, after underwriting discounts and commissions and estimated offering costs. 2021 Equity Incentive Plan On February 8, 2021, the Company’s board of directors and stockholders approved and adopted the HilleVax, Inc. 2021 Equity Incentive Plan (the “2021 Plan”). The term of the 2021 Plan is ten years from the adoption date. Under the 2021 Plan, the Company may grant stock options, restricted stock, restricted stock units, and other stock-based awards to employees, directors or consultants of the Company and its subsidiaries. The stock options granted under the plan generally vest over a four-year period from the vesting commencement date. Upon the effectiveness of the 2022 Plan defined and described below, no further grants will be made under the 2021 Plan, and any outstanding awards granted under the 2021 Plan will remain subject to the terms of the 2021 Plan and applicable award agreements. 2022 Incentive Award Plan In April 2022, the Company’s board of directors and stockholders approved the 2022 Incentive Award Plan (the “2022 Plan,” and together with the 2021 Plan, the "Plans") under which the Company may grant stock options, restricted stock, dividend equivalents, restricted stock units, stock appreciation rights, and other stock or cash-based awards to its employees, consultants and directors. The 2022 Plan became effective in connection with the Company’s IPO and will remain in effect until the tenth anniversary of its effective date, which will be April 28, 2032, unless earlier terminated by the Company’s board of directors. The number of shares of the Company's common stock initially available for issuance under awards granted pursuant to the 2022 Plan was the sum of (1) 4,900,000 shares of the Company’s common stock, plus (2) 216,849 shares remaining available for issuance under the 2021 Plan as of the effective date of the 2022 Plan, plus (3) any shares subject to outstanding awards under the 2021 Plan as of the effective date of the 2022 Plan that become available for issuance under the 2022 Plan thereafter in accordance with its terms. The number of shares initially available for issuance will be increased by an annual increase on January 1 of each calendar year ending in and including 2032 , equal to the lesser of (1) 5 % of the shares of common stock outstanding on the final day of the immediately preceding calendar year and (2) such smaller number of shares as determined by the Company’s board of directors. As of September 30, 2023, 7,197,502 shares were reserved for issuance under the 2022 Plan, of which 3,762,865 shares remained available for future issuance. 2022 Employee Stock Purchase Plan In April 2022, the Company’s board of directors and stockholders approved the 2022 Employee Stock Purchase Plan (the “2022 ESPP”). The 2022 ESPP became effective in connection with the Company’s IPO. The 2022 ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to a specified percentage of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the 2022 ESPP. The price of common stock purchased under the 2022 ESPP is equal to 85 % of the lower of the fair market value of the common stock on the first trading day of the offering period or the relevant purchase date. A total of 410,000 shares of the Company’s common stock was initially reserved for issuance under the 2022 ESPP. In addition, the number of shares available for issuance under the 2022 ESPP will be annually increased on January 1 of each calendar year, ending in and including 2032 , by an amount equal to the lesser of (1) 1 % of the shares outstanding on the final day of the immediately preceding calendar year and (2) such smaller number of shares as is determined by the Company’s board of directors, provided that no more than 10,000,000 shares of the Company’s common stock may be issued under the 2022 ESPP. A summary of the Company’s stock option activity under the Plans is as follows (in thousands, except share and per share data): Number of Weighted Weighted Aggregate Balance at December 31, 2022 2,111,989 $ 10.62 9.33 $ 13,330 Granted 1,842,225 17.68 Exercised ( 22,382 ) 7.49 Cancelled ( 161,131 ) 13.02 Balance at September 30, 2023 3,770,701 $ 13.78 9.21 $ 14,070 Vested and expected to vest at September 30, 2023 3,770,701 $ 13.78 9.19 $ 14,070 Exercisable at September 30, 2023 769,785 $ 8.28 8.61 $ 4,395 Stock-Based Compensation Expense The assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants were as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Risk-free interest rate 4.1 %– 4.6 % 2.7 %– 4.0 % 3.5 %– 4.6 % 1.9 %– 4.0 % Expected volatility 94.5 %– 95.1 % 92.9 %– 94.3 % 91.7 %– 95.9 % 83.4 %– 94.3 % Expected term (in years) 6.1 5.3 – 6.1 5.5 – 6.1 5.3 – 6.1 Expected dividend yield 0 % 0 % 0 % 0 % Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of the awards. Expected volatility . Given the Company's limited historical stock price volatility data, the expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Expected term . The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected life assumption using the simplified method, for employees, which is an average of the contractual term of the option and its vesting period. Expected dividend yield . The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends and, therefore, used an expected dividend yield of zero . Stock-based compensation expense has been reported in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,894 $ 456 $ 4,710 $ 1,034 General and administrative 2,052 388 5,124 638 Total $ 3,946 $ 844 $ 9,834 $ 1,672 The weighted average grant date fair value per share of option grants for the three and nine months ended September 30, 2023 and 2022 was $ 13.69 , $ 11.11 , $ 17.68 , and $ 8.49 , respectively. As of September 30, 2023, total unrecognized stock-based compensation cost related to stock options was approximately $ 29.7 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.9 years. A summary of the Company’s unvested shares is as follows: Number of Weighted Average Grant-Date Fair Value Balance at December 31, 2022 1,584,709 $ 0.001 Shares granted 759,266 18.000 Shares forfeited ( 88,849 ) 0.001 Share vested ( 513,036 ) 0.001 Balance at September 30, 2023 1,742,090 — The Company did not issue any shares of restricted common stock during the three months ended September 30, 2023. The Company issued shares of restricted common stock during the nine months ended September 30, 2023 , which consisted only of restricted stock units. The Company did no t issue any shares of restricted common stock during the three and nine months ended September 30, 2022. The weighted average grant date fair value per share of restricted common stock grants for the nine months ended September 30, 2023 was $ 18.00 . As of September 30, 2023, total unrecognized stock-based compensation cost related to restricted stock was approximately $ 11.1 million, which is expected to be recognized over a remaining weighted-average period of approximately 3.3 years. For accounting purposes, unvested shares of restricted common stock are not considered outstanding until they vest. As of September 30, 2023 and December 31, 2022, the Company had no material repurchase liability related to the unvested shares in the table above. Common Stock Reserved for Future Issuance Common stock reserved for future issuance consists of the following: September 30, Common stock options outstanding 3,770,701 Shares available for issuance under the Plans 3,762,865 Shares available for issuance under the ESPP 747,679 8,281,245 |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | 11. Subsequent Event On November 9, 2023, the Company entered into a Second Amendment to Loan and Security Agreement (the "Second Amendment") with Hercules and the Lenders party thereto, which amended the Loan Agreement. The Second Amendment amended the following: (i) with respect to the remaining $ 5.0 million under Term Loan Tranche 1, modified the period during which the Company may borrow thereunder to start on January 1, 2024 and end July 19, 2024 (or such earlier date if Lenders elect in their sole discretion), (ii) with respect to Term Loan Tranche 2, modified the period during which the Company may borrow thereunder to start on January 1, 2024 and end July 19, 2024 (or such earlier date if Lenders elect in their sole discretion) and (iii) with respect to Term Loan Tranche 3, modified the period during which the Company may borrow thereunder to end on the earlier of (x) September 15, 2024 and (y) 30 days following the date the Company achieves the Tranche 3 Milestone. The Company did not incur any fees in connection with the Second Amendment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Forward Stock Split | Forward Stock Split On April 22, 2022, the Company effected a 1.681 -for-1 forward split of shares of the Company’s common stock (the “Forward Stock Split”). The par value of the common stock was not adjusted as a result of the Forward Stock Split and the authorized shares were increased to 50,000,000 shares of common stock in connection with the Forward Stock Split. The accompanying financial statements and notes to the financial statements give retroactive effect to the Forward Stock Split for all periods presented, unless otherwise indicated. |
Liquidity and Capital Resources | Liquidity and Capital Resources From inception to September 30, 2023, the Company has devoted substantially all of its efforts to organizing and staffing the Company, business planning, raising capital, in-licensing its initial vaccine candidate, HIL-214, preparing for and managing its clinical trials of HIL-214, and providing other general and administrative support for these operations. The Company has a limited operating history, has never generated any revenue, and the sales and income potential of its business is unproven. The Company has incurred net losses and negative cash flows from operating activities since its inception and expects to continue to incur net losses into the foreseeable future as it continues the development and potential commercialization of HIL-214. From inception to September 30, 2023 , the Company has funded its operations through the issuance of convertible promissory notes, commercial bank debt, the sale of 13,529,750 shares of common stock for net proceeds of approximately $ 209.5 million in its initial public offering ("IPO") which closed in May 2022, and the sale of 9,200,000 shares of common stock for net proceeds of approximately $ 107.8 million in its underwritten public offering which closed in September 2023 (see Note 10). The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. Management is required to perform a two-step analysis over the Company’s ability to continue as a going concern. Management must first evaluate whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern (Step 1). If management concludes that substantial doubt is raised, management is also required to consider whether its plans alleviate that doubt (Step 2). Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these financial statements were issued. There can be no assurance that the Company will be successful in acquiring additional funding, if needed, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. |
Basis of Presentation | Basis of Presentation The Company's financial statements include the accounts of HilleVax Security Corporation, a wholly-owned subsidiary formed in Massachusetts, and HilleVax GmbH, a wholly-owned subsidiary formed in Zurich, Switzerland. The functional currency of the Company, HilleVax Security Corporation and HilleVax GmbH is the U.S. dollar. The Company’s assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense), in the condensed consolidated statements of operations and were not material for the periods presented. All intercompany transactions have been eliminated in consolidation. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The unaudited condensed consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 2023 and 2022, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”), and with U.S. generally accepted accounting principles (“GAAP”) applicable to interim financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited financial statements and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year or future periods. The condensed consolidated balance sheet data as of December 31, 2022 was derived from the Company’s audited financial statements but does not include all disclosures required by GAAP. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 17, 2023. |
Use of Estimates | Use of Estimates The preparation of the Company’s unaudited condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s unaudited condensed consolidated financial statements relate to accruals for research and development expenses, and prior to the Company's IPO, the valuation of convertible promissory notes, warrant liabilities and various other equity instruments. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results could differ materially from those estimates and assumptions. |
Fair Value Option | Fair Value Option As permitted under Accounting Standards Codification (“ASC”) 825, Financial Instruments , (“ASC 825”), the Company has elected the fair value option to account for its convertible promissory notes issued through May 2022, when the convertible promissory notes converted into equity in connection with the Company's IPO. In accordance with ASC 825, the Company recorded these convertible promissory notes at fair value with changes in fair value recorded in the condensed consolidated statements of operations. As a result of applying the fair value option, direct costs and fees related to the convertible promissory notes were recognized in earnings as incurred and not deferred. |
Fair Value Measurements | Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts and money market funds. |
Restricted Cash | Restricted Cash Restricted cash consists of a money market account securing a standby letter of credit issued in connection with the Company’s Boston Lease (as defined and described in Note 6). |
Marketable Securities | Marketable Securities Marketable securities represent holdings of available-for-sale marketable debt securities in accordance with the Company’s investment policy. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit) until realized or until a determination is made that an other-than-temporary decline in market value has occurred. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, together with interest on securities sold, is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income (expense). |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and restricted cash. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets as follows: Estimated Useful Life Computer equipment 3 years Lab equipment 5 years Furniture and fixtures 5 years Leasehold improvements 3 – 10 years or term of lease Repairs and maintenance costs are charged to expense as incurred. |
Leases | Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. Lease terms are determined at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise. For its long-term operating leases, the Company recognizes a lease liability and a right-of-use (“ROU”) asset on its balance sheet and recognizes lease expense on a straight-line basis over the lease term. The lease liability is determined as the present value of future lease payments, reduced by any reimbursements for tenant improvements, using the discount rate implicit in the lease or, if the implicit rate is not readily determinable, an estimate of the Company’s incremental borrowing rate. The ROU asset is based on the lease liability, adjusted for any prepaid or deferred rent, and reduced by any reimbursements for tenant improvements. The Company aggregates all lease and non-lease components for each class of underlying assets into a single lease component and variable charges for common area maintenance and other variable costs are recognized as expense as incurred. The Company has elected to not recognize a lease liability or ROU asset in connection with short-term operating leases and recognizes lease expense for short-term operating leases on a straight-line basis over the lease term. The Company does not have any financing leases. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets, such as property and equipment, for impairment whenever events or changes in circumstances indicate the carrying amount of an asset 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 as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Fair value would be assessed using discounted cash flows or other appropriate measures of fair value. The Company has not recognized any impairment losses through September 30, 2023 . |
Research and Development Expenses and Accruals | Research and Development Expenses and Accruals All research and development costs are expensed in the period incurred and consist primarily of salaries, payroll taxes, employee benefits, stock-based compensation charges for those individuals involved in research and development efforts, external research and development costs incurred under agreements with contract research organizations and consultants to conduct and support the Company’s clinical trials of HIL-214. The Company has entered into various research and development contracts with clinical research organizations, clinical manufacturing organizations and other companies. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. |
In-Process Research and Development | In-Process Research and Development The Company evaluates whether acquired intangible assets are a business under applicable accounting standards. Additionally, the Company evaluates whether the acquired assets have a future alternative use. Intangible assets that do not have future alternative use are considered acquired in-process research and development. When the acquired in-process research and development assets are not part of a business combination, the value of the consideration paid is expensed on the acquisition date. |
Patent Costs | Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expenses and expensed as incurred since recoverability of such expenditures is uncertain. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of equity awards, primarily consisting of stock options, restricted common stock, and employee stock purchase rights, recognized on a straight-line basis over the requisite service period for stock options and restricted common stock, and over the respective offering period for employee stock purchase plan rights. The Company recognizes forfeitures as they occur. |
Benefit plans | Benefit plans The Company has established a defined contribution savings plan for its employees in the United States under Section 401(k) of the Internal Revenue Code, and a defined benefits plan for its employees outside of the United States. The defined benefits plan is valued by an independent actuary using the projected unit credit method. The liabilities correspond to the projected benefit obligations of which the discounted net present value is calculated based on years of employment, expected salary increase, and pension adjustments. The Company reviews its actuarial assumptions on an annual basis and makes modifications to the assumptions based on current rates and trends. This plan is recognized under ASC 715, Compensation - Retirement Benefits . |
Income Taxes | Income Taxes The Company accounts for income taxes under 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 included in the financial statements. Under this method, 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. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in the condensed consolidated statements of operations in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (i) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense in the condensed consolidated statements of operations. Any accrued interest and penalties are included within the related tax liability in the condensed consolidated balance sheets. The Company did not recognize any interest or penalties during the periods presented. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. For the three and nine months ended September 30, 2023, comprehensive loss included gains on the Company's pension benefit obligation and unrealized losses on marketable securities. For the three and nine months ended September 30, 2022 , the Company’s comprehensive loss was the same as its reported net loss. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the consolidated net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company included 5,883,500 shares of common stock under the Takeda Warrant (as defined below) in the calculation of basic weighted-average common shares outstanding from the time the Takeda Warrant became exercisable upon the Company’s IPO because the Takeda Warrant was exercisable for minimal consideration. The Company has excluded weighted-average unvested shares of 1,149,612 shares, 1,954,126 shares, 1,318,737 shares, and 2,214,463 shares from the basic weighted-average number of common shares outstanding for the three months ended September 30, 2023 and 2022 and the nine months ended September 30, 2023 and 2022, respectively. Diluted net loss per share is computed by dividing the consolidated net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of unvested common stock, common stock options, contingently issuable shares under the Company's employee stock purchase plan, and common stock warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive common stock equivalents would be antidilutive. Potentially dilutive securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares): September 30, 2023 2022 Common stock options 3,770,701 1,795,989 Unvested common stock 1,742,090 1,781,874 ESPP shares 16,767 7,186 Total potentially dilutive shares 5,529,558 3,585,049 |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to avail itself of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. |
Recently Adopted/Issued Accounting Standards/Pronouncements | Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-13, Financial Instruments – Credit Losses (Topic 326), to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in Topic 326 replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. We adopted Topic 326 on January 1, 2023 . The adoption did no t have a material impact on our unaudited condensed consolidated financial statements’. Recently Issued Accounting Pronouncements The Company assesses the adoption impacts of recently issued accounting standards by the Financial Accounting Standards Board or other standard setting bodies on the Company's condensed consolidated financial statements as well as material updates to previous assessments, if any. Although there were several other new accounting pronouncements issued or proposed by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life of the Related assets | Property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful life of the related assets as follows: Estimated Useful Life Computer equipment 3 years Lab equipment 5 years Furniture and fixtures 5 years Leasehold improvements 3 – 10 years or term of lease |
Schedule of Potentially Dilutive Securities Not Included in the Calculation of Diluted Net Loss Per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares): September 30, 2023 2022 Common stock options 3,770,701 1,795,989 Unvested common stock 1,742,090 1,781,874 ESPP shares 16,767 7,186 Total potentially dilutive shares 5,529,558 3,585,049 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets that are measured at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands): Fair Value Measurements at Total Quoted Prices in Significant Significant Cash equivalents Money market funds $ 201,473 $ 201,473 $ — $ — Marketable securities: U.S. treasury notes 31,396 31,396 — — U.S government agency bonds 84,512 — 84,512 — Total $ 317,381 $ 232,869 $ 84,512 $ — Fair Value Measurements at Total Quoted Prices in Significant Significant Cash equivalents Money market funds $ 277,043 $ 277,043 $ — $ — Total $ 277,043 $ 277,043 $ — $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Fair Value of Available-For-Sale Marketable Debt Securities | As of September 30, 2023, the fair value of available-for-sale marketable debt securities by type of security was as follows (in thousands): September 30, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Marketable securities: U.S. treasury notes $ 31,417 $ - $ ( 21 ) $ 31,396 U.S. government agency bonds 84,556 3 ( 47 ) 84,512 Total $ 115,973 $ 3 $ ( 68 ) $ 115,908 |
Other Balance Sheet Details (Ta
Other Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Property and Equipment | Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2023 2022 Computer equipment $ 103 $ - Furniture and equipment 372 11 Leasehold improvements 11,870 378 Lab equipment 1,844 — Construction in progress 5 5,198 Total property and equipment, at cost 14,194 5,587 Less accumulated depreciation 450 1 Property and equipment, net $ 13,744 $ 5,586 |
Accrued Expenses | Accrued expenses consisted of the following (in thousands): September 30, December 31, 2023 2022 Accrued external research and development costs $ 8,118 $ 3,510 Accrued payroll and payroll-related costs 3,729 4,018 Accrued professional costs 498 307 Other 544 375 Total accrued expenses $ 12,889 $ 8,210 |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash recorded within the accompanying condensed consolidated balance sheets that sum to the amounts shown in the condensed consolidated statements of cash flows (in thousands): September 30, December 31, 2023 2022 Cash and cash equivalents $ 208,502 $ 279,401 Restricted cash 1,631 1,631 Total cash, cash equivalents and restricted cash $ 210,133 $ 281,032 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Operating Lease Expense | The following table summarizes operating lease expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Lease expense: Operating lease expense $ 780 $ 779 $ 2,339 $ 1,573 The Company incurred an immaterial amount of expense related to short-term leases and variable lease costs during the three and nine months ended September 30, 2023 and the |
Schedule of Weighted Average Lease Term and Discount Rate for Operating Lease | The following table summarizes the lease term and discount rate for operating leases: September 30, December 31, 2023 2022 Other information: Weighted-average remaining lease term 9.20 9.96 Weighted-average discount rate 7.4 % 7.4 % |
Summary of Cash Paid for Amounts Included in Measurement of Lease Liabilities | The following table summarizes the cash paid for amounts included in the measurement of lease liabilities (in thousands): September 30, Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) $ 2,613 |
Schedule of Future Minimum Noncancelable Operating Lease Payments | At September 30, 2023, the future minimum noncancelable operating lease payments were as follows (in thousands): September 30, Years ending December 31: 2023 $ 871 2024 3,584 2025 3,688 2026 3,784 2027 3,860 Thereafter 21,075 Total undiscounted operating lease payments 36,862 Present value adjustment ( 10,175 ) Tenant improvement reimbursements ( 786 ) Operating lease liability 25,901 Less current portion of operating lease liability 2,654 Operating lease liability, net of current portion $ 23,247 |
Convertible Promissory Notes _2
Convertible Promissory Notes and Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Term Loan | The Company’s Term Loan consists of the following (in thousands): September 30, Long-term debt $ 25,000 Accumulated PIK interest 463 Total principal (including PIK interest) 25,463 Unamortized debt discount ( 425 ) Long-term debt, net of debt discount $ 25,038 |
Schedule of Future Minimum Principal and Interest Payments | Future minimum principal and interest payments, including the final payment fee, as of September 30, 2023 are as follows (in thousands): September 30, Years ending December 31: 2023 $ 390 2024 1,599 2025 8,433 2026 13,303 2027 10,645 Total principal payments, interest payments and final payment fee 34,370 Less: interest, PIK interest and final payment fee ( 8,907 ) Long-term debt $ 25,463 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Summary of Stock Option Activity | A summary of the Company’s stock option activity under the Plans is as follows (in thousands, except share and per share data): Number of Weighted Weighted Aggregate Balance at December 31, 2022 2,111,989 $ 10.62 9.33 $ 13,330 Granted 1,842,225 17.68 Exercised ( 22,382 ) 7.49 Cancelled ( 161,131 ) 13.02 Balance at September 30, 2023 3,770,701 $ 13.78 9.21 $ 14,070 Vested and expected to vest at September 30, 2023 3,770,701 $ 13.78 9.19 $ 14,070 Exercisable at September 30, 2023 769,785 $ 8.28 8.61 $ 4,395 |
Summary of Assumptions used in Black-Scholes Option Pricing Model to Determine Fair Value of Stock Option Grants | The assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants were as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Risk-free interest rate 4.1 %– 4.6 % 2.7 %– 4.0 % 3.5 %– 4.6 % 1.9 %– 4.0 % Expected volatility 94.5 %– 95.1 % 92.9 %– 94.3 % 91.7 %– 95.9 % 83.4 %– 94.3 % Expected term (in years) 6.1 5.3 – 6.1 5.5 – 6.1 5.3 – 6.1 Expected dividend yield 0 % 0 % 0 % 0 % |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense has been reported in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,894 $ 456 $ 4,710 $ 1,034 General and administrative 2,052 388 5,124 638 Total $ 3,946 $ 844 $ 9,834 $ 1,672 |
Summary of Unvested Shares | A summary of the Company’s unvested shares is as follows: Number of Weighted Average Grant-Date Fair Value Balance at December 31, 2022 1,584,709 $ 0.001 Shares granted 759,266 18.000 Shares forfeited ( 88,849 ) 0.001 Share vested ( 513,036 ) 0.001 Balance at September 30, 2023 1,742,090 — |
Schedule of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance consists of the following: September 30, Common stock options outstanding 3,770,701 Shares available for issuance under the Plans 3,762,865 Shares available for issuance under the ESPP 747,679 8,281,245 |
Organization - Additional Infor
Organization - Additional Information (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 41 Months Ended | 57 Months Ended | |||
May 03, 2022 USD ($) $ / shares shares | Apr. 22, 2022 shares | Sep. 30, 2022 USD ($) | May 31, 2022 USD ($) shares | Sep. 30, 2023 USD ($) shares | Dec. 31, 2022 shares | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Forward split of shares | 1.681 | |||||
Common stock shares authorized | shares | 50,000,000 | 500,000,000 | 500,000,000 | |||
Sale of common stock | shares | 13,529,750 | |||||
Net proceeds from initial public offering | $ | $ 230,006 | |||||
Agreegate offering price | $ | $ 209,515 | |||||
Initial Public Offering | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Common stock shares authorized | shares | 500,000,000 | |||||
Sale of common stock | shares | 13,529,750 | |||||
Public offering price per share | $ / shares | $ 17 | |||||
Net proceeds from initial public offering | $ | $ 209,500 | $ 209,500 | ||||
Underwriting discounts, commissions and offering costs | $ | $ 20,500 | |||||
Underwritten public offering | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Sale of common stock | shares | 9,200,000 | |||||
Net proceeds from common stock | $ | $ 107,800 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 shares | Sep. 30, 2022 shares | Sep. 30, 2023 Segment shares | Sep. 30, 2022 shares | |
Summary of Significant Accounting Policies [Line Item] | ||||
Number of operating segment | Segment | 1 | |||
Basic weighted-average common shares outstanding | 39,039,553 | 37,323,626 | 38,252,981 | 23,640,388 |
Weighted-average unvested shares excluded from computation of earnings per share amount | 1,149,612 | 1,954,126 | 1,318,737 | 2,214,463 |
ASU 2016-13 | ||||
Summary of Significant Accounting Policies [Line Item] | ||||
Change in accounting principle, accounting standards update, adopted | true | true | ||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | Jan. 01, 2023 | ||
Change in accounting principle, accounting standards update, immaterial effect | true | true | ||
Takeda Warrant | ||||
Summary of Significant Accounting Policies [Line Item] | ||||
Basic weighted-average common shares outstanding | 5,883,500 |
Summary of Accounting Policies
Summary of Accounting Policies - Schedule of Estimated Useful Life of the Related Assets (Details) | Sep. 30, 2023 |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Lab equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeTermOfLeaseMember |
Leasehold improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Leasehold improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 10 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Potential Dilutive Securities Not Included in the Calculation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,529,558 | 3,585,049 |
Common Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,770,701 | 1,795,989 |
Unvested common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,742,090 | 1,781,874 |
ESPP shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 16,767 | 7,186 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets Measured at Fair Value on Recurring Basis (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 317,381 | $ 277,043 |
Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 201,473 | 277,043 |
U.S. Treasury Notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 31,396 | |
U.S Government Agency Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 84,512 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 232,869 | 277,043 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 201,473 | $ 277,043 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury Notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 31,396 | |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | 84,512 | |
Significant Other Observable Inputs (Level 2) | U.S Government Agency Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured at fair value | $ 84,512 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - Non-Recurring | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Non-financial assets at fair value | $ 0 |
Non-financial liabilities at fair value | $ 0 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Fair Value of Available-For-Sale Marketable Debt Securities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 115,973,000 | |
Gross Unrealized Gains | 3,000 | |
Gross Unrealized Losses | (68,000) | |
Fair Value | 115,908,000 | $ 0 |
U.S. Treasury Notes | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 31,417,000 | |
Gross Unrealized Losses | (21,000) | |
Fair Value | 31,396,000 | |
U.S. Government Agency Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 84,556,000 | |
Gross Unrealized Gains | 3,000 | |
Gross Unrealized Losses | (47,000) | |
Fair Value | $ 84,512,000 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |||
Marketable debt securities | $ 115,908,000 | $ 115,908,000 | $ 0 |
Impairment of assets measured and carried at fair value | $ 0 | $ 0 |
Other Balance Sheet Details - S
Other Balance Sheet Details - Summary of Components of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | $ 14,194 | $ 5,587 |
Less accumulated depreciation | 450 | 1 |
Property, Plant and Equipment, Net, Total | 13,744 | 5,586 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | 103 | |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | 372 | 11 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | 11,870 | 378 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | 1,844 | |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, at cost | $ 5 | $ 5,198 |
Other Balance Sheet Details - A
Other Balance Sheet Details - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Other Balance Sheet Details [Abstract] | ||
Depreciation expense | $ 400 | $ 450 |
Other Balance Sheet Details -_2
Other Balance Sheet Details - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued external research and development costs | $ 8,118 | $ 3,510 |
Accrued payroll and payroll-related costs | 3,729 | 4,018 |
Accrued professional costs | 498 | 307 |
Other | 544 | 375 |
Total accrued expenses | $ 12,889 | $ 8,210 |
Other Balance Sheet Details -_3
Other Balance Sheet Details - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||||
Cash and cash equivalents | $ 208,502 | $ 279,401 | ||
Restricted cash | 1,631 | 1,631 | ||
Total cash, cash equivalents and restricted cash | $ 210,133 | $ 281,032 | $ 293,691 | $ 124,566 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |
Mar. 31, 2022 | Aug. 31, 2021 | Sep. 30, 2023 | |
Switzerland | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease term | 5 years | ||
Operating lease option to extend | The Company has an option to extend the lease for a period of five years which the Company is not reasonably certain to exercise. | ||
Operating lease, existence of option to extend [true false] | true | ||
Operating lease renewal term | 5 years | ||
Boston, Massachusetts | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease option to extend | an option for the Company to extend the lease for a period of five years | ||
Operating lease, existence of option to extend [true false] | true | ||
Operating lease renewal term | 5 years | ||
Increase in operating lease liability | $ 5.6 | ||
Maximum lessee operating lease tenant improvement allowances for reimbursement cost | 6.3 | ||
Lease incentive | 6.3 | ||
Irrevocable standby letter of credit secured by restricted cash amount | $ 1.6 |
Leases - Schedule of Operating
Leases - Schedule of Operating Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lease expense: | ||||
Operating lease expense | $ 780 | $ 779 | $ 2,339 | $ 1,573 |
Leases - Schedule of Weighted A
Leases - Schedule of Weighted Average Lease Term and Discount Rate for Operating Lease (Details) | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Weighted-average remaining lease term | 9 years 2 months 12 days | 9 years 11 months 15 days |
Weighted-average discount rate | 7.40% | 7.40% |
Leases - Schedule of Cash Paid
Leases - Schedule of Cash Paid for Amounts Included in the Measurement of Lease Liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Leases [Abstract] | |
Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) | $ 2,613 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Noncancelable Operating Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 | $ 871 | |
2024 | 3,584 | |
2025 | 3,688 | |
2026 | 3,784 | |
2027 | 3,860 | |
Thereafter | 21,075 | |
Total undiscounted operating lease payments | 36,862 | |
Present value adjustment | (10,175) | |
Tenant improvement reimbursements | (786) | |
Operating lease liability | 25,901 | |
Less current portion of operating lease liability | 2,654 | $ 37 |
Operating lease liability, net of current portion | $ 23,247 | $ 21,569 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||||||
Change in fair value of convertible promissory notes | $ 51,469,000 | ||||||
Accounts payable and accrued expenses | $ 12,889,000 | $ 12,889,000 | $ 8,210,000 | ||||
August 2021 Notes | Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Debt instrument conversion, common stock shares issued | 10,672,138 | 10,672,138 | |||||
Frazier | |||||||
Related Party Transaction [Line Items] | |||||||
Due to related parties | 0 | 0 | 6,000 | ||||
Shared operating expenses | 0 | $ 3,000 | 0 | 37,000 | |||
Change in fair value of convertible promissory notes | 13,200,000 | ||||||
Interest Expense | 700,000 | ||||||
Takeda | TSA | |||||||
Related Party Transaction [Line Items] | |||||||
Research and development expenses | 55,000 | $ 700,000 | 300,000 | $ 2,300,000 | |||
Accounts payable and accrued expenses | $ 77,000 | $ 77,000 | $ 300,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jul. 02, 2021 | Nov. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Cash paid for purchased in-process research and development | $ 2,500,000 | |||||||
Common stock shares issued | 48,417,931 | 48,417,931 | 39,240,746 | |||||
Company made matching contributions | $ 100,000 | $ 0 | $ 500,000 | $ 0 | ||||
Matching contribution | the Company made matching contributions equal to 100% of the employee’s contributions, subject to a maximum of 4% of eligible compensation. The Company made matching contributions of $0.1 million and $0.5 million, respectively, during the three and nine months ended September 30, 2023. The Company did not make any matching contributions during the three and nine months ended September 30, 2022. | |||||||
Percentage Of employee's contributions | 100% | |||||||
Percentage of maximum eligible compensation | 4% | |||||||
Takeda | ||||||||
Commitments And Contingencies Disclosure [Line Items] | ||||||||
Purchase of common stock upon exercise of outstanding warrant | 5,883,500 | |||||||
Transaction prices per share | $ 0.0000595 | |||||||
Cash paid for purchased in-process research and development | $ 2,500,000 | $ 2,500,000 | ||||||
Common stock shares issued | 840,500 | |||||||
Issuance of common stock in connection with Takeda License | $ 4,400,000 | |||||||
Promissory notes initial fair value | 34,000 | |||||||
Development Milestones | 7,500,000 | |||||||
Sales Milestones | $ 150,000,000 | |||||||
License agreement milestone payments | $ 0 | $ 0 |
Convertible Promissory Notes _3
Convertible Promissory Notes and Long-Term Debt - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 14 Months Ended | |||||
Jun. 16, 2023 | Apr. 18, 2022 | Aug. 31, 2021 | Sep. 30, 2023 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Jun. 15, 2023 | |
Convertible Promissory Notes [Line Items] | |||||||||
Change in fair value of convertible promissory notes | $ 51,469,000 | ||||||||
Debt instrument, carrying amount | $ 25,000,000 | $ 25,000,000 | |||||||
Long-Term Debt | 25,038,000 | 25,038,000 | |||||||
Debt instrument, amount borrowed | 25,463,000 | 25,463,000 | |||||||
PIK interest | 375,000 | 48,000 | |||||||
Amortization of debt discount | $ 410,000 | 182,000 | |||||||
Minimum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Notes issuance, maturity period | 12 months | ||||||||
Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Notes issuance, maturity period | 18 months | ||||||||
Loan Agreement | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, amount borrowed | 25,000,000 | $ 25,000,000 | |||||||
Term Loan | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Interest expense | 1,000,000 | 1,700,000 | |||||||
Debt instrument, accretion of final payment fee | 100,000 | 300,000 | |||||||
PIK interest | 200,000 | 400,000 | |||||||
Debt instrument, coupon interest | $ 400,000 | $ 900,000 | |||||||
Term Loan | Loan Agreement | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, interest rate | 4.55% | 6.05% | 6.05% | ||||||
Debt instrument, maximum borrowing capacity | $ 75,000,000 | ||||||||
Debt instrument, amount borrowed | $ 15,000,000 | ||||||||
Debt instrument, minimum draw amount | $ 5,000,000 | ||||||||
Debt instrument, basis spread on variable rate | 5% | ||||||||
Debt instrument, interest rate per annum | 2.85% | ||||||||
Debt instrument, payment terms | The monthly payments consist of interest-only through June 1, 2025 or, if prior to April 30, 2025, the Company achieves the Tranche 3 Milestone, subject to reasonable verification by Hercules, through June 1, 2026. Subsequent to the interest-only period, the Term Loans will be payable in equal monthly installments of principal, plus accrued and unpaid interest, through the maturity date of May 1, 2027. | ||||||||
Debt instrument, maturity date | May 01, 2027 | ||||||||
Debt instrument, final payment fee | $ 2,145,000 | $ 2,100,000 | $ 2,100,000 | ||||||
Percentage of original principal amount payable | 7.15% | ||||||||
Financing costs | 200,000 | ||||||||
Percentage of interest upon event of default | 4% | ||||||||
Term Loan | Loan Agreement | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Percentage of prepayment fee on outstanding principal balance | 1% | ||||||||
Term Loan | Prime Rate | Loan Agreement | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, basis spread on variable rate | 1.05% | ||||||||
Frazier | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | $ 8,500,000 | $ 8,500,000 | |||||||
Frazier | Minimum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Bearing interest | 0.12% | 0.12% | |||||||
Frazier | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Bearing interest | 2.52% | 2.52% | |||||||
2019 Frazier Notes | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | $ 900,000 | $ 900,000 | |||||||
2020 Frazier Notes | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | 1,300,000 | 1,300,000 | |||||||
2021 Frazier Notes | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | $ 6,300,000 | $ 6,300,000 | |||||||
August 2021 Notes | Common Stock | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument conversion, common stock shares issued | 10,672,138 | 10,672,138 | |||||||
August 2021 Notes | Frazier Life Sciences X, L.P. | Common Stock | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument conversion, common stock shares issued | 2,736,234 | ||||||||
August 2021 Notes | Note Purchase Agreement | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | $ 139,520,000 | ||||||||
Debt instrument, interest rate | 6% | ||||||||
Debt instrument, frequency of periodic payment | annually | ||||||||
Interest expense | 2,800,000 | ||||||||
Change in fair value of convertible promissory notes | $ 51,500,000 | ||||||||
August 2021 Notes | Note Purchase Agreement | New Investors | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | $ 103,750,000 | ||||||||
August 2021 Notes | Note Purchase Agreement | Frazier Life Sciences X, L.P. | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Aggregate amount | 10,770,000 | ||||||||
Cash proceeds from issuance of convertible notes | $ 25,000,000 | ||||||||
Term Loan 1 Borrowing through June 30, 2023 | Term Loan 1 | Loan Agreement | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, amount borrowed | $ 10,000,000 | ||||||||
Term Loan 1 Borrowing through June 30, 2023 | Term Loan 1 | Loan Agreement | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, available credit under loan agreement | 15,000,000 | ||||||||
Term Loan 2 Borrowing through June 30, 2023 | Term Loan 2 | Loan Agreement | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, available credit under loan agreement | 20,000,000 | ||||||||
Term Loan 3 Borrowing through March 31, 2024 | Term Loan 3 | Loan Agreement | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, available credit under loan agreement | $ 25,000,000 | ||||||||
Term Loan 1 Borrowing December 1, 2023 through May 31, 2024 | Term Loan 1 | Loan Agreement | Maximum | |||||||||
Convertible Promissory Notes [Line Items] | |||||||||
Debt instrument, available credit under loan agreement | $ 5,000,000 |
Convertible Promissory Notes _4
Convertible Promissory Notes and Long-Term Debt - Schedule of Term Loan (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
Long-term debt | $ 25,000 |
Accumulated PIK interest | 463 |
Total principal (including PIK interest) | 25,463 |
Unamortized debt discount | (425) |
Long-term debt, net of debt discount | $ 25,038 |
Convertible Promissory Notes _5
Convertible Promissory Notes and Long-Term Debt - Schedule of Future Minimum Principal and Interest Payments (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 390 |
2024 | 1,599 |
2025 | 8,433 |
2026 | 13,303 |
2027 | 10,645 |
Total principal payments, interest payments and final payment fee | 34,370 |
Less: interest, PIK interest and final payment fee | (8,907) |
Long-term debt | $ 25,463 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 41 Months Ended | |||||||
Sep. 22, 2023 | May 12, 2023 | May 03, 2022 | Apr. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | May 31, 2022 | Dec. 31, 2022 | Apr. 22, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Expected dividend yield | 0% | 0% | 0% | 0% | |||||||
Weighted average grant date fair value per share of option grants | $ 13.69 | $ 17.68 | $ 11.11 | $ 8.49 | |||||||
Number of issued shares of restricted common stock grants | 0 | 759,266 | 0 | ||||||||
Weighted Average Grant-Date Fair Value, Shares granted | $ 18 | ||||||||||
Common Stock, Shares, Issued | 48,417,931 | 48,417,931 | 39,240,746 | ||||||||
Total unrecognized stock-based compensation cost related to stock options | $ 29,700 | $ 29,700 | |||||||||
Sale of common stock | 13,529,750 | ||||||||||
Net proceeds from initial public offering | $ 230,006 | ||||||||||
Agreegate offering price | $ 209,515 | ||||||||||
Increase in number of authorized shares of common stock | 500,000,000 | 500,000,000 | 500,000,000 | 50,000,000 | |||||||
Increase in number of authorized shares of preferred stock | 50,000,000 | 50,000,000 | 50,000,000 | ||||||||
Shares reserved for issuance | 8,281,245 | 8,281,245 | |||||||||
Total unrecognized stock-based compensation cost related to restricted stock | $ 11,100 | $ 11,100 | |||||||||
Sales Agreement | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sales agreement date | May 12, 2023 | ||||||||||
Maximum commission percentage on gross proceeds of shares of common stock sold | 3% | ||||||||||
Maximum | Sales Agreement | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Agreegate offering price | $ 100,000 | ||||||||||
Stock Options | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total unrecognized stock-based compensation cost expected to be recognized over remaining weighted-average period | 2 years 10 months 24 days | ||||||||||
Shares reserved for issuance | 3,770,701 | 3,770,701 | |||||||||
Restricted Stock | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Total unrecognized stock-based compensation cost expected to be recognized over remaining weighted-average period | 3 years 3 months 18 days | ||||||||||
Initial Public Offering | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of common stock | 13,529,750 | ||||||||||
Public offering price per share | $ 17 | ||||||||||
Net proceeds from initial public offering | $ 209,500 | $ 209,500 | |||||||||
Underwriting discounts, commissions and offering costs | $ 20,500 | ||||||||||
Increase in number of authorized shares of common stock | 500,000,000 | ||||||||||
Increase in number of authorized shares of preferred stock | 50,000,000 | ||||||||||
Underwritten Public Offering | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of common stock | 9,200,000 | ||||||||||
Public offering price per share | $ 12.5 | ||||||||||
Agreegate offering price | $ 107,750 | $ 107,750 | |||||||||
Net proceeds after deducting underwriters commission | $ 107,800 | ||||||||||
Common Stock | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of outstanding options, Exercised | 1,000 | 22,382 | |||||||||
Sale of common stock | 13,529,750 | ||||||||||
Agreegate offering price | $ 1 | ||||||||||
Common Stock | Underwritten Public Offering | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Sale of common stock | 1,200,000 | 9,200,000 | 9,200,000 | ||||||||
Agreegate offering price | $ 1 | $ 1 | |||||||||
2021 Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Plan term | ten years | ||||||||||
Vesting period | 4 years | ||||||||||
Shares reserved for issuance | 3,762,865 | 3,762,865 | |||||||||
Number of shares remained available for issuance under awards granted | 216,849 | ||||||||||
2022 Incentive Award Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Plan term | The 2022 Plan became effective in connection with the Company’s IPO and will remain in effect until the tenth anniversary of its effective date, which will be April 28, 2032, unless earlier terminated by the Company’s board of directors. The number of shares of the Company's common stock initially available for issuance under awards granted pursuant to the 2022 Plan was the sum of (1) 4,900,000 shares of the Company’s common stock, plus (2) 216,849 shares remaining available for issuance under the 2021 Plan as of the effective date of the 2022 Plan, plus (3) any shares subject to outstanding awards under the 2021 Plan as of the effective date of the 2022 Plan that become available for issuance under the 2022 Plan thereafter in accordance with its terms. | ||||||||||
Shares reserved for issuance | 7,197,502 | 7,197,502 | |||||||||
Number of shares remained available for issuance under awards granted | 4,900,000 | 3,762,865 | 3,762,865 | ||||||||
Shares issuance, ending year | 2032 | ||||||||||
Percentage of shares issued from outstanding number of shares | 5% | ||||||||||
2022 Employee Stock Purchase Plan | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares reserved for issuance | 410,000 | ||||||||||
Shares reserved for issuance | 747,679 | 747,679 | |||||||||
Maximum number of shares that may be authorized in accordance with plan | 10,000,000 | ||||||||||
Shares issuance, ending year | 2032 | ||||||||||
Percentage of shares issued from outstanding number of shares | 1% | ||||||||||
Purchase price of common stock, percent | 85% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) - Plans $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of outstanding options, Beginning balance | shares | 2,111,989 | |
Number of outstanding options, Granted | shares | 1,842,225 | |
Number of outstanding options, Exercised | shares | (22,382) | |
Number of outstanding options, Cancelled | shares | (161,131) | |
Number of outstanding options, Ending Balance | shares | 3,770,701 | 2,111,989 |
Number of outstanding options, Vested and expected to vest at September 30, 2023 | shares | 3,770,701 | |
Number of outstanding options, Exercisable at September 30, 2023 | shares | 769,785 | |
Weighted average exercise price, Beginning balance | $ / shares | $ 10.62 | |
Weighted average exercise price, Granted | $ / shares | 17.68 | |
Weighted average exercise price, Exercised | $ / shares | 7.49 | |
Weighted average exercise price, Cancelled | $ / shares | 13.02 | |
Weighted average exercise price, Ending balance | $ / shares | 13.78 | $ 10.62 |
Weighted average exercise price, Vested and expected to vest at September 30, 2023 | $ / shares | 13.78 | |
Weighted average exercise price, Exercisable at September 30, 2023 | $ / shares | $ 8.28 | |
Weighted-average remaining contractual term (in years) | 9 years 2 months 15 days | 9 years 3 months 29 days |
Weighted-average remaining contractual term (in years), Vested and expected to vest at September 30, 2023 | 9 years 2 months 8 days | |
Weighted-average remaining contractual term (in years) Exercisable at September 30, 2023 | 8 years 7 months 9 days | |
Aggregate intrinsic value | $ | $ 14,070 | $ 13,330 |
Aggregate intrinsic value, Vested and expected to vest at September 30, 2023 | $ | 14,070 | |
Aggregate intrinsic value, Exercisable at September 30, 2023 | $ | $ 4,395 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Assumptions used in Black-Scholes Option Pricing Model to Determine Fair Value of Stock Option Grants (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Risk-free interest rate, minimum | 4.10% | 2.70% | 3.50% | 1.90% |
Risk-free interest rate, maximum | 4.60% | 4% | 4.60% | 4% |
Expected volatility, minimum | 94.50% | 92.90% | 91.70% | 83.40% |
Expected volatility, maximum | 95.10% | 94.30% | 95.90% | 94.30% |
Expected term (in years) | 6 years 1 month 6 days | |||
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 3 months 18 days | 5 years 6 months | 5 years 3 months 18 days | |
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | $ 3,946 | $ 844 | $ 9,834 | $ 1,672 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | 1,894 | 456 | 4,710 | 1,034 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | $ 2,052 | $ 388 | $ 5,124 | $ 638 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Unvested Shares (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |||
Number of unvested shares, Beginning balance | 1,584,709 | ||
Number of unvested shares, Shares granted | 0 | 759,266 | 0 |
Number of unvested shares, Shares forfeited | (88,849) | ||
Number of unvested shares, Shares vested | (513,036) | ||
Number of unvested shares, Ending balance | 1,742,090 | ||
Weighted Average Grant-Date Fair Value, Beginning balance | $ 0.001 | ||
Weighted Average Grant-Date Fair Value, Shares granted | 18 | ||
Weighted Average Grant-Date Fair Value, Shares forfeited | 0.001 | ||
Weighted Average Grant-Date Fair Value, Shares vested | $ 0.001 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Common Stock Reserved for Future Issuance (Details) | Sep. 30, 2023 shares |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 8,281,245 |
Common Stock Options | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 3,770,701 |
Shares Available for Issuance Under the 2021 Plan | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 3,762,865 |
Shares available for issuance under the ESPP | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 747,679 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Term Loan 1 Borrowing January 1, 2024 through July 19, 2024 - Term Loan 1 - Loan Agreement - Maximum - USD ($) | Nov. 09, 2023 | Jun. 15, 2023 |
Subsequent Event [Line Items] | ||
Debt instrument, available credit under loan agreement | $ 15,000,000 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Debt instrument, available credit under loan agreement | $ 5,000,000 |