Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38210 | |
Entity Registrant Name | Krystal Biotech, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-1080209 | |
Entity Address, Address Line One | 2100 Wharton Street | |
Entity Address, Address Line Two | Suite 701 | |
Entity Address, City or Town | Pittsburgh | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 15203 | |
City Area Code | 412 | |
Local Phone Number | 586-5830 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | KRYS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 25,747,647 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001711279 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 186,409 | $ 341,246 |
Short-term investments | 208,011 | 96,850 |
Prepaid expenses and other current assets | 3,158 | 4,171 |
Total current assets | 397,578 | 442,267 |
Property and equipment, net | 157,786 | 112,355 |
Long-term investments | 12,557 | 64,371 |
Right-of-use assets | 8,253 | 7,228 |
Other non-current assets | 205 | 74 |
Total assets | 576,379 | 626,295 |
Current liabilities | ||
Accounts payable | 5,761 | 8,398 |
Current portion of lease liability | 1,547 | 1,041 |
Accrued expenses and other current liabilities | 20,724 | 16,297 |
Total current liabilities | 28,032 | 25,736 |
Lease liability | 7,575 | 6,983 |
Total liabilities | 35,607 | 32,719 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity | ||
Preferred stock; $0.00001 par value; 20,000,000 shares authorized at September 30, 2022 and December 31, 2021; 2,061,773 shares issued, and no shares outstanding at September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock; $0.00001 par value; 80,000,000 shares authorized a September 30, 2022 and December 31, 2021; 25,709,664 shares issued and outstanding at September 30, 2022; and 25,207,985 shares issued and outstanding at December 31, 2021 | 0 | 0 |
Additional paid-in capital | 790,954 | 734,523 |
Accumulated other comprehensive loss | (1,475) | (163) |
Accumulated deficit | (248,707) | (140,784) |
Total stockholders' equity | 540,772 | 593,576 |
Total liabilities and stockholders' equity | $ 576,379 | $ 626,295 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 2,061,773 | 2,061,773 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 25,709,664 | 25,207,985 |
Common stock, shares outstanding | 25,709,664 | 25,207,985 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Expenses | ||||
Research and development | $ 11,516 | $ 6,080 | $ 31,720 | $ 18,875 |
General and administrative | 19,935 | 9,572 | 53,705 | 27,524 |
Litigation settlement | 0 | 0 | 25,000 | 0 |
Total operating expenses | 31,451 | 15,652 | 110,425 | 46,399 |
Loss from operations | (31,451) | (15,652) | (110,425) | (46,399) |
Other Income (Expense) | ||||
Interest and other income, net | 1,601 | 63 | 2,502 | 127 |
Interest expense | 0 | 0 | 0 | (1,492) |
Net loss | (29,850) | (15,589) | (107,923) | (47,764) |
Unrealized gain (loss) on available-for-sale securities and currency translation adjustment | 70 | 7 | (1,312) | (20) |
Comprehensive loss | $ (29,780) | $ (15,582) | $ (109,235) | $ (47,784) |
Net loss per common share: basic (in dollars per share) | $ (1.17) | $ (0.70) | $ (4.24) | $ (2.18) |
Net loss per common share: diluted (in dollars per share) | $ (1.17) | $ (0.70) | $ (4.24) | $ (2.18) |
Weighted-average common shares outstanding: basic | 25,619,125 | 22,212,266 | 25,428,097 | 21,893,656 |
Weighted-average common shares outstanding: diluted | 25,619,125 | 22,212,266 | 25,428,097 | 21,893,656 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 19,714,220 | ||||
Beginning balance at Dec. 31, 2020 | $ 292,084 | $ 0 | $ 363,292 | $ 6 | $ (71,214) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 2,489,837 | ||||
Issuance of common stock, net | 152,033 | 152,033 | |||
Stock-based compensation expense | 2,350 | 2,350 | |||
Unrealized gain (loss) on investments and other | (3) | (3) | |||
Net loss | (15,812) | (15,812) | |||
Ending balance (in shares) at Mar. 31, 2021 | 22,204,057 | ||||
Ending balance at Mar. 31, 2021 | 430,652 | $ 0 | 517,675 | 3 | (87,026) |
Beginning balance (in shares) at Dec. 31, 2020 | 19,714,220 | ||||
Beginning balance at Dec. 31, 2020 | 292,084 | $ 0 | 363,292 | 6 | (71,214) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain (loss) on investments and other | (20) | ||||
Net loss | (47,764) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 22,237,984 | ||||
Ending balance at Sep. 30, 2021 | 408,237 | $ 0 | 527,229 | (14) | (118,978) |
Beginning balance (in shares) at Mar. 31, 2021 | 22,204,057 | ||||
Beginning balance at Mar. 31, 2021 | 430,652 | $ 0 | 517,675 | 3 | (87,026) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 975 | ||||
Issuance of common stock, net | 14 | 14 | |||
Stock-based compensation expense | 4,261 | 4,261 | |||
Unrealized gain (loss) on investments and other | (24) | (24) | |||
Net loss | (16,363) | (16,363) | |||
Ending balance (in shares) at Jun. 30, 2021 | 22,205,032 | ||||
Ending balance at Jun. 30, 2021 | 418,540 | $ 0 | 521,950 | (21) | (103,389) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 32,952 | ||||
Issuance of common stock, net | 1,534 | 1,534 | |||
Stock-based compensation expense | 3,745 | 3,745 | |||
Unrealized gain (loss) on investments and other | 7 | 7 | |||
Net loss | (15,589) | (15,589) | |||
Ending balance (in shares) at Sep. 30, 2021 | 22,237,984 | ||||
Ending balance at Sep. 30, 2021 | 408,237 | $ 0 | 527,229 | (14) | (118,978) |
Beginning balance (in shares) at Dec. 31, 2021 | 25,207,985 | ||||
Beginning balance at Dec. 31, 2021 | 593,576 | $ 0 | 734,523 | (163) | (140,784) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 1,475 | ||||
Issuance of common stock, net | 55 | 55 | |||
Shares surrendered for taxes and forfeitures (in shares) | (10,379) | ||||
Shares surrendered for taxes and forfeitures | (649) | (649) | |||
Stock-based compensation expense | 6,571 | 6,571 | |||
Unrealized gain (loss) on investments and other | (1,034) | (1,034) | |||
Net loss | (49,965) | (49,965) | |||
Ending balance (in shares) at Mar. 31, 2022 | 25,199,081 | ||||
Ending balance at Mar. 31, 2022 | 548,554 | $ 0 | 740,500 | (1,197) | (190,749) |
Beginning balance (in shares) at Dec. 31, 2021 | 25,207,985 | ||||
Beginning balance at Dec. 31, 2021 | 593,576 | $ 0 | 734,523 | (163) | (140,784) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain (loss) on investments and other | (1,312) | ||||
Net loss | (107,923) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 25,709,664 | ||||
Ending balance at Sep. 30, 2022 | 540,772 | $ 0 | 790,954 | (1,475) | (248,707) |
Beginning balance (in shares) at Mar. 31, 2022 | 25,199,081 | ||||
Beginning balance at Mar. 31, 2022 | 548,554 | $ 0 | 740,500 | (1,197) | (190,749) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 472,706 | ||||
Issuance of common stock, net | $ 30,748 | 30,748 | |||
Shares surrendered for taxes and forfeitures (in shares) | (7,500) | ||||
Stock-based compensation expense | $ 8,335 | 8,335 | |||
Unrealized gain (loss) on investments and other | (348) | (348) | |||
Net loss | (28,108) | (28,108) | |||
Ending balance (in shares) at Jun. 30, 2022 | 25,664,287 | ||||
Ending balance at Jun. 30, 2022 | 559,181 | $ 0 | 779,583 | (1,545) | (218,857) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock, net, (in shares) | 45,377 | ||||
Issuance of common stock, net | 2,176 | 2,176 | |||
Stock-based compensation expense | 9,195 | 9,195 | |||
Unrealized gain (loss) on investments and other | 70 | 70 | |||
Net loss | (29,850) | (29,850) | |||
Ending balance (in shares) at Sep. 30, 2022 | 25,709,664 | ||||
Ending balance at Sep. 30, 2022 | $ 540,772 | $ 0 | $ 790,954 | $ (1,475) | $ (248,707) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Activities | ||
Net loss | $ (107,923) | $ (47,764) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 2,966 | 1,985 |
Stock-based compensation expense | 23,678 | 10,174 |
Loss on disposals of fixed assets | 22 | 0 |
Non-cash interest expense | 0 | 1,492 |
Other, net | (224) | (224) |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | 1,031 | 1,038 |
Other non-current assets | (31) | 0 |
Lease liability | (459) | (240) |
Accounts payable | (316) | (225) |
Accrued expenses and other current liabilities | 3,016 | 6,726 |
Net cash used in operating activities | (78,240) | (27,038) |
Investing Activities | ||
Purchases of property and equipment | (47,762) | (27,453) |
Purchases of investments | (214,712) | (83,810) |
Proceeds from maturities of investments | 153,599 | 11,033 |
Net cash used in investing activities | (108,875) | (100,230) |
Financing Activities | ||
Issuance of common stock, net | 32,927 | 153,573 |
Taxes paid related to settlement of restricted stock awards | (649) | 0 |
Repayment of ASTRA build to suit liability | 0 | (7,960) |
Net cash provided by financing activities | 32,278 | 145,613 |
Net (decrease) increase in cash and cash equivalents | (154,837) | 18,345 |
Cash and cash equivalents at beginning of period | 341,246 | 268,269 |
Cash and cash equivalents at end of period | 186,409 | 286,614 |
Supplemental Disclosures of Non-Cash Investing and Financing Activities | ||
Unpaid purchases of property and equipment included in accounts payable and accrued expenses | 15,305 | 23,213 |
Initial recognition of right-of-use assets | $ 1,556 | $ 4,396 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Organization | Organization Krystal Biotech, Inc. (the “Company,” or “we” or other similar pronouns) commenced operations on April 15, 2016. On March 31, 2017, the Company converted from a California limited liability company to a Delaware C-corporation, and changed its name from Krystal Biotech LLC to Krystal Biotech, Inc. On June 19, 2018, the Company incorporated Krystal Australia Pty Ltd., an Australian proprietary limited company, a wholly-owned subsidiary, for the purpose of undertaking preclinical and clinical studies in Australia. On April 23, 2019, the Company incorporated Jeune Aesthetics, Inc., formerly known as Jeune, Inc. ("Jeune"), in Delaware, a wholly-owned subsidiary, for the purpose of undertaking preclinical and clinical studies for aesthetic skin conditions. On January 7, 2022 and August 25, 2022, the Company incorporated Krystal Biotech Switzerland GmbH and Krystal Biotech Netherlands, B.V., respectively, for the purpose of establishing initial operations in Europe for the development and commercialization of Krystal's pipeline. We are a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. Using our patented platform that is based on engineered HSV-1, we create vectors that efficiently deliver therapeutic transgenes to cells of interest in multiple organ systems. The cell’s own machinery then transcribes and translates the encoded effector to treat or prevent disease. We formulate our vectors for non-invasive or minimally invasive routes of administration at a healthcare professional’s office or potentially in the patient’s home by a healthcare professional. Our goal is to develop easy-to-use medicines to dramatically improve the lives of patients living with rare diseases and chronic conditions. Our innovative technology platform is supported by in-house, commercial scale current good manufacturing practices ("cGMP") manufacturing capabilities. Liquidity As of September 30, 2022, the Company had an accumulated deficit of $248.7 million. With the net proceeds raised from its public offerings, the Company believes that its cash, cash equivalents and short-term investments of approximately $394.4 million as of September 30, 2022 will be sufficient to allow the Company to fund its planned operations for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. As the Company continues to incur losses, a transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability and unless and until it does, the Company will continue to need to raise additional capital or obtain financing from other sources. Management intends to fund future operations through the sale of equity and debt financings and may also seek additional capital through arrangements with strategic partners or other sources. There can be no assurance that additional funding will be available on terms acceptable to the Company, if at all. The Company is subject to risks common to companies in the biotechnology industry, including but not limited to the failure of product candidates in clinical and preclinical studies, the development of competing product candidates or other technological innovations by competitors, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to c ommercialize product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying interim condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). In the opinion of management, all adjustments, which consist of all normal recurring adjustments necessary for a fair presentation of the Company's financial position and results of operations for the interim periods presented, are reflected in the interim condensed consolidated financial statements. All intercompany balances and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassified amounts have no impact on the Company’s previously reported financial position or results of operation. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on February 28, 2022. Risks and Uncertainties The coronavirus ("COVID-19") pandemic has resulted, and is likely to continue to result, in significant national and global economic uncertainty and may adversely affect the Company's business. The Company is continuing to actively monitor the impact of the COVID-19 pandemic and the related effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. The full extent, consequences, and duration of the COVID-19 pandemic and the resulting impact on the Company cannot currently be predicted. The Company will continue to evaluate the impact that the pandemic could have on the operations, financial position, and the results of operations and cash flows during fiscal year 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Estimates are used in the following areas including stock-based compensation expense, accrued expenses, the fair value of financial instruments, the incremental borrowing rate for lease liabilities, and the valuation allowance included in the deferred income tax calculation. Segment and Geographical Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company’s chief operating decision maker view the Company’s operations and manage its business in one operating segment, which is the business of developing and commercializing pharmaceutical products. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents and investments. The Company’s policy is to invest its cash, cash equivalents and investments in money market funds, corporate bonds, commercial paper, government agency securities and various other bank deposit accounts. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing. The Company is exposed to credit risk in the event of default by the financial institutions to the extent amounts recorded on the condensed consolidated balance sheets are in excess of insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. Cash, Cash Equivalents and Investments Cash and cash equivalents consist of money market funds and bank deposits. Cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. Investments with maturities of less than one year are classified as short-term investments on the condensed consolidated balance sheets and consist of commercial paper, corporate bonds, and government agency securities. Investments with maturities of greater than one year are classified as long-term investments on the condensed consolidated balance sheets and consist of corporate bonds and government agency securities. Accrued interest on corporate bonds and government agency securities are also classified as short-term investments. As our entire investment portfolio is considered available for use in current operations, we classify all investments as available-for-sale securities. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive loss, which is a separate component of stockholders’ equity in the condensed consolidated balance sheets. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. There is a three-level hierarchy that prioritizes the inputs used in determining fair value by their reliability and preferred use, as follows: • Level 1 — Valuations based on quoted prices in active markets for identical assets or liabilities. • Level 2 — Valuations based on quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Valuations based on inputs that are both significant to the fair value measurement and unobservable. To the extent that a valuation is based on models or inputs that are less observable, or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized within Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There have been no significant changes to the valuation methods utilized by the Company during the periods presented. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented. The carrying amounts of financial instruments consisting of cash and cash equivalents, investments, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities included in the Company’s condensed consolidated financial statements, are reasonable estimates of fair value, primarily due to their short maturities. Our available-for-sale, short-term and long-term investments, which consist of commercial paper, corporate bonds, and U.S. government agency securities are considered to be Level 2 valuations. The fair value of Level 2 financial assets is determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data, such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. Property and Equipment, net Property and equipment, net, is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Computer equipment and software 3 - 7 years Laboratory and manufacturing equipment 3 - 20 years Furniture and fixtures 3 - 7 years Leasehold improvement lesser of remaining useful life or remaining lease term The Company reviews the estimated useful lives of its property and equipment on a continuing basis. In evaluating the useful lives, the Company considers how long assets will remain functionally effective, whether the technology continues to be relevant and considers other competitive and economic factors. If the assessment indicates that the assets will be used for a shorter or longer period than previously anticipated, the useful life of the assets is adjusted, resulting in a change in estimate. Changes in estimates are accounted for on a prospective basis by depreciating the current carrying values of the assets over their revised remaining useful lives. The review performed by the Company in the current year indicated that certain pieces of lab equipment would be functional for a longer term than previously estimated and as a result, the Company increased the useful lives of these assets from 7 to 15 years. This change was effective and accounted for prospectively beginning in Q3 2022. The effect of this change in useful life estimate did not result in a material change to depreciation expense. Construction in progress ("CIP") is not depreciated until the asset is placed in service. Impairment of Long-Lived Assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount of the asset. The Company has not recognized any impairment losses for the three and nine months ended September 30, 2022 and 2021, respectively. Leases The Company accounts for its lease agreements in accordance with FASB ASC Topic 842, Leases . Right-of-use lease assets represent the right to use an underlying asset during the lease term and the lease obligations represent the commitment to make lease payments arising from the lease. Right-of-use lease assets and obligations are recognized based on the present value of remaining lease payments over the lease term. As the Company’s existing lease agreements do not provide an implicit rate and as the Company does not have any external borrowings, the Company has used an estimated incremental borrowing rate based on the information available at lease commencement in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Variable lease expense is recognized in the period in which the obligation for the payment is incurred. In addition, the Company also has made an accounting policy election to exclude leases with an initial term of twelve months or less from its balance sheet and to account for lease and non-lease components of its operating leases as a single component. For lease arrangements where it has been determined that the Company has control over an asset that is under construction and is thus considered the accounting owner of the asset during the construction period, the Company records a construction in progress asset and corresponding financial obligation on the condensed consolidated balance sheet. Once the construction is complete, an assessment is performed to determine whether the lease meets certain sale-leaseback criteria. If the sale-leaseback criteria are determined to be met, the Company will remove the asset and related financial obligation from the condensed consolidated balance sheet and treat the lease as either an operating or finance lease based on an assessment of the guidance. If, upon completion of construction, the project does not meet the "sale-leaseback" criteria, the lease will be treated as a financing obligation and the Company will depreciate the asset over its estimated useful life for financial reporting purposes once the asset has been placed into service. Research and Development Expenses Research and development costs are charged to expense as incurred in performing research and development activities. These costs include employee compensation costs, facilities and overhead, preclinical and clinical activities, clinical manufacturing costs, contract management services, regulatory and other related costs. The Company estimates contract research and clinical trials materials manufacturing expenses based on the services performed pursuant to contracts with research organizations and manufacturing organizations that manufacture materials used in the Company’s ongoing preclinical and clinical studies. Non-refundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers and the Company’s estimates of accrued expenses using information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Stock-Based Compensation Expense The Company applies the fair value recognition provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification, or ASC, Topic 718, Compensation—Stock Compensation ("ASC 718"), to account for stock-based compensation. Compensation costs related to stock options granted are based on the estimated fair value of the awards on the date of grant. ASC 718 requires all stock-based payments, including grants of stock options and restricted stock, to be recognized in the consolidated statements of operations based on their grant-date fair values. Compensation expense is recognized on a straight-line basis based on the grant-date fair value over the associated service period of the award, which is generally the vesting term. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including: (i) the expected stock price volatility; (ii) the expected term of the award; (iii) the risk-free interest rate; and (iv) expected dividends. Once the Company's own sufficient historical volatility data was obtained, the Company eliminated the use of a representative peer group and began using only its own historical volatility data in its estimate of expected volatility. The Company estimates the expected term of its stock options using the “simplified” method, whereby the expected term equals the arithmetic mean of the vesting term and the original contractual term of the option. The risk-free interest rates are based on US Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid and does not expect to pay dividends in the foreseeable future. The Company accounts for forfeitures as they occur. Stock-based compensation expense recognized in the financial statements is based on awards for which service conditions are expected to be satisfied. Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions from non-owner sources. Unrealized gains or losses on available-for-sale securities is a component of other comprehensive gains or losses. We have not recorded any reclassifications from other comprehensive gains or losses to net loss during any period presented. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other accounting standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards have or may have a material impact on the condensed consolidated statements or disclosures. |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | Net Loss Per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is calculated by dividing net loss attributable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of shares of common stock and common share equivalents outstanding for the period. Common share equivalents consist of common stock issuable upon exercise of stock options and vesting of restricted stock awards. There were 3,565,110 and 1,900,638 common share equivalents outstanding as of September 30, 2022 and 2021, respectively, in the form of stock options and unvested restricted stock awards, that have been excluded from the calculation of diluted net loss per common share as their effect would be anti-dilutive for all periods presented. Three Months Ended Nine Months Ended (In thousands, except share and per share data) 2022 2021 2022 2021 Numerator: Net loss $ (29,850) $ (15,589) $ (107,923) $ (47,764) Denominator: Weighted-average basic and diluted common shares 25,619,125 22,212,266 25,428,097 21,893,656 Basic and diluted net loss per $ (1.17) $ (0.70) $ (4.24) $ (2.18) |
Fair Value Instruments
Fair Value Instruments | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Instruments | Fair Value Instruments The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of September 30, 2022 and December 31, 2021, respectively (in thousands): September 30, 2022 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash and cash equivalents $ 186,409 $ — $ — $ 186,409 $ 186,409 $ — $ — Subtotal 186,409 — — 186,409 186,409 — — Level 2: Commercial paper 52,777 2 (41) 52,738 — 52,738 — Corporate bonds 94,415 — (886) 93,529 — 87,291 6,238 U.S. government agency securities 74,824 36 (559) 74,301 — 67,982 6,319 Subtotal 222,016 38 (1,486) 220,568 — 208,011 12,557 Total $ 408,425 $ 38 $ (1,486) $ 406,977 $ 186,409 $ 208,011 $ 12,557 December 31, 2021 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash and cash equivalents $ 341,246 $ — $ — $ 341,246 $ 341,246 $ — $ — Subtotal 341,246 — — 341,246 341,246 — — Level 2: Commercial paper 40,469 1 (4) 40,466 — 40,466 — Corporate bonds 83,300 10 (114) 83,196 — 35,768 47,428 U.S. government agency securities 37,621 — (62) 37,559 — 20,616 16,943 Subtotal 161,390 11 (180) 161,221 — 96,850 64,371 Total $ 502,636 $ 11 $ (180) $ 502,467 $ 341,246 $ 96,850 $ 64,371 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company's long-term marketable securities mature between one year and two years. See Note 2 to these unaudited condensed consolidated financial statements for additional discussion regarding the Company’s fair value measurements. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Property and Equipment, Net Property and equipment, net consist of the following (in thousands): September 30, December 31, Construction in progress $ 130,071 $ 104,340 Leasehold improvements 21,503 5,723 Furniture and fixtures 949 891 Computer equipment and software 96 85 Laboratory and manufacturing equipment 10,968 5,530 Total property and equipment 163,587 116,569 Accumulated depreciation (5,801) (4,214) Property and equipment, net $ 157,786 $ 112,355 Depreciation expense was $669 thousand and $1.6 million for the three and nine months ended September 30, 2022 and $474 thousand and $1.4 million for the three and nine months ended September 30, 2021, respectively. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, Accrued construction in progress $ 10,905 $ 9,606 Accrued professional fees 2,960 2,011 Accrued payroll and benefits 3,934 2,882 Accrued preclinical and clinical expenses 2,325 1,602 Accrued financing costs 10 26 Accrued taxes 122 83 Other current liabilities 468 87 Total $ 20,724 $ 16,297 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Significant Contracts and Agreements Lease Agreements On May 26, 2016, the Company signed an operating lease for laboratory and office space that commenced in June 2016 and was scheduled to expire on October 31, 2017 (the “2016 Lease”). The 2016 Lease has been amended several times to increase the area leased, which currently consists of approximately 47,000 square feet and includes the commercial scale cGMP-compliant manufacturing facility, ANCORIS. As a result of the lease amendments, the 2016 Lease expiration date was extended to October 31, 2031. On September 30, 2022, the Company amended the 2016 Lease ("Short-Term Amendment") to add a short-term lease for additional office space that commenced on October 1, 2022 and expires on September 30, 2023. The amendment increased the area leased by approximately 7,000 square feet through September 30, 2023, resulting in a total area leased of approximately 54,000 square feet. On December 26, 2019, the Company entered into a lease agreement for a second commercial gene therapy facility ("ASTRA") in the Pittsburgh, Pennsylvania area ("ASTRA lease") with Northfield I, LLC (the "Landlord", "Northfield", or "Lessor") with an initial lease term that expired on October 31, 2035. The ASTRA lease contained an option ("Purchase Option") to purchase the building, related improvements and take corresponding assignment of the Landlord's rights under its existing Ground Lease (the "Ground Lease"). On October 5, 2020, the Company was provided with notice that the initial delivery conditions of the building had been met, including completion of the building shell, interior slab, and exterior doors, and on October 15, 2020, the Company gave the Landlord notice of its intent to purchase ASTRA for approximately $9.4 million, subject to the parties entering into a commercially reasonable purchase and sale agreement. As a result of the Company's ability to exercise its option to purchase ASTRA, the Company obtained control over the construction in progress of ASTRA as of October 5, 2020. The Company recorded a $10.0 million CIP asset and a corresponding build to suit lease liability related to the costs incurred by the Landlord, offset by the previous cash contributions of $2.4 million. On January 29, 2021, the Company entered into a Purchase and Sale Agreement ("PSA") for ASTRA with Northfield related to the purchase option exercised by the Company on October 15, 2020, for a purchase price of $9.4 million. The Company held approximately $1.5 million on deposit with Northfield under the existing lease agreement and applied this deposit as a credit against the purchase price at closing. On February 1, 2021, Northfield delivered the space as substantially complete and made the space available for access by the Company, thus triggering lease commencement. As a result, the Company concluded that this transaction did not qualify for sale-leaseback accounting because it did not meet the definition of a sale. As control did not transfer to the Lessor at lease commencement, the transaction continued to be accounted for as construction in progress and a financing obligation. On March 5, 2021, the purchase closed and the Company determined that reclassification of the construction in progress to buildings and leasehold improvements was not appropriate as the interior of the building was not yet ready for its intended use. The building continues to be held under construction in progress as of September 30, 2022. The interior of the building is currently under construction and is expected to be completed in 1H 2023. From construction completion to the closing of the purchase, the Company recognized interest expense to accrete the financial obligation to a balance that equaled the cash consideration that was paid upon the close of purchase. For more information about the expected construction costs associated with ASTRA, see "ASTRA Contractual Obligations" below. As part of the transaction, the Company also became the accounting owner of the Ground Lease, due to obtaining control over ASTRA, and recorded the applicable operating right-of-use asset and corresponding lease liability as of October 5, 2020. When the PSA was finalized, the Company took assignment of the Lessor's Ground Lease, in accordance with the Purchase Option, of which lease payments are based on annual payments of $82 thousand, and are subject to a cumulative 10% escalation clause every 5 years through 2071. On December 15, 2021, the Company entered into a 3 year lease agreement for the Boston, Massachusetts office that commenced in January 2022 and expires in January 2025. On May 16, 2022, the Company entered into a 16 month lease agreement for the Zug, Switzerland office that commenced on September 1, 2022 and expires December 31, 2023. As of September 30, 2022, future minimum commitments under the Company’s operating leases with lease terms in excess of 12 months were as follows (in thousands): Operating 2022 (remaining three months) $ 404 2023 1,640 2024 1,539 2025 1,277 2026 1,277 Thereafter 12,062 Future minimum operating lease payments $ 18,199 Less: Interest 9,077 Present value of lease liability $ 9,122 Due to the Short-Term Amendment not exceeding twelve months, the Company has not recorded a right-of-use asset or corresponding lease liability for the amendment as of September 30, 2022. Future minimum remaining operating lease payments under this amendment are $40 thousand and $121 thousand for the years ending December 31, 2022 and 2023, respectively. Supplemental condensed consolidated balance sheet information related to leases is as follows: September 30, 2022 December 31, 2021 Operating leases: Right-of-use assets $ 8,253 $ 7,228 Current portion of lease liability 1,547 1,041 Lease liability 7,575 6,983 Total lease liability $ 9,122 $ 8,024 Weighted average remaining lease term, in years 12.6 14.4 Weighted average discount rate 9.4 % 9.5 % The components of the Company's lease expense are as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Lease cost: Operating lease expense $ 399 $ 339 $ 1,200 $ 836 Variable lease expense 48 65 168 183 Total lease expense $ 447 $ 404 $ 1,368 $ 1,019 Agreements with Contract Manufacturing Organizations and Contract Research Organizations The Company enters into various agreements in the normal course of business with Contract Research Organizations ("CROs"), Contract Manufacturing Organizations ("CMOs") and other third parties for preclinical research studies, clinical trials and testing and manufacturing services. The agreements with CMOs relate to the manufacturing of sterile gel that is mixed with in-house produced vectors as part of the final drug product applied in certain of our clinical trials. These agreements may also include research and development activities, storage, packaging, labeling, and/or testing of our preclinical and clinical-stage products. The Company is obligated to make milestone payments under certain of these agreements. The estimated remaining commitment as of September 30, 2022 under these agreements is approximately $2.4 million. The Company may also be responsible for the payment of a monthly service fee for project management services for the duration of any agreements. The Company has incurred expenses under these agreements of $2.1 million and $5.1 million for each of the three and nine months ended September 30, 2022 and $744 thousand and $3.3 million for the three and nine months ended September 30, 2021. Commercial Preparedness Activities The Company has contracted with various third parties to facilitate, coordinate and perform agreed upon commercial preparedness and market research activities relating to our lead product candidate. These contracts typically call for the payment of fees for services upon the achievement of certain milestones. The estimated remaining commitment as of September 30, 2022 is $6.2 million. The Company has incurred expenses under these activities of $3.2 million and $9.5 million for the three and nine months ended September 30, 2022 and $1.8 million and $4.1 million for the three and nine months ended September 30, 2021. ASTRA Contractual Obligations The Company has contracted with various third parties to complete the interior build-out of our second cGMP facility, ASTRA. Additionally, the Company has entered into various non-cancellable purchase agreements for long-lead materials to help avoid potential schedule disruptions or material shortages. These contracts typically call for the payment of fees for services or materials upon the achievement of certain milestones. The estimated remaining commitment as of September 30, 2022 is $10.3 million. The Company has included costs incurred to-date associated with ASTRA within construction in progress as of September 30, 2022. On June 30, 2021, the Company entered into a Standard Form of Contract for Construction and the corresponding General Conditions of the Contract for Construction (collectively, the “Agreement”) with The Whiting-Turner Contracting Company (“Whiting-Turner”), pursuant to which Whiting-Turner is constructing and managing the interior construction of ASTRA. Subject to certain conditions in the Agreement, the Company will pay Whiting-Turner a contract price consisting of the cost of work plus a fee equal to 1.75% of the cost of work. Effective September 13, 2021, the Company entered into a guaranteed maximum price amendment (the "Amendment") to the Agreement to set forth the guaranteed maximum price, as well as the date by which Whiting-Turner is to achieve Substantial Completion (as defined in the Agreement). Under the Amendment, the guaranteed maximum price to be paid by the Company is $84.1 million, subject to certain additions and deductions by change orders as provided by the Agreement. Whiting-Turner’s work under the Agreement represents a portion of the work necessary to complete construction of the ASTRA facility and, therefore the date of Substantial Completion of Whiting-Turner’s work under the Agreement does not equate to the date of completion of ASTRA. The guaranteed maximum price under the Agreement with Whiting-Turner constitutes only a portion of the total estimated cost of building and equipping ASTRA as there are various other third parties engaged in the project for which contracts are not individually material. Legal Proceedings On May 1, 2020, a complaint was filed against the Company in the United States District Court for the Western District of Pennsylvania by PeriphaGen, Inc. ("PeriphaGen"), which also named our Chief Executive Officer and President, R&D, Krish Krishnan and Suma Krishnan, respectively. The complaint alleged breach of contract and misappropriation of trade secrets, which secrets the plaintiff asserted were used to develop our product candidates, including the vector backbones, and our STAR-D platform. The Company answered the complaint on June 26, 2020 by denying the allegations and brought a counterclaim asking the court to declare that the Company did not misappropriate PeriphaGen’s trade secrets or confidential information, and to further declare that the Company is the rightful and sole owner of our product candidates and STAR-D platform. In addition, the Company filed a third-party complaint against two principals of PeriphaGen, James Wechuck and David Krisky, alleging breach of contract and seeking contribution and indemnification from them in the event PeriphaGen is awarded damages. On March 9, 2022, the court officially ordered the parties to attend mediation on March 11, 2022. During the course of the mediation process, the parties were able to exchange information, allowing the parties to value their positions. On March 12, 2022, the Company entered into a binding term sheet to settle the dispute. On April 27, 2022, the Company entered into a final settlement agreement and paid PeriphaGen an upfront payment of $25.0 million on April 28, 2022 for: (i) the release of all claims in the trade secret litigation with PeriphaGen; (ii) the acquisition of certain PeriphaGen assets, and (iii) the grant of a license by PeriphaGen for dermatological applications. Upon approval of the Company's first product by the U.S. Food and Drug Administration, the Company will pay PeriphaGen an additional $12.5 million, followed by three additional $12.5 million contingent milestone payments upon reaching $100.0 million in total cumulative sales, $200.0 million in total cumulative sales and $300.0 million in total cumulative sales. As defined in the settlement agreement, cumulative sales shall include all revenue from sales of the Company products by the Company and its affiliates and licensees, as reported by the Company in its annual Form 10-K filings. If all milestones are achieved, the total consideration for settling the dispute, acquiring certain assets, and granting of a license from PeriphaGen will be $75.0 million. The Company recorded the $25.0 million under litigation settlement expense on the condensed consolidated statements of operations for the nine months ended September 30, 2022. The additional contingent milestone payments were not deemed probable due to uncertainty in the achievement of these milestones as of September 30, 2022, and therefore no additional accrual has been recorded. The Company has received $0 and $768 thousand of insurance proceeds during the three and nine months ended September 30, 2022 and Company recorded an additional $372 thousand as a receivable within prepaid expenses and other current assets on the condensed consolidated balance sheet as management determined that the amount was probable of collection relating to legal defense costs and expenses associated with the PeriphaGen litigation. The reimbursements have been recorded as an offset to our legal fees included in general and administrative expenses on the condensed consolidated statements of operations and within operating activities on the condensed consolidated statements of cash flows. |
Capitalization
Capitalization | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Capitalization | Capitalization Sale of Common Stock The Company sells shares of common stock from time to time pursuant to its previously executed sales agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") with respect to an at-the-market equity offering program ("ATM Program") finalized on December 31, 2020, under which Cowen acts as the Company's agent and/or principal and may issue and sell from time to time, during the term of the Sales Agreement, shares of common stock having an aggregate offering price up to $150.0 million ("Placement Shares"). The issuance and sale of the Placement Shares by the Company under the Sales Agreement are made pursuant to the Company's effective "shelf" registration statement on Form S-3. During 2021, the Company issued and sold 262,500 shares of common stock at a weighted average price of $66.50 per share for net proceeds of $16.9 million after deducting selling commissions of approximately $524 thousand. During the nine months ended September 30, 2022, the Company issued and sold 434,782 shares of common stock at a weighted average price of $69.00 per share for net proceeds of $29.1 million after deducting selling commissions of approximately $900 thousand, resulting in a remaining $102.5 million available for issuance under the ATM Program. On December 3, 2021, the Company completed an underwritten public offering of 2,866,667 shares of its common stock, including 200,000 shares purchased by the underwriters pursuant to their option to purchase additional shares, at $75.00 per share. Net proceeds to the Company from the offering were $201.9 million after deducting underwriting discounts and commissions of approximately $12.9 million, and other offering expenses payable by the Company of $227 thousand. On February 1, 2021, the Company completed an underwritten public offering of 2,211,538 shares of its common stock, including 288,461 shares purchased by the underwriters pursuant to their option to purchase additional shares, at $65.00 per share. Net proceeds to the Company from the offering were $134.9 million after deducting underwriting discounts and commissions of approximately $8.6 million, and other offering expenses payable by the Company of $198 thousand. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock Options Options granted to employees and non-employees vest ratably over four-year periods and stock options granted to directors of the company vest ratably over one The Company granted 189,000 and 1,913,000 stock options to employees and directors of the Company during the three and nine months ended September 30, 2022, respectively, and 297,500 and 799,950 stock options to employees and directors of the Company during the three and nine months ended September 30, 2021, respectively. The Company granted zero and 45,000 stock options to non-employees during the three and nine months ended September 30, 2022, respectively, and 50,000 stock options to non-employees during the three and nine months ended September 30, 2021, respectively. The following table summarizes the Company’s stock option activity: Stock Weighted- Weighted- Aggregate Intrinsic Value (In thousands) (1) Outstanding at December 31, 2021 2,043,179 $ 57.00 9.0 $ 31,331 Granted 1,958,000 $ 63.03 Exercised (84,776) $ 46.28 Cancelled or forfeited (412,892) $ 58.90 Expired (5,001) $ 78.19 Outstanding at September 30, 2022 3,498,510 $ 60.38 8.8 $ 37,213 Exercisable at September 30, 2022 637,315 $ 48.74 7.1 $ 14,225 (1) Aggregate intrinsic value represents the difference between the closing stock price of our common stock on September 30, 2022 and the exercise price of outstanding in-the-money options. The total intrinsic value (the amount by which the fair market value exceeds the exercise price) of stock options exercised during the three and nine months ended September 30, 2022 was $1.3 million and $2.1 million, respectively, and during the three and nine months ended September 30, 2021 was $64 thousand and $872 thousand, respectively. The weighted-average grant-date fair value per share of options granted to employees, non-employees, and directors during the three and nine months ended September 30, 2022 was $49.59 and $43.66, respectively, and during the three and nine months ended September 30, 2021 was $34.85 and $43.31, respectively. There was $105.5 million of unrecognized stock-based compensation expense related to employees', non-employees', and directors’ option awards that is expected to be recognized over a weighted-average period of 3.1 years as of September 30, 2022. The Company has recorded aggregate stock-based compensation expense related to the issuance of stock option awards in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 2,184 $ 673 $ 5,547 $ 2,273 General and administrative 6,433 2,502 16,791 6,742 Total stock-based compensation $ 8,617 $ 3,175 $ 22,338 $ 9,015 We capitalize the portion of stock-based compensation that relates to work performed on the construction of new buildings. There was $137 thousand and $423 thousand of stock-based compensation that was capitalized in the three and nine months ended September 30, 2022, respectively, and $79 thousand and $182 thousand of stock-based compensation that was capitalized in the three and nine months ended September 30, 2021, respectively. The fair value of options was estimated at the date of grant using the Black-Scholes valuation model with the following weighted-average assumptions for the three and nine months ended September 30, 2022 and 2021: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected stock price volatility 78 % 73 % 78 % 73 % Expected term of the award (years) 6.23 6.10 6.21 6.18 Risk-free interest rate 3.20 % 1.13 % 2.27 % 1.05 % Weighted average exercise price $ 70.91 $ 53.69 $ 63.03 $ 67.15 Forfeiture rate — % — % — % — % Restricted Stock Awards Restricted stock awards ("RSAs") granted to employees vest ratably over a four-year period. The Company granted zero RSAs to employees of the Company during the three and nine months ended September 30, 2022, respectively, and zero and 98,800 RSAs to employees of the Company during the three and nine months ended September 30, 2021, respectively. Number of Shares Weighted Average Non-vested RSAs as of December 31, 2021 98,800 $ 78.89 Granted — $ — Vested (14,321) $ 78.89 Surrendered or forfeited (17,879) $ 78.89 Non-vested RSAs as of September 30, 2022 66,600 $ 78.89 There was $4.2 million of unrecognized stock-based compensation expense related to employees’ awards that is expected to be recognized over a weighted-average period of 2.4 years as of September 30, 2022. The Company recorded stock-based compensation expense related to RSAs in the condensed consolidated statement of operations for the three and nine months ended September 30, 2022 and 2021 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 441 $ 491 $ 1,340 $ 1,159 Total stock-based compensation $ 441 $ 491 $ 1,340 $ 1,159 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsThe Company evaluates events or transactions that occur after the balance sheet date, but prior to the issuance of the financial statements, to identify matters that require disclosure. The Company concluded that no subsequent events have occurred that would require recognition or disclosure in the condensed consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). In the opinion of management, all adjustments, which consist of all normal recurring adjustments necessary for a fair presentation of the Company's financial position and results of operations for the interim periods presented, are reflected in the interim condensed consolidated financial statements. All intercompany balances and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified to conform to the current period presentation. The reclassified amounts have no impact on the Company’s previously reported financial position or results of operation. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on February 28, 2022. |
Risks and Uncertainties | Risks and Uncertainties The coronavirus ("COVID-19") pandemic has resulted, and is likely to continue to result, in significant national and global economic uncertainty and may adversely affect the Company's business. The Company is continuing to actively monitor the impact of the COVID-19 pandemic and the related effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. The full extent, consequences, and duration of the COVID-19 pandemic and the resulting impact on the Company cannot currently be predicted. The Company will continue to evaluate the impact that the pandemic could have on the operations, financial position, and the results of operations and cash flows during fiscal year 2022. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Estimates are used in the following areas including stock-based compensation expense, accrued expenses, the fair value of financial instruments, the incremental borrowing rate for lease liabilities, and the valuation allowance included in the deferred income tax calculation. |
Segment and Geographical Information | Segment and Geographical InformationOperating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company’s chief operating decision maker view the Company’s operations and manage its business in one operating segment, which is the business of developing and commercializing pharmaceutical products. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents and investments. The Company’s policy is to invest its cash, cash equivalents and investments in money market funds, corporate bonds, commercial paper, government agency securities and various other bank deposit accounts. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing. The Company is exposed to credit risk in the event of default by the financial institutions to the extent amounts recorded on the condensed consolidated balance sheets are in excess of insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments Cash and cash equivalents consist of money market funds and bank deposits. Cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. Investments with maturities of less than one year are classified as short-term investments on the condensed consolidated balance sheets and consist of commercial paper, corporate bonds, and government agency securities. Investments with maturities of greater than one year are classified as long-term investments on the condensed consolidated balance sheets and consist of corporate bonds and government agency securities. Accrued interest on corporate bonds and government agency securities are also classified as short-term investments. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. There is a three-level hierarchy that prioritizes the inputs used in determining fair value by their reliability and preferred use, as follows: • Level 1 — Valuations based on quoted prices in active markets for identical assets or liabilities. • Level 2 — Valuations based on quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Valuations based on inputs that are both significant to the fair value measurement and unobservable. To the extent that a valuation is based on models or inputs that are less observable, or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized within Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. There have been no significant changes to the valuation methods utilized by the Company during the periods presented. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented. The carrying amounts of financial instruments consisting of cash and cash equivalents, investments, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities included in the Company’s condensed consolidated financial statements, are reasonable estimates of fair value, primarily due to their short maturities. Our available-for-sale, short-term and long-term investments, which consist of commercial paper, corporate bonds, and U.S. government agency securities are considered to be Level 2 valuations. The fair value of Level 2 financial assets is determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data, such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. |
Property and Equipment, net | Property and Equipment, net Property and equipment, net, is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Computer equipment and software 3 - 7 years Laboratory and manufacturing equipment 3 - 20 years Furniture and fixtures 3 - 7 years Leasehold improvement lesser of remaining useful life or remaining lease term The Company reviews the estimated useful lives of its property and equipment on a continuing basis. In evaluating the useful lives, the Company considers how long assets will remain functionally effective, whether the technology continues to be relevant and considers other competitive and economic factors. If the assessment indicates that the assets will be used for a shorter or longer period than previously anticipated, the useful life of the assets is adjusted, resulting in a change in estimate. Changes in estimates are accounted for on a prospective basis by depreciating the current carrying values of the assets over their revised remaining useful lives. The review performed by the Company in the current year indicated that certain pieces of lab equipment would be functional for a longer term than previously estimated and as a result, the Company increased the useful lives of these assets from 7 to 15 years. This change was effective and accounted for prospectively beginning in Q3 2022. The effect of this change in useful life estimate did not result in a material change to depreciation expense. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount of the asset. The Company has not recognized any impairment losses for the three and nine months ended September 30, 2022 and 2021, respectively. |
Leases | Leases The Company accounts for its lease agreements in accordance with FASB ASC Topic 842, Leases . Right-of-use lease assets represent the right to use an underlying asset during the lease term and the lease obligations represent the commitment to make lease payments arising from the lease. Right-of-use lease assets and obligations are recognized based on the present value of remaining lease payments over the lease term. As the Company’s existing lease agreements do not provide an implicit rate and as the Company does not have any external borrowings, the Company has used an estimated incremental borrowing rate based on the information available at lease commencement in determining the present value of lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Variable lease expense is recognized in the period in which the obligation for the payment is incurred. In addition, the Company also has made an accounting policy election to exclude leases with an initial term of twelve months or less from its balance sheet and to account for lease and non-lease components of its operating leases as a single component. For lease arrangements where it has been determined that the Company has control over an asset that is under construction and is thus considered the accounting owner of the asset during the construction period, the Company records a construction in progress asset and corresponding financial obligation on the condensed consolidated balance sheet. Once the construction is complete, an assessment is performed to determine whether the lease meets certain sale-leaseback criteria. If the sale-leaseback criteria are determined to be met, the Company will remove the asset and related financial obligation from the condensed consolidated balance sheet and treat the lease as either an operating or finance lease based on an assessment of the guidance. If, upon completion of construction, the project does not meet the "sale-leaseback" criteria, the lease will be treated as a financing obligation and the Company will depreciate the asset over its estimated useful life for financial reporting purposes once the asset has been placed into service. |
Research and Development Expenses | Research and Development Expenses Research and development costs are charged to expense as incurred in performing research and development activities. These costs include employee compensation costs, facilities and overhead, preclinical and clinical activities, clinical manufacturing costs, contract management services, regulatory and other related costs. The Company estimates contract research and clinical trials materials manufacturing expenses based on the services performed pursuant to contracts with research organizations and manufacturing organizations that manufacture materials used in the Company’s ongoing preclinical and clinical studies. Non-refundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers and the Company’s estimates of accrued expenses using information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company applies the fair value recognition provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification, or ASC, Topic 718, Compensation—Stock Compensation ("ASC 718"), to account for stock-based compensation. Compensation costs related to stock options granted are based on the estimated fair value of the awards on the date of grant. ASC 718 requires all stock-based payments, including grants of stock options and restricted stock, to be recognized in the consolidated statements of operations based on their grant-date fair values. Compensation expense is recognized on a straight-line basis based on the grant-date fair value over the associated service period of the award, which is generally the vesting term. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including: (i) the expected stock price volatility; (ii) the expected term of the award; (iii) the risk-free interest rate; and (iv) expected dividends. Once the Company's own sufficient historical volatility data was |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions from non-owner sources. Unrealized gains or losses on available-for-sale securities is a component of other comprehensive gains or losses. We have not recorded any reclassifications from other comprehensive gains or losses to net loss during any period presented. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other accounting standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards have or may have a material impact on the condensed consolidated statements or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Estimated Useful Lives of Assets | Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Computer equipment and software 3 - 7 years Laboratory and manufacturing equipment 3 - 20 years Furniture and fixtures 3 - 7 years Leasehold improvement lesser of remaining useful life or remaining lease term |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Attributable to Common Stockholders | Three Months Ended Nine Months Ended (In thousands, except share and per share data) 2022 2021 2022 2021 Numerator: Net loss $ (29,850) $ (15,589) $ (107,923) $ (47,764) Denominator: Weighted-average basic and diluted common shares 25,619,125 22,212,266 25,428,097 21,893,656 Basic and diluted net loss per $ (1.17) $ (0.70) $ (4.24) $ (2.18) |
Fair Value Instruments (Tables)
Fair Value Instruments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Cash, Cash Equivalents and Available-for-Sale Securities | The following tables show the Company’s cash, cash equivalents and available-for-sale securities by significant investment category as of September 30, 2022 and December 31, 2021, respectively (in thousands): September 30, 2022 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash and cash equivalents $ 186,409 $ — $ — $ 186,409 $ 186,409 $ — $ — Subtotal 186,409 — — 186,409 186,409 — — Level 2: Commercial paper 52,777 2 (41) 52,738 — 52,738 — Corporate bonds 94,415 — (886) 93,529 — 87,291 6,238 U.S. government agency securities 74,824 36 (559) 74,301 — 67,982 6,319 Subtotal 222,016 38 (1,486) 220,568 — 208,011 12,557 Total $ 408,425 $ 38 $ (1,486) $ 406,977 $ 186,409 $ 208,011 $ 12,557 December 31, 2021 Amortized Cost Gross Gross Aggregate Fair Cash and Cash Short-term Marketable Securities (1) Long-term Marketable Securities (2) Level 1: Cash and cash equivalents $ 341,246 $ — $ — $ 341,246 $ 341,246 $ — $ — Subtotal 341,246 — — 341,246 341,246 — — Level 2: Commercial paper 40,469 1 (4) 40,466 — 40,466 — Corporate bonds 83,300 10 (114) 83,196 — 35,768 47,428 U.S. government agency securities 37,621 — (62) 37,559 — 20,616 16,943 Subtotal 161,390 11 (180) 161,221 — 96,850 64,371 Total $ 502,636 $ 11 $ (180) $ 502,467 $ 341,246 $ 96,850 $ 64,371 (1) The Company’s short-term marketable securities mature in one year or less. (2) The Company's long-term marketable securities mature between one year and two years. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consist of the following (in thousands): September 30, December 31, Construction in progress $ 130,071 $ 104,340 Leasehold improvements 21,503 5,723 Furniture and fixtures 949 891 Computer equipment and software 96 85 Laboratory and manufacturing equipment 10,968 5,530 Total property and equipment 163,587 116,569 Accumulated depreciation (5,801) (4,214) Property and equipment, net $ 157,786 $ 112,355 |
Schedule of Accrued Expenses And Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, Accrued construction in progress $ 10,905 $ 9,606 Accrued professional fees 2,960 2,011 Accrued payroll and benefits 3,934 2,882 Accrued preclinical and clinical expenses 2,325 1,602 Accrued financing costs 10 26 Accrued taxes 122 83 Other current liabilities 468 87 Total $ 20,724 $ 16,297 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Operating Lease Payments | As of September 30, 2022, future minimum commitments under the Company’s operating leases with lease terms in excess of 12 months were as follows (in thousands): Operating 2022 (remaining three months) $ 404 2023 1,640 2024 1,539 2025 1,277 2026 1,277 Thereafter 12,062 Future minimum operating lease payments $ 18,199 Less: Interest 9,077 Present value of lease liability $ 9,122 |
Schedule of Supplemental Condensed Consolidated Balance Sheet Information Related to Leases | Supplemental condensed consolidated balance sheet information related to leases is as follows: September 30, 2022 December 31, 2021 Operating leases: Right-of-use assets $ 8,253 $ 7,228 Current portion of lease liability 1,547 1,041 Lease liability 7,575 6,983 Total lease liability $ 9,122 $ 8,024 Weighted average remaining lease term, in years 12.6 14.4 Weighted average discount rate 9.4 % 9.5 % |
Lease, Cost | The components of the Company's lease expense are as follows: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Lease cost: Operating lease expense $ 399 $ 339 $ 1,200 $ 836 Variable lease expense 48 65 168 183 Total lease expense $ 447 $ 404 $ 1,368 $ 1,019 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Company's Stock Option Activity | The following table summarizes the Company’s stock option activity: Stock Weighted- Weighted- Aggregate Intrinsic Value (In thousands) (1) Outstanding at December 31, 2021 2,043,179 $ 57.00 9.0 $ 31,331 Granted 1,958,000 $ 63.03 Exercised (84,776) $ 46.28 Cancelled or forfeited (412,892) $ 58.90 Expired (5,001) $ 78.19 Outstanding at September 30, 2022 3,498,510 $ 60.38 8.8 $ 37,213 Exercisable at September 30, 2022 637,315 $ 48.74 7.1 $ 14,225 (1) Aggregate intrinsic value represents the difference between the closing stock price of our common stock on September 30, 2022 and the exercise price of outstanding in-the-money options. |
Summary of Stock Based Compensation Expense Related to Issuance of Stock Option Awards and Restricted Stock Awards | The Company has recorded aggregate stock-based compensation expense related to the issuance of stock option awards in the condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 2,184 $ 673 $ 5,547 $ 2,273 General and administrative 6,433 2,502 16,791 6,742 Total stock-based compensation $ 8,617 $ 3,175 $ 22,338 $ 9,015 The Company recorded stock-based compensation expense related to RSAs in the condensed consolidated statement of operations for the three and nine months ended September 30, 2022 and 2021 as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 441 $ 491 $ 1,340 $ 1,159 Total stock-based compensation $ 441 $ 491 $ 1,340 $ 1,159 |
Fair Value of Stock Options, Valuation Assumptions | The fair value of options was estimated at the date of grant using the Black-Scholes valuation model with the following weighted-average assumptions for the three and nine months ended September 30, 2022 and 2021: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Expected stock price volatility 78 % 73 % 78 % 73 % Expected term of the award (years) 6.23 6.10 6.21 6.18 Risk-free interest rate 3.20 % 1.13 % 2.27 % 1.05 % Weighted average exercise price $ 70.91 $ 53.69 $ 63.03 $ 67.15 Forfeiture rate — % — % — % — % |
Share-based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity | Number of Shares Weighted Average Non-vested RSAs as of December 31, 2021 98,800 $ 78.89 Granted — $ — Vested (14,321) $ 78.89 Surrendered or forfeited (17,879) $ 78.89 Non-vested RSAs as of September 30, 2022 66,600 $ 78.89 |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||
Accumulated deficit | $ 248,707 | $ 140,784 |
Cash, cash equivalents and short-term investments | $ 394,400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2022 | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Number of operating segment | segment | 1 | ||||
Laboratory and manufacturing equipment | |||||
Significant Accounting Policies [Line Items] | |||||
Estimated useful lives of assets | 15 years | 7 years | |||
Recognized impairment losses for long lived assets | $ | $ 0 | $ 0 | $ 0 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Estimated Useful Lives of Assets (Detail) | 3 Months Ended | 6 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | |
Computer equipment and software | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 3 years | ||
Computer equipment and software | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 7 years | ||
Laboratory and manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 15 years | 7 years | |
Laboratory and manufacturing equipment | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 3 years | ||
Laboratory and manufacturing equipment | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 20 years | ||
Furniture and fixtures | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 3 years | ||
Furniture and fixtures | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives of assets | 7 years |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Additional Information (Detail) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||
Common share equivalents outstanding, excluded from the calculation of diluted net loss per common share | 3,565,110 | 1,900,638 |
Net Loss Per Share Attributab_4
Net Loss Per Share Attributable to Common Stockholders - Schedule of Basic and Diluted Net Loss Per Share and Per Unit (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||||||
Net loss | $ (29,850) | $ (28,108) | $ (49,965) | $ (15,589) | $ (16,363) | $ (15,812) | $ (107,923) | $ (47,764) |
Denominator: | ||||||||
Weighted-average common shares outstanding: basic | 25,619,125 | 22,212,266 | 25,428,097 | 21,893,656 | ||||
Weighted-average common shares outstanding: diluted | 25,619,125 | 22,212,266 | 25,428,097 | 21,893,656 | ||||
Net loss per common share: basic (in dollars per share) | $ (1.17) | $ (0.70) | $ (4.24) | $ (2.18) | ||||
Net loss per common share: diluted (in dollars per share) | $ (1.17) | $ (0.70) | $ (4.24) | $ (2.18) |
Fair Value Instruments - Summar
Fair Value Instruments - Summary of Cash, Cash Equivalents and Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 186,409 | $ 341,246 |
Gross Unrealized Gains | 38 | 11 |
Gross Unrealized Losses | (1,486) | (180) |
Amortized Cost | 408,425 | 502,636 |
Aggregate fair value, total | 406,977 | 502,467 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 52,777 | 40,469 |
Gross Unrealized Gains | 2 | 1 |
Gross Unrealized Losses | (41) | (4) |
Aggregate Fair Value | 52,738 | 40,466 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 94,415 | 83,300 |
Gross Unrealized Gains | 0 | 10 |
Gross Unrealized Losses | (886) | (114) |
Aggregate Fair Value | 93,529 | 83,196 |
U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 74,824 | 37,621 |
Gross Unrealized Gains | 36 | 0 |
Gross Unrealized Losses | (559) | (62) |
Aggregate Fair Value | 74,301 | 37,559 |
Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate fair value, total | 186,409 | 341,246 |
Short-term Marketable Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate fair value, total | 208,011 | 96,850 |
Short-term Marketable Securities | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 52,738 | 40,466 |
Short-term Marketable Securities | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 87,291 | 35,768 |
Short-term Marketable Securities | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 67,982 | 20,616 |
Long-term Marketable Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate fair value, total | 12,557 | 64,371 |
Long-term Marketable Securities | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 0 | 0 |
Long-term Marketable Securities | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 6,238 | 47,428 |
Long-term Marketable Securities | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | 6,319 | 16,943 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 186,409 | 341,246 |
Aggregate Fair Value | 186,409 | 341,246 |
Level 1 | Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 186,409 | 341,246 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 222,016 | 161,390 |
Gross Unrealized Gains | 38 | 11 |
Gross Unrealized Losses | (1,486) | (180) |
Aggregate Fair Value | 220,568 | 161,221 |
Level 2 | Short-term Marketable Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | $ 208,011 | 96,850 |
Debt securities, available-for-sale, term | 1 year | |
Level 2 | Long-term Marketable Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Aggregate Fair Value | $ 12,557 | 64,371 |
Level 2 | Long-term Marketable Securities | Minimum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt securities, available-for-sale, term | 1 year | |
Level 2 | Long-term Marketable Securities | Maximum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Debt securities, available-for-sale, term | 2 years | |
Cash and cash equivalents | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 186,409 | 341,246 |
Aggregate Fair Value | 186,409 | 341,246 |
Cash and cash equivalents | Level 1 | Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 186,409 | $ 341,246 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 163,587 | $ 116,569 |
Accumulated depreciation | (5,801) | (4,214) |
Property and equipment, net | 157,786 | 112,355 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 130,071 | 104,340 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 21,503 | 5,723 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 949 | 891 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 96 | 85 |
Laboratory and manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 10,968 | $ 5,530 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation expense | $ 669 | $ 474 | $ 1,600 | $ 1,400 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Expenses And Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued construction in progress | $ 10,905 | $ 9,606 |
Accrued professional fees | 2,960 | 2,011 |
Accrued payroll and benefits | 3,934 | 2,882 |
Accrued preclinical and clinical expenses | 2,325 | 1,602 |
Accrued financing costs | 10 | 26 |
Accrued taxes | 122 | 83 |
Other current liabilities | 468 | 87 |
Total | $ 20,724 | $ 16,297 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) ft² in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||||||
Apr. 28, 2022 USD ($) | Mar. 12, 2022 USD ($) | Oct. 15, 2020 USD ($) | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² milestone | Sep. 30, 2021 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | May 16, 2022 | Dec. 15, 2021 | Sep. 13, 2021 USD ($) | Oct. 05, 2020 USD ($) | May 26, 2016 ft² | |
Operating Leased Assets [Line Items] | ||||||||||||||
Cash contribution | $ 2,400 | |||||||||||||
Purchase price of potential purchase | $ 9,400 | |||||||||||||
Construction in progress, gross | 10,000 | |||||||||||||
Finance lease, liability | $ 10,000 | |||||||||||||
Escrow deposit | $ 1,500 | |||||||||||||
Lessor, operating lease, liability, annual lease payments | $ 82 | |||||||||||||
Cumulative escalation clause | 0.10 | |||||||||||||
Cumulative escalation clause, term | 5 years | |||||||||||||
Future minimum operating lease payments | $ 18,199 | $ 18,199 | ||||||||||||
Loss contingency, guaranteed maximum price to be paid | $ 84,100 | |||||||||||||
Litigation settlement | 0 | $ 0 | 25,000 | $ 0 | ||||||||||
Proceeds from insurance settlement, operating activities | 0 | 768 | ||||||||||||
Gain related to litigation settlement | 372 | |||||||||||||
Forecast | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Future minimum operating lease payments | $ 121 | $ 40 | ||||||||||||
PeriphaGen | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Litigation settlement | $ 25,000 | 25,000 | ||||||||||||
Litigation settlement, amount awarded to other party | $ 12,500 | |||||||||||||
Number of milestones | milestone | 3 | |||||||||||||
Litigation settlement, total consideration | $ 75,000 | |||||||||||||
PeriphaGen | Milestone Two | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Litigation settlement, amount awarded to other party | $ 12,500 | |||||||||||||
Litigation settlement, milestone payments, sales threshold | 200,000 | |||||||||||||
PeriphaGen | Milestone Three | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Litigation settlement, amount awarded to other party | 12,500 | |||||||||||||
Litigation settlement, milestone payments, sales threshold | 300,000 | |||||||||||||
PeriphaGen | Milestone One | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Litigation settlement, amount awarded to other party | 12,500 | |||||||||||||
Litigation settlement, milestone payments, sales threshold | $ 100,000 | |||||||||||||
Clinical Supply Agreements | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Estimated remaining commitment | 2,400 | 2,400 | ||||||||||||
Project management service fee | 2,100 | 744 | 5,100 | 3,300 | ||||||||||
Other Contractual Obligations | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Estimated remaining commitment | 6,200 | 6,200 | ||||||||||||
Project management service fee | 3,200 | $ 1,800 | 9,500 | $ 4,100 | ||||||||||
ASTRA Facility | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Contractual obligation | $ 10,300 | $ 10,300 | ||||||||||||
Cost of work, percentage | 0.0175 | 0.0175 | ||||||||||||
2016 Lease Agreement | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Additional area of real estate property leased | ft² | 54 | 54 | 47 | |||||||||||
Short-Term Amendment | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Additional area of real estate property leased | ft² | 7 | 7 | ||||||||||||
Boston, Massachusetts Lease | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Operating lease, term of contract | 3 years | |||||||||||||
Switzerland Lease | ||||||||||||||
Operating Leased Assets [Line Items] | ||||||||||||||
Operating lease, term of contract | 16 months |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Operating Lease Payments (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 (remaining three months) | $ 404 | |
2023 | 1,640 | |
2024 | 1,539 | |
2025 | 1,277 | |
2026 | 1,277 | |
Thereafter | 12,062 | |
Future minimum operating lease payments | 18,199 | |
Less: Interest | 9,077 | |
Present value of lease liability | $ 9,122 | $ 8,024 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Supplemental Condensed Consolidated Balance Sheet Information Related to Leases (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
Right-of-use assets | $ 8,253 | $ 7,228 |
Current portion of lease liability | 1,547 | 1,041 |
Lease liability | 7,575 | 6,983 |
Total lease liability | $ 9,122 | $ 8,024 |
Weighted average remaining lease term, in years | 12 years 7 months 6 days | 14 years 4 months 24 days |
Weighted average discount rate | 9.40% | 9.50% |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease costs | $ 399 | $ 339 | $ 1,200 | $ 836 |
Variable lease costs | 48 | 65 | 168 | 183 |
Lease, Cost | $ 447 | $ 404 | $ 1,368 | $ 1,019 |
Capitalization - Additional Inf
Capitalization - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||||
Apr. 05, 2022 | Dec. 03, 2021 | Feb. 01, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Capitalization, Equity [Line Items] | ||||||
Offering expenses | $ 227 | $ 198 | ||||
Placement Shares | ||||||
Schedule of Capitalization, Equity [Line Items] | ||||||
Sale of stock, aggregate offering price | $ 150,000 | |||||
Public Offering | ||||||
Schedule of Capitalization, Equity [Line Items] | ||||||
Sale of stock, number of shares issued in transaction | 434,782 | 2,866,667 | 2,211,538 | 262,500 | ||
Sale of stock, price per share (in dollars per share) | $ 75 | $ 65 | $ 69 | $ 66.50 | ||
Proceeds from initial offering of shares | $ 29,100 | $ 201,900 | $ 134,900 | |||
Underwriting discounts and commissions | $ 12,900 | $ 8,600 | ||||
ATM Program | ||||||
Schedule of Capitalization, Equity [Line Items] | ||||||
Proceeds from initial offering of shares | $ 16,900 | |||||
Underwriting discounts and commissions | $ 900 | $ 524 | ||||
Sale of stock, remaining available issuance amount | $ 102,500 | |||||
Over-Allotment Option | ||||||
Schedule of Capitalization, Equity [Line Items] | ||||||
Sale of stock, number of shares issued in transaction | 200,000 | 288,461 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option expiration period | 10 years | ||||
Stock options granted (in shares) | 1,958,000 | ||||
Intrinsic value of options exercised | $ 1,300 | $ 64 | $ 2,100 | $ 872 | |
Share-based payment arrangement, amount capitalized | $ 137 | $ 79 | $ 423 | $ 182 | |
Director | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options granted (in shares) | 189,000 | 297,500 | 1,913,000 | 799,950 | |
Stock Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares remaining available for grant | 607,366 | 607,366 | |||
Share-based Payment Arrangement, Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vesting period | 4 years | ||||
Weighted-average grant-date fair value per share of options granted (in dollars per share) | $ 49.59 | $ 34.85 | $ 43.66 | $ 43.31 | |
Stock-based compensation expense | $ 8,617 | $ 3,175 | $ 22,338 | $ 9,015 | |
Share-based Payment Arrangement, Option | Director | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized stock-based compensation expense | $ 105,500 | $ 105,500 | |||
Estimated weighted average period | 3 years 1 month 6 days | ||||
Non-Employee Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options granted (in shares) | 0 | 50,000 | 45,000 | 50,000 | |
Non-Employee Stock Option | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vesting period | 1 year | ||||
Non-Employee Stock Option | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vesting period | 4 years | ||||
Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock award granted (in shares) | 0 | 0 | 0 | 98,800 | |
Restricted stock award outstanding (in shares) | 66,600 | 66,600 | 98,800 | ||
Unrecognized stock-based compensation expense | $ 4,200 | $ 4,200 | |||
Estimated weighted average period | 2 years 4 months 24 days | ||||
Stock-based compensation expense | $ 441 | $ 491 | $ 1,340 | $ 1,159 | |
Restricted Stock | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vesting period | 4 years | ||||
Incentive Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares remaining available for grant | 7,223 | 7,223 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Company's Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Stock Options Outstanding | ||
Beginning balance (in shares) | shares | 2,043,179 | |
Granted (in shares) | shares | 1,958,000 | |
Exercised (in shares) | shares | (84,776) | |
Cancelled or forfeited (in shares) | shares | (412,892) | |
Expired (in shares) | shares | (5,001) | |
Ending balance (in shares) | shares | 3,498,510 | 2,043,179 |
Exercisable end of period (in shares) | shares | 637,315 | |
Weighted- average Exercise Price | ||
Beginning balance (in dollars per share) | $ / shares | $ 57 | |
Granted (in dollars per share) | $ / shares | 63.03 | |
Exercised (in dollars per share) | $ / shares | 46.28 | |
Cancelled or forfeited (in dollars per share) | $ / shares | 58.90 | |
Exercised (in dollars per share) | $ / shares | 78.19 | |
Ending balance (in dollars per share) | $ / shares | 60.38 | $ 57 |
Exercisable end of period (in dollars per share) | $ / shares | $ 48.74 | |
Weighted- average Remaining Contractual Life (Years) | ||
Weighted-average remaining contractual life (Years) | 8 years 9 months 18 days | 9 years |
Weighted-average remaining contractual life (Years), exercisable | 7 years 1 month 6 days | |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value, outstanding | $ | $ 37,213 | $ 31,331 |
Exercisable at September 30, 2022 | $ | $ 14,225 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Based Compensation Expense Related to Issuance of Stock Option Awards and Restricted Stock Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 8,617 | $ 3,175 | $ 22,338 | $ 9,015 |
Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 441 | 491 | 1,340 | 1,159 |
Research and development | Share-based Payment Arrangement, Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 2,184 | 673 | 5,547 | 2,273 |
General and administrative | Share-based Payment Arrangement, Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 6,433 | 2,502 | 16,791 | 6,742 |
General and administrative | Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 441 | $ 491 | $ 1,340 | $ 1,159 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options, Valuation Assumptions (Detail) - Share-based Payment Arrangement, Option - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected stock price volatility | 78% | 73% | 78% | 73% |
Expected term of the award (years) | 6 years 2 months 23 days | 6 years 1 month 6 days | 6 years 2 months 15 days | 6 years 2 months 4 days |
Risk-free interest rate | 3.20% | 1.13% | 2.27% | 1.05% |
Weighted average exercise price (in dollars per share) | $ 70.91 | $ 53.69 | $ 63.03 | $ 67.15 |
Forfeiture rate | 0% | 0% | 0% | 0% |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Company's Restricted Stock Activity (Details) - Restricted Stock - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Number of Shares | ||||
Beginning balance (in shares) | 98,800 | |||
Granted (in shares) | 0 | 0 | 0 | 98,800 |
Vested (in shares) | (14,321) | |||
Surrendered or forfeited (in shares) | (17,879) | |||
Ending balance (in shares) | 66,600 | 66,600 | ||
Weighted Average Grant Date Fair Value | ||||
Beginning balance (in dollars per share) | $ 78.89 | |||
Granted (in dollars per share) | 0 | |||
Vested (in dollars per share) | 78.89 | |||
Surrendered or forfeited (in dollars per share) | 78.89 | |||
Ending balance (in dollars per share) | $ 78.89 | $ 78.89 |