Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 04, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | CABA | |
Entity Registrant Name | CABALETTA BIO, INC. | |
Entity Current Reporting Status | Yes | |
Entity Central Index Key | 0001759138 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 39,805,032 | |
Entity File Number | 001-39103 | |
Entity Tax Identification Number | 82-1685768 | |
Entity Address, Address Line One | 2929 Arch Street | |
Entity Address, Address Line Two | Suite 600 | |
Entity Address, City or Town | Philadelphia | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19104 | |
City Area Code | 267 | |
Local Phone Number | 759-3100 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.00001 per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 128,072 | $ 81,607 |
Short-term investments | 48,256 | 24,940 |
Prepaid expenses and other current assets | 1,244 | 2,287 |
Total current assets | 177,572 | 108,834 |
Property and equipment, net | 2,303 | 2,578 |
Operating lease right-of-use assets | 4,077 | 4,991 |
Other assets | 685 | 565 |
Total Assets | 184,637 | 116,968 |
Current liabilities: | ||
Accounts payable | 2,341 | 2,463 |
Accrued and other current liabilities | 3,959 | 4,847 |
Operating lease liabilities, current portion | 2,182 | 2,179 |
Total current liabilities | 8,482 | 9,489 |
Operating lease liabilities, net of current portion | 2,014 | 2,959 |
Total Liabilities | 10,496 | 12,448 |
Commitments and Contingencies (see Note 5 and 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.00001 par value: 10,000,000 shares authorized as of June 30, 2023 and December 31, 2022; no shares issued or outstanding at June 30, 2023 and December 31, 2022 | 0 | 0 |
Voting and non-voting common stock, $0.00001 par value: 150,000,000 (143,590,481 voting and 6,409,519 non-voting) shares authorized as of June 30, 2023 and December 31, 2022; 39,793,682 (37,932,923 voting and 1,860,759 non-voting) shares issued and outstanding as of June 30, 2023 and 29,445,134 (27,584,375 voting and 1,860,759 non-voting) shares issued and outstanding as of December 31, 2022 | 0 | 0 |
Additional paid-in capital | 370,047 | 270,129 |
Accumulated other comprehensive loss | (3) | (47) |
Accumulated deficit | (195,903) | (165,562) |
Total stockholders’ equity | 174,141 | 104,520 |
Total liabilities and stockholders’ equity | $ 184,637 | $ 116,968 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
Preferred stock, authorized shares | 10,000,000 | 10,000,000 |
Preferred stock, issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Common stock, authorized shares | 150,000,000 | 150,000,000 |
Common stock, issued shares | 39,793,682 | 29,445,134 |
Common stock, outstanding shares | 39,793,682 | 29,445,134 |
Voting Common Stock | ||
Common stock, par value | $ 0.00001 | $ 0.00001 |
Common stock, authorized shares | 143,590,481 | 143,590,481 |
Common stock, issued shares | 37,932,923 | 27,584,375 |
Common stock, outstanding shares | 37,932,923 | 27,584,375 |
Non-voting Common Stock | ||
Common stock, par value | $ 0.00001 | $ 0.00001 |
Common stock, authorized shares | 6,409,519 | 6,409,519 |
Common stock, issued shares | 1,860,759 | 1,860,759 |
Common stock, outstanding shares | 1,860,759 | 1,860,759 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 11,797 | $ 9,514 | $ 24,232 | $ 18,684 |
General and administrative | 4,093 | 3,546 | 8,614 | 7,375 |
Total operating expenses | 15,890 | 13,060 | 32,846 | 26,059 |
Loss from operations | (15,890) | (13,060) | (32,846) | (26,059) |
Other income: | ||||
Interest income | 1,403 | 150 | 2,505 | 203 |
Net loss | (14,487) | (12,910) | (30,341) | (25,856) |
Other comprehensive loss: | ||||
Net unrealized loss (income) on available-for-sale investments, net of tax | (3) | (97) | 44 | (249) |
Net comprehensive loss | $ (14,490) | $ (13,007) | $ (30,297) | $ (26,105) |
Net loss per share of voting and non-voting common stock, basic | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Net loss per share of voting and non-voting common stock, diluted | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance at Dec. 31, 2021 | $ 117,956 | $ 230,543 | $ (112,587) | ||
Beginning balance, Shares at Dec. 31, 2021 | 28,927,129 | ||||
Stock-based compensation | 1,811 | 1,811 | |||
Net unrealized losses on available-for-sale securities | (152) | $ (152) | |||
Issuance of common stock in connection with exercise of stock options | 51 | 51 | |||
Issuance of common stock in connection with exercise of stock options, Shares | 50,000 | ||||
Net Income (Loss) | (12,946) | (12,946) | |||
Ending balance at Mar. 31, 2022 | 106,720 | 232,405 | (152) | (125,533) | |
Ending balance, Shares at Mar. 31, 2022 | 28,977,129 | ||||
Beginning balance at Dec. 31, 2021 | 117,956 | 230,543 | (112,587) | ||
Beginning balance, Shares at Dec. 31, 2021 | 28,927,129 | ||||
Net Income (Loss) | (25,856) | ||||
Ending balance at Jun. 30, 2022 | 95,530 | 234,222 | (249) | (138,443) | |
Ending balance, Shares at Jun. 30, 2022 | 29,013,995 | ||||
Beginning balance at Mar. 31, 2022 | 106,720 | 232,405 | (152) | (125,533) | |
Beginning balance, Shares at Mar. 31, 2022 | 28,977,129 | ||||
Stock-based compensation | 1,777 | 1,777 | |||
Net unrealized losses on available-for-sale securities | (97) | (97) | |||
Issuance of common stock under employee stock purchase plan | 40 | 40 | |||
Issuance of common stock under employee stock purchase plan, Shares | 36,866 | ||||
Net Income (Loss) | (12,910) | (12,910) | |||
Ending balance at Jun. 30, 2022 | 95,530 | 234,222 | (249) | (138,443) | |
Ending balance, Shares at Jun. 30, 2022 | 29,013,995 | ||||
Beginning balance at Dec. 31, 2022 | $ 104,520 | 270,129 | (47) | (165,562) | |
Beginning balance, Shares at Dec. 31, 2022 | 29,445,134 | 29,445,134 | |||
Stock-based compensation | $ 2,480 | 2,480 | |||
Net unrealized losses on available-for-sale securities | 47 | 47 | |||
Issuance of common stock in connection with exercise of stock options | 458 | 458 | |||
Issuance of common stock in connection with exercise of stock options, Shares | 84,264 | ||||
Issuance of common stock upon exercise of pre-funded warrants | 1,811,591 | ||||
Net Income (Loss) | (15,854) | (15,854) | |||
Ending balance at Mar. 31, 2023 | 91,651 | 273,067 | (181,416) | ||
Ending balance, Shares at Mar. 31, 2023 | 31,340,989 | ||||
Beginning balance at Dec. 31, 2022 | $ 104,520 | 270,129 | (47) | (165,562) | |
Beginning balance, Shares at Dec. 31, 2022 | 29,445,134 | 29,445,134 | |||
Net Income (Loss) | $ (30,341) | ||||
Ending balance at Jun. 30, 2023 | $ 174,141 | 370,047 | (3) | (195,903) | |
Ending balance, Shares at Jun. 30, 2023 | 39,793,682 | 39,793,682 | |||
Beginning balance at Mar. 31, 2023 | $ 91,651 | 273,067 | (181,416) | ||
Beginning balance, Shares at Mar. 31, 2023 | 31,340,989 | ||||
Stock-based compensation | 2,803 | 2,803 | |||
Common stock issuance | 93,755 | 93,755 | |||
Common stock issuance, Shares | 8,337,500 | ||||
Net unrealized losses on available-for-sale securities | (3) | (3) | |||
Issuance of common stock in connection with exercise of stock options | 390 | 390 | |||
Issuance of common stock in connection with exercise of stock options, Shares | 107,122 | ||||
Issuance of common stock under employee stock purchase plan | 32 | 32 | |||
Issuance of common stock under employee stock purchase plan, Shares | 8,071 | ||||
Net Income (Loss) | (14,487) | (14,487) | |||
Ending balance at Jun. 30, 2023 | $ 174,141 | $ 370,047 | $ (3) | $ (195,903) | |
Ending balance, Shares at Jun. 30, 2023 | 39,793,682 | 39,793,682 |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Unaudited) (Parenthetical) | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Common Stock | |
Issuance costs | $ 6,295 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (30,341) | $ (25,856) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 5,283 | 3,588 |
Depreciation | 735 | 457 |
Non-cash lease expense | 915 | 0 |
Accretion of lease liabilities | 198 | 0 |
Amortization of discount on investments | (186) | (122) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,043 | 380 |
Other assets | (120) | (608) |
Accounts payable | (145) | (162) |
Accrued and other current liabilities | (740) | (2,012) |
Lease liabilities | (1,139) | 0 |
Net cash used in operating activities | (24,497) | (24,335) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (437) | (1,045) |
Purchases of investments | (48,085) | (49,764) |
Proceeds from maturities of investments | 25,000 | 0 |
Net cash used in investing activities | (23,522) | (50,809) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock, net of issuance costs | 93,604 | 0 |
Proceeds from issuance of common stock in connection with the exercise of stock options | 848 | 51 |
Proceeds from issuance of common stock under employee stock purchase plan | 32 | 40 |
Net cash provided by financing activities | 94,484 | 91 |
Net increase (decrease) in cash and cash equivalents | 46,465 | (75,053) |
Cash and cash equivalents—beginning of period | 81,607 | 122,222 |
Cash and cash equivalents—end of period | 128,072 | 47,169 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Issuance costs included in accrued expenses | 142 | 0 |
Property and equipment purchases included in accounts payable | $ 23 | $ 416 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (14,487) | $ (15,854) | $ (12,910) | $ (12,946) | $ (30,341) | $ (25,856) |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | 1. Basis of Presentation Cabaletta Bio, Inc. (the Company or Cabaletta) was incorporated in April 2017 in the State of Delaware as Tycho Therapeutics, Inc. and, in August 2018, changed its name to Cabaletta Bio, Inc. The Company is headquartered in Philadelphia, Pennsylvania. Cabaletta is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for autoimmune diseases. Principal operations commenced in April 2018. Risks and Uncertainties The Company does not expect to generate revenue from sales of engineered T cell therapies for autoimmune diseases or any other revenue unless and until the Company completes preclinical and clinical development and obtains regulatory approval for one or more product candidates. If the Company seeks to obtain regulatory approval for any of its product candidates, the Company expects to incur significant commercialization expenses. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. As a result, the Company is unable to predict the timing or amount of increased expenses or when or if the Company will be able to achieve or maintain profitability. Further, the Company is dependent on third parties including Penn and certain Penn-affiliated entities for certain research and development activities, including manufacturing services (Note 5 and Note 6). Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. Even if the Company is able to generate revenues from the sale of its product candidates, if approved, it may not become profitable. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and be forced to reduce its operations. Liquidity The Company has sustained annual operating losses since inception and expects to continue to generate operating losses for the foreseeable future. The Company’s ultimate success depends on the outcome of its research and development activities. The Company had cash, cash equivalents and short-term investments of $ 176,328 as of June 30, 2023. Through June 30, 2023, the Company has incurred an accumulated deficit of $ 195,903 . Management expects to incur additional losses in the future as it continues its research and development and will need to raise additional capital to fully implement its business plan and to fund its operations. The Company intends to raise such additional capital through a combination of equity offerings, debt financings, government funding arrangements, strategic alliances or other sources. However, if such financing is not available at adequate levels and on a timely basis, or such agreements are not available on favorable terms, or at all, as and when needed, the Company will need to reevaluate its operating plan and may be required to delay or discontinue the development of one or more of its product candidates or operational initiatives. The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2023, will be sufficient to fund its projected operations for at least 12 months following the date the Company files this Quarterly Report on Form 10-Q with the Securities and Exchange Commission (SEC). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The accompanying unaudited interim financial statements have been prepared in conformity with generally accepted accounting principles (GAAP) and the applicable rules and regulations of the SEC regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). As permitted under these rules, certain footnotes and other financial information that are normally required by GAAP have been condensed or omitted. In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2023 and the results of its operations and its cash flows for the three and six months ended June 30, 2023 and 2022. The results for the three and six months ended June 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. The balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. The unaudited interim financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements, which are included in the Company’s 2022 Annual Report on Form 10-K, filed with the SEC on March 16, 2023 (2022 Annual Report). Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, the valuation allowance on the Company’s deferred tax assets and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Off-Balance Sheet Risk and Concentrations of Credit Risk Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist of cash and cash equivalents, which are invested in U.S. treasury-based money market funds, and available-for-sale debt securities, which are invested in U.S. treasury securities. A portion of the Company’s cash is maintained at two federally insured financial institutions. The deposits held at these institutions are in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk. The cash in these accounts is or will be set up to be swept daily into U.S. treasury-based money market funds. The Company has no off‑balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Significant Accounting Policies There have been no significant changes to the Company’s accounting policies during the six months ended June 30, 2023, as compared to the significant accounting policies described in Note 2 of the “Notes to the Financial Statements” in the Company’s audited financial statements included in its 2022 Annual Report. Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value of financial instruments At June 30, 2023 and December 31, 2022, the Company’s financial instruments included cash and cash equivalents, available-for-sale debt securities, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for cash and cash equivalents, accounts payable and accrued expenses approximate their respective fair values because of the short-term nature of these instruments. The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: June 30, 2023 Total Quoted Significant Significant Financial assets Cash and Cash equivalents: Money market funds $ 128,072 $ 128,072 $ — $ — Short-term investments: U.S. Treasury securities 48,256 — 48,256 — Total $ 176,328 $ 128,072 $ 48,256 $ — December 31, 2022 Total Quoted Significant Significant Financial assets Cash and Cash equivalents: Money market funds $ 81,607 $ 81,607 $ — $ — Short-term investments: U.S. Treasury securities 24,940 — 24,940 — Total $ 106,547 $ 81,607 $ 24,940 $ — Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1 inputs. Investments are measured at fair value based on inputs other than quoted prices that are derived from observable market data and are classified as Level 2 inputs. For debt securities classified as available-for-sale investments, the Company records unrealized gains or losses resulting from changes in fair value between measurement dates as a component of other comprehensive income. June 30, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair value Financial assets Money market funds Included in cash and cash equivalents $ 128,072 $ — $ — $ 128,072 Treasury securities - due in one year or less Included in short-term investments 48,259 16 ( 19 ) 48,256 Total $ 176,331 $ 16 $ ( 19 ) $ 176,328 December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair value Financial assets Money market funds Included in cash and cash equivalents $ 81,607 $ — $ — $ 81,607 Treasury securities - due in one year or less Included in short-term investments 24,987 — ( 47 ) 24,940 Total $ 106,594 $ — $ ( 47 ) $ 106,547 |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued and Other Current Liabilities | 4. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following: June 30, December 31, Research and development services $ 1,710 $ 1,194 General and administrative services 254 99 Compensation expense 1,975 3,515 Other 20 39 $ 3,959 $ 4,847 |
Collaborations, Licensing Agree
Collaborations, Licensing Agreements and Other Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Collaborations Licensing Agreements And Other Agreements [Abstract] | |
Collaborations, Licensing Agreements and Other Agreements | 5. Collaborations, Licensing Agreements and Other Agreements Amended and Restated License Agreement with the Trustees of the University of Pennsylvania and Children’s Hospital of Philadelphia In August 2018, the Company entered into a license agreement with Penn, as amended and restated in July 2019 to include the Children’s Hospital of Philadelphia (CHOP) as a party, and as amended in May 2020 and October 2021 (the License Agreement) pursuant to which the Company obtained (a) a non-exclusive, non-sublicensable worldwide license to certain of Penn’s intellectual property to conduct research, product development, clinical trials, cell manufacturing and other activities, and (b) an exclusive, worldwide, royalty-bearing right and license, with a right to sublicense, on a target-by-target basis, under certain of Penn’s intellectual property to make, use, sell, offer for sale, import, and otherwise commercialize products for the treatment of autoimmune and alloimmune diseases. Unless earlier terminated, the License Agreement expires on the expiration or abandonment or other termination of the last valid claim in Penn’s intellectual property licensed by the Company. The Company may terminate the License Agreement at any time for convenience upon 60 days written notice. In the event of an uncured, material breach, Penn may terminate the License Agreement upon 60 days written notice. Under the terms of the License Agreement, the Company was obligated to pay $ 2,000 annually for three years beginning August 2018 for funding to the laboratories of each of Drs. Milone and Payne. This was satisfied through completed sponsored research agreements with a total cost of $ 12,560 . During the term of the License Agreement until the first commercial sale of the first product, the Company is obligated to pay Penn a non-refundable, non-creditable annual license maintenance fee of $ 10 . In May 2020, the Company paid Penn an additional, non-refundable, non-creditable license fee of $ 33 under the amended License Agreement. The Company is required to pay certain milestone payments upon the achievement of specified clinical and commercial milestones. Milestone payments are reduced by a certain percentage for the second product that achieves a milestone, by an additional percentage for the third product that achieves a milestone, and so on, for each subsequent product that achieves a milestone. In the event that the Company is able to successfully develop and launch multiple products under the License Agreement, total milestone payments could be approximately $ 21,000 . Penn is also eligible to receive tiered royalties at percentage rates in the low single-digits, subject to an annual minimum royalty, on annual worldwide net sales of any products that are commercialized by the Company or its sublicensees that contain or incorporate, or are covered by, the intellectual property licensed by the Company. To the extent the Company sublicenses its license rights under the License Agreement, Penn would be eligible to receive tiered sublicense income at percentage rates in the mid-single to low double-digits. There were no amounts due under the License Agreement as of June 30, 2023. Master Translational Research Services Agreements In October 2018 and February 2023, the Company entered into services agreements (the CAART and CARTA Services Agreements) with Penn for research, development and manufacturing services from various laboratories within Penn. The activities are detailed in separately executed Penn organization-specific addenda. In May 2020, the Company amended its Addendum with the Center for Advanced Retinal and Ocular Therapeutics (CAROT) to expand access to vector manufacturing. Research and development expense related to executed addenda under the master translational research service agreements with Penn recognized in the accompanying statements of operations was $ 694 and $ 2,205 for the three and six months ended June 30, 2023 and $ 966 and $ 1,601 for the three and six months ended June 30, 2022, respectively. The Company may incur additional expenses up to $ 643 through the remaining term of the CAROT Amended Addendum. Exclusive License Agreement with IASO Biotherapeutics On October 7, 2022, the Company entered into an Exclusive License Agreement (the IASO Agreement) with Nanjing IASO Biotherapeutics Co., Ltd. (IASO). Pursuant to the IASO Agreement, the Company received an exclusive, worldwide license under certain IASO intellectual property to use a novel clinical-stage anti-CD19 binder to develop, manufacture, commercialize and otherwise exploit T cell products directed to CD19 for the purpose of diagnosis, prevention or treatment of any autoimmune or alloimmune indications in humans. As partial consideration for the exclusive license, IASO received an upfront payment of $ 2,500 . IASO is also eligible to receive up to mid double digit millions in milestone payments based upon the achievement of specified pre-clinical, development and regulatory milestones, and up to an additional low triple digit millions in milestone payments based upon achievement of specified sales milestones, for a total consideration, inclusive of the upfront payment, of up to $ 162,000 , along with tiered mid-single digit royalties on future net sales for licensed products that may result from the IASO Agreement. Upon the U.S. Food and Drug Association’s clearance of the CABA-201 Investigational New Drug application for the treatment of systemic lupus erythematosus in March 2023, a milestone payment of $1,000 was recognized in the accompanying statements of operations. No amount was owed to IASO as of June 30, 2023. IASO has the right of first negotiation if the Company desires to grant a third party an exclusive license to develop, manufacture, commercialize or otherwise exploit the licensed products in the Greater China region. Pursuant to the IASO Agreement, each of IASO and the Company have agreed, subject to certain exceptions, to refrain from engaging in certain competitive activities with respect to certain programs. The Company also may sublicense through multiple tiers the rights granted to it by IASO under the IASO Agreement at any time, however, it must pay IASO a low double-digit percentage of any revenue obtained from sublicenses or options to third parties, subject to certain customary exclusions. The IASO Agreement will continue on a country-by-country, licensed product-by-licensed product basis until the expiration of the royalty term as identified in the IASO Agreement, unless earlier terminated. Each of the Company and IASO may terminate the Agreement for a material, uncured breach or insolvency of the other party. The Company may also terminate the Agreement at will upon advance written notice and in the event IASO rejects the Agreement due to bankruptcy-related matters. IASO may also terminate the Agreement if the Company fails to achieve certain specified diligence milestones in a timely manner and/or if the Company commences any patent challenges with respect to the patents and patent applications relating to the licensed sequence, in each case upon advance written notice. Artisan Collaboration and License Agreement In July 2020, and as amended in January 2023, the Company entered into a collaboration and license agreement with Artisan Bio, Inc. (Artisan), wherein the Company and Artisan agreed to collaborate to potentially enhance certain pipeline products of the Company at specific targets using Artisan’s gene editing and engineering technology. If the Artisan technology is applied to any of the Company’s products, the Company will be responsible for the development, manufacturing, and commercialization of any such products. Under the terms of the agreement, the Company was required to pay Artisan a nominal upfront fee, as well as costs associated with research and development activities. Artisan is eligible to receive future research, development and regulatory milestones, and is also eligible to receive sales milestones and tiered royalties on net sales of products that incorporate the Artisan technology. The Company can terminate the agreement at will upon advance written notice with payment of a nominal cancellation fee. Licence and Supply Agreement with Oxford Biomedica In December 2021, the Company entered into a Licence and Supply agreement (LSA) with Oxford Biomedica (UK) Limited (Oxford), wherein the LSA grants the Company a non-exclusive license to Oxford’s LentiVector® platform for its application in the Company’s DSG3-CAART program and puts in place a multi-year vector supply agreement. Under the terms of the agreement, the Company is required to pay Oxford an upfront fee, as well as costs associated with initial vector manufacturing activities for a total cost of up to approximately $ 4,000 , of which project to date expense of $ 1,100 has been recognized. Oxford is eligible to receive regulatory and sales milestones in the low tens of millions and royalties in the low single digits on net sales of products that incorporate the Oxford technology. The Company can terminate the agreement at will upon advance written notice and subject to certain manufacturing slot cancellation fees. In May 2023, the Company amended the LSA with Oxford to expand the license to include the Company's CABA-201 program for an upfront fee of $ 500 , recognized as expense in the accompanying statements of operations for the three and six months ended June 30, 2023. Option and License Agreement with Autolus In January 2023, the Company entered into an Option and License Agreement (Autolus Agreement) with Autolus Holdings (UK) Limited (Autolus), wherein the Autolus Agreement granted the Company a non-exclusive license to access Autolus' RQR8 technology in its CD19-CAR T cell therapy program, and subject to additional nominal option exercise fees, up to four additional targets. Under the terms of the Autolus Agreement, the Company is required to pay Autolus an upfront license fee of $ 1,200 , of which $ 800 was paid in February 2023 and $ 100 will be paid at the end of each calendar quarter in 2023. The upfront fee of $ 1,200 was recognized as expense in the first quarter of 2023 in the accompanying statements of operations and as of June 30, 2023, $ 200 is recorded in accrued and other liabilities in the accompanying balance sheets. Autolus is also eligible to receive regulatory milestones of up to $ 12,000 for each licensed target, sales milestones of up to a total of $ 15,000 and royalties in the low single digits on net sales of all products that incorporate the RQR8 technology. The Autolus Agreement will continue on a country-by-country, licensed product-by-licensed product basis until the expiration of the royalty term as identified in the Autolus Agreement, unless earlier terminated. The Company can terminate the Autolus Agreement at will upon advance written notice. Each of the Company and Autolus may terminate the Agreement for a material, uncured breach or insolvency of the other party. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Manufacturing Agreement In January 2021, the Company entered into a Development and Manufacturing Services Agreement (WuXi Agreement) with WuXi Advanced Therapies, Inc. (WuXi) to serve as the Company’s cell processing manufacturing partner for the MuSK-CAART Phase 1 clinical trial, or MusCAARTes TM trial. The Company has the right to terminate the WuXi Agreement for convenience or other reasons specified in the WuXi Agreement upon prior written notice. WuXi has the right to terminate the WuXi Agreement for convenience with 18 months’ notice. If the Company terminates the WuXi Agreement, it will be obligated to pay an early termination fee of up to $ 1,500 . The WuXi Agreement will expire the later of January 2024, or upon completion of WuXi’s services related to MuSK-CAART. Research Service Agreement In February 2021, the Company entered into a research service agreement with CHOP for vector manufacturing. In May 2021, this agreement was amended to provide additional vector manufacturing services. Research and development expense related to this research service agreement with CHOP recognized in the accompanying statements of operations was $ 0 and $ 166 for the three and six months ended June 30, 2022, respectively. No expense was recognized for the three and six months ended June 30, 2023. As of June 30, 2023, this agreement has a remaining cost of up to $ 480 . Other Purchase Commitments In the normal course of business, the Company enters into various purchase commitments with third-party contract manufacturers for the manufacture and processing of its product candidates and related raw materials, contracts with contract research organizations for clinical trials and agreements with vendors for other services and products for operating purposes. These agreements generally provide for termination or cancellation, other than for costs already incurred. Indemnification The Company enters into certain types of contracts that contingently require the Company to indemnify various parties against claims from third parties. These contracts primarily relate to (i) the Company’s Amended and Restated Bylaws, as amended, (bylaws) under which the Company must indemnify directors and executive officers, and may indemnify other officers and employees, for liabilities arising out of their relationship, (ii) contracts under which the Company must indemnify directors and certain officers and consultants for liabilities arising out of their relationship, (iii) contracts under which the Company may be required to indemnify partners against certain claims, including claims from third parties asserting, among other things, infringement of their intellectual property rights, and (iv) procurement, consulting, or license agreements under which the Company may be required to indemnify vendors, consultants or licensors for certain claims, including claims that may be brought against them arising from the Company’s acts or omissions with respect to the supplied products, technology or services. From time to time, the Company may receive indemnification claims under these contracts in the normal course of business. In addition, under these contracts, the Company may have to modify the accused infringing intellectual property and/or refund amounts received. In the event that one or more of these matters were to result in a claim against the Company, an adverse outcome, including a judgment or settlement, may have a material adverse effect on the Company’s future business, operating results or financial condition. It is not possible to determine the maximum potential amount under these contracts due to the limited history of prior indemnification claims and the unique facts and circumstances involved in each particular agreement. Litigation From time to time, the Company may become involved in litigation or legal proceedings. While the outcome of any such proceedings cannot be predicted with certainty, as of June 30, 2023, the Company is not involved in any material litigation or legal proceedings that it would expect to have a material adverse impact on its financial position, results of operations, or cash flows. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company determines whether an arrangement is or contains a lease based on the unique facts and circumstances present at the inception of an arrangement. The Company leases office and laboratory space under operating leases that have a weighted average remaining term of 2 years as of June 30, 2023. The Company also leases office space under short-term leases that provide for either party to terminate the lease without cause and with 30 days’ notice. The Company’s operating leases include rent escalations and are subject to additional variable charges, including common area maintenance, property taxes and property insurance. Given the variable nature of such costs, they are recognized as expense as incurred. Additionally, some of the Company’s leases are subject to certain fixed fees which the Company has determined to be non-lease components. The Company has elected the practical expedient to account for lease and non-lease components as a single-lease component and has included fixed payments related to non-lease compo nents in calculating the operating lease liability. The weighted average discount rate for the Company’s operating leases as of June 30, 2023 is 8.3 %, representing the Company's incremental borrowing rate at the beginning of each lease. For the six months ended June 30, 2023, total lease cost was $ 1,458 , consisting of $ 1,113 operating lease cost, $ 34 of variable lease costs and $ 311 of short-term lease cost. Cash paid for amounts included in the measurement of operating lease liabilities was $ 1,139 for the six months ended June 30, 2023. Rent expense for the six months ended June 30, 2022 was $ 578 . Future lease payments under the non-cancelable operating leases as of June 30, 2023 are as follows: July 1, 2023 - December 31, 2023 $ 1,139 2024 2,286 2025 1,146 Total undiscounted lease payments 4,571 Less imputed interest ( 375 ) Total lease liability $ 4,196 In January 2021, the Company entered into the WuXi Agreement, which included a dedicated manufacturing suite to be used for the Company’s cell processing manufacturing for its MusCAARTes TM trial . The Company concluded the WuXi Agreement had an embedded lease. In August 2022, the Company's dedicated suite arrangement was converted into a shared suite arrangement. The Company concluded the WuXi Agreement no longer contained an embedded lease and recognized a gain on derecognition of this lease asset and liability of $ 149 for the year ended December 31, 2022. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 8. Common Stock Common Stock Pursuant to the Company’s Third Amended and Restated Certificate of Incorporation (the amended and restated certificate of incorporation) filed in October 2019, the Company is authorized to issue 143,590,481 shares of voting common stock and 6,409,519 shares of non-voting common stock. Holders of voting common stock shall have the exclusive right to vote for the election of directors of the Company and on all other matters requiring stockholder action. Each share of the Company’s non-voting common stock may be converted at any time into one share of common stock at the option of its holder by providing 61 days written notice to the Company , subject to certain limitations, as described in the amended and restated certificate of incorporation. May 2023 Financing In May 2023, the Company issued 8,337,500 shares of its common stock in an underwritten public offering, including the exercise in full by the underwriters of their option to purchase an additional 1,087,500 shares, at a public offering price of $ 12.00 per share. Aggregate net proceeds were $ 93,755 after deducting underwriting discounts and commissions and offering expenses of $ 6,295 . December 2022 Financing In December 2022, the Company issued 126,815 shares of its common stock at a price of $ 5.52 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase 6,213,776 shares of common stock at a price of $ 5.51999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $ 0.00001 per share exercise price of such pre-funded warrant. Aggregate net proceeds were $ 32,562 after deducting underwriting discounts and commissions and offering expenses. As of June 30, 2023, 2,083,334 pre-funded warrants had been exercised. The pre-funded warrants were classified as a component of permanent stockholders’ equity within additional paid-in capital and were recorded at the issuance date using a relative fair value allocation method. The pre-funded warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, such pre-funded warrants do not provide any guarantee of value or return. At-the-Market Offering On March 16, 2023, the Company filed a Shelf Registration Statement in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, the Company’s common stock, debt securities or other equity securities in one or more offerings. This S-3 was declared effective on April 26, 2023. T he Company has a Sales Agreement with Cowen and Company, LLC, or Cowen, to provide for the offering, issuance and sale of up to an aggregate amount of $ 100.0 million of common stock from time to time in “at-the-market” offerings (the ATM Program) pursuant to its shelf registration statement on Form S-3 (File No. 333-270599), which was declared effective April 26, 2023, and subject to the limitations thereof. No shares were sold pursuant to the ATM Program in 2023. On May 10, 2023, the Company delivered written notice to Cowen that it was terminating the Sales Agreement dated November 10, 2020 (the 2020 Sales Agreement), by and between the Company and Cowen. Upon waiver of the notice period by Cowen, the termination was effective as of May 10, 2023 (the Termination Date) . All of the continuing obligations under the 2020 Sales Agreement will be terminated as of the Termination Date, other than those provisions which expressly survive termination as provided in the 2020 Sales Agreement. The Company is not subject to any termination penalties related to the termination of the 2020 Sales Agreement. Prior to termination, 4,792,562 shares of common stock, $ 0.00001 par value per share, had been sold pursuant to the 2020 Sales Agreement. As a result of the termination of the 2020 Sales Agreement, the Company will not offer or sell any additional shares under the 2020 Sales Agreement. 2018 Stock Option and Grant Plan In September 2018, the Company adopted the 2018 Stock Option and Grant Plan (the 2018 Plan), which provided for the Company to sell or issue common stock, or other stock-based awards, to employees, members of the board of directors and consultants of the Company. The Company generally granted stock-based awards with service conditions only (service-based awards), although there was one grant with performance conditions. There are no unvested options with performance conditions. Stock options granted under the 2018 Plan generally vest over three to four years . There were 1,959,411 options granted under the 2018 Plan prior to the Company’s IPO in October 2019. No further grants may be made under the 2018 Plan subsequent to the IPO. 2019 Stock Option and Incentive Plan The 2019 Stock Option and Incentive Plan (2019 Plan) was approved by the Company’s board of directors on October 14, 2019, and became effective on October 23, 2019. The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors and consultants. The number of shares initially reserved for issuance under the 2019 Plan was 2,342,288 , and such number of shares will be increased each January 1 thereafter by 4 % of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors (the 2019 Plan Evergreen Provision). On January 1, 2023, the total number of shares under the 2019 Plan was increased by 1,177,805 shares pursuant to the 2019 Plan Evergreen Provision. On June 1, 2023, at the 2023 Annual Meeting of Stockholders of the Company, the stockholders of the Company approved Amendment No. 1 to the 2019 Plan, increasing the number of shares of common stock reserved for issuance under the 2019 Plan by 3,000,000 shares. As of June 30, 2023, there were 3,128,223 shares remaining available for issuance under the 2019 Plan. A summary of stock option activity is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2023 6,013,384 $ 6.60 7.8 $ 22,202 Granted 2,308,450 10.95 Exercised ( 191,386 ) 4.43 1,302 Forfeited/Cancelled ( 52,166 ) 14.76 Outstanding as of June 30, 2023 8,078,282 $ 7.84 7.9 $ 41,935 Options Exercisable at June 30, 2023 3,599,958 $ 6.92 6.8 $ 22,386 The aggregate intrinsic value of options granted is calculated as the difference between the exercise price of the options and the estimated fair value of the Company’s common stock. The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2023 and 2022 was $ 9.13 and $ 2.11 , respectively. The fair value of each award is estimated using Black-Scholes based on the following assumptions: Six months ended June 30, 2023 2022 Risk-free interest rate 3.38 %— 3.95 % 1.47 %— 3.36 % Expected term 5.5 years— 6.1 years 5.5 years— 6.1 years Expected volatility 106 %— 107 % 79 %— 83 % Expected dividend yield 0 % 0 % Black-Scholes requires the use of subjective assumptions which determine the fair value of stock-based awards. These assumptions include: Expected term —The expected term represents the period that stock-based awards are expected to be outstanding. The expected term for option grants is determined using the simplified method, which is the midpoint between the vesting period and the contractual term of the option. Expected volatility —As a privately held company prior to the Company’s IPO in October 2019, the Company has limited trading history for its common stock and, as such, the expected volatility is estimated based on a weighted average volatility for the Company's stock price and comparable publicly traded biotechnology companies over a period equal to the expected term of the stock-based awards. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-free interest rate —The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of a stock-based award. Expected dividend —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. Stock-based Compensation The Company has recorded stock-based compensation in the accompanying statements of operations as follows: Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 1,392 $ 857 $ 2,628 $ 1,729 General and administrative 1,411 920 2,655 1,859 Total $ 2,803 $ 1,777 $ 5,283 $ 3,588 As of June 30, 2023, there was $ 27,230 of unrecognized compensation cost related to unvested option awards, which is expected to be recognized over a weighted-average period of 2.9 years. 2019 Employee Stock Purchase Plan The 2019 Employee Stock Purchase Plan (2019 ESPP) was approved by the Company’s board of directors on October 14, 2019, and became effective on October 23, 2019. A total of 234,229 shares of common stock were initially reserved for issuance under the 2019 ESPP, and such number of shares will be increased each January 1 thereafter through January 1, 2029 by the least of (i) 234,229 shares of common stock, (ii) 1 % of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or (iii) such lesser number of shares determined by the 2019 ESPP’s administrator. There was no increase to the total number of shares available under the 2019 ESPP on January 1, 2023 or 2022, respectively. Employee contributions are made through payroll deductions of up to 15 % of eligible compensation over the offering period. A participant may not accrue rights to purchase more than $ 25 worth of the Company’s common stock for each calendar year in which such right is outstanding. At the end of each offering period, shares of the Company’s common stock may be purchased at 85 % of the lesser of the Company’s common stock on (i) the first trading day of the relevant offering period and (ii) the last trading day of the relevant offering period. Each offering period will be six months in duration and will commence on each December 1 and June 1. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | . Income Taxes The Company did no t record an income tax benefit in its statements of operations for the three and six months ended June 30, 2023 and 2022 as it is more likely than not that the Company will not recognize the federal and state deferred tax benefits generated by its losses. The Company has provided a valuation allowance for the full amount of its net deferred tax assets and liabilities as of June 30, 2023 and December 31, 2022, as management has determined it is more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized. The Company has no t recorded any amounts for unrecognized tax benefits as of June 30, 2023 and December 31, 2022. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The Company calculates basic and diluted net loss per share attributable to common stockholders in conformity with the two-class method required for participating securities. For the three and six months ended June 30, 2023 and 2022, the Company had voting and non-voting common stock outstanding. Since the rights of the voting and non-voting common stock are identical, except with respect to voting, the undistributed losses of the Company have been allocated on a proportionate basis to the two classes. Basic net loss per share of common stock is computed by dividing the net loss per share of common stock by the weighted average number of shares of common stock outstanding for the period. The weighted-average shares of common stock outstanding as of June 30, 2023 included outstanding pre-funded warrants to purchase up to an aggregate of 4,130,442 shares of common stock. Diluted net loss per share is calculated using the if-converted method, which assumes conversion of all non-voting common stock to voting common stock. Three months ended Six months ended Voting common stock Non-voting common stock Voting common stock Non-voting common stock Basic net loss per share: Numerator Allocation of undistributed losses attributable to common stockholders $ ( 13,798 ) $ ( 689 ) $ ( 28,827 ) $ ( 1,514 ) Denominator Weighted average number of shares used in basic per share computation 37,312,047 1,860,759 35,460,528 1,860,759 Net loss per share, basic $ ( 0.37 ) $ ( 0.37 ) $ ( 0.81 ) $ ( 0.81 ) Diluted net loss per share: Numerator Allocation of undistributed losses for basic computation $ ( 13,798 ) $ ( 689 ) $ ( 28,827 ) $ ( 1,514 ) Reallocation of undistributed losses as a result of conversion of ( 689 ) — ( 1,514 ) — Allocation of undistributed losses $ ( 14,487 ) $ ( 689 ) $ ( 30,341 ) $ ( 1,514 ) Denominator Weighted average number of shares used in basic per share computation 37,312,047 1,860,759 35,460,528 1,860,759 Add: conversion of non-voting to voting common shares outstanding 1,860,759 — 1,860,759 — Weighted average number of shares used in diluted per share computation 39,172,806 1,860,759 37,321,287 1,860,759 Net loss per share, diluted $ ( 0.37 ) $ ( 0.37 ) $ ( 0.81 ) $ ( 0.81 ) Three months ended Six months ended Voting common stock Non-voting common stock Voting common stock Non-voting common stock Basic net loss per share: Numerator Allocation of undistributed losses attributable to common stockholders $ ( 11,314 ) $ ( 1,596 ) $ ( 22,426 ) $ ( 3,430 ) Denominator Weighted average number of shares used in basic per share computation 25,404,022 3,582,830 25,127,804 3,843,992 Net loss per share, basic $ ( 0.45 ) $ ( 0.45 ) $ ( 0.89 ) $ ( 0.89 ) Diluted net loss per share: Numerator Allocation of undistributed losses for basic computation $ ( 11,314 ) $ ( 1,596 ) $ ( 22,426 ) $ ( 3,430 ) Reallocation of undistributed losses as a result of conversion of ( 1,596 ) — ( 3,430 ) — Allocation of undistributed losses $ ( 12,910 ) $ ( 1,596 ) $ ( 25,856 ) $ ( 3,430 ) Denominator Weighted average number of shares used in basic per share computation 25,404,022 3,582,830 25,127,804 3,843,992 Add: conversion of non-voting to voting common shares outstanding 3,582,830 — 3,843,992 — Weighted average number of shares used in diluted per share computation 28,986,852 3,582,830 28,971,796 3,843,992 Net loss per share, diluted $ ( 0.45 ) $ ( 0.45 ) $ ( 0.89 ) $ ( 0.89 ) The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share, as their effect is anti-dilutive: As of June 30, 2023 2022 Stock options to purchase common stock 8,078,282 6,134,842 8,078,282 6,134,842 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying unaudited interim financial statements have been prepared in conformity with generally accepted accounting principles (GAAP) and the applicable rules and regulations of the SEC regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). As permitted under these rules, certain footnotes and other financial information that are normally required by GAAP have been condensed or omitted. In the opinion of management, the accompanying unaudited interim financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2023 and the results of its operations and its cash flows for the three and six months ended June 30, 2023 and 2022. The results for the three and six months ended June 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. The balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. The unaudited interim financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements, which are included in the Company’s 2022 Annual Report on Form 10-K, filed with the SEC on March 16, 2023 (2022 Annual Report). |
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 of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, the valuation allowance on the Company’s deferred tax assets and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. |
Off-Balance Sheet Risk and Concentrations of Credit Risk | Off-Balance Sheet Risk and Concentrations of Credit Risk Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist of cash and cash equivalents, which are invested in U.S. treasury-based money market funds, and available-for-sale debt securities, which are invested in U.S. treasury securities. A portion of the Company’s cash is maintained at two federally insured financial institutions. The deposits held at these institutions are in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk. The cash in these accounts is or will be set up to be swept daily into U.S. treasury-based money market funds. The Company has no off‑balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Significant Accounting Policies There have been no significant changes to the Company’s accounting policies during the six months ended June 30, 2023, as compared to the significant accounting policies described in Note 2 of the “Notes to the Financial Statements” in the Company’s audited financial statements included in its 2022 Annual Report. |
Fair Value Measurement | Fair Value Measurement Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: June 30, 2023 Total Quoted Significant Significant Financial assets Cash and Cash equivalents: Money market funds $ 128,072 $ 128,072 $ — $ — Short-term investments: U.S. Treasury securities 48,256 — 48,256 — Total $ 176,328 $ 128,072 $ 48,256 $ — December 31, 2022 Total Quoted Significant Significant Financial assets Cash and Cash equivalents: Money market funds $ 81,607 $ 81,607 $ — $ — Short-term investments: U.S. Treasury securities 24,940 — 24,940 — Total $ 106,547 $ 81,607 $ 24,940 $ — |
Schedule of Debt Securities Classified as Available-for-Sale Investments | June 30, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair value Financial assets Money market funds Included in cash and cash equivalents $ 128,072 $ — $ — $ 128,072 Treasury securities - due in one year or less Included in short-term investments 48,259 16 ( 19 ) 48,256 Total $ 176,331 $ 16 $ ( 19 ) $ 176,328 December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair value Financial assets Money market funds Included in cash and cash equivalents $ 81,607 $ — $ — $ 81,607 Treasury securities - due in one year or less Included in short-term investments 24,987 — ( 47 ) 24,940 Total $ 106,594 $ — $ ( 47 ) $ 106,547 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following: June 30, December 31, Research and development services $ 1,710 $ 1,194 General and administrative services 254 99 Compensation expense 1,975 3,515 Other 20 39 $ 3,959 $ 4,847 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Schedule of Future Minimum Payments for Operating Leases | Future lease payments under the non-cancelable operating leases as of June 30, 2023 are as follows: July 1, 2023 - December 31, 2023 $ 1,139 2024 2,286 2025 1,146 Total undiscounted lease payments 4,571 Less imputed interest ( 375 ) Total lease liability $ 4,196 In January 2021, the Company entered into the WuXi Agreement, which included a dedicated manufacturing suite to be used for the Company’s cell processing manufacturing for its MusCAARTes TM trial . The Company concluded the WuXi Agreement had an embedded lease. In August 2022, the Company's dedicated suite arrangement was converted into a shared suite arrangement. The Company concluded the WuXi Agreement no longer contained an embedded lease and recognized a gain on derecognition of this lease asset and liability of $ 149 for the year ended December 31, 2022. |
Common Stock (Tables)
Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Activity | A summary of stock option activity is presented below: Number of Weighted Weighted Aggregate Outstanding as of January 1, 2023 6,013,384 $ 6.60 7.8 $ 22,202 Granted 2,308,450 10.95 Exercised ( 191,386 ) 4.43 1,302 Forfeited/Cancelled ( 52,166 ) 14.76 Outstanding as of June 30, 2023 8,078,282 $ 7.84 7.9 $ 41,935 Options Exercisable at June 30, 2023 3,599,958 $ 6.92 6.8 $ 22,386 |
Schedule of Assumptions Used to Estimate Fair Value of Stock Options | The fair value of each award is estimated using Black-Scholes based on the following assumptions: Six months ended June 30, 2023 2022 Risk-free interest rate 3.38 %— 3.95 % 1.47 %— 3.36 % Expected term 5.5 years— 6.1 years 5.5 years— 6.1 years Expected volatility 106 %— 107 % 79 %— 83 % Expected dividend yield 0 % 0 % |
Summary of Stock-Based Compensation | The Company has recorded stock-based compensation in the accompanying statements of operations as follows: Three Months Ended Six Months Ended 2023 2022 2023 2022 Research and development $ 1,392 $ 857 $ 2,628 $ 1,729 General and administrative 1,411 920 2,655 1,859 Total $ 2,803 $ 1,777 $ 5,283 $ 3,588 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings Per Share | Diluted net loss per share is calculated using the if-converted method, which assumes conversion of all non-voting common stock to voting common stock. Three months ended Six months ended Voting common stock Non-voting common stock Voting common stock Non-voting common stock Basic net loss per share: Numerator Allocation of undistributed losses attributable to common stockholders $ ( 13,798 ) $ ( 689 ) $ ( 28,827 ) $ ( 1,514 ) Denominator Weighted average number of shares used in basic per share computation 37,312,047 1,860,759 35,460,528 1,860,759 Net loss per share, basic $ ( 0.37 ) $ ( 0.37 ) $ ( 0.81 ) $ ( 0.81 ) Diluted net loss per share: Numerator Allocation of undistributed losses for basic computation $ ( 13,798 ) $ ( 689 ) $ ( 28,827 ) $ ( 1,514 ) Reallocation of undistributed losses as a result of conversion of ( 689 ) — ( 1,514 ) — Allocation of undistributed losses $ ( 14,487 ) $ ( 689 ) $ ( 30,341 ) $ ( 1,514 ) Denominator Weighted average number of shares used in basic per share computation 37,312,047 1,860,759 35,460,528 1,860,759 Add: conversion of non-voting to voting common shares outstanding 1,860,759 — 1,860,759 — Weighted average number of shares used in diluted per share computation 39,172,806 1,860,759 37,321,287 1,860,759 Net loss per share, diluted $ ( 0.37 ) $ ( 0.37 ) $ ( 0.81 ) $ ( 0.81 ) Three months ended Six months ended Voting common stock Non-voting common stock Voting common stock Non-voting common stock Basic net loss per share: Numerator Allocation of undistributed losses attributable to common stockholders $ ( 11,314 ) $ ( 1,596 ) $ ( 22,426 ) $ ( 3,430 ) Denominator Weighted average number of shares used in basic per share computation 25,404,022 3,582,830 25,127,804 3,843,992 Net loss per share, basic $ ( 0.45 ) $ ( 0.45 ) $ ( 0.89 ) $ ( 0.89 ) Diluted net loss per share: Numerator Allocation of undistributed losses for basic computation $ ( 11,314 ) $ ( 1,596 ) $ ( 22,426 ) $ ( 3,430 ) Reallocation of undistributed losses as a result of conversion of ( 1,596 ) — ( 3,430 ) — Allocation of undistributed losses $ ( 12,910 ) $ ( 1,596 ) $ ( 25,856 ) $ ( 3,430 ) Denominator Weighted average number of shares used in basic per share computation 25,404,022 3,582,830 25,127,804 3,843,992 Add: conversion of non-voting to voting common shares outstanding 3,582,830 — 3,843,992 — Weighted average number of shares used in diluted per share computation 28,986,852 3,582,830 28,971,796 3,843,992 Net loss per share, diluted $ ( 0.45 ) $ ( 0.45 ) $ ( 0.89 ) $ ( 0.89 ) |
Schedule of Antidilutive Shares Excluded from Calculation of Diluted Net Loss Per Share | The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share, as their effect is anti-dilutive: As of June 30, 2023 2022 Stock options to purchase common stock 8,078,282 6,134,842 8,078,282 6,134,842 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents and investments | $ 176,328 | |
Accumulated deficit | $ 195,903 | $ 165,562 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Short-term investments: | ||
Short-term investments | $ 48,256 | $ 24,940 |
Fair Value, Measurements, Recurring | ||
Short-term investments: | ||
Total | 176,328 | 106,547 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Cash and Cash equivalents: | ||
Money market funds | 128,072 | 81,607 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Short-term investments: | ||
Total | 128,072 | 81,607 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Cash and Cash equivalents: | ||
Money market funds | 128,072 | 81,607 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Short-term investments: | ||
Total | 48,256 | 24,940 |
Fair Value, Measurements, Recurring | U.S. Treaury securities | ||
Short-term investments: | ||
Short-term investments | 48,256 | 24,940 |
Fair Value, Measurements, Recurring | U.S. Treaury securities | Significant Other Observable Inputs (Level 2) | ||
Short-term investments: | ||
Short-term investments | $ 48,256 | $ 24,940 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value Disclosures [Abstract] | ||
Available-for-sale securities | $ 176,328 | $ 106,547 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Debt Securities Classified as Available-for-Sale Investments (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 176,331 | $ 106,594 |
Gross Unrealized Gains | 16 | |
Gross Unrealized Losses | (19) | (47) |
Fair value | 176,328 | 106,547 |
Money Market Funds Included in Cash and Cash Equivalents | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 128,072 | 81,607 |
Fair value | 128,072 | 81,607 |
Government securities - due in one year or less | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 48,259 | 24,987 |
Gross Unrealized Gains | 16 | |
Gross Unrealized Losses | (19) | (47) |
Fair value | $ 48,256 | $ 24,940 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development services | $ 1,710 | $ 1,194 |
General and administrative services | 254 | 99 |
Compensation expense | 1,975 | 3,515 |
Other | 20 | 39 |
Accrued and other current liabilities | $ 3,959 | $ 4,847 |
Collaborations, Licensing Agr_2
Collaborations, Licensing Agreements and Other Agreements - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
May 31, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | May 31, 2023 | Mar. 31, 2023 | Feb. 28, 2023 | Jan. 01, 2023 | Oct. 07, 2022 | Dec. 31, 2021 | |
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Research and development expense | $ 11,797 | $ 9,514 | $ 24,232 | $ 18,684 | ||||||||
Upfront Payment | $ 500 | |||||||||||
Accrued and Other Current Liabilities | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Expenses | 200 | |||||||||||
License and Service [Member] | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Upfront Payment | 1,200 | 1,200 | ||||||||||
License Agreement | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Obligation to be paid | 2,000 | $ 2,000 | ||||||||||
Payment term | 3 years | |||||||||||
Payment commencement date | 2018-08 | |||||||||||
License maintenance fee | $ 33 | $ 10 | ||||||||||
Total milestone payments | 21,000 | |||||||||||
Amounts due to agreement | 0 | 0 | ||||||||||
Sponsored Research Agreements | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Obligation to be paid | 12,560 | 12,560 | ||||||||||
Master Translational Research Services Agreement | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Research and development expense | 694 | $ 966 | 2,205 | $ 1,601 | ||||||||
Remaining research and development expense to be incurred | 643 | |||||||||||
Oxford Biomedica | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Obligation to be paid | $ 4,000 | |||||||||||
Research and development expense | $ 1,100 | |||||||||||
Nanjing IASO Biotherapeutics Co., Ltd. [Member] | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Upfront Payment | $ 162,000 | 162,000 | $ 2,500 | |||||||||
Autolus Holdings [Member] | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Upfront Payment | $ 100 | $ 800 | $ 1,200 | |||||||||
Autolus Holdings [Member] | Maximum [Member] | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Total milestone payments | 15,000 | |||||||||||
Autolus Holdings [Member] | Maximum [Member] | License and Service [Member] | ||||||||||||
Collaborations, Licensing Agreements And Other Agreements [Line Items] | ||||||||||||
Total milestone payments | $ 12,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Commitments and Contingencies [Line Items] | ||||
Monthly fee included in minimum lease payment | $ 578,000 | |||
Research and development expense | $ 11,797,000 | $ 9,514,000 | 24,232,000 | $ 18,684,000 |
Wuxi Agreement | WuXi Advanced Therapies | ||||
Commitments and Contingencies [Line Items] | ||||
Early termination fee | 1,500,000 | $ 1,500,000 | ||
Lease expiration month | 18 months | |||
Research Service Agreement | Children's Hospital of Philadelphia | ||||
Commitments and Contingencies [Line Items] | ||||
Research and development expense | 0 | $ 0 | $ 0 | $ 166,000 |
Liability related to agreement | $ 480,000 | $ 480,000 |
Leases (Additional Information)
Leases (Additional Information) (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Leases [Abstract] | ||
Weighted average remaining lease term | 2 years | |
Operating lease right-of-use assets | $ 4,077 | $ 4,991 |
Gain on derecognition of lease asset and liability | $ 149 | |
Weighted average discount rate | 8.30% | |
Total lease cost | $ 1,458 | |
Operating lease cost | 1,113 | |
Variable lease cost | 34 | |
Short-term lease cost | 311 | |
Operating lease payments | 1,139 | |
Rent expenses | $ 578 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Payments for Operating Leases (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Leases [Abstract] | |
July 1, 2023 - December 31, 2023 | $ 1,139 |
2024 | 2,286 |
2025 | 1,146 |
Total undiscounted lease payments | 4,571 |
Less imputed interest | (375) |
Total lease liability | $ 4,196 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
Oct. 23, 2019 | May 31, 2023 | Dec. 31, 2022 | Oct. 31, 2019 | Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 01, 2023 | Jan. 01, 2023 | Jan. 01, 2022 | Oct. 30, 2019 | Jan. 31, 2019 | |
Class Of Stock [Line Items] | ||||||||||||
Common stock, authorized shares | 150,000,000 | 150,000,000 | 150,000,000 | |||||||||
Non-voting common stock, Terms of conversion | Each share of the Company’s non-voting common stock may be converted at any time into one share of common stock at the option of its holder by providing 61 days written notice to the Company | |||||||||||
Common stock issuance | $ 93,755 | |||||||||||
Weighted average grant-date fair value of stock options granted | $ 9.13 | $ 2.11 | ||||||||||
Unrecognized compensation cost related to unvested stock-based awards | $ 27,230 | $ 27,230 | ||||||||||
Unrecognized compensation cost, period for recognition | 2 years 10 months 24 days | |||||||||||
At-The-Market Offering Sales Agreement | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock issuance, Shares | 0 | |||||||||||
Termination, shares | 4,792,562 | |||||||||||
Common stock, par value | $ 0.00001 | $ 0.00001 | ||||||||||
At-The-Market Offering Sales Agreement | Maximum | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock issuance | $ 100,000 | |||||||||||
December 2022 Financing | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock issuance, Shares | 126,815 | |||||||||||
Common stock price per share | $ 5.52 | |||||||||||
May 2023 Financing | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock issuance, Shares | 8,337,500 | |||||||||||
May 2023 Financing | Employee Stock Option | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Additional Options to be purchased by underwriters | 1,087,500 | |||||||||||
2018 Plan | Employee Stock Option | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Share-based compensation unvested number of shares | 0 | 0 | ||||||||||
Number of options granted | 1,959,411 | |||||||||||
2018 Plan | Maximum | Employee Stock Option | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Share-based compensation, vesting period | 4 years | |||||||||||
2018 Plan | Minimum | Employee Stock Option | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Share-based compensation, vesting period | 3 years | |||||||||||
2019 Plan | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Shares reserved for issuance | 2,342,288 | 3,128,223 | 3,128,223 | 1,177,805 | ||||||||
Increase in share reserved percentage | 4% | |||||||||||
2019 Plan | Employee Stock Option | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Number of options granted | 2,308,450 | |||||||||||
2019 ESPP | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Shares reserved for issuance | 234,229 | 0 | 0 | |||||||||
2019 ESPP | Minimum | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Shares reserved for issuance | 234,229 | |||||||||||
Increase in share reserved percentage | 1% | |||||||||||
Payroll deduction percentage of eligible compensation | 15% | |||||||||||
Employee stock purchase plan maximum annual rights to purchase common stock | $ 25 | |||||||||||
Percentage of shares to be purchased | 85% | |||||||||||
Voting Common Stock | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock, authorized shares | 143,590,481 | 143,590,481 | 143,590,481 | 143,590,481 | ||||||||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||||||
Voting Common Stock | 2019 Plan | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Shares reserved for issuance | 3,000,000 | |||||||||||
Non-voting Common Stock | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock, authorized shares | 6,409,519 | 6,409,519 | 6,409,519 | 6,409,519 | ||||||||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||||||
Pre-funded Warrants | December 2022 Financing | ||||||||||||
Class Of Stock [Line Items] | ||||||||||||
Common stock issuance, Shares | 6,213,776 | |||||||||||
Common stock price per share | $ 5.51999 | |||||||||||
Decrease in exercise price of Warrents | $ 12 | $ 0.00001 | ||||||||||
Net proceeds from exercise of warrants | $ 93,755 | $ 32,562 | ||||||||||
Warrants exercised | 6,295 | 2,083,334 |
Common Stock - Summary of Stock
Common Stock - Summary of Stock Option Activity (Details) - Employee Stock Option - 2019 Plan - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Number of Shares, Beginning Balance | 6,013,384 | |
Number of Shares, Granted | 2,308,450 | |
Number of Shares, Exercised | (191,386) | |
Number of shares, Forfeited/Cancelled | (52,166) | |
Number of Shares, Ending Balance | 8,078,282 | 6,013,384 |
Number of Shares, Options Exercisable | 3,599,958 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning Balance | $ 6.6 | |
Weighted Average Exercise Price, Granted | 10.95 | |
Weighted Average Exercise Price, Exercised | 4.43 | |
Weighted Average Exercise Price, Forfeited/Cancelled | 14.76 | |
Weighted Average Exercise Price, Ending Balance | 7.84 | $ 6.6 |
Weighted Average Exercise Price, Options Exercisable | $ 6.92 | |
Weighted Average Remaining Contractual Term (years) | ||
Term (years) | 7 years 10 months 24 days | 7 years 9 months 18 days |
Weighted Average Remaining Contractual Term (years), Options Exercisable | 6 years 9 months 18 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Beginning Balance | $ 22,202 | |
Aggregate Intrinsic Value, Exercised | 1,302 | |
Aggregate Intrinsic Value, Ending Balance | 41,935 | $ 22,202 |
Aggregate Intrinsic Value, Options Exercisable | $ 22,386 |
Common Stock - Schedule of Assu
Common Stock - Schedule of Assumptions Used to Estimate Fair Value of Stock Options (Details) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.38% | 1.47% |
Risk-free interest rate, maximum | 3.95% | 3.36% |
Expected volatility, minimum | 106% | 79% |
Expected volatility, maximum | 107% | 83% |
Expected dividend yield | 0% | 0% |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term | 6 years 1 month 6 days | 6 years 1 month 6 days |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term | 5 years 6 months | 5 years 6 months |
Common Stock - Summary of Sto_2
Common Stock - Summary of Stock-Based Compensation (Details) - Employee Stock Option - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based compensation | $ 2,803 | $ 1,777 | $ 5,283 | $ 3,588 |
Research and Development | ||||
Stock-based compensation | 1,392 | 857 | 2,628 | 1,729 |
General and Administrative | ||||
Stock-based compensation | $ 1,411 | $ 920 | $ 2,655 | $ 1,859 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit | $ 0 | $ 0 | |
Unrecognized tax benefits | $ 0 | $ 0 |
Net Loss Per Share (Additional
Net Loss Per Share (Additional Information) (Details) | 6 Months Ended |
Jun. 30, 2023 shares | |
Earnings Per Share [Abstract] | |
Weighted Average Number of Shares Outstanding, Basic | 4,130,442 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Basic net loss per share: | ||||
Weighted average number of shares used in basic per share computation | 4,130,442 | |||
Net loss per share, basic | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Diluted net loss per share: | ||||
Weighted average number of shares used in basic per share computation | 4,130,442 | |||
Net loss per share, diluted | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Voting Common Stock | ||||
Basic net loss per share: | ||||
Allocation of undistributed losses attributable to common stockholders | $ (13,798) | $ (11,314) | $ (28,827) | $ (22,426) |
Weighted average number of shares used in basic per share computation | 37,312,047 | 25,404,022 | 35,460,528 | 25,127,804 |
Net loss per share, basic | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Diluted net loss per share: | ||||
Allocation of undistributed losses for basic computation | $ (13,798) | $ (11,314) | $ (28,827) | $ (22,426) |
Reallocation of undistributed losses as a result of conversion of non-voting to voting common shares | (689) | (1,596) | (1,514) | (3,430) |
Allocation of undistributed losses | $ (14,487) | $ (12,910) | $ (30,341) | $ (25,856) |
Weighted average number of shares used in basic per share computation | 37,312,047 | 25,404,022 | 35,460,528 | 25,127,804 |
Add: conversion of non-voting to voting common shares outstanding | 1,860,759 | 3,582,830 | 1,860,759 | 3,843,992 |
Weighted average number of shares used in diluted per share computation | 39,172,806 | 28,986,852 | 37,321,287 | 28,971,796 |
Net loss per share, diluted | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Non-voting Common Stock | ||||
Basic net loss per share: | ||||
Allocation of undistributed losses attributable to common stockholders | $ (689) | $ (1,596) | $ (1,514) | $ (3,430) |
Weighted average number of shares used in basic per share computation | 1,860,759 | 3,582,830 | 1,860,759 | 3,843,992 |
Net loss per share, basic | $ (0.37) | $ (0.45) | $ (0.81) | $ (0.89) |
Diluted net loss per share: | ||||
Allocation of undistributed losses for basic computation | $ (689) | $ (1,596) | $ (1,514) | $ (3,430) |
Allocation of undistributed losses | $ (689) | $ (1,596) | $ (1,514) | $ (3,430) |
Weighted average number of shares used in basic per share computation | 1,860,759 | 3,582,830 | 1,860,759 | 3,843,992 |
Weighted average number of shares used in diluted per share computation | 1,860,759 | 3,582,830 | 1,860,759 | 3,843,992 |
Net loss per share, diluted | $ (0.37) | $ (0.45) | $ 0.81 | $ (0.89) |
Net Loss Per Share - Schedule_2
Net Loss Per Share - Schedule of Antidilutive Shares Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares have been excluded from calculation of diluted net loss per share | 8,078,282 | 6,134,842 |
Stock Options to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares have been excluded from calculation of diluted net loss per share | 8,078,282 | 6,134,842 |