Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Entity File Number | 001-39343 | |
Entity Registrant Name | AKOUOS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-1716654 | |
Entity Address, Address Line One | 645 Summer Street, Suite 200 | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02210 | |
City Area Code | 857 | |
Local Phone Number | 410-1818 | |
Title of 12(b) Security | Common Stock, $0.0001 Par Value per Share | |
Trading Symbol | AKUS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 34,493,896 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001722271 | |
Amendment Flag | false | |
Entity Ex Transition Period | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 114,626 | $ 68,932 |
Marketable securities | 135,032 | 239,078 |
Prepaid expenses and other current assets | 4,845 | 2,626 |
Total current assets | 254,503 | 310,636 |
Property and equipment, net | 19,516 | 15,388 |
Operating lease right-of-use assets | 20,624 | 5,964 |
Restricted cash | 2,448 | 1,317 |
Other assets | 363 | 45 |
Total assets | 297,454 | 333,350 |
Current liabilities: | ||
Accounts payable | 1,067 | 895 |
Accrued expenses and other current liabilities | 11,412 | 8,699 |
Operating lease liabilities | 637 | 1,115 |
Total current liabilities | 13,116 | 10,709 |
Operating lease liabilities, net of current portion | 28,114 | 12,027 |
Total liabilities | 41,230 | 22,736 |
Commitments and contingencies (See Note 12) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2021 and December 31, 2020; 34,492,507 shares issued and outstanding at September 30, 2021 and 34,383,719 shares issued and outstanding at December 31, 2020 | 3 | 3 |
Additional paid-in capital | 399,690 | 392,322 |
Accumulated other comprehensive income | (13) | 13 |
Accumulated deficit | (143,456) | (81,724) |
Total stockholders' equity | 256,224 | 310,614 |
Total liabilities and stockholders' equity | $ 297,454 | $ 333,350 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, Par value | $ 0.0001 | $ 0.0001 |
Preferred stock, Shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, Shares issued | 0 | 0 |
Preferred stock, Shares outstanding | 0 | 0 |
Common stock, Par value | $ 0.0001 | $ 0.0001 |
Common stock, Shares authorized | 200,000,000 | 200,000,000 |
Common stock, Shares issued | 34,492,507 | 34,383,719 |
Common stock, Shares outstanding | 34,492,507 | 34,383,719 |
CONSOLIDATED STATEMENT OF OPERA
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 17,399 | $ 8,641 | $ 45,776 | $ 26,612 |
General and administrative | 5,513 | 4,478 | 16,068 | 9,646 |
Total operating expenses | 22,912 | 13,119 | 61,844 | 36,258 |
Loss from operations | (22,912) | (13,119) | (61,844) | (36,258) |
Other income (expense): | ||||
Interest income | 483 | 21 | 1,546 | 201 |
Other expense, net | (477) | 9 | (1,434) | 5 |
Total other income, net | 6 | 30 | 112 | 206 |
Net loss | $ (22,906) | $ (13,089) | $ (61,732) | $ (36,052) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.67) | $ (0.85) | $ (1.80) | $ (3.01) |
Weighted-average common shares outstanding, basic and diluted | 34,436,793 | 15,334,241 | 34,360,274 | 11,991,870 |
Unrealized gain (loss) on marketable securities | $ (31) | $ 8 | $ (26) | $ 8 |
Total other comprehensive income (loss) | (31) | 8 | (26) | 8 |
Total comprehensive loss | $ (22,937) | $ (13,081) | $ (61,758) | $ (36,044) |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY/(DEFICIT) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
Balances at beginning of period at Dec. 31, 2019 | $ 58,690 | ||||
Convertible preferred stock, Shares outstanding, beginning of period at Dec. 31, 2019 | 178,349,005 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Issuance of convertible preferred stock, net | $ 104,837 | ||||
Issuance of convertible preferred stock, net (in shares) | 221,399,223 | ||||
Balances at end of period at Mar. 31, 2020 | $ 163,527 | ||||
Convertible preferred stock, Shares outstanding, end of period at Mar. 31, 2020 | 399,748,228 | ||||
Balances at beginning of period at Dec. 31, 2019 | $ 323 | $ (33,124) | $ (32,801) | ||
Balances at beginning of period (in shares) at Dec. 31, 2019 | 997,165 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 7 | 7 | |||
Issuance of common stock upon exercise of stock options (in shares) | 13,630 | ||||
Vesting of restricted common stock from early-exercised stock options | 12 | 12 | |||
Stock-based compensation expense | 111 | 111 | |||
Net loss | (10,440) | (10,440) | |||
Balances at end of period at Mar. 31, 2020 | 453 | (43,564) | (43,111) | ||
Balances at end of period (in shares) at Mar. 31, 2020 | 1,010,795 | ||||
Balances at beginning of period at Dec. 31, 2019 | $ 58,690 | ||||
Convertible preferred stock, Shares outstanding, beginning of period at Dec. 31, 2019 | 178,349,005 | ||||
Balances at beginning of period at Dec. 31, 2019 | 323 | (33,124) | $ (32,801) | ||
Balances at beginning of period (in shares) at Dec. 31, 2019 | 997,165 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (36,052) | ||||
Unrealized gain on marketable securities | 8 | ||||
Balances at end of period at Sep. 30, 2020 | $ 3 | 390,473 | $ 8 | (69,176) | 321,308 |
Balances at end of period (in shares) at Sep. 30, 2020 | 34,374,348 | ||||
Balances at beginning of period at Mar. 31, 2020 | $ 163,527 | ||||
Convertible preferred stock, Shares outstanding, beginning of period at Mar. 31, 2020 | 399,748,228 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Conversion of convertible preferred stock to common stock | $ (163,527) | ||||
Conversion of convertible preferred stock, shares | (399,748,228) | ||||
Balances at beginning of period at Mar. 31, 2020 | 453 | (43,564) | $ (43,111) | ||
Balances at beginning of period (in shares) at Mar. 31, 2020 | 1,010,795 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 31 | 31 | |||
Issuance of common stock upon exercise of stock options (in shares) | 15,181 | ||||
Vesting of restricted common stock from early-exercised stock options | 7 | 7 | |||
Stock-based compensation expense | 490 | 490 | |||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs | $ 1 | 223,849 | 223,850 | ||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs, shares | 14,375,000 | ||||
Conversion of Stock, Amount Issued | $ 2 | 163,510 | 163,512 | ||
Conversion of Stock, Shares Issued | 18,969,672 | ||||
Net loss | (12,523) | (12,523) | |||
Balances at end of period at Jun. 30, 2020 | $ 3 | 388,340 | (56,087) | 332,256 | |
Balances at end of period (in shares) at Jun. 30, 2020 | 34,370,648 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 3 | 3 | |||
Issuance of common stock upon exercise of stock options (in shares) | 3,700 | ||||
Vesting of restricted common stock from early-exercised stock options | 54 | 54 | |||
Stock-based compensation expense | 2,076 | 2,076 | |||
Net loss | (13,089) | (13,089) | |||
Unrealized gain on marketable securities | 8 | 8 | |||
Balances at end of period at Sep. 30, 2020 | $ 3 | 390,473 | 8 | (69,176) | 321,308 |
Balances at end of period (in shares) at Sep. 30, 2020 | 34,374,348 | ||||
Balances at beginning of period at Dec. 31, 2020 | $ 3 | 392,322 | 13 | (81,724) | 310,614 |
Balances at beginning of period (in shares) at Dec. 31, 2020 | 34,383,719 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 225 | 225 | |||
Issuance of common stock upon exercise of stock options (in shares) | 62,197 | ||||
Vesting of restricted common stock from early-exercised stock options | 21 | 21 | |||
Stock-based compensation expense | 2,000 | 2,000 | |||
Net loss | (16,086) | (16,086) | |||
Unrealized gain on marketable securities | 28 | 28 | |||
Balances at end of period at Mar. 31, 2021 | $ 3 | 394,568 | 41 | (97,810) | 296,802 |
Balances at end of period (in shares) at Mar. 31, 2021 | 34,445,916 | ||||
Balances at beginning of period at Dec. 31, 2020 | $ 3 | 392,322 | 13 | (81,724) | 310,614 |
Balances at beginning of period (in shares) at Dec. 31, 2020 | 34,383,719 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (61,732) | ||||
Unrealized gain on marketable securities | (26) | ||||
Balances at end of period at Sep. 30, 2021 | $ 3 | 399,690 | (13) | (143,456) | 256,224 |
Balances at end of period (in shares) at Sep. 30, 2021 | 34,492,507 | ||||
Balances at beginning of period at Mar. 31, 2021 | $ 3 | 394,568 | 41 | (97,810) | 296,802 |
Balances at beginning of period (in shares) at Mar. 31, 2021 | 34,445,916 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 28 | 28 | |||
Issuance of common stock upon exercise of stock options (in shares) | 7,323 | ||||
Vesting of restricted common stock from early-exercised stock options | 5 | 5 | |||
Stock-based compensation expense | 2,456 | 2,456 | |||
Net loss | (22,740) | (22,740) | |||
Unrealized gain on marketable securities | (23) | (23) | |||
Balances at end of period at Jun. 30, 2021 | $ 3 | 397,057 | 18 | (120,550) | 276,528 |
Balances at end of period (in shares) at Jun. 30, 2021 | 34,453,239 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options | 140 | 140 | |||
Issuance of common stock upon exercise of stock options (in shares) | 39,268 | ||||
Vesting of restricted common stock from early-exercised stock options | 5 | 5 | |||
Stock-based compensation expense | 2,488 | 2,488 | |||
Net loss | (22,906) | (22,906) | |||
Unrealized gain on marketable securities | (31) | (31) | |||
Balances at end of period at Sep. 30, 2021 | $ 3 | $ 399,690 | $ (13) | $ (143,456) | $ 256,224 |
Balances at end of period (in shares) at Sep. 30, 2021 | 34,492,507 |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY/DEFICIT (Parenthetical) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Feb. 29, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | |
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY/(DEFICIT) | |||
Issuance cost | $ 200 | $ 228 | $ 3,419 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||||||||
Net loss | $ (22,906) | $ (16,086) | $ (13,089) | $ (10,440) | $ (61,732) | $ (36,052) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization expense | 700 | 500 | 1,842 | 1,433 | ||||
Net amortization of premiums and accretion of discounts on marketable securities | 1,389 | (10) | ||||||
Amortization of operating lease right-of-use assets | 879 | 179 | ||||||
Stock-based compensation expense | 6,944 | 2,677 | ||||||
Loss on disposal of property and equipment | 73 | |||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | (2,219) | (1,093) | ||||||
Accounts payable | 172 | 348 | ||||||
Other assets | 35 | |||||||
Operating lease liabilities | 70 | (392) | ||||||
Accrued expenses and other current liabilities | 4,751 | 2,582 | ||||||
Net cash used in operating activities | (47,796) | (30,328) | ||||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (8,114) | (3,234) | ||||||
Purchases of marketable securities | (151,370) | (141,434) | ||||||
Maturities of marketable securities | 254,001 | |||||||
Net cash provided by (used in) investing activities | 94,517 | (144,668) | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of convertible preferred stock, net of issuance costs paid | 104,837 | |||||||
Proceeds from initial public offering of common stock | 227,269 | |||||||
Payments of finance lease obligations | (189) | (189) | ||||||
Proceeds from exercise of stock options | 393 | 42 | ||||||
Payments of initial public offering costs | (228) | (3,419) | ||||||
Payments of offering costs | (100) | |||||||
Net cash provided by financing activities | 104 | 328,540 | ||||||
Net increase in cash, cash equivalents and restricted cash | 46,825 | 153,544 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | $ 70,249 | $ 26,395 | 70,249 | 26,395 | ||||
Cash, cash equivalents and restricted cash at end of period | 117,074 | 179,939 | 117,074 | 179,939 | $ 26,395 | |||
Supplemental cash flow information: | ||||||||
Cash paid for interest | 1 | 5 | ||||||
Supplemental disclosure of noncash investing and financing information: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | 157 | |||||||
Deferred offering costs included in accounts payable and accrued expenses | 253 | |||||||
Operating lease liabilities arising from obtaining right-of-use assets | 9,946 | 6,600 | ||||||
Remeasurement of operating lease right-of-use asset for lease modification | 5,592 | |||||||
Vesting of common stock subject to repurchase | 31 | 73 | ||||||
Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
Cash and cash equivalents | 114,626 | 178,622 | 114,626 | 178,622 | $ 68,932 | |||
Restricted cash | 2,448 | 1,317 | 2,448 | 1,317 | 1,317 | |||
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 117,074 | $ 179,939 | $ 117,074 | $ 179,939 | $ 26,395 | $ 70,249 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Akouos, Inc., together with its consolidated subsidiary (the “Company” or “Akouos”), is a precision genetic medicine company dedicated to its mission of developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide. The Company was formed as a limited liability corporation under the laws of the Commonwealth of Massachusetts in March 2016 under the name Akouos, LLC and converted into a corporation under the laws of the State of Delaware in November 2016 under the name Akouos, Inc. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the impact of the COVID-19 pandemic, and the ability to secure additional capital to fund operations. 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. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. On June 18, 2020, the Company effected a one-for-21.073 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s convertible preferred stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split and adjustment of the preferred stock conversion ratios. On June 30, 2020, the Company completed its initial public offering of its common stock and issued and sold 14,375,000 shares of its common stock, at a public offering price of $17.00 per share, for gross proceeds of $244.4 million, or net proceeds of $223.8 million after deducting underwriting discounts, commissions, and offering expenses. Upon the closing of the Company’s initial public offering on June 30, 2020, all shares of convertible preferred stock automatically converted into 18,969,672 shares of common stock. In August 2021, the Company entered into a sales agreement, or the ATM Sales Agreement, with Cowen and Company, LLC, or Cowen, to issue and sell, from time to time at prevailing market prices, shares of the Company’s common stock having aggregate gross proceeds of up to $100.0 million. Sales of common stock under the ATM Sales Agreement may be made by any method that is deemed an “at the market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company agreed to pay Cowen a commission of 3.0% of the aggregate gross proceeds of any shares sold by Cowen under the ATM Sales Agreement. As of September 30, 2021, no sales have been made pursuant to the ATM Sales Agreement. The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has primarily funded its operations with proceeds from sales of convertible preferred stock and proceeds from the Company’s initial public offering of common stock. The Company has incurred losses and negative cash flows from operations since its inception. As of September 30, 2021, the Company had an accumulated deficit of $143.5 million. The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. The Company expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements. The Company expects to seek additional funding through public and private equity financings, debt financings, collaborations, licensing arrangements, and/or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other such arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce, or eliminate some or all of its research and development programs, product portfolio expansion, or commercialization efforts, which could adversely affect its business prospects. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. Impact of the COVID-19 Pandemic The COVID-19 pandemic, which began in December 2019 and has spread worldwide, has caused many governments to implement measures to slow the spread of the pandemic. The pandemic and government measures taken in response have had and will continue to have a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, and facilities and production have been suspended. The Company has experienced manufacturing delays at its third-party manufacturers, including delays related to the COVID-19 pandemic, and may experience additional delays in the future, including supply chain delays or shortages, which could further delay product development timelines. The future progression of the pandemic and its continued effects on the Company’s business and operations are uncertain. The COVID-19 pandemic may affect the Company’s ability to initiate and complete nonclinical studies, delay the initiation of its planned clinical trial or future clinical trials, disrupt regulatory activities, or have other adverse effects on its business and operations. In particular, the Company and its third-party manufacturers and contract research organizations, or CROs, may face additional disruptions that may affect the Company’s ability to initiate and complete nonclinical studies, obtain nonclinical and clinical supplies, and initiate clinical trial sites. The pandemic may cause significant disruptions in the financial markets, which could impact the Company’s ability to raise additional funds to support its operations. Moreover, the pandemic has significantly impacted economies worldwide, which could result in adverse effects on the Company’s business and operations. As described above, to date, the Company has experienced a business disruption at its third-party manufacturers, including delays related to the COVID-19 pandemic. The Company is continuing to monitor the impact of the COVID-19 pandemic on its business and financial statements. To date, the Company has not incurred impairment losses in the carrying values of its assets as a result of the pandemic and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these condensed consolidated financial statements. The extent to which the COVID-19 pandemic will continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including planned and future clinical trials and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the actions taken to contain or treat it, and the duration and intensity of the related effects. Basis of Presentation The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly owned, domestic subsidiary. Intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses. The Company bases its estimates on historical experience, known trends, and other market specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 and the condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2021 and 2020 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2021 and the results of its operations for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are also unaudited. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. The accompanying balance sheet as of December 31, 2020 has been derived from the Company’s audited financial statements for the year ended December 31, 2020. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and related notes for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2021 (the “Annual Report on Form 10-K”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Summary of Significant Accounting Policies The significant accounting policies and estimates used in the preparation of the accompanying consolidated financial statements are described in the Company’s audited consolidated financial statements included in the Annual Report on Form 10-K. There have been no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2021. Recently Adopted Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Requirements for Fair Value Measurement eliminated and modified disclosure requirements. An entity is permitted to early adopt any removed or modified disclosures upon issuance of ASU 2018-13 and delay adoption of the additional disclosures until their effective date. For all entities, this guidance is required to be adopted for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU 2018-13 as of the required effective date of January 1, 2020, and the adoption did not have a material impact on the Company’s consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU ”) Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and non-public companies, the Company can adopt the new or revised standard at the time non-public companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for non-public companies. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments—Credit Losses Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value (in thousands): Fair Value Measurements at September 30, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 113,826 $ — $ — $ 113,826 Restricted cash: Money market funds 2,448 — — 2,448 Marketable securities: U.S. Treasury notes — 135,032 — 135,032 $ 116,274 $ 135,032 $ — $ 251,306 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 68,016 $ — $ — $ 68,016 Restricted cash: Money market funds 1,292 — — 1,292 Marketable securities: U.S. Treasury notes — 239,078 — 239,078 $ 69,308 $ 239,078 $ — $ 308,386 U.S. government money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. As of September 30, 2021, the Company’s marketable securities consisted of U.S. Treasury notes, which were valued based on Level 2 inputs. In determining the fair value of its U.S. Treasury notes, the Company relied on quoted prices for similar securities in active markets or other inputs that are observable or can be corroborated by observable market data. During the three and nine months ended September 30, 2021 and 2020, there were no transfers between Level 1, Level 2, and Level 3. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities | 4. Marketable Securities As of September 30, 2021 and December 31, 2020, the fair value of available-for-sale marketable debt securities by type of security was as follows (in thousands): September 30, 2021 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Assets Marketable securities: U.S. Treasury notes $ 135,045 $ 6 $ (19) $ 135,032 $ 135,045 $ 6 $ (19) $ 135,032 December 31, 2020 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Assets Marketable securities: U.S. Treasury notes $ 239,065 $ 16 $ (3) $ 239,078 $ 239,065 $ 16 $ (3) $ 239,078 At September 30, 2021, all available-for-sale marketable securities had contractual maturities of less than two years. At December 31, 2020, all available-for-sale marketable securities had contractual maturities of less than one year. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2021 | |
Property and Equipment, Net | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): September 30, 2021 December 31, 2020 Laboratory equipment $ 6,907 $ 4,576 Furniture and fixtures 600 461 Leasehold improvements 15,871 8,915 Construction in progress 299 3,755 23,677 17,707 Less: Accumulated depreciation and amortization (4,161) (2,319) $ 19,516 $ 15,388 Depreciation and amortization expense for the three and nine months ended September 30, 2021 was approximately $0.7 million and $1.8 million, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2020 was approximately $0.5 million and $1.4 million, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Accrued external research, development, and manufacturing expenses $ 7,556 $ 2,442 Accrued employee compensation and benefits 2,306 2,438 Accrued professional fees 1,389 1,175 Payments due for leasehold improvements — 2,071 Other 161 573 $ 11,412 $ 8,699 |
Convertible Preferred Stock
Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2021 | |
Convertible Preferred Stock abstract | |
Convertible Preferred Stock | 7. Convertible Preferred Stock The Company issued Series Seed convertible preferred stock (the “Series Seed preferred stock”), Series Seed 1 convertible preferred stock (the “Series Seed 1 preferred stock”), Series A convertible preferred stock (the “Series A preferred stock”), and Series B convertible preferred stock (the “Series B preferred stock,” and collectively with the Series Seed preferred stock, the Series Seed 1 preferred stock, and the Series A preferred stock, the “Preferred Stock”). In February 2020, the Company issued and sold 221,399,223 shares of Series B preferred stock, at a price of $0.47455 per share, for gross proceeds of $105.1 million. The Company incurred issuance costs in connection with this transaction of $0.2 million. Upon the closing of the Company’s initial public offering on June 30, 2020, all outstanding shares of Preferred Stock automatically converted into 18,969,672 shares of common stock. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock As of September 30, 2021 and December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 200,000,000 shares of common stock, $0.0001 par value per share. On June 18, 2020, the Company effected a one-for-21.073 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s convertible preferred stock. Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split adjustment of the preferred stock conversion ratios. On June 30, 2020, the Company completed its initial public offering of its common stock and issued and sold 14,375,000 shares of common stock, at a public offering price of $17.00 per share, for gross proceeds of $244.4 million, or net proceeds of $223.8 million after deducting underwriting discounts, commissions, and offering expenses. In August 2021, the Company entered into the ATM Sales Agreement with Cowen to issue and sell from time to time at prevailing market prices, up to $100.0 million in shares of the Company’s common stock. As of September 30, 2021, the Company has not yet issued or sold any securities under the ATM Sales Agreement. Preferred Stock As of September 30, 2021, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 5,000,000 shares of preferred stock, $0.0001 par value per share. As of September 30, 2021, no shares of preferred stock were issued or outstanding. |
StockBased Compensation
StockBased Compensation | 9 Months Ended |
Sep. 30, 2021 | |
StockBased Compensation | |
Stock-Based Compensation | 9. Stock-Based Compensation 2016 Stock Plan The Company’s 2016 Stock Plan (the “2016 Plan”) provides for the Company to grant incentive stock options or non-qualified stock options, restricted stock, restricted stock units, and other equity awards to employees, directors, and consultants of the Company. The 2016 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting, and other restrictions are determined at the discretion of the board of directors, or its committee or any such officer if so delegated. Stock options granted under the 2016 Plan with service-based vesting conditions generally vest over four ten During the year ended December 31, 2020, the Company increased the number of shares of common stock authorized for issuance under the 2016 plan from 1,508,669 to 3,722,685 shares. As of September 30, 2021 and December 31, 2020, no shares remained available for future issuance under the 2016 Plan. 2020 Stock Plan On May 28, 2020, the Company’s board of directors adopted, and on June 17, 2020 its stockholders approved, the 2020 Stock Plan (the “2020 Plan”). The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. The number of shares initially reserved for issuance under the 2020 Plan is the sum of 4,294,594, plus the number of shares (up to 3,622,691 shares) equal to the sum of (i) the number of shares remaining available for issuance under the 2016 Plan upon the effectiveness of the 2020 Plan and (ii) the number of shares of common stock subject to outstanding awards granted under the 2016 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right. The number of shares of common stock that may be issued under the 2020 Plan will automatically increase on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2021 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2030, equal to the lowest of (i) 2,728,610 shares, (ii) 4% of the number of shares of common stock outstanding on such date, and (iii) an amount determined by the Company’s board of directors. On January 1, 2021, the number of shares reserved for issuance under the 2020 Plan increased, pursuant to the terms of the 2020 Plan, by an additional 1,375,348 shares, equal to 4% of the Company’s then-outstanding common stock. The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2020 Plan will be added back to the shares of common stock available for issuance under the 2020 Plan. As of September 30, 2021, the total number of shares of common stock available for issuance under the 2020 Plan is 4,580,104 shares. 2020 Employee Stock Purchase Plan On May 28, 2020, the Company’s board of directors adopted, and on June 17, 2020 its stockholders approved, the 2020 Employee Stock Purchase Plan (the “2020 ESPP”). A total of 360,651 shares of common stock were initially reserved for issuance under this plan. The number of shares of common stock that may be issued under the 2020 ESPP will automatically increase on the first day of each fiscal year, beginning with the fiscal year commencing on January 1, 2021 and continuing for each fiscal year until, and including, the fiscal year commencing on January 1, 2031, equal to the lowest of (i) 640,630 shares, (ii) 1% of the number of shares of common stock outstanding on such date, and (iii) an amount determined by the Company’s board of directors. On January 1, 2021, the number of shares reserved for issuance under the 2020 ESPP increased, pursuant to the terms of the 2020 ESPP, by an additional 343,837 shares, equal to 1% of the Company’s then-outstanding common stock. As of September 30, 2021, the total number of shares of common stock available for issuance under the 2020 ESPP is 704,488. Stock Option Valuation The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. Stock Options The following table summarizes the Company’s stock option activity since December 31, 2020: Weighted ‑ Weighted ‑ Average Average Aggregate Number of Exercise Contractual Intrinsic Shares Price Term Value (in years) (in thousands) Outstanding as of December 31, 2020 3,674,687 $ 9.92 9.1 $ 38,170 Granted 1,347,290 $ 16.41 Exercised (108,788) $ 3.60 Forfeited (415,439) $ 11.20 Outstanding as of September 30, 2021 4,497,750 $ 11.89 8.6 $ 14,115 Vested and expected to vest as of September 30, 2021 4,497,750 $ 11.89 8.6 $ 14,115 Options exercisable as of September 30, 2021 1,258,811 $ 8.30 7.8 $ 6,646 The weighted-average grant-date fair value of stock options granted during the three months ended September 30, 2021 and 2020 was $8.24 per share and $17.81 per share, respectively. The weighted-average grant-date fair value of stock options outstanding during the nine months ended September 30, 2021 and 2020 was $11.12 per share and $7.08 per share, respectively. Early Exercise of Stock Options into Restricted Stock Certain option grants permit option holders to elect to exercise unvested options in exchange for unvested common stock. The options that are exercised prior to vesting will continue to vest according to the respective option agreement, and such unvested shares are subject to repurchase by the Company at the optionee’s original exercise price in the event the optionee’s service with the Company voluntarily or involuntarily terminates. A summary of the Company’s unvested common stock from option early exercises that is subject to repurchase by the Company is as follows: Shares Unvested restricted common stock as of December 31, 2020 47,731 Vested (29,890) Unvested restricted common stock as of September 30, 2021 17,841 Proceeds from the early exercise of options are recorded as a liability within accrued expenses and other current liabilities on the condensed consolidated balance sheet. The liability for unvested common stock subject to repurchase is then reclassified to additional paid-in capital as the Company’s repurchase right lapses. The shares purchased by the employees and directors pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares have vested. As of September 30, 2021 and December 31, 2020, the liability related to the payments for unvested shares from early-exercised options was less than $0.1 million. Restricted Common Stock Awards The Company has both (i) granted restricted stock awards, with the recipient not paying for the shares of common stock, and (ii) issued and sold restricted stock, with the recipient purchasing the common stock at its fair value per share. In both circumstances, the restricted shares of common stock have service-based vesting conditions and unvested shares are either subject to forfeiture by the employee or subject to repurchase by the Company, at the lesser of holder’s original purchase price or fair value, in the event the holder’s service with the Company voluntarily or involuntarily terminates. Service-based restricted stock awards generally vest over four Proceeds from the issuance and sale of restricted common stock are recorded as a liability within accrued expenses and other current liabilities on the condensed consolidated balance sheet. The liability for unvested common stock subject to repurchase is then reclassified to additional paid-in capital as the Company’s repurchase right lapses. Shares of restricted common stock granted or sold to employees and directors are not deemed, for accounting purposes, to be outstanding until those shares have vested. The Company did not grant or sell restricted common stock awards during 2020 or the nine months ended September 30, 2021. As of September 30, 2021 and December 31, 2020, the liability related to the payments received for shares of unvested restricted stock was less than $0.1 million. The following table summarizes the Company’s restricted common stock award activity for the nine months ended September 30, 2021: Weighted ‑ Average Grant ‑ Date Shares Fair Value Unvested restricted common stock as of December 31, 2020 93,908 $ 0.0529 Vested (83,409) 0.0347 Unvested restricted common stock as of September 30, 2021 10,499 $ 0.1334 The total fair value of restricted common stock vested during the three and nine months ended September 30, 2021 was less than $0.1 million. Stock-Based Compensation The Company records compensation cost for all stock-based payment arrangements, including employee, director, and consultant stock options and restricted stock. The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development expenses $ 1,031 $ 399 $ 3,216 $ 617 General and administrative expenses 1,457 1,677 3,728 2,060 $ 2,488 $ 2,076 $ 6,944 $ 2,677 As of September 30, 2021, there was $28.8 million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.7 years. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2021 | |
License Agreements | |
License Agreements | 10. License Agreements License Agreement with Massachusetts Eye and Ear In October 2017, the Company entered into a license agreement with Massachusetts Eye and Ear Infirmary and the Schepens Eye Research Institute, Inc. (collectively referred to as “MEE”) (the “MEE License”). Under the MEE License, the Company received an exclusive, non-transferable, sublicensable, worldwide, royalty-bearing license to certain patent rights and know-how, including rights related to adeno-associated virus (“AAV”), ancestral technology, including AAVAnc80, to use, research, develop, manufacture, and commercialize licensed products in the treatment, diagnosis, and prevention of any and all balance disorders, including hearing disorders of the inner ear, in each case, with a total prevalence in the United States of less than 3,000 patients, and an exclusive, non-transferable, sublicensable right and license under MEE’s rights, title, and interest in certain patents co-owned by MEE and Children’s Medical Center Corporation to use, research, develop, manufacture, and commercialize licensed products. The Company is obligated to use commercially reasonable efforts to develop and commercialize the MEE licensed products, including filing an investigational new drug application (“IND”) in the United States or investigational medicinal product dossier (“IMPD”) in any country in the European Union or an equivalent application in any country within 18 months of completion of specified toxicology studies for a licensed product. Upon entering into the MEE License in 2017, the Company issued to MEE shares of the Company’s common stock then having a fair value of $0.1 million. The Company is obligated to make aggregate milestone payments to MEE of up to $17.7 million upon the achievement of specified development, regulatory, and sales milestones. The Company is also obligated to pay tiered royalties of a mid to high single-digit percentage based on annual net sales of licensed products by the Company and any of its affiliates and sublicensees. Royalties will be paid by the Company on a licensed product-by-licensed product and country-by-country basis beginning after the first commercial sale of an MEE licensed product and lasting until the later of (i) the expiration of the last valid claim in the licensed patents or (ii) ten The MEE License remains in effect until the last expiration date of the last to expire MEE Royalty Term, unless terminated earlier. The Company has the right to terminate the MEE License at will, with or without cause, by 90 days’ advance written notice to MEE or upon MEE’s material breach of the MEE License, provided that MEE does not cure such material breach within a specified period. MEE has the right to terminate the MEE License in its entirety if (i) the Company fails to make any payment due within a specified period after MEE notifies the Company of such failure, (ii) the Company or its affiliates challenge the validity of the licensed patent rights, (iii) the Company fails to maintain required insurance, or (iv) the Company becomes insolvent or bankrupt. MEE also has the right to terminate the Company’s rights to specific intellectual property rights it has licensed to the Company under the MEE License if the Company materially breaches certain diligence obligations and does not cure within a specified period after written notice from MEE. During the three and nine months ended September 30, 2021 and 2020, the Company did not make any payments to MEE or recognize any research and development expenses under the MEE License. Sublicense Agreement with Lonza Houston, Inc. In October 2017, the Company entered into a sublicense agreement with Lonza Houston, Inc. (“Lonza”), as amended in December 2018 (the “Lonza Sublicense”). Under the agreement, the Company received an exclusive, non-transferable, sublicensable, worldwide, royalty-bearing sublicense to certain patent rights and know-how related to AAV ancestral technology, including AAVAnc80, to use, research, develop, manufacture, and commercialize licensed products for the treatment, diagnosis, and prevention of any and all balance disorders or diseases pertaining to the inner ear and/or any and all hearing diseases or disorders, including hearing disorders of the inner ear, but excluding all such disorders or diseases with a total prevalence in the United States of less than 3,000 patients. The Company is obligated to use commercially reasonable efforts to develop and commercialize the Lonza sublicensed products, including filing an IND in the United States or IMPD in any country in the European Union or an equivalent application in any country within 18 months of completion of specified toxicology studies for a licensed product. Upon entering into the Lonza Sublicense in 2017, the Company issued to Lonza shares of the Company’s common stock then having a fair value of $0.1 million. The Company is obligated to make aggregate milestone payments to Lonza of up to $18.5 million upon the achievement of specified development, regulatory, and sales milestones. The Company is also obligated to pay tiered royalties of a mid to high single-digit percentage based on annual net sales of licensed products by the Company and any of its affiliates and sublicensees as denoted in the Lonza Sublicense. Royalties will be paid by the Company on a licensed product-by-licensed product and country-by-country basis beginning after the first commercial sale of a Lonza sublicensed product and lasting until the later of (i) the expiration of the last valid claim in the patent or (ii) ten The Lonza Sublicense remains in effect until the last expiration date of the last to expire Lonza Royalty Term, unless terminated earlier. The Company has the right to terminate the Lonza Sublicense at will, with or without cause, by 90 days’ advance written notice to Lonza or upon Lonza’s material breach of the Lonza Sublicense, provided that Lonza does not cure such material breach within a specified period. Lonza has the right to terminate the Lonza Sublicense in its entirety if (i) the Company fails to make any payment due within a specified period after Lonza notifies the Company of such failure, (ii) the Company or its affiliates challenge the validity of the sublicensed patent rights, (iii) the Company fails to maintain required insurance, or (iv) the Company becomes insolvent or bankrupt. Lonza also has the right to terminate the Company’s rights to specific intellectual property rights it has sublicensed to the Company under the Lonza Sublicense if the Company materially breaches certain diligence obligations and does not cure within a specified period after written notice from Lonza. During the three and nine months ended September 30, 2021 and 2020, the Company did not make any payments to Lonza or recognize any research and development expenses under the Lonza Sublicense. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Leases | 11. Leases The Company leases its office and laboratory facility in Boston, Massachusetts pursuant to a lease agreement entered into in December 2018 (the “2018 Lease”), which includes a lease incentive, fixed payment escalations, and a rent holiday. The 2018 Lease term commenced in May 2019, which was the point at which the Company obtained control of the leased premises, and expires in February 2028. Under the 2018 lease, the Company is entitled to one five Leases The Company entered into an agreement in January 2021 that amended the 2018 Lease. Under the amended lease, the Company’s leased space expanded the 2018 leased premises to include an additional 37,500 square feet for a total of approximately 75,000 square feet and extended the term of the 2018 Lease for an additional ten -year term. The term extension of existing square feet under the 2018 Lease is accounted for as a lease modification, which resulted in the remeasurement of the existing right-of-use asset and lease liability of $5.9 million and $13.1 million, respectively, to $11.5 million and $18.7 million, respectively, in January 2021, the effective date of the amended lease agreement, and is accounted for as an operating lease. The lease term of the additional leased premises commenced in April 2021 , which was the point at which the Company obtained control of the leased premises. On commencement date the Company recorded a right-of-use asset and lease liability of $9.9 million, respectively, and is accounted for as an operating lease. The amended 2018 Lease included a landlord-provided tenant improvement allowance of up to $7.1 million to be applied to the costs of the construction of leasehold improvements. The Company determined that it owns the leasehold improvements related to the amended 2018 Lease and, as such, reflected the $7.1 million lease incentive as a reduction of the rental payments used to measure the operating lease liability, and, in turn, the operating lease right-of-use asset as of the lease commencement date in April 2021. As of September 30, 2021, the Company has not yet incurred any leasehold improvement costs related to the amended 2018 Lease that were paid for by the lessor. The lease disclosures for the three and nine months ended September 30, 2021 in these financial statements have been adjusted for the modification of the current lease. The Company also leased laboratory equipment under an agreement which was classified as a finance lease. This lease ended in September 2021 and the Company exercised its purchase option for $1. As of September 30, 2021, the financing lease liability was fully amortized to $0 and the financing lease asset of $0.2 million will be depreciated over the remaining economic life of two years . The components of the Company’s lease expense are as follows (in thousands): September 30, 2021 Operating lease cost $ 2,729 Variable lease cost $ 161 Finance lease cost: Amortization of lease assets $ 82 Interest on lease liabilities 1 Total finance lease cost $ 83 Supplemental disclosure of cash flow information related to leases was as follows (in thousands): September 30, 2021 Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) $ 1,782 Cash paid for amounts included in the measurement of finance lease liabilities (operating cash flows) $ 1 Cash paid for amounts included in the measurement of finance lease liabilities (financing cash flows) $ 189 The weighted-average remaining lease term and discount rate were as follows: September 30, December 31, 2021 2020 Weighted‑average remaining lease term (in years) used for: Operating leases 10.25 7.17 Finance leases — 0.75 Weighted‑average discount rate used for: Operating leases 10.00 % 10.00 % Finance leases N/A 1.99 % Because the interest rate implicit in the lease was not readily determinable, the borrowing rate was used to calculate the present value of the amended 2018 Lease. In determining its incremental borrowing rate, the Company considered its credit quality and assessed interest rates available in the market for similar borrowings, adjusted for the impact of collateral over the term of the lease. The present value of the Company’s laboratory equipment lease was calculated using the rate implicit in the lease. Future annual lease payments under the 2018 Lease, as amended, as of September 30, 2021 were as follows (in thousands): Years Ending December 31, Operating Leases 2021 $ 599 2022 (3,911) 2023 5,020 2024 5,611 2025 5,785 Thereafter 40,378 Total future lease payments 53,482 Less: Imputed interest (24,731) Total lease liabilities $ 28,751 The following table presents lease assets and liabilities and their classification on the consolidated balance sheet (in thousands): September 30, December 31, Leases Consolidated Balance Sheet Classification (unaudited) 2021 2020 Assets: Operating lease assets Operating lease right‑of‑use assets $ 20,624 $ 5,964 Finance lease assets Property and equipment, net 218 300 Total lease assets $ 20,842 $ 6,264 Liabilities: Current: Operating lease liabilities Operating lease liabilities $ 637 $ 1,115 Finance lease liabilities Accrued expenses and other current liabilities — 188 Non‑current: Operating lease liabilities Operating lease liabilities, net of current portion 28,114 12,027 Total lease liabilities $ 28,751 $ 13,330 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies 401(k) Plan The Company has a defined-contribution plan under Section 401(k) of the Internal Revenue Code of 1986 (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. As currently established, the Company is not required to make, and to date has not made, any contributions to the 401(k) Plan. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, CROs, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and certain of its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnifications and is not currently aware of any indemnification claims. Legal Proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss per Share | |
Net Loss per Share and Unaudited Pro Forma Net Loss per Share | 13. Net Loss per Share Net Loss per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss attributable to common stockholders $ (22,906) $ (13,089) $ (61,732) $ (36,052) Denominator: Weighted‑average common shares outstanding, basic and diluted 34,436,793 15,334,241 34,360,274 11,991,870 Net loss per share attributable to common stockholders, basic and diluted $ (0.67) $ (0.85) $ (1.80) $ (3.01) The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: September 30, 2021 2020 Unvested restricted common stock 28,340 176,037 Stock options to purchase common stock 4,497,750 2,861,128 4,526,090 3,037,165 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Requirements for Fair Value Measurement eliminated and modified disclosure requirements. An entity is permitted to early adopt any removed or modified disclosures upon issuance of ASU 2018-13 and delay adoption of the additional disclosures until their effective date. For all entities, this guidance is required to be adopted for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU 2018-13 as of the required effective date of January 1, 2020, and the adoption did not have a material impact on the Company’s consolidated financial statements. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU ”) Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and non-public companies, the Company can adopt the new or revised standard at the time non-public companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for non-public companies. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Codification Improvements to Topic 326, Financial Instruments—Credit Losses Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis | Fair Value Measurements at September 30, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 113,826 $ — $ — $ 113,826 Restricted cash: Money market funds 2,448 — — 2,448 Marketable securities: U.S. Treasury notes — 135,032 — 135,032 $ 116,274 $ 135,032 $ — $ 251,306 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 68,016 $ — $ — $ 68,016 Restricted cash: Money market funds 1,292 — — 1,292 Marketable securities: U.S. Treasury notes — 239,078 — 239,078 $ 69,308 $ 239,078 $ — $ 308,386 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of the fair value of available-for-sale marketable debt securities by type of security | September 30, 2021 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Assets Marketable securities: U.S. Treasury notes $ 135,045 $ 6 $ (19) $ 135,032 $ 135,045 $ 6 $ (19) $ 135,032 December 31, 2020 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Assets Marketable securities: U.S. Treasury notes $ 239,065 $ 16 $ (3) $ 239,078 $ 239,065 $ 16 $ (3) $ 239,078 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property and Equipment, Net | |
Schedule of property and equipment, net | September 30, 2021 December 31, 2020 Laboratory equipment $ 6,907 $ 4,576 Furniture and fixtures 600 461 Leasehold improvements 15,871 8,915 Construction in progress 299 3,755 23,677 17,707 Less: Accumulated depreciation and amortization (4,161) (2,319) $ 19,516 $ 15,388 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | September 30, 2021 December 31, 2020 Accrued external research, development, and manufacturing expenses $ 7,556 $ 2,442 Accrued employee compensation and benefits 2,306 2,438 Accrued professional fees 1,389 1,175 Payments due for leasehold improvements — 2,071 Other 161 573 $ 11,412 $ 8,699 |
StockBased Compensation (Tables
StockBased Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
StockBased Compensation | |
Schedule of stock option activity | Weighted ‑ Weighted ‑ Average Average Aggregate Number of Exercise Contractual Intrinsic Shares Price Term Value (in years) (in thousands) Outstanding as of December 31, 2020 3,674,687 $ 9.92 9.1 $ 38,170 Granted 1,347,290 $ 16.41 Exercised (108,788) $ 3.60 Forfeited (415,439) $ 11.20 Outstanding as of September 30, 2021 4,497,750 $ 11.89 8.6 $ 14,115 Vested and expected to vest as of September 30, 2021 4,497,750 $ 11.89 8.6 $ 14,115 Options exercisable as of September 30, 2021 1,258,811 $ 8.30 7.8 $ 6,646 |
Schedule of unvested common stock from option early exercises | Shares Unvested restricted common stock as of December 31, 2020 47,731 Vested (29,890) Unvested restricted common stock as of September 30, 2021 17,841 |
Schedule of restricted common stock award activity | Weighted ‑ Average Grant ‑ Date Shares Fair Value Unvested restricted common stock as of December 31, 2020 93,908 $ 0.0529 Vested (83,409) 0.0347 Unvested restricted common stock as of September 30, 2021 10,499 $ 0.1334 |
Schedule of stock based compensation expense | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Research and development expenses $ 1,031 $ 399 $ 3,216 $ 617 General and administrative expenses 1,457 1,677 3,728 2,060 $ 2,488 $ 2,076 $ 6,944 $ 2,677 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Schedule of lease costs, supplemental disclosure, weighted average lease term and discount rate and lease classification | September 30, 2021 Operating lease cost $ 2,729 Variable lease cost $ 161 Finance lease cost: Amortization of lease assets $ 82 Interest on lease liabilities 1 Total finance lease cost $ 83 Supplemental disclosure of cash flow information related to leases was as follows (in thousands): September 30, 2021 Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) $ 1,782 Cash paid for amounts included in the measurement of finance lease liabilities (operating cash flows) $ 1 Cash paid for amounts included in the measurement of finance lease liabilities (financing cash flows) $ 189 The weighted-average remaining lease term and discount rate were as follows: September 30, December 31, 2021 2020 Weighted‑average remaining lease term (in years) used for: Operating leases 10.25 7.17 Finance leases — 0.75 Weighted‑average discount rate used for: Operating leases 10.00 % 10.00 % Finance leases N/A 1.99 % |
Schedule of future annual payments under operating lease | Years Ending December 31, Operating Leases 2021 $ 599 2022 (3,911) 2023 5,020 2024 5,611 2025 5,785 Thereafter 40,378 Total future lease payments 53,482 Less: Imputed interest (24,731) Total lease liabilities $ 28,751 |
Schedule of lease assets and liabilities and their classification on the consolidated balance sheet | September 30, December 31, Leases Consolidated Balance Sheet Classification (unaudited) 2021 2020 Assets: Operating lease assets Operating lease right‑of‑use assets $ 20,624 $ 5,964 Finance lease assets Property and equipment, net 218 300 Total lease assets $ 20,842 $ 6,264 Liabilities: Current: Operating lease liabilities Operating lease liabilities $ 637 $ 1,115 Finance lease liabilities Accrued expenses and other current liabilities — 188 Non‑current: Operating lease liabilities Operating lease liabilities, net of current portion 28,114 12,027 Total lease liabilities $ 28,751 $ 13,330 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss per Share | |
Schedule of net loss per share | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss attributable to common stockholders $ (22,906) $ (13,089) $ (61,732) $ (36,052) Denominator: Weighted‑average common shares outstanding, basic and diluted 34,436,793 15,334,241 34,360,274 11,991,870 Net loss per share attributable to common stockholders, basic and diluted $ (0.67) $ (0.85) $ (1.80) $ (3.01) |
Schedule of securities excluded from computation of net loss per share | September 30, 2021 2020 Unvested restricted common stock 28,340 176,037 Stock options to purchase common stock 4,497,750 2,861,128 4,526,090 3,037,165 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) $ / shares in Units, $ in Thousands | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 18, 2020 | Aug. 31, 2021USD ($)shares | Jun. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) |
Temporary Equity [Line Items] | ||||||
Value of shares issued | $ 223,850 | |||||
Accumulated deficit | $ (143,456) | $ (81,724) | ||||
Scenario, Plan [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Shares issued | shares | 100,000,000 | |||||
Shares issued, gross proceeds | $ 100,000 | |||||
Commission for sale of stock, per agreement, as a percent | 3.00% | |||||
Common Stock | ||||||
Temporary Equity [Line Items] | ||||||
Reverse stock split ratio | 21.073 | |||||
Shares issued | shares | 14,375,000 | 14,375,000 | ||||
Share price | $ / shares | $ 17 | $ 17 | ||||
Value of shares issued | $ 223,800 | $ 1 | ||||
Shares issued, gross proceeds | $ 244,400 | |||||
Common stock issued in conversion, shares | shares | 18,969,672 | 18,969,672 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Fair Value, Transfers Between Level 1 and Level 2, Description and Policy [Abstract] | |||||
Transfer of fair value asset, Level 1 into Level 2 | $ 0 | $ 0 | $ 0 | $ 0 | |
Transfer of fair value asset, Level 2 into Level 1 | 0 | 0 | 0 | 0 | |
Transfer of fair value asset, into Level 3 | 0 | 0 | 0 | 0 | |
Transfer of fair value asset, out of Level 3 | 0 | $ 0 | 0 | $ 0 | |
Recurring | |||||
Assets: | |||||
Assets | 251,306 | 251,306 | $ 308,386 | ||
Recurring | Money market funds | |||||
Assets: | |||||
Cash equivalents | 113,826 | 113,826 | 68,016 | ||
Restricted cash | 2,448 | 2,448 | 1,292 | ||
Recurring | US Treasury Securities [Member] | |||||
Assets: | |||||
Marketable securities | 135,032 | 135,032 | 239,078 | ||
Recurring | Level 1 | |||||
Assets: | |||||
Assets | 116,274 | 116,274 | 69,308 | ||
Recurring | Level 1 | Money market funds | |||||
Assets: | |||||
Cash equivalents | 113,826 | 113,826 | 68,016 | ||
Restricted cash | 2,448 | 2,448 | 1,292 | ||
Recurring | Level 2 | |||||
Assets: | |||||
Assets | 135,032 | 135,032 | 239,078 | ||
Recurring | Level 2 | US Treasury Securities [Member] | |||||
Assets: | |||||
Marketable securities | $ 135,032 | $ 135,032 | $ 239,078 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities, Amortized Cost | $ 135,045 | $ 239,065 |
Unrealized gain | 6 | 16 |
Unrealized loss | (19) | (3) |
Fair market value | 135,032 | 239,078 |
US Treasury Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities, Amortized Cost | 135,045 | 239,065 |
Unrealized gain | 6 | 16 |
Unrealized loss | (19) | (3) |
Fair market value | $ 135,032 | $ 239,078 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Property and Equipment | |||||
Property and equipment, Gross | $ 23,677 | $ 23,677 | $ 17,707 | ||
Less: Accumulated depreciation and amortization | (4,161) | (4,161) | (2,319) | ||
Property and Equipment, Net | 19,516 | 19,516 | 15,388 | ||
Depreciation and amortization expense | 700 | $ 500 | 1,842 | $ 1,433 | |
Laboratory equipment | |||||
Property and Equipment | |||||
Property and equipment, Gross | 6,907 | 6,907 | 4,576 | ||
Furniture and fixtures | |||||
Property and Equipment | |||||
Property and equipment, Gross | 600 | 600 | 461 | ||
Leasehold improvements | |||||
Property and Equipment | |||||
Property and equipment, Gross | 15,871 | 15,871 | 8,915 | ||
Construction in progress | |||||
Property and Equipment | |||||
Property and equipment, Gross | $ 299 | $ 299 | $ 3,755 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Accrued external research, development, and manufacturing expenses | $ 7,556 | $ 2,442 |
Accrued employee compensation and benefits | 2,306 | 2,438 |
Accrued professional fees | 1,389 | 1,175 |
Payments due for leasehold improvements | 2,071 | |
Other | 161 | 573 |
Total | $ 11,412 | $ 8,699 |
Convertible Preferred Stock (De
Convertible Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2020 | Feb. 29, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Temporary Equity [Line Items] | ||||||||
Convertible preferred stock, Shares outstanding | 399,748,228 | 178,349,005 | ||||||
Gross proceeds received from sale of convertible preferred stock | $ 104,837 | |||||||
Issuance costs | $ 200 | $ 228 | $ 3,419 | |||||
Preferred stock, Shares issued | 0 | 0 | ||||||
Preferred stock, Shares outstanding | 0 | 0 | ||||||
Series B Preferred Stock [Member] | ||||||||
Temporary Equity [Line Items] | ||||||||
Shares issued | 221,399,223 | |||||||
Share price | $ 0.47455 | |||||||
Gross proceeds received from sale of convertible preferred stock | $ 105,100 | |||||||
Common Stock | ||||||||
Temporary Equity [Line Items] | ||||||||
Shares issued | 14,375,000 | 14,375,000 | ||||||
Share price | $ 17 | $ 17 | ||||||
Common stock shares converted | 18,969,672 | 18,969,672 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 18, 2020 | Aug. 31, 2021USD ($)shares | Jun. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2021$ / sharesshares | Dec. 31, 2020$ / sharesshares |
Class of Stock [Line Items] | ||||||
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 | ||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs | $ | $ 223,850 | |||||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | ||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Preferred Stock, Shares Issued | 0 | 0 | ||||
Preferred Stock, Shares Outstanding | 0 | 0 | ||||
Scenario, Plan [Member] | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs, shares | 100,000,000 | |||||
Shares issued, gross proceeds | $ | $ 100,000 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Reverse stock split ratio | 21.073 | |||||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs, shares | 14,375,000 | 14,375,000 | ||||
Share Price | $ / shares | $ 17 | $ 17 | ||||
Shares issued, gross proceeds | $ | $ 244,400 | |||||
Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs | $ | $ 223,800 | $ 1 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | Jan. 01, 2021 | Jun. 17, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
2016 Plan | |||||
Stock-Based Compensation | |||||
Number of shares authorized for issuance | 3,722,685 | 1,508,669 | |||
Remaining shares available for issuance | 0 | ||||
2016 Plan | Stock option | |||||
Stock-Based Compensation | |||||
Vesting period | 4 years | ||||
Expiration period | 10 years | ||||
2020 Stock Plan | |||||
Stock-Based Compensation | |||||
Number of shares authorized for issuance | 4,580,104 | ||||
Number of shares authorized, fixed portion | 4,294,594 | ||||
Number of shares authorized, variable portion | 3,622,691 | ||||
Annual increase in shares reserved for issuance | 2,728,610 | ||||
Annual increase in shares reserved for issuance, as a percent of stock outstanding | 4.00% | 4.00% | |||
Increase in shares reserved for issuance | 1,375,348 | ||||
2020 Employee Stock Purchase Plan | |||||
Stock-Based Compensation | |||||
Remaining shares available for issuance | 704,488 | ||||
Number of shares authorized, fixed portion | 360,651 | ||||
Annual increase in shares reserved for issuance | 640,630 | ||||
Annual increase in shares reserved for issuance, as a percent of stock outstanding | 1.00% | 1.00% | |||
Increase in shares reserved for issuance | 343,837 |
StockBased Compensation - Stock
StockBased Compensation - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||||
Weighted-average grant-date fair value of stock options granted | $ 8.24 | $ 17.81 | $ 11.12 | $ 7.08 | |
Stock option | |||||
Number of Shares | |||||
Outstanding as at beginning of period (in shares) | 3,674,687 | ||||
Granted (in shares) | 1,347,290 | ||||
Exercised (in shares) | (108,788) | ||||
Forfeited (in shares) | (415,439) | ||||
Outstanding as at end of period (in shares) | 4,497,750 | 4,497,750 | 3,674,687 | ||
Vested and expected to vest as at end of period (in shares) | 4,497,750 | 4,497,750 | |||
Options exercisable as at end of period (in shares) | 1,258,811 | 1,258,811 | |||
Weighted Average Exercise Price | |||||
Weighted average exercise price outstanding as at beginning of period (in dollars per share) | $ 9.92 | ||||
Weighted average exercise price, Granted (in dollars per share) | 16.41 | ||||
Weighted average exercise price, Exercised (in dollars per share) | 3.60 | ||||
Weighted average exercise price, Forfeited (in dollars per share) | 11.20 | ||||
Weighted average exercise price, Outstanding as at end of period (in dollars per share) | $ 11.89 | 11.89 | $ 9.92 | ||
Vested and expected to vest as at end of period (in dollars per share) | 11.89 | 11.89 | |||
Options exercisable as at end of period (in dollars per share) | $ 8.30 | $ 8.30 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||||
Contractual term, Outstanding (in years) | 8 years 7 months 6 days | 9 years 1 month 6 days | |||
Contractual term, Vested and expected to vest (in years) | 8 years 7 months 6 days | ||||
Contractual term, Options exercisable (in years) | 7 years 9 months 18 days | ||||
Average intrinsic value, Outstanding | $ 14,115 | $ 14,115 | $ 38,170 | ||
Average intrinsic value, Vested and expected to vest | 14,115 | 14,115 | |||
Average intrinsic value, Exercisable | $ 6,646 | $ 6,646 |
StockBased Compensation - Early
StockBased Compensation - Early exercise of stock options into restricted stock (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($)shares | |
Maximum | |
Stock-Based Compensation | |
Liability for unvested shares | $ | $ 0.1 |
Restricted stock from early exercise of options | |
Stock-Based Compensation | |
Unvested restricted common stock at beginning of period | 47,731 |
Vested | (29,890) |
Unvested restricted common stock at end of period | 17,841 |
StockBased Compensation - Restr
StockBased Compensation - Restricted common stock award activity (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Restricted stock awards | |||
Shares | |||
Unvested restricted common stock at beginning of period | 93,908 | ||
Vested | (83,409) | ||
Unvested restricted common stock at end of period | 10,499 | 10,499 | 93,908 |
Weighted Average Grant Date Fair Value | |||
Unvested restricted common stock at beginning of period | $ 0.0529 | ||
Vested | 0.0347 | ||
Unvested restricted common stock at end of period | $ 0.1334 | $ 0.1334 | $ 0.0529 |
Restricted stock awards | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Liability for unvested awards | $ 0.1 | $ 0.1 | $ 0.1 |
Weighted Average Grant Date Fair Value | |||
Total fair value of restricted common stock vested | $ 0.1 | $ 0.1 | |
Service-based restricted stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 4 years | ||
Issued in period | 0 | 0 |
StockBased Compensation - Sto_2
StockBased Compensation - Stock based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 2,488 | $ 2,076 | $ 6,944 | $ 2,677 |
Total unrecognized stock-based compensation expense related to the unvested stockbased awards | 28,800 | $ 28,800 | ||
Unrecognized stock-based compensation expense, weighted average period | 2 years 8 months 12 days | |||
Research and development expenses | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | 1,031 | 399 | $ 3,216 | 617 |
General and administrative expenses | ||||
Stock-Based Compensation | ||||
Stock-based compensation expense | $ 1,457 | $ 1,677 | $ 3,728 | $ 2,060 |
License Agreements (Details)
License Agreements (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Oct. 31, 2017USD ($) | Sep. 30, 2021USD ($)item | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)item | Sep. 30, 2020USD ($) | |
License Agreements | |||||
Research and development | $ 17,399,000 | $ 8,641,000 | $ 45,776,000 | $ 26,612,000 | |
MEE License | |||||
License Agreements | |||||
Number of domestic patients | item | 3,000 | 3,000 | |||
IND filing period | 18 months | ||||
Fair value of stock | $ 100,000 | ||||
Milestone payment amount | $ 0 | 0 | $ 0 | 0 | |
Period for start commercial sale of product | 10 years | ||||
Number of days for advance written notice | 90 days | ||||
Research and development | 0 | 0 | $ 0 | 0 | |
MEE License | Maximum | |||||
License Agreements | |||||
Milestone payment amount | $ 17,700,000 | $ 17,700,000 | |||
Lonza Sublicense | |||||
License Agreements | |||||
Number of domestic patients | item | 3,000 | 3,000 | |||
IND filing period | 18 months | ||||
Fair value of stock | $ 100,000 | ||||
Milestone payment amount | $ 0 | 0 | $ 0 | 0 | |
Period for start commercial sale of product | 10 years | ||||
Number of days for advance written notice | 90 days | ||||
Research and development | 0 | $ 0 | $ 0 | $ 0 | |
Lonza Sublicense | Maximum | |||||
License Agreements | |||||
Milestone payment amount | $ 18,500,000 | $ 18,500,000 |
Leases (Details)
Leases (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Apr. 30, 2021USD ($) | Jan. 31, 2021USD ($)ft² | Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Jan. 01, 2021USD ($) | Dec. 31, 2020USD ($) | |
Leases | ||||||||
Option to extend | true | |||||||
Lease extension period | 10 years | 5 years | 5 years | |||||
Annual base rent | $ 2,300 | |||||||
Percentage of annual increase | 3.00% | |||||||
Letter of credit related to lease agreement | $ 1,300 | $ 1,300 | ||||||
Amount of tenant lease improvement allowance | $ 7,100 | $ 6,600 | ||||||
Operating lease liabilities arising from obtaining right-of-use assets | 9,946 | $ 6,600 | ||||||
Additional area under lease | ft² | 37,500 | |||||||
Leased area | ft² | 75,000 | |||||||
Operating Lease, Right-of-Use Asset | 9,900 | $ 11,500 | 20,624 | 20,624 | $ 5,900 | $ 5,964 | ||
Operating Lease, Liability | $ 9,900 | $ 18,700 | 28,751 | 28,751 | $ 13,100 | |||
Finance lease assets | $ 218 | 218 | 300 | |||||
Asset Purchased At End Of Lease, Remaining Useful Life | 2 years | |||||||
Finance lease liabilities | $ 0 | $ 0 | $ 188 |
Leases - Components of lease co
Leases - Components of lease cost (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Lease cost | |
Operating lease cost | $ 2,729 |
Variable lease cost | 161 |
Finance lease cost: | |
Amortization of lease assets | 82 |
Interest on lease liabilities | 1 |
Total finance lease cost | $ 83 |
Leases - Supplemental disclosur
Leases - Supplemental disclosure of cash flow information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flow information related to leases | ||
Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) | $ 1,782 | |
Cash paid for amounts included in the measurement of finance lease liabilities (operating cash flows) | 1 | |
Cash paid for amounts included in the measurement of finance lease liabilities (financing cash flows) | $ 189 | $ 189 |
Leases - Weighted average infor
Leases - Weighted average information (Details) | Sep. 30, 2021 | Dec. 31, 2020 |
Leases | ||
Weighted-average remaining lease term (in years) used for: Operating Lease | 10 years 3 months | 7 years 2 months 1 day |
Weighted-average remaining lease term (in years) used for: Finance Leases | 9 months | |
Weighted-average discount rate used for: Operating leases | 10.00% | 10.00% |
Weighted-average discount rate used for: Finance leases | 1.99% |
Leases - Future annual payments
Leases - Future annual payments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Apr. 30, 2021 | Jan. 31, 2021 | Jan. 01, 2021 |
Operating lease | ||||
2022 | $ (3,911) | |||
2021 | 599 | |||
2023 | 5,020 | |||
2024 | 5,611 | |||
2025 | 5,785 | |||
Thereafter | 40,378 | |||
Total future lease payments | 53,482 | |||
Less: Imputed interest | (24,731) | |||
Total lease liabilities | $ 28,751 | $ 9,900 | $ 18,700 | $ 13,100 |
Leases - Assets and Liabilities
Leases - Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Apr. 30, 2021 | Jan. 31, 2021 | Jan. 01, 2021 | Dec. 31, 2020 |
Leases | |||||
Operating lease assets | $ 20,624 | $ 9,900 | $ 11,500 | $ 5,900 | $ 5,964 |
Finance lease assets | 218 | 300 | |||
Total lease assets | 20,842 | 6,264 | |||
Current: | |||||
Operating lease liabilities | 637 | 1,115 | |||
Finance lease liabilities | $ 0 | $ 188 | |||
Finance lease liabilities, Balance sheet location | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities | |||
Noncurrent: | |||||
Operating lease liabilities, net of current portion | $ 28,114 | $ 12,027 | |||
Total lease liabilities | $ 28,751 | $ 13,330 |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Net Loss per Share | ||||||||
Net loss attributable to common stockholders | $ (22,906) | $ (22,740) | $ (16,086) | $ (13,089) | $ (12,523) | $ (10,440) | $ (61,732) | $ (36,052) |
Weighted-average common shares outstanding, basic and diluted | 34,436,793 | 15,334,241 | 34,360,274 | 11,991,870 | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ (0.67) | $ (0.85) | $ (1.80) | $ (3.01) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Net Loss per Share and Unaudited Pro Forma Net Loss per Share | ||
Securities excluded from computation of earnings per share amount | 4,526,090 | 3,037,165 |
Restricted stock awards | ||
Net Loss per Share and Unaudited Pro Forma Net Loss per Share | ||
Securities excluded from computation of earnings per share amount | 28,340 | 176,037 |
Stock option | ||
Net Loss per Share and Unaudited Pro Forma Net Loss per Share | ||
Securities excluded from computation of earnings per share amount | 4,497,750 | 2,861,128 |