Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Jul. 31, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-38938 | |
Entity Registrant Name | Stoke Therapeutics, Inc. | |
Entity Central Index Key | 0001623526 | |
Entity Tax Identification Number | 47-1144582 | |
Entity Address, Address Line One | 45 Wiggins Ave | |
Entity Address City Or Town | Bedford | |
Entity Address State Or Province | MA | |
Entity Address Postal Zip Code | 01730 | |
City Area Code | 781 | |
Local Phone Number | 430-8200 | |
Trading Symbol | STOK | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 52,647,799 | |
Entity Incorporation State Country Code | DE | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Document Quarterly Report | true | |
Document Transition Report | false |
Consolidated balance sheets
Consolidated balance sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 193,476 | $ 191,442 |
Marketable securities | 88,506 | 9,952 |
Prepaid expenses | 10,345 | 11,320 |
Restricted cash - short-term | 75 | |
Interest receivable | 305 | 64 |
Other current assets | 4,287 | 2,561 |
Total current assets | 296,994 | 215,339 |
Restricted cash - long-term | 494 | 569 |
Operating lease right-of-use assets | 5,499 | 6,611 |
Property and equipment, net | 4,770 | 5,823 |
Total Assets | 307,757 | 228,342 |
Current liabilities: | ||
Accounts payable | 3,945 | 1,695 |
Accrued and other current liabilities | 14,500 | 13,815 |
Deferred revenue - current portion | 26,051 | 15,309 |
Total current liabilities | 44,496 | 30,819 |
Deferred revenue - net of current portion | 16,946 | 33,074 |
Other long term liabilities | 3,606 | 4,884 |
Total long term liabilities | 20,552 | 37,958 |
Total liabilities | 65,048 | 68,777 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity | ||
Common stock, par value of $0.0001 per share; 300,000,000 shares authorized, 52,305,641 and 45,918,233 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 5 | 5 |
Additional paid-in capital | 696,637 | 561,433 |
Accumulated other comprehensive loss | (15) | (24) |
Accumulated deficit | (453,918) | (401,849) |
Total stockholders’ equity | 242,709 | 159,565 |
Total liabilities and stockholders’ equity | $ 307,757 | $ 228,342 |
Consolidated balance sheets (Pa
Consolidated balance sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 52,305,641 | 45,918,233 |
Common stock, shares outstanding | 52,305,641 | 45,918,233 |
Consolidated statements of oper
Consolidated statements of operations and comprehensive loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Revenue | $ 4,831 | $ (2,481) | $ 9,048 | $ 2,671 |
Operating expenses: | ||||
Research and development | 21,136 | 20,551 | 43,504 | 40,182 |
General and administrative | 13,037 | 10,230 | 23,258 | 20,442 |
Total operating expenses | 34,173 | 30,781 | 66,762 | 60,624 |
Loss from operations | (29,342) | (33,262) | (57,714) | (57,953) |
Other income (expense): | ||||
Interest income (expense), net | 3,695 | 2,567 | 6,121 | 4,670 |
Other income (expense), net | (48) | 41 | (476) | 84 |
Total other income (expense) | 3,647 | 2,608 | 5,645 | 4,754 |
Net loss | $ (25,695) | $ (30,654) | $ (52,069) | $ (53,199) |
Net loss per share, basic | $ (0.46) | $ (0.69) | $ (1.02) | $ (1.23) |
Net loss per share, diluted | $ (0.46) | $ (0.69) | $ (1.02) | $ (1.23) |
Weighted-average common shares outstanding, basic | 55,765,948 | 44,188,464 | 51,288,222 | 43,367,032 |
Weighted-average common shares outstanding, diluted | 55,765,948 | 44,188,464 | 51,288,222 | 43,367,032 |
Comprehensive loss: | ||||
Net Income (Loss) | $ (25,695) | $ (30,654) | $ (52,069) | $ (53,199) |
Other comprehensive gain (loss): | ||||
Unrealized gain (loss) on marketable securities | (15) | 219 | 9 | 796 |
Total other comprehensive gain (loss) | (15) | 219 | 9 | 796 |
Comprehensive loss | $ (25,710) | $ (30,435) | $ (52,060) | $ (52,403) |
Consolidated statements of stoc
Consolidated statements of stockholders' equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2022 | $ 184,849 | $ 4 | $ 483,170 | $ (1,175) | $ (297,150) |
Balance, Shares at Dec. 31, 2022 | 39,439,575 | ||||
Net loss | (22,545) | (22,545) | |||
Unrealized gain on marketable securities | 577 | 577 | |||
Stock-based compensation | 5,887 | 5,887 | |||
Issuance of common stock upon exercise of stock options | 158 | 158 | |||
Issuance of common stock upon exercise of stock options, Shares | 80,611 | ||||
Issuance of common stock related to employee stock purchase plan | 153 | 153 | |||
Issuance of common stock related to employee stock purchase plan, Shares | 19,550 | ||||
Shares sold as part of controlled equity offering sales agreement | 44,743 | 44,743 | |||
Shares sold as part of controlled equity offering sales agreement, Shares | 4,635,353 | ||||
Balance at Mar. 31, 2023 | 213,822 | $ 4 | 534,111 | (598) | (319,695) |
Balance, Shares at Mar. 31, 2023 | 44,175,089 | ||||
Balance at Dec. 31, 2022 | 184,849 | $ 4 | 483,170 | (1,175) | (297,150) |
Balance, Shares at Dec. 31, 2022 | 39,439,575 | ||||
Net loss | (53,199) | ||||
Unrealized gain on marketable securities | 796 | ||||
Balance at Jun. 30, 2023 | 190,195 | $ 4 | 540,919 | (379) | (350,349) |
Balance, Shares at Jun. 30, 2023 | 44,202,997 | ||||
Balance at Mar. 31, 2023 | 213,822 | $ 4 | 534,111 | (598) | (319,695) |
Balance, Shares at Mar. 31, 2023 | 44,175,089 | ||||
Net loss | (30,654) | (30,654) | |||
Unrealized gain on marketable securities | 219 | 219 | |||
Stock-based compensation | 6,760 | 6,760 | |||
Issuance of common stock upon exercise of stock options | 48 | 48 | |||
Issuance of common stock upon exercise of stock options, Shares | 27,908 | ||||
Balance at Jun. 30, 2023 | 190,195 | $ 4 | 540,919 | (379) | (350,349) |
Balance, Shares at Jun. 30, 2023 | 44,202,997 | ||||
Balance at Dec. 31, 2023 | 159,565 | $ 5 | 561,433 | (24) | (401,849) |
Balance, Shares at Dec. 31, 2023 | 45,918,233 | ||||
Net loss | (26,374) | (26,374) | |||
Unrealized gain on marketable securities | 24 | 24 | |||
Stock-based compensation | 5,410 | 5,410 | |||
Issuance of common stock upon exercise of stock options | 250 | 250 | |||
Issuance of common stock upon exercise of stock options, Shares | 270,032 | ||||
Issuance of common stock related to employee stock purchase plan | 168 | 168 | |||
Issuance of common stock related to employee stock purchase plan, Shares | 37,542 | ||||
Shares sold as part of controlled equity offering sales agreement | 1,299 | 1,299 | |||
Shares sold as part of controlled equity offering sales agreement, Shares | 272,270 | ||||
Balance at Mar. 31, 2024 | 140,342 | $ 5 | 568,560 | (428,223) | |
Balance, Shares at Mar. 31, 2024 | 46,498,077 | ||||
Balance at Dec. 31, 2023 | 159,565 | $ 5 | 561,433 | (24) | (401,849) |
Balance, Shares at Dec. 31, 2023 | 45,918,233 | ||||
Net loss | (52,069) | ||||
Unrealized gain on marketable securities | 9 | ||||
Balance at Jun. 30, 2024 | 242,709 | $ 5 | 696,637 | (15) | (453,918) |
Balance, Shares at Jun. 30, 2024 | 52,305,641 | ||||
Balance at Mar. 31, 2024 | 140,342 | $ 5 | 568,560 | (428,223) | |
Balance, Shares at Mar. 31, 2024 | 46,498,077 | ||||
Net loss | (25,695) | (25,695) | |||
Unrealized gain on marketable securities | (15) | (15) | |||
Stock-based compensation | 7,427 | 7,427 | |||
Issuance of common stock upon exercise of stock options | 766 | 766 | |||
Issuance of common stock upon exercise of stock options, Shares | 252,007 | ||||
Issuance of common stock upon follow-on offering, net of underwriting discounts, commissions and offering costs | 119,884 | 119,884 | |||
Issuance of common stock upon follow-on offering, net of underwriting discounts, commissions and offering costs, Shares | 5,555,557 | ||||
Balance at Jun. 30, 2024 | $ 242,709 | $ 5 | $ 696,637 | $ (15) | $ (453,918) |
Balance, Shares at Jun. 30, 2024 | 52,305,641 |
Consolidated statements of cash
Consolidated statements of cash flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (52,069) | $ (53,199) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,111 | 1,208 |
Amortization and accretion of marketable securities | (313) | (114) |
Stock-based compensation | 12,837 | 12,647 |
Reduction in the carrying amount of right of use assets | 1,112 | 1,106 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (993) | (310) |
Accounts payable, accrued liabilities and lease liabilities | 1,658 | (4,076) |
Deferred revenue | (5,386) | (418) |
Net cash used in operating activities | (42,043) | (43,156) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (88,232) | |
Purchases of property and equipment | (58) | (1,004) |
Sales of marketable securities | 10,000 | 77,562 |
Net cash (used in) provided by investing activities | (78,290) | 76,558 |
Cash flows from financing activities: | ||
Proceeds from Employee Stock Purchase Plan | 168 | 206 |
Proceeds from issuance of common stock upon exercise of stock options | 1,016 | 153 |
Proceeds from issuance of common stock in controlled equity offering sales agreements | 1,299 | 44,743 |
Proceeds from follow-on offering, net of underwriting discounts, commissions and offering costs | 119,884 | |
Net cash provided by financing activities | 122,367 | 45,102 |
Net increase in cash, cash equivalents and restricted cash | 2,034 | 78,504 |
Cash, cash equivalents and restricted cash—beginning of period | 192,011 | 114,125 |
Cash, cash equivalents and restricted cash—end of period | $ 194,045 | $ 192,629 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (25,695) | $ (26,374) | $ (30,654) | $ (22,545) | $ (52,069) | $ (53,199) |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the six months ended June 30, 2024, none of our directors or officers, as defined in Rule 16a-1(f), informed us of the adoption , modification or termination of a "Rule 10b5-1 trading agreement" or "non-Rule 10b-51 trading agreement," as those terms are defined in Regulations S-K, Item 408. |
Directors Or Officers Except Corporate Secretary CEO, COO And CBO [Member] | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Non Rule 10b5-1 Arr Modified Flag | false |
Rule 10b5-1 Arr Modified Flag | false |
Nature of the Business
Nature of the Business | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Nature of the business | 1. Nature of the business Organization Stoke Therapeutics, Inc. (the “Company”) was founded in June 2014 and was incorporated under the laws of the State of Delaware . The Company is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Shelf Registration In May 2022, the Company filed a universal Shelf Registration statement on Form S-3 (the “Registration Statement”) with the SEC. The Registration Statement was declared effective by the SEC on May 31, 2022, and contains two prospectuses: a base prospectus, which covers the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 400.0 million of its common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or debt securities, subscription rights to purchase common stock, preferred stock or debt securities and/or units consisting of some or all of these securities; and a sales agreement prospectus covering the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 150.0 million of its common stock that may be issued and sold under a Controlled Equity Offering Sales Agreement (“Sales Agreement”). The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The $ 150.0 million of common stock that may be offered, issued and sold under the sales agreement prospectus is included in the $ 400.0 million of securities that may be offered, issued and sold by the Company under the base prospectus. As of June 30, 2024 , the Company had issued approximately 6.5 million shares of common stock pursuant to the Sales Agreement for net proceeds of $53.4 million. Since June 30, 2024, the Company has issued approximately 0.3 million shares of common stock pursuant to the Sales Agreement for net proceeds of $4.0 million. The Company may terminate this at-the-market program at any time, pursuant to its terms. On April 2, 2024, the Company completed an underwritten public offering of its common stock and issued and sold 5,555,557 shares of common stock at a public offering price of $ 13.50 per share and issued pre-funded warrants to purchase 3,703,730 shares of common stock at a public offering price of $ 13.499 per share subject to an exercise price equal to $ 0.0001 . The common stock and pre-funded warrants sold resulted in net proceeds of $ 119.9 million after deducting underwriting discounts, commissions and offering costs. Uncertainties 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 and 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 product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Liquidity The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. As of the issuance date of these unaudited consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least twelve months from the issuance date of these unaudited consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies and recent accounting pronouncements | 2. Summary of significant accounting policies and recent accounting pronouncements Basis of presentation and consolidation The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include the accounts of the Company and its wholly-owned subsidiary. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany transactions between and among the Company and its consolidated subsidiary have been eliminated. Unaudited interim financial information The accompanying interim unaudited consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements and related notes as of and for the year ended December 31, 2023, which was filed with the SEC on March 25, 2024. The Company’s financial information as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023 is unaudited, but in the opinion of management, all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the financial position, results of operations and cash flows at the dates and for the periods presented of the results of these interim periods have been included. The balance sheet information as of December 31, 2023 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and disclosure of contingent assets and liabilities. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Cash, cash equivalents and restricted cash The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. The Company deposits its cash in checking, sweep and money market accounts. At June 30, 2024, restricted cash consisted of money market accounts collateralizing letters of credit issued as security deposits in connection with the Company’s leases of its corporate facilities. Cash and cash equivalents, and restricted cash in the consolidated statements of cash flows consists of the following (in thousands): As of June 30, 2024 2023 Cash and cash equivalents $ 193,476 $ 192,060 Restricted cash - short-term 75 — Restricted cash - long-term 494 569 Total cash, cash equivalents and restricted cash $ 194,045 $ 192,629 Emerging growth company and smaller reporting company status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, the Company’s consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. The Company will remain an emerging growth company until the earliest of (i) the last day of the first fiscal year (a) following the fifth anniversary of the completion of the Company's IPO, (b) in which the Company has total annual gross revenue of at least $1.235 billion or (c) in which the Company is deemed to be a large accelerated filer, which means the market value of the Company’s common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (ii) the date on which the Company has issued more than $1.0 billion in non-convertible debt securities during the prior three- year period. The Company anticipates ceasing to be an emerging growth company as of December 31, 2024, which is the last day of the fiscal year following the fifth anniversary of the completion of the Company's IPO. The Company is also a “smaller reporting company,” meaning that in the event of an IPO the market value of its stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to the Company as a result of such offering is less than $700.0 million and its annual revenue is less than $100.0 million during the most recently completed fiscal year. The Company may continue to be a smaller reporting company as long as either (i) the market value of its stock held by non-affiliates is less than $250.0 million or (ii) its annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of its stock held by non-affiliates is less than $700.0 million. If the Company is a smaller reporting company at the time it ceases to be an emerging growth company, the Company may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, the Company may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | 3. Fair value measurements The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): Fair value measurements as of June 30, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 186,819 $ — $ — $ 186,819 Total $ 186,819 $ — $ — $ 186,819 Marketable Securities: US Government debt securities $ — $ 88,506 $ — $ 88,506 Total $ — $ 88,506 $ — $ 88,506 Fair value measurements as of December 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 186,186 $ — $ — $ 186,186 Total $ 186,186 $ — $ — $ 186,186 Marketable Securities: US Government debt securities $ — $ 9,952 $ — $ 9,952 Total $ — $ 9,952 $ — $ 9,952 The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy. The carrying value of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities. The Company’s assets with fair value categorized as Level 1 within the fair value hierarchy include money market funds. Money market funds are publicly traded mutual funds and are presented as cash equivalents on the consolidated balance sheets as of June 30, 2024 and December 31, 2023. The Company measures its marketable securities at fair value on a recurring basis and classifies those instruments within Level 2 of the fair value hierarchy. Marketable securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. There were no transfers to Level 3 in the periods presented. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities | 4. Marketable securities The following table summarizes the Company’s marketable securities as of June 30, 2024 (in thousands): June 30, 2024 Amortized Cost Unrealized Gains Unrealized Loss Fair Value Marketable securities: US Government debt securities $ 88,521 $ — $ ( 15 ) $ 88,506 Total $ 88,521 $ — $ ( 15 ) $ 88,506 The following table summarizes the Company’s marketable securities as of December 31, 2023 (in thousands): December 31, 2023 Amortized Cost Unrealized Gains Unrealized Loss Fair Value Marketable securities: US Government debt securities $ 9,976 $ — $ ( 24 ) $ 9,952 Total $ 9,976 $ — $ ( 24 ) $ 9,952 As of June 30, 2024 , the weighted average maturity of the Company’s marketable securities ranges from approximately 0.13 years to 0.83 years. The Company did no t record an allowance for credit losses as of June 30, 2024 related to its marketable securities. Further, given the lack of significant change in the credit risk of these investments, the Company did not recognize any other-than-temporary impairment losses. |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued and other current liabilities | 5. Accrued and other current liabilities Accrued and other current liabilities consisted of the following (in thousands): June 30, December 31, 2024 2023 Accrued employee compensation costs $ 3,540 $ 5,611 Accrued professional costs 2,149 651 Accrued research and development costs 5,497 4,634 Current portion of operating lease liabilities 2,277 2,062 Other current liabilities 1,037 857 $ 14,500 $ 13,815 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 6. Commitments and contingencies Operating lease The Company determines whether an arrangement is a lease at inception. The Company accounts for a lease when it has the right to control the leased asset for a period of time while obtaining substantially all of the assets’ economic benefits. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the lease commencement date. The discount rate used to determine the present value of the lease payments is the Company’s incremental borrowing rate based on the information available at lease inception, as the Company did not have information to determine the rate implicit in the leases. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments (which include initial direct costs and lease incentives). The expense is included in operating expenses in the consolidated statements of operations and comprehensive loss. The Company’s lease agreements also contain variable payments, primarily maintenance-related costs, which are expensed as incurred and not included in the measurement of the right-of-use assets and lease liabilities. In August 2018, the Company entered into an agreement to lease approximately 23,000 square feet of space for a term of three years . Lease terms are triple net lease commencing at $ 0.9 million per year, then with 3 % annual base rent increases plus operating expenses, real estate taxes, utilities and janitorial fees. The lease commencement date was December 10, 2018 . In September 2021, the Company entered into an agreement to extend the initial term of the 23,000 square foot lease for a period of three years commencing on December 15, 2021 and ending December 31, 2024 . In addition, this lease provides for the lease of an additional 15,000 square feet of rentable space beginning on April 1, 2022 and ending on December 31, 2024 . In December 2021, the Company recognized a right-of-use asset and operating lease liability of $ 3.5 million for the 23,000 square feet. On April 1, 2022, the Company recognized a right-of-use asset and operating lease liability of $ 1.8 million for the 15,000 square feet. In December 2023, the Company entered into an agreement to extend the term of the 38,000 square foot lease for a period of two years commencing on January 1, 2025 and ending on December 31, 2026 . In December 2023, the Company recognized a right-of-use asset and operating lease liability of $ 4.1 million. In December 2018, the Company entered into an agreement to lease 2,485 square feet of space for an initial term of three years . The lease includes one renewal option for an additional two years ; however, any time after the initial term the landlord may relocate the Company from the premises to a space reasonably comparable in size and utility. As the Company does not have the right to control the use of the identified asset after the initial term, the renewal option was excluded from the lease liability calculation. Lease terms commence at $ 0.2 million per annum, with 2.5 % annual base rent increases plus operating expenses, real estate taxes, utilities and janitorial fees. The lease commencement date was May 1, 2019 . In June 2021, the Company amended the agreement to extend the initial term of the 2,485 square foot lease for a period of three years commencing May 1, 2022 and ending April 30, 2025 . In addition, the amendment provided for the lease of an additional 2,357 square feet of rentable space beginning on July 6, 2021 and ending on April 30, 2025 . The amended lease provides the Company with the option to extend the term of the lease for an additional two years . In 2021, the Company recognized a right-of-use asset and operating lease liabilities of $ 0.7 million for the extension of the lease to April 30, 2025 and a right-of-use asset and operating lease liabilities of $ 0.8 million for the additional 2,357 square feet of rentable space. Future minimum lease payments under non-cancellable leases as of June 30, 2024 were as follows (in thousands): 2024 $ 1,307 2025 2,661 2026 2,564 Total lease payments 6,532 Less imputed interest ( 704 ) Present value of lease liabilities $ 5,828 Lease balances as of June 30, 2024 were as follows (in thousands): Operating right-of-use assets $ 5,499 Current Portion of operating lease liabilities $ 2,277 Non-current portion of operating lease liabilities 3,551 Total operating lease liabilities $ 5,828 The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases as of June 30, 2024 were as follows: Weighted average remaining lease term in years 2.4 Weighted average discount rate 10.03 % Lease expense incurred under operating leases was $ 0.7 million for the three months ended June 30, 2024 and was $ 0.7 million for the three months ended June 30, 2023 . Lease expense incurred under operating leases was $ 1.4 million for the six months ended June 30, 2024 and was $ 1.2 million for the six months ended June 30, 2023. License and research agreements In April 2016, the Company entered into an exclusive, worldwide license agreement with the University of Southampton (the “Southampton Agreement”), whereby the Company acquired rights to foundational technologies related to the Company’s TANGO technology. Under the Southampton Agreement, the Company receives an exclusive, worldwide license under certain licensed patents and applications relating to TANGO. Under the Southampton Agreement, the Company may be obligated to make additional payments that are contingent upon certain milestones being achieved, as well as royalties on future product sales. These royalty obligations survive until the latest of (i) the expiration of the last valid claim of a licensed patent covering a subject product or (ii) the expiration of any regulatory exclusivity for the subject product in a country. In addition, if the Company sublicenses its rights under the Southampton Agreement, the Company is required to pay a mid-single digit percentage of the sublicense revenue to the University of Southampton. As of June 30, 2024 , the Company had paid $ 0.70 million under the Southampton Agreement as a result of entering into the Acadia Pharmaceuticals Inc. license and collaboration agreement in January 2022 (see Note 7). Additionally, certain licenses under the Southampton Agreement require the Company to reimburse the University of Southampton for certain past and ongoing patent related expenses. For the three months ended June 30, 2024 these expenses were $ 0.04 million compared to $ 0.10 million for the three months ended June 30, 2023 , and for the six months ended June 30, 2024 these expenses were $ 0.07 million compared to $ 0.14 million for the six months ended June 30, 2023. |
License and Collaboration Agree
License and Collaboration Agreement with Acadia Pharmaceuticals Inc | 6 Months Ended |
Jun. 30, 2024 | |
License And Collaboration Agreement [Abstract] | |
License and collaboration agreement with Acadia Pharmaceuticals Inc | 7. License and collaboration agreement with Acadia Pharmaceuticals Inc. In January 2022, the Company entered into a license and collaboration agreement with Acadia Pharmaceuticals Inc. (“Acadia”) for the discovery, development and commercialization of novel RNA-based medicines for the treatment of severe and rare genetic neurodevelopmental diseases of the central nervous system. The agreement focuses on the targets SYNGAP1, MECP2 (Rett syndrome), and an undisclosed neurodevelopmental target of mutual interest. In connection with each target, the Company will collaborate with Acadia to identify potential treatments for further development and commercialization as licensed products. With respect to SYNGAP1, the Company has agreed with Acadia to co-develop and co-commercialize licensed products for such target globally, and in connection therewith the Company granted to Acadia worldwide, co-exclusive (with the Company) licenses for such licensed products. With respect to MECP2 and the neurodevelopmental target, the Company granted to Acadia worldwide, exclusive licenses to develop and commercialize licensed products for such targets. Pursuant to the terms of the agreement, the Company received an upfront payment of $ 60.0 million from Acadia. Acadia agreed to fund the research to identify potential licensed products for MECP2 and the neurodevelopmental target, and the Company will equally fund with Acadia the research to identify potential licensed products for SYNGAP1. The Company is eligible to receive up to $ 907.5 million in potential total milestone payments based upon the achievement of certain development, regulatory, first commercial sales and sales milestone events across the programs for the three targets, assuming each milestone were achieved at least once. With respect to licensed products for MECP2 and the neurodevelopmental target, the Company is also eligible to receive tiered royalties at percentages ranging from the mid-single digits to the mid-teens on future net sales by Acadia of licensed products worldwide. Royalties payable under the agreement are subject to standard royalty reductions. For SYNGAP1 licensed products that the Company is co-developing and co-commercializing, the Company will be responsible for 50% of the development and commercialization costs and will receive 50% of the profits from global commercialization. The Company is provided with a co-development and co-commercialization opt out option relating to the SYNGAP1 target indication at the Company’s discretion. Such opt-out would reduce development and commercialization milestones but would provide the Company with royalties on an escalating basis attributable to net sales milestones. Acadia agreement accounting At the commencement of the Acadia agreement, the Company identified three performance obligations consisting of pre-clinical research activities for each of the three targets, SYNGAP1, MECP2, and the undisclosed neurodevelopmental target. The exclusive or co-exclusive licenses granted to Acadia to conduct pre-clinical research activities on each of the three targets, and participation on each of the respective joint research committees were identified as promised services. However, the licenses granted to Acadia and the research activities were determined to be not distinct from each other, and therefore are considered a combined performance obligation for each of the three targets. Participation on each of the joint research committees was determined to be quantitatively and qualitatively immaterial in the context of the arrangement with Acadia. The Company is recognizing the transaction price for the pre-clinical research activities for each of the three targets over time as the research services are provided. The transfer of control to Acadia occurs over this time period, and in management’s judgment, is the best measure of progress towards satisfying the performance obligation. An input method is used that measures the cost incurred to date in satisfying each of the three research activities in relation to the estimated total projected cost of each of the research activities to fulfill the respective obligations. The cumulative effect of revisions to estimated costs and/or the transaction price to complete the research performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. Milestone payments that are not within the control of the Company, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. For other milestones, the Company evaluated factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. Milestones that are outside of the Company’s or Acadia’s control will not be recognized until such milestones are achieved. As to the other milestones, to date, no milestone payments have been included in the transaction price due to the uncertainty as to whether these milestones will be achieved. The Company will at the end of each reporting period reevaluate the probability of achievement of all milestones subject to constraint and, if necessary, adjust its estimate of the overall transaction price for each of the research activities on the three targets. Any such adjustments will be recorded on a cumulative catch-up basis. As of June 30, 2024 , the Company had $ 43.0 million in upfront consideration associated with the Acadia agreement relating to performance obligations that are unsatisfied or partially unsatisfied. |
Equity Incentive Plans
Equity Incentive Plans | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Equity incentive plans | 8. Equity incentive plans In June 2019, the Company’s board of directors and stockholders approved the 2019 Equity Incentive Plan (the “2019 Plan”) which became effective on June 17, 2019 and replaced the Company’s 2014 Equity Incentive Plan (the “2014 Plan”). In addition to the shares of common stock reserved for future issuance under the 2014 Plan that were added to the 2019 Plan upon its effective date, the Company initially reserved 2,200,000 shares of common stock for issuance under the 2019 Plan. The number of shares reserved for issuance under the 2019 Plan will increase automatically on January 1 of each of 2020 through 2029 by the number of shares equal to 4 % of the aggregate number of outstanding shares of the Company’s common stock as of the immediately preceding December 31, or a lesser number as may be determined by the Company’s board of directors. In April 2023, the Company’s board of directors adopted the Stoke Therapeutics, Inc. 2023 Inducement Plan (the “2023 Plan”). As permitted by Nasdaq stock market rules, the Company’s stockholders were not required to approve the 2023 Plan. The 2023 Plan provides for up to 1,000,000 shares of the Company’s common stock under awards granted to newly hired employees. An “award” is any right to receive common stock of the Company through nonstatutory stock options or restricted stock units (“RSUs”). As of June 30, 2024 , there were no shares available for future issuance under the 2014 Plan, 2,362,405 shares were available under the 2019 Plan and 190,400 shares were available under the 2023 Plan. During the three months ended June 30, 2024 , the Company granted options to purchase 897,712 shares of common stock to certain of its employees. The options vest over a period of up to four years and are exercisable at a per share price equal to the fair value of the common stock on the grant date. During the three months ended June 30, 2024 , the Company did no t grant RSUs or performance stock units (“PSUs”) to its employees. Stock-based compensation As of June 30, 2024 , there was $ 30.9 million of unrecognized compensation cost related to unvested stock options granted under the 2019 and 2023 Plans. Compensation expense is expected to be recognized over a weighted average period of 3.0 years as of June 30, 2024. As of June 30, 2024 , there was $ 29.3 million of unrecognized stock-based compensation related to RSUs and is expected to be recognized over a weighted average period of 2.4 years. As of June 30, 2024 there was $ 4.2 million of unrecognized stock-based compensation related to PSUs. Stock-based compensation expense recorded as research and development and general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 2,924 $ 2,776 $ 5,015 $ 5,031 General and administrative 4,503 3,984 7,822 7,616 Total $ 7,427 $ 6,760 $ 12,837 $ 12,647 2019 Employee stock purchase plan In June 2019, the Company adopted the 2019 Employee Stock Purchase Plan (the “ESPP”), which became effective on June 18, 2019. The Company initially reserved 315,000 shares of common stock for sale under the ESPP. At June 30, 2024 , the Company had 1,631,069 shares available for issuance under the ESPP. The average grant date fair value per share under the ESPP was $ 5.86 for 2024. The total ESPP stock-based compensation expense for the three and six months ended June 30, 2024 was $ 0.1 million and $ 0.2 million, respectively, and for the three and six months ended June 30, 2023 was $ 0.1 million and $ 0.2 million, respectively. The number of shares reserved for issuance under the ESPP will increase automatically on January 1 of each of the first ten calendar years following the first offering date by the number of shares equal to the lesser of 1 % of the total outstanding shares of the Company’s common stock as of the immediately preceding December 31 or a lower amount determined by the Company’s board of directors. The aggregate number of shares issued over the term of the ESPP will not exceed 3,150,000 shares of the Company’s common stock. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net loss per share | 9. Net loss per share The following table summarizes the computation of basic and diluted net loss per share of the Company (in thousands except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Numerator: Net loss $ ( 25,695 ) $ ( 30,654 ) $ ( 52,069 ) $ ( 53,199 ) Denominator: Weighted-average number of common shares, 55,765,948 44,188,464 51,288,222 43,367,032 Net loss per share, basic and diluted $ ( 0.46 ) $ ( 0.69 ) $ ( 1.02 ) $ ( 1.23 ) The Company has included the outstanding pre-funded warrants from the April 2024 offering in the number of total outstanding shares used for the computation of basic and diluted net loss per share for the period ending June 30, 2024, since they have a de minimis exercise price. The Company’s potential dilutive securities, which include common stock options, RSUs, PSUs, and ESPP purchase rights, have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive. Therefore, the weighted average number of shares of the Company’s common stock outstanding, including warrants, used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: June 30, 2024 2023 Outstanding options to purchase common stock 8,064,604 9,441,904 Restricted stock units 2,390,957 783,600 Total 10,455,561 10,225,504 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 10. Income taxes The Company did no t record an income tax benefit in its consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023 as it is more likely than not that the Company will not recognize the federal and state deferred tax benefits generated by its losses. The Company has provided a valuation allowance for the full amount of its net deferred tax assets as of June 30, 2024 and December 31, 2023, as management has determined it is more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized. The Company did no t record any amounts for unrecognized tax benefits as of June 30, 2024 or December 31, 2023. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent events | 11. Subsequent events Since June 30, 2024 , through the date of the issuance of these consolidated financial statements, the Company sold 0.3 million shares of our common stock and received $ 4.0 million after deducting commissions related to the Sales Agreement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of presentation and consolidation The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include the accounts of the Company and its wholly-owned subsidiary. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany transactions between and among the Company and its consolidated subsidiary have been eliminated. |
Unaudited Interim Financial Information | Unaudited interim financial information The accompanying interim unaudited consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with GAAP for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements and related notes as of and for the year ended December 31, 2023, which was filed with the SEC on March 25, 2024. The Company’s financial information as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023 is unaudited, but in the opinion of management, all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation of the financial position, results of operations and cash flows at the dates and for the periods presented of the results of these interim periods have been included. The balance sheet information as of December 31, 2023 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. |
Use of Estimates | Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and disclosure of contingent assets and liabilities. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. |
Cash, Cash Equivalents and Restricted Cash | Cash, cash equivalents and restricted cash The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. The Company deposits its cash in checking, sweep and money market accounts. At June 30, 2024, restricted cash consisted of money market accounts collateralizing letters of credit issued as security deposits in connection with the Company’s leases of its corporate facilities. Cash and cash equivalents, and restricted cash in the consolidated statements of cash flows consists of the following (in thousands): As of June 30, 2024 2023 Cash and cash equivalents $ 193,476 $ 192,060 Restricted cash - short-term 75 — Restricted cash - long-term 494 569 Total cash, cash equivalents and restricted cash $ 194,045 $ 192,629 |
Emerging Growth Company and Smaller Reporting Company Status | Emerging growth company and smaller reporting company status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, the Company’s consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. The Company will remain an emerging growth company until the earliest of (i) the last day of the first fiscal year (a) following the fifth anniversary of the completion of the Company's IPO, (b) in which the Company has total annual gross revenue of at least $1.235 billion or (c) in which the Company is deemed to be a large accelerated filer, which means the market value of the Company’s common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (ii) the date on which the Company has issued more than $1.0 billion in non-convertible debt securities during the prior three- year period. The Company anticipates ceasing to be an emerging growth company as of December 31, 2024, which is the last day of the fiscal year following the fifth anniversary of the completion of the Company's IPO. The Company is also a “smaller reporting company,” meaning that in the event of an IPO the market value of its stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to the Company as a result of such offering is less than $700.0 million and its annual revenue is less than $100.0 million during the most recently completed fiscal year. The Company may continue to be a smaller reporting company as long as either (i) the market value of its stock held by non-affiliates is less than $250.0 million or (ii) its annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of its stock held by non-affiliates is less than $700.0 million. If the Company is a smaller reporting company at the time it ceases to be an emerging growth company, the Company may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, the Company may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents and Restricted Cash | Cash and cash equivalents, and restricted cash in the consolidated statements of cash flows consists of the following (in thousands): As of June 30, 2024 2023 Cash and cash equivalents $ 193,476 $ 192,060 Restricted cash - short-term 75 — Restricted cash - long-term 494 569 Total cash, cash equivalents and restricted cash $ 194,045 $ 192,629 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on Recurring Basis and Level of Fair Value Hierarchy Utilized | The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): Fair value measurements as of June 30, 2024 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 186,819 $ — $ — $ 186,819 Total $ 186,819 $ — $ — $ 186,819 Marketable Securities: US Government debt securities $ — $ 88,506 $ — $ 88,506 Total $ — $ 88,506 $ — $ 88,506 Fair value measurements as of December 31, 2023 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 186,186 $ — $ — $ 186,186 Total $ 186,186 $ — $ — $ 186,186 Marketable Securities: US Government debt securities $ — $ 9,952 $ — $ 9,952 Total $ — $ 9,952 $ — $ 9,952 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities as of June 30, 2024 (in thousands): June 30, 2024 Amortized Cost Unrealized Gains Unrealized Loss Fair Value Marketable securities: US Government debt securities $ 88,521 $ — $ ( 15 ) $ 88,506 Total $ 88,521 $ — $ ( 15 ) $ 88,506 The following table summarizes the Company’s marketable securities as of December 31, 2023 (in thousands): December 31, 2023 Amortized Cost Unrealized Gains Unrealized Loss Fair Value Marketable securities: US Government debt securities $ 9,976 $ — $ ( 24 ) $ 9,952 Total $ 9,976 $ — $ ( 24 ) $ 9,952 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consisted of the following (in thousands): June 30, December 31, 2024 2023 Accrued employee compensation costs $ 3,540 $ 5,611 Accrued professional costs 2,149 651 Accrued research and development costs 5,497 4,634 Current portion of operating lease liabilities 2,277 2,062 Other current liabilities 1,037 857 $ 14,500 $ 13,815 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases | Future minimum lease payments under non-cancellable leases as of June 30, 2024 were as follows (in thousands): 2024 $ 1,307 2025 2,661 2026 2,564 Total lease payments 6,532 Less imputed interest ( 704 ) Present value of lease liabilities $ 5,828 |
Summary of Lease Balances | Lease balances as of June 30, 2024 were as follows (in thousands): Operating right-of-use assets $ 5,499 Current Portion of operating lease liabilities $ 2,277 Non-current portion of operating lease liabilities 3,551 Total operating lease liabilities $ 5,828 |
Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate of Operating Leases | The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases as of June 30, 2024 were as follows: Weighted average remaining lease term in years 2.4 Weighted average discount rate 10.03 % |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Expense | Stock-based compensation expense recorded as research and development and general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Research and development $ 2,924 $ 2,776 $ 5,015 $ 5,031 General and administrative 4,503 3,984 7,822 7,616 Total $ 7,427 $ 6,760 $ 12,837 $ 12,647 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Share | The following table summarizes the computation of basic and diluted net loss per share of the Company (in thousands except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Numerator: Net loss $ ( 25,695 ) $ ( 30,654 ) $ ( 52,069 ) $ ( 53,199 ) Denominator: Weighted-average number of common shares, 55,765,948 44,188,464 51,288,222 43,367,032 Net loss per share, basic and diluted $ ( 0.46 ) $ ( 0.69 ) $ ( 1.02 ) $ ( 1.23 ) |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share | June 30, 2024 2023 Outstanding options to purchase common stock 8,064,604 9,441,904 Restricted stock units 2,390,957 783,600 Total 10,455,561 10,225,504 |
Nature of the Business - Additi
Nature of the Business - Additional Information (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Apr. 02, 2024 | Aug. 07, 2024 | May 31, 2022 | Jun. 30, 2024 | |
Nature Of Business [Line Items] | ||||
Entity incorporation state name | DE | |||
Base Prospectus | ||||
Nature Of Business [Line Items] | ||||
Maximum aggregate offering price | $ 400,000,000 | |||
Sales Agreement Prospectus | ||||
Nature Of Business [Line Items] | ||||
Maximum aggregate offering price | $ 150,000,000 | |||
Issuance of common stock, Shares | 6,500,000 | |||
Sales Agreement Prospectus | Subsequent Event | ||||
Nature Of Business [Line Items] | ||||
Issuance of common stock, Shares | 300,000 | |||
Underwritten Public Offering | ||||
Nature Of Business [Line Items] | ||||
Net proceeds from common stock and pre-funded warrants | $ 119,900,000 | |||
Underwritten Public Offering | Common Stock | ||||
Nature Of Business [Line Items] | ||||
Issuance of common stock, Shares | 5,555,557 | |||
Price per share | $ 13.5 | |||
Underwritten Public Offering | Pre-Funds Warrants | ||||
Nature Of Business [Line Items] | ||||
Price per share | 13.499 | |||
Warrants excercise price | $ 0.0001 | |||
Warrants To Purchase Shares Of Common Stock | 3,703,730 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 193,476 | $ 191,442 | $ 192,060 | |
Restricted cash - short-term | 75 | |||
Restricted cash - long-term | 494 | 569 | 569 | |
Total cash, cash equivalents and restricted cash | $ 194,045 | $ 192,011 | $ 192,629 | $ 114,125 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets Measured at Fair Value on Recurring Basis and Level of Fair Value Hierarchy Utilized (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Marketable Securities | $ 88,506 | $ 9,952 |
US Government Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Marketable Securities | 88,506 | 9,952 |
Fair Value, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 186,819 | 186,186 |
Total Marketable Securities | 88,506 | 9,952 |
Fair Value, Recurring | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 186,819 | 186,186 |
Fair Value, Recurring | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 186,819 | 186,186 |
Fair Value, Recurring | Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 186,819 | 186,186 |
Fair Value, Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Marketable Securities | 88,506 | 9,952 |
Fair Value, Recurring | US Government Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Marketable Securities | 88,506 | 9,952 |
Fair Value, Recurring | US Government Debt Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Marketable Securities | $ 88,506 | $ 9,952 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | ||
Fair value assets, transfers to level 3, amount | $ 0 | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable securities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Marketable Securities [Line Items] | ||
Marketable Securities, Amortized Cost | $ 88,521 | $ 9,976 |
Marketable Securities, Unrealized Loss | (15) | (24) |
Marketable Securities, Fair Value | 88,506 | 9,952 |
US Government Debt Securities | ||
Marketable Securities [Line Items] | ||
Marketable Securities, Amortized Cost | 88,521 | 9,976 |
Marketable Securities, Unrealized Loss | (15) | (24) |
Marketable Securities, Fair Value | $ 88,506 | $ 9,952 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Marketable Securities [Line Items] | |
Allowance for credit losses | $ 0 |
Minimum | |
Marketable Securities [Line Items] | |
Weighted average maturity marketable securities period | 1 month 17 days |
Maximum | |
Marketable Securities [Line Items] | |
Weighted average maturity marketable securities period | 9 months 29 days |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation costs | $ 3,540 | $ 5,611 |
Accrued professional costs | 2,149 | 651 |
Accrued research and development costs | 5,497 | 4,634 |
Current portion of operating lease liabilities | 2,277 | 2,062 |
Other current liabilities | 1,037 | 857 |
Total accrued and other current liabilities | $ 14,500 | $ 13,815 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Dec. 31, 2023 USD ($) ft² | Sep. 30, 2021 ft² | Jun. 30, 2021 ft² | Dec. 31, 2018 USD ($) ft² Option | Aug. 31, 2018 USD ($) ft² | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Apr. 01, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Commitments And Contingencies [Line Items] | |||||||||||
Area of space subject to operating lease | ft² | 2,485 | 23,000 | |||||||||
Operating lease term | 3 years | 3 years | |||||||||
Operating lease cost per year | $ 200 | $ 900 | |||||||||
Annual base rent increase percentage for operating lease | 2.50% | 3% | |||||||||
Operating lease commencement date | May 01, 2019 | Dec. 10, 2018 | |||||||||
Operating lease right-of-use assets | $ 6,611 | $ 5,499 | $ 5,499 | ||||||||
Operating lease liabilities | 5,828 | 5,828 | |||||||||
Number of options to renewal operating lease term | Option | 1 | ||||||||||
Operating lease, renewal term | 2 years | ||||||||||
Southampton Agreement | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Expenses related to reimbursable patent costs | 40 | $ 100 | 70 | $ 140 | |||||||
Payment for license and collaboration agreement | 700 | ||||||||||
ASU 2016-02 | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Operating leases expense | $ 700 | $ 700 | $ 1,400 | $ 1,200 | |||||||
Lease Commencement on December 15, 2021 | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Area of space subject to operating lease | ft² | 23,000 | ||||||||||
Operating lease term | 3 years | ||||||||||
Operating lease commencement date | Dec. 15, 2021 | ||||||||||
Operating lease expiration date | Dec. 31, 2024 | ||||||||||
Operating lease right-of-use assets | $ 3,500 | ||||||||||
Operating lease liabilities | 3,500 | ||||||||||
Lease Commencement on April 2022 | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Area of space subject to operating lease | ft² | 15,000 | ||||||||||
Operating lease commencement date | Apr. 01, 2022 | ||||||||||
Operating lease expiration date | Dec. 31, 2024 | ||||||||||
Operating lease right-of-use assets | $ 1,800 | ||||||||||
Operating lease liabilities | $ 1,800 | ||||||||||
Lease Extension End Date April 30, 2025 | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Area of space subject to operating lease | ft² | 2,485 | ||||||||||
Operating lease term | 3 years | ||||||||||
Operating lease commencement date | May 01, 2022 | ||||||||||
Operating lease expiration date | Apr. 30, 2025 | ||||||||||
Operating lease right-of-use assets | 700 | ||||||||||
Operating lease liabilities | 700 | ||||||||||
Operating lease, renewal term | 2 years | ||||||||||
Area of additional space subject to operating lease | ft² | 2,357 | ||||||||||
Additional operating lease commencement date | Jul. 06, 2021 | ||||||||||
Additional operating lease expiration date | Apr. 30, 2025 | ||||||||||
Additional operating lease, right-of-use asset | 800 | ||||||||||
Additional operating lease, liabilities | $ 800 | ||||||||||
Operating lease, option to extend | The amended lease provides the Company with the option to extend the term of the lease for an additional two years. | ||||||||||
Operating lease, existence of option to extend [true false] | true | ||||||||||
Lease Commencement on January 1, 2025 | |||||||||||
Commitments And Contingencies [Line Items] | |||||||||||
Area of space subject to operating lease | ft² | 38,000 | ||||||||||
Operating lease term | 2 years | ||||||||||
Operating lease commencement date | Jan. 01, 2025 | ||||||||||
Operating lease expiration date | Dec. 31, 2026 | ||||||||||
Operating lease right-of-use assets | $ 4,100 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments Under Non-Cancellable Leases (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Future minimum lease payments under non-cancellable leases | |
2024 | $ 1,307 |
2025 | 2,661 |
2026 | 2,564 |
Total lease payments | 6,532 |
Less imputed interest | (704) |
Present value of lease liabilities | $ 5,828 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Lease Balances (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 5,499 | $ 6,611 |
Current Portion of operating lease liabilities | $ 2,277 | $ 2,062 |
Operating Lease Liability Current Statement Of Financial Position Extensible List | Liabilities, Current | |
Non-current portion of operating lease liabilities | $ 3,551 | |
Operating Lease Liability Noncurrent Statement Of Financial Position Extensible List | Other long term liabilities | |
Total operating lease liabilities | $ 5,828 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate of Operating Leases (Details) | Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] | |
Weighted average remaining lease term in years | 2 years 4 months 24 days |
Weighted average discount rate | 10.03% |
License and collaboration agr_2
License and collaboration agreement with Acadia Pharmaceuticals Inc - Additional Information (Details) - Acadia Pharmaceuticals Inc. - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended |
Jan. 31, 2022 | Jun. 30, 2024 | |
License And Collaboration Agreement [Line Items] | ||
Upfront Payment received | $ 60 | |
Potential milestone payments receivable | $ 907.5 | |
Remaining upfront consideration | $ 43 |
Equity Incentive Plans - Additi
Equity Incentive Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Apr. 30, 2023 | Jun. 30, 2019 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option granted to purchase shares | 897,712 | |||||
Unrecognized compensation cost | $ 30,900 | $ 30,900 | ||||
Weighted average period of unrecognized compensation cost expected to be recognized | 3 years | |||||
Stock based compensation expense | $ 7,427 | $ 6,760 | $ 12,837 | $ 12,647 | ||
Employee Stock Option | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Restricted Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Restricted stock units granted | 0 | |||||
Unrecognized compensation cost | $ 29,300 | $ 29,300 | ||||
Weighted average period of unrecognized compensation cost expected to be recognized | 2 years 4 months 24 days | |||||
Performance Stock Units | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Restricted stock units granted | 0 | |||||
Unrecognized compensation cost | $ 4,200 | $ 4,200 | ||||
2019 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of common stock reserved for issuance | 2,200,000 | |||||
Percentage of increase in reserved common shares | 4% | |||||
Number of common shares available for future issuance | 2,362,405 | 2,362,405 | ||||
2014 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of common shares available for future issuance | 0 | 0 | ||||
2019 ESPP | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of common stock reserved for issuance | 315,000 | |||||
Number of common shares available for future issuance | 1,631,069 | 1,631,069 | ||||
Average grant date fair value per share under the plan | $ 5.86 | |||||
Stock based compensation expense | $ 100 | $ 100 | $ 200 | $ 200 | ||
2019 ESPP | Maximum | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares of common stock reserved for issuance | 3,150,000 | |||||
Percentage of increase in reserved common shares | 1% | |||||
2023 Inducement Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of common shares available for future issuance | 190,400 | 190,400 | ||||
2023 Inducement Plan | Common Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Option granted to purchase shares | 1,000,000 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 7,427 | $ 6,760 | $ 12,837 | $ 12,647 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | 2,924 | 2,776 | 5,015 | 5,031 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock based compensation expense | $ 4,503 | $ 3,984 | $ 7,822 | $ 7,616 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net loss | $ (25,695) | $ (26,374) | $ (30,654) | $ (22,545) | $ (52,069) | $ (53,199) |
Denominator: | ||||||
Weighted-average number of common shares, basic | 55,765,948 | 44,188,464 | 51,288,222 | 43,367,032 | ||
Weighted-average number of common shares, diluted | 55,765,948 | 44,188,464 | 51,288,222 | 43,367,032 | ||
Net loss per share, basic | $ (0.46) | $ (0.69) | $ (1.02) | $ (1.23) | ||
Net loss per share, diluted | $ (0.46) | $ (0.69) | $ (1.02) | $ (1.23) |
Net Loss Per Share - Schedule_2
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share, amount | 10,455,561 | 10,225,504 |
Employee Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share, amount | 8,064,604 | 9,441,904 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share, amount | 2,390,957 | 783,600 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |||||
Income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 | |
Unrecognized tax benefits | $ 0 | $ 0 | $ 0 |
Subsequent events - Additional
Subsequent events - Additional Information (Details) - Sales Agreement Prospectus - USD ($) shares in Millions, $ in Millions | 1 Months Ended | 6 Months Ended |
Aug. 07, 2024 | Jun. 30, 2024 | |
Subsequent Event [Line Items] | ||
Issuance of common stock, Shares | 6.5 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Issuance of common stock, Shares | 0.3 | |
Proceeds from issuance of common stock net of commissions | $ 4 |