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 | |
Entity Registrant Name | TREVI THERAPEUTICS, INC. | |
Entity Central Index Key | 0001563880 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | TRVI | |
Entity Common Stock, Shares Outstanding | 72,591,917 | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Entity File Number | 001-38886 | |
Entity Tax Identification Number | 45-0834299 | |
Entity Address, Address Line One | 195 Church Street | |
Entity Address, Address Line Two | 16th Floor | |
Entity Address, City or Town | New Haven | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06510 | |
City Area Code | 203 | |
Local Phone Number | 304-2499 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 12,963 | $ 32,397 |
Marketable securities | 56,532 | 50,574 |
Prepaid expenses | 1,804 | 3,621 |
Other current assets | 830 | 955 |
Total current assets | 72,129 | 87,547 |
Operating lease right-of-use assets | 1,029 | 1,137 |
Finance lease right-of-use assets | 181 | 206 |
Property, equipment and leasehold improvements, net | 198 | 216 |
Other non-current assets | 273 | 297 |
Total assets | 73,810 | 89,403 |
Current liabilities: | ||
Accounts payable | 1,511 | 1,809 |
Accrued expenses | 4,932 | 3,709 |
Operating lease liabilities | 216 | 184 |
Finance lease liabilities | 93 | 122 |
Total current liabilities | 6,752 | 5,824 |
Operating lease liabilities | 884 | 1,001 |
Finance lease liabilities | 31 | |
Total liabilities | 7,636 | 6,856 |
Commitments and contingencies (Note 12) | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value; 5,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued or outstanding at June 30, 2024 and December 31, 2023. | ||
Common stock: $0.001 par value; 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; and 72,591,917 and 68,283,699 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively. | 73 | 68 |
Additional paid-in capital | 328,573 | 321,642 |
Accumulated other comprehensive loss | (84) | (29) |
Accumulated deficit | (262,388) | (239,134) |
Total stockholders’ equity | 66,174 | 82,547 |
Total liabilities and stockholders’ equity | $ 73,810 | $ 89,403 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement Of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
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 or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 |
Common Stock, Shares, Issued | 72,591,917 | 68,283,699 |
Common Stock, Shares, Outstanding | 72,591,917 | 68,283,699 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses: | ||||
Research and development | $ 10,021 | $ 5,842 | $ 18,825 | $ 10,842 |
General and administrative | 3,268 | 2,540 | 6,370 | 5,103 |
Total operating expenses | 13,289 | 8,382 | 25,195 | 15,945 |
Loss from operations | (13,289) | (8,382) | (25,195) | (15,945) |
Other income (expense): | ||||
Interest income, net | 935 | 1,207 | 1,933 | 2,428 |
Other (expense) income, net | (5) | 153 | (6) | 318 |
Interest expense | (1) | (153) | (2) | (384) |
Total other income, net | 929 | 1,207 | 1,925 | 2,362 |
Loss before income taxes | (12,360) | (7,175) | (23,270) | (13,583) |
Income tax benefit | 8 | 30 | 16 | 37 |
Net loss | $ (12,352) | $ (7,145) | $ (23,254) | $ (13,546) |
Basic net loss per common share outstanding | $ (0.12) | $ (0.07) | $ (0.23) | $ (0.14) |
Diluted net loss per common share outstanding | $ (0.12) | $ (0.07) | $ (0.23) | $ (0.14) |
Weighted average common shares used in net loss per share attributable to common stockholders, basic | 101,041,573 | 98,698,579 | 100,279,393 | 98,654,868 |
Weighted average common shares used in net loss per share attributable to common stockholders, diluted | 101,041,573 | 98,698,579 | 100,279,393 | 98,654,868 |
Net loss | $ (12,352) | $ (7,145) | $ (23,254) | $ (13,546) |
Other comprehensive loss: | ||||
Net unrealized losses on available-for-sale marketable securities | (17) | (160) | (55) | (126) |
Comprehensive loss | $ (12,369) | $ (7,305) | $ (23,309) | $ (13,672) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | At The Market Sales Agreement [Member] | Common Stock [Member] | Common Stock [Member] At The Market Sales Agreement [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member] At The Market Sales Agreement [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2022 | $ 107,459 | $ 60 | $ 317,590 | $ (122) | $ (210,069) | |||
Beginning Balance (in shares) at Dec. 31, 2022 | 59,943,430 | |||||||
Stock-based compensation | 1,183 | 1,183 | ||||||
Issuance of common stock from exercise of stock options | 70 | 70 | ||||||
Issuance of common stock from exercise of stock options (in shares) | 136,914 | |||||||
Issuance of common stock from Employee Stock Purchase Plan | 33 | 33 | ||||||
Issuance of common stock from Employee Stock Purchase Plan (in shares) | 19,273 | |||||||
Issuance of common stock from pre-funded warrant exercise | $ 3 | (3) | ||||||
Issuance of common stock from pre-funded warrant exercise (in shares) | 2,998,838 | |||||||
Unrealized losses on available-for-sale marketable securities | (126) | (126) | ||||||
Net loss | (13,546) | (13,546) | ||||||
Ending Balance at Jun. 30, 2023 | 95,073 | $ 63 | 318,873 | (248) | (223,615) | |||
Ending Balance (in shares) at Jun. 30, 2023 | 63,098,455 | |||||||
Beginning Balance at Mar. 31, 2023 | 101,732 | $ 60 | 318,230 | (88) | (216,470) | |||
Beginning Balance (in shares) at Mar. 31, 2023 | 60,065,408 | |||||||
Stock-based compensation | 606 | 606 | ||||||
Issuance of common stock from exercise of stock options | 7 | 7 | ||||||
Issuance of common stock from exercise of stock options (in shares) | 14,936 | |||||||
Issuance of common stock from Employee Stock Purchase Plan | 33 | 33 | ||||||
Issuance of common stock from Employee Stock Purchase Plan (in shares) | 19,273 | |||||||
Issuance of common stock from pre-funded warrant exercise | $ 3 | (3) | ||||||
Issuance of common stock from pre-funded warrant exercise (in shares) | 2,998,838 | |||||||
Unrealized losses on available-for-sale marketable securities | (160) | (160) | ||||||
Net loss | (7,145) | (7,145) | ||||||
Ending Balance at Jun. 30, 2023 | 95,073 | $ 63 | 318,873 | (248) | (223,615) | |||
Ending Balance (in shares) at Jun. 30, 2023 | 63,098,455 | |||||||
Beginning Balance at Dec. 31, 2023 | 82,547 | $ 68 | 321,642 | (29) | (239,134) | |||
Beginning Balance (in shares) at Dec. 31, 2023 | 68,283,699 | |||||||
Stock-based compensation | 1,850 | 1,850 | ||||||
Issuance of common stock from exercise of stock options | $ 218 | 218 | ||||||
Issuance of common stock from exercise of stock options (in shares) | 129,518 | 129,518 | ||||||
Issuance of common stock from Employee Stock Purchase Plan | $ 34 | 34 | ||||||
Issuance of common stock from Employee Stock Purchase Plan (in shares) | 30,675 | |||||||
Issuance of common stock, net of commissions and allocated fees, less issuance costs | $ 4,834 | $ 2 | $ 4,832 | |||||
Issuance of common stock, net of commissions and allocated fees, less issuance costs (in shares) | 1,474,926 | |||||||
Issuance of common stock from pre-funded warrant exercise | $ 3 | (3) | ||||||
Issuance of common stock from pre-funded warrant exercise (in shares) | 2,673,099 | |||||||
Unrealized losses on available-for-sale marketable securities | (55) | (55) | ||||||
Net loss | (23,254) | (23,254) | ||||||
Ending Balance at Jun. 30, 2024 | 66,174 | $ 73 | 328,573 | (84) | (262,388) | |||
Ending Balance (in shares) at Jun. 30, 2024 | 72,591,917 | |||||||
Beginning Balance at Mar. 31, 2024 | 72,334 | $ 69 | 322,368 | (67) | (250,036) | |||
Beginning Balance (in shares) at Mar. 31, 2024 | 68,960,167 | |||||||
Stock-based compensation | 1,127 | 1,127 | ||||||
Issuance of common stock from exercise of stock options | 214 | 214 | ||||||
Issuance of common stock from exercise of stock options (in shares) | 126,887 | |||||||
Issuance of common stock from Employee Stock Purchase Plan | 34 | 34 | ||||||
Issuance of common stock from Employee Stock Purchase Plan (in shares) | 30,675 | |||||||
Issuance of common stock, net of commissions and allocated fees, less issuance costs | $ 4,834 | $ 2 | $ 4,832 | |||||
Issuance of common stock, net of commissions and allocated fees, less issuance costs (in shares) | 1,474,926 | |||||||
Issuance of common stock from pre-funded warrant exercise | $ 2 | (2) | ||||||
Issuance of common stock from pre-funded warrant exercise (in shares) | 1,999,262 | |||||||
Unrealized losses on available-for-sale marketable securities | (17) | (17) | ||||||
Net loss | (12,352) | (12,352) | ||||||
Ending Balance at Jun. 30, 2024 | $ 66,174 | $ 73 | $ 328,573 | $ (84) | $ (262,388) | |||
Ending Balance (in shares) at Jun. 30, 2024 | 72,591,917 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities: | ||
Net loss | $ (23,254) | $ (13,546) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,850 | 1,183 |
Operating lease right-of-use assets | 233 | 140 |
Depreciation and amortization | 73 | 53 |
Accretion of available-for-sale marketable securities, net | (717) | (1,302) |
Accretion/accrual of term loan discounts and debt issuance costs | 180 | |
Loss on disposal of property, equipment and leasehold improvements | 10 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,914 | (2,489) |
Accounts payable | (324) | (1,506) |
Accrued expenses and other liabilities | 1,075 | (795) |
Net cash used in operating activities | (19,150) | (18,072) |
Investing activities: | ||
Proceeds from maturities of available-for-sale marketable securities | 34,927 | 37,679 |
Purchases of available-for-sale marketable securities | (40,222) | (8,981) |
Purchases of property, equipment and leasehold improvements | (28) | (97) |
Net cash (used in) provided by investing activities | (5,323) | 28,601 |
Financing activities: | ||
Proceeds from at-the-market sales, net of commissions | 4,850 | |
Proceeds from exercises of stock options | 218 | 70 |
Proceeds from employee stock purchase plan | 34 | 33 |
Payments of finance lease | (63) | (32) |
Repayments of term loan | (9,409) | |
Payments of offering costs | (28) | |
Net cash used in financing activities | 5,039 | (9,366) |
Net increase in cash and cash equivalents | (19,434) | 1,163 |
Cash and cash equivalents at beginning of period | 32,397 | 12,589 |
Cash and cash equivalents at end of period | $ 12,963 | $ 13,752 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (12,352) | $ (7,145) | $ (23,254) | $ (13,546) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | |
Name | Farrell Simon |
Title | Chief Commercial Officer |
Non-Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Aggregate Available | 131,900 |
Expiration Date | July 9, 2025 |
Chief Commercial Officer | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | April 9, 2024 |
Rule 10b5-1 Arrangement Terminated | false |
Nature of the Business
Nature of the Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of the Business | 1. Nature of the Business Trevi Therapeutics, Inc. (“Trevi” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (“IPF”) and refractory chronic cough. Haduvio is an oral extended-release formulation of nalbuphine. Nalbuphine is a mixed κ-opioid receptor agonist and μ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 30 years in the United States (“U.S.”) and Europe. The κ- and μ-opioid receptors are known to be critical mediators of cough. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with μ-opioid agonists because it antagonizes, or blocks, the μ-opioid receptor. Parenteral nalbuphine is not scheduled as a controlled substance in the U.S. and most of Europe. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited interim Condensed Consolidated Financial Statements for the three and six months ended June 30, 2024 and 2023 included herein have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim information. Certain information and footnote disclosures typically prepared in accordance with GAAP have been condensed or omitted pursuant to SEC rules and regulations. The accompanying unaudited Condensed Consolidated Financial Statements and notes should be read in conjunction with the audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The accompanying Condensed Consolidated Financial Statements include the accounts of Trevi Therapeutics, Inc. and its wholly-owned subsidiary Trevi Therapeutics Limited. Intercompany balances and transactions have been eliminated. All amounts presented are in thousands of dollars, except share and per share amounts, unless noted otherwise. The Company has evaluated events occurring subsequent to June 30, 2024 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure . Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Condensed Consolidated Financial Statements include but are not limited to the recognition of research and development (“R&D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Unaudited Interim Financial Information The accompanying interim Condensed Consolidated Balance Sheet as of June 30, 2024 and the Condensed Consolidated Statements of Comprehensive Loss, the Condensed Consolidated Statements of Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three and six months ended June 30, 2024 and 2023 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 Company’s opinion, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statements of its financial position as of June 30, 2024 and the results of its operations and its cash flows for the three and six months ended June 30, 2024 and 2023. The results for the three and six months ended June 30, 2024 and 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or any other interim period or any future year or period. Cash Equivalents The Company classifies short-term, highly liquid investments with an original term of three months or less at the date of purchase as cash equivalents. Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short- to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents or marketable securities on the Condensed Consolidated Balance Sheets. Marketable securities with an original maturity date greater than 90 days at each balance sheet date are classified as short-term. Marketable securities are classified as current assets as these investments are intended to be available to the Company for use in funding current operations. All of the Company’s marketable securities are considered available-for-sale and are reported at fair value. For securities with unrealized gains and losses, when the Company expects to receive cash flows sufficient to recover the amortized cost basis of a security, such gains and losses are included in accumulated other comprehensive income as a component of stockholders’ equity. Credit losses are identified when the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. Realized gains and losses, if any, on marketable securities are included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. The cost of securities sold is determined using specific identification. The Company evaluates whether declines in the fair values of its marketable securities below their amortized cost are credit losses on a quarterly basis. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss, as well as the Company’s ability and intent to hold the marketable security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the marketable security or whether it is more likely than not that it will be required to sell any marketable securities before recovery of its amortized cost basis. Factors considered include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company’s strategy and intentions for holding the marketable security. Fair Value Measurements The Company’s financial instruments have consisted of cash and cash equivalents, available-for-sale marketable securities, other current assets, accounts payable, accrued expenses, term loans and warrants to acquire the Company’s common stock. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. The carrying amounts of cash and cash equivalents, other current assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Available-for-sale marketable securities are reported at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below. The warrants to acquire the Company’s common stock are not required to be accounted for at fair value. Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect market assumptions and are classified into the following fair value hierarchy: Level 1—Observable inputs—quoted prices in active markets for identical assets and liabilities. Level 2—Observable inputs other than the quoted prices in active markets for identical assets and liabilities—such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data. Level 3—Unobservable inputs—includes amounts derived from valuation models where one or more significant inputs are unobservable and require the company to develop relevant assumptions. Valuation Techniques - Level 2 Inputs The Company estimates the fair values of its financial instruments categorized as level 2 in the fair value hierarchy, including U.S. treasury securities, U.S. government agency obligations, corporate bonds, commercial paper, asset-backed securities and municipal bonds, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service. Property, Equipment and Leasehold Improvements Property, equipment and leasehold improvements (consisting of furniture, computer and office equipment and leasehold improvements) are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets ( three years for computer equipment, five years for furniture and office equipment, and the shorter of the term of the lease or useful life for leasehold improvements). Foreign Currency Transactions The Company, at times, contracts with vendors and consultants outside of the U.S., resulting in liabilities denominated in foreign currency. The transactions are recorded in U.S. dollars on the transaction dates and any currency fluctuation through the payment date is recorded as currency gains or losses in other income, net in the Condensed Consolidated Statements of Comprehensive Loss. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the financings. Should the planned equity financing no longer be considered probable of being consummated, the deferred offering costs are expensed immediately as a charge to general and administrative expenses. The deferred offering costs are included in Other current and non-current assets on the Condensed Consolidated Balance Sheets. Research and Development (“R&D”) Expenses All of the Company’s R&D expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include certain payroll and personnel expenses, including stock-based compensation, consulting costs, contract manufacturing costs and fees paid to contract research organizations (“CROs”) to conduct certain R&D activities on the Company’s behalf. The Company expenses both internal and external R&D expenses as they are incurred. Accrued R&D Expenses The Company has entered into agreements with CROs, contract manufacturing organizations (“CMOs”) and other companies that provide services in connection with the Company’s R&D activities. The Company’s R&D accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events and contracted costs. The estimated costs of R&D provided, but not yet invoiced, are included in accrued expenses on the Condensed Consolidated Balance Sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs, CMOs and other companies under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or as other non-current assets, as applicable, and are recognized as expenses as the goods are delivered or the related services are performed. Patent Costs All patent-related costs in connection with filing and prosecuting patent applications are expensed to general and administrative expense as incurred, as recoverability of such expenditures is uncertain. Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and then in accordance with ASC 815, Derivatives and Hedging (“ASC 815”), depending on the specific terms of the warrant. Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If the warrants do not meet liability classification under ASC 480, the Company assesses the requirements under ASC 815, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of comprehensive loss as a gain or loss. For equity classified warrants, no changes in fair value are recognized after the issuance date. Stock-Based Compensation The Company accounts for stock-based compensation arrangements with employees and non-employees for consultancy services in accordance with ASC 718, Stock Compensation (“ASC 718”). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based awards including stock options. The Company’s determination of the fair value of stock-based awards on the date of grant utilizes the Black-Scholes valuation model for stock options with time-based and performance-based vesting and is impacted by the price of its common stock as well as changes in assumptions regarding a number of subjective variables. These variables include the expected term that stock options will remain outstanding, expected common stock price volatility over the term of the stock options, risk-free interest rates and expected dividends. Changes in the variables can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require analysis and judgment to develop. Expected Term—The expected term assumption represents the weighted average period that the stock-based awards are expected to be outstanding. The Company has elected to use the “simplified method” for estimating the expected term of its stock options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. Expected Volatility—For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer companies. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. Expected Dividend—The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company currently has no history or expectation of paying cash dividends on its common stock. Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to the expected term of the stock-based award. The fair value is recognized over the period during which an optionee is required to provide services in exchange for the stock option, known as the requisite service period (usually the vesting period) on a straight-line basis. For performance-based vesting, the fair value is recognized when it is probable the performance conditions will be achieved. The Company reassesses the probability of achieving the performance conditions at each reporting date. Forfeitures are accounted for as they occur. Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized. The Company applies the provisions of ASC 740, Income Taxes , which prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return. These Condensed Consolidated Financial Statements reflect expected future tax consequences of such positions presuming the taxing authorities possess full knowledge of the position and all relevant facts. There are no material uncertainties regarding the tax positions that the Company has taken through June 30, 2024 and December 31, 2023 . The Company does not have any interest or penalties accrued related to tax positions as it does not have any unrecognized tax benefits. Leases Under ASC 842, Leases , the Company determines if an arrangement is a lease at its inception. Leases are classified as either operating or finance, based on the Company’s evaluation of certain criteria. If a lease has a term greater than one year, the lease is recognized in the balance sheet as a right-of-use asset and a lease liability at lease commencement. The Company elected the short-term lease practical expedient, therefore, if a lease has a term less than one year, the Company will not recognize the lease on its balance sheet. The right-of-use asset represents the Company’s right of use to an underlying asset for the term of the lease and the lease liability represents the Company’s obligation to make lease payments arising from the lease. If the Company’s leases do not provide an implicit rate within the lease, the Company uses its incremental borrowing rate, based on information available at the commencement date of the lease to determine the present value of the lease payments. Operating lease right-of-use assets and operating lease liabilities are determined and recognized on the commencement date of the lease based on the present value of lease payments over the term of the lease. For operating leases, rent expense is recognized on a straight-line basis over the term of the lease, and right-of-use assets are subsequently re-measured to reflect the effect of uneven lease payments. For finance leases, right-of-use assets are amortized on a straight-line basis over the shorter of the lease term or the useful life of the underlying asset. Expenses for finance leases include the amortization of right-of-use assets, which is recorded as depreciation and amortization expense, and interest expense, which reflects interest accrued on the lease liability. Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average common shares outstanding during the period. Basic shares outstanding includes the weighted average effect of the Company’s outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock. For all periods presented, shares issuable upon exercise of stock options and warrants to purchase shares of common stock (other than pre-funded warrants) have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per share are the same for each of the periods presented. Segments The Company has one reporting segment which is also the Company’s only operating segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long-lived assets are maintained in the U.S. Recently Adopted Accounting Pronouncements There have been no new pronouncements adopted during the six months ended June 30, 2024. Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280, Segment Reporting , on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2024 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | 3. Marketable Securities The fair value and amortized cost of available-for-sale marketable securities by major security type are presented in the following tables as of the periods presented: June 30, 2024 Type of security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 30,245 $ 4 $ ( 28 ) $ 30,221 U.S. government agency securities 12,830 1 ( 24 ) 12,807 U.S. treasury securities 5,647 — ( 24 ) 5,623 Commercial paper 4,201 — ( 3 ) 4,198 Asset backed securities 3,693 — ( 10 ) 3,683 Total marketable securities $ 56,616 $ 5 $ ( 89 ) $ 56,532 December 31, 2023 Type of Security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 45,686 $ 20 $ ( 53 ) $ 45,653 U.S. government agency securities 4,917 9 ( 5 ) 4,921 Total marketable securities $ 50,603 $ 29 $ ( 58 ) $ 50,574 The net amortized cost and fair value of available-for-sale marketable securities are presented in the following table as of the periods presented by contractual maturity. Actual maturities may differ from contractual maturities because securities may be restructured, called or prepaid, or the Company may intend to sell a security prior to maturity. June 30, 2024 Amortized Cost Fair Value Due to mature: Less than one year $ 51,333 $ 51,265 One year through two years 5,283 5,267 Total $ 56,616 $ 56,532 December 31, 2023 Amortized Cost Fair Value Due to mature: Less than one year $ 49,651 $ 49,618 One year through two years 952 956 Total $ 50,603 $ 50,574 During the three and six months ended June 30, 2024 and 2023 , there were no realized gains or losses on available-for-sale marketable securities. As of June 30, 2024 and December 31, 2023, the Company had six and zero securities, respectively, in a continuous unrealized loss position for more than 12 months and considered all such losses to be temporary in nature. The Company reviewed the securities in the tables above and considered the decline in market value for these securities to be primarily attributable to economic and market conditions. As of the periods noted in the tables above, the Company did not intend to sell these securities and did not believe it was more likely than not that it would be required to sell these securities before recovery of their amortized cost basis. Accordingly, the Company did no t recognize any credit losses related to its marketable securities in an unrealized loss position during any of the periods noted in the table above. As of June 30, 2024 and December 31, 2023 , accrued interest receivables on the Company’s available-for-sale marketable securities were $ 478 and $ 485 , respectively, and were included within other current assets as presented on its Condensed Consolidated Balance Sheets. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following table summarizes the Company's financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy, as follows: Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total June 30, 2024 Financial assets: Cash equivalents Money market funds $ 11,971 $ — $ — $ 11,971 Marketable securities Corporate bonds — 30,221 — 30,221 Marketable securities U.S. government agency securities — 12,807 — 12,807 Marketable securities U.S. treasury securities — 5,623 — 5,623 Marketable securities Commercial paper — 4,198 — 4,198 Marketable securities Asset backed securities — 3,683 — 3,683 Total assets $ 11,971 $ 56,532 $ — $ 68,503 Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total December 31, 2023 Financial assets: Cash equivalents Money market funds $ 30,404 $ — $ — $ 30,404 Marketable securities Corporate bonds — 45,653 — 45,653 Marketable securities U.S. government agency securities — 4,921 — 4,921 Total assets $ 30,404 $ 50,574 $ — $ 80,978 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | 5. Leases The Company entered into a lease for office space in New Haven, Connecticut, effective March 1, 2013, and entered into a First Amendment (the “First Amendment”) to such lease on December 5, 2017 and a Second Amendment (the “Second Amendment”) to such lease on November 21, 2022 (collectively, the “Office Space Lease”). The leased space approximated 5,600 square feet and, prior to the Second Amendment, the Office Space Lease had a term of 60 months expiring on February 28, 2023 . Under the First Amendment, the Company was required to make monthly payments ranging from approximately $ 10 to $ 12 through February 1, 2023 and received two designated months of free rent. As a result of the Company entering into the Second Amendment, the leased space increased to 12,500 square feet effective in March 2023 and the term for the Office Space Lease was extended for an additional 60 months from its prior termination date, until February 28, 2028 . The Second Amendment requires monthly payments ranging from approximately $ 23 to $ 32 effective in March 2023 through February 2028 . The first year of payments are based on 10,500 square feet of occupied space, the second year of payments are based on 11,500 square feet of occupied space and the remaining lease payments are based on 12,500 square feet of occupied space. In December 2022, the Company entered into a 24 month lease for the financing of the furniture installed in the Company’s new office space. The furniture lease requires monthly payments of approximately $ 11 starting in March 2023. The Company also entered into an immaterial office equipment lease during 2022 that has a term of 36 months. The following table presents the Company's lease-related assets and liabilities as presented on its Condensed Consolidated Balance Sheets: Classification on the Condensed Consolidated Balance Sheet June 30, 2024 December 31, 2023 Assets: Operating lease assets Operating lease right-of-use assets $ 1,029 $ 1,137 Finance lease assets Finance lease right-of-use assets 181 206 Total lease assets $ 1,210 $ 1,343 Liabilities: Current Operating lease liabilities Operating lease liabilities, current portion $ 216 $ 184 Finance lease liabilities Finance lease liabilities, current portion 93 122 Non-current Operating lease liabilities Operating lease liabilities, non-current portion 884 1,001 Finance lease liabilities Finance lease liabilities, non-current portion — 31 Total lease liabilities $ 1,193 $ 1,338 The following table presents information related to the Company's lease expense for the periods shown: Three Months Ended Six Months Ended 2024 2023 2024 2023 Operating lease expense $ 85 $ 85 $ 170 $ 117 Finance lease expense 12 12 24 12 Total lease expense $ 97 $ 97 $ 194 $ 129 Future minimum lease payments from June 30, 2024 until the expiration of the leases are as follows: Operating Leases Finance Leases 2024 $ 156 $ 63 2025 349 32 2026 368 — 2027 377 — 2028 95 — Total minimum lease payments 1,345 95 Less: Amount of lease payments representing interest ( 245 ) ( 2 ) Present value of future minimum lease payments $ 1,100 $ 93 The following table presents certain information related to the lease terms and discount rates for the Company's leases: June 30, 2024 December 31, 2023 Weighted average remaining lease term: Operating leases 3.8 years 4.3 years Finance leases 0.8 years 1.3 years Weighted average discount rate: Operating leases 11.00 % 11.00 % Finance leases 4.37 % 4.37 % The following table presents supplemental cash flow information related to the Company's leases for the periods shown: Three Months Ended Six Months Ended 2024 2023 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 69 $ 69 $ 138 $ 93 Finance lease payments $ 32 $ 32 $ 63 $ 32 Supplemental non-cash information: Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ — $ — $ 1,289 Right-of-use assets obtained in exchange for new finance lease liabilities $ — $ — $ — $ 242 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following: June 30, 2024 December 31, 2023 Accrued R&D projects $ 2,690 $ 1,579 Accrued compensation and benefits 1,503 1,614 Accrued consulting and professional fees 704 510 Accrued other 35 6 Total accrued expenses $ 4,932 $ 3,709 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Debt | 7. Debt Silicon Valley Bank Term Loan On May 9, 2023, the Company paid the remaining amount due under the SVB Loan Agreement, resulting in the full extinguishment of the SVB Term Loan (as defined below). As a result, after May 9, 2023, the Company had no outstanding debt. The total payoff amount was $ 6.5 million, consisting of the remaining principal amount due of $ 5.2 million, the final payment fee of $ 1.2 million, and $ 0.1 million of accrued interest and prepayment premium. During the year ended December 31, 2023, an immaterial effect from early extinguishment of debt was recorded in connection with the Company paying the remaining amounts due under the SVB Loan Agreement, which was included in other income, net on the Company’s Condensed Consolidated Statement of Comprehensive Loss. On August 13, 2020 (the “Effective Date”), the Company entered into a loan and security agreement (the “SVB Loan Agreement”) with Silicon Valley Bank (“SVB”), as lender, pursuant to which SVB provided a term loan to the Company in the original principal amount of $ 14.0 million (the “SVB Term Loan”). The SVB Term Loan bore interest at a floating rate per annum equal to the greater of (A) the prime rate plus 1.00 % and (B) 4.25 %. If SVB received evidence satisfactory to it that the Company had (i) received positive data for the Phase 2b/3 clinical trial of Haduvio sufficient to advance Haduvio into a second Phase 3 clinical trial for prurigo nodularis, and (ii) raised sufficient financing to fund such Phase 3 clinical trial and the Company’s operations, (together, the “Phase 3 Event”), the interest rate under the SVB Term Loan would have been adjusted to a floating rate equal to the greater of (A) the prime rate plus 3.00 % and (B) 6.25 % (see term loan derivative liability discussion below). Commencing on March 1, 2022 and on the first business day of each month thereafter, the Company was required to make monthly interest payments and to repay the SVB Term Loan in 24 consecutive installments of principal plus monthly payments of accrued interest. All outstanding principal and accrued and unpaid interest under the SVB Term Loan and all other outstanding obligations with respect to the SVB Term Loan were due and payable in full on February 1, 20 24 . The SVB Loan Agreement permitted voluntary prepayment of all, but not less than all, of the SVB Term Loan, subject to a prepayment premium. Such prepayment premium would have been 3.00 % of the principal amount of the SVB Term Loan if prepaid prior to the first anniversary of the Effective Date, 2.00 % of the principal amount of the SVB Term Loan if prepaid on or after the first anniversary of the Effective Date but prior to the second anniversary of the Effective Date, and 1.00 % of the principal amount of the SVB Term Loan if prepaid on or after the second anniversary of the Effective Date but prior to February 1, 2024 . Upon repayment in full of the SVB Term Loan, the Company was required to pay a final payment fee equal to $ 1.2 million. The SVB Term Loan and related obligations under the SVB Loan Agreement were secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property (which was subject to a negative pledge under the SVB Loan Agreement). On July 6, 2021, the Company and SVB entered into a First Amendment (the “Loan Amendment”) to the SVB Loan Agreement. The Loan Amendment modified the conditions under which the Company was required to cash collateralize all outstanding amounts owed to SVB under the SVB Loan Agreement. Under the Loan Amendment, if the Company failed to receive positive data in its Phase 2b/3 PRISM trial or to raise by June 30, 2022 sufficient net proceeds from the sale of equity securities to finance its planned second Phase 3 clinical trial of Haduvio for prurigo nodularis and its ongoing operations (each a “Milestone Condition”), the Company would have been required to deposit unrestricted and unencumbered cash equal to 100 % of all outstanding amounts owed to SVB in a cash collateral account with SVB, which could have been used by SVB to prepay the SVB Term Loan at any time. In addition, the Loan Amendment provided that if the Company failed to maintain at least $ 20.0 million in unrestricted and unencumbered cash in its accounts with SVB at any time prior to the satisfaction of all the Milestone Conditions (the “Minimum Required Cash”), the Company would have been required to cash collateralize all outstanding amounts owed to SVB under the SVB Loan Agreement. The Company would also have been required to cash collateralize all outstanding amounts owed to SVB under the SVB Loan Agreement if it did not raise at least $ 15.0 million in net proceeds from the sale of equity securities during the period from June 1, 2021 through October 31, 2021. The Company satisfied this equity funding condition through a combination of equity issuances under the Company’s at-the-market sales agreement entered into with SVB Securities LLC (formerly SVB Leerink LLC) (“SVB Securities”) in June 2020 (the “ATM Sales Agreement”) and two private placements, which took place in October 2021 (see Note 8). On April 6, 2022, the Company and SVB entered into a Third Amendment (the “Third Amendment”) to the SVB Loan Agreement. The Third Amendment principally modified the conditions under which the Company would have been required to cash collateralize all outstanding amounts owed to SVB under the SVB Loan Agreement. Under the terms of the Third Amendment, if the Company raised $ 45.0 million in net proceeds from the sale of equity securities (the “2022 Equity Event”), the Company’s obligations to achieve the Milestone Conditions and maintain the Minimum Required Cash would have terminated and the sole remaining trigger for cash collateralization would have been if the Company did not receive positive final data by December 31, 2022 from either its Phase 2b/3 PRISM trial of Haduvio for prurigo nodularis or its Phase 2 CANAL trial of Haduvio for the treatment of chronic cough in IPF. In addition, the Third Amendment modified the interest rate on the principal amount outstanding under the SVB Loan Agreement. As a result of the Third Amendment, amounts outstanding under the SVB Loan Agreement accrued interest at a floating per annum rate equal to (i) prior to the occurrence of the 2022 Equity Event, the greater of (A) the prime rate plus 1.00 % and (B) 4.25 %, and (ii) upon and after the occurrence of the 2022 Equity Event, the greater of (A) the prime rate plus 3.00 % and (B) 6.25 %. The closing of the April 2022 Private Placement, as discussed in Note 8 below, constituted the 2022 Equity Event and thereby terminated the Company’s obligations to achieve the Milestone Conditions and maintain the Minimum Required Cash. On August 3, 2022, SVB confirmed that the reported data from the Phase 2b/3 PRISM trial satisfied the requirement for positive final data and that the cash collateralization requirements of the SVB Loan Agreement were no longer in effect. The SVB Loan Agreement contained customary representations, warranties, events of default and covenants. The occurrence and continuation of an event of default could have caused interest to be charged at the rate that was otherwise applicable plus 5.00 % (unless SVB elected to impose a smaller increase) and would have provided SVB with the right to accelerate all obligations under the SVB Loan Agreement and exercise remedies against the Company and the collateral securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including foreclosure against assets securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including the Company’s cash. The SVB Loan Agreement also restricted the payment of dividends on the Company’s common stock. Interest expense on the SVB Term Loan, which was comprised of interest payments, accretion and amortization of term loan discounts and the accrual of the final payment fee, is shown below for the three and six months ended June 30, 2023. For the three and six months ended June 30, 2023 , the weighted average interest rate applicable to borrowings under the SVB Term Loan was 9.45 % and 10.25 %, respectively. For the three and six months ended June 30, 2024 , there was no interest expense on the SVB Term Loan as the loan was fully extinguished in May 2023. Three Months Ended Six Months Ended 2023 2023 Interest payments $ 53 $ 202 Accrual of the final payment fee 91 150 Accretion and amortization of term loan discounts 7 30 $ 151 $ 382 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity The Company had reserved shares of common stock for future issuance as shown in the table below: June 30, December 31, Shares of common stock reserved for future issuance upon exercise of outstanding warrants and pre-funded warrants 38,257,447 40,931,506 Shares of common stock reserved for future issuance under the 2019 Stock Incentive Plan 8,684,716 6,549,183 Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan 1,146,781 1,177,456 Shares of common stock reserved for future issuance under the 2012 Stock Incentive Plan 406,364 565,792 48,495,308 49,223,937 At-the-Market Offering In June 2020, the Company entered into the ATM Sales Agreement with SVB Securities under which the Company was able to issue and sell shares of its common stock, from time to time, having an aggregate offering price of up to $ 12.0 million. In May 2022, the Company and SVB Securities amended the ATM Sales Agreement to increase the maximum aggregate offering price of common stock that it was able to issue and sell from time to time under the ATM Sales Agreement by $ 50.0 million, from $ 12.0 million to up to $ 62.0 million. Sales of common stock under the ATM Sales Agreement were able to be made by any method that was deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"). The Company was not obligated to make any sales of its common stock under the ATM Sales Agreement. The Company began making sales pursuant to the ATM Sales Agreement in July 2020. As of August 15, 2023, the date of termination of the ATM Sales Agreement, the Company had issued and sold an aggregate of 4,333,394 shares of common stock for gross proceeds of $ 12.7 million pursuant to the ATM Sales Agreement, before deducting estimated commissions and allocated fees of $ 1.0 million. In June 2023, the Company filed with the SEC a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”), which allows the Company to offer and sell up to $ 200 .0 million of common stock, preferred stock, debt securities, units and/or warrants from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale. The Shelf Registration Statement was filed to replace the Company’s prior universal shelf registration statement on Form S-3 and was declared effective on August 15, 2023. Further, in June 2023, the Company entered into a new at-the-market sales agreement with Leerink Partners, LLC (formerly SVB Securities) (the “2023 ATM Sales Agreement”), under which the Company may issue and sell shares of common stock, from time to time by any method that is deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act. The Company is not obligated to make any sales of its common stock under the 2023 ATM Sales Agreement. The Company filed a prospectus under the Shelf Registration Statement for the offer and sale of shares of the Company’s common stock having an aggregate offering price of up to $ 75.0 million pursuant to the 2023 ATM Sales Agreement. In accordance with the terms of the 2023 ATM Sales Agreement, the ATM Sales Agreement terminated upon effectiveness of the Shelf Registration Statement, at which point the Company was no longer able to issue and sell shares of its common stock under the ATM Sales Agreement. As of June 30, 2024, the Company had issued and sold 1,474,926 shares of common stock under the 2023 ATM Sales Agreement for gross proceeds of $ 5.0 million, before deducting estimated commissions and allocated fees of $ 0.2 million. Private Placements On October 5, 2021, the Company issued and sold to an initial investor, in a private placement priced at-the-market under Nasdaq rules, (i) 2,373,201 shares of the Company’s common stock and accompanying warrants to purchase an aggregate of 4,746,402 shares of the Company’s common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 4,926,069 shares of the Company’s common stock and accompanying warrants to purchase an aggregate of 9,852,138 shares of the Company’s common stock. Each share of the Company’s common stock and accompanying common stock warrants were sold together at a combined price of $ 1.62 , and each pre-funded warrant and accompanying common stock warrants were sold together at a combined price of $ 1.619 , for gross proceeds of approximately $ 11.8 million. Each pre-funded warrant had an exercise price of $ 0.001 per share, became exercisable immediately upon issuance and was exercisable until exercised in full. The accompanying common stock warrants have an exercise price of $ 1.37 per share and became exercisable immediately upon issuance. Of the accompanying common stock warrants, warrants to purchase an aggregate of 7,299,270 shares had an expiration date of April 5, 2025 , and warrants to purchase an aggregate of 7,299,270 shares had an expiration date of October 5, 2028 . All of the accompanying common stock warrants expiring on April 5, 2025 have been exercised and accompanying common stock warrants to purchase 1,299,270 shares expiring on October 5, 2028 have been exercised. On October 18, 2021, the Company issued and sold to New Enterprise Associates 16, L.P., an existing stockholder of the Company (“NEA”) and related party, in a private placement, 1,851,852 shares of the Company’s common stock and accompanying warrants to purchase an aggregate of 3,703,704 shares of the Company’s common stock. Each share of the Company’s common stock and accompanying common stock warrants were sold together at a combined price of $ 1.62 for gross proceeds of approximately $ 3.0 million. The accompanying common stock warrants have an exercise price of $ 1.37 per share and became exercisable immediately upon issuance. Of the accompanying common stock warrants, warrants to purchase an aggregate of 1,851,852 shares of the Company’s common stock will expire on April 18, 2025 , and warrants to purchase an aggregate of 1,851,852 shares of the Company’s common stock will expire on October 18, 2028 . None of the accompanying common stock warrants issued to NEA in the private placement have been exercised. Total net proceeds from the two October 2021 private placements were $ 13.7 million, after deducting issuance costs of $ 1.1 million . On April 6, 2022, the Company entered into a securities purchase agreement with certain purchasers, pursuant to which the Company agreed to issue and sell to the purchasers, in a private placement priced at-the-market under Nasdaq rules, (i) 4,580,526 shares of the Company’s common stock at a purchase price of $ 1.90 per share, and (ii) pre-funded warrants to purchase up to an aggregate of 24,379,673 shares of common stock at a purchase price of $ 1.899 per warrant (the “April 2022 Private Placement”). Each pre-funded warrant has an exercise price of $ 0.001 per share, became exercisable immediately upon issuance and will be exercisable until the pre-funded warrant is exercised in full. The April 2022 Private Placement, which closed on April 11, 2022, resulted in gross proceeds to the Company of approximately $ 55.0 million. NEA, an existing stockholder of the Company and a related party, as well as an affiliate of NEA, participated in the offering. Public Offering On September 27, 2022, the Company issued and sold 14,252,670 shares of the Company’s common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 14,247,330 shares of common stock in a public offering (the “September 2022 Offering”), at a public offering price of $ 1.93 per share of common stock and $ 1.929 per pre-funded warrant pursuant to an underwriting agreement (the “Underwriting Agreement”) with SVB Securities, Stifel, Nicolaus & Company, Incorporated and Oppenheimer & Co. Inc., as representatives of the several underwriters (the “Underwriters”). Each pre-funded warrant has an exercise price of $ 0.001 per share, became exercisable immediately upon issuance and will be exercisable until the pre-funded warrant is exercised in full. Under the terms of the Underwriting Agreement, the Company granted the Underwriters an option (the “Option”), exercisable for 30 days, to purchase up to an additional 4,275,000 shares of common stock (the “Additional Shares”), at the public offering price of $ 1.93 per share. The Underwriters partially exercised the Option to purchase 1,600,428 Additional Shares, which shares were issued and sold on October 25, 2022. The September 2022 Offering, including the initial closing on September 27, 2022 and the Option closing on October 25, 2022, resulted in aggregate gross proceeds to the Company of approximately $ 58.1 million. Warrants Warrant activity, including activity related to pre-funded warrants, is shown in the table below: Number of Number of Total Number of Weighted Outstanding as of December 31, 2023 31,227,802 9,703,704 40,931,506 $ 0.33 Exercised ( 2,674,059 ) — ( 2,674,059 ) $ 0.001 Outstanding as of June 30, 2024 28,553,743 9,703,704 38,257,447 $ 0.35 The pre-funded and common stock warrants are classified as equity in accordance with ASC 815 given that the pre-funded and common stock warrants are indexed to the Company’s own shares of common stock and meet the requirements to be classified in permanent equity. Stock-Based Awards The 2012 Stock Incentive Plan (the “2012 Plan”) was adopted by the Company’s board of directors and stockholders. The 2012 Plan provides for the issuance of stock-based awards to the Company’s employees, officers, directors, consultants and advisors. The Company’s board of directors administers the 2012 Plan. In April 2019, the Company’s board of directors adopted a resolution effective May 7, 2019, that no further equity-based awards may be granted under the 2012 Plan. In April 2019, the Company’s board of directors adopted the 2019 Stock Incentive Plan (the “2019 Plan”), which became effective on May 7, 2019. The 2019 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 Company’s employees, officers, directors, consultants and advisors are eligible to receive awards under the 2019 Plan. The 2019 Plan is administered by the Company’s board of directors. The total number of shares of common stock that may be issued under the 2019 Plan and the 2012 Plan w as 9,091,080 as of June 30, 2024, of which 1,129,376 shares remained available for grant under the 2019 Plan. Awards may be made under the 2019 Plan for up to such number of shares of the Company’s common stock as is equal to the sum of: i) 1,578,947 shares; plus ii) the number of shares (up to 1,157,894 shares) of the Company’s common stock subject to outstanding awards under the 2012 Plan that expire, terminate or are otherwise cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus iii) an annual increase to be added on the first day of each fiscal year, beginning with 2020 and continuing through 2029, equal to the least of (a) 2,105,623 shares of common stock, (b) 4 % of the number of outstanding shares of the Company’s common stock on such date, and (c) an amount determined by the Company’s board of directors. Effective January 1, 2024 and January 1, 2023, the number of shares reserved for issuance under the 2019 Plan increased, pursuant to the terms of the 2019 Plan, by an additional 2,105,623 shares in each case, equal to the 2019 Plan determined maximum for each year. Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years . Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25 % vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four years. Options granted to directors generally vest over one to two years . The Company generally settles stock option exercises with newly issued shares of common stock. As of June 30, 2024 and December 31, 2023, respectively, options to purchase 7,555,340 shares and 4,746,508 shares of common stock were granted and outstanding, net of cancellations, under the 2019 Plan. As of June 30, 2024 and December 31, 2023, respectively, options to purchase 406,364 and 565,792 shares of common stock were granted and outstanding, net of cancellations, under the 2012 Plan. In February 2024, the Company granted options to purchase 832,250 shares of common stock subject to performance-based vesting (“PSOs”) to employees of the Company. The PSOs granted in February 2024 vest based on the timing and results of the Company’s clinical trials. A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan is as follows: Number of Weighted Outstanding as of December 31, 2023 5,312,300 $ 3.24 Granted 2,846,750 $ 2.45 Exercised ( 129,518 ) $ 1.68 Expired ( 67,828 ) $ 2.63 Forfeited — $ — Outstanding as of June 30, 2024 7,961,704 $ 2.98 Options exercisable as of June 30, 2024 3,488,041 $ 3.83 Options unvested as of June 30, 2024 4,473,663 $ 2.33 In April 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (the “2019 ESPP”), which became effective on May 7, 2019. The 2019 ESPP is administered by the Company’s board of directors. The total number of shares of common stock that may be issued under the 2019 ESPP was 1,146,781 as of June 30, 2024 , all of which remain available for issuance. The number of shares of the Company’s common stock that have been approved to be issued under the 2019 ESPP is equal to the sum of i) 155,106 shares plus ii) an annual increase to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2020 and continuing for each fiscal year until and including, the fiscal year ending December 31, 2029, equal to the least of (a) 526,315 shares of common stock, (b) 1 % of the number of outstanding shares of the Company’s common stock on such date and (c) an amount determined by the Company’s board of directors. Effective January 1, 2023 , the aggregate number of shares of the Company’s common stock that may be issued under the 2019 ESPP increased, pursuant to the terms of the 2019 ESPP, by an additional 526,315 shares, equal to the 2019 ESPP determined maximum for the year. No increase was made on January 1, 2024. The following table summarizes the classifications of stock-based compensation expenses for the 2012 Plan, the 2019 Plan and the 2019 ESPP recognized in the Condensed Consolidated Statements of Comprehensive Loss: Three Months Ended Six Months Ended 2024 2023 2024 2023 General and administrative expense $ 645 $ 372 $ 1,070 $ 737 Research and development expense 482 234 780 446 Total stock-based compensation expenses $ 1,127 $ 606 $ 1,850 $ 1,183 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes As of June 30, 2024 and December 31, 2023, the Company maintained a full valuation allowance on deferred tax assets. The income tax benefit recorded during the three and six months ended June 30, 2024 and 2023 was for the Company ’ s estimates for its state research and development tax credits in each given year. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 10. Net Loss per Share The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended Six Months Ended 2024 2023 2024 2023 Net loss $ ( 12,352 ) $ ( 7,145 ) $ ( 23,254 ) $ ( 13,546 ) Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 101,041,573 98,698,579 100,279,393 98,654,868 Basic and diluted net loss per common share outstanding $ ( 0.12 ) $ ( 0.07 ) $ ( 0.23 ) $ ( 0.14 ) Basic shares outstanding includes the weighted average effect of the Company’s pre-funded warrants from the date of issuance, the exercise of which requires little or no consideration for the delivery of shares of common stock. As of June 30, 2024 and December 31, 2023, the Company had pre-funded warrants to purchase 28,553,743 and 31,227,802 shares of common stock outstanding, respectively, which were issued in the April 2022 Private Placement and the September 2022 Offering, which warrants are included in the weighted average common shares used in calculating the net loss per share attributable to common stockholders, basic and diluted, for the three and six months ended June 30, 2024 and 2023, respectively. The Company’s potential dilutive securities, which include stock options and warrants that are not pre-funded, have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, 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 following potential common shares, presented based on shares outstanding as of June 30, 2024 and 2023, respectively, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Shares as of June 30, 2024 2023 Warrants 9,703,704 9,703,704 Stock Options 7,961,704 5,384,564 Total potential common shares 17,665,408 15,088,268 |
Collaborative and Licensing Agr
Collaborative and Licensing Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative and Licensing Agreements | 11. Collaborative and Licensing Agreements The Company enters into collaborative and licensing agreements with pharmaceutical companies to in-license, develop, manufacture and/or market products that fit within its business strategy. Endo Pharmaceuticals Inc. In May 2011, the Company entered into an agreement with Penwest Pharmaceuticals Co., which subsequently merged into its parent, Endo Pharmaceuticals Inc. (“Endo”), for an exclusive worldwide sublicensable license under certain patent rights and know-how controlled by Endo to develop and commercialize products incorporating nalbuphine hydrochloride in any formulation, including an extended-release formulation such as Haduvio, in all fields and for any use. Under the license agreement, the Company paid Endo a non-creditable, non-refundable upfront license fee. The Company may also become obligated to make milestone payments to Endo of $ 0.3 million, which would become due upon the successful completion of the first Phase 3 clinical trial of a licensed product candidate, and $ 0.8 million, which would become due upon the marketing approval of a licensed product in the U.S., and to pay royalties based on net sales of the licensed products by the Company, its affiliates and sublicensees. In addition, the Company is obligated to pay Endo a low-to-mid double-digit percentage of certain income it receives from sublicensees, based on the date of the definitive agreement under which the sublicense was granted. The Company’s royalty obligation with respect to each licensed product in each country commences upon the first commercial sale of the product in that country and extends until the later of the expiration, unenforceability or invalidation of the last valid claim of any licensed patent or application covering the licensed product in the country or the expiration of 10 years after the first commercial sale of the licensed product in the country, which period is referred to as the royalty term. Upon the expiration of the royalty term for a product in a country , the Company is thereafter obligated to pay a low single-digit know-how and trademark royalty. Under the agreement, the Company has granted Endo a non-exclusive, royalty-free (except for pass-through payments to third parties), sublicensable license under its relevant patent rights to use any improvement the Company makes to Endo’s controlled release technology for any product other than the products under which it is licensed by Endo. Both the Company and Endo have the right to terminate the agreement if the other party materially breaches the agreement and fails to cure the breach within specified cure periods. Endo also has the right to terminate in the event the Company undergoes specified bankruptcy, insolvency or liquidation events. The Company has the right to terminate the agreement at its convenience at any time on 180 days’ notice to Endo. Additionally, if the Company or any of the Company’s sublicensees challenge the validity or enforceability of any licensed patent rights covering a licensed product and that challenge is not terminated within a specified period, the agreement will immediately terminate and all licenses granted under the agreement shall be revoked. Upon termination of the agreement, the Company must transfer to Endo all regulatory filings and approvals relating to the development, manufacture or commercialization of the licensed products and all trademarks, other than the Company’s corporate trademarks, then being used in connection with the licensed products. If the agreement is terminated under certain specified circumstances, the Company will be deemed to have granted Endo a perpetual, royalty-free (except for pass-through payments to third parties), worldwide, exclusive, sublicensable license under any improvements the Company made to the licensed know-how and any related patent rights the Company has to manufacture and commercialize the licensed products. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies A significant portion of the Company’s development activities are outsourced to third parties under agreements, including with CROs and contract manufacturers in connection with the production of clinical trial materials. These arrangements may require the Company to pay termination costs to the third parties for reimbursement of costs and expenses incurred in the event of the orderly termination of contractual services. The Company also has commitments under lease and licensing agreements (Note 5 and Note 11). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim Condensed Consolidated Financial Statements for the three and six months ended June 30, 2024 and 2023 included herein have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim information. Certain information and footnote disclosures typically prepared in accordance with GAAP have been condensed or omitted pursuant to SEC rules and regulations. The accompanying unaudited Condensed Consolidated Financial Statements and notes should be read in conjunction with the audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The accompanying Condensed Consolidated Financial Statements include the accounts of Trevi Therapeutics, Inc. and its wholly-owned subsidiary Trevi Therapeutics Limited. Intercompany balances and transactions have been eliminated. All amounts presented are in thousands of dollars, except share and per share amounts, unless noted otherwise. The Company has evaluated events occurring subsequent to June 30, 2024 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure . |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Condensed Consolidated Financial Statements include but are not limited to the recognition of research and development (“R&D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim Condensed Consolidated Balance Sheet as of June 30, 2024 and the Condensed Consolidated Statements of Comprehensive Loss, the Condensed Consolidated Statements of Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three and six months ended June 30, 2024 and 2023 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 Company’s opinion, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statements of its financial position as of June 30, 2024 and the results of its operations and its cash flows for the three and six months ended June 30, 2024 and 2023. The results for the three and six months ended June 30, 2024 and 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2024 or any other interim period or any future year or period. |
Cash Equivalents | Cash Equivalents The Company classifies short-term, highly liquid investments with an original term of three months or less at the date of purchase as cash equivalents. |
Marketable Securities | Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short- to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents or marketable securities on the Condensed Consolidated Balance Sheets. Marketable securities with an original maturity date greater than 90 days at each balance sheet date are classified as short-term. Marketable securities are classified as current assets as these investments are intended to be available to the Company for use in funding current operations. All of the Company’s marketable securities are considered available-for-sale and are reported at fair value. For securities with unrealized gains and losses, when the Company expects to receive cash flows sufficient to recover the amortized cost basis of a security, such gains and losses are included in accumulated other comprehensive income as a component of stockholders’ equity. Credit losses are identified when the Company does not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. Realized gains and losses, if any, on marketable securities are included in interest income, net on the Condensed Consolidated Statements of Comprehensive Loss. The cost of securities sold is determined using specific identification. The Company evaluates whether declines in the fair values of its marketable securities below their amortized cost are credit losses on a quarterly basis. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss, as well as the Company’s ability and intent to hold the marketable security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the marketable security or whether it is more likely than not that it will be required to sell any marketable securities before recovery of its amortized cost basis. Factors considered include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company’s strategy and intentions for holding the marketable security. |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments have consisted of cash and cash equivalents, available-for-sale marketable securities, other current assets, accounts payable, accrued expenses, term loans and warrants to acquire the Company’s common stock. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. The carrying amounts of cash and cash equivalents, other current assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Available-for-sale marketable securities are reported at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below. The warrants to acquire the Company’s common stock are not required to be accounted for at fair value. Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect market assumptions and are classified into the following fair value hierarchy: Level 1—Observable inputs—quoted prices in active markets for identical assets and liabilities. Level 2—Observable inputs other than the quoted prices in active markets for identical assets and liabilities—such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data. Level 3—Unobservable inputs—includes amounts derived from valuation models where one or more significant inputs are unobservable and require the company to develop relevant assumptions. Valuation Techniques - Level 2 Inputs The Company estimates the fair values of its financial instruments categorized as level 2 in the fair value hierarchy, including U.S. treasury securities, U.S. government agency obligations, corporate bonds, commercial paper, asset-backed securities and municipal bonds, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service. |
Property, Equipment and Leasehold Improvements | Property, Equipment and Leasehold Improvements Property, equipment and leasehold improvements (consisting of furniture, computer and office equipment and leasehold improvements) are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets ( three years for computer equipment, five years for furniture and office equipment, and the shorter of the term of the lease or useful life for leasehold improvements). |
Foreign Currency Transactions | Foreign Currency Transactions The Company, at times, contracts with vendors and consultants outside of the U.S., resulting in liabilities denominated in foreign currency. The transactions are recorded in U.S. dollars on the transaction dates and any currency fluctuation through the payment date is recorded as currency gains or losses in other income, net in the Condensed Consolidated Statements of Comprehensive Loss. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the financings. Should the planned equity financing no longer be considered probable of being consummated, the deferred offering costs are expensed immediately as a charge to general and administrative expenses. The deferred offering costs are included in Other current and non-current assets on the Condensed Consolidated Balance Sheets. |
Research and Development ("R&D") Expenses | Research and Development (“R&D”) Expenses All of the Company’s R&D expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include certain payroll and personnel expenses, including stock-based compensation, consulting costs, contract manufacturing costs and fees paid to contract research organizations (“CROs”) to conduct certain R&D activities on the Company’s behalf. The Company expenses both internal and external R&D expenses as they are incurred. |
Accrued R&D Expenses | Accrued R&D Expenses The Company has entered into agreements with CROs, contract manufacturing organizations (“CMOs”) and other companies that provide services in connection with the Company’s R&D activities. The Company’s R&D accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events and contracted costs. The estimated costs of R&D provided, but not yet invoiced, are included in accrued expenses on the Condensed Consolidated Balance Sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs, CMOs and other companies under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or as other non-current assets, as applicable, and are recognized as expenses as the goods are delivered or the related services are performed. |
Patent Costs | Patent Costs All patent-related costs in connection with filing and prosecuting patent applications are expensed to general and administrative expense as incurred, as recoverability of such expenditures is uncertain. |
Warrants | Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and then in accordance with ASC 815, Derivatives and Hedging (“ASC 815”), depending on the specific terms of the warrant. Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If the warrants do not meet liability classification under ASC 480, the Company assesses the requirements under ASC 815, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of comprehensive loss as a gain or loss. For equity classified warrants, no changes in fair value are recognized after the issuance date. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation arrangements with employees and non-employees for consultancy services in accordance with ASC 718, Stock Compensation (“ASC 718”). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock-based awards including stock options. The Company’s determination of the fair value of stock-based awards on the date of grant utilizes the Black-Scholes valuation model for stock options with time-based and performance-based vesting and is impacted by the price of its common stock as well as changes in assumptions regarding a number of subjective variables. These variables include the expected term that stock options will remain outstanding, expected common stock price volatility over the term of the stock options, risk-free interest rates and expected dividends. Changes in the variables can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require analysis and judgment to develop. Expected Term—The expected term assumption represents the weighted average period that the stock-based awards are expected to be outstanding. The Company has elected to use the “simplified method” for estimating the expected term of its stock options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the stock option. Expected Volatility—For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer companies. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. Expected Dividend—The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company currently has no history or expectation of paying cash dividends on its common stock. Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to the expected term of the stock-based award. The fair value is recognized over the period during which an optionee is required to provide services in exchange for the stock option, known as the requisite service period (usually the vesting period) on a straight-line basis. For performance-based vesting, the fair value is recognized when it is probable the performance conditions will be achieved. The Company reassesses the probability of achieving the performance conditions at each reporting date. Forfeitures are accounted for as they occur. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized. The Company applies the provisions of ASC 740, Income Taxes , which prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return. These Condensed Consolidated Financial Statements reflect expected future tax consequences of such positions presuming the taxing authorities possess full knowledge of the position and all relevant facts. There are no material uncertainties regarding the tax positions that the Company has taken through June 30, 2024 and December 31, 2023 . The Company does not have any interest or penalties accrued related to tax positions as it does not have any unrecognized tax benefits. |
Leases | Leases Under ASC 842, Leases , the Company determines if an arrangement is a lease at its inception. Leases are classified as either operating or finance, based on the Company’s evaluation of certain criteria. If a lease has a term greater than one year, the lease is recognized in the balance sheet as a right-of-use asset and a lease liability at lease commencement. The Company elected the short-term lease practical expedient, therefore, if a lease has a term less than one year, the Company will not recognize the lease on its balance sheet. The right-of-use asset represents the Company’s right of use to an underlying asset for the term of the lease and the lease liability represents the Company’s obligation to make lease payments arising from the lease. If the Company’s leases do not provide an implicit rate within the lease, the Company uses its incremental borrowing rate, based on information available at the commencement date of the lease to determine the present value of the lease payments. Operating lease right-of-use assets and operating lease liabilities are determined and recognized on the commencement date of the lease based on the present value of lease payments over the term of the lease. For operating leases, rent expense is recognized on a straight-line basis over the term of the lease, and right-of-use assets are subsequently re-measured to reflect the effect of uneven lease payments. For finance leases, right-of-use assets are amortized on a straight-line basis over the shorter of the lease term or the useful life of the underlying asset. Expenses for finance leases include the amortization of right-of-use assets, which is recorded as depreciation and amortization expense, and interest expense, which reflects interest accrued on the lease liability. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average common shares outstanding during the period. Basic shares outstanding includes the weighted average effect of the Company’s outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock. For all periods presented, shares issuable upon exercise of stock options and warrants to purchase shares of common stock (other than pre-funded warrants) have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per share are the same for each of the periods presented. |
Segments | Segments The Company has one reporting segment which is also the Company’s only operating segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. All long-lived assets are maintained in the U.S. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements There have been no new pronouncements adopted during the six months ended June 30, 2024. Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280, Segment Reporting , on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments Debt And Equity Securities [Abstract] | |
Schedule of Fair Value And Amortized Cost Of Available-for-sale Marketable Securities | The fair value and amortized cost of available-for-sale marketable securities by major security type are presented in the following tables as of the periods presented: June 30, 2024 Type of security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 30,245 $ 4 $ ( 28 ) $ 30,221 U.S. government agency securities 12,830 1 ( 24 ) 12,807 U.S. treasury securities 5,647 — ( 24 ) 5,623 Commercial paper 4,201 — ( 3 ) 4,198 Asset backed securities 3,693 — ( 10 ) 3,683 Total marketable securities $ 56,616 $ 5 $ ( 89 ) $ 56,532 December 31, 2023 Type of Security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 45,686 $ 20 $ ( 53 ) $ 45,653 U.S. government agency securities 4,917 9 ( 5 ) 4,921 Total marketable securities $ 50,603 $ 29 $ ( 58 ) $ 50,574 |
Summary Of Contractual Maturities Of Available-for-sale Marketable Securities | The net amortized cost and fair value of available-for-sale marketable securities are presented in the following table as of the periods presented by contractual maturity. Actual maturities may differ from contractual maturities because securities may be restructured, called or prepaid, or the Company may intend to sell a security prior to maturity. June 30, 2024 Amortized Cost Fair Value Due to mature: Less than one year $ 51,333 $ 51,265 One year through two years 5,283 5,267 Total $ 56,616 $ 56,532 December 31, 2023 Amortized Cost Fair Value Due to mature: Less than one year $ 49,651 $ 49,618 One year through two years 952 956 Total $ 50,603 $ 50,574 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Financial Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes the Company's financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy, as follows: Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total June 30, 2024 Financial assets: Cash equivalents Money market funds $ 11,971 $ — $ — $ 11,971 Marketable securities Corporate bonds — 30,221 — 30,221 Marketable securities U.S. government agency securities — 12,807 — 12,807 Marketable securities U.S. treasury securities — 5,623 — 5,623 Marketable securities Commercial paper — 4,198 — 4,198 Marketable securities Asset backed securities — 3,683 — 3,683 Total assets $ 11,971 $ 56,532 $ — $ 68,503 Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total December 31, 2023 Financial assets: Cash equivalents Money market funds $ 30,404 $ — $ — $ 30,404 Marketable securities Corporate bonds — 45,653 — 45,653 Marketable securities U.S. government agency securities — 4,921 — 4,921 Total assets $ 30,404 $ 50,574 $ — $ 80,978 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Schedule of Lease-related Assets and Liabilities | The following table presents the Company's lease-related assets and liabilities as presented on its Condensed Consolidated Balance Sheets: Classification on the Condensed Consolidated Balance Sheet June 30, 2024 December 31, 2023 Assets: Operating lease assets Operating lease right-of-use assets $ 1,029 $ 1,137 Finance lease assets Finance lease right-of-use assets 181 206 Total lease assets $ 1,210 $ 1,343 Liabilities: Current Operating lease liabilities Operating lease liabilities, current portion $ 216 $ 184 Finance lease liabilities Finance lease liabilities, current portion 93 122 Non-current Operating lease liabilities Operating lease liabilities, non-current portion 884 1,001 Finance lease liabilities Finance lease liabilities, non-current portion — 31 Total lease liabilities $ 1,193 $ 1,338 |
Schedule of Information Related to Lease Expense | The following table presents information related to the Company's lease expense for the periods shown: Three Months Ended Six Months Ended 2024 2023 2024 2023 Operating lease expense $ 85 $ 85 $ 170 $ 117 Finance lease expense 12 12 24 12 Total lease expense $ 97 $ 97 $ 194 $ 129 |
Schedule of Future Lease Payments of Leases | Future minimum lease payments from June 30, 2024 until the expiration of the leases are as follows: Operating Leases Finance Leases 2024 $ 156 $ 63 2025 349 32 2026 368 — 2027 377 — 2028 95 — Total minimum lease payments 1,345 95 Less: Amount of lease payments representing interest ( 245 ) ( 2 ) Present value of future minimum lease payments $ 1,100 $ 93 |
Schedule of Information Related to the Lease Terms and Discount Rates of Leases | The following table presents certain information related to the lease terms and discount rates for the Company's leases: June 30, 2024 December 31, 2023 Weighted average remaining lease term: Operating leases 3.8 years 4.3 years Finance leases 0.8 years 1.3 years Weighted average discount rate: Operating leases 11.00 % 11.00 % Finance leases 4.37 % 4.37 % |
Schedule of Supplemental Cash Flow Information Related to Leases | The following table presents supplemental cash flow information related to the Company's leases for the periods shown: Three Months Ended Six Months Ended 2024 2023 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 69 $ 69 $ 138 $ 93 Finance lease payments $ 32 $ 32 $ 63 $ 32 Supplemental non-cash information: Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ — $ — $ 1,289 Right-of-use assets obtained in exchange for new finance lease liabilities $ — $ — $ — $ 242 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: June 30, 2024 December 31, 2023 Accrued R&D projects $ 2,690 $ 1,579 Accrued compensation and benefits 1,503 1,614 Accrued consulting and professional fees 704 510 Accrued other 35 6 Total accrued expenses $ 4,932 $ 3,709 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Components of Interest Expense of Term Loan | Interest expense on the SVB Term Loan, which was comprised of interest payments, accretion and amortization of term loan discounts and the accrual of the final payment fee, is shown below for the three and six months ended June 30, 2023. For the three and six months ended June 30, 2023 , the weighted average interest rate applicable to borrowings under the SVB Term Loan was 9.45 % and 10.25 %, respectively. For the three and six months ended June 30, 2024 , there was no interest expense on the SVB Term Loan as the loan was fully extinguished in May 2023. Three Months Ended Six Months Ended 2023 2023 Interest payments $ 53 $ 202 Accrual of the final payment fee 91 150 Accretion and amortization of term loan discounts 7 30 $ 151 $ 382 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders Equity Note [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | The Company had reserved shares of common stock for future issuance as shown in the table below: June 30, December 31, Shares of common stock reserved for future issuance upon exercise of outstanding warrants and pre-funded warrants 38,257,447 40,931,506 Shares of common stock reserved for future issuance under the 2019 Stock Incentive Plan 8,684,716 6,549,183 Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan 1,146,781 1,177,456 Shares of common stock reserved for future issuance under the 2012 Stock Incentive Plan 406,364 565,792 48,495,308 49,223,937 |
Warrant Activity Including Activity Related To Pre-funded Warrants | Warrants Warrant activity, including activity related to pre-funded warrants, is shown in the table below: Number of Number of Total Number of Weighted Outstanding as of December 31, 2023 31,227,802 9,703,704 40,931,506 $ 0.33 Exercised ( 2,674,059 ) — ( 2,674,059 ) $ 0.001 Outstanding as of June 30, 2024 28,553,743 9,703,704 38,257,447 $ 0.35 |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan is as follows: Number of Weighted Outstanding as of December 31, 2023 5,312,300 $ 3.24 Granted 2,846,750 $ 2.45 Exercised ( 129,518 ) $ 1.68 Expired ( 67,828 ) $ 2.63 Forfeited — $ — Outstanding as of June 30, 2024 7,961,704 $ 2.98 Options exercisable as of June 30, 2024 3,488,041 $ 3.83 Options unvested as of June 30, 2024 4,473,663 $ 2.33 |
Schedule of Stock-based Compensation Expenses Recognized | The following table summarizes the classifications of stock-based compensation expenses for the 2012 Plan, the 2019 Plan and the 2019 ESPP recognized in the Condensed Consolidated Statements of Comprehensive Loss: Three Months Ended Six Months Ended 2024 2023 2024 2023 General and administrative expense $ 645 $ 372 $ 1,070 $ 737 Research and development expense 482 234 780 446 Total stock-based compensation expenses $ 1,127 $ 606 $ 1,850 $ 1,183 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended Six Months Ended 2024 2023 2024 2023 Net loss $ ( 12,352 ) $ ( 7,145 ) $ ( 23,254 ) $ ( 13,546 ) Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 101,041,573 98,698,579 100,279,393 98,654,868 Basic and diluted net loss per common share outstanding $ ( 0.12 ) $ ( 0.07 ) $ ( 0.23 ) $ ( 0.14 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potential common shares, presented based on shares outstanding as of June 30, 2024 and 2023, respectively, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Shares as of June 30, 2024 2023 Warrants 9,703,704 9,703,704 Stock Options 7,961,704 5,384,564 Total potential common shares 17,665,408 15,088,268 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 USD ($) Segment | |
Summary Of Significant Accounting Policies [Line Items] | |
Dividends, common stock, cash | $ | $ 0 |
Number of reporting segment | 1 |
Number of operating segment | 1 |
Computer Equipment [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Property, Equipment and leasehold improvements, useful life | 3 years |
Furniture and Office Equipment [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Property, Equipment and leasehold improvements, useful life | 5 years |
Marketable Securities - Schedul
Marketable Securities - Schedule of Fair Value And Amortized Cost Of Available-for-sale Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | $ 56,616 | $ 50,603 |
Gross Unrealized Gains | 5 | 29 |
Gross Unrealized Losses | (89) | (58) |
Estimated Fair Value | 56,532 | 50,574 |
Corporate Bonds [Member] | ||
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | 30,245 | 45,686 |
Gross Unrealized Gains | 4 | 20 |
Gross Unrealized Losses | (28) | (53) |
Estimated Fair Value | 30,221 | 45,653 |
U.S. Government Agency Securities [Member] | ||
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | 12,830 | 4,917 |
Gross Unrealized Gains | 1 | 9 |
Gross Unrealized Losses | (24) | (5) |
Estimated Fair Value | 12,807 | $ 4,921 |
U.S. Treasury Securities [Member] | ||
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | 5,647 | |
Gross Unrealized Losses | (24) | |
Estimated Fair Value | 5,623 | |
Commercial Paper [Member] | ||
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | 4,201 | |
Gross Unrealized Losses | (3) | |
Estimated Fair Value | 4,198 | |
Asset Backed Securities [Member] | ||
Schedule Of Investment Income Reported Amounts By Category [Line Items] | ||
Amortized Cost | 3,693 | |
Gross Unrealized Losses | (10) | |
Estimated Fair Value | $ 3,683 |
Marketable Securities - Summary
Marketable Securities - Summary Of Contractual Maturities Of Available-for-sale Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Investments Debt And Equity Securities [Abstract] | ||
Amortized cost, less than one year | $ 51,333 | $ 49,651 |
Amortized cost, one year through two years | 5,283 | 952 |
Amortized Cost | 56,616 | 50,603 |
Fair value, less than one year | 51,265 | 49,618 |
Fair Value, one year through two years | 5,267 | 956 |
Fair Value | $ 56,532 | $ 50,574 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) Security | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) Security | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) Security | |
Investments Debt And Equity Securities [Abstract] | |||||
Realized gains or losses on available-for-sale marketable securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Marketable securities, continuous unrealized loss position, 12 months or longer | Security | 6 | 6 | 0 | ||
Credit losses related to its marketable securities | $ 0 | $ 0 | |||
Accrued interest receivables | $ 478,000 | $ 478,000 | $ 485,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Financial Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Financial assets: | ||
Total assets | $ 68,503 | $ 80,978 |
Corporate Bonds [Member] | ||
Financial assets: | ||
Marketable securities | 30,221 | 45,653 |
U.S. Treasury Securities [Member] | ||
Financial assets: | ||
Marketable securities | 5,623 | |
U.S. Government Agency Securities [Member] | ||
Financial assets: | ||
Marketable securities | 12,807 | 4,921 |
Commercial Paper [Member] | ||
Financial assets: | ||
Marketable securities | 4,198 | |
Asset Backed Securities [Member] | ||
Financial assets: | ||
Marketable securities | 3,683 | |
Level 1 [Member] | ||
Financial assets: | ||
Total assets | 11,971 | 30,404 |
Level 2 [Member] | ||
Financial assets: | ||
Total assets | 56,532 | 50,574 |
Level 2 [Member] | Corporate Bonds [Member] | ||
Financial assets: | ||
Marketable securities | 30,221 | 45,653 |
Level 2 [Member] | U.S. Treasury Securities [Member] | ||
Financial assets: | ||
Marketable securities | 5,623 | |
Level 2 [Member] | U.S. Government Agency Securities [Member] | ||
Financial assets: | ||
Marketable securities | 12,807 | 4,921 |
Level 2 [Member] | Commercial Paper [Member] | ||
Financial assets: | ||
Marketable securities | 4,198 | |
Level 2 [Member] | Asset Backed Securities [Member] | ||
Financial assets: | ||
Marketable securities | 3,683 | |
Money Market Funds [Member] | ||
Financial assets: | ||
Cash equivalents | 11,971 | 30,404 |
Money Market Funds [Member] | Level 1 [Member] | ||
Financial assets: | ||
Cash equivalents | $ 11,971 | $ 30,404 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||||
Nov. 21, 2022 USD ($) ft² | Dec. 05, 2017 USD ($) ft² | Mar. 31, 2023 USD ($) | Jun. 30, 2024 ft² | Dec. 31, 2022 | |
Leases [Line Items] | |||||
First year of payments square feet of occupied space | 10,500 | ||||
Second year of payments square feet of occupied space | 11,500 | ||||
Remaining lease payments square feet of occupied space | 12,500 | ||||
Building [Member] | |||||
Leases [Line Items] | |||||
Leased spaced area | 12,500 | 5,600 | |||
Lease expiration date | Feb. 28, 2028 | Feb. 28, 2023 | |||
Operating lease term | 60 months | 60 months | |||
Term of required monthly payments | 2028-02 | ||||
Building [Member] | Minimum [Member] | |||||
Leases [Line Items] | |||||
Operating lease rent expense | $ | $ 23 | $ 10 | |||
Building [Member] | Maximum [Member] | |||||
Leases [Line Items] | |||||
Operating lease rent expense | $ | $ 32 | $ 12 | |||
Furniture [Member] | |||||
Leases [Line Items] | |||||
Operating lease term | 24 months | ||||
Operating lease rent expense | $ | $ 11 | ||||
Office Equipment [Member] | |||||
Leases [Line Items] | |||||
Operating lease term | 36 months |
Leases - Schedule of Lease-rela
Leases - Schedule of Lease-related Assets and Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Assets: | ||
Operating lease right-of-use assets | $ 1,029 | $ 1,137 |
Finance lease right-of-use assets | 181 | 206 |
Total lease assets | 1,210 | 1,343 |
Liabilities: | ||
Operating lease liabilities, current portion | 216 | 184 |
Finance lease liabilities, current portion | 93 | 122 |
Operating lease liabilities, long term portion | 884 | 1,001 |
Finance lease liabilities, long term portion | 31 | |
Total lease liabilities | $ 1,193 | $ 1,338 |
Leases - Schedule of Informatio
Leases - Schedule of Information Related to Lease Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Leases [Abstract] | ||||
Operating lease expense | $ 85 | $ 85 | $ 170 | $ 117 |
Finance lease expense | 12 | 12 | 24 | 12 |
Total lease expense | $ 97 | $ 97 | $ 194 | $ 129 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Detail) $ in Thousands | Jun. 30, 2024 USD ($) |
Operating Leases | |
2024 | $ 156 |
2025 | 349 |
2026 | 368 |
2027 | 377 |
2028 | 95 |
Total minimum lease payments | 1,345 |
Less: Amount of lease payments representing interest | (245) |
Present value of future minimum lease payments | 1,100 |
Finance Leases | |
2024 | 63 |
2025 | 32 |
Total minimum lease payments | 95 |
Less: Amount of lease payments representing interest | (2) |
Present value of future minimum lease payments | $ 93 |
Leases - Schedule of Informat_2
Leases - Schedule of Information Related to the Lease Terms and Discount Rates of Leases (Detail) | Jun. 30, 2024 | Dec. 31, 2023 |
Weighted average remaining lease term: | ||
Operating leases | 3 years 9 months 18 days | 4 years 3 months 18 days |
Finance leases | 9 months 18 days | 1 year 3 months 18 days |
Weighted average discount rate: | ||
Operating leases | 11% | 11% |
Finance leases | 4.37% | 4.37% |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash outflows relating to operating leases | $ 69 | $ 69 | $ 138 | $ 93 |
Finance lease payments | $ 32 | $ 32 | $ 63 | 32 |
Supplemental non-cash information: | ||||
Right-of-use assets obtained in exchange for new operating lease liabilities | 1,289 | |||
Right-of-use assets obtained in exchange for new finance lease liabilities | $ 242 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Payables And Accruals [Abstract] | ||
Accrued R&D projects | $ 2,690 | $ 1,579 |
Accrued compensation and benefits | 1,503 | 1,614 |
Accrued consulting and professional fees | 704 | 510 |
Accrued other | 35 | 6 |
Total accrued expenses | $ 4,932 | $ 3,709 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 5 Months Ended | 6 Months Ended | ||||||
May 09, 2023 USD ($) | Apr. 06, 2022 USD ($) | Jul. 06, 2021 USD ($) | Aug. 13, 2020 USD ($) Installment | Oct. 31, 2021 PrivatePlacement | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Oct. 31, 2021 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | |
Total payoff amount of term loan | $ 9,409 | |||||||||
Interest expense | $ 1 | $ 153 | $ 2 | $ 384 | ||||||
Private Placement [Member] | ||||||||||
Number of private placements | PrivatePlacement | 2 | |||||||||
SVB Term Loan [Member] | ||||||||||
Total payoff amount of term loan | $ 6,500 | |||||||||
Term loan | 5,200 | |||||||||
Debt instrument, principal amount | 0 | $ 14,000 | ||||||||
Interest-only payment period | 24 months | |||||||||
Loan payment, number of consecutive equal monthly installments of principal including accrued interest | Installment | 24 | |||||||||
Debt instrument, maturity date | Feb. 01, 2024 | |||||||||
Debt instrument, final payment fee amount | 1,200 | $ 1,200 | ||||||||
Debt default additional interest charge | 5% | |||||||||
Interest rate, floating | 9.45% | 10.25% | ||||||||
Interest expense | $ 0 | $ 151 | $ 0 | $ 382 | ||||||
Debt instrument accrued interest and prepayment premium | $ 100 | |||||||||
SVB Term Loan [Member] | Minimum [Member] | ||||||||||
Interest rate, floating | 4.25% | |||||||||
Long term debt percentage bearing adjusted floating interest rate | 6.25% | |||||||||
SVB Term Loan [Member] | First Amendment | ||||||||||
Debt instruments percentage of required to deposit unrestricted and unencumbered cash collateral | 100% | |||||||||
Equity raise requirements, description | if the Company failed to receive positive data in its Phase 2b/3 PRISM trial or to raise by June 30, 2022 sufficient net proceeds from the sale of equity securities to finance its planned second Phase 3 clinical trial of Haduvio for prurigo nodularis and its ongoing operations (each a “Milestone Condition”), the Company would have been required to deposit unrestricted and unencumbered cash equal to 100% of all outstanding amounts owed to SVB in a cash collateral account with SVB, which could have been used by SVB to prepay the SVB Term Loan at any time. | |||||||||
SVB Term Loan [Member] | First Amendment | Minimum [Member] | ||||||||||
Debt instruments amount of required to maintain unrestricted and unencumbered cash | $ 20,000 | |||||||||
Proceeds from the sale of equity securities | $ 15,000 | |||||||||
SVB Term Loan [Member] | Third Amendment [Member] | ||||||||||
Variable interest rate | 3% | |||||||||
Proceeds from the sale of equity securities | $ 45,000 | |||||||||
SVB Term Loan [Member] | Third Amendment [Member] | Minimum [Member] | ||||||||||
Interest rate, floating | 4.25% | |||||||||
Long term debt percentage bearing adjusted floating interest rate | 6.25% | |||||||||
SVB Term Loan [Member] | Prepayment Prior to First Anniversary of Effective Date [Member] | ||||||||||
Prepayment premium percentage on principal amount | 3% | |||||||||
SVB Term Loan [Member] | Prepayment After First Anniversary of Effective Date and Prior To Second Anniversary of Effective Date [Member] | ||||||||||
Prepayment premium percentage on principal amount | 2% | |||||||||
SVB Term Loan [Member] | Prepayment After Second Anniversary of the Effective Date and Prior to February 1, 2024 [Member] | ||||||||||
Prepayment premium percentage on principal amount | 1% | |||||||||
SVB Term Loan [Member] | Prime Rate [Member] | ||||||||||
Variable interest rate | 1% | |||||||||
SVB Term Loan [Member] | Prime Rate [Member] | Third Amendment [Member] | ||||||||||
Variable interest rate | 1% | |||||||||
SVB Term Loan [Member] | Adjusted Prime Rate [Member] | ||||||||||
Variable interest rate | 3% |
Debt - Schedule of Components o
Debt - Schedule of Components of Interest Expense of Term Loan (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Instrument [Line Items] | ||||
Interest expense | $ 1 | $ 153 | $ 2 | $ 384 |
SVB Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Interest payments | 53 | 202 | ||
Accrual of the final payment fee | 91 | 150 | ||
Accretion and amortization of term loan discounts | 7 | 30 | ||
Interest expense | $ 0 | $ 151 | $ 0 | $ 382 |
Stockholders' Equity - Shares R
Stockholders' Equity - Shares Reserved For Future Issuances (Detail) - shares | Jun. 30, 2024 | Dec. 31, 2023 |
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 48,495,308 | 49,223,937 |
Exercise of Outstanding Warrants And Pre-funded Warrants [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 38,257,447 | 40,931,506 |
2012 Stock Option And Grant Plan [Member] | 2012 Stock Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 406,364 | 565,792 |
2019 Stock Option And Grant Plan [Member] | 2019 Stock Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 8,684,716 | 6,549,183 |
2019 Stock Option And Grant Plan [Member] | 2019 Employee Stock Purchase Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 1,146,781 | 1,177,456 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | |||||||||
Aug. 15, 2023 USD ($) shares | Sep. 27, 2022 USD ($) $ / shares shares | Apr. 06, 2022 USD ($) $ / shares shares | Oct. 18, 2021 USD ($) PrivatePlacement $ / shares shares | Oct. 05, 2021 USD ($) $ / shares shares | Feb. 29, 2024 shares | Jun. 30, 2023 USD ($) | May 31, 2022 USD ($) | Oct. 31, 2021 PrivatePlacement | Jun. 30, 2020 USD ($) | Jun. 30, 2024 USD ($) shares | |
Stockholders Equity [Line Items] | |||||||||||
Share based compensation options grants in the period | 2,846,750 | ||||||||||
Performance-Based Vesting Stock Options [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Share based compensation options grants in the period | 832,250 | ||||||||||
Private Placement [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Number of private placements | PrivatePlacement | 2 | ||||||||||
Private Placement [Member] | Investor [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 9,852,138 | ||||||||||
Warrants Exercised | 1,299,270 | ||||||||||
Warrants expiration date | Oct. 05, 2028 | ||||||||||
Private Placement [Member] | Investor [Member] | Common Stock [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Sale of stock during the period | 2,373,201 | ||||||||||
Warrants to purchase aggregate shares of common stock | 4,746,402 | ||||||||||
Private Placement [Member] | Investor [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Exercise price per share of warrants | $ / shares | $ 0.001 | ||||||||||
Private Placement [Member] | Investor [Member] | Common Stock and Accompanying Common Stock Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Combined price of each shares | $ / shares | 1.62 | ||||||||||
Private Placement [Member] | Investor [Member] | Pre-funded Warrant and Accompanying Common Stock Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Combined price of each shares | $ / shares | $ 1.619 | ||||||||||
Proceeds from sale of common stock and warrants under public and private placements, net of issuance costs | $ | $ 11,800,000 | ||||||||||
Private Placement [Member] | Investor [Member] | Common Stock Warrants | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 7,299,270 | ||||||||||
Exercise price per share of warrants | $ / shares | $ 1.37 | ||||||||||
Warrants expiration date | Apr. 05, 2025 | ||||||||||
Private Placement [Member] | Investor [Member] | Warrant [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 7,299,270 | ||||||||||
Warrants expiration date | Oct. 05, 2028 | ||||||||||
Private Placement [Member] | New Enterprise Associates 16, L.P [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 3,703,704 | ||||||||||
Proceeds from sale of common stock and warrants under public and private placements, net of issuance costs | $ | $ 13,700,000 | ||||||||||
Number of private placements | PrivatePlacement | 2 | ||||||||||
Proceeds from issuance of private placement net of issuance costs | $ | $ 1,100,000 | ||||||||||
Private Placement [Member] | New Enterprise Associates 16, L.P [Member] | Common Stock [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Sale of stock during the period | 1,851,852 | ||||||||||
Private Placement [Member] | New Enterprise Associates 16, L.P [Member] | Common Stock and Accompanying Common Stock Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Common stock warrants exercise price and expiration date description | The accompanying common stock warrants have an exercise price of $1.37 per share and became exercisable immediately upon issuance. Of the accompanying common stock warrants, warrants to purchase an aggregate of 1,851,852 shares of the Company’s common stock will expire on April 18, 2025, and warrants to purchase an aggregate of 1,851,852 shares of the Company’s common stock will expire on October 18, 2028. None of the accompanying common stock warrants issued to NEA in the private placement have been exercised. | ||||||||||
Combined price of each shares | $ / shares | $ 1.62 | ||||||||||
Proceeds from sale of common stock and warrants under public and private placements, net of issuance costs | $ | $ 3,000,000 | ||||||||||
Private Placement [Member] | New Enterprise Associates 16, L.P [Member] | Common Stock Warrants | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 1,851,852 | ||||||||||
Exercise price per share of warrants | $ / shares | $ 1.37 | ||||||||||
Warrants expiration date | Apr. 18, 2025 | ||||||||||
Private Placement [Member] | New Enterprise Associates 16, L.P [Member] | Warrant [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 1,851,852 | ||||||||||
Warrants expiration date | Oct. 18, 2028 | ||||||||||
Private Placement [Member] | Securities Purchase Agreement [Member] | Common Stock [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Sale of stock during the period | 4,580,526 | ||||||||||
Combined price of each shares | $ / shares | $ 1.90 | ||||||||||
Private Placement [Member] | Securities Purchase Agreement [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Combined price of each shares | $ / shares | $ 1.899 | ||||||||||
Proceeds from sale of common stock and warrants under public and private placements, net of issuance costs | $ | $ 55,000,000 | ||||||||||
Exercise price per share of warrants | $ / shares | $ 0.001 | ||||||||||
September 2022 Offering [Member] | Underwriting Agreement [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Proceeds from sale of common stock and warrants under public and private placements, net of issuance costs | $ | $ 58,100,000 | ||||||||||
Warrants expiration date | Sep. 27, 2022 | ||||||||||
September 2022 Offering [Member] | Underwriting Agreement [Member] | Common Stock [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Sale of stock during the period | 14,252,670 | ||||||||||
Combined price of each shares | $ / shares | $ 1.93 | ||||||||||
Exercise price per share of warrants | $ / shares | $ 0.001 | ||||||||||
September 2022 Offering [Member] | Underwriting Agreement [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 14,247,330 | ||||||||||
Combined price of each shares | $ / shares | $ 1.929 | ||||||||||
Options to purchase additional shares | 1,600,428 | ||||||||||
Maximum [Member] | Private Placement [Member] | Investor [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 4,926,069 | ||||||||||
Maximum [Member] | Private Placement [Member] | Securities Purchase Agreement [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 24,379,673 | ||||||||||
Maximum [Member] | September 2022 Offering [Member] | Underwriting Agreement [Member] | Pre-funded Warrants [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Warrants to purchase aggregate shares of common stock | 4,275,000 | ||||||||||
ATM Sales Agreement [Member] | |||||||||||
Stockholders Equity [Line Items] | |||||||||||
Aggregate offering price of common stock which may issue and sell under agreement | $ | $ 75,000,000 | $ 50,000,000 | $ 12,000,000 | $ 62,000,000 | |||||||
Sale of stock during the period | 4,333,394 | 1,474,926 | |||||||||
Proceeds from issuance of common stock | $ | $ 12,700,000 | $ 5,000,000 | |||||||||
Estimated commissions and allocated fees | $ | $ 1,000,000 | $ 200,000 | |||||||||
Proceeds from issuance of common stock, preferred stock, debt securities, units and or warrants | $ | $ 200,000,000 |
Stockholders' Equity - Warrant
Stockholders' Equity - Warrant Activity Including Activity Related To Pre-funded Warrants (Detail) | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Pre-funded Warrants [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | |
Outstanding, Beginning | 31,227,802 |
Exercised | (2,674,059) |
Outstanding, Ending | 28,553,743 |
Common Stock Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | |
Outstanding, Beginning | 9,703,704 |
Outstanding, Ending | 9,703,704 |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Outstanding [Roll Forward] | |
Outstanding, Beginning | 40,931,506 |
Exercised | (2,674,059) |
Outstanding, Ending | 38,257,447 |
Weighted Average Exercise Price | |
Outstanding, Beginning | $ / shares | $ 0.33 |
Exercised | $ / shares | 0.001 |
Outstanding, Ending | $ / shares | $ 0.35 |
Stockholders' Equity (Stock-Bas
Stockholders' Equity (Stock-Based Awards) - Additional Information (Detail) - shares | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jan. 01, 2023 | Jan. 01, 2020 | Apr. 30, 2019 | Jun. 30, 2024 | Dec. 31, 2023 | Jan. 01, 2024 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock, capital shares reserved for future issuance | 48,495,308 | 49,223,937 | ||||
Share based compensation options to purchase no of common stock | 7,961,704 | 5,312,300 | ||||
Share based compensation options grants in the period | 2,846,750 | |||||
2019 Stock Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation, award description | The total number of shares of common stock that may be issued under the 2019 Plan and the 2012 Plan was 9,091,080 as of June 30, 2024, of which 1,129,376 shares remained available for grant under the 2019 Plan. Awards may be made under the 2019 Plan for up to such number of shares of the Company’s common stock as is equal to the sum of: i) 1,578,947 shares; plus ii) the number of shares (up to 1,157,894 shares) of the Company’s common stock subject to outstanding awards under the 2012 Plan that expire, terminate or are otherwise cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus iii) an annual increase to be added on the first day of each fiscal year, beginning with 2020 and continuing through 2029, equal to the least of (a) 2,105,623 shares of common stock, (b) 4% of the number of outstanding shares of the Company’s common stock on such date, and (c) an amount determined by the Company’s board of directors. | |||||
Number of shares available for grant | 1,129,376 | |||||
Common stock, capital shares reserved for future issuance | 2,105,623 | 1,578,947 | 2,105,623 | |||
Share based compensation grant period | 10 years | |||||
Share based compensation vesting description | Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years. Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25% vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four years. | |||||
Share based compensation options to purchase no of common stock | 7,555,340 | 4,746,508 | ||||
Share based compensation options grants in the period | 7,555,340 | 4,746,508 | ||||
2019 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 4 years | |||||
2019 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | Vesting First Anniversary Date of Grant [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting Percentage | 25% | |||||
2019 Stock Incentive Plan [Member] | Director [Member] | Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 1 year | |||||
2019 Stock Incentive Plan [Member] | Director [Member] | Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 2 years | |||||
2019 Stock Incentive Plan [Member] | Common Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Increase in additional number of shares to be issued | 2,105,623 | |||||
Percentage of number of common stock, shares outstanding | 4% | |||||
2019 Plan and 2012 Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total number of common shares authorized under the plan | 9,091,080 | |||||
2012 Stock Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation grant period | 10 years | |||||
Share based compensation vesting description | Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years. Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25% vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four years. | |||||
Share based compensation options to purchase no of common stock | 406,364 | 565,792 | ||||
Share based compensation options grants in the period | 406,364 | 565,792 | ||||
2012 Stock Incentive Plan [Member] | Other Equity-Based Award [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation options grants in the period | 0 | |||||
2012 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 4 years | |||||
2012 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | Vesting First Anniversary Date of Grant [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting Percentage | 25% | |||||
2012 Stock Incentive Plan [Member] | Director [Member] | Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 1 year | |||||
2012 Stock Incentive Plan [Member] | Director [Member] | Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation vesting period | 2 years | |||||
2012 Stock Incentive Plan [Member] | Common Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation options to purchase number of shares outstanding | 1,157,894 | |||||
2019 Employee Stock Purchase Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Share based compensation, award description | The total number of shares of common stock that may be issued under the 2019 ESPP was 1,146,781 as of June 30, 2024, all of which remain available for issuance. The number of shares of the Company’s common stock that have been approved to be issued under the 2019 ESPP is equal to the sum of i) 155,106 shares plus ii) an annual increase to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2020 and continuing for each fiscal year until and including, the fiscal year ending December 31, 2029, equal to the least of (a) 526,315 shares of common stock, (b) 1% of the number of outstanding shares of the Company’s common stock on such date and (c) an amount determined by the Company’s board of directors. Effective January 1, 2023, the aggregate number of shares of the Company’s common stock that may be issued under the 2019 ESPP increased, pursuant to the terms of the 2019 ESPP, by an additional 526,315 shares, equal to the 2019 ESPP determined maximum for the year. | |||||
Total number of common shares authorized under the plan | 1,146,781 | |||||
Common stock, capital shares reserved for future issuance | 155,106 | |||||
2019 Employee Stock Purchase Plan [Member] | Common Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Increase in additional number of shares to be issued | 526,315 | 526,315 | ||||
Percentage of number of common stock, shares outstanding | 1% |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options, Activity (Detail) - $ / shares | 6 Months Ended |
Jun. 30, 2024 | |
Number of Option Shares | |
Outstanding, Beginning | 5,312,300 |
Granted | 2,846,750 |
Exercised | (129,518) |
Expired | (67,828) |
Outstanding, Ending | 7,961,704 |
Options exercisable | 3,488,041 |
Options unvested | 4,473,663 |
Weighted Average Exercise Price | |
Outstanding, Beginning | $ 3.24 |
Granted | 2.45 |
Exercised | 1.68 |
Expired | 2.63 |
Outstanding, Ending | 2.98 |
Options exercisable | 3.83 |
Options unvested | $ 2.33 |
Stockholders' Equity - Stock-ba
Stockholders' Equity - Stock-based Compensation Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expenses | $ 1,127 | $ 606 | $ 1,850 | $ 1,183 |
General and Administrative Expense [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expenses | 645 | 372 | 1,070 | 737 |
Research and Development Expense [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expenses | $ 482 | $ 234 | $ 780 | $ 446 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (12,352) | $ (7,145) | $ (23,254) | $ (13,546) |
Weighted average common shares used in net loss per share attributable to common stockholders, basic | 101,041,573 | 98,698,579 | 100,279,393 | 98,654,868 |
Weighted average common shares used in net loss per share attributable to common stockholders, diluted | 101,041,573 | 98,698,579 | 100,279,393 | 98,654,868 |
Basic net loss per common share outstanding | $ (0.12) | $ (0.07) | $ (0.23) | $ (0.14) |
Diluted net loss per common share outstanding | $ (0.12) | $ (0.07) | $ (0.23) | $ (0.14) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) - shares | Jun. 30, 2024 | Dec. 31, 2023 |
April 2022 Private Placement [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Pre-funded warrants to purchase of common stock | 28,553,743 | 31,227,802 |
Net Loss per Share - Calculatio
Net Loss per Share - Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 17,665,408 | 15,088,268 |
Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 9,703,704 | 9,703,704 |
Employee Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 7,961,704 | 5,384,564 |
Collaborative and Licensing A_2
Collaborative and Licensing Agreements - Additional Information (Detail) - Endo Pharmaceuticals Inc [Member] $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Royalty terms | first commercial sale of the product in that country and extends until the later of the expiration, unenforceability or invalidation of the last valid claim of any licensed patent or application covering the licensed product in the country or the expiration of 10 years after the first commercial sale of the licensed product in the country, which period is referred to as the royalty term. Upon the expiration of the royalty term for a product in a country |
Completion Of Stage One [Member] | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Milestone payments to be paid | $ 0.3 |
Completion Of Stage Two [Member] | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Milestone payments to be paid | $ 0.8 |