Trevi Therapeutics, Inc. Condensed Consolidated Balance Sheets (Amounts in thousands, except share and per share amounts) June 30, 2026 December 31, 2025 Assets Unaudited Current assets: Cash and cash equivalents $ 54,302 $ 18,914 Marketable securities 264,568 169,346 Prepaid expenses 4,263 1,263 Other current assets 2,572 2,133 Total current assets 325,705 191,656 Operating lease right-of-use assets 542 677 Property, equipment and leasehold improvements, net 336 178 Other non-current assets 3,935 928 Total assets $ 330,518 $ 193,439 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 3,098 $ 3,911 Accrued expenses 5,309 5,531 Operating lease liabilities 329 307 Total current liabilities 8,736 9,749 Operating lease liabilities 276 446 Total liabilities 9,012 10,195 Commitments and contingencies (Note 10) Stockholders’ equity: Preferred stock: $0.001 par value; 5,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued or outstanding at June 30, 2026 and December 31, 2025. — — Common stock: $0.001 par value; 400,000,000 and 200,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; and 142,420,883 and 128,306,056 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively. 142 128 Additional paid-in capital 682,582 512,772 Accumulated other comprehensive (loss) income (425 ) 148 Accumulated deficit (360,793 ) (329,804 ) Total stockholders’ equity 321,506 183,244 Total liabilities and stockholders’ equity $ 330,518 $ 193,439 The accompanying notes are an integral part of these condensed consolidated financial statements. 1 Trevi Therapeutics, Inc. Condensed Consolidated Statements of Comprehensive Loss (unaudited) (Amounts in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 15,152 $ 9,389 $ 25,093 $ 17,200 General and administrative 5,357 4,333 10,328 7,992 Total operating expenses 20,509 13,722 35,421 25,192 Loss from operations (20,509 ) (13,722 ) (35,421 ) (25,192 ) Other income (expense): Interest income, net 2,696 1,407 4,392 2,532 Other (expense) income, net (3 ) (7 ) 1 (13 ) Total other income, net 2,693 1,400 4,393 2,519 Loss before income taxes (17,816 ) (12,322 ) (31,028 ) (22,673 ) Income tax benefit (19 ) (21 ) (39 ) (32 ) Net loss $ (17,797 ) $ (12,301 ) $ (30,989 ) $ (22,641 ) Basic and diluted net loss per common share outstanding $ (0.11 ) $ (0.09 ) $ (0.21 ) $ (0.18 ) Weighted average shares of common stock used in net loss per share attributable to common stockholders, basic and diluted 156,602,158 130,350,391 151,127,942 124,015,763 Net loss $ (17,797 ) $ (12,301 ) $ (30,989 ) $ (22,641 ) Other comprehensive loss: Net unrealized losses on available-for-sale marketable securities (235 ) (49 ) (573 ) (37 ) Comprehensive loss $ (18,032 ) $ (12,350 ) $ (31,562 ) $ (22,678 ) The accompanying notes are an integral part of these condensed consolidated financial statements. 2 Trevi Therapeutics, Inc. Condensed Consolidated Statements of Stockholders’ Equity (unaudited) (Amounts in thousands, except share amounts) Additional Accumulated Other Total Common Stock Paid- Comprehensive Accumulated Stockholders’ Shares Amount in Capital (Loss) Income Deficit Equity Balance at March 31, 2026 128,411,048 $ 128 $ 515,185 $ (190 ) $ (342,996 ) $ 172,127 Stock-based compensation — — 3,272 — — 3,272 Issuance of common stock from exercise of stock options 663,281 1 1,720 — — 1,721 Issuance of common stock from Employee Stock Purchase Plan 6,554 — 66 — — 66 Issuance of common stock under offering, less issuance costs 13,340,000 13 162,339 — — 162,352 Unrealized losses on available-for-sale marketable securities — — — (235 ) — (235 ) Net loss — — — — (17,797 ) (17,797 ) Balance at June 30, 2026 142,420,883 $ 142 $ 682,582 $ (425 ) $ (360,793 ) $ 321,506 Balance at March 31, 2025 99,892,915 $ 100 $ 396,669 $ 73 $ (297,385 ) 99,457 Stock-based compensation — — 1,384 — — 1,384 Issuance of common stock from exercise of stock options 5,088 — 13 — — 13 Issuance of common stock from Employee Stock Purchase Plan 15,898 — 59 — — 59 Issuance of common stock from warrant exercise 1,851,852 2 2,535 — — 2,537 Issuance of common stock under offering, less issuance costs 20,010,000 20 107,373 — — 107,393 Unrealized losses on available-for-sale marketable securities — — — (49 ) — (49 ) Net loss — — — — (12,301 ) (12,301 ) Balance at June 30, 2025 121,775,753 $ 122 $ 508,033 $ 24 $ (309,686 ) $ 198,493 3 Additional Accumulated Other Total Common Stock Paid- Comprehensive Accumulated Stockholders’ Shares Amount in Capital (Loss) Income Deficit Equity Balance at December 31, 2025 128,306,056 $ 128 $ 512,772 $ 148 $ (329,804 ) $ 183,244 Stock-based compensation — — 5,463 — — 5,463 Issuance of common stock from exercise of stock options 768,273 1 1,942 — — 1,943 Issuance of common stock from Employee Stock Purchase Plan 6,554 — 66 — — 66 Issuance of common stock under offering, less issuance costs 13,340,000 13 162,339 — — 162,352 Unrealized losses on available-for-sale marketable securities — — — (573 ) — (573 ) Net loss — — — — (30,989 ) (30,989 ) Balance at June 30, 2026 142,420,883 $ 142 $ 682,582 $ (425 ) $ (360,793 ) $ 321,506 Balance at December 31, 2024 93,602,631 $ 94 $ 386,534 $ 61 $ (287,045 ) $ 99,644 Stock-based compensation — — 2,592 — — 2,592 Issuance of common stock from exercise of stock options 295,372 — 731 — — 731 Issuance of common stock from Employee Stock Purchase Plan 15,898 — 59 — — 59 Issuance of common stock from warrant exercise 7,851,852 8 10,749 — — 10,757 Issuance of common stock under offering, less issuance costs 20,010,000 20 107,368 — — 107,388 Unrealized losses on available-for-sale marketable securities — — — (37 ) — (37 ) Net loss — — — — (22,641 ) (22,641 ) Balance at June 30, 2025 121,775,753 $ 122 $ 508,033 $ 24 $ (309,686 ) 198,493 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 Trevi Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (unaudited) (Amounts in thousands) Six Months Ended June 30, 2026 2025 Operating activities: Net loss $ (30,989 ) $ (22,641 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 5,463 2,592 Operating lease right-of-use assets 207 222 Depreciation and amortization 68 75 Accretion of available-for-sale marketable securities, net (948 ) (778 ) Changes in operating assets and liabilities: Accounts payable (1,759 ) (439 ) Accrued expenses and other liabilities (390 ) (1,003 ) Prepaid expenses and other current assets (5,770 ) (1,606 ) Net cash used in operating activities (34,118 ) (23,578 ) Investing activities: Proceeds from maturities of available-for-sale marketable securities 67,202 32,095 Purchases of available-for-sale marketable securities (162,049 ) (44,656 ) Purchases of property, equipment and leasehold improvements (226 ) — Net cash used in investing activities (95,073 ) (12,561 ) Financing activities: Proceeds from offering of common stock, net of commissions 163,015 108,154 Proceeds from exercises of stock options 1,943 731 Proceeds from Employee Stock Purchase Plan 66 59 Payments of offering costs (445 ) (590 ) Proceeds from exercises of warrants — 10,757 Payments of finance lease — (11 ) Net cash provided by financing activities 164,579 119,100 Net increase in cash and cash equivalents 35,388 82,961 Cash and cash equivalents at beginning of period 18,914 34,097 Cash and cash equivalents at end of period $ 54,302 $ 117,058 The accompanying notes are an integral part of these condensed consolidated financial statements. Trevi Therapeutics, Inc. Notes to Condensed Consolidated Financial Statements (unaudited) (in thousands, except share and per share data) 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 patients with idiopathic pulmonary fibrosis (“IPF”), non-IPF interstitial lung disease (“non-IPF ILD”), and refractory chronic cough (“RCC”). Haduvio is an oral extended-release formulation of nalbuphine. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa receptor agonist and a mu receptor antagonist (“KAMA”), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine has been approved and marketed as an injectable for pain indications for decades in the United States (“U.S.”) and Europe. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with mu-opioid agonists because it antagonizes, or blocks, the mu-opioid receptor. Parenteral nalbuphine is not scheduled as a controlled substance by the U.S. Drug Enforcement Agency and in most of Europe. 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, 2026 and 2025 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, 2025. 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, 2026 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure other than those provided in Note 11. 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 prepaid expenses, accrued expenses and 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, 2026 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, 2026 and 2025 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, 2026 and the results of its operations and its cash flows for the three and six months ended June 30, 2026 and 2025. The results for the three and six months ended June 30, 2026 and 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2026 or any other interim period or any future year or period. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at financial institutions that management believes to be of high credit quality, and the Company has not experienced any losses on these deposits. The Company’s marketable securities potentially subject the Company to concentrations of credit risk. The Company’s cash management and investment policy limits investment instruments to investment-grade securities with the objective to preserve capital and to maintain liquidity until the funds can be used in business operations. The Company has no off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign-hedging arrangements. 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 (loss) 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 such as the extent to which the fair value is less than the amortized cost basis and the issuer’s financial condition. Additionally, declines in value are evaluated in order to assess whether the decline is other than temporary. In order to perform this evaluation, 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 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. 7 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). Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company has not recognized any significant impairment charges from inception through June 30, 2026. 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 an in process 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. 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. 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 value of goods and services received from CROs and CMOs in the reporting period are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, timing of payments made 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 current assets on the Condensed Consolidated Balance Sheets, 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. 8 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—The Company estimates expected volatility based on a combination of its own historical stock price volatility, when sufficient trading history is available, and the historical volatility of a group of publicly traded 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, (“ASC 740”), 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, 2026 and December 31, 2025. 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. 9 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 shares of common stock 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 shares of common stock used to calculate both basic and diluted net loss per share are the same for each of the periods presented. Segments The Company operates and manages its business as one reportable segment, which is also the Company’s only operating segment. The Company’s chief operating decision maker (“CODM”) is the President and Chief Executive Officer. The CODM evaluates the Company’s financial performance and allocates resources based on consolidated net loss, which is reported on the Company’s consolidated statements of comprehensive loss. The CODM uses consolidated net loss to evaluate the Company’s spend and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. Comprehensive Loss Comprehensive loss represents the net change in stockholders’ equity during a period from sources other than transactions with stockholders. As reflected in the accompanying Condensed Consolidated Statements of Comprehensive Loss, our comprehensive loss is comprised of net losses and unrealized gains and losses on marketable securities. Recently Adopted Accounting Pronouncements In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Company adopted this accounting standard, on a prospective basis, for the fiscal year beginning on January 1, 2025 and it has resulted in incremental disclosures within the footnotes to the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which requires disaggregation and disclosure of specified information about certain costs and expenses in the notes to the financial statements. The standard is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2024-03. 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, 2026 Type of security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury securities $ 97,245 $ 18 $ (259 ) $ 97,004 Commercial paper 83,562 — (69 ) 83,493 Corporate bonds 67,589 11 (115 ) 67,485 Asset backed securities 13,523 2 (5 ) 13,520 U.S. government agency securities 3,074 — (8 ) 3,066 Total marketable securities $ 264,993 $ 31 $ (456 ) $ 264,568 10 December 31, 2025 Type of Security Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value U.S. treasury securities $ 62,572 $ 100 $ — $ 62,672 Commercial paper 46,773 14 (4 ) 46,783 Corporate bonds 41,991 17 (3 ) 42,005 Asset backed securities 13,558 17 — 13,575 U.S. government agency securities 4,304 7 — 4,311 Total marketable securities $ 169,198 $ 155 $ (7 ) $ 169,346 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, 2026 Amortized Cost Fair Value Due to mature: Less than one year $ 175,980 $ 175,727 One year through three years 89,013 88,841 Total $ 264,993 $ 264,568 December 31, 2025 Amortized Cost Fair Value Due to mature: Less than one year $ 110,769 $ 110,863 One year through three years 58,429 58,483 Total $ 169,198 $ 169,346 During the three and six months ended June 30, 2026 and 2025, there were no realized gains or losses on available-for-sale marketable securities. As of June 30, 2026 and December 31, 2025, no marketable securities had been in a continuous unrealized loss position for more than 12 months and the Company considered any 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. Additionally, the Company did not 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, 2026 and December 31, 2025, accrued interest receivables on the Company’s available-for-sale marketable securities were $1.6 million and $1.0 million, respectively, and were included within other current assets as presented on its Condensed Consolidated Balance Sheets. 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, 2026 Financial assets: Cash equivalents Money market funds $ 28,530 $ — $ — $ 28,530 Cash equivalents Commercial paper — 24,194 — 24,194 Marketable securities U.S. treasury securities — 97,004 — 97,004 Marketable securities Commercial paper — 83,493 — 83,493 Marketable securities Corporate bonds — 67,485 — 67,485 Marketable securities Asset backed securities — 13,520 — 13,520 Marketable securities U.S. government agency securities — 3,066 — 3,066 Total assets $ 28,530 $ 288,762 $ — $ 317,292 11 Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total December 31, 2025 Financial assets: Cash equivalents Money market funds $ 17,926 $ — $ — $ 17,926 Marketable securities U.S. treasury securities — 62,672 — 62,672 Marketable securities Commercial paper — 46,783 — 46,783 Marketable securities Corporate bonds — 42,005 — 42,005 Marketable securities Asset backed securities — 13,575 — 13,575 Marketable securities U.S. government agency securities — 4,311 — 4,311 Total assets $ 17,926 $ 169,346 $ — $ 187,272 5.Accrued Expenses Accrued expenses consisted of the following: June 30, 2026 December 31, 2025 Accrued R&D $ 2,332 $ 2,043 Accrued compensation and benefits 2,099 2,746 Accrued consulting and professional fees 748 558 Accrued other 130 184 Total accrued expenses $ 5,309 $ 5,531 6.Stockholders’ Equity On June 3, 2026, the Company filed an amendment to the Company’s Restated Certificate of Incorporation, as amended to increase the number of authorized shares of the Company’s common stock from 200,000,000 to 400,000,000 shares, following approval of the amendment by the stockholders of the Company at the Company’s 2026 annual meeting of stockholders held on the same date. The Company had reserved shares of common stock for future issuance as shown in the table below: June 30, 2026 December 31, 2025 Shares of common stock reserved for future issuance upon exercise of outstanding warrants and pre-funded warrants 19,100,800 19,100,800 Shares of common stock reserved for future issuance upon exercise under the Amended and Restated 2019 Stock Incentive Plan 11,386,272 9,023,200 Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan 1,097,288 1,103,842 Shares of common stock reserved for future issuance upon exercise under the 2012 Stock Incentive Plan 278,418 278,418 31,862,778 29,506,260 At-the-Market Offering In June 2023, the Company entered into an at-the-market sales agreement with Leerink Partners, LLC (formerly SVB Securities LLC) (the “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 ATM Sales Agreement. In November 2025, the Company filed an automatic universal shelf registration statement on Form S-3 (the “2025 Shelf Registration Statement”) with the SEC, which became effective upon filing. The 2025 Shelf Registration Statement permits the Company to offer and sell an indeterminate amount 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 2025 Shelf Registration Statement was filed to replace the Company’s prior universal shelf registration statement. Concurrently with the filing of the 2025 Shelf Registration Statement, the Company filed a new prospectus supplement pursuant to which shares of the Company’s common stock having an aggregate offering price of up to $200.0 million may be offered and sold from time to time under the ATM Sales Agreement. No shares were sold under the ATM Sales Agreement during the six months ended June 30, 2026. 12 Private Placements 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 were scheduled to 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. On April 17, 2025, NEA exercised all of the warrants that would have expired on April 18, 2025. None of the accompanying common stock warrants issued to NEA in the private placement that expire on October 18, 2028 have been exercised. 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. As of June 30, 2026, pre-funded warrants that were issued and sold in the April 2022 Private Placement to purchase 12,531,332 shares of common stock remain outstanding. Registered Offerings 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. As of June 30, 2026, pre-funded warrants that were issued and sold in the September 2022 Offering to purchase 4,717,616 shares of common stock remain outstanding. On June 5, 2025, the Company issued and sold 17,400,000 shares of the Company’s common stock to the public in an underwritten offering (the “June 2025 Offering”), at an offering price of $5.75 per share of common stock pursuant to an underwriting agreement with Morgan Stanley & Co. LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated and Cantor Fitzgerald & Co., as representatives of the several underwriters. In connection with the offering, the Company also granted the underwriters a 30-day option to purchase up to an additional 2,610,000 shares of common stock at the price to the public, less underwriting discounts and commissions. The underwriters exercised the option in full and settled in cash, concurrent with the offering. The June 2025 Offering resulted in aggregate gross proceeds to the Company of approximately $115.1 million. On April 16, 2026, the Company issued and sold 11,600,000 shares of the Company’s common stock to the public in an underwritten offering (the “April 2026 Offering”), at an offering price of $13.00 per share of common stock pursuant to an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners LLC, as representatives of the several underwriters. In connection with the offering, the Company also granted the underwriters a 30-day option to purchase up to an additional 1,740,000 shares of common stock at the price to the public, less underwriting discounts and commissions. The underwriters option was exercised in full and settled in cash, concurrent with the closing of the offering. The April 2026 Offering resulted in aggregate gross proceeds to the Company of $173.4 million or net proceeds to the Company of approximately $162.3 million, after deducting underwriting discounts and commissions and offering expenses. 13 Warrants Warrant activity, including activity related to pre-funded warrants, is shown in the table below: Number of Pre-funded Warrant Shares Number of Common Stock Warrant Shares Total Number of Warrant Shares Weighted Average Exercise Price Outstanding as of December 31, 2025 17,248,948 1,851,852 19,100,800 $ 0.13 Exercised — — — $ — Outstanding as of June 30, 2026 17,248,948 1,851,852 19,100,800 $ 0.13 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. In April 2025, the Company’s board of directors approved, and in June 2025 the Company’s stockholders subsequently approved, an amendment to the 2019 Plan, which (i) increased the number of shares authorized for issuance under the plan by 6,000,000 shares to 16,490,422 shares and (ii) eliminated the evergreen provision of the plan. In April 2026, the Company’s board of directors approved, and in June 2026 the Company’s stockholders subsequently approved, an amendment and restatement of the 2019 Plan, which (i) increased the number of shares authorized for issuance under the 2019 Plan by 8,000,000 shares to 24,490,422 shares, (ii) limited non-employee director compensation, (iii) prohibited liberal share recycling by providing that shares delivered to the Company in satisfaction of an exercise price or tax withholding do not become available under the 2019 Plan for future grants and (iv) clarified that any dividends or dividend equivalents paid with respect to awards under the 2019 Plan are subject to the same vesting and forfeiture provisions as the award with respect to which the dividend or dividend equivalent is paid. Accordingly, the total number of shares of common stock that may be issued under both the 2019 Plan and the 2012 Plan was 23,444,372 as of June 30, 2026, of which 11,779,682 shares remained available for grant under the 2019 Plan. 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, 2026 and December 31, 2025, respectively, options to purchase 11,386,272 shares and 9,023,200 shares of common stock were granted and outstanding, net of cancellations, under the 2019 Plan. As of June 30, 2026 and December 31, 2025 options to purchase 278,418 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 were subject to vesting based on performance criteria related to the timing and results of two of the Company’s clinical trials. By May 2025, the timing and results of both clinical trials had been determined, and the compensation committee of the Company's board of directors had certified to the satisfaction of the related performance metrics, resulting in PSOs to purchase 642,160 shares vesting and the remaining PSOs being cancelled. In February 2026, the Company granted PSOs to purchase 710,500 shares of common stock to employees of the Company. The PSOs are subject to vesting based on performance criteria related to the timing and results of the Company’s clinical trials. 14 A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan is as follows: Number of Option Shares Weighted Average Exercise Price Outstanding as of December 31, 2025 9,301,618 $ 3.63 Granted 3,581,500 $ 11.19 Exercised (768,273 ) $ 2.53 Forfeited (337,655 ) $ 6.73 Expired — $ — Outstanding as of June 30, 2026 11,777,190 $ 5.91 Options exercisable as of June 30, 2026 5,920,713 $ 3.80 Options unvested as of June 30, 2026 5,856,477 $ 8.04 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 1,097,288 as of June 30, 2026. 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. No annual increase was made on January 1, 2025 and 2026, respectively. 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 June 30, Six Months Ended June 30, 2026 2025 2026 2025 General and administrative expense $ 1,896 $ 787 $ 3,245 $ 1,471 Research and development expense 1,376 597 2,218 1,121 Total stock-based compensation expenses $ 3,272 $ 1,384 $ 5,463 $ 2,592 7.Income Taxes As of June 30, 2026 and December 31, 2025, 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, 2026 and 2025 was for the Company’s estimates for its state research and development tax credits in each given year. 8.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 June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net loss $ (17,797 ) $ (12,301 ) $ (30,989 ) $ (22,641 ) Weighted average shares of common stock used in net loss per share attributable to common stockholders, basic and diluted 156,602,158 130,350,391 151,127,942 124,015,763 Basic and diluted net loss per common share outstanding $ (0.11 ) $ (0.09 ) $ (0.21 ) $ (0.18 ) 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 both June 30, 2026 and December 31, 2025, the Company had pre-funded warrants to purchase 17,248,948 shares of common stock outstanding, which were issued in the April 2022 Private Placement and the September 2022 Offering, which warrants are included in the weighted average shares of common stock used in calculating the net loss per share attributable to common stockholders, basic and diluted, for each of the three and six months ended June 30, 2026 and 2025. 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 15 them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following potential shares of common stock, presented based on shares outstanding as of June 30, 2026 and 2025, 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, 2026 2025 Stock Options 11,777,190 10,239,338 Warrants 1,851,852 1,851,852 Total potential shares of common stock 13,629,042 12,091,190 9.Segments The Company's single reportable segment is the business of developing and commercializing the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with IPF, non-IPF ILD, and RCC. The accounting policies of the segment are described in Note 2 of the notes to the Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q. The following table presents reportable segment loss, including significant expense categories, attributable to the Company’s reportable segment for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Chronic cough in IPF clinical trial expense $ 4,347 $ 3,039 $ 6,034 $ 5,921 Refractory chronic cough clinical trial expense 2,028 434 3,106 1,252 Clinical trial material 2,351 330 3,904 564 Other clinical trials and studies 1 1,144 1,269 2,443 1,317 Other clinical development expenses 2 1,848 1,861 3,371 3,279 Employee compensation (excluding stock compensation expense) 3,347 2,818 6,506 5,775 Stock-based compensation expense 3,272 1,384 5,463 2,592 Other segment items 3 2,156 2,573 4,554 4,473 Interest income, net (2,696 ) (1,407 ) (4,392 ) (2,532 ) Net loss $ 17,797 $ 12,301 $ 30,989 $ 22,641 (1) Includes expense related to the Company’s Phase 1 NDA supportive studies (2) Includes expense related to general research and development activities, regulatory, medical affairs, and quality assurance. (3) Includes general administrative expense, other (expense) income, net and income tax benefit. 10.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. There have been no material changes to the Company's lease obligations or licensing agreements from those disclosed in the consolidated financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025. 16 11.Subsequent Events In July 2026, the Company purchased an active pharmaceutical ingredient from Par Health for use in the manufacture of the Company's product candidate, Haduvio, for approximately $2.4 million. The active pharmaceutical ingredient was delivered in July 2026, and the related payment obligation was outstanding as of the date of this Quarterly Report on Form 10-Q. Michael Heffernan, a member of the Company's board of directors, serves as chairman of the board of directors of Par Health.