Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC.

The accompanying unaudited condensed financial statements include the accounts of the Company and have been prepared in accordance with Article 8 of Regulation S-X promulgated by the SEC. Accordingly, as permitted by Article 8, the unaudited condensed financial statements do not include all of the information required by U.S. GAAP. The balance sheet as of December 31, 2025, was derived from the audited financial statements as of that date and does not include all the disclosures required by U.S. GAAP. In the opinion of management, all adjustments which are of a normal recurring nature and necessary for a fair presentation have been reflected in the unaudited condensed financial statements. These unaudited condensed financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2025, and the related footnotes thereto included in the 2025 10-K. Operating results for any interim period are not necessarily indicative of results to be expected during the remainder of the current year or for any other future period.

Accounting Estimates

Management uses estimates and assumptions in preparing these unaudited condensed financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenue and expenses. Actual results could differ from those estimates, and the difference could be material. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation and the determination of prepaid or accrued clinical trial costs.

Pre-Launch Inventory

The Company expenses pre-launch inventory as research and development expense in the period incurred unless objective and persuasive evidence exists that regulatory approval and subsequent commercialization of a product candidate is probable and where the Company also expects the future economic benefit from the sales of the product candidate to be realized. As of June 30, 2026, the Company had not capitalized any pre-launch inventory.

Property and Equipment

As the Company prepares for the commercial launch of REVTORPYK, it reevaluated the estimated useful lives of its property and equipment as follows:

The change in estimated useful lives does not have a material impact on the Company's depreciation expense.

License Agreement

The License Agreement is being accounted for as an asset acquisition under U.S. GAAP.

The License Agreement requires payments for upfront fees and upon the achievement of certain development and commercial milestones. Upfront fees and developmental milestone payments incurred prior to regulatory approval are expensed as research and development expense, with upfront fees recognized upon receipt of the license and development milestones recognized when achievement of the milestone becomes probable. Payments for development milestones incurred upon or after regulatory approval, for which the related intangible asset has an alternative future use, are capitalized as finite-lived intangible assets. Commercial milestone payments are expensed as cost of sales when the related sales threshold is achieved.

Finite-Lived Intangible Assets

Finite-lived intangible assets consist of milestone payments capitalized under license agreements upon or after regulatory approval and are recorded at cost. These assets are amortized on a straight-line basis over their estimated remaining useful lives. Amortization begins when the intangible asset is available for its intended use, which occurs upon commercial launch of the related product, and is recorded as a component of cost of sales on the condensed statements of operations. The Company evaluates the remaining useful lives of finite-lived intangible assets each reporting period and accounts for any revision to the remaining amortization period prospectively.

Long-Lived Assets

Long-lived assets, such as property and equipment and finite-lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary.

Selling, General and Administrative

Selling, general and administrative expenses primarily consist of employee-related costs, including salaries, benefits, stock-based compensation and recruiting costs for personnel in executive, sales, market access, marketing, commercial operations, legal, finance and support functions. Non-employee-related expenses consist primarily of professional and consulting fees, software costs, the acquisition of data and other launch-related activities incurred to support the commercialization of REVTORPYK, legal services associated with being a public company, director and officer insurance, investor relations, and travel expenses.

In connection with the FDA Approval, certain prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses to conform to the current period presentation. During the three and six months ended June 30, 2025, the Company reclassified $3.8 million and $6.3 million, respectively, from research and development expenses to selling, general and administrative expenses. There were no changes to previously reported total operating expenses or net loss.

The stock-based compensation amounts included in Note 8 reflect the impact of these prior period reclassifications.

Recently Adopted Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the annual income tax disclosures for the effective tax rate reconciliation, income taxes paid, and continuing operations. ASU 2023-09 also eliminates certain disclosure requirements related to unrecognized tax benefits. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-09 on January 1, 2025, on a retrospective basis.

In July 2025, the FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”), which provides certain entities with an additional practical expedient for estimating expected credit losses on current accounts receivable and current contract assets arising from revenue transactions under Accounting Standards Codification (“ASC”) 606. ASU 2025-05 is effective for annual and interim periods beginning after December 15, 2025. The Company adopted ASU 2025-05 on January 1, 2026, and the adoption did not have a material impact on its unaudited condensed financial statements and related disclosures.

Recent Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires public entities to provide disaggregated disclosure of income statement expense. In January 2025, the FASB issued ASU 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, to clarify the effective date of ASU 2024-03. ASU 2024-03 is effective for annual reporting periods 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 ASU 2024-03 on its unaudited condensed financial statements and related disclosures.

In September 2025, the FASB issued ASU No. 2025-06, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which modernizes the accounting for internal-use software. ASU 2025-06 removes all references to software development stages and requires capitalization of software costs when management has committed to the software project, and it is probable the software will be completed and perform to its intended use. In evaluating whether it is probable the project will be completed, management is required to consider whether there is significant uncertainty associated with the development activities of the software. ASU 2025-06 is effective for annual and interim periods beginning after December 15, 2027, with early adoption permitted. ASU 2025-06 may be applied on a prospective basis, a modified basis for in-process projects, or a retrospective basis. The Company is currently evaluating the method of adoption and the impact of ASU 2025-06 on its unaudited condensed financial statements and related disclosures.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow Scope Improvements (“ASU 2025-11”), which provides clarity on the required interim disclosures under Topic 270 by providing a comprehensive list of required interim disclosures, and clarifies the applicability of Topic 270. ASU 2025-11 is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. ASU 2025-11 may be applied on a prospective or retrospective basis. The Company is currently evaluating the method of adoption and the impact of ASU 2025-11 on its unaudited condensed financial statements and related disclosures.