Celcuity Inc.

1. Organization and Liquidity

Organization

Celcuity Inc., a Delaware corporation (the “Company”), is a biotechnology company developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The Company’s first FDA-approved product is REVTORPYKTM (gedatolisib), a potent pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades thephosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”), or PI3K/AKT/mTOR ("PAM"), pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. The Company's Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with hormone receptor-positive ("HR+"), human epidermal growth factor receptor 2-negative ("HER2-") locally advanced or metastatic breast cancer (“ABC”). Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting (the "FDA Approval"). Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. The Company's Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC"), is ongoing. The Company was co-founded in 2012 by Brian F. Sullivan and Dr. Lance G. Laing and is based in Minnesota.

Liquidity

Since inception, the Company has not generated any revenue from product sales or other sources and has incurred operating losses and negative cash flows from operations. The Company’s primary uses of cash, cash equivalents, and investments to date have been funding clinical trials and research and development activities, the scaling of commercial launch-related activities such as marketing, supply chain, distribution, market access and other commercial operations, business planning, establishing and maintaining the Company’s intellectual property portfolio, hiring personnel, leasing premises and associated capital expenditures, raising capital, and providing general and administrative support for these operations. As of June 30, 2026, the Company had an accumulated deficit of$580.6 million. To date, the Company has funded operations primarily through private placements, registered offerings of its equity securities, convertible notes, and borrowings under loan agreements.

As of June 30, 2026, the Company had$754.0 million in cash, cash equivalents and short-term investments. The Company believes its existing cash, cash equivalents and short-term investments will be sufficient to fund planned operations for at least one year from the issuance of these unaudited condensed financial statements.

The Company is subject to risks common to companies in the development and early commercialization stage including, but not limited to, the clinical success of investigational uses of gedatolisib, and the commercial success of its first approved drug product, REVTORPYK; its ability to obtain the regulatory approval of any sNDAs for gedatolisib; its ability to obtain regulatory approval to commercialize REVTORPYK outside the United States; the potential need for additional financing to achieve its goals; the uncertainty of broad adoption of its approved product by physicians and consumers; and significant competition.

2. Basis of Presentation and Summary of Significant Accounting Policies

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 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.

3. Net Loss Per Common Share

Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, the common shares underlying the convertible notes, options, warrants, restricted stock awards (“RSAs”), restricted stock units (“RSUs”) and preferred stock have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same.

The following table summarizes the potentially-dilutive shares that have been excluded from the calculation of diluted weighted-average shares outstanding because their inclusion would be anti-dilutive:

The maximum number of shares of common stock issuable upon conversion of the Company’s 2.750% Senior Notes due 2031 (the “2031 Notes”) is 5,296,053. As of June 30, 2026, the number of shares issuable would be 3,923,002 if the 2031 Notes were converted in full. The maximum number of shares of common stock issuable upon conversion of the Company’s 0.250% Senior Notes due 2032 (the “2032 Notes”) is 6,464,306. As of June 30, 2026, the number of shares issuable would be 4,617,361 if the 2032 Notes were converted in full.

As of June 30, 2026 and 2025, pre-funded warrant shares of 6,147,787 and 5,747,787, respectively, were included in the computation of basic and diluted net loss per share, as the pre-funded warrants are exercisable for nominal consideration.

4. Investments

Debt investments for which the Company has the positive intent and ability to hold to maturity are classified as held-to-maturity and reported at historical cost adjusted for amortization of premiums and accretion of discounts. Expected credit losses, if any, are recorded through the establishment of an allowance for credit losses. All of the Company’s held-to-maturity investments are U.S. treasury securities that are guaranteed or otherwise supported by the U.S. government and have no history of credit losses. Accordingly, the Company does not expect to incur any credit losses on held-to-maturity investments and has no allowance for credit losses recorded for these investments. As of June 30, 2026, all of the Company’s held-to-maturity investments had maturities of one year or less.

The following tables summarize the Company’s held-to-maturity investments (in thousands):

The fair value of the Company’s U.S. treasury securities is determined using quoted prices in active markets for similar assets or other inputs that are observable or can be corroborated by observable market data, which are considered Level 2 inputs.

There were no changes in valuation techniques or transfers between levels within the fair value hierarchy during the periods presented.

5. Other Accrued Expenses

Other accrued expenses consisted of the following (in thousands):

6. Commitments

Operating Leases

In November 2025, the Company entered into a lease for clinical laboratory and office space in Minnesota for 19,594 square feet. The lease term commenced in April 2026 and is 62 months with two options to extend the lease term for five years each. The Company also has a one-time option to terminate the lease at the end of the third year, provided certain conditions are met. To exercise this option, the Company must pay a termination fee equal to eight months’ rent plus the landlord’s unamortized transaction costs, which include abated rent, tenant improvement allowances and broker fees. The initial annual lease payment is$0.3 million and increases by 3.5% on an annual basis, resulting in total undiscounted future minimum lease payments of$1.5 million over the initial 62-month term. The Company classified the lease as an operating lease and recognized an initial right-of-use asset and lease liability of$1.1 million using a discount rate of 8.7%. As the implicit rate is not readily determinable for the lease, the Company uses an estimated incremental borrowing rate to determine the initial present value of lease payments.

In April 2026, the Company's previous lease for clinical laboratory and office space terminated in accordance with the applicable lease agreement.

Clinical Research Studies

The Company enters into contracts in the normal course of business to conduct research and development programs internally and through third-party service providers that include, among others, arrangements with vendors, consultants, contract manufacturing organizations, and contract research organizations. Contracts related to the Company’s ongoing clinical trials are generally cancelable with advance notice and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subject to amendments as a result of any change orders executed. As of June 30, 2026, the Company had$3.0 million of non-cancelable purchase commitments with respect to these arrangements.

Registration Rights Agreement

In connection with a securities purchase agreement with certain investors pursuant to which the Company agreed to sell to the investors in a private placement pre-funded warrants to purchase up to 5,747,787 shares of the Company’s common stock in October 2023 (the “Securities Purchase Agreement”), the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the investors. Under the Registration Rights Agreement, the Company agreed to file a registration statement and to use commercially reasonable efforts to cause such registration statement to become effective and to keep such registration statement effective until such time as there are no longer registrable securities held by the investors.

If the Company fails to meet the specified filing deadlines, effectiveness deadlines, or maintain the effectiveness of the registration statement, the Company is required to make pro rata payments to each holder as liquidated damages in an amount equal to 1.0% of the aggregate amount paid pursuant to the Securities Purchase Agreement by such investor for each 30-day period or pro rata for any portion thereof during which such event continues, provided that the maximum liquidated damages shall not exceed 6.0%of the aggregate amount invested by each such holder in the registrable securities.

The Company accounts for these arrangements in accordance with ASC 825-20, Registration Payment Arrangements. The required registration statement has been timely filed and declared effective by the SEC, and as of June 30, 2026, the Company remains in compliance with the maintenance requirements. Management has determined that it is not probable that the Company will be obligated to pay any liquidated damages; accordingly, no liability has been recorded for these arrangements.

7. Stockholders' Equity (Deficit)

Capital Stock

As of June 30, 2026, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 48,922,556 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A preferred stock, of whichnone were outstanding. As of June 30, 2026, no dividends have been declared on the Company’s capital stock.

July 2025 Equity Offering

On July 30, 2025, the Company entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies LLC (“Jefferies”), TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “2031 Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering (i)1,836,842 shares (the “Shares”) of the Company’s common stock, at a price to the public of$38.00 per Share and (ii) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded Warrants”), at a price to the public of$37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the$0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”). In addition, pursuant to the Equity Underwriting Agreement, the Company granted the 2031 Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The 2031 Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025.

The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were$91.6 million, including the proceeds from the 2031 Underwriters’ exercise of their option in full to purchase the Option Shares. The Company may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

Common Stock Warrants

The following table summarizes the activity for all common stock warrants outstanding:

8. Stock-Based Compensation

2026 Stock Incentive Plan

On April 1, 2026, the board of directors (the “Board”) approved the Company’s 2026 Stock Incentive Plan (“the 2026 Plan”). The 2026 Plan became effective on May 14, 2026, the date it was approved by the Company’s stockholders.

The 2026 Plan provides for the grant of options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The exercise price of each option granted under the 2026 Plan is not less than the fair market value of one share on the grant date. The maximum permitted term of options granted under the 2026 Plan is ten years. The 2026 Plan is generally administered by the compensation committee of the Board, which has the authority to interpret the 2026 Plan, grant awards and make all other determinations necessary for the administration of the 2026 Plan.

The number of shares reserved for issuance under the 2026 Plan will automatically increase on January 1 of each year from 2027 to 2036 by the number of shares equal to 1.0% of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31. However, the Board may reduce the amount of the increase in any particular year.

As of June 30, 2026, the number of shares available for issuance under the 2026 Plan was 2,956,270.

2017 Amended and Restated Stock Incentive Plan

The number of shares reserved for issuance under the 2017 Amended and Restated Stock Incentive Plan (the "2017 Plan") was automatically increased by 482,450 and 371,432 shares on January 1, 2026 and 2025, respectively. During the six months ended June 30, 2025, the Board and the stockholders approved a 3,000,000 share increase to the number of shares reserved for issuance under the 2017 Plan.

Upon the approval of the 2026 Plan, no further awards may be made under the 2017 Plan. Outstanding awards granted under the 2017 Plan continue to remain subject to the terms and conditions of the 2017 Plan. Any shares subject to awards outstanding under the 2017 Plan that expire, are cancelled, forfeited, or settled in cash will become available for issuance under the 2026 Plan.

Stock Options

The following table summarizes the activity for all stock options outstanding:

During the six months ended June 30, 2026 and 2025, the weighted-average grant date fair value of options granted was$78.90 and$7.53 per share, respectively. The total intrinsic value of options exercised during thesix months ended June 30, 2026 and 2025, was$20.9 million and less than $0.1 million, respectively. Upon the exercise of stock options, the Company will issue new shares of its common stock. As of June 30, 2026, the unrecognized compensation cost related to outstanding employee and non-employee options was$45.4 million and is expected to be recognized as expense over a weighted-average period of 1.5 years.

The assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and non-employee stock options granted, were as follows:

During the three months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense for stock options of$4.2 million and$2.4 million, respectively. During the six months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense for stock options of$8.7 million and$4.6 million, respectively.

Restricted Stock Awards and Restricted Stock Units

The following table summarizes the activity for RSAs and RSUs:

As of June 30, 2026, the unrecognized compensation cost related to outstanding RSAs and RSUs was$34.8 million and is expected to be recognized over a weighted-average period of 2.3 years.

During the three months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense for RSAs and RSUs of$1.9 million and less than $0.1 million, respectively. During thesix months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense for RSAs and RSUs of$2.3 million and less than $0.1 million, respectively.

Amended and Restated 2017 Employee Stock Purchase Plan

The number of shares reserved for issuance under the 2017 Employee Stock Purchase Plan (the “ESPP”) was automatically increased by 241,225 and 185,716 shares on January 1, 2026 and 2025, respectively.

On April 1, 2026, the Board approved and adopted the Amended and Restated 2017 Employee Stock Purchase Plan (the “Restated ESPP”). The Restated ESPP became effective on May 14, 2026, upon approval by the Company’s stockholders. The Restated ESPP increased the number of shares of common stock available for issuance under the ESPP by 289,199 shares and extended the expiration date of the ESPP for an additionalten-year period.

As of June 30, 2026, the number of shares available for issuance under the Restated ESPP was 939,395.

During the three months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense related to the ESPP and Restated ESPP of$0.8 million and$0.3 million, respectively. During the six months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense related to the ESPP and Restated ESPP of$1.2 million and$0.5 million, respectively.

Stock-based Compensation

The Company recognized the following stock-based compensation expense in its unaudited condensed statements of operations (in thousands):

9. Debt

June 2026 Convertible Notes Offering

On June 3, 2026, the Company entered into an underwriting agreement (the “2032 Note Underwriting Agreement”) with Jefferies, J.P. Morgan Securities LLC, TD Securities (USA) LLC and Guggenheim Securities, LLC (the "2032 Underwriters"), subject to customary conditions, to issue and sell in a public offering$500.0 million aggregate principal amount of the 2032 Notes to the 2032 Underwriters (the “2032 Note Offering”). In addition, pursuant to the 2032 Note Underwriting Agreement, the Company granted the 2032 Underwriters an option to purchase up to an additional$75.0 million aggregate principal amount of the 2032 Notes, solely to cover over-allotments. On June 4, 2026, the 2032 Underwriters exercised such option in full. The issuance of$575.0 million aggregate principal amount of the 2032 Notes was completed on June 8, 2026.

The 2032 Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a second supplemental indenture (the “Second Supplemental Indenture,” and the Base Indenture, as supplemented by the Second Supplemental Indenture, the “2032 Indenture”), dated as of June 8, 2026, between the Company and the Trustee. The net proceeds from the 2032 Note Offering, after deducting underwriting discounts and commissions and offering expenses, were$557.2 million, including the proceeds from the 2032 Underwriters’ exercise of their over-allotment option in full.

The 2032 Notes are general, unsecured, senior obligations of the Company. The 2032 Notes accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2027, at a rate equal to 0.250% per year. In addition, special interest will accrue on the 2032 Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the 2032 Indenture and as described below. The 2032 Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the 2032 Indenture) with certain interest penalty provisions. The 2032 Notes mature on August 1, 2032, unless earlier converted, redeemed or repurchased by the Company.

Noteholders may convert their 2032 Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 8.0302 shares of common stock, per$1,000 principal amount of the 2032 Notes, which is equivalent to an initial conversion price of$124.53 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the 2032 Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the 2032 Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.

The 2032 Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any time, and from time to time, on a redemption date on or after August 6, 2029, and on or before the 31st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the 2032 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding 2032 Notes unless at least$50.0 million aggregate principal amount of the 2032 Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any 2032 Note for redemption will constitute a Make-Whole Fundamental Change with respect to that 2032 Note, in which case the conversion rate applicable to the conversion of that 2032 Note will be increased in certain circumstances if it is converted after it is called for redemption.

If a “Fundamental Change” (as defined in the 2032 Indenture) occurs, then, subject to certain conditions and except as set forth in the 2032 Indenture, noteholders may require the Company to repurchase their 2032 Notes at a cash repurchase price equal to the principal amount of the 2032 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the 2032 Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock.

The fair value of the 2032 Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices for the 2032 Notes observed in market trading. The market for trading of the 2032 Notes is not considered to be an active market and therefore the fair value is determined using Level 2 inputs. As of June 30, 2026, the carrying value and fair value of the 2032 Notes was$557.4 million and$655.6 million, respectively.

The issuance costs attributed to the 2032 Notes amounted to$17.8 million and were discounted from the 2032 Notes. The issuance costs will be amortized to interest expense over the term of the 2032 Notes based on the effective interest rate method. During each of the three and six months ended June 30, 2026, the effective interest rate was 0.8%. Interest expense related to the 2032 Notes was$0.3 million for each of the three and six months ended June 30, 2026, including$0.2 million related to the amortization of issuance costs.

As of June 30, 2026, the Company was in full compliance with all financial covenants under the 2032 Notes.

July 2025 Convertible Notes Offering

On July 30, 2025, the Company entered into an underwriting agreement (the “2031 Note Underwriting Agreement”) with the 2031 Underwriters, subject to customary conditions, to issue and sell in a public offering$175.0 million aggregate principal amount of the 2031 Notes to the 2031 Underwriters (the “2031 Note Offering”). In addition, pursuant to the 2031 Note Underwriting Agreement, the Company granted the 2031 Underwriters an option to purchase up to an additional$26.3 million aggregate principal amount of the 2031 Notes, solely to cover over-allotments. On July 30, 2025, the 2031 Underwriters exercised such option in full. The issuance of$201.3 million aggregate principal amount of the 2031 Notes was completed on August 1, 2025.

The 2031 Notes were issued pursuant to, and are governed by the Base Indenture, as supplemented by a first supplemental indenture (the “First Supplemental Indenture,” and the Base Indenture, as supplemented by the First Supplemental Indenture, the “2031 Indenture”), dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the 2031 Note Offering, after deducting underwriting discounts and commissions and offering expenses, were$194.9 million, including the proceeds from the 2031 Underwriters’ exercise of their over-allotment option in full.

The 2031 Notes are general, unsecured, senior obligations of the Company. The 2031 Notes accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year. In addition, special interest will accrue on the 2031 Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the 2031 Indenture and as described below. The 2031 Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the 2031 Indenture) with certain interest penalty provisions. The 2031 Notes mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company.

Noteholders may convert their 2031 Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per$1,000 principal amount of the 2031 Notes, which is equivalent to an initial conversion price of$51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the 2031 Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the 2031 Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.

The 2031 Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any time, and from time to time, on a redemption date on or after August 6, 2029, and on or before the 51st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the 2031 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding 2031 Notes unless at least$50.0 million aggregate principal amount of the 2031 Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any 2031 Note for redemption will constitute a Make-Whole Fundamental Change with respect to that 2031 Note, in which case the conversion rate applicable to the conversion of that 2031 Note will be increased in certain circumstances if it is converted after it is called for redemption.

If a “Fundamental Change” (as defined in the 2031 Indenture) occurs, then, subject to certain conditions and except as set forth in the 2031 Indenture, noteholders may require the Company to repurchase their 2031 Notes at a cash repurchase price equal to the principal amount of the 2031 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the 2031 Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock.

The 2031 Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all or any portion of the 2031 Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the 2031 Notes; provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation in no event can exceed 19.99%.

The fair value of the 2031 Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices for the 2031 Notes observed in market trading. The market for trading of the 2031 Notes is not considered to be an active market and therefore the fair value is determined using Level 2 inputs. As of June 30, 2026, the carrying value and fair value of the 2031 Notes was$195.8 million and$422.2 million, respectively. As of December 31, 2025, the carrying value and fair value of the 2031 Notes was$195.3 million and$436.5 million, respectively.

The issuance costs attributed to the 2031 Notes amounted to$6.4 million and were discounted from the 2031 Notes. The issuance costs will be amortized to interest expense over the term of the 2031 Notes based on the effective interest rate method. During each of the three and six months ended June 30, 2026, the effective interest rate was 3.3%. During the three and six months ended June 30, 2026, interest expense related to the 2031 Notes was$1.6 million and$3.3 million, respectively, including$0.2 million and$0.5 million, respectively, related to the amortization of issuance costs.

As of June 30, 2026, the Company was in full compliance with all financial covenants under the 2031 Notes.

Amended and Restated Loan and Security Agreement

Third Amendment

On September 9, 2025, the Company entered into the Third Amendment (the “Third Amendment”) to the Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”), as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”)) and provide for the immediate disbursement of the$30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from$50.0 million to up to$100.0 million, which Term E Loan could only have been drawn upon FDA approval of gedatolisib in second line WT ABC patients post CDK4/6 inhibitor therapy; (iv) add three new up to$40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), for a total of$120.0 million, which could only have been drawn upon achievement of certain trailing three months’ product revenue thresholds; (v) replace the prior$45.0 million Term F Loan (as defined in the A&R Loan Agreement) with a new$150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement), which continued to be available only in the Lenders’ sole discretion upon the Company’s request; (vi) require an amendment fee payable by the Company to the Lenders in the amount of$0.1 million, which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3% of the applicable unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that the Company may make by notice to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans to November 1, 2029. The Term E Loan and each Term F Loan also were subject to other customary conditions and limits on when the Company could request funding. With the disbursement of the$30.0 million Term D Loan, the Company received net proceeds of$27.7 million.

In accordance with the Amended A&R Loan Agreement, a Final Fee of$1.4 million, equal to 4.5% of the$30.0 million Term D Loan, was recognized.

In connection with the Third Amendment, the Company issued warrants with an exercise price of$14.84 per share to purchase an aggregate of 50,537 shares of the Company’s common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment Warrants”). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant.

A portion of the proceeds from the Term D Loan in the amount of$2.8 million was allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional paid in capital in the accompanying condensed balance sheets and were discounted from the Term D Loan. The relative fair value of the Third Amendment Warrants was based on the Black-Scholes model with the following assumptions: risk-free interest rate of 4.1%; expected volatility of 74.4%; expected life of 10.0 years; and expected dividend yield of 0%. The underlying stock price used in the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense ratably over the term of the Term D Loan.

Second Amendment

On July 28, 2025, the Company entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus and Oxford, as Lenders, agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to$180.0 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the 2031 Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection with the pricing of the 2031 Notes, (iii) require an amendment fee payable by the Company to Oxford in the amount of less than$0.1 million, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026, the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of$10.00.

On May 1, 2026, Innovatus converted$3,438,029 of the outstanding principal of the Term A Loan into 343,802 shares of the Company’s common stock.

Further, in connection with the release of the topline data from the WT cohort of the VIKTORIA-1 Phase 3 trial, the Company achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional$30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to the Company in connection with the Third Amendment.

First Amendment

On May 13, 2025, the Company entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which the Company agreed to(i) pay Oxford an amendment fee of less than$0.1 million on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if the Company had failed to achieve the Term D Milestone prior to June 1, 2025, and to decrease the Minimum Liquidity Percentage back to 30% if the Company had subsequently achieved the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.

Amended and Restated Loan Agreement

On May 30, 2024, the Company entered into the A&R Loan Agreement, which amended and restated, in its entirety, the April 8, 2021 Loan and Security Agreement between the Company and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).

Pursuant to the A&R Loan Agreement, the Company was entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions had been met. The Term Loans bore interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii)7.75%, plus (b) 2.85%, provided that 1.0% of such interest was payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement was secured by all assets of the Company. Proceeds were used- for working capital purposes and to fund the Company’s general business requirements, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 Phase 1b/2 trial, and the VIKTORIA-2 Phase 3 trial. The A&R Loan Agreement contained customary representations and warranties and covenants, subject to customary carve-outs, and included financial covenants related to liquidity and other financial measures. Prior to the Second Amendment, Innovatus also had the right, at its election and until August 9, 2025, to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of$10.00.

The A&R Loan Agreement contained a Final Fee, which is equal to 4.5% of the initial funding of the agreement and was due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There was also a contingent non-utilization fee for the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization provisions related to the Term D Loan are no longer operative. The Term D Loan became due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If the Company had achieved the Term E Milestone and (i) failed to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) failed to notify collateral agent, at any time before the date that was four weeks after the Company’s achievement of the Term E Milestone, of the Company’s intent not to draw the full amount of the Term E Loan, a non-utilization fee with respect to the Term E Loan would have become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, the Company had the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provided written notice to collateral agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) paid to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that were due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

The Company evaluated the change of terms under ASC 470-50, Debt – Modification and Extinguishment, with respect to the Third Amendment, the Second Amendment, the First Amendment and the A&R Loan Agreement and concluded the change in terms did not result in significant and consequential changes to the economic substance of the debt and thus resulted in a modification of the debt and not an extinguishment of the debt.

Voluntary Prepayment

On June 8, 2026, the Company utilized$137.4 million of the net proceeds from the 2032 Notes to complete a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended A&R Loan Agreement (the “Payoff Amount”). Upon receipt by the Lenders of the Payoff Amount on June 8, 2026, all obligations, covenants, debts and liabilities of the Company under the Amended A&R Loan Agreement were satisfied and discharged in full, and the Amended A&R Loan Agreement and all other documents entered into in connection with the Amended A&R Loan Agreement, were terminated. In connection with the termination of the Amended A&R Loan Agreement, the Company wrote off$7.3 million of unamortized discounts and incurred a loss on debt extinguishment of$11.5 million, which was included in other expense in the Company's condensed statements of operations.

Note payable consisted of the following (in thousands):

As of December 31, 2025, the fair value of the note payable, which differed from its carrying value, was$160.2 million. The fair value of the note payable was determined using the Company’s estimated discount rate, volatility and risk-free rate, which are considered Level 3 inputs.

The debt issuance costs and discount were being amortized to interest expense over the term of the Amended A&R Loan Agreement based on the effective interest rate method. During the six months ended June 30, 2026 and 2025, the effective interest rate was 12.7% and 12.3%, respectively. During the three months ended June 30, 2026 and 2025, interest expense related to the note payable was$3.5 million and$3.2 million, respectively, including$0.4 million and$0.3 million, respectively, related to debt issuance costs and discount amortization. During the six months ended June 30, 2026 and 2025, interest expense related to the note payable was$7.9 million and$6.4 million, respectively, including$0.9 million and$0.6 million, respectively, related to debt issuance costs and discount amortization.

As of June 30, 2026, there areno future payments or financial covenants under the Amended A&R Loan Agreement.

10. License Agreement

On April 8, 2021, the Company entered into the License Agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib. During 2021, the Company paid$5.0 million in upfront fees and issued 349,406 shares of the Company’s common stock to Pfizer pursuant to an Equity Grant Agreement.

The Company is required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of$335.0 million, consisting of up to$155.0 million related to development milestone and up to$180.0 million related to commercial milestones, payable within 60 days of the milestone achievement.

The development milestones include payments of (i)$5.0 million following the FDA regulatory filing of an NDA for gedatolisib; (ii)$50.0 million following the FDA regulatory approval of an NDA for gedatolisib; (iii) and seven other development milestones totaling$100.0 million.

The FDA granted the Company’s request to submit its NDA via the FDA’s Real-Time Oncology Review program, and the Company completed its final NDA submission to the FDA in November 2025. The FDA accepted the Company's NDA submission on January 16, 2026. The Company recorded the$5.0 million NDA filing milestone as research and development expense in June 2025 and paid this amount in January 2026.

On July 14, 2026, subsequent to the balance sheet date but prior to the issuance of these condensed financial statements, the Company received FDA Approval, which triggered a one-time regulatory milestone payment of$50.0 million to Pfizer. The Company concluded that FDA Approval provided additional evidence with respect to the contingent contractual obligation that existed as of June 30, 2026, and accordingly accounted for FDA Approval as a recognized subsequent event. As a result, the Company recognized an accrued license milestone of$50.0 million and a corresponding intangible asset for the licensed rights as of June 30, 2026. The intangible asset will be amortized on a straight-line basis over its estimated useful life, commencing upon commercial launch, and will be evaluated for impairment whenever events or changes in circumstances indicate the carrying amount may not be recoverable. The milestone payment is due to Pfizer within 60 days of FDA Approval.

Additionally, the Company will pay Pfizer tiered royalties on sales of REVTORPYK at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid patent claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product, or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, a valid claim of a licensed patent right.

The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party.

11. Subsequent Events

The Company evaluated subsequent events and transactions that occurred after the balance sheet date through the date that the unaudited condensed financial statements were issued. Based upon this review, other than as described in Note 10 above, the Company did not identify any subsequent events or transactions that would have required adjustment or disclosure in the unaudited condensed financial statements.