Celcuity Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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Mar 31, 2026 · Filed May 14, 2026
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Notes to Condensed Financial Statements
CELCUITY INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. Organization and Liquidity
Organization
Celcuity Inc., a Delaware corporation (the “Company”), is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the 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. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) locally advanced or metastatic breast cancer (“ABC”), has reported detailed results for Study 1, which evaluated patients withPIK3CA WT tumors, and announced topline results for Study 2, which evaluated patients withPIK3CA MT tumors. The Company’s Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined 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 March 31, 2026, the Company had an accumulated deficit of $501.7 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 March 31, 2026, the Company had $387.1 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 stage including, but not limited to, the clinical and commercial success of its initial drug product, gedatolisib, the regulatory approval of gedatolisib, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, 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.
Selling, General and Administrative
Selling, general and administrative expenses primarily consist of salaries and employee-related costs, including stock-based compensation, for personnel in executive, commercial, market access, marketing, 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 in anticipation of the commercialization of gedatolisib, legal services associated with being a public company, director and officer insurance, investor relations, and travel expenses.
In connection with the FDA’s acceptance for filing of the Company’s NDA for gedatolisib in HR+/HER2-PIK3CA WT ABC and the Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, 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 months ended March 31, 2025, the Company reclassified $2.5 million from selling, general and administrative expenses to research and development 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 options, convertible notes, 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:
| Three Months Ended March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Options to purchase common stock | 5,820,708 | 4,847,454 |
| Convertible notes as-if-converted-to-common stock | 5,296,053 | — |
| Warrants to purchase common stock | 225,705 | 4,825,502 |
| Restricted stock awards and restricted stock units | 107,064 | 1,079 |
| Preferred stock as-if-converted-to-common stock | — | 3,175,770 |
| Total | 11,449,530 | 12,849,805 |
The maximum number of shares of common stock issuable upon conversion of the Company’s 2.750% Senior Notes due 2031 (the “Notes”) is 5,296,053. As of March 31, 2026, the number of shares issuable would be 3,923,002 if the Notes were converted in full.
During the three months ended March 31, 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 United States 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 March 31, 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):
| Amortized Cost, as Adjusted | Gross Unrealized Holding Gains | Gross Unrealized Holding Losses | Estimated Fair Value | |
|---|---|---|---|---|
| U.S. treasury securities | $241,873 | $6 | $(35) | $241,844 |
| Total | $241,873 | $6 | $(35) | $241,844 |
| Amortized Cost, as Adjusted | Gross Unrealized Holding Gains | Gross Unrealized Holding Losses | Estimated Fair Value | |
|---|---|---|---|---|
| U.S. treasury securities | $275,794 | $225 | $— | $276,019 |
| Total | $275,794 | $225 | $— | $276,019 |
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):
| As of | ||
|---|---|---|
| March 31, 2026 | December 31, 2025 | |
| Employee compensation and benefits | $5,441 | $8,338 |
| License milestone | — | 5,000 |
| Research and development costs | 3,011 | 1,218 |
| Interest | 1,998 | 3,379 |
| Consulting and professional fees | 2,271 | 2,335 |
| Other | 1,252 | 595 |
| Total | $13,973 | $20,865 |
6. Commitments
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 March 31, 2026, the Company had $2.6 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 March 31, 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
Capital Stock
As of March 31, 2026, the Company’s authorized capital stock consisted of 95,000,000 shares of common stock, of which 48,347,390 shares were outstanding, and 2,500,000 shares of preferred stock, including 1,850,000 shares designated as Series A preferred stock, of which none were outstanding. As of March 31, 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 “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 Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The 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 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:
| Common stock warrants | Weighted-average exercise price per share | |
|---|---|---|
| Outstanding as of December 31, 2025 | 6,422,560 | $0.53 |
| Issued | — | — |
| Exercised | (45,788) | 7.60 |
| Surrendered upon cashless exercise | (3,280) | 7.56 |
| Expired | — | — |
| Outstanding as of March 31, 2026 | 6,373,492 | $0.48 |
8. Stock-Based Compensation
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. As of March 31, 2026, the number of shares available for issuance under the 2017 Plan was 2,959,809.
Stock Options
The following table summarizes the activity for all stock options outstanding:
| Shares | Weighted-average exercise price per share | Weighted-average remaining contractual term | Aggregate intrinsic value | |
|---|---|---|---|---|
| (in years) · (in thousands) | ||||
| Options outstanding as of December 31, 2025 | 5,842,485 | $19.62 | 7.9 | $468,191 |
| Granted | 42,150 | 106.59 | ||
| Exercised | (56,427) | 8.08 | ||
| Forfeited | (7,500) | 10.64 | ||
| Options outstanding as of March 31, 2026 | 5,820,708 | $20.37 | 7.7 | $545,814 |
| Options exercisable as of March 31, 2026 | 2,954,055 | $11.71 | 6.6 | $302,579 |
In January 2025, the Company modified previously granted stock option awards to 44 employees by reducing the exercise price of these options to the Company’s closing common stock price on the modification date. During the three months ended March 31, 2026 and 2025, the incremental compensation expense recognized as a result of these modifications was less than $0.1 million and $0.1 million, respectively. The effect of these modifications on stock-based compensation over the remaining service periods will be $0.2 million.
During the three months ended March 31, 2026 and 2025, the weighted-average grant date fair value of options granted was $78.90 and $7.43 per share, respectively. The total intrinsic value of options exercised during the three months ended March 31, 2026 and 2025, was $5.6 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 March 31, 2026, the unrecognized compensation cost related to outstanding employee and non-employee options was $51.4 million and is expected to be recognized as expense over a weighted-average period of 1.6 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:
| Three Months Ended March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Risk-free interest rate | 3.6% − 3.9% | 4.0% − 4.7% |
| Expected volatility | 84.5% − 85.5% | 76.2% – 77.3% |
| Expected life (years) | 6.1 − 6.3 | 5.0 – 6.4 |
| Expected dividend yield | 0% | 0% |
During the three months ended March 31, 2026 and 2025, the Company recognized stock-based compensation expense for stock options of $4.5 million and $2.3 million, respectively.
Restricted Stock Awards and Restricted Stock Units
The following table summarizes the activity for RSAs and RSUs:
| Shares | Weighted-average grant date fair value per share | |
|---|---|---|
| Outstanding as of December 31, 2025 | 27,439 | $87.25 |
| Granted | 79,625 | 108.85 |
| Vested | — | — |
| Forfeited | — | — |
| Outstanding as of March 31, 2026 | 107,064 | $103.31 |
As of March 31, 2026, the unrecognized compensation cost related to outstanding RSAs and RSUs was $10.6 million and is expected to be recognized over a weighted-average period of 2.3 years. No RSAs or RSUs vested during the three months ended March 31, 2026.
During the three months ended March 31, 2026 and 2025, the Company recognized stock-based compensation expense for RSAs and RSUs of $0.4 million and less than $0.1 million, respectively.
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. As of March 31, 2026, the number of shares available for issuance under the ESPP was 710,801.
During the three months ended March 31, 2026 and 2025, the Company recognized stock-based compensation expense related to the ESPP of $0.4 million and $0.2 million, respectively.
Stock-based Compensation
The Company recognized the following stock-based compensation expense in its unaudited condensed statements of operations (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2026 | 2025 | |
| Research and development | $2,112 | $1,164 |
| Selling, general and administrative | 3,213 | 1,280 |
| Total | $5,325 | $2,444 |
9. Debt
July 2025 Convertible Notes Offering
On July 30, 2025, the Company entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of the Notes to the Underwriters (the “Note Offering”). In addition, pursuant to the Note Underwriting Agreement, the Company granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of the Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option in full. The issuance of $201.3 million aggregate principal amount of the Notes was completed on August 1, 2025.
The 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 first supplemental indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”), dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full.
The Notes are general, unsecured, senior obligations of the Company. The 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 Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company.
Noteholders may convert their 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 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 Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.
The 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 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 Notes unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that 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 Indenture) occurs, then, subject to certain conditions and except as set forth in the Indenture, noteholders may require the Company to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock.
Lastly, the 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 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 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 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 Notes observed in market trading. The market for trading of the Notes is not considered to be an active market and therefore the fair value is determined using Level 2 inputs. As of March 31, 2026, the carrying value and fair value of the Notes was $195.6 million and $491.5 million, respectively. As of December 31, 2025, the carrying value and fair value of the Notes was $195.3 million and $436.5 million, respectively.
The issuance costs attributed to the Notes amounted to $6.4 million and were discounted from the Notes. The issuance costs will be amortized to interest expense over the term of the Notes based on the effective interest rate method. During the three months ended March 31, 2026, the effective interest rate was 3.3% and the interest expense related to the Notes was $1.6 million, including $0.2 million related to discount amortization.
As of March 31, 2026, the Company was in full compliance with all financial covenants under the 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 may only be 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 may only be 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 continues 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 3.0% 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 are subject to other customary conditions and limits on when the Company can 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, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $180 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the 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 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.
Further, in connection with the release of the topline data from the WT cohort of the VIKTORIA-1 Phase 3 clinical 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 subsequently achieves 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 is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans bear 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 will be 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 is secured by all assets of the Company. Proceeds are being used for working capital purposes and to fund the Company’s general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes 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 contains a Final Fee, which is equal to 4.5% of the initial funding of the agreement and is 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 is 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 shall become 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 achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify collateral agent, at any time before the date that is 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 shall 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 shall have 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) provides written notice to collateral agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pays 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 are 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.
Note payable consisted of the following (in thousands):
| As of | ||
|---|---|---|
| March 31, 2026 | December 31, 2025 | |
| Principal amount | $130,000 | $130,000 |
| Add: Final fee | 5,850 | 5,850 |
| Add: PIK interest (added to principal) | 2,022 | 1,697 |
| Less: unamortized debt issuance costs | (2,094) | (2,619) |
| Less: unamortized debt discount | (7,916) | (8,401) |
| Total note payable | $127,862 | $126,527 |
The fair value of the note payable, which differs from its carrying value, is determined using the Company’s estimated discount rate, volatility and risk-free rate, which are considered Level 3 inputs. As of March 31, 2026, and December 31, 2025, the fair value of the note payable was $167.8 million and $160.2 million, respectively.
The debt issuance costs will be amortized to interest expense over the term of the Amended A&R Loan Agreement based on the effective interest rate method. During the three months ended March 31, 2026 and 2025, the effective interest rate was 12.7% and 12.3%, respectively. During the three months ended March 31, 2026, interest expense related to the note payable was $4.5 million, including $1.0 million related to discount amortization. During the three months ended March 31, 2025, interest expense related to the note payable was $3.2 million, including $0.3 million related to discount amortization.
As of March 31, 2026, future principal payments, including the incurred PIK interest and Final Fee, are as follows (in thousands):
| Year Ending December 31, | |
|---|---|
| 2028 | $44,008 |
| 2029 | 93,864 |
| Total | $137,872 |
As of March 31, 2026, the Company was in full compliance with all financial covenants under the Amended A&R Loan Agreement.
10. License Agreement
On April 8, 2021, the Company entered into a 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 also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $335.0 million. One of these milestone events requires a $5.0 million payment within 60 days following the FDA regulatory filing of an NDA for gedatolisib. The FDA granted the Company’s request to submit its NDA via the FDA’s RTOR program, and the Company completed its final NDA submission to the FDA in November 2025. 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. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib 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 below, the Company did not identify any subsequent events or transactions that would have required adjustment or disclosure in the unaudited condensed financial statements.
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. As of May 14, 2026, there were 3,000,000 shares available for issuance under the 2026 Plan and no new awards will be made under the 2017 Plan.
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 additional ten-year period.
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.