LISATA THERAPEUTICS, INC. 10-Q

ITEM 1. FINANCIAL STATEMENTS LISATA THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except share data) September 30, 2025 December 31, 2024 ASSETS (Unaudited) Cash and cash equivalents $ 18,998 $ 16,209 Marketable securities — 15,036 Accounts receivable 502 900 Prepaid and other current assets 2,075 2,433 Total current assets 21,575 34,578 Property and equipment, net 22 72 Acquired license - intangible, net 139 192 Other assets 23 160 Total assets $ 21,759 $ 35,002 LIABILITIES, NON-CONTROLLING INTERESTS AND STOCKHOLDERS' EQUITY Liabilities Accounts payable $ 619 $ 1,284 Accrued liabilities 3,949 4,329 Total current liabilities 4,568 5,613 Other long-term liabilities 72 72 Total liabilities 4,640 5,685 Commitments and Contingencies (Note 14) Stockholders' Equity Common stock, $ 0.001 par value, authorized 500,000,000 shares; issued 8,756,686 and 8,409,582 shares at September 30, 2025 and December 31, 2024, respectively; and outstanding, 8,755,948 and 8,408,844 shares at September 30, 2025 and December 31, 2024, respectively 9 8 Additional paid-in capital 579,812 578,418 Treasury stock, at cost; 738 shares at September 30, 2025 and December 31, 2024 ( 708 ) ( 708 ) Accumulated deficit ( 561,698 ) ( 548,066 ) Accumulated other comprehensive loss ( 42 ) ( 81 ) Total Lisata Therapeutics, Inc. stockholders' equity 17,373 29,571 Non-controlling interests ( 254 ) ( 254 ) Total equity 17,119 29,317 Total liabilities, non-controlling interests and stockholders' equity $ 21,759 $ 35,002 See accompanying notes to consolidated financial statements. 5 Index LISATA THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue $ — $ — $ 70 $ — Operating Expenses: Research and development 1,959 2,542 6,815 8,384 General and administrative 2,455 2,794 8,385 9,076 Total operating expenses 4,414 5,336 15,200 17,460 Operating loss ( 4,414 ) ( 5,336 ) ( 15,130 ) ( 17,460 ) Other income (expense): Investment income, net 183 451 665 1,533 Other expense, net ( 18 ) ( 45 ) ( 129 ) ( 246 ) Total other income 165 406 536 1,287 Net loss before benefit from income taxes and noncontrolling interests ( 4,249 ) ( 4,930 ) ( 14,594 ) ( 16,173 ) Benefit from income taxes — — ( 962 ) ( 798 ) Net loss $ ( 4,249 ) $ ( 4,930 ) $ ( 13,632 ) $ ( 15,375 ) Less - net income (loss) attributable to noncontrolling interests — — — — Net loss attributable to Lisata Therapeutics, Inc. common stockholders $ ( 4,249 ) $ ( 4,930 ) $ ( 13,632 ) $ ( 15,375 ) Basic and diluted loss per share Lisata Therapeutics, Inc. common stockholders $ ( 0.49 ) $ ( 0.59 ) $ ( 1.58 ) $ ( 1.85 ) Weighted average common shares outstanding Basic and diluted shares 8,738 8,321 8,649 8,307 See accompanying notes to consolidated financial statements. 6 Index LISATA THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Net loss $ ( 4,249 ) $ ( 4,930 ) $ ( 13,632 ) $ ( 15,375 ) Other comprehensive gain (loss): Available for sale securities - net unrealized gain 1 12 4 3 Cumulative translation adjustment arising during the period 7 33 35 7 Total other comprehensive gain 8 45 39 10 Comprehensive loss attributable to Lisata Therapeutics, Inc. common stockholders $ ( 4,241 ) $ ( 4,885 ) $ ( 13,593 ) $ ( 15,365 ) See accompanying notes to consolidated financial statements. 7 Index LISATA THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EQUITY (Unaudited) (In thousands) Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Treasury Stock Total Lisata Therapeutics, Inc. Stockholders' Equity Non- Controlling Interest in Subsidiary Total Equity Shares Amount Balance at June 30, 2024 8,322 $ 8 $ 577,552 $ ( 77 ) $ ( 538,526 ) $ ( 708 ) $ 38,249 $ ( 254 ) $ 37,995 Net loss — — — — ( 4,930 ) — ( 4,930 ) — ( 4,930 ) Share-based compensation ( 2 ) — 326 — — — 326 — 326 Unrealized gain on marketable securities — — — 12 — — 12 — 12 Foreign currency translation adjustment — — — 33 — — 33 — 33 Balance at September 30, 2024 8,320 $ 8 $ 577,878 $ ( 32 ) $ ( 543,456 ) $ ( 708 ) $ 33,690 $ ( 254 ) $ 33,436 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Treasury Stock Total Lisata Therapeutics, Inc. Stockholders' Equity Non- Controlling Interest in Subsidiary Total Equity Shares Amount Balance at December 31, 2023 8,151 $ 8 $ 576,971 $ ( 42 ) $ ( 528,081 ) $ ( 708 ) $ 48,148 $ ( 254 ) $ 47,894 Net loss — — — — ( 15,375 ) — ( 15,375 ) — ( 15,375 ) Share-based compensation 155 — 875 — — — 875 — 875 Net proceeds from issuances of common stock 14 — 32 — — — 32 — 32 Unrealized gain on marketable securities — — — 3 — — 3 — 3 Foreign currency translation adjustment — — — 7 — — 7 — 7 Balance at September 30, 2024 8,320 $ 8 $ 577,878 $ ( 32 ) $ ( 543,456 ) $ ( 708 ) $ 33,690 $ ( 254 ) $ 33,436 8 Index Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Treasury Stock Total Lisata Therapeutics, Inc. Stockholders' Equity Non- Controlling Interest in Subsidiary Total Equity Shares Amount Balance at June 30, 2025 8,627 $ 9 $ 579,227 $ ( 50 ) $ ( 557,449 ) $ ( 708 ) $ 21,029 $ ( 254 ) $ 20,775 Net loss — — — — ( 4,249 ) — ( 4,249 ) — ( 4,249 ) Share-based compensation — — 232 — — — 232 — 232 Net proceeds from issuances of common stock 130 — 353 — — — 353 — 353 Unrealized gain on marketable securities — — — 1 — — 1 1 Foreign currency translation adjustment — — — 7 — — 7 — 7 Balance at September 30, 2025 8,757 $ 9 $ 579,812 $ ( 42 ) $ ( 561,698 ) $ ( 708 ) $ 17,373 $ ( 254 ) $ 17,119 Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Treasury Stock Total Lisata Therapeutics, Inc. Stockholders' Equity Non- Controlling Interest in Subsidiary Total Equity Shares Amount Balance at December 31, 2024 8,410 $ 8 $ 578,418 $ ( 81 ) $ ( 548,066 ) $ ( 708 ) $ 29,571 $ ( 254 ) $ 29,317 Net loss — — — — ( 13,632 ) — ( 13,632 ) — ( 13,632 ) Share-based compensation 129 — 748 — — — 748 — 748 Net proceeds from issuances of common stock 214 1 638 — — — 639 — 639 Proceeds from option exercise 4 — 8 — — — 8 — 8 Unrealized gain on marketable securities — — — 4 — — 4 4 Foreign currency translation adjustment — — — 35 — — 35 — 35 Balance at September 30, 2025 8,757 $ 9 $ 579,812 $ ( 42 ) $ ( 561,698 ) $ ( 708 ) $ 17,373 $ ( 254 ) $ 17,119 9 Index LISATA THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (In thousands) Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net loss $ ( 13,632 ) $ ( 15,375 ) Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation 1,001 1,018 Depreciation and amortization 131 133 Loss from equity method investment — 130 Amortization/accretion on marketable securities ( 75 ) ( 376 ) Changes in operating assets and liabilities: Accounts receivable 398 — Prepaid and other current assets 407 1,572 Other assets 140 126 Accounts payable, accrued liabilities and other liabilities ( 1,070 ) ( 2,056 ) Net cash used in operating activities ( 12,700 ) ( 14,828 ) Cash flows from investing activities: Purchase of marketable securities ( 9,180 ) ( 43,953 ) Sale of marketable securities 24,294 55,927 Purchase of property and equipment ( 28 ) — Investment in Impilo Therapeutics — ( 130 ) Net cash provided by investing activities 15,086 11,844 Cash flows from financing activities: Proceeds from exercise of options 8 — Tax withholding payments on net share settlement equity awards ( 253 ) ( 142 ) Net proceeds from issuance of common stock 639 32 Net cash provided by (used in) financing activities 394 ( 110 ) Effect of exchange rate changes on cash 9 10 Net increase (decrease) in cash and cash equivalents 2,789 ( 3,084 ) Cash and cash equivalents at beginning of period 16,209 22,593 Cash and cash equivalents at end of period $ 18,998 $ 19,509 See accompanying notes to consolidated financial statements. 10 Index LISATA THERAPEUTICS, INC. AND SUBSIDIARIES NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS Note 1 – Description of Business Overview Lisata Therapeutics, Inc. (together with its subsidiaries, the “Company”) is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other major diseases. The Company's investigational product, certepetide (formerly known as LSTA1 or CEND-1), is designed to activate a novel uptake pathway (the C-end rule active transport mechanism) that allows co-administered or tethered (i.e., molecularly bound) anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are expected to remain unaffected. Certepetide has also been shown to modify the tumor microenvironment (“TME”) by reducing T-regulatory cells and augmenting cytotoxic T cells, thereby making tumors more susceptible to immunotherapies while also inhibiting the metastatic cascade (i.e., the spread of cancer to other parts of the body). The Company, its collaborators and other researchers have amassed and continue to amass significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics. In addition, certain preclinical data using certepetide in combination with antibody drug conjugates (ADCs) has been generated as part of the Company’s research collaboration with Catalent. These data were presented recently at the 16 th Annual World ADC San Diego Conference on November 4, 2025. To date, certepetide has also demonstrated favorable safety, tolerability and activity in completed and ongoing clinical trials designed to enhance delivery of standard-of-care chemotherapy, with and without added immunotherapy, for pancreatic cancer. The Company is exploring certepetide as a means to enable a variety of therapeutic modalities to treat a range of solid tumors more effectively. Currently, certepetide is the subject of several Phase 2 clinical studies globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer and glioblastoma multiforme in combination with a variety of anti-cancer regimens. The Company's leadership team has amassed many decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development, ranging from preclinical through to product registration and launch. The Company's goal is to develop and commercialize products that address important unmet medical needs. The Company has a history of net operating losses and negative cash flows from its operating activities, and has cash, cash equivalents and marketable securities of approximately $ 19.0 million as of September 30, 2025. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its products currently in development. To manage capital for operating needs in the short-term, as previously disclosed, the Company has delayed commencement of certain readiness activities for its planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC), particularly those related to chemistry, manufacturing and controls (“CMC”). The Company’s ongoing trials continue to progress as planned. The Company also continued to identify certain operating efficiencies which had a positive impact on the cash flow forecast. The Company believes that, as a result, it currently has sufficient cash to meet its funding requirements over the next 12 months. To meet our long-term liquidity needs, the Company expects that it will need additional financing by the end of 2026, which could result in additional potential issuances of debt or equity securities in public or private financings, partnerships and/or collaborations and/or sale of assets. Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2025, and the results of its operations and its cash flows for the periods presented. The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2024 and 2023 included in our 2024 Form 10-K. Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. 11 Index Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The Company makes critical estimates and assumptions in determining stock-based awards values. Accordingly, actual results could differ from those estimates and assumptions. Segment Information The Company operates as one operating segment, the research and development of its investigational drug product. The Company's Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer, who manages the business on a consolidated basis. Principles of Consolidation The Consolidated Financial Statements include the accounts of Lisata Therapeutics, Inc. and its wholly owned and majority owned subsidiaries and affiliates. All intercompany activities have been eliminated in consolidation . Foreign Currency Remeasurement The Company’s reporting currency is the U.S. Dollar. The functional currency of Lisata Therapeutics Australia Pty Ltd., which is a foreign subsidiary of the Company, is the Australian Dollar. The assets and liabilities of Lisata Therapeutics Australia Pty Ltd. are translated into U.S. Dollars at the exchange rates in effect at each balance sheet date, and the results of operations are translated using the average exchange rates prevailing throughout the reporting period. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in stockholders' equity. Note 2 – Summary of Significant Accounting Policies Cash and Cash Equivalents Cash and cash equivalents include short-term, highly liquid, investments with maturities of ninety days or less when purchased. Concentration of Risks The Company is subject to credit risk from its portfolio of cash, cash equivalents, accounts receivable and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government, thereby reducing credit risk exposure. Cash is held at major banks in the United States and may exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The goals of the Company's investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk, liquidity of investments sufficient to meet cash flow requirements, and a competitive after-tax rate of return. The Company’s accounts receivable balance as of September 30, 2025 and December 31, 2024 is primarily derived from its license agreement dated November 30, 2024, more fully described in Note 17. The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Accounts Receivable Accounts receivable is stated at historical cost, less allowance for credit losses. The Company records an expense based on a forward-looking current expected credit loss model to maintain its allowance for credit losses. When determining its allowance for trade accounts receivable, the Company considers the probability of recoverability of accounts receivable based on experience, taking into account current collection trends and general economic factors, including bankruptcy rates. The Company also considers future economic trends to estimate expected credit losses over the lifetime of the asset. Credit risks are assessed based on historical write-offs, net of recoveries, as well as an analysis of the aged accounts receivable balances with allowances generally increasing as the receivable ages. Accounts receivable may be fully reserved for when specific collection issues are known to exist, such as pending bankruptcies. Account balances are written off against the allowance when it is determined that the receivable will not be recovered. As of September 30, 2025 and December 31, 2024, there was no allowance for credit losses. 12 Index Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company's marketable securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents and marketable securities. Unrealized gains and losses on available-for-sale securities, that are not the result of credit losses, are excluded from net income and reported in accumulated other comprehensive income (loss) as a separate component of stockholders' equity. Other income (expense), net, includes interest, dividends, amortization of purchase premiums and discounts, realized gains and losses on sales of securities and credit losses recognized through an allowance for credit losses, if any. The cost of securities sold is based on the specific identification method. The Company regularly reviews all of its investments for other-than-temporary declines in fair value. The Company's review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that it will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other-than-temporary, it reduces the carrying value of the security it holds and records a loss for the amount of such decline. Property and Equipment The cost of property and equipment is depreciated over the estimated useful lives of the related assets. Depreciation is computed on the straight-line method. Repairs and maintenance expenditures that do not extend original asset lives are charged to expense as incurred. The estimated useful lives of property and equipment are as follows: Furniture and fixtures 10 years Computer equipment 3 years Software 3 years Leasehold improvements Shorter of useful life or lease term Long-lived Assets Long-lived assets consist of property and equipment. The assets are amortized on a straight-line basis over their respective useful lives. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset exceeds the fair value of the asset. If other events or changes in circumstances indicate that the carrying amount of an asset that the Company expects to hold and use may not be recoverable, the Company will estimate the undiscounted future cash flows expected to result from the use of the asset and/or its eventual disposition, and recognize an impairment loss, if any. The impairment loss, if determined to be necessary, would be measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Share-Based Compensation The Company expenses all share-based payment awards to employees, directors, and consultants, including grants of stock options, warrants, and restricted stock, over the requisite service period based on the grant date fair value of the awards. For awards with performance-based vesting criteria, the Company estimates the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest. The Company determines the fair value of option awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate the fair value. This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or warrants. Share-based compensation expense also includes an estimate, which is made at the time of the grant, of the number of awards that are expected to be forfeited. The fair value of the Company’s restricted stock and restricted stock units is based on the closing market price of the Company’s common stock on the date of grant. Loss Per Share Basic loss per share is based on the weighted effect of all shares of common stock issued and outstanding and is calculated by dividing net loss attributable to common stockholders by the weighted average shares outstanding during the period. Diluted loss per share is calculated by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock used in the basic loss per share calculation plus the number of shares of common stock that would be issued assuming conversion of all potentially dilutive securities outstanding. Diluted loss per share is not presented as such potentially dilutive securities are anti-dilutive to losses incurred in all periods presented. 13 Index Treasury Stock Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock. Gains or losses on the subsequent reissuance of shares are credited or charged to additional paid in capital. Research and Development Costs Research and development (“R&D”) expenses include salaries, benefits, and other headcount related costs, clinical trial and related clinical manufacturing costs, contract and other outside service fees including sponsored research agreements, and facilities and overhead costs. The Company expenses the costs associated with research and development activities when incurred. To further drive the Company’s initiatives, the Company will continue targeting key governmental agencies and not-for-profit organizations to contribute funds for the Company’s research and development programs. The Company accounts for such grants as a deduction to the related expense in research and development operating expenses when earned. In-process Research and Development Expense Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as IPR&D in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under U.S. GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. The Company accounts for contingent consideration payable upon achievement of certain regulatory, development or sales milestones in such asset acquisitions when the underlying contingency is probable and estimable. Milestone payments made to third parties subsequent to regulatory approval will be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Intangible Asset The Company’s intangible asset consists of a single asset, a license agreement with Qilu Pharmaceutical, Co., Ltd. (“Qilu”) acquired in the Company's acquisition of Cend Therapeutics, Inc. (the “Cend Merger”), with a value of $ 0.4 million. The intangible asset is stated at fair value and is amortized using the straight-line method over its estimated useful life of 5.00 years. Amortization expense was $ 18 thousand and $ 53 thousand for the three and nine months ended September 30, 2025, respectively, and $ 18 thousand and $ 53 thousand for the three and nine months ended September 30, 2024, respectively. The intangible asset is reviewed for potential impairment when events or circumstances indicate that carrying amounts may not be recoverable. The projected amortization expense is $ 70 thousand per year for the next 2.00 years. Revenue Recognition The Company evaluates license and collaboration arrangements to determine whether units of account within the arrangement exhibit the characteristics of a vendor and customer relationship. For arrangements and units of account where a customer relationship exists, the Company applies the revenue recognition guidance. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Taxes imposed by governmental authorities on the Company's revenue, such as sales taxes and withholding taxes, are excluded from net revenue. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. If licenses are bundled with other performance obligations, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company recognized $ 70 thousand and $ 0 revenue for the nine months ended September 30, 2025 and 2024, respectively. 14 Index Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are allocated on a cumulative catch-up basis to satisfied and partially satisfied performance obligations, with the consideration allocated to an ongoing performance obligation being recognized over the period of performance. For the three and nine months ended September 30, 2025 and September 30, 2024, the Company has not recognized revenue related to milestones. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from any collaborative arrangement. Note 3 – Available-for-Sale Securities The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in the Company's Consolidated Balance Sheets (in thousands): September 30, 2025 December 31, 2024 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ — $ — $ — $ — $ 16,025 $ — $ ( 4 ) $ 16,021 Money market funds 14,492 — — 14,492 6,614 — — 6,614 Agency bonds — — — — 613 — — 613 Treasury bills — — — — 1,496 — — 1,496 Municipal debt securities — — — — 905 — — 905 Total $ 14,492 $ — $ — $ 14,492 $ 25,653 $ — $ ( 4 ) $ 25,649 Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table summarizes the classification of the available-for-sale securities in the Company's Consolidated Balance Sheets (in thousands): September 30, 2025 December 31, 2024 Cash equivalents $ 14,492 $ 10,613 Marketable securities — 15,036 Total $ 14,492 $ 25,649 15 Index The following table summarizes the Company's portfolio of available-for-sale securities by contractual maturity (in thousands): September 30, 2025 Amortized Cost Estimated Fair Value Less than one year $ 14,492 $ 14,492 Greater than one year — — Total $ 14,492 $ 14,492 Note 4 – Property and Equipment Property and equipment consisted of the following (in thousands): September 30, 2025 December 31, 2024 Computer equipment 494 589 Leasehold improvements — 72 Property and equipment, gross 494 661 Accumulated depreciation ( 472 ) ( 589 ) Property and equipment, net $ 22 $ 72 The Company’s results included depreciation expense of approximately $ 78 thousand and $ 79 thousand for the nine months ended September 30, 2025 and 2024, respectively. Note 5 – Income (Loss) Per Share For the nine months ended September 30, 2025 and 2024, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive in the periods presented. At September 30, 2025 and 2024, the Company excluded the following potentially dilutive securities (in thousands): September 30, 2025 2024 Stock options 1,503 1,454 Warrants 1,497 1,497 Restricted stock units 325 353 Note 6 – Fair Value Measurements Fair value of financial assets and liabilities that are being measured and reported are defined as the exchange price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company is required to classify fair value measurements in one of the following categories: Level 1 inputs are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 inputs are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly. Level 3 inputs are defined as unobservable inputs for the assets or liabilities. Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels. 16 Index The Company's financial assets and liabilities that were accounted for at fair value on a recurring basis as of September 30, 2025 and December 31, 2024 were as follows (in thousands): September 30, 2025 December 31, 2024 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ 14,492 $ — $ — $ 14,492 $ 10,613 $ — $ — $ 10,613 Marketable securities - available-for-sale — — — — — 15,036 — 15,036 $ 14,492 $ — $ — $ 14,492 $ 10,613 $ 15,036 $ — $ 25,649 The carrying values of cash, cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value as of September 30, 2025 and December 31, 2024, due to the short maturity nature of these items. Note 7 – Accrued Liabilities Accrued liabilities as of September 30, 2025 and December 31, 2024 were as follows (in thousands): September 30, 2025 December 31, 2024 Salaries, employee benefits and related taxes $ 2,116 $ 2,640 Clinical and R&D related liabilities 1,418 1,333 Accounting & tax consulting liabilities 153 55 Operating lease liabilities — current — 137 Other 262 164 Total $ 3,949 $ 4,329 Note 8 – Operating Leases The Company had an operating lease for one office which expired on September 30, 2025. The Company estimates its incremental borrowing rate at lease commencement to determine the present value of lease payments as the Company's lease does not provide an implicit rate of return. The Company recognizes lease expense on a straight-line basis over the lease term. For lease agreements entered into or reassessed after the adoption of ASU No. 2016-02, Leases (Topic 842), the Company elected to account for non-lease components associated with its leases and lease components as a single lease component. The Company's lease included an option for the Company to extend the lease term and/or sub-lease space in whole or in part for which the Company has not exercised. 17 Index Operating lease liabilities and right-of-use assets were recorded in the following captions of the Company's balance sheet as follows (in thousands): September 30, 2025 December 31, 2024 Right-of-Use Assets: Other assets $ — $ 138 Total Right-of-Use Assets $ — $ 138 Operating Lease Liabilities: Accrued liabilities $ — $ 137 Total Operating Lease Liabilities $ — $ 137 As of September 30, 2025, the weighted average remaining lease term for the Company's operating lease was 0.00 years, and the weighted average discount rate for the Company's operating lease was 0.0 %. As of December 31, 2024, the weighted average remaining lease term for the Company's operating lease was 0.75 years, and the weighted average discount rate for the Company's operating lease was 9.625 %. Future minimum lease payments under the lease agreement as of September 30, 2025 were as follows (in thousands): Years ended Operating Leases 2025 — Total lease payments — Less: Amounts representing interest — Present value of lease liabilities $ — Note 9 – Stockholders' Equity Equity Issuances At The Market Offering Agreement On June 4, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent, in connection with an “at the market offering” under which the Company from time to time may offer and sell shares of its common stock, having an aggregate offering price of up to $ 50.0 million. As of the date of this filing and so long as the Company’s public float remains below $75.0 million, the Company is subject to limitations pursuant to General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”), which limits the amount the Company can offer to up to one-third of its public float during any trailing 12-month period. Subsequent to the filing of a prospectus supplement to the Company's Registration Statement on Form S-3 (File No. 333-279034) relating to the at the market offering on August 21, 2024, the aggregate market value of its outstanding common stock held by non-affiliates was approximately $ 29.6 million. Pursuant to the Baby Shelf Limitation, since the aggregate market value of the Company's outstanding common stock held by non-affiliates was below $ 75.0 million at the time of such prospectus supplement filing, the aggregate amount of securities that the Company is permitted to offer and sell is now $ 9,855,890 , which is equal to one-third of the aggregate market value of our common stock held by non-affiliates as of August 20, 2024. If the Company’s public float exceeds $75.0 million on a future measurement date, it will no longer be subject to the Baby Shelf Limitation. During the nine months ended September 30, 2025, the Company issued 197,980 shares of common stock under the ATM Agreement for net proceeds of $ 600,663 . Since inception through September 30, 2025, the Company has issued 266,153 shares of common stock under the ATM Agreement for net proceeds of $ 881,510 . 18 Index Stock Options and Warrants The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2025: Stock Options Warrants Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Outstanding at December 31, 2024 1,440,535 $ 8.82 5.46 $ 157.0 1,496,744 $ 40.52 1.29 $ 7.5 Changes during the period: Granted 111,400 3.80 — — Exercised ( 4,329 ) 1.88 — — Forfeited ( 17,930 ) 3.53 — — Expired ( 26,795 ) 141.14 — — Outstanding at September 30, 2025 1,502,881 $ 6.17 5.02 $ 110.3 1,496,744 $ 40.52 0.55 $ — Vested at September 30, 2025 or expected to vest in the future 1,495,374 $ 6.18 5.00 $ 110.3 1,496,744 $ 40.52 0.55 $ — Vested at September 30, 2025 1,337,823 $ 6.51 4.58 $ 109.5 1,496,744 $ 40.52 0.55 $ — Restricted Stock During the nine months ended September 30, 2025 and 2024, the Company issued restricted stock for services as follows (in thousands, except share data): Nine Months Ended September 30, 2025 2024 Number of shares of restricted stock issued 215,550 203,800 Value of restricted stock issued $ 819 $ 628 The weighted average estimated fair value of restricted stock issued for services in the nine months ended September 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively. The fair value of the restricted stock was determined using the Company’s closing stock price on the date of issuance. The vesting terms of restricted stock issuances are generally between one year and four years . The following is a summary of the changes in non-vested restricted stock for the nine months ended September 30, 2025: Restricted Stock Shares Weighted Average Grant-Date Fair Value Non-vested at December 31, 2024 228,428 $ 3.67 Changes during the Year: Granted 215,550 $ 3.80 Vested ( 161,492 ) $ 4.20 Forfeited ( 17,450 ) $ 3.50 Non-vested at September 30, 2025 265,036 $ 3.46 19 Index Restricted Stock Units During the nine months ended September 30, 2025 and 2024, the Company issued restricted stock units for services as follows (in thousands, except share data): Nine Months Ended September 30, 2025 2024 Number of restricted stock units issued 78,945 205,300 Value of restricted stock units issued $ 300 $ 632 The weighted average estimated fair value of restricted stock units issued for services in the nine months ended September 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively. The fair value of the restricted stock units was determined using the Company’s closing stock price on the date of issuance. The vesting terms of restricted stock unit issuances are generally one year , or upon the achievement of performance-based milestones. The following is a summary of the changes in non-vested restricted stock units for the nine months ended September 30, 2025: Restricted Stock Units Weighted Average Grant-Date Fair Value Non-vested at December 31, 2024 103,800 $ 3.28 Changes during the Year: Granted 78,945 $ 3.80 Vested ( 103,800 ) $ 3.28 Forfeited — $ — Non-vested at September 30, 2025 78,945 $ 3.80 Note 10 – Share-Based Compensation Share-Based Compensation The Company utilizes share-based compensation in the form of stock options, restricted stock, restricted stock units and warrants. The following table summarizes the components of share-based compensation expense for the three and nine months ended September 30, 2025 and 2024 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Research and development $ 38 $ 35 $ 190 $ 158 General and administrative 194 292 811 860 Total share-based compensation expense $ 232 $ 327 $ 1,001 $ 1,018 Total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at September 30, 2025 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 263 $ 83 $ 631 Expected weighted-average period in years of compensation cost to be recognized 1.81 0.28 1.91 20 Index Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2025 and 2024 were as follows (in thousands): Stock Options Warrants Nine Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Total fair value of shares vested $ 267 $ 204 $ 150 $ — Weighted average estimated fair value of shares granted $ 2.60 $ 2.15 $ — $ 1.99 Valuation Assumptions The fair value of stock options and warrants at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s stock. The expected term for the options is based upon observation of actual time elapsed between date of grant and exercise of options for all employees. The expected term for the warrants is based upon the contractual term of the warrants. Note 11 – Income Taxes In assessing the realizability of deferred tax assets, including the net operating loss carryforwards (NOLs), the Company assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize its existing deferred tax assets. Based on its assessment, the Company has provided a full valuation allowance against its net deferred tax assets as their future utilization remains uncertain at this time. As of December 31, 2024 and 2023, the Company had approximately $ 57.9 million and $ 43.7 million, respectively, of Federal NOLs available to offset future taxable income expiring from 2030 through 2036. The Company performed an analysis and determined that they had an ownership change of greater than 50% on September 15, 2022. As a result of the ownership change, $ 88.2 million of Federal NOLs will expire unutilized. The Company wrote off that portion of the deferred tax asset and reduced the corresponding valuation allowance resulting in $ 34.0 million of remaining Federal NOLs as of December 31, 2022. The write-off of the deferred tax asset and the corresponding reduction in valuation allowance has no impact to the consolidated balance sheet or income statement. Losses incurred before the ownership change on September 15, 2022 will be subject to an annual limitation of zero while losses incurred after September 15, 2022 will not be subject to limitations. As of December 31, 2022, Cend Therapeutics, Inc. (“Cend”) had approximately $ 3.6 million of Federal NOLs available to offset future taxable income. The Company performed an analysis and determined that there was an ownership change of greater than 50% on September 15, 2022. As of September 15, 2022 Cend has approximately $ 3.1 million of Federal and $ 4.3 million of state NOLs. The state NOLs will expire from the 2036 through 2042 tax years. Using a fair market value of $ 36.1 million and applying an applicable federal rate of 2.54 % Cend will have an annual limitation of approximately $ 917 thousand each year. The Federal NOL of $ 459 thousand incurred in the post-acquisition period September 15, 2022 to December 31, 2022 is not subject to limitation, and does not expire. As of December 31, 2024 and 2023, the Company's wholly owned Australian subsidiary had approximately $ 2.3 million and $ 2.4 million, respectively, of NOLs which will be carried forward and do not expire. There is a full valuation allowance against the NOLs. As of December 31, 2024, the Company had federal research and development credit carryforwards of $ 0.5 million expiring from 2027 through 2034 if unutilized, and state research and development credit carryforwards of $ 0.1 million, which carryforward indefinitely. Utilization of these credits may be subject to an annual limitation based on changes in ownership. As of December 31, 2024 and 2023, the Company had State NOLs available in New Jersey of $ 24.6 million and $ 19.4 million, respectively, California of $ 9.2 million and $ 9.2 million, respectively, and New York City of $ 1.9 million and $ 1.9 million, respectively, to offset future taxable income expiring from 2032 through 2044. The usage of the Company’s NOLs is limited given the change in ownership. The Company applies the Financial Accounting Standards Board provisions for uncertain tax positions. The Company utilizes the two-step process to determine the amount of recognized tax benefit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant taxing authority. The Company recognizes interest and penalties associated with certain tax positions as a component of income tax expense. As of December 31, 2024 and 2023, the Company’s uncertain tax positions were $ 344 thousand and $ 344 thousand, respectively. The uncertain tax positions are due to the acquisition of Cend related to Federal and state credits and certain state 21 Index NOLs. The Company will continue to evaluate its uncertain tax positions in future periods. The Company does not believe there will be any material changes in its unrecognized tax positions over the next year. For years prior to 2021, the federal statute of limitations is closed for assessing tax. The Company’s state tax returns remain open to examination for a period of three to four years from the date of the tax return filing. In January 2025, the Company sold a portion of their unused New Jersey net operating losses through the State of New Jersey Economic Development Authority's (“NJEDA”) Technology Business Tax Certificate Transfer Program (“Program”). Under the Program, the Company sold $ 10.7 million of its New Jersey net operating losses (“NJ NOLs”) for net proceeds of $ 871 thousand. The sale of NJ NOLs resulted in a $ 962 thousand deferred income tax benefit and a loss on sale of $ 91 thousand recorded in other income (expense) in the consolidated financial statements. On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (“OBBBA”). The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including 100% bonus depreciation, domestic research cost expensing, and the business interest expense limitation. ASC 740, “Income Taxes”, requires the tax effects of changes in tax rates and tax law be recognized in the period in which the legislation is enacted. The Company completed its initial assessment of OBBBA for the quarter ended September 30, 2025. For the provisions effective in 2025, there was no material impact to the Company’s effective tax rate for the quarter ended September 30, 2025. The Company will continue to evaluate the impact of the new legislation on its consolidated financial statements as additional guidance is issued. Note 12 – Segment Information The Company operates as one operating segment, the research and development of its investigational drug product. The Company used the management approach to determine its reportable operating segment. The Company's Chief Operating Decision Maker ("CODM") is its Chief Executive Officer, who reviews financial information presented on a consolidated basis. The Company is a clinical-stage pharmaceutical company and has limited revenue associated with a license and collaboration agreement. The CODM uses net loss as a measure of profit and loss, and assesses Company performance through the achievement of its clinical development goals. The CODM is regularly provided with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation to its development programs. The CODM uses cash and marketable securities as a measure of segment assets in managing the enterprise. The Company had revenue of $ 0 and $ 70 thousand for the three and nine months ended September 30, 2025, respectively, and $ 0 and $ 0 for the three and nine months ended September 30, 2024, respectively. Depreciation and amortization expense was $ 44 thousand and $ 131 thousand for the three and nine months ended September 30, 2025, respectively and $ 42 thousand and $ 133 thousand for the three and nine months ended September 30, 2024, respectively. Equity method investment expense was $ 0 and $ 0 for the three and nine months ended September 30, 2025, respectively, and $ 30 thousand and $ 130 thousand for the three and nine months ended September 30, 2024, respectively. 22 Index The following table illustrates our segment information for significant operating expenses and includes a reconciliation to net loss for the three and nine months ended September 30, 2025 and 2024: Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue $ — $ — $ 70 $ — Operating Expenses: Research and development by significant expense: BOLSTER trial 829 475 2,222 2,820 ASCEND trial 8 133 61 271 Chemistry, manufacturing and controls 157 764 543 1,703 Clinical department 654 1,001 2,802 3,191 Other (1) 311 169 1,187 399 Research and development 1,959 2,542 6,815 8,384 General and administrative by significant expense: Corporate 1,068 1,183 3,370 3,587 Investor relations/public relations/communications 306 338 946 969 Finance 539 562 1,706 1,727 Legal 183 174 734 1,084 Business development 134 120 401 437 Share based compensation expense 195 292 811 860 Other (2) 30 125 417 412 General and administrative 2,455 2,794 8,385 9,076 Operating loss ( 4,414 ) ( 5,336 ) ( 15,130 ) ( 17,460 ) Other income, net 165 406 536 1,287 Benefit from income taxes — — ( 962 ) ( 798 ) Net loss $ ( 4,249 ) $ ( 4,930 ) $ ( 13,632 ) $ ( 15,375 ) Cash, cash equivalents, and marketable securities $ 18,998 $ 35,856 (1) Included in Other are the GBM study, FORTIFIDE study and research oncology expenses (2) Included in Other are facilities expense, human resource and information technology expenses Note 13 – Australia Research and Development Tax Incentive The Company’s Australian subsidiary, which conducts core research and development activities, is eligible to receive a refundable tax incentive between 43.5 % to 48.5 % (depending upon the income tax rate) for qualified research and development activities. As of September 30, 2025 and December 31, 2024, the Company had $ 0.7 million and $ 0.6 million, respectively, recorded as an income tax incentive receivable in prepaid and other current assets in the consolidated balance sheets, as the Company determined that the expenses met the eligibility criteria and the amounts claimed are expected to be received shortly after the related tax returns are filed. Note 14 – Commitments and Contingencies Second Amended and Restated Employment Agreement On June 10, 2025, the Company entered into an amended and restated employment agreement with David J. Mazzo, Ph.D., the Company’s Chief Executive Officer (the “Mazzo Second Amended and Restated Employment Agreement”). The Mazzo 23 Index Second Amended and Restated Employment Agreement supplements and amends the Amended and Restated Employment Agreement, dated and effective as of March 19, 2021, between Dr. Mazzo and the Company. The Mazzo Second Amended and Restated Employment Agreement: (i) amends Dr. Mazzo’s base salary to $ 717,229 from $ 633,032 and removed the non-accountable expense allowance of $ 12,000 per year, (ii) clarifies that a material reduction in Dr. Mazzo’s base salary is included in the definition of “Good Reason”, (iii) amends that in the event of Dr. Mazzo’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Dr. Mazzo’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Dr. Mazzo’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (iv) amends Dr. Mazzo’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Dr. Mazzo’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Dr. Mazzo a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (v) amends the form of payment of Dr. Mazzo’s bonus payments in the event of a termination not in connection to a Change in Control to a lump-sum payment, (vi) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (vii) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Internal Revenue Code of 1986, as amended (the “Code”), comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Dr. Mazzo may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment; and (viii) clarifies other technical terms for compliance with Section 409A of the Code. Amended and Restated Employment Agreement On June 10, 2025, the Company entered into an amended and restated employment agreement with Kristen K. Buck, M.D., the Company’s Vice President, R&D and Chief Medical Officer (the “Buck Amended and Restated Employment Agreement”). The Buck Amended and Restated Employment Agreement supplements and amends the Employment Agreement, dated and effective as of July 26, 2021, between Dr. Buck and the Company. The Buck Amended and Restated Employment Agreement: (i) amends Dr. Buck’s base salary to $ 599,342 from $ 550,000 , (ii) clarifies that a material reduction in Dr. Buck’s base salary is included in the definition of “Good Reason”, (iii) amends that in the event of Dr. Buck’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Dr. Buck’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Dr. Buck’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (iv) amends Dr. Buck’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Dr. Buck group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Dr. Buck a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (v) amends Dr. Buck’s bonus payments in the event of a termination not in connection to a Change in Control such that the amount will not be pro-rated for the number of days Dr. Buck was employed in the year of termination of employment, (vi) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (vii) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Code comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Dr. Buck may receive such severance payments as a lump sum payment on the next payroll period following the date of her termination from employment; and (viii) clarifies other technical terms for compliance with Section 409A of the Code. Amended and Restated Separation Benefits Agreement On June 10, 2025, the Company entered into an amended and restated separation benefits agreement with James Nisco, Senior Vice President Finance and Treasury and Chief Accounting Officer of the Company (the “Nisco Amendment”). The Nisco Amendment supplements and amends the separation benefits provided in the Non-Change in Control Separation Pay 24 Index Agreement between the Company and Mr. Nisco, dated as of December 24, 2024, and the severance agreement between Mr. Nisco and the Company, dated and effective as of September 12, 2016, and further amended on March 25, 2022. The Nisco Amendment: (i) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (ii) includes a condition that Mr. Nisco’s right to the severance payments and benefits described therein are subject to Mr. Nisco’s timely execution and non-revocation of a general release of claims within sixty days following Mr. Nisco’s termination or such shorter time period set forth therein, (iii) amends Mr. Nisco’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Mr. Nisco’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Mr. Nisco a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (iv) amends that in the event of Mr. Nisco’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Mr. Nisco’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Mr. Nisco’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (v) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Code, comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Mr. Nisco may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment; and (vi) clarifies other technical terms for compliance with Section 409A of the Code. Amended and Restated Separation Benefits Agreement On June 10, 2025, the Company entered into an amended and restated separation benefits agreement (the “Imam Amendment”) with Tariq Imam, Senior Vice President, Business Development and Operations and General Counsel of the Company. The Imam Amendment supplements and amends the separation benefits provided in the Non-Change in Control Separation Pay Agreement between the Company and Mr. Imam, dated as of December 24, 2024, effective as of February 1, 2025 (the “Imam Non-Change in Control Separation Pay Agreement”) and the severance agreement between Mr. Imam and the Company, dated as of March 25, 2022 (the “Imam Severance Agreement”). Imam Severance Agreement Pursuant to the Imam Severance Agreement, Mr. Imam is entitled to receive certain payments following his termination from the Company in specific circumstances. If Mr. Imam terminates his employment for Good Reason (as defined in the Imam Severance Agreement) during the period commencing on the effective date of a Change in Control (as defined in the Imam Severance Agreement) and ending on the second anniversary of the effective date of a Change in Control (as defined in the Imam Severance Agreement), or the Company terminates Mr. Imam’s employment without Cause (as defined in the Imam Severance Agreement) (other than by reason of his death or disability), the Company will (a) continue to pay Mr. Imam’s current base salary of $ 356,000 (the “Imam Salary Payment”) for 12 months following the date the termination becomes effective (the "Imam Severance Period"), commencing on the next payroll period following the date the termination becomes effective and (b) pay Mr. Imam a lump-sum equal to 100 % of Mr. Imam’s then annual target bonus on the next payroll period following the date the termination becomes effective (the “Imam Cash Severance”) and (c) pay monthly the monthly premium amount for continued COBRA coverage. If the Company may not pay Mr. Imam’s COBRA premiums without incurring tax penalties or violating any requirement of law, the Company shall use its commercially reasonable best efforts to provide Mr. Imam with substantially similar assistance in an alternative manner (the “Imam COBRA Payments”), provided that the cost of doing so does not exceed the cost that the Company would have incurred had the Company been able to pay the COBRA premiums on Mr. Imam’s behalf. In addition to the Imam Salary Payment, Imam Cash Severance and the Imam COBRA Payments, the Company shall (i) fully vest as of the date the termination becomes effective, all outstanding unvested equity awards, including options granted to Mr. Imam; and (ii) extend the exercise date of the options to the earlier of the one-year anniversary of the date the termination becomes effective and the original expiration date of the options. Imam Non-Change in Control Separation Pay Agreement Pursuant to the Imam Non-Change in Control Separation Pay Agreement, Mr. Imam is entitled to a salary continuation of his current base salary of $ 356,000 for 12 months from the date of his termination, as well as a lump-sum cash payment of 100 % of his then annual target bonus on the next payroll period following the date the termination becomes effective. Mr. Imam is also entitled to payment of accrued but unpaid paid time off and wages up to the date of termination and monthly COBRA coverage reimbursements for 12 months from the date of termination. The Imam Non-Change in Control Separation 25 Index Pay Agreement also provides an extension of the time period for exercising any fully vested option awards to the earlier of the one-year anniversary of the date the termination becomes effective and the original expiration date of the options. The Imam Amendment: (i) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (ii) includes a condition that Mr. Imam’s right to the severance payments and benefits described therein are subject to Mr. Imam’s timely execution and non-revocation of a general release of claims within sixty days following Mr. Imam’s termination or such shorter time period set forth therein, (iii) amends Mr. Imam’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Mr. Imam’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Mr. Imam a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (iv) clarifies that in the event of Mr. Imam’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Mr. Imam’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Mr. Imam’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (v) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of Code, comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Mr. Imam may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment and (vi) clarifies other technical terms for compliance with Section 409A of the Code. Legal Proceedings and Claims From time to time, the Company is subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business. While the outcome of pending claims cannot be predicted with certainty, the Company does not believe that the outcome of any pending claims will have a material adverse effect on the Company's financial condition or operating results. The Company has elected to recognize expense for legal fees as incurred when the legal services are provided. In May 2021, Cend received a written threat of litigation on behalf of a Chinese entity called Lingmed Limited (“Lingmed”) claiming Lingmed was entitled to a success fee based on Cend’s Collaboration and License Agreement with Qilu Pharmaceuticals. Cend responded by denying that Lingmed is entitled to a success fee under the terms of their agreement. In May 2022, Cend was served with a complaint filed by Lingmed in the San Diego County Superior Court, alleging claims for breach of contract, fraud and declaratory relief. Cend’s response to the complaint was filed on June 6, 2022 and denied all of Lingmed’s material allegations. Lingmed filed an answer to Cend’s response on July 11, 2022, denying all of the Company’s material allegations. On March 25, 2024 the Company entered into a settlement agreement whereby the Company was required to pay Lingmed $ 0.5 million within 30 days of the effective date and the Company effected payment on April 4, 2024. Lingmed is also entitled to 5.0 % of any future milestone payments received by the Company under the license agreement with Qilu in addition to a sum of $ 250 thousand with respect to the first future milestone received by the Company. On April 9, 2024, pursuant to the parties’ joint request, the Court entered a dismissal with prejudice of the entire action as to all parties and all claims and the matter was settled. Note 15 – Technology Transfer Agreement Impilo Therapeutics In July 2023, the Company entered into a technology transfer agreement with Impilo Therapeutics (“Impilo”) under which the Company transferred its rights to its tumor penetrating nanocomplex (TPN) platform to Impilo. As consideration for the technology transfer, Impilo issued a total of 766,000 shares of its pre-seed preferred stock to the Company. On October 3, 2023, in connection with the Sanford Burnham Prebys license agreement (see Note 16 - License Agreements) Impilo cancelled the original stock certificate for 766,000 shares and reissued 574,500 shares of its pre-seed preferred stock to the Company. On March 15, 2024, the Company purchased a Simple Agreement for Future Equity (“SAFE”) from Impilo for $ 100 thousand. On July 12, 2024, the Company purchased an additional SAFE from Impilo for $ 30 thousand. As of September 30, 2025 and December 31, 2024, the Company owned 38.6 % of Impilo. These investments were expensed under the equity method of accounting in the prior year in other expense, net in the accompanying statement of operations. The SAFE has a valuation cap of $ 30.0 million and an 80 % discount rate. 26 Index Note 16 – License Agreements Sanford Burnham Prebys In December 2015, Cend entered into a license agreement with Sanford Burnham Prebys (“SBP”) under which Cend was granted an exclusive, worldwide, royalty-bearing license to certain patent rights and know-how controlled by SBP related to the development of certepetide. At the time the license agreement was entered into, Cend’s founding shareholder was an executive at SBP. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. As consideration for the license, Cend issued a total of 382,030 shares of common stock, as adjusted for the Reverse Stock Split and Exchange Ratio. The Company is required to pay an annual license maintenance fee of $ 10 thousand increasing to $ 20 thousand on year seven of the agreement. The Company could also be required to make milestone payments to SBP upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $ 10.6 million. The Company has also agreed to pay SBP royalties of 4 % of net sales of products sold by the Company, or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay SBP 25 % of any sublicensing income received, which, pursuant to the technology transfer agreement with Impilo, resulted in SBP receiving 191,500 shares of the Company’s pre-seed preferred stock in Impilo on October 3, 2023. The agreement will expire upon the later of (i) the final abandonment of all pending patent applications within the licensed patents or (ii) the expiration of the last to expire patent within the licensed patents. The agreement may be terminated in its entirety by the Company at any time by giving SBP sixty days’ prior written notice. The agreement may be terminated in its entirety by SBP if the Company, at any time, defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice. The agreement may be terminated in its entirety by either SBP or the Company (i) in the event of an uncured material breach by the other party, or (ii) in the event the other party (a) files for, or is involuntarily petitioned with, bankruptcy (other than dissolution or winding up for the purposes of reconstruction or amalgamation), (b) makes an assignment of all or substantially all of its assets for the benefit of creditors, or (c) has a receiver or trustee is appointed and is unable to secure a dismissal, stay or other suspension of such proceedings within thirty days. Upon termination of the agreement for any reason, all rights and obligations of the Company with respect to the patents and patent applications shall terminate and revert to SBP. SBP did no t own shares of the Company’s common stock as of September 30, 2025. Note 17 – Research Collaboration and License Agreements Exclusive License and Collaboration Agreement - Qilu Pharmaceutical In February 2021, Cend entered into an Exclusive License and Collaboration Agreement (the “Qilu Agreement”) in which Cend granted an exclusive license to Qilu for the development and commercialization of certepetide in the Territory (defined as the Greater Area of China including China, Macau, Hong Kong, and Taiwan). Under the terms of the agreement, Qilu is solely responsible for the development of certepetide in its Territory. In consideration for the license, Qilu made an upfront payment of $ 10.0 million to Cend, which was recognized as revenue by Cend prior to the Company's acquisition of Cend on September 15, 2022 (the “Cend Merger”). In addition, Cend received and recognized as revenue a $ 5.0 million development milestone prior to the Cend Merger. The Company is eligible to receive additional development and commercial milestone payments up to $ 96.0 million and $ 125.0 million, respectively, tiered royalties on net sales ranging from 10 % to 15 %, and tiered sublicensing revenues ranging from 12 % to 35 %. On March 25, 2024, the Company entered into a settlement agreement with Lingmed whereby Lingmed is entitled to 5.0 % of any future milestone payments received by the Company under the Qilu Agreement. In addition, Lingmed is entitled to a sum of $ 250 thousand with respect to the first future milestone received by the Company. Unless terminated early, the Qilu Agreement will continue in effect until the expiration of all Qilu payment obligations. Either party may terminate the Qilu Agreement if an undisputed material breach by the other party is not cured within a defined period of time, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period. Qilu may terminate the Qilu Agreement in its entirety, at any time with at least sixty days written notice. All rights and obligations of Qilu with respect to such licensed patents and patent applications would terminate simultaneously. Exclusive License and Collaboration Agreement - Kuva Labs In November 2024, the Company entered into an Exclusive License and Collaboration Agreement in which the Company granted an exclusive license to Kuva Labs, Inc. (Kuva) to explore the synergistic potential of the Company's certepetide as a targeting and delivery agent for Kuva’s NanoMark™ imaging technology in solid tumors. Under the Agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while the Company will be responsible for 27 Index supplying certepetide for additional consideration pursuant to a Clinical Supply Agreement. In consideration for the license, the Company recognized $ 1.0 million as revenue upon delivery of the license in November 2024. The Company is eligible to receive additional development and commercial milestone payments up to $ 1.5 million and $ 17.5 million, respectively, a 5.0 % percent royalty on net sales, and sublicensing revenues of 50 %. Note 18 – Subsequent Events Non-Exclusive License Agreement On October 8, 2025, the Company entered into a worldwide Non-Exclusive License Agreement (the “Non-Exclusive License Agreement” or the “Agreement”) with Catalent, Inc. (“Catalent”), pursuant to which the Company granted to Catalent, on a non-exclusive basis, certain of its intellectual property to exploit use of the Company’s novel iRGD cyclic peptide, certepetide, as an antibody drug conjugate (ADC) payload as part of Catalent’s SMARTag ® ADC platform. Under the Agreement, Catalent will assume full responsibility for research, development, and commercialization costs. In connection with entering into the Non-Exclusive License Agreement, the Company is eligible to receive pre-determined development milestone payments of up to $ 10.5 million in the aggregate. The Company is also eligible to receive tiered revenue sharing on future sales and/or partnerships, subject to specified royalty reductions as set forth in the Agreement, as well as a portion of any sublicense consideration received from the grant of any sublicense or similar rights under any of the rights or licenses granted to Catalent under the Agreement. The Agreement will remain in effect until it expires on a product-by-product and country-by-country basis at the end of the royalty term. Either party may terminate the Agreement upon the other party’s material breach, subject to specified notice and cure provisions, as well as resulting from the bankruptcy or insolvency of the other party. Catalent may also terminate the Agreement in its entirety at any time by giving the Company at least thirty (30) days prior written notice. In connection with the Agreement, Catalent has agreed to grant the Company a right of first negotiation for a license, in the event Catalent initiates a specific, organized out-licensing process of an asset resulting from the Agreement. 28 Index