RenovoRx, Inc.

1. Business and Principal Activities

Description of Business

RenovoRx, Inc. (the “Company”, "RenovoRx", "we", "us", "our" or similar terminology) was incorporated in the state of Delaware in December 2012 and operates from its headquarters in Mountain View, California.

The Company is a life sciences company commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared device for local drug delivery designed to address significant unmet medical needs, with a focus on difficult-to-treat tumors. The Company is also evaluating intra-arterial gemcitabine (known as "IAG") delivered via RenovoCath using RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) platform as a novel drug-device product candidate for difficult-to-treat locally advanced pancreatic cancer ("LAPC").

The Company's patented TAMP platform, enabled by RenovoCath, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor locally, while potentially minimizing a therapy’s toxicities versus systemic intravenous chemotherapy. The Company's novel approach to targeted drug-delivery offers the potential for increased tolerance and improved safety and efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

The Company is actively commercializing the TAMP platform and RenovoCath as a stand-alone device. The Company's commercial model is currently focused on active commercial cancer center customer expansion, with additional centers driving increased procedures and revenue growth. The Company defines "active" commercial cancer center customers as centers where doctors are actively treating patients with RenovoCath.

Until 2025, the Company primarily focused on evaluating IAG delivered via RenovoCath, through its ongoing Phase III TIGeR-PaC study for LAPC. IAG is currently under investigation and has not been approved for commercial sale. IAG received Orphan Drug Designation ("ODD") for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. In the second quarter of 2026, the Company was granted an additional ODD for oxaliplatin for the treatment of pancreatic cancer.

The Company continues to advance broader clinical programs by generating new data through its continued support of registry studies and investigator-initiated trials ("IITs") in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in the TIGeR-PaC study), and use of TAMP in other solid tumors. In the second quarter of 2026, the Company began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, with institutional review board (“IRB”) submission expected by year end 2026. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP platform which is enabled by RenovoCath.

Liquidity and Capital Resources

From the Company’s inception through September 30, 2026, it has raised an aggregate of approximately $84.9 million from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in the Company’s August 2021 initial public offering (the “IPO”), other registered equity financings, and the exercise of warrants and common stock options. As of September 30, 2026, the Company had cash and cash equivalents of approximately$10.4 million.

The Company has incurred significant losses and negative cash flows from operations since its inception. For the nine months ended September 30, 2026, the Company reported a net loss of$10.1 million and an accumulated deficit of$71.5 million and does not expect to generate positive cash flows from operations in the near future. The Company expects to incur significant losses until revenues from RenovoCath sales grow and outpace cash and non-cash expenses. Losses may also continue until regulatory approval is granted for the Company's lead product candidate, IAG, and until IAG is commercially launched and revenues are generated from sales of IAG, all of which, with respect to IAG, will not occur for several years. The Company faces the risk that commercial sales of RenovoCath will not grow as anticipated, and regulatory approval of IAG is not guaranteed and may never be obtained.

The Company believes it will be able, if and when necessary, to raise additional capital through debt financings, private or public equity financings, exercise of outstanding common stock warrants, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available if and when needed or will be at terms acceptable to the Company. The inability to raise capital as and when needed would have a negative impact on the Company’s liquidity financial condition and its ability to pursue its business strategy. The Company will need to generate significant revenue to achieve positive cash flows and profitability, and it may never do so.

On October 16, 2026, the Company filed on Form RW, requesting SEC consent to the withdrawal of the Company's universal Registration Statement on Form S-3 filed on November 14, 2025. Such Registration Statement was never declared effective, and no securities were sold in connection under such Registration Statement. The Company will reconsider filing a new universal Form S-3 to allow the Company to access capital via this method.

The accompanying unaudited condensed interim financial statements have been prepared assuming that the Company will continue as a going concern and has reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, negative cash flows from operations, including cash requirements for the upcoming year, funding capacity, net working capital, total stockholders’ equity and future access to capital. Based upon this review and the Company’s current financial condition, the Company has concluded its current cash and cash equivalents will be sufficient to fund its operations through at least the next 12 months from the issuance of these condensed interim financial statements.

2. Summary of Significant Accounting Policies

Basis of Presentation and Unaudited Condensed Interim Financial Information

The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in unaudited condensed interim financial statements prepared in accordance with GAAP have been condensed or omitted. The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The condensed balance sheet as of December 31, 2025 is derived from the Company’s audited financial statements. The results of operations for the three and nine months ended September 30, 2026, are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any other future annual or interim period. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

There have been no material changes to the significant accounting policies during the nine months ended September 30, 2026, from those previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 30, 2026 (as amended, the “2025 Annual Report”).

For the nine months ended September 30, 2026, the Company established a Sales Commissions Plan (the “Plan”). The Company incurs incremental costs to obtain customer contracts, primarily in the form of sales commissions. The Company capitalizes such costs when they are expected to be recovered and amortizes the resulting asset over the period of expected benefit. The Company applies the practical expedient under ASC 340-40 to expense such costs when the amortization period that otherwise would have been recognized is one year or less. For the nine months ended September 30, 2026, costs subject to capitalization with an expected benefit greater than one year were not material, and no material contract cost asset was recognized as of September 30, 2026.

Risks and Uncertainties

The Company and its business are subject to a number of significant risks associated with clinical-stage and early commercial stage life science companies, including the risks associated with (i) its relatively early stage commercialization efforts for RenovoCath, (ii) the development of IAG or other product candidates that must receive regulatory approval before market launch, (iii) possible failure of current or future preclinical studies or clinical trials, (iv) dependence on key third parties such as device manufacturers and providers of clinical trial administration services; (v) the need to obtain and maintain insurance coding for its products and product candidates, (vi) dependence on key officer and employees, (vii) competition from larger and more established companies, (viii) obtaining and maintaining intellectual property protections, (ix) changes in the Company’s technology or industry, (x) volatility in the public capital markets and the Company’s ability to maintain the listing of its common stock on Nasdaq, (xi) the Company’s ability to obtain adequate financing when needed to support the Company’s business plan, (xii) the ability to attract and retain additional qualified personnel to manage the anticipated growth of the Company and (xiii) general economic and political conditions.

Use of Estimates

The preparation of the condensed interim financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, income and expenses as well as the disclosure of contingent assets and liabilities, at the date of the condensed interim financial statements during the reporting periods. In preparing these condensed interim financial statements, management has made its best estimates and judgments of certain amounts included in the condensed interim financial statements. Significant estimates and assumptions made in the accompanying condensed interim financial statements include, but are not limited to, accruals of certain liabilities, including clinical trial accruals and other contingencies, the valuation of financial instruments, the fair value of the Company’s common stock warrants and the fair value of options granted under the Company’s equity incentive plan. On an ongoing basis, the Company evaluates its estimates, including those related to the fair values of assets, stock-based compensation, clinical trial accruals and other contingencies. Management bases its estimates on historical experience or on various other assumptions that it believes to be reasonable under the circumstances. Actual results could differ materially from these estimates.

Emerging Growth Company and Smaller Reporting Company Status

The Company is currently an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from complying with new or revised financial accounting standards until private companies are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards. The Company will lose its status as an emerging growth company status as of December 31, 2026, the last day of the fiscal year following the fifth anniversary of the closing of its IPO in August 2021.

The Company is also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act. If the Company is a smaller reporting company at the time the Company ceases to be an emerging growth company, the Company may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, the Company may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.

Recently Issued and Adopted Accounting Pronouncements

There were no new accounting pronouncements that were issued or became effective since the issuance of the 2025 Annual Report that had, or are expected to have, a material impact on our unaudited condensed balance sheets, unaudited condensed statement of operations or unaudited condensed statement of cash flows.

The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting pronouncements issued through the date of this report will have a material impact on the Company’s condensed interim financial statements.

3. Inventory

Inventory as of September 30, 2026 and December 31, 2025 at$341,000 and$189,000, respectively, consists of RenovoCath finished goods manufactured under contract by the Company’s third-party RenovoCath manufacturer. Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the condensed balance sheets. The Company periodically reviews its inventory to identify obsolete, slow-moving, or otherwise unsalable inventories based on ongoing assessments of market conditions, technological advancements, and historical sales patterns, and establishes allowances for situations in which the cost of the inventory is not expected to be recovered. Based on the Company’s assessment, no reserves were deemed necessary to be established for inventory, as of September 30, 2026 and December 31, 2025, respectively.

4. Property and Equipment, Net

Property and equipment, net are as follows (in thousands):

During the nine months ended September 30, 2026, the Company purchased approximately$90,000 in property and equipment and recorded a loss of disposition of assets of approximately$2,000.

Depreciation is computed on a straight-line basis over the estimated useful lives of the assets. The useful life for furniture and equipment isseven years.

Depreciation expense for the nine months ended September 30, 2026, was approximately$11,000.

5. Accrued Expenses

The components of accrued expenses are as follows (in thousands):

6. Fair Value Measurements

As of September 30, 2026 and December 31, 2025, the Company held cash equivalents of$10.0 million and$6.6 million, respectively, in a money market account.

The following tables summarize the Company’s financial assets and liabilities, measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):

There were no transfers between Level 1, Level 2 or Level 3 during the periods presented. The Company had no other financial assets or liabilities that were required to be measured at fair value on a recurring basis.

Common Stock Warrants Liability, Changes on Level 3 Liabilities Measured at Fair Value on a Recurring Basis

The following table reflects the change in the Company’s Level 3 common stock warrant liability for thenine months ended September 30, 2026 (in thousands):

The Company remeasures the fair value of its common stock warrant liability at each reporting date. The fair value of the common stock warrants was determined using a probability weighted scenario method with a Monte Carlo simulation and Black-Scholes model. The scenario-based method estimates the fair value of the Company’s common stock warrants by considering various outcomes as assessed by the Company. Quantitative elements associated with the inputs impacting the fair value measurement of the common stock warrants include the underlying fair value of common stock, timing of the expected scenarios, risk-free rate, and volatility of the Company’s shares. The risk-free rate is determined by reference to the U.S. Treasury yield curve for the respective time periods based on the remaining contractual term of the warrants. The volatility is based on the historical volatility of the Company’s stock. The Monte Carlo simulation projects the Company’s volume weighted average stock price based on the various fundamental transaction scenarios considered and utilizes a Black-Scholes model to value the warrants within these scenarios.

The following table details the assumptions used in the Monte Carlo simulation to estimate the fair value of the common stock warrant liability:

The Company had no other financial assets or liabilities that were required to be measured at fair value on a recurring basis.

7. Leases, Commitments and Contingencies

Operating Leases

On April 1, 2026, the Company terminated its existing lease agreement, without penalty, and entered into a 33-month non-cancelable operating lease for different space within the same office building , commencing on April 1, 2026, and ending on December 31, 2028. The lease has a one-time option to renew the term for an extension period of 36 months.

Classification of the Company’s operating lease on the condensed balance sheets are as follows (in thousands):

The current operating lease of$133,000 is classified as an accrued expense on the condensed balance sheet, see “Note 5. Accrued Expenses” in Notes to Condensed Interim Financial Statements.

Lease expense and cash paid by lease type that was recognized during thethree and nine months ended September 30, 2026 and 2025 are as follows (in thousands):

The minimum lease payments are expected to be as follows for the years ending December 31, (in thousands):

The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate of 6.75% based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. As of September 30, 2026, the Company had a remaining lease term of 2.25 years.

Commercial Supply Agreement

The Company entered into a Supply Agreement with Medical Murray, Inc., the Company’s primary third-party RenovoCath manufacturer ("Medical Murray"), with an effective date of June 5, 2025. Under the supply agreement, the Company has agreed to purchase certain minimum order quantities of the Company’s RenovoCath device, based on issued purchase orders modified for limited cancellations or delays as provided in the supply agreement. The Company recognizes the release of RenovoCath devices from Medical Murray as finished goods and records as inventory.

The supply agreement has an initial three-year term, with an automatic one-year renewal unless either party provides written notice of termination at least 30 days prior to the expiration date. The supply agreement may be terminated by either party in the event of a force majeure, bankruptcy or insolvency of the other party, and uncured material breach. The Company may terminate the supply agreement if RenovoCath is withdrawn or suspended by a government authority. In addition, either party may terminate for convenience with one-year written notice. In the event of early termination, the Company is obligated to pay the shortfall commitment as of the date of termination.

As of September 30, 2026, the value of the Company’s outstanding non-cancellable purchase commitments associated with the supply agreement is approximately $1.8 million, consisting of two separate purchase commitments for the RenovoCath device.

Warranties

The Company generally provides warranties for its products from manufacturing defects on a limited basis for a period of 60 days to 30 months. During the term of the warranty, if the device fails to operate properly from defects in materials and workmanship, the Company will replace the defective product.

The Company estimates the costs that it may incur under its warranty program based on the number of units sold, historical and anticipated rates of warranty claims, and cost per claim. The Company has experienced minimal warranty claims to date, and significant warranty claims are not expected, and accordinglyno liability for warranty claims was recorded for thethree and nine months ended September 30, 2026, and year ended December 31, 2025.

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. The Company was not subject to any material legal proceedings during three and nine months ended September 30, 2026, and no material legal proceedings are subsequently outstanding or pending.

Guarantees and Indemnification

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. As permitted under Delaware law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its officers and directors. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments that the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company is not currently aware of any indemnification claims. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of September 30, 2026.

8. Equity Incentive Plan – Stock-Based Compensation Expense

2021 Omnibus Equity Incentive Plan

On July 19, 2021, the Company’s Board of Directors (the “Board”) adopted the RenovoRx, Inc. 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). The 2021 Plan, which became effective immediately prior to the closing of the IPO, initially reserved 2,185,832 shares of common stock, which included 10,832 shares of common stock reserved but unissued under the Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”). The Company’s 2013 Plan was terminated immediately prior to the closing of the IPO; however, shares subject to awards granted under the 2013 Plan continued to be governed by the 2013 Plan. In accordance with the terms of the 2021 Plan, on January 1, 2026, the number of shares reserved and available for issuance increased by 1,830,696 shares.

The Company accounts for stock-based compensation to employees, consultants and non-employee directors in accordance with ASC Topic 718, Compensation – Stock Compensation. The Company estimates the fair value of stock option awards using the Black-Scholes option pricing model on the date of grant using the assumptions in the table below. Stock options granted to employees and consultants generally vest over four years and have a term of ten years. Stock-based compensation expense for stock options is recognized as expense over the requisite service period, which is the vesting period. As the Company has not paid dividends since inception, nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is zero. The expected volatility is estimated based on the historical stock volatility of the Company’s own common stock over a period equal to the expected term of the options including by taking the average historic price volatility for industry peers, consisting of several public companies in the Company’s industry that are either similar in size, stage, or financial leverage, over a period equivalent to the expected term of the awards. The risk-free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options.

On April 16, 2026, the Board approved an amendment to the 2021 Plan to add 2,000,000 shares of common stock to the total number of shares of common stock reserved and available for issuance under the 2021 Plan, which amendment was subsequently approved by the Company's stockholders at the Company's 2026 annual meeting of stockholders held on June 30, 2026.

A summary of the stock option activity for thenine months ended September 30, 2026 is as follows:

As of September 30, 2026, there was $3.1 million of unrecognized stock-based compensation expense related to options granted but not yet amortized, which will be recognized over a weighted-average period of approximately 2.79 years.

For the nine months ended September 30, 2026 and 2025, the Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock option granted. The Company estimated the fair value of each option grant on the grant date using the Black-Scholes option pricing model with the following weighted-average assumptions:

The following table summarizes the components of stock-based compensation expense recognized in the Company’s Condensed Statements of Operations during thethree and nine months ended September 30, 2026 and 2025 (in thousands):

Restricted Stock Units and Restricted Stock Awards Issued for Services

Restricted stock units (“RSU”) are valued based on the closing price of the Company’s common stock on the date of the grant. The fair value of RSU is recognized and amortized on a straight-line basis over the requisite service period of the award.

A summary of the restricted stock units activity for thenine months ended September 30, 2026 is as follows:

As of September 30, 2026, there was $143,000 of total unrecognized compensation cost related to unvested RSUs, which the Company expects to recognize over a remaining weighted-average period of approximately 1.42 years.

The compensation expense is allocated on a departmental basis, based on the classification of the option holder. No income tax benefits have been recognized in the statements of operations and comprehensive loss for stock-based compensation arrangements.

9. Common Stock Warrants

On March 17, 2026, the Company entered into a securities purchase agreement (the “March 2026 Securities Purchase Agreement”) in connection with a private placement offering by the Company (the “March 2026 Offering”) to 15 accredited investors or qualified institutional buyers (the “Investors”), five of whom are directors, officers or employees of the Company (the “Insiders”) and the remaining are non-affiliated institutional investors (the “Institutional Investors”). The March 2026 Offering closed on March 20, 2026.

Pursuant to the March 2026 Securities Purchase Agreement, in connection with the March 2026 Offering, the Company sold to the Investors an aggregate of: (i)8,438,790 shares of common stock, (ii) pre-funded warrants to purchase an aggregate of 2,200,000 shares of common stock and (iii) revenue milestone warrants (with an exercise price per share of $1.751 for the Institutional Investors and $1.9326 for the Insiders) to purchase an aggregate of 5,319,392 shares of common stock (the “Milestone Warrants”), representing 50% warrant coverage for aggregate gross proceeds of approximately $10.0 million, before deducting placement agent fees and expenses payable by the Company. The purchase price paid by the Institutional Investors for each Share and related Milestone Warrant was $0.938. To comply with Nasdaq Stock Market rules, the purchase price paid by the Insiders for each Share and related Milestone Warrant was $1.0288.

During August and September 2026, given a rise in the prevailing market prices for the Company's common stock, outstanding warrants to purchase an aggregate of 2,858,609 shares of the Company's common stock were exercised for cash by the holders thereof (excluding warrants to purchase 491,923 shares of the Company's common stock that were exercised on a cashless basis). As of September 30, 2026, these common stock warrants exercises generated gross proceeds of approximately $3.5 million.

In April 2026, the April 2024 two-year Series B warrants to purchase up to an aggregate of 3,956,182 shares of common stock expired. During July 2026,225,000 performance-based warrants for Medical Murray expired. The initial warrants became exercisable over time in tranches and was contingent upon the achievement of specific manufacturing milestones by Medical Murray. During August 2026, the Company’s five-year initial public offering ("the IPO") common warrants of 2,786,995, underwriter and private warrants, expired. Cash exercise of these warrants were only expected to occur when the trading price of the common stock was in excess of the $10.80 per share exercise price of such outstanding warrants.

The following table is a summary of the common stock warrants activity during thenine months ended September 30, 2026.

10. Income Taxes

The Company hadno income tax expense for thenine months ended September 30, 2026. The Company’s effective income tax rate was 0% for thethree and nine months ended September 30, 2026 and 2025. During the nine months ended September 30, 2026 and 2025, the Company had a net operating loss (“NOL”) for each period that generated deferred tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences between the financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, the Company has determined that it is more likely than not that these deferred tax assets will not be realized. Accordingly, the Company has established a full valuation allowance against its deferred tax assets as of September 30, 2026.

The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. For the nine months ended September 30, 2026 and 2025, the Company hadno accrued interest or penalties related to uncertain tax positions.

11. Net Loss Per Share

Basic and diluted net loss per share of common stock was calculated as follows (in thousands except per share amounts):

For the three and nine months ended September 30, 2026 and 2025, the Company had a net loss and as such, all outstanding shares of potentially dilutive securities were excluded from the calculation of diluted net loss per share as the inclusion would be anti-dilutive.

Potentially dilutive securities not included in the computation of diluted net loss per share because to do so would be antidilutive are as follows (in common stock equivalent shares):

12. Segment Information

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision maker (the "CODM") in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as asingle reporting segment, focused on developing novel targeted oncology therapies and offering RenovoCath delivery system as stand-alone device targeting high unmet medical needs. The Company’s measure of segment profit or loss is net loss. The CODM is the Company's Chief Executive Officer (the "CEO"). The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a company basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions, clinical, manufacturing and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The CODM also uses net loss in competitive analysis by benchmarking to the Company’s peer group. The competitive analysis along with the monitoring of budgeted versus actual results are used in assessing performance of the segment. All the Company’s assets are held in the United States and all the Company’s revenues are derived from the United States.

The following table is representative of revenue and significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment (in thousands):

(1)

Includes external research expenses, clinical studies, manufacturing including manufacturing and non-recurring engineering costs, professional and consulting, regulatory, and trade shows for 2026.

(2)

Includes selling, general and administrative expenses for professional and consulting expenses, audit fees, board fees, legal expenses, insurance expenses, travel, marketing expenses for 2026 and other office expenses.

(3)

Includes interest income and interest expense and gain recognized on the fair value of common stock warrant liability.

Major Customers

For the three and nine months ended September 30, 2026, four cancer center customers for the Company's RenovoCath device, (referred to for these purposes as Customers A, B, C, and D) each accounted for more than 10% of the Company's total revenue. For thethree months ended September 30, 2026, Customers A, and B accounted for approximately 21.6%,and 12.0%, respectively. For thenine months ended September 30, 2026, Customers C, and D accounted for approximately 15.5%, and 10.8%, respectively.

For the three and nine months ended September 30, 2025, five cancer center customers for the Company's RenovoCath device (referred to for these purposes as Customers A, B, C, D, and E) each accounted for more than 10% of the Company's total revenue. For thethree months ended September 30, 2025, Customers A, and B, accounted for approximately 45.2%, and 25.8%, respectively, while Customers C and D each accounted for 12.9%. For thenine months ended September 30, 2025, Customers A, B, C, and E accounted for approximately 27.1%,22.2%,20.3%, and 10.6%, respectively.

13. Related Party Transactions

Dr. Ramtin Agah has served as the Company’s Chief Medical Officer and Co-Founder since December 2009, as Chairman of the Board since May 2018. In January 2018, the Company entered into a consulting agreement with Dr. Agah pursuant to which Dr. Agah provides monthly consulting services as the Company’s Chief Medical Officer by overseeing Company-sponsored clinical trials. Since 2018, the Company has amended Dr. Agah’s consulting agreement and may, in the Company’s discretion, proportionally adjust the monthly consulting fee if Dr. Agah’s time commitment increases or decreases. The consulting agreement may be terminated by either party on 30 days’ notice. The consulting agreement amendment also provides for Dr. Agah’s eligibility for an annual target cash incentive bonus equal to 40% of his annualized base consulting fee. In November 2025, the Company amended and restated the Change in Control and Severance Agreement with Dr. Agah. In January 2024, Dr. Agah was awarded options to purchase 125,132 shares of the Company’s common stock, vesting monthly over four years. In addition, in January 2024, Dr. Agah was awarded 28,424 shares of fully vested options to purchase the Company’s common stock. In April and July 2025, Dr. Agah was awarded options to purchase 254,542 and 63,636 shares, respectively, of the Company’s common stock vesting monthly over four years. Consulting fees paid to Dr. Agah for the years ended December 31, 2025 were $337,000. In addition, the Board approved a discretionary bonus to Dr. Agah in recognition of Company and individual performance during the periods ended March 31, 2026 and December 31, 2025, of $96,000 and $121,000, respectively.

On March 24, 2026, the Board appointed Dr. Agah to the newly created position of Executive Chairman, effective February 27, 2026. In connection with his roles as Chief Medical Officer and Executive Chairman, Dr. Agah accepted an offer letter from the Company on the same date (the “Agah Offer Letter”) to amend, restate and replace certain Consulting Agreement, dated January 1, 2018, between Dr. Agah and the Company. Dr. Agah acknowledged that certain Amended and Restated Change in Control and Severance Agreement, dated November 10, 2025, between the Company and Dr. Agah, remained in full force and effect.