RNXT US Equity☆

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations for our fiscal year ended December 31, 2025 should be read in conjunction with Item 1. Business and our financial statements and related notes thereto included in Part II, Item 8, “Financial Statements and Supplementary Data,” included elsewhere in this Annual Report on Form 10-K. All information presented herein is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ended December 31 and the associated quarters, months and periods of those fiscal years.

Some of the information contained in this discussion and analysis or set forth elsewhere in this Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involves risks and uncertainties. See “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements.

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. As used herein, the term “common stock” refers to our common stock, par value $0.0001 per share.

Overview

We are a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared local drug-delivery device, targeting high unmet medical needs. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

RenovoCath utilizes our patented TAMPTM therapy platform, which is designed for targeted therapeutic delivery across the arterial wall near the tumor site (known as intra-arterial , or IA delivery) to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

We are actively commercializing the Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform and RenovoCath as a stand-alone device within its FDA cleared fields of use. We are in the relatively early stages of commercializing RenovoCath in the United States, have received our first commercial purchase orders for RenovoCath devices in December 2024. For the year ended December 31, 2025, we generated revenue from RenovoCath sales, primarily from U.S. cancer centers that initiated repeat orders as well as new institutions adopting the device. In February 2026, we announced continued commercial progress, with 12 U.S. cancer centers utilizing the RenovoCath and 21 additional centers are evaluating the device, or have completed evaluation, or, are preparing for activation.

We are also evaluating our novel drug-device combination oncology product candidate (IA delivery of the FDA-approved chemotherapy gemcitabine via RenovoCath, which we call IAG) in our ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Our IAG combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.

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Beyond LAPC, we believe there are many clinical applications for RenovoCath to improve targeted delivery of therapeutic agents. These potential applications have shaped our market development efforts, including the launch of a cost-effective post-market registry study and support of investigator-initiated trials to generate additional data for both clinical and commercial advancement. We continue to expand these broader clinical programs through post-marketing registry studies in solid tumors and ongoing IITs in borderline resectable and metastatic pancreatic cancer, while also exploring physician interest in other areas. These registry and IIT studies are designed to be capital-efficient and cost-neutral, producing meaningful data that may further broaden the application of TAMP, alongside ongoing discussions with prospective customers and potential distribution partners.

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of December 31, 2025, we had cash and cash equivalents of $7.0 million (although we raised an additional $10.0 million in gross proceeds through a private placement offering completed in March 2026). We had net losses of $11.2 million and $8.8 million for the years ended December 31, 2025, and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $61.4 million. We expect to continue to incur significant expenses as we seek to grow our revenues from RenovoCath commercial sales, reduce cash burn, and advance toward the goal of achieving cash-flow breakeven operations. As we work to achieve these goals, we expect to continue to incur operating losses. We will not generate revenues from IAG sales unless and until we successfully complete development and obtain regulatory approval for IAG or another product candidate. Given economic and market conditions and timing of regulatory approval, we expect that our expenses could increase, particularly if and when we decide to:

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Advance clinical development of IAG and our platform technology by continuing to enroll patients in our ongoing Phase III TIGeR-PaC clinical trial, expand our post marketing RR5 Study, and advance IAG through other preclinical and clinical pipeline indication opportunities beyond LAPC;

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Make investments as necessary to expand our commercial sales operation for RenovoCath (including expenses related to salaries, bonuses and equity compensation);

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Hire additional personnel as necessary beyond sales and marketing;

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Pursue collaborations, licensing arrangements or other strategic or commercial activities relating to our product candidates or technology;

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Maintain, expand, enforce, defend, and protect our intellectual property portfolio; and

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Expand our operational, financial and management systems.

In addition to the variables described above, if and when IAG or any of our product candidates successfully complete development and FDA approval, we will incur substantial additional costs associated with establishing a distribution infrastructure and incur other expense needed to commercialize IAG as its own product, which will be in addition to the costs incurred and to be incurred in commercializing RenovoCath as a standalone device. We cannot reasonably estimate these costs at this time as we will not even achieve final results from our Phase III TIGeR-PaC clinical trial for IAG until 2027.

Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, even after taking into account the $10.0 million in gross proceeds we received from our recent March 2026 private placement (the “March 2026 Private Placement”), we will likely be required to raise additional capital to complete the development of IAG (or any other product candidates) and expand commercialization of RenovoCath. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.

Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by

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entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operations.

Our financial statements as of December 31, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report (after taking into account the March 2026 Private Placement) will be sufficient to fund our operating, investing and financing cash flow needs for at least the next 12 months from the date of issuance of the report, assuming our programs advance as currently contemplated.

However, until such time, if ever, as we can generate substantial product revenue and generate positive cash flows, there is a risk that we may need to again finance our cash needs through private or public equity financings, debt financings and collaborations, licenses or other similar arrangements. We currently have no credit facility or committed sources of capital other than our “at-the-market” offering program through Jones Trading as sales agent (however, pursuant to the terms of the March 2026 Private Placement, we are prohibited from using such offering program 275 days from the effectiveness of the registration statement registering the securities issued in the March 2026 Private Placement). To the extent that we raise additional capital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would restrict our operations. We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future, we may have to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through private or public equity financings or debt financings when needed, we may be required to delay, limit, reduce or terminate development or future commercialization efforts, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements, and our shareholders may lose their entire investment in our common stock.

Further, on December 31, 2025, we received a letter from the Listing Qualifications Staff of the Nasdaq Stock Market, LLC (“Nasdaq”) indicating that we are not in compliance with the requirement to maintain a minimum bid price of $1.00 per share required for continued listing on Nasdaq. We have until the end of June 2026 to regain compliance with this requirement, which may be extended for 180 days. We may be required to effectuate a reverse stock split to regain compliance with the minimum bid price requirement, although this is not our desired course of action. If we do not regain compliance and continue to not meet such requirement or any other continued listing requirements of Nasdaq, our common stock may be delisted, which could affect the market price and liquidity for our common stock and reduce our ability to raise additional capital and otherwise properly function as a public company.

Components of Our Results of Operations

Revenue

In the fourth quarter of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025. We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. We have not experienced any product returns to date, and accordingly no allowance for returns was recorded for the year ended December 31, 2025.

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Cost of Revenue

Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, Inc. our third-party RenovoCath manufacturer. Prior to the commercialization of RenovoCath, all costs of manufacturing to produce the RenovoCath devices were allocated to our TIGeR-PaC Phase III clinical trial study in prior periods and expensed as research and development. The cost for RenovoCath devices not associated with the TIGeR-PaC study represents primarily third-party manufacturing costs and shipping and handling costs when applicable.

Operating Expenses

Research and Development

Research and development expenses consist of costs related to the research and development of our TAMP technology and our ongoing clinical trial. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors and consultants. We outsource a substantial portion of our clinical trial activities, having utilized the services of third-party clinical trial sites and contract research organizations to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath delivery device, which comprises part of our IAG product candidate. Accordingly, we are able to charge our clinical trial sites for the RenovoCath delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices offset our research and development expenses. We expect our research and development expenses to increase for the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate other new clinical trials, post marketing RR5 study, and pursue regulatory approval of our product candidates. It is difficult to predict with any certainty the duration and costs of completing our current or future clinical trials of our product candidates or if, when or to what extent we will achieve regulatory approval and generate revenue from the commercialization and sale of our product candidates. The duration, costs and timing of clinical trials and other development of our product candidates will depend on a variety of factors, including uncertainties in clinical trial enrollment, timing and extent of future clinical trials, development of new product candidates and significant and changing government regulation. We may never succeed in achieving regulatory approval for any of our product candidates.

Our research and development expenses include:

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expenses incurred under agreements with clinical trial sites, contract research organizations, and consultants that are involved in conducting our clinical trials;

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costs of acquiring and developing clinical trial materials;

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personnel costs, including salaries, benefits, bonuses, and stock-based compensation for employees engaged in preclinical and clinical research and development;

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costs related to compliance with regulatory requirements;

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third-party vendor costs related to manufacturing materials and testing to develop the next generation of our delivery device, RenovoCath, including additional non-recurring engineering costs;

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costs related to preclinical studies and pilot testing;

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travel expenses; and

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allocated selling, general and administrative expenses which includes facilities and other indirect administrative expenses including employee-related overhead expenses as salaries, stock-based compensation and travel to support research and development activities.

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Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and animal studies, are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by third party vendors.

Selling, General and Administrative

Selling, general and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrative functions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property and other matters, consulting costs, conferences, travel and allocated expenses for rent, insurance and other general overhead costs. We expect to continue to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations of the Securities and Exchange Commission, or SEC, and Nasdaq listing standards and increased expenses in the areas of insurance, professional services and investor relations. As a result, we expect our selling, general and administrative expenses to increase in the foreseeable future. Selling, general and administrative expenses are expensed as incurred.

Other Income, Net

Interest Income, Net

Interest expense consists of expense for the amortization of Directors and Officers liability insurance premiums.

Interest income is earned from cash deposited in our short-term marketable securities and money market account.

Change in Fair Value of Warrant Liability

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the common stock warrant liability for warrants issued under the registered direct offering. On April 3, 2023, we completed a registered direct offering financing issuing common shares and common stock warrants. The fair value of the common stock warrant per share was $0.31 and $0.78 on December 31, 2025 and 2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date,

Income Tax Expense

We account for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities are recorded based on the estimated future tax effects of differences between the financial statement and income tax basis of existing assets and liabilities. Deferred income tax assets and liabilities are recorded net and classified as noncurrent on the balance sheets. A valuation allowance is provided against our deferred income tax assets when their realization is more likely than not.

We are subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, we recognize tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more-likely-than-not (greater than 50%) of being realized upon settlement. Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense.

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Results of Operations

Comparison of the Years Ended December 31, 2025 and 2024

The following table summarizes the significant components of our results of operations for the periods presented (in thousands, except percentages):

Years EndedDecember 31, Increase /(Decrease)

Operating expenses:

Other income, net

Change in fair value of common stock warrant liability 915 1,772 (857 ) (48 %)

Revenue

We recognized approximately $1.1 million of revenue from sales of RenovoCath for the year ended December 31, 2025, compared to $43,000 for the same period in 2024. Fiscal year 2025 marked our first full year of revenue generation from RenovoCath sales. Our commercialization efforts were new to our operations in 2025 and were handled by limited staff, with limited number of patients impacted revenue at this stage. We expect to grow revenue from RenovoCath over time as we expand our commercial efforts on the number of customers and patients.

Cost of Revenue

Cost of revenue was approximately $0.3 million for the year ended December 31, 2025, compared to no cost of revenue for the same period in 2024. Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party manufacturer. The cost of revenue for our TIGeR-PaC clinical trial study is expensed as research and development expense and was approximately $166,000 and $25,000 for the year ended December 31, 2025 and 2024, respectively. The cost for devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices from Medical Murray including costs for devices under the commercial supply agreement.

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Research and Development

The following table summarizes our research and development expenses (in thousands):

Years EndedDecember 31, Increase /(Decrease)

Manufacturing and other research and development $ 1,979 $ 1,821 $ 158

Clinical site payments for RenovoCath devices (344 ) (118 ) (226 )

Research and development expenses were approximately $6.3 million for the year ended December 31, 2025 compared to approximately $6.0 million for the year ended December 31, 2024, an increase of approximately $0.3 million. The period-over-period increase in research and development expenses is primarily driven by an increase in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system of $0.5 million and other research and development costs, primarily animal studies, of $0.1 million. This increase was offset by a decrease in selling, general and administrative expenses allocated to research and development of approximately $0.4 million. Clinical development increased $0.2 million from the same period in 2024 due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC and costs for our RR5 Registry study. Personnel expenses for employees and benefits increased by $0.1 million, which is primarily due to an increase in the number of employees. Regulatory expenses remained relatively unchanged from the same period last year. Cash payments made for use of RenovoCath delivery devices used in our Phase III clinical trial increase $0.2 million compared to the previous year. Payments received from clinical trial sites for the devices have been adequate to cover our direct costs of manufacturing the RenovoCath delivery devices and to offset research and development expenses. We anticipate research and development expenses to increase next year as we advance our clinical development of IAG and develop our next generation of RenovoCath device.

Selling, General and Administrative Expenses

The following table summarizes our selling, general and administrative expenses (in thousands):

Years EndedDecember 31, Increase /(Decrease)

Total selling, general and administrative $ 7,038 $ 4,988 $ 2,050

Selling, general and administrative expenses were approximately $7.0 million for the year ended December 31, 2025 compared to approximately $5.0 million for the year ended December 31, 2024, an increase of approximately $2.1 million. The period-over-period increase in selling, general and administrative expenses was primarily attributable to an increase in professional services and other of $1.3 million, comprising of $0.2 million in consulting services adopting policies and controls to remediate the material weakness; including increases in audit services in relation to registration statements and other professional expenses of $0.4 million; investor and public relations of $0.1 million; travel related expenses of $0.2 million; office and other expenses of $0.2 million; a decrease of $0.4 million in the allocation of selling, general and administrative expenses to research and development, offset by a decrease in directors and officers insurance of $0.2 million. Personnel expenses for employees and benefits increased by $0.6 million due to an increase in employee head count. Legal fees increased by $0.2 million for the year ended December 31, 2025 compared to the previous year. We anticipate selling, general and administrative expenses to increase next year as we progress with our commercialization activities for our RenovoCath delivery system, due primarily to increased hiring of sales and marketing personnel which is expected to continue.

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Interest Income, Net (in thousands)

Years EndedDecember 31, Increase /(Decrease)

Interest income (expense), net $ 427 $ 384 $ 43

Interest income was approximately $0.4 million for the years ended December 31, 2025 and 2024. Interest income represents income earned on excess operating cash invested in short-term U.S. Treasury bills.

Change in Fair Value of Common Stock Warrant Liability (in thousands)

Years EndedDecember 31, Increase /(Decrease)

Change in fair value of common stock warrant liability $ 915 $ 1,772 $ (857 )

The change in fair value of common stock warrant liability was approximately $0.9 million and $1.8 million for the years ended December 31, 2025 and 2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date.

Liquidity and Capital Resources

From our inception through December 31, 2025, we had raised an aggregate of $71.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in public and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $64.3 million. As of December 31, 2025, the Company had cash and cash equivalents of $7.0 million (although we raised an additional $10.0 million in gross proceeds through the March 2026 Private Placement).

We have incurred significant losses and negative cash flows from operations since our inception. For the year ended December 31, 2025, we recorded a net loss of $11.2 million and an accumulated deficit of $61.4 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the foreseeable future. We also expect to incur losses from our clinical activities until regulatory approval is granted for its first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements or marketing its proprietary catheter device on a standalone basis. No assurances can be made that we will pursue these strategies, and even if it does, there is a risk that we will be unable to generate revenue from such activities.

We believe we will be able to raise additional required capital through debt financings, private or public equity financings, 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 or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and its ability to pursue its business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve profitability, and we may never do so.

On November 14, 2025, we filed a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules.

On January 26, 2024, we completed a private placement to 92 accredited investors with gross proceeds of $6.1 million before deducting placement agent fees and other offering expenses of approximately $0.7 million. In this private placement, we issued 6,133,414 shares of common stock and common stock warrants to purchase up to an aggregate of 6,133,414 shares of common stock, which expire five years on January 26, 2029. In connection with such private placement, we entered into a placement agent agreement as additional compensation to the placement agent, and issued common stock warrants to purchase up to an aggregate of 511,940 shares of common stock, which warrants

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expire five years from the issuance date. The significant majority of the warrants issued in this private placement have an exercise price of $0.99 per share. The warrants purchased by our directors, officers, employees and consultants in this private placement have an exercise price of $1.22 per share.

On April 11, 2024, we completed another private placement offering to 172 accredited investors, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offering were $11.1 million, and the net offering proceeds were $9.6 million after deducting placement agent fees of $1.3 million and other professional expenses of $0.2 million. In conjunction with the issuance of 6,960,864 shares of common stock, we bundled the offering with: (i) a pre-funded warrant exercisable for 951,500 shares of common stock at an exercise price of $0.0001 per share, with an unlimited term and immediate exercisability upon issuance, subject to specific beneficial ownership limitations; (ii) Series A warrants exercisable for 7,912,364 shares of common stock at $1.22 per share, valid for 5 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations; and (iii) Series B warrants exercisable for 3,956,182 shares of common stock at $1.22 per share, valid for 2 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations. We have the right to call the Series B warrants under certain conditions. Additionally, as compensation to the placement agent, we issued warrants on the same date to purchase up to an aggregate of 701,243 shares of common stock (the “April 2024 PA Warrants”) at $1.69 per share over a 5-year term, with provisions for cashless exercise if the shares are unregistered or no current prospectus is available for resale. The April 2024 PA Warrants become exercisable on October 11, 2024, subject to specific beneficial ownership limitations and customary adjustments.

On February 10, 2025, we completed an underwriting offering to investors pursuant to our shelf registration while subject to the baby-shelf rules. The aggregate gross proceeds from the offering were $12.1 million after deducting underwriter's fees and other professional expenses of $1.3 million. In connection with the offering, we sold to investors and aggregate of 11,523,810 shares of common stock and we issued 576,191 common warrants, as partial compensation for the underwriter's services, expiring five years from the closing date.

On March 20, 2026, we closed on a private placement offering to 15 accredited investors and 5 insider investors and issued 8,438,790 shares of common stock, 2,200,00 pre-funded warrants, and 5,319,392 revenue milestone warrants, representing 50% warrant coverage. The revenue milestone warrants have an exercise price equal to two times (2x) the purchase price paid for the shares of common stock in the offer, and they expire on the earlier of: (i) 30 days of our reporting $1.5 million in gross product sales in any fiscal quarter and (ii) January 30, 2029. We raised an aggregate gross proceeds of $10.0 million in this financing, before deducting placement agent fees and other legal and professional fees of approximately $0.7 million.

As of the date of this Report, we believe that we have sufficient cash resources, including our private placement closing in March 2026 described above, to allow us to fund our operating, investing and financing cash flow needs through at least the next 12 months. The accompanying audited financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying audited financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if we are unable to continue as a going concern.

We have and believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances that such financing will be available if and when needed, or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section of this Report titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

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Sources of Liquidity

Since our inception, we have been primarily a clinical stage company on IAG, our clinical development stage lead product candidate, a novel drug-device combination product for the treatment of LAPC. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we generated revenue in the fourth quarter of 2024. Our goal is to grow revenues from our RenovoCath commercialization efforts in 2026. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generate meaningful revenues, of which no assurances can be given.

Cash Flows

Our primary uses of cash are to fund our operations including research and development, commercialization of our RenovoCath as a standalone device and selling, general and administrative expenses. We will continue to incur operating losses in the future and expect that our research and development and selling, general and administrative expenses will continue to increase as we continue our research and development efforts with respect to clinical development of our product candidates and further develop our platform, commercializing our stand-alone device and ensure we are complying with the requirements of being a public company. The cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

The following table summarizes our cash flows for the periods indicated (in thousands):

Net cash (used in) provided by:

Investing activities (2 ) (12 )

Increase (decrease) in cash and cash equivalents $ (130 ) $ 5,981

Operating Activities

Net cash used in operating activities was $11.0 million for the year ended December 31, 2025, which was primarily attributable to our net loss of $11.2 million and non-cash charges of $0.4 million, adjusted for net changes in operating assets and liabilities of $0.2 million. Noncash charges included primarily stock-based compensation expense, gain on the fair value of common stock warrants and lease expense. Net cash used in operating activities for the year ended December 31, 2024 reflected a net loss of $8.8 million and noncash charges of $0.6 million, adjusted for net changes in operating assets and liabilities of $0.3 million. Noncash charges included primarily stock-based compensation expense, and a gain on the fair value of common stock warrants.

Investing Activities

Net cash used in investing activities for the year ended December 31, 2025 was 2,000 compared to $12,000 consisting of purchase of property and equipment for the year ended December 31, 2024.

Financing Activities

Net cash provided by financing for the year ended December 31, 2025 was $10.8 million, consisting primarily of gross proceeds of approximately $12.1 from investors pursuant to our shelf registration less issuance costs of $1.3 million. Net cash provided by financing in the year ended December 31, 2024 was $15.1 million, consisting primarily of the two private placements for net proceeds of approximately $15.0 million and proceeds from exercise of stock options and common stock warrants of $0.1 million.

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Contractual Obligations and Other Commitments

In October 2024, we entered into a 36-month lease agreement, commencing on December 1, 2024, non-cancelable operating lease consisting of approximately 1,900 rentable square feet of office space in Mountain View, California. The lease has a one-time option to renew the term for an extension period of 36 months, see “Note 6. Leases, Commitments and Contingencies” in Notes to Financial Statements.

Commercial Supply Agreement

We entered into a Supply Agreement with Medical Murray, Inc., our primary third-party RenovoCath manufacturer, with an effective date of June 5, 2025. Under the supply agreement, we agreed to purchase certain minimum order quantities of our RenovoCath device, based on issued purchase orders modified for limited cancellations or delays as provided in the supply agreement. Beginning with the quarter ended September 30, 2025, we recognized 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. We 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, we are obligated to pay the shortfall commitment as of the date of termination.

As of December 31, 2025, the value of outstanding non-cancellable purchase commitments associated with the supply agreement is approximately $0.7 million. Approximately $0.2 million in payments were made under the supply agreement during the fiscal year ended December 31, 2025.

Critical Accounting Policies and Significant Judgments and Estimates

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our financial statements and the related disclosures, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. While our significant accounting policies are described in the notes to our financial statements included elsewhere in this report, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results because they require us to make estimates, assumptions and judgments about matters that are inherently uncertain.

A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective, or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: (i) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (ii) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.

Revenue Recognition

We recognize revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The provisions of ASC 606 require the following steps to determine revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each

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performance obligation. At contract inception, we assess the goods or services promised within each contract, determine whether each promised good or service is distinct and identify those that are performance obligations. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. With respect to our commercial sales activities for our RenovoCath device, we expect we will recognize revenue at the point in time that the customer obtains control, which is typically based upon the terms of delivery, but subject to the variables discussed above under “Components of Our Results of Operations – Revenue.”

Clinical Trial Expenses

We make payments in connection with our Phase III clinical trial under contracts with clinical trial sites and contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones.

Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably estimable. If the amounts we are obligated to pay under clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the accruals are adjusted accordingly. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.

Stock-Based Compensation

We estimate the fair value of stock options using the Black-Scholes option pricing model, which incorporates various assumptions including those related to the fair value of our common stock, volatility, expected term, and risk-free interest rate. Compensation related to service-based awards is recognized starting on the grant date on a straight-line basis over the vesting period, which is generally four years, see “Note 7. Equity Incentive Plan – Stock-Based Compensation and Common Stock Warrants” in Notes to Financial Statements.

Determining the grant date fair value of options using the Black-Scholes option pricing model requires management to make assumptions and judgments. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation for future awards may differ materially compared with the awards granted previously. The assumptions and estimates are as follows:

Fair Value of Common Stock—Given the absence of a public trading market, prior to our initial public offering in August 2021, our Board considered numerous objective and subjective factors to determine the fair value of our common stock at each grant date. These factors included but were not limited to: (i) contemporaneous third-party valuations of common stock; (ii) the prices for preferred stock sold to outside investors; (iii) the rights and preferences of preferred stock relative to common stock; (iv) the lack of marketability of our common stock; (v) developments in the business; and (vi) the likelihood of achieving a liquidity event, such as an initial public offering or sale of the business, given prevailing market conditions. The methodology to determine the fair value of our common stock included estimating the fair value of the enterprise using the “back solve” method, which is a market approach that assigns an implied enterprise value by accounting for all share class rights and preferences based on the latest round of financing. The total equity value implied was then applied in the context of an option pricing model to determine the value of each class of our shares.

For grants issued after our initial public offering, we rely on the closing price of our common stock as reported on the date of grant to determine the fair value of our common stock, as shares of our common stock are traded in the public market.

Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding. We determine the expected term using the simplified method for pre-initial public offering and post-initial public

85

offering awards. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options.

Expected Volatility—Given the absence of a public trading market, pre-initial public offering and post-initial public offering, the expected volatility was estimated by taking the average historic price volatility for industry peers, consisting of several public companies in our industry that are either similar in size, stage, or financial leverage, over a period equivalent to the expected term of the awards.

Risk-Free Interest Rate—The risk-free interest rate is calculated using the average of the published interest rates of U.S. Treasury zero-coupon issues with maturities that are commensurate with the expected term.

Dividend Rate—The dividend yield assumption is zero as we have no plans to make dividend payments.

Convertible Instruments and Embedded Derivatives

We evaluate all of our agreements to determine whether such instruments have derivatives or contain features that qualify as embedded derivatives. We account for certain redemption features that are associated with the terms of convertible notes as liabilities at fair value and adjusts the instruments to their fair value at the end of each reporting period. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in other income (expenses), net in the statements of operations. Derivative instrument liabilities are classified in the balance sheets as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.

Pre-Funded Common Stock Warrants and Common Stock Warrants

We evaluate pre-funded common stock warrants and common stock warrants issued in connection direct financing to determine whether such warrants qualify for equity classification, or meet the definition of a derivative instrument, classified as a liability on the Balance Sheets and measured at fair value at inception and at each reporting date with changes in fair value recognized in the Statements of Operations and Comprehensive Loss in the period of change.

Direct Offering Costs

Direct offering costs consist principally of commissions, placement fees and other expenses, including other professional expenses incurred. We evaluate the terms under the financing agreement to determine the classification of direct costs in the accompanying Balance Sheets or accompanying Statements of Operations and Comprehensive Loss or some combinations of both.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

•

we may present only two years of audited financial statements, plus unaudited condensed financial statements for any interim period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations;

86

•

we may avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;

•

we may provide reduced disclosure about our executive compensation arrangements; and

•

we do not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

We have elected to take advantage of certain of the reduced disclosure obligations in this Annual Report on Form 10-K and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (1) the market value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, like emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recently Issued and Adopted Accounting Pronouncements

See “Note 2. Summary of Significant Accounting Policies” in Notes to Financial Statements, to our audited financial statements included elsewhere in this Report for more information.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The disclosures in this section are not required because we qualify as a smaller reporting company under federal securities laws.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Our financial statements and the report of our independent registered public accounting firm, as listed under Part IV, Item 15. “Exhibits and Financial Statement Schedules,” are included as a separate section of this Report beginning on page F-1 and are incorporated herein by reference.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A. CONTROLS AND PROCEDURES

(a) Management's Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the year ended December 31, 2025.

Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act and the material weaknesses previously identified and further discussed below, our Chief Executive Officer and Chief

87

Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable level of assurance as of December 31, 2025.

(b) Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control framework and processes were designed to provide reasonable assurance to management and the Board of Directors that our financial reporting is reliable and that our financial statements for external purposes have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP").

Our management recognizes its responsibility for fostering a strong ethical climate so that our affairs are conducted according to the highest standards of personal and corporate conduct.

Our internal control over financial reporting includes policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our business transactions; (ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors of the issuer; and (iii) provide reasonable assurance that the unauthorized acquisition, use, or disposition of our assets will be prevented or detected in a timely manner.

Remediation of Material Weakness

During the fiscal year 2025, material weaknesses was identified related to (i) inadequate formal accounting policies for complex and non-routine transactions; (ii) inexperienced finance and accounting personnel with appropriate U.S. GAAP technical expertise; (iii) deficiencies in the financial statement close process around the absence of a formalized and timely review and approval, inadequate segregation of duties driven by the small size of the finance and accounting team; and (iv) ineffective information technology general controls (“ITGC”) over user access.

To remediate these material weaknesses, management engaged a national consulting firm and implemented the following measures to strengthen the control environment, enhance the financial statement close process, and improve the overall design and operating effectiveness of internal controls:

•

Implemented formal, written accounting policies and procedures for complex and non-routine transactions and established standardized review and approval workflows for such transactions.

•

Increased finance and accounting staffing with personnel processing relevant U.S. GAAP and SEC reporting experience to enhance technical accounting capabilities.

•

Implemented a structured financial close calendar with defined responsibilities and deadlines, along with documented review procedures and sign-off over key financial reporting areas.

•

Reorganized finance roles and workflows to improve segregation of duties, supplemented by secondary reviews and higher-level management oversight, and began deploying automation tools and templates (FloQast) to support reconciliations and close activities.

•

Established role-based access within financial systems, formalized review and approval requirements for non-standard and manual journal entries, and instituted periodic reviews of user access and system rights.

•

Centralized IT user access management processes, implemented periodic independent user access reviews, and documented access changes and related review procedures to provide an audit trail over ITGC user access controls.

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Management has completed the implementation of these remedial measures and, based on testing of the design and operating effectiveness of the remediated controls, concluded that the previously identified material weaknesses were remediated as of December 31, 2025.

We maintain a dynamic system of internal controls and processes--including internal control over financial reporting--designed to ensure reliable financial recordkeeping, transparent financial reporting and protection of physical and intellectual property.

All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

This Report does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of the Company’s registered public accounting firm due to a transition period established by SEC rules for newly public companies. For as long as we remain an emerging growth company under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting. When we lose our status as an emerging growth company and reach an accelerated filer threshold, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting.

(c) Changes in Internal Control over Financial Reporting

Other than the changes as noted above, there were no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the last fiscal quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B. OTHER INFORMATION

None.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

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PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

We incorporate herein by reference the relevant information concerning directors, executive officers and corporate governance to be included in our definitive proxy statement for the 2026 annual meeting of stockholders (the “2026 Proxy Statement”) under the caption “Board of Directors, Management and Corporate Governance.”

We have adopted a Code of Business Conduct and Ethics that applies to all of our employees, officers and directors, including our Chief Executive Officer and other executive and senior financial officers. The full text of our Corporate Governance Guidelines and our Code of Business Conduct and Ethics is available on our website under the “Investors - Corporate Governance – Documents and Charters” tabs https://renovorx.com/investors/corporate-governance/documents-charters. We will post amendments to our Code of Business Conduct and Ethics or waivers of our Code of Business Conduct and Ethics for directors and executive officers on the same website.

ITEM 11. EXECUTIVE COMPENSATION

We incorporate herein by reference the relevant information concerning executive compensation to be included in the 2026 Proxy Statement under the captions “Executive Compensation,” and “Director Compensation.”

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

We incorporate herein by reference the relevant information concerning security ownership of certain beneficial owners and management to be included in the 2026 Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” and “Equity Compensation Plan Information.”

ITEM 13. CERTAIN RELATIONSHIPS AND RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

We incorporate herein by reference the relevant information concerning certain other relationships and related transactions to be included in the 2026 Proxy Statement under the captions “Corporate Governance” and “Certain Relationships and Related Party Transactions.”

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

We incorporate herein by reference the relevant information concerning principal accountant fees and services to be included in the 2026 Proxy Statement under the caption “Principal Accountant Fees and Services.”

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PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a) The following documents are filed as part of this Annual Report on Form 10-K

1. Financial Statements

Page

Financial Statements for the Years Ended December 31, 2025 and 2024

Balance Sheets F-2

Statements of Operations F-3

Statements of Convertible Preferred Stock and Stockholders’ Equity F-4

Statements of Cash Flows F-5

Notes to Financial Statements F-6

2. Financial Statement Schedules

All financial statement schedules have been omitted because the required information is not applicable or is not present in amounts sufficient to require submission of the schedules, or because the information required is included in the financial statements and accompanying notes included in this Report.

3. Exhibits

See “Exhibit Index” immediately preceding the signature page of this Report, which is incorporated herein by reference.

ITEM 16. FORM 10-K SUMMARY

None.

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RENOVORX, INC.

EXHIBIT INDEX

Incorporated by Reference

Exhibit No. Exhibit Description Form File No. Exhibit Filing Date

92

93

23.1 Consent of Frank, Rimerman + Co. LLP Filed herewith

94

† Indicates management contract or compensatory plan or arrangement

+ Confidential portions of this Exhibit were redacted pursuant to Item 601(b)(2) of Regulation S-K and RenovoRx, Inc. agrees to furnish supplementally to the Securities and Exchange Commission a copy of any redacted information or omitted schedule and/or exhibit upon request.

# Certain information has been omitted from this exhibit pursuant to Item 601(a)(6) or Item 601(b)(10)(iv) of Regulation S-K.

* The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report on Form 10-K are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report, irrespective of any general incorporation language contained in such filing.

95

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

RENOVORX, INC.

Date: March 30, 2026 /s/ Shaun R. Bagai

Shaun R. Bagai

Chief Executive Officer

Date: March 30, 2026 /s/ Mark Voll

Mark Voll

Chief Financial Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

Signature Title Date

/s/ Shaun R. Bagai Chief Executive Officer, Director March 30, 2026

Shaun R. Bagai (Principal Executive Officer)

/s/ Mark Voll Chief Financial Officer March 30, 2026

Mark Voll (Principal Financial and Accounting Officer)

/s/ Ramtin Agah Executive Chairman and Chief Medical Officer March 30, 2026

Ramtin Agah, M.D.

/s/ Laurence J. Marton Director March 30, 2026

Laurence J. Marton, M.D.

/s/ Una S. Ryan Director March 30, 2026

Una S. Ryan, O.B.E., Ph.D., D.Sc.

/s/ Kirsten Angela Macfarlane Director March 30, 2026

Kirsten Angela Macfarlane

/s/ Robert J. Spiegel Director March 30, 2026

Robert J. Spiegel, M.D., FACP

96

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Stockholders of RenovoRx, Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheets of RenovoRx, Inc. (the “Company”) as of December 31, 2025 and 2024, and the related statements of operations, convertible preferred stock and stockholders’ equity, and cash flows, for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of RenovoRx, Inc. as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the U.S. Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Frank, Rimerman + Co. LLP

We served as the Company’s auditor from 2019 to 2021. We were subsequently re-engaged during the third quarter of 2024.

San Francisco, California

March 30, 2026

F-1

RenovoRx, Inc.

Balance Sheets

(in thousands, except share and per share amounts)

Assets

Current assets:

Cash and cash equivalents $ 7,024 $ 7,154

Accounts receivable 139 43

Operating lease right-of-use asset 190 278

Property and equipment, net 12 12

Liabilities and Stockholders' Equity

Current liabilities:

Accrued expenses and other current liabilities 1,163 1,323

Common stock warrant liability 604 1,519

Operating lease liability, net of current portion 107 212

Commitments and contingencies

Stockholders' equity:

Total liabilities and stockholders’ equity $ 8,095 $ 8,118

The accompanying notes are an integral part of these financial statements.

F-2

RenovoRx, Inc.

Statements of Operations

(in thousands, except share and per share amounts)

Year Ended

December 31,

Cost of Revenue 327 -

Operating expenses:

Selling, general and administrative 7,037 4,988

Other income, net

Change in fair value of warrant liability 915 1,772

Net loss per share - basic and diluted $ (0.32 ) $ (0.40 )

The accompanying notes are an integral part of these financial statements.

F-3

RenovoRx, Inc.

Statements of Convertible Preferred Stock and Stockholders’ Equity

(in thousands, except share amounts)

Shares Amount Shares Amount Capital Deficit (Deficit)

Issuance of common stock upon exercise of common warrants - - 25,252 - 25 - 25

Issuance of common stock upon exercise of stock options - - 39,650 - 17 - 17

Issuance of restricted stock awards, net - - 39,032 - - - -

Stock-based compensation expense - - - - 1,267 - 1,267

Issuance of common stock upon exercise of stock options - - 93,481 - 69 - 69

Issuance of common stock upon exercise of common warrants - - 33,333 - 33 - 33

Issuance of restricted stock awards - - 120,000 - - - -

Stock-based compensation expense - - - - 1,174 - 1,174

The accompanying notes are an integral part of these financial statements.

F-4

RenovoRx, Inc.

Statements of Cash Flows

(in thousands)

Year Ended December 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense 1,267 1,174

Non-cash lease expense 88 7

Depreciation 2 -

Changes in operating assets and liabilities:

Accounts receivable (96 ) -

Inventory (189 ) -

Prepaid expenses 90 (160 )

Other current assets - (221 )

Net cash used in operating activities (10,973 ) (9,125 )

Cash flows from investing activities:

Purchase of property and equipment (2 ) (12 )

Net cash used in investing activities (2 ) (12 )

Cash flows from financing activities:

Proceeds from common stock and pre-funded common stock warrants 12,102 17,248

Costs of issuance of common stock upon private placement (1,299 ) (2,232 )

Proceeds from exercise of common stock warrants 25 33

Proceeds from exercise of stock options 17 69

Net cash provided by financing activities 10,845 15,118

Change in cash and cash equivalents (130 ) 5,981

Cash and cash equivalents, beginning of period 7,154 1,173

Cash and cash equivalents, end of period $ 7,024 $ 7,154

Supplemental Disclosure of Cash Flow Information

Cash paid for income taxes $ 1 $ 2

Cash paid for interest $ 16 $ 21

Supplemental disclosure of non-cash investing and financing activities:

Right-of-use assets obtained in exchange for lease obligations $ - $ 285

The accompanying notes are an integral part of these financial statements.

F-5

RenovoRx, Inc.

Notes to Financial Statements

1. Business and Principal Activities

Description of Business

RenovoRx, Inc. (the “Company”) 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 developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug-delivery device, targeting high unmet medical needs.

The Company’s clinical stage lead product candidate is a novel drug-device combination product consisting of intra-arterial delivery of the chemotherapy gemcitabine via RenovoCath which the Company refers to as “IAG.” IAG is currently the subject of a Phase III clinical study for the treatment of locally advanced pancreatic cancer (“LAPC”).

The Company is also commercializing RenovoCath as a standalone device for use by interventional radiologists, oncologists, and other medical professionals who can use the device to treat patients within its FDA-cleared fields of use. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

RenovoCath utilizes the patented Trans-Arterial Micro-Perfusion (“TAMPTM”) therapy platform, which is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy, including chemotherapy. The Company’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. The Company holds a robust portfolio of 19 issued patents and 12 pending patents covering its TAMP technology.

Liquidity and Capital Resources

From the Company’s inception through December 31, 2025, it has raised an aggregate of $71.4 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”), and the exercise of warrants and common stock options. As of December 31, 2025, the Company had cash and cash equivalents of $7.0 million.

The Company has incurred significant losses and negative cash flows from operations since its inception. For the year ended December 31, 2025, the Company reported a net loss of $11.2 million and an accumulated deficit of $61.4 million and does not expect to generate positive cash flows from operations in the foreseeable future. The Company expects to incur significant and increasing losses until regulatory approval is granted for its first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. The Company believes it will be able to raise additional capital through debt financings, private or public equity financings, 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 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 profitability, and it may never do so.

On November 14, 2025, the Company has filed an a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of the Company’s securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules.

The accompanying 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 this report.

F-6

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying 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 SEC for annual reporting. 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”).

Certain prior period amounts and disclosures in the financial statements and accompanying notes have been reclassified or modified to conform to the current period’s presentation.

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, (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 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 financial statements during the reporting periods. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, accruals of certain liabilities, including clinical trial accruals and other contingences, the valuation of financial instruments, the fair value of the Company’s common stock 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.

Concentration of Risks

Financial Instruments

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains bank deposits in federally insured financial institutions and these deposits may exceed federally insured limits of $250,000 per depositor. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash equivalents to the extent recorded in the balance sheets. The Company has not experienced any losses on its deposits of cash and cash equivalents to date.

Supply

The Company relied, and expects to rely, on a small number of third-party manufacturers to manufacture and supply its RenovoCath devices and its product candidates for commercial customers and clinical trials. These activities could be adversely affected by a significant interruption in supply of these items.

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Demand

For the year ended Decemer 31, 2025, three customers each accounted for 10% or more of the total revenues. Customer A, Customer B, and Customer C represented 22.9%, 22.0% and 20.7%, respectively.

Operating Segment

The Company operates and manages its business as one reportable and operating segment, which is the development of IAG via the RenovoCath delivery device both in clinical studies and commercially. The Company’s chief executive officer (“CEO”), who is the Chief Operating Decision Maker (“CODM”), reviews financial information on an aggregate basis for allocating resources and evaluating financial performance, see “Note 11. Segment Information” in Notes to Financial Statements.

Net Loss per Share

Basic net loss per common share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined using the treasury stock and if-converted methods. Potentially dilutive common stock equivalents are comprised of convertible preferred stock, convertible notes, and warrants including options and restricted stock awards outstanding under the Company’s Equity Incentive Plan. For the years ended December 31, 2025 and 2024, there was no difference in the number of shares used to calculate basic and diluted shares outstanding as the inclusion of the potentially dilutive securities would be anti-dilutive.

Fair Value of Financial Instruments

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date. Fair value measurement establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs when measuring fair value.

The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows:

Level 1 – Valuations based on quoted prices for identical assets and liabilities in active markets.

Level 2 – Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

Level 3 – Valuations based on unobservable inputs reflecting the Company’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3.

The carrying amount of current assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of their short-term nature.

February 2025 Offering

The Company evaluated the underwriter warrants issued in connection with the underwritten public offering in February 2025 (the "February 2025 Offering") in accordance with ASC Topic 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Entity and concluded that the underwriter warrants are freestanding financial instruments, meeting ASC Topic 480’s criteria for legal detachment

F-8

and separate exercisability from the common stock. The underwriter warrants are classified as equity, not liabilities, as they do not embody obligations for cash settlement or issuance of variable shares. The initial recognition involves recording proceeds in Additional Paid-In Capital (“APIC”) with issuance costs as contra-equity. For diluted Earnings Per Share (“EPS”), the treasury stock method applies, as the underwriter warrants are dilutive but not participating securities before exercise, ensuring no impact on basic EPS until shares are issued.

Cash, Cash Equivalents and Investments

The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Available-for-sale securities, comprised of obligations of the U.S. government and its agencies, are carried at fair value, with unrealized gains and losses recorded within other comprehensive income (loss) as a separate component of stockholders’ equity. Realized gains and losses and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in earnings. Purchases and sales of investment securities are recognized on a trade date basis. The cost of investment securities sold is determined by the specific identification method.

Inventories

Inventories consist of RenovoCath devices which are finished goods held for sale manufactured under contract by the Company’s third-party RenovoCath manufacturer. Inventories are stated at the lower of cost or net realizable value, and are determined using the specific identification method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. 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. Such impairment charges, if any, are recorded in cost of goods sold, on the statements of operations. As of December 31, 2025 and 2024, the Company determined that the devices returned were not warranty related, and, as such, a warranty allowance was not recorded.

Accounts Receivable

Accounts receivable represents amounts arising from product sales and are reported at outstanding amounts where management has the intent and ability to collect and are recorded net of allowances for returns and credit losses. The Company estimates an allowance for credit losses by considering factors such as credit quality, the age of the accounts receivable balances, and current economic conditions that may impact a customer’s ability to pay. The Company has no historical write-offs of its accounts receivable and its payment terms are generally less than 90 days from the invoice date. The Company evaluates the creditworthiness of each counterparty on a regular basis. As of December 31, 2025 and 2024, the credit profiles for these counterparties were deemed to be in good standing and, as such, an allowance for credit losses was not recorded.

Property and Equipment, Net

Property and equipment are recorded at cost, net of accumulated depreciation and represent furniture and fixtures on the Company’s new occupied office lease space. The furniture and fixtures are treated as a group asset and $2,000 of depreciation was recorded for the year ended December 31, 2025. Depreciation expense will be recorded using the straight-line method over the estimated useful life of seven years. Repairs and maintenance costs that do not extend the useful life are expensed as incurred.

Leases

The Company determines if an arrangement is a lease at contract inception. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise those options. The Company utilizes the Company’s incremental borrowing rate when the implicit interest rate is not readily determinable based upon the information available at the commencement date of the lease in determining the present value of the lease payments and the implicit interest rate when readily determinable.

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The lease payments used to determine the Company’s operating lease assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation, when determinable, and are recognized in the Company’s operating lease assets in the Company’s balance sheets. In addition, the Company’s contracts may contain lease and non-lease components. The Company combines lease and non-lease components, which are accounted for together as lease components.

The Company’s operating leases are reflected in the right-of-use operating asset; operating lease liability, current portion; and operating lease liability, net of current portion in the Company’s balance sheets. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are not recorded on the Company’s balance sheets and are recognized in the statements of operations and loss on a straight-line basis over the term of the lease.

Variable lease payments are the amounts owed by the Company to a lessor that are not fixed, such as reimbursement for common area maintenance and utilities costs for facility leases. Variable lease payments are expensed when incurred.

Warranties

The Company generally provides warranties for its products from manufacturing defects on a limited basis for a period of up to 120 days after purchase. 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 not experienced any warranty claims to date, and significant warranty claims are not expected, and accordingly no liability for warranty claims was recorded for the years ended December 31, 2025 and 2024.

Revenue Recognition

The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The provisions of ASC 606 require the following steps to determine revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines whether each promised good or service is distinct and identifies those that are performance obligations. The Company 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.

The Company derives revenue through sales of its FDA-cleared catheter drug-delivery device, RenovoCath, directly to end users, which began sales in the fourth quarter of 2024. The Company considers customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. The Company’s contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath stand-alone device and generally with payment terms expected net 30 - 90 days upon shipment of device. The Company recognizes revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration the Company offers is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore the Company expects minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. The Company experienced limited product returns to date, and accordingly no allowance for returns was recorded for the year ended December 31, 2025.

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Research and Development Costs

Research and development expenses are charged to expense as incurred. Research and development expenses includes personnel costs including salaries, benefits and stock-based compensation. In addition, it includes expenses for consultants that support clinical trial studies, materials costs, external clinical drug product manufacturing costs, outside services costs, regulatory activities including filing fees, fees for maintaining licenses and other amounts due to third-party agreements, laboratory materials, clinical trial, as noted above, and supplies to support the Company's research activities, manufacturing development and non-recurring engineering costs for the next generation of RenovoCath device, including allocated facility and selling, general and administrative indirect overhead related costs. The Company also receives payments from clinical trial sites for RenovoCath delivery devices used in the Phase III clinical trial. Payments received from clinical sites cover the direct costs of manufacturing the RenovoCath delivery devices and offset research and development expenses were $344,000 and $118,000 for December 31, 2025 and 2024, respectively.

Clinical Trial Expenses

The Company makes payments in connection with its ongoing Phase III clinical trial under contracts with clinical trial sites and contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of the obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones.

Expenses related to clinical trials are accrued based on estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably estimable. If amounts and obligations to pay under clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), the accruals are adjusted accordingly. Revisions to contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.

Selling, General and Administrative

Selling, general and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrative functions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property, consulting costs, conferences and travel, including allocated facility and selling, general and administrative indirect overhead related costs to research and development expenses. Selling, general and administrative expenses are expensed in the period incurred.

Marketing

The Company implements a comprehensive multi-channel digital marketing program focused on 1) growing awareness around its therapeutic offerings and its pipeline of clinical stage drug candidates and 2) a national campaign to accelerate patient recruitment for the ongoing Phase III clinical trial study. The marketing efforts aim is to increase Company awareness focusing on name recognition, disease awareness, current treatment alternative options and recent clinical accomplishments and successes. Digital marketing expenses are classified as research and development and selling, general and administrative expenses and are expensed in the period incurred. Digital marketing expenses for patient recruitment for the ongoing Phase III clinical trial study are considered research and development expenses and were $73,000 and nil for December 31, 2025 and 2024, respectively. Marketing expenses to increase Company awareness are classified as selling, general and administrative and were $290,000 and $413,000 for December 31, 2025 and 2024, respectively.

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Stock-Based Compensation

The Company estimates the fair value of stock options using the Black-Scholes option pricing model, which incorporates various assumptions including volatility, expected term and risk-free interest rate. Compensation related to service-based awards is recognized starting on the grant date on a straight-line basis over the vesting period, which is generally four years. Forfeitures are recorded as they occur.

The determination of the fair value of each stock award using this option-pricing model is affected by the Company’s assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the fair value of the common stock at the date of grant, the expected term of the awards, the expected stock price volatility over the expected term of the awards, the risk-free interest rate, and the dividend rate as follows:

Fair Value of Common Stock

For grants issued post-IPO the closing price of the Company’s common stock as reported on the date of grant will determine the fair value of the Company’s common stock, as shares of the Company’s common stock are traded in the public market.

Expected Term—The expected term represents the period that the stock-based awards are expected to be outstanding. The Company determines the expected term using the simplified method for awards. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options for employees. For non-employees and board members the expected term is ten years.

Expected Volatility—Given the absence of a public trading market, pre-IPO and post IPO, the expected volatility is estimated 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.

Risk-Free Interest Rate—The risk-free interest rate is calculated using the average of the published interest rates of U.S. Treasury zero-coupon issues with maturities that are commensurate with the expected term.

Dividend Rate—The dividend yield assumption is zero as the Company has no plans to make dividend payments.

The Company generally granted stock options, pre-IPO, to its employees and consultants for a fixed number of shares with an exercise price equal to the fair value of the underlying shares at date of grant. For all post-IPO grants issued, the fair value will be the closing price of the Company’s common stock on the date of the grant. The Company accounts for all stock option grants using the fair value method and stock-based compensation is recognized as the underlying options vest.

Income Taxes

Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards for all periods presented, as realization of such deferred tax assets cannot be determined to be more likely than not. Due to losses incurred for all periods presented, the Company does not record a tax provision or benefit for income taxes.

Emerging Growth Company and Smaller Reporting Company Status

The Company is 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 expects to 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 closing its IPO in August 2021.

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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.

Recent Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 modifies the rules on income tax disclosures to enhance the transparency and decision-usefulness of income tax disclosures, particularly in the rate reconciliation table and disclosures about income taxes paid. The amendments are intended to address investors’ requests for income tax disclosures that provide more information to help them better understand an entity’s exposure to potential changes in tax laws and the ensuing risks and opportunities and to assess income tax information that affects cash flow forecasts and capital allocation decisions. The guidance also eliminates certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. The guidance is effective for all entities for annual periods beginning after December 15, 2025. All entities should apply the guidance prospectively but have the option to apply it retrospectively. Early adoption is permitted. The Company adopted the standard as of December 31, 2025 on a prospective basis.

Recently Issued Accounting Pronouncements

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) (ASU 2024-03). ASU 2024-03 modifies the rules on income statement disclosures to enhance the transparency of and include more detailed information about the types of expenses, including purchases of inventory, employee compensation, depreciation, amortization, and depletion, in commonly presented expense captions such as cost of sales, research and development, and selling, general and administrative expenses. The amendments are intended to address investors’ requests for income statement expense disclosures that provide more information to help them better understand the components of an entity’s expenses, make their own judgments about the entity’s performance, and more accurately forecast expenses, and enable investors to better assess an entity’s prospects for future cash flows. It will also provide contextual information for an entity’s presentation and consideration of management’s discussion and analysis of financial position and results of operations. The guidance is effective for all entities for annual periods beginning after December 15, 2026. All entities should apply the guidance prospectively but have the option to apply it retrospectively. Early adoption is permitted. The Company is continuing to assess the timing of adoption and the potential impacts of ASU 2024-03 on the financial statements and related disclosures.

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 of $189,000 as of December 31, 2025, nil at December 31, 2024, 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 balance sheets. Given the early stages of the Company’s commercialization strategy, there were no reserves for inventory, and no inventory was classified as non-current as of December 31, 2025.

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4. Property and Equipment, Net

Property and equipment are as follows (in thousands):

Years Ended December 31,

Property and equipment $ 14 $ 12

Less accumulated depreciation (2 ) -

Property and equipment $ 12 $ 12

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

Depreciation expense for the years ended December 31, 2025 and 2024 was $2,000 and nil, respectively.

5. Accrued Expenses

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

Years Ended December 31,

Current portion of operating lease liability 105 66

6. Fair Value Measurements

As of December 31, 2025, and 2024, the Company held $6.6 million and $7.0 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):

Fair Value Measurements at December 31, 2025 using:

Level 1 Level 2 Level 3 Total

Cash equivalents:

Money market funds $ 6,640 $ - $ - $ 6,640

Total cash equivalents $ 6,640 $ - $ - $ 6,640

Liabilities:

Common stock warrant liability $ - $ - $ 604 $ 604

Total liabilities $ - $ - $ 604 $ 604

Fair Value Measurements at December 31, 2024 using:

Level 1 Level 2 Level 3 Total

Cash equivalents:

Money market funds $ 7,008 $ - $ - $ 7,008

Total cash equivalents $ 7,008 $ - $ - $ 7,008

Liabilities:

Common stock warrant liability $ - $ - $ 1,519 $ 1,519

Total liabilities $ - $ - $ 1,519 $ 1,519

F-14

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 the year ended December 31, 2025 (in thousands):

Schedule of Level 3 Liabilities Measured at Fair Value on a Recurring Basis

Change in fair value (915 )

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:

Dividend rate - % - %

7. Leases, Commitments and Contingencies

Operating Leases

In October 2024, the Company entered into a 36-month lease agreement, commencing on December 1, 2024, non-cancelable operating lease consisting of approximately 1,900 rentable square feet of office space in Mountain View, California. The lease has a one-time option to renew the term for an extension period of 36 months. The office space lease has a remaining lease term of approximately two years. The option to renew the term was not included for purposes of determining the right-of-use asset and associated lease liabilities as the Company determined that the renewal of the lease is not reasonably certain so only the original lease term was taken into consideration. The accounting lease commencement in accordance with ASC 842, Leases, occurred on December 1, 2024, and the Company recorded a total associated right-of-use asset and corresponding lease liability of $285,000.

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

Years Ended December 31,

Assets

Right-of-use operating asset $ 190 $ 278

Liability

Operating lease liability – current $ 105 $ 66

Operating lease liability – noncurrent 107 212

The current operating lease of $105,000 is classified as an accrued expense on the balance sheet, see “Note 5. Accrued Expenses” in Notes to Financial Statements.

Lease expense and cash paid by lease type that was recognized during the years ended December 31, 2025 and 2024 are as follows (in thousands):

Years Ended December 31,

Operating lease $ 108 $ 9

Short-term lease 6 76

Total lease expense $ 114 $ 85

Short-term leases for periods ended December 31, 2025 and 2024 of $6,000 and $76,000, respectively, were month-to-month lease arrangements where the Company recognized the lease payments as an expense in the period in which the obligation for those payments incurred. The Company made an election policy not to apply the recognition requirements under ASC 842, Leases, for month-to-month lease agreements.

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

Total lease payments $ 229

Less imputed interest (17 )

Present value of operating lease liability $ 212

The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate of 7.75% 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 December 31, 2025, the Company has a remaining lease term of 1.92 years.

Commercial Supply Agreement

The Company entered into a Supply Agreement with Medical Murray, Inc., the Company’s primary third-party RenovoCath manufacturer, 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. Beginning with the quarter ended September 30, 2025, the Company recognizes the release of RenovoCath devices from Medical Murray as finished goods and records as inventory.

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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 December 31, 2025, the value of the Company’s outstanding non-cancellable purchase commitments associated with the supply agreement is approximately $0.8 million. Approximately $0.2 million in payments were made under the supply agreement during the fiscal 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 the year ended December 31, 2025, 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 December 31, 2025.

8. Equity Incentive Plan – Stock-Based Compensation Expense

2021 Omnibus Equity Incentive Plan

On July 19, 2021, the Company’s Board of Directors 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 shares 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 will continue to be governed by the 2013 Plan. In accordance with the terms of the 2021 Plan, on January 1, 2025, the number of shares reserved and available for issuance increased by 721,040 shares.

On April 29, 2025, the Board approved the following amendments to the 2021 Plan to be adopted at the Annual Shareholders’ Meeting, (i) the addition of 913,794 shares of common stock to the total number of shares of common stock available under the 2021 Plan and (ii) an increase in in the 2021 Plan’s evergreen provision to increase the size of the 2021 Plan each year from three percent of shares outstanding on the final day of the immediately preceding calendar year to five percent. The amendments to the 2021 Plan were adopted at the Annual Shareholder’ Meeting on June 24, 2025.

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

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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.

A summary of the stock option activity for the year ended December 31, 2025 is as follows:

The weighted-average grant-date fair value of options granted during 2025 and 2024 was $0.90 and $1.09 per share, respectively. During 2025 and 2024 the Company issued 39,650 and 93,481 shares of common stock, respectively, in conjunction with stock option exercises. The Company received cash proceeds from the exercise of stock options of approximately $17,000 and $69,000 during 2025 and 2024, respectively. As of December 31, 2025, there was $2.1 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 2.52 years.

The following table summarizes the outstanding and exercisable options as of December 31, 2025:

Options Outstanding Options Exercisable

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For the years ended December 31, 2025, and 2024, 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:

Years Ended December 31,

Dividend rate -% -%

The following table summarizes the components of stock-based compensation expense recognized in the Company’s Statements of Operations (in thousands):

Years Ended December 31,

Research and development $ 565 $ 724

Selling, general and administrative $ 702 450

Total stock-based compensation expense $ 1,267 $ 1,174

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.

The following table summarizes RSU activity under the 2021 Plan, as of December 31, 2025:

Shares Weighted-AverageGrant DateValue

Outstanding as of December 31, 2024 - $ -

Forfeited - $ -

Outstanding as of December 31, 2025 - $ -

In March 2025, the Board approved the issuance of 30,000 shares of restricted stock to an entity as consideration for a commercial contract, vested immediately, in a private placement. The shares were issued outside the 2021 Plan and the Company recognized $31,000 of stock-based compensation expense for the restricted stock.

During the years ended December 31, 2025, and 2024, the Company recognized $1.3 million and $1.2 million, respectively, in stock-based compensation expense from stock option grants and restricted stock awards. 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.

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9. Common Stock Warrants

Common Stock Warrants

In connection with the Company’s February 2025 Offering, the Company issued to the underwriter warrants to purchase up to 576,191 shares of common stock at $1.21 per share over a five-year term. All such warrants under the February 2025 Offering expire on February 10, 2030.

In September 2024, to create performance incentives for the Company’s third-party RenovoCath manufacturer, Medical Murray, Inc., the Company issued a warrant to Medical Murray to purchase up to 709,500 shares of the Company’s common stock. This warrant vests and is only exercisable over time in tranches and only if Medical Murray achieves certain manufacturing milestones. During the year ended December 31, 2025, 166,500 shares had expired as certain manufacturing milestones were not achieved by Medical Murray.

The following is a summary of the common stock warrant activity during the year ended December 31, 2025.