RNXT 10-K & 10-Q changes, risk factors and insider trading

We have no drug/device combination products approved for commercial sale, only limited experience as a company in the commercialization of standalone medical devices and no extended operating history as a revenue generating company. These factors make it difficult to evaluate our current business and predict our future success and viability.

We are a clinical stage biopharmaceutical company who is also executing on a new relatively new commercial strategy to sell our device on a standalone basis alongside our efforts to gain regulatory approval for our lead drug/device combination product. We have no drug/device combination products approved for commercial salesale. andWhile arewe onlyhave at the beginning stages ofcommenced generating any revenue from salesRenovoCath ofcommercial sales, our device on a standalone basis. We have no operating history as a revenuerevenue-generating generatingcompany company,remains limited, and the commercial prospects for our novel therapy platform (either as part of an approved drug/device combination product or whether sold as a standalone product) are unproven, uncertain and involve a substantial degree of risk.

Alongside our Phase III clinical activities related to IAG, in 2024 we commenced effortscommercial tosales commercialize of our FDA-approvedFDA-cleared RenovoCath device on a standalone basis.basis Ourin commercializationlate efforts for RenovoCath are relatively new2024 and evolving and we presently have verybeen littlegenerating revenue therefrom in 2025. While our commercial traction has grown, our operating experience in this business model.model remains limited and our commercialization efforts continue to evolve.

We are a clinical stage, currently pre-revenueearly-revenue-stage company and have incurred significant losses since our formation. As of December 31, 2024, 2025, we have an accumulated deficit of approximately $50.2$61.4 million. For the fiscal years ended December 31, 20242025 and 2023,2024, we had net losses of approximately $8.8$11.2 million and $10.2$8.8 million, respectively. To date, we have experienced negative cash flow from the development of our drug/device product candidate, our platform technology, TAMP, and our RenovoCath delivery system. We have generated minimallimited revenue from operations,our RenovoCath commercial activities and we expect to incur net losses until we receive FDA approval for our product candidate or until our commercial strategy for RenovoCath generates sufficient revenues.revenues Becauseto offset our expenses. While a key goal of our company is to increase revenues from RenovoCath sales and thus reduce or losses and “cash burn”, because of the numerous risks and uncertainties associated with developing and commercializing our product candidate or our device commercial strategy, we are unable to predict with precision the extent of any future losses or when we will attain profitability, cash flow positive or profitable operations, if ever. Investors in our securities must carefully consider the substantial challenges, risks and uncertainties inherent in theour business plans. We may never receive regulatory approval for ourIAG or any other product candidate and we may never successfully commercialize RenovoCath, and in either case, if we are unable to do so, our business could fail.

On the clinical development side of our business, ourany product candidates beyond IAG will require substantial additional development time and resources before we will be able to receive regulatory approvals, if any, and, if approved, to begin generating revenue from product sales. Even with respect to our lead product candidate IAG and our TIGeR-PaC trial, we are anticipating final results of that trial in 2027, which could subsequently lead to an NDA submission and FDA review and decision. As a result, we expect that it will be severalat least a few years, if ever, before we receive approval to commercialize a drug/device product and generate revenue from such product. Even if we succeed in receiving marketing approval for and commercializing oneIAG or more of ourother drug/device product candidates, we expect that we will continue to incur substantial expenses andand, if our commercial efforts do not generate sufficient revenues, operating losses. The amount of our future net losses will depend, in part, on the level of our future expenditure and revenue. Moreover, our net losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. If we are unable to generate significant revenue or attain cash flow positive operations or profitability, we will not be able to sustain operations.

Alongside our Phase III clinical activities related to IAG, in late 2024 we commenced effortscommercial tosales commercializeof our FDA-approvedFDA-cleared RenovoCath device on a standalone basis.basis, Toand datewe generated nominal revenues of $43,000 for the year ended December 31, 2024 and approximately $1.1 million in revenue from such sales for the year ended December 31, 2025. While we have focusedbegun almostto exclusivelygain oncommercial the clinical development of IAG as our lead product candidate. Therefore, as a company,traction, we nonetheless have nolimited experience in self-commercializing medical devices. This commercial strategy, which itself is relatively new and subject to evolution and change, is subject to significant inherent risks relating to, among other matters, our manufacturing, supply chain, and sales and marketing efforts for RenovoCath, as well as our internal accounting and operational requirements for these efforts. Moreover, the past experiences of certain members of our management with commercializing medical devices may not translate to our plans for RenovoCath. Also, we may be subject to competition from alternative devices or methods of drug administration offered by larger, better funded, and more experienced companies. Therefore, we are and will continue to be faced with the risk that we may be unable to adequately execute one or more elements of our commercial plans for RenovoCath.

We may also choose to enter into a commercial collaboration with a third party who could take some or even primary responsibility for sales, marketing, and/or distribution efforts for RenovoCath. In such a case, we would be reliant, at least in part, on such third party for the success of our commercial efforts, and the failure of any such third party to execute the agreed uponagreed-upon strategy could lead to suboptimal results for our company. Moreover, in any such collaboration, we would be required to share the part of the economics of RenovoCath commercialization with such third-party, which could mean less revenue generated by our company.

We are atin the beginningrelatively early stages of our RenovoCath commercialization efforts and have not had to recognize revenue from our operations in the past. A primary goal from these efforts is to generate and recognize revenue from RenovoCath sales. However, revenue recognition under generally accepted accounting principles requires subjective judgements to be made by our management and could otherwise be complex and create uncertainties, including uncertainties arising from varying terms of sale we may offer to different customers. We may also be required to defer recognition of revenues until certain conditions are met. Risks and uncertainties relating to our accounting for revenue recognition could have a material adverse effect on our estimates of our future revenue performance and on our actual financial results. Any statements we make in this Report or otherwise from time to time regarding our future revenue performance could prove inaccurate because of the complexities of revenue recognition, and readers should take these complexities and associated risks in accounting when assessing our statements regarding our revenues.

Our revenues and results of operationsoperations, mayparticularly beas they relate to RenovoCath sales, are difficult to predict and may fluctuate from quarter to quarter, which could adversely affect our business and the market price of our common stock.

We are just commencingOur commercial sales ofactivities for our RenovoCath device.device are still relatively new. While our goal is to grow our revenues over time, at present our revenues and results of operations may beare difficult to predict and may fluctuate substantially from quarter to quarter.quarter, with fluctuations potentially being the result of just a small number of RenovoCath procedures undertaken by our customers. These fluctuations can adversely affect our business and the market price of our common stock. Revenues in any quarter depend substantially upon our total contracting activity with our customers, and our ability to recognize revenues in that quarter in accordance with our revenue recognition policies. Our contracting activity is difficult to forecast for a variety of reasons, including the following:

the number, timing and significance of our and our competitors’ product enhancements may affect purchasing decisions; and certain expenses, including those over which we exercise little or no control, such as health costs, compliance with new legislation, and property and liability insurance, may be difficult to manage; and Due to all of the foregoing factors, in some future quarters our operating results may fall below the expectations of securities analysts and investors. In such event, the market price of our common stock would likely decrease.

We will face the risk that we may need to raise substantial additional capital over the longer term to both develop and commercialize IAG (assuming FDA approval) and to separately engage in sales and marketing activities for RenovoCath as a standalone device. Our failure to obtain funding when needed (even following this offering) may force us to delay, reduce or eliminate our product development programs, commercial efforts or collaboration efforts. Moreover, if we do not obtain adequate and timely funding, we may not be able to continue as a going concern.

As of March 1,23, 2025,2026 (taking into account the net proceeds from our March 2026 private placement), we had cash and cash equivalents of approximately $15.8$13.0 million. Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we willface the risk that we may be required to raise substantial additional capital over the longer term to both (i) complete the testing, development and (assuming FDA approval) commercialization of IAG or other product candidates and (ii) separately engage in sales and marketing activities for RenovoCath as a standalone device. We have historically financed our operations primarily through public and private sales of our equity or equity-linked securities as well as debt financing. 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. For example, we have filed an omnibus shelf registration statement on Form S-3 (File No. 333-268302) that provides for aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while we are subject to the “baby-shelf” rules. We also have filed a registration statement on Form S-1 to register the cash exercise of our outstanding warrants, with such cash exercise only expected to occur when the trading price of our common stock is in excess of the $10.80 per share exercise price of our outstanding warrants (which is significantly above our current stock price). 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 our development and/or commercialization plans, restrict or cease our operations or obtain funds by 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. Based on our operating plans, we expect that our current cash and cash equivalents as the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated. Based upon our review and our current financial condition, we have concluded that we will be able to continue operating as a going concern.

Our product candidates’The commercial viability of IAG or other product candidates remains subject to current and future preclinical studies, clinical trials (notably our Phase III TIGeR-PaC study), regulatory approvals, and the risks generally inherent in the development of a pharmaceuticaldrug-device product candidate. If we are unable to successfully advance or develop ourIAG or any other product candidate, our business will be materially harmed.

In the near-term, failure to successfully advance the development of any of our product candidates may have a material adverse effect on us. To date, we have not successfully developed or commercially marketed, distributed, or sold any drug or drug-device combination product candidate. The success of our business depends in part upon our ability to successfully advance the development of our currentIAG and future product candidates through preclinical studies and clinical trials (notably our Phase III TIGeR-PaC study with respect to IAG), have thesuch product candidates approved for sale by the FDA or regulatory authorities in other countries, and ultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure you that the results of our ongoing preclinical studies or clinical trials (notably our Phase III TIGeR-PaC study) will support or justify the continued development of our product candidates, or that we will receive regulatory approval from the FDA, or similar regulatory authorities in other countries, to advance the development of our product candidates.

The following discussion and analysis of our financial condition and results of operations for our fiscal year ended December 31, 20242025 should be read in conjunction with theItem 1. Business and our financial statements and related notes thereto included in Part II, Item 8, “Financial Statements and Supplementary Data,” ofincluded elsewhere in this Report.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.

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.

We are a life sciences company offeringdeveloping innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S.FDA-cleared Food and Drug Administration (“FDA”)-cleared local drug-delivery system,device, targeting high unmet medical needs,needs. withOur amission present focus on difficultis to treattransform cancers.the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

IAG our RenovoCath device utilizeutilizes our patented Trans-Arterial Micro-Perfusion (‘TAMP™”) therapy platform, which is designed tofor ensure precisetargeted 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, Including traditional chemotherapy.therapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted therapeutic delivery RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of December 31, 2024, 2025, we had cash and cash equivalents of $7.2$7.0 million (although we raised an additional $10.9$10.0 million in netgross proceeds through a public private placement offering completed in FebruaryMarch 20252026). We had net losses of $8.8$11.2 million and $10.2$8.8 million for the years ended December 31, 2024, 2025, and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $50.2$61.4 million. We expect to continue to incur significant expenses,expenses operating losses and negative cash flows whileas we seek to grow our revenues from RenovoCath commercial sales. 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 willcould increase in connection with our ongoing research and development activities,increase, particularly if and when we decide to:

In addition to the variables described above, if and when IAG or any of our product candidates successfully complete development,development and FDA approval, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure and incur other expense needed to commercialize products forIAG as its own product, which wewill may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements,be in addition to otherthe commercialcosts costs.incurred and to be incurred in commercializing RenovoCath as a standalone device. We cannot reasonably estimate these costs at this time.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 and any of our product candidates.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 financial statements as of December 31, 20242025 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 throughfor at least the firstnext half12 months from the date of 2026,issuance of the report, assuming our programs advance as currently contemplated.

As aHowever, result, we will likely require significant additional funding to support our continuing operations. Untiluntil such time, if ever, as we can generate substantial product revenue,revenue and generate positive cash flows, there is a risk that we expectmay 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. 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.

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, 2024.2025.

Research and development expenses consist of costs related to the research and development of our platformTAMP technology.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, utilizinghaving utilized the serviceservices 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 trialstrials, 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.

Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and preclinicalanimal 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.

Other Income (Expenses),Income, Net

Interest Income (Expense)Income, Net

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 $0.78 $0.31 and $1.69$0.78 on December 31, 20242025 and 2023,2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price. price combined with a shorter number of years remaining to the warrant expiration date,

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 compared to $5.7 million for the year ended December 31, 2023,2024, an increase of approximately $0.3 million. The period-over-period increase in research and development expenses is primarily driven by $0.3 millionan increase in manufacturing and non-recurring engineering costs to scale manufacturing to supportfor the commercialdevelopment effortof onthe next generation of our RenovoCath delivery system. Clinicalsystem of $0.5 million and other research and development expensescosts, decreasedprimarily animal studies, of $0.1 million. This increase was offset by $0.2 million, which includes a decrease in professionalselling, and consulting feesgeneral 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 $0.3$0.1 million, which is primarily due to an increase in employeethe incentive compensationnumber of $0.2 million.employees. Regulatory expenseexpenses decreasedremained byrelatively $0.1 millionunchanged primarily due tofrom the reductionsame inperiod consultinglast expenses.year. Cash payments made for use of RenovoCath delivery devices used in our Phase III clinical trial wereincrease relatively$0.2 flat for the year ended December 31, 2024million 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 expectanticipate research and development expenses to increase duringnext 2025year as we continue advance our commercializationclinical activitiesdevelopment forof IAG and develop our next generation of RenovoCath device and progress our Phase III TIGeR-PaC clinical trial study for IAG.device.

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, 20242024, comparedan to $5.7 million for the year ended December 31, 2023, a decreaseincrease of $0.7approximately $2.1 million. The period-over-period decreaseincrease in selling, general and administrative expenses was primarily attributable to aan decreaseincrease in professional services and other of $1.3 million, comprising of $0.2 million in consulting feesservices adopting policies and controls to remediate the material weakness; including increases in audit services in relation to registration statements and other professional expenses of $0.5$0.4 million,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 in directors and officers insurance of $0.2 million, and a $0.1$0.4 million increase in the allocation of selling, general and administrative expenses to research and development.development, offset by a decrease in directors and officers insurance of $0.2 million. Personnel expenses for employees and benefits increased by $0.2$0.6 million, which is primarilymillion due to an increase in employee incentivehead compensation.count. Legal fees decreasedincreased by $0.2 million for the year ended December 31, 20242025 compared to the previous year. The decrease was primarily due to transitioning to a new firm to lower expenses. We anticipate selling, general and administrative expenses to increase next year as we progress with our commercialization activities for our RenovoCath device. delivery system, due primarily to increased hiring of sales and marketing personnel which is expected to continue.

Interest (Expense) Income, Net (in thousands)

Interest income was approximately $0.4 million and $0.1 million for the years ended December 31, 20242025 and 2024, respectively.2024. Interest income represents income earned on excess operating cash invested in short-term U.S. Treasury bills. The increase of $0.3 million in interest income was due to an increase in our average cash balance held in U.S. Treasury bills primarily from the closing of two financings in early 2024.

The change in fair value of common stock warrant liability was $1.8approximately $0.9 million and $1.7$1.8 million for the years ended December 31, 20242025 and 2023, 2024, respectively. The increasedecrease ofin $0.1the millionfair value was primarily due to the fairdecrease value of the common stock warrant due to a decrease in our common stock price duringcombined with a shorter number of years remaining to the period.warrant expiration date.

From our inception through December 31, 2024,2025, we havehad raised an aggregate of $59.2$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 $53.5$64.3 million. As of December 31, 2024,2025, the Company had cash and cash equivalents of $7.2$7.0 million (although we raised an additional $10.9$10.0 million in netgross proceeds through a publicthe offeringMarch completed2026 inPrivate February 2025Placement). As used herein, the term “common stock” refers to the Company’s common stock, par value $0.0001 per share.

On November 10,14, 2022,2025, we filed an omnibusa 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 February 10, 2025, we closed a public offering subject to the baby-shelf limitations rules and raised an aggregate of $12.1 million (see “Note 14. Subsequent Events” in notes to the accompanying financial statements). As a result of such offering, we presently have very little capacity under such omnibus shelf registration statement.

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 (the “January 2024 PA Warrants”),stock, which warrants 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.

Our estimates of totalour serviceable addressable market,market (SAM), potential revenues and similar metrics related to our commercialization efforts for RenovoCath may prove inaccurate, particularly given that our commercialization efforts are relatively new and are evolving.

We are not currently in compliance with the “minimum bid price” continued listing requirement for The Nasdaq Stock Market. If we do not regain compliance by the end of 2026 and continue to meet the such requirement or any other continued listing requirements, 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.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we havewere initially provided 180 calendar daysdays, fromor receiptuntil ofJune 30, 2026, to regain compliance. On July 1, 2026, we received a noticenotification letter from Nasdaq (theinforming “Complianceus Period”),that, towhile regainwe have not yet regained compliance with the Minimum Bid Price Requirement.Requirement, Nasdaq has determined that we are eligible for an additional 180 calendar day period, or until December 28, 2026 (the “Second Compliance Period”), to regain compliance. If at any time during the Second Compliance Period, the bid price of our common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, Nasdaq will provide us with written confirmation of compliance with the Minimum Bid Price Requirement and the matter will be closed. In the event we do not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, we may be eligible for an additional 180-calendar day grace period. Pursuant to Nasdaq Listing Rule 5810(3)(A)(iii), if during any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A), a company’s security has a closing bid price of $0.10 or less for ten consecutive trading days, the Listing Qualifications Department of Nasdaq will issue a Staff Delisting Determination under Nasdaq Listing Rule 5810 with respect to that security (the “Low Priced Stocks Rule”). If a company receives such delisting notice, the company can request a hearing before a Nasdaq hearings panel (the “Panel”). If our common stock closes at or below $0.10 for ten consecutive days during the Second Compliance Period or any additional compliance period,Period, we could receive a Staff Delisting Determination during the Second Compliance Period or any additional compliance period or, if we receive such Staff Delisting Determination, Nasdaq may not grant our request for a hearing, or if Nasdaq grants our request for a hearing, the Panel may not grant our request for continued listing of our common stock on The Nasdaq Capital Market pending our compliance with all applicable listing criteria, including the Minimum Bid Price Requirement, or we may be unable to timely satisfy the terms of any extension that may be granted by the Panel.

We will continue to monitor the closing bid price of our common stock and seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods and may, if appropriate, consider available options, including implementation of a reverse stock split, to regain compliance with the Minimum Bid Price Requirement or the Low Priced Stocks Rule, as applicable. A reverse stock split, would require approval of our stockholders, which may not be obtained, and if implemented,we are unable to otherwise regain compliance with the Minimum Bid Price Requirement, we will be subject to delisting from Nasdaq as described above. Even if we are able to implement, such split could have a material adverse effect on our stock price and valuation.valuation, including as public stock prices often decrease following the occurrence of a reverse stock split.

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2025, which is included in our 2025 Annual Report on Form 10-K.10-K, as amended.

This discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that reflect our plans, estimates, and beliefs that involve risks and uncertainties, including those described in the section of this Report titled “Cautionary Note Regarding Forward-Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this Reportfiling and in the 2025 Annual Report.

Our patented Trans-Arterial Micro-Perfusion (TAMP™) therapyplatform, platformutilizing RenovoCath, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor locally, while potentially minimizing a therapy’s toxicities versus systemic intravenous chemotherapy. RenovoRx’sOur novel approach to targeted treatmentdrug-delivery offers the potential for increasedimproved efficacy, safety, tolerance, and improved efficacy,tolerability, and our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents. We hold a strong and growing global intellectual property portfolio with 19 issued or allowed patents and 14 published and pending patents covering our TAMP therapy platform and RenovoCath.

UntilAs 2025, we focused our efforts primarily on progressing IAG through our ongoing Phase IIIthe TIGeR-PaC study forprogressed, LAPC.we The clinical efforts led toreceived unsolicited (and subsequently solicited) feedback from oncologists, surgeons, and interventional radiologists regardinghighlighting strong interest in our technology, indicating a demand and commercial opportunity for targeted delivery of diagnostic and/or therapeutic agents. As a result, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone medical device. We launched this effort with relatively little capital outlay, and in December 2024, we announced the receipt of our first commercial purchase orders for RenovoCath devices with overmore than ten medical institutions initiating the purchasepurchasing process, while in discussions with more than twenty otheradditional institutions.

We are actively commercializing the TAMP therapy platform and RenovoCath as a stand-alone device. In 2025, our first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales.sales with effectively zero sales and marketing infrastructure for the majority of the year. In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth, commercial momentum, and expansion beyond locally advanced pancreatic cancer (LAPC). We sawgenerated furtherrecord acceleration in the commercial rolloutrevenue of RenovoCath$909,000, duringan increase of approximately 61% compared to the first quarter of 2026,2026 achievingand ourapproximately strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase115% compared to the fourthsecond quarter of 20252025. andOur totalingstrong morefirst thanhalf 50%performance ofgives us confidence that our totalsecond half revenue generatedwill inexceed 2025.our original full-year forecast. This significantoutlook growthis reflectsdriven continuedby expansion ofmore active commercial cancer centerscenter customers, more patients treated via procedures with RenovoCath, and increasingrepeat procedural utilization of RenovoCathordering across our installedexisting customer base. We define "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

We continue to observe organic repeat ordering behavior from existing customers, which we view as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone device and a foundational platform for future drug-device combination therapies.

We continue to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device representscould translate into an approximately $400 million peak annual U.S. sales opportunity,opportunity withfor long-term,our several-billion-dollarcompany. potentialOver time, as we expand the platform expands into additional solid tumor indications.indications, we believe we could unlock more than $1 billion in peak annual sales potential.

OurMore ongoing Phase IIIspecifically, TIGeR-PaC clinical trial is studying the intra-arterial ("IA") administration of gemcitabine to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares the treatment of LAPC using IA delivery of gemcitabine with RenovoCath versus systemic, standard of care, IVintravenous (i.e., systemic) administration of gemcitabine and nab-paclitaxel. Our protocol for TIGeR-PaC involves systemic chemotherapy and SBRT during the induction phase of the study (prior to randomization). In December 2021, we amended our protocol and statistical analysis plan for TIGeR-PaC (the “Modified SAP”) to (i) enroll and analyze only patients receiving SBRT during the induction phase, (ii) include a second interim analysis, (iii) change the total number of patients randomized in the study to 114 with a total of 86 events (deaths) from SBRT patients required to complete the final analysis, and (iv) repower the study from 90% to 80%. The change to the 80% power calculation aligns with common practice for clinical trials and we believe this design will shorten the timeframe needed to complete the study, as well as significantly decrease its cost. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.

During the firstsecond quarter of 2026, we continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across ourits clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent data monitoring committee ("DMC") recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, and after discussions with the DMC and consultation with our regulatory advisors, we elected to defer publication of interim data until after study completion. We will revisit publishing the actual second interim data, most likely after completion of the study as is common practice for Phase III trials.

We continue to advance broader clinical programs by generating new data through ourthe Company’s continued support of investigator-initiatedregistries trialsand (IIT)IITs in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. In the second quarter of 2026, we began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, which is in process to begin soon. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath.

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of MarchJune 31,30, 2026, we had cash and cash equivalents of $12.4$9.5 million. We reported net losses of $3.5$2.9 million and $2.4$6.4 million for the three and six months ended MarchJune 31,30, 2026, and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $64.9$67.8 million. We expect to continue to incur significant expenses, operating losses and negative cash flows while we seek to grow our revenues from RenovoCath commercial sales and work towards our goal of cashflow positive operations. We will not generate revenues from IAG sales unless and until we successfully complete development anddevelopment, obtain regulatory approval forfor, IAGand orcommercially anotherlaunch product candidate.IAG. Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:

In addition to the variables described above, if and when IAG or any of our other potential future product candidates successfully complete development and receive regulatory approval, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition toand other commercial costs. We cannot reasonably estimate these costs at this time.

Our condensed interim financial statements as of MarchJune 31,30, 2026, 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 will be sufficient to fund our operating, investing and financing cash flow needs at least the next 12 months from the date of issuance of this report,report (i.e., into the second half of 2027), assuming our commercial strategy and our development programs advance as currently contemplated.

As a result, while weraising believecapital is not our current focus, we domay not need to raise new capital for at least a year, we are faced with the risk of requiring significantrequire additional funding atin somethe pointfuture to support our operations.strategy. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations, licenseslicensing agreements or other similar arrangements. We currently have no credit facility or committed sources of capital. 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 could 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 condensed interim financial statements, and our shareholders may lose their entire investment in our common stock.

In the fourth quarter of 2024, we began to derivegenerating revenue through the sale of our RenovoCath device on a standalone basis directly to end usersuser customers (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025 and accelerated in the first and second quarters of 2026, with the second quarter of 2026.2026 being a record revenue quarter for us. 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 itwe expectsexpect 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. As of MarchJune 31,30, 2026 and December 31, 2025, we recorded nil of allowance for returns.

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.

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 study (what we call our RR5 study,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.

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, marketing, 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 continued 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.

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 shares of common sharesstock and common stock warrants. The fair value of the common stock warrant per share was $0.36$0.18 and $0.31$0.66 on MarchJune 31,30, 2026, and December 31, 2025, respectively. The increasedecrease in the fair value was primarily due to the increasedecrease in our stock price combined with a shorter number of years remaining to the warrant expiration date.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

We recognized approximatelyrecord $563,000quarterly revenue of revenueapproximately $0.9 million from sales of RenovoCath for the three months ended MarchJune 31,30, 2026, compared to $197,000$0.4 million for the same period last year, representing a significant$0.5 million increase in sales volume. The growth was driven by continued expansion of active commercial cancer centers and repeat ordering from our existing commercial cancer center base. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Cost of revenue was approximately $84,000$0.1 million for the three months ended MarchJune 31,30, 2026, compared to approximately $94,000$0.2 million cost of revenue for the same period last year.year, Theremaining decreaserelatively inflat costs of revenue is due tofrom the costsprior ofperiod deviceslast sold for the three months ended were manufactured under our Medical Murray supply agreement of approximately $1,200 per device.year. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials,materials approximatelywhich $8,300resulted in higher manufacturing costs per device. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Research and development expenses were approximately $1.2 million for the three months ended MarchJune 31,30, 2026, compared to $1.6$1.4 million for the same period last year, a decrease of $0.4$0.2 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.3$0.1 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease of $0.2 million in selling, general, and administrative expenses allocated to research and development costsexpense. of $0.2 million, and clinical, oncology and interventional radiology conferences and other scientific trade shows activities decreased of $0.1 million. TheThis decrease was off-set by an increase in employee and related benefit costs of $0.2$0.1 million primarily due to an increase in employees and salaries changes associated with cost-of-living adjustments. Non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system and regulatory expenses remained relatively unchanged from the same period as last year.million. We anticipate research and development expenses to increase in the second half of 2026 as we advance our clinical development of IAG and the developdevelopment of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Selling, general and administrative expenses were approximately $2.7$2.9 million for the three months ended MarchJune 31,30, 2026, compared to $1.6$1.5 million for the same period last year, an increase of approximately $1.1$1.4 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $0.5$0.8 million as we increasedmade ourtargeted effortsinvestments onin expanding our RenovoCath commercialization programprogram, ofresulting increasingin pipelinean andincreased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. ProfessionalProfessional, and consultingother expenses to include travel and marketing expenses increased by $0.2 million, including travel related expenses of $0.1$0.4 million primarily due to supporting theour RenovoCath commercialization strategystrategy, including otherthe selling, general and administrative expenses of $0.1 million. The increase was further impacted by a decreasedecreased in selling, general, and administrative expenses allocated to research and development expenses of $0.2 million. We anticipate selling, general and administrative expenses to increase during the second half of 2026 as we progress with our commercialization activities for our RenovoCath delivery system, due primarily to increase hiring of sales and marketing personnel which is expected to continue.RenovoCath.

Other Income (Expense), Net