RenovoRx, Inc.: Form 10-Q for the period ended Sep 30, 2025

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 interim condensed financial statements and related notes included elsewhere in this Report, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2024, which is included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 1, 2025 (the “2024 Annual Report”).

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 Report and in the 2024 Annual Report.

As used herein, the term “common stock” refers to our common stock, par value $0.0001 per share. In addition, capitalized terms used but not defined in the below discussion shall have the meanings ascribed to them in the footnotes to the accompanying condensed interim financial statements.

Overview

We are a commercial and clinical stage life sciences company offering RenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug delivery device, targeting high unmet medical needs, with a present focus on difficult to treat cancers. Our mission is to integrate our approach for therapeutic drug-delivery into the standard of care and ultimately improve patient outcomes by offering a more targeted and tolerable treatment option.

Our clinical stage lead product candidate is a novel drug-device combination product consisting of intra-arterial delivery of the chemotherapy gemcitabine via RenovoCath — we refer to our lead product candidate herein as “IAG.” IAG is currently the subject of a Phase III clinical study (called the TIGeR-PaC study) for the treatment of locally advanced pancreatic cancer (“LAPC”).

At the same time, we are commercializing RenovoCath for standalone use by interventional radiologists, oncologists, and other medical professionals who can use the device to treat patients within its FDA-cleared fields of use.

Our RenovoCath device utilizes our patented Trans-Arterial Micro-Perfusion (“TAMP™”) therapy platform, which is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration where it is needed. This targeted approach is designed to minimize systemic exposure and toxicities related to chemotherapy and addresses the longstanding challenge in cancer care of poor blood supply to tumor sites. 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 hold a robust portfolio of 19 issued patents and 12 pending patents covering our TAMP technology.

The early signs of clinical adoption of RenovoCath are promising. We are seeing interest and adoption from academic medical centers, NCI-designated cancer centers, and large community hospitals. Importantly, physicians who have used TAMP, enabled by RenovoCath, are treating additional patients, validating the utility and safety of our technology.

Commercialization of RenovoCath

For the past several years, we have focused our efforts on progressing IAG through clinical trials. However, based on organic demand from doctors in the field who have become familiar with our technology, in 2024 we made the decision to launch an effort to commercialize our RenovoCath delivery device as a standalone device within its FDA cleared uses. Commenced in the field in the fourth quarter of 2024, this commercial effort has already begun to achieve positive results, including our first commercial sales revenue in the fourth quarter of 2024. To accommodate increased need for RenovoCath supply, we expanded our relationship with our U.S.-based, primary third-party RenovoCath manufacturer, Medical Murray, Inc.

Since launching commercial sales less than a year ago in the fourth quarter of 2024, and without a dedicated sales and marketing team, we have expanded from five centers approved to purchase RenovoCath at the start of 2025 to fourteen leading cancer centers now. Five of these centers have already used the device in patients and made repeat orders, demonstrating both demand and customer satisfaction. Physician feedback continues to underscore, what we view, are the benefits of the targeted drug-delivery that can be achieved with TAMP, including reducing systemic chemotherapy toxicity and improving patient quality of life.

As of September 30, 2025, and through the first nine months of 2025, RenovoCath sales totaled approximately $900,000, and we expect that revenue generated from sales of RenovoCath will increase over time.

With our small team, we have established a geographically diverse network of clinical institutions using and interested in the TAMP technology, enabled by RenovoCath, spanning throughout the United States. This network represents not only leading academic institutions and NCI-designated cancer centers, but also high-volume community hospitals, giving us confidence in the potential for deep market penetration of our technology. Our focus remains on strategic, data-driven expansion, ensuring each new center is well supported through onboarding, training, and case follow-up. We are also seeing growing physician-to-physician advocacy, one of the strongest indicators of adoption in interventional oncology.

To support and expand our commercial efforts, in August 2025, we announced the hiring of Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings more than 25 years of MedTech leadership, including a decade focused on interventional oncology. His expertise will be invaluable as we broaden our footprint across the U.S., while maintaining a lean operating structure. In alignment with our existing budget, we have added two additional regional sales managers and plan to add a marketing director by the end of 2025 to drive physician engagement.

We continue to gather important data about our market (such as sales cycles, activation times, individual customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders and position ourselves for commercial growth over the long term. We plan on applying these learnings into 2026.

We are experiencing repeat orders and use with RenovoCath, as well as an expansion of interest among a growing number of approved centers with increasing market awareness and interest across oncology disciplines. As we refine and grow our efforts with a small but dedicated and experienced sales and marketing team, we continue to expect our revenues to grow during 2026 and beyond.

We are encouraged by our early adoption curve and believe our commercial growth strategy positions us for long-term success. Our vision is for RenovoCath to address a large unmet need in oncology. Based on our internal assumptions, we continue to estimate that the initial peak U.S. market opportunity of RenovoCath as a standalone device is approximately $400 million annually, and ultimately, a several-billion-dollar opportunity as we expand into other tumor types.

Readers are advised that our RenovoCath commercialization efforts are new and have experienced fluctuations in revenue, and we may not be able to achieve revenue growth for a variety of reasons. Thus, our efforts remain focused on the longer term. Moreover, revenue recognition under generally accepted accounting principles requires subjective judgments 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. See “Components of Our Results of Operations – Revenue” below for further information.

Our Ongoing Pivotal Phase III Trial for IAG

In parallel to our RenovoCath commercialization efforts, our ongoing Phase III TIGeR-PaC clinical trial to investigate IAG for the treatment of LAPC continues to progress, with enrollment expected to be completed in early 2026 and final data anticipated in 2027. TIGeR-PaC is the cornerstone of our clinical development program, validating our mechanism of action and safety profile through rigorous, long-term evaluation. This trial is being conducted under a U.S. Investigational New Drug (“IND”) application that is regulated by the FDA’s 21 CFR 312 pathway. IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon approval by the FDA.

The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events (namely, patient deaths) necessary to complete the final analysis.

The 52nd event in the TIGeR-PaC trial occurred during the second quarter of 2025, triggering the pre-planned second interim analysis and review by the independent Data Monitoring Committee (DMC) for the trial, which took place in August 2025. The role of the DMC is to independently review the trial data and make recommendations to our company, mainly whether the data support, from a third-party point of view, continuing the trial to completion.

In August of 2025, we reported that the TIGeR-PaC independent DMC completed their review of our second interim analysis and recommended that we continue with the trial. We believe the independent DMC’s recommendation is an expression of confidence in the potential for a positive outcome in the trial overall. The second interim review of data reinforces that the trial should proceed as planned to the final analysis as we seek to potentially demonstrate the safety and superiority of intra-arterial gemcitabine delivered via RenovoCath for the treatment of LAPC as compared to intravenous chemotherapy, the current standard of care. With a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions with the independent DMC, and consultation with our regulatory advisors, we have decided to defer publishing the detailed data from the second interim analysis. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials.

Recently we strengthened our Scientific Advisory Board to now include recognized surgeon and pancreatic cancer expert, Dr. Timothy Donahue, and internationally renowned interventional oncologist, Dr. Thierry de Baère. Dr. Donahue is Director of UCLA’s Agi Hirshberg Center for Pancreatic Diseases and as Chief of the Division of Surgical Oncology at the David Geffen School of Medicine. He also is the Garry Shandling Chair in Pancreatic Surgery. Professor de Baère is Head of the Interventional Radiology at both Gustave Roussy Cancer Centre and University Paris-Saclay in France.

We may also evaluate the safety of RenovoCath for the delivery of therapeutic agents as a potential therapy in other indications.

Launch of the RR5 Multi-Center Post-Marketing Registry Study to Evaluate Chemotherapy Delivered by RenovoCath Device to Solid Tumors

In July 2025, we launched our RR5 Post-Marketing Registry Study for RenovoCath (NCT06805461) (which we call the RR5 Study). The RR5 Study is progressing well, generating real-world data on the safety and effectiveness of RenovoCath across a range of solid tumors and demonstrates our commitment to advance our future clinical strategy by evaluating potential expansions of the use of RenovoCath for chemotherapy-delivery in additional high-unmet need oncology indications beyond LAPC.

A registry study, sometimes called a post-approval study, is a type of clinical study that involves collecting data on the long-term use and performance of a medical device, in this case RenovoCath, after it has been cleared for market by the FDA. These trials can serve as a critical tool for understanding a product’s safety and effectiveness in a real-world setting and can provide valuable insights into long-term effectiveness, patient outcomes, and additional safety information that may emerge years after implantation or extended use.

The RR5 Study is a registry study designed to evaluate long-term safety and survival outcomes for patients diagnosed with solid tumors that are treated using the RenovoCath device for targeted chemotherapy delivery.

The RR5 Study aims to enroll adult patients who have been diagnosed with solid tumors and treated using the RenovoCath device. The registry study will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. Additionally, this data is expected to be used to inform future clinical trial designs.

In September 2025, we reported that the first patient procedure in the RR5 Study had taken place at the University of Vermont Cancer Center was completed, and Baptist Health Miami Cancer Institute and the University of Pittsburgh Medical Center had joined the registry study as additional sites.

In addition, we continue to advance investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer. These studies are designed to be cost-neutral to our company while providing meaningful data that may further broaden the application of our TAMP therapy platform.

Cash Resources, History of Losses and Planned Activities

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of September 30, 2025, we had cash and cash equivalents of approximately $10.0 million. We reported net losses of $2.9 million and $8.2 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $58.4 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. Further, 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 for IAG, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:

• 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;
• Make targeted investments we deem necessary to expand our RenovoCath commercial sales efforts (which we have done in the second half of 2025 as noted above);
• Hire additional research, development, sales and marketing, selling, and general and administrative personnel;
• Pursue future collaborations, licensing arrangements or other strategic or commercial activities relating to our technology;
• Maintain, expand, enforce, defend, and protect our intellectual property portfolio; and
• Expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development, manufacturing and commercialization efforts.

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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 to other commercial costs. We cannot reasonably estimate these costs at this time.

Based on our current plans, our cash on hand is expected to fund both the RenovoCath commercial scale-up and continued progress of our Phase III TIGeR-PaC trial, as well as other activities, into the middle of 2026. Any increase in sales momentum beyond our current expectations could extend this timeline. However, due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we will be required to raise additional capital to fund our operations through at least the next 12 months from the issuance of this Report, continue the commercialization of RenovoCath and complete the development of and gain regulatory approval for IAG or any other of our future potential product candidates. 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.

As we continue to make progress commercially, and as each day we get closer to our final Phase 3 TIGeR-PaC study data readout (anticipated in 2027), we have multiple potential opportunities to strengthen our balance sheet as needed including, but not limited to, debt and/or equity financing (including via our shelf registration statement) as well as our current ongoing licensing and partnerships discussions. All of these financing options should provide our company with the best flexibility as we continue to drive shareholder value. Further, we plan to use our shelf registration statement to establish a customary “at the market” offering program.

However, we may not be able to obtain financing on favorable terms when needed, 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 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 condensed interim financial statements as of September 30, 2025 have been prepared under the assumption that the Company will continue as a going concern and, despite the Company’s findings to the contrary, do not include any adjustments that may result from the negative outcome of this uncertainty.

As a result, we are faced with the risk of requiring significant additional funding to support our continuing operations. 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, licenses 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.

Components of Our Results of Operations

Revenue

In December 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). 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 commercial product returns to date and, accordingly, no allowance for returns was recorded as of September 30, 2025.

Cost of Revenue

Cost of revenue consist 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, utilizing the service of third-party clinical trial sites and several clinical research vendors and consultants 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, expand our RR5 Study, and pursue regulatory approval of IAG or other 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. 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:

• expenses incurred under agreements with clinical trial sites, contract research organizations, and consultants that are involved in conducting our clinical trials;
• costs of acquiring and developing clinical trial materials;
• personnel costs, including salaries, benefits, bonuses, and stock-based compensation for employees engaged in preclinical and clinical research and development;
• 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;
• costs related to preclinical studies and pilot testing;
• travel expenses; and
• allocated selling, general and administrative expenses which includes facilities and other indirect administrative expenses to support research and development activities.

Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and preclinical 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, commercial 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 U.S. Securities and Exchange Commission, (“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 as we expand our commercialization efforts, due primarily to anticipated hiring of a limited number of additional sales and marketing personnel. Selling, general and administrative expenses are expensed as incurred.

Other Income

Interest income is earned from cash deposited in our 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 $0.57 and $0.61 on September 30, 2025 and 2024, respectively. The decrease in the fair value of the liability from the prior year was primarily due to the decrease in our stock price combined with a shorter term to expiration.

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.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

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

(unaudited)

Revenue

We recognized approximately $266,000 of revenue from sales of RenovoCath for the three months ended September 30, 2025, compared to no revenue for the same period in 2024. The quarter ended September 30, 2025 marked our third consecutive full quarter of revenue generation from RenovoCath sales. We experienced relatively minor fluctuation in sales during the third quarter of 2025 as compared to the second quarter of 2025 given that our commercialization efforts are so new, have been handled by limited staff, and that only a handful of patients can impact revenue at this stage. This was not unexpected, and we continue to expect to grow revenue from RenovoCath over time.

Cost of Revenue

Cost of revenue was approximately $53,000 for the three months ended September 30, 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 from Medical Murray, our third-party manufacturer.

Gross Margin

Gross profit was $213,000 for the three months ended September 30, 2025 (resulting in gross profit margin of approximately 80%), compared to no gross profit for the same period in 2024.

Prior to the commencement of commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC 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 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.

Research and Development

Research and development expenses were approximately $1.7 million for the three months ended September 30, 2025, and 2024, remaining relatively unchanged. The period-over-period modest increase in research and development expenses is primarily driven by an increase in clinical expenses of $0.2 million and non-recurring engineering costs for the development of our next generation RenovoCath delivery system of $0.1 million to support our commercial effort program. The increase was offset by decreases in personnel expenses and regulatory of $0.2 million and selling, general and administrative expense allocation of approximately $0.1 million each. We expect research and development expenses to increase during 2025 as we continue to develop our next generation for our RenovoCath device, progress our Phase III TIGeR-PaC clinical trial study for IAG and to launch our new RenovoCath Post-Marketing Registry Study called RR5 Study.

Selling, General and Administrative

Selling, general and administrative expenses were approximately $1.7 million for the three months ended September 30, 2025 compared to $1.2 million for the three months ended September 30, 2024, an increase of $0.5 million. Professional and consulting expenses increased by $0.2 million compared to the same period last year, primarily due to the implementation of our new enterprise resource planning software and incurred additional outside consultation to advise on adopting policies and controls to remediate the material weakness. Investor and public relations increased by $0.1 million due to an increase in digital marketing expenses including personnel related expenses of $0.1 million and a decrease in selling, general and administrative allocation to research and development of $0.1 million. We anticipate selling, general and administrative expenses to increase during 2025 as we progress with our commercialization activities for our RenovoCath device, due primarily to anticipated hiring of sales and marketing personnel as described above.

Other Income, net

Other income was approximately $0.3 million for the three months ended September 30, 2025, a decrease in other income of approximately $0.1 million compared to other income of $0.4 million for the same period last year. The decrease in other income was primarily due to approximately $0.1 million change in the fair value of the common warrant liability primarily due to an increase in our stock price and shorter term to expiration.

Comparison of the Nine Months Ended September 30, 2025 and 2024

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

(unaudited)

Revenue

We recognized approximately $0.9 million of revenue from sales of RenovoCath for the nine months ended September 30, 2025, compared to no revenue for the same period last year as we launched initial commercial sales activity for RenovoCath during the fourth quarter of 2024. We expect to grow revenue from RenovoCath sales over time as we expand our commercial efforts.

Cost of Revenue

Cost of revenue was approximately $0.3 million for the nine months ended September 30, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party manufacturer. Prior to the commencement of our RenovoCath commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. 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.

Research and Development

Research and development expenses were approximately $4.8 million for the nine months ended September 30, 2025, compared to $4.4 million for the same period last year, an increase of $0.4 million. The period-over-period increase in research and development expenses is primarily due to an increase in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system by $0.3 million. Clinical increased $0.3 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC and costs for our RR5 Study. Clinical, oncology and interventional radiology conferences and other scientific trade shows activities increased by $0.1 million including the costs of other research activities of $0.1 million. The increases were offset by an increase of payments from clinical trial sites in consideration for RenovoCath delivery devices of $0.2 million and a decrease in selling, general and administration expenses allocated to research and development of $0.2 million. We expect research and development expenses to increase during 2025 as we continue to incur non-recurring engineering activities for the next generation of our RenovoCath device, progress our Phase III TIGeR-PaC clinical trial study for IAG, and to expand our new RR5 Study.

Selling, General and Administrative

Selling, general and administrative expenses were approximately $4.8 million for the nine months ended September 30, 2025, compared to $3.9 million for the same period last year, an increase of approximately $0.9 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 $0.2 million, professional and consulting fees of $0.4 million primarily due to the implementation of our new enterprise resource planning software and adopting policies and controls to remediate the material weakness, and an decrease in selling, general and administrative expenses allocated to research and development expenses of $0.2 million compared to the same period last year We anticipate selling, general and administrative expenses to increase during 2025 as we progress and expand our commercialization activities for our RenovoCath delivery system, due primarily to anticipated hiring of sales and marketing personnel.

Other Income, net

Other income was approximately $0.8 million for the nine months ended September 30, 2025, a decrease of approximately $1.6 million compared to approximately $2.4 million for the same period last year. The decrease was primarily due to a $1.7 million decrease in the fair value of the common warrant liability due to an increase in our stock price and shorter term to expiration.

Liquidity and Capital Resources

From our inception through September 30, 2025, we have 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 September 30, 2025, we had cash and cash equivalents of approximately $10.0 million. As discussed above under the caption “Cash Resources, History of Losses and Planned Activities”, based on our operational plans, we do not 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 needs for at least the next twelve months from the date of this Report. This raises a current substantial doubt about our ability to continue as a going concern.

We have incurred significant losses and negative cash flows from operations since our inception. At September 30, 2025, we had an accumulated deficit of approximately $58.4 million. For the three and nine months ended September 30, 2025, we reported a net loss of $2.9 million and $8.2 million, respectively. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations until we generate sufficient revenues from RenovoCath sales, which we may be unable to achieve. We also expect to incur losses from our clinical activities until regulatory approval is granted for our 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 commercializing RenovoCath 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 when needed 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 when needed 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 the ability to pursue our business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve positive cash flow or profitability, and we may never do so.

Our ability to obtain additional financing we may need in the future will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available 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, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. 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 titled “Risk Factors” in this Report and in our 2024 Annual Report. 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.

Sources of Liquidity

Since our inception, we have been primarily a clinical stage company on our clinical development stage lead product candidate, novel drug-device combination product consists of IAG via RenovoCath 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 started to generate revenue in the fourth quarter of 2024. We anticipate continuing to generate revenue from RenovoCath sales and growing such sales over time, which would support our liquidity. 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 generates 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 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, further develop our therapy platform and ensure that 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 Operating Activities

Cash used in operating activities for the nine months ended September 30, 2025 of $8.0 million reflected a net loss of $8.2 million and a net change in our operating assets and liabilities of $0.4 million, offset by non-cash charges of $0.6 million.

Cash used in operating activities of $6.7 million for the nine months ended September 30, 2024, reflected a net loss of $5.9 million and non-cash charges of $1.2 million, offset by net change in our operating assets and liabilities of $0.4 million.

Cash Used in Investing Activities

Cash used in investing activities for the nine months ended September 30, 2025 consisted of $0.2 million for the purchase of property and equipment.

Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $10.8 million, consisting primarily of net proceeds from the public equity offering.

Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.1 million, consisting primarily of net proceeds from private placement offerings.

Contractual Obligations and Other Commitments

There have been no material changes in our contractual obligations or other commitments since we filed our 2024 Annual Report, other than an increase to certain purchase obligations with our commercial supply agreement of approximately $0.7 million, see Note 7, Leases, Commitments and Contingencies.

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 unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim 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. Our critical accounting policies and estimates are detailed in our 2024 Annual Report.

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the nine months ended September 30, 2025, from those previously disclosed in our 2024 Annual Report.

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 adjust 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.

April 2023 Warrants

We evaluated pre-funded warrants and the April 2023 Warrant issued in connection with registered direct financing in April 2023 to determine whether such warrants qualify for equity classification, or meet the definition of a derivative instrument, classified as a liability on the condensed balance sheets and measured at fair value at inception and at each reporting date with changes in fair value recognized in the condensed statements of operations in the period of change.

Direct Offering Costs

Direct offering costs consist principally of commissions, placement fees and legal fees, including other professional expenses incurred. We evaluate the terms under the financing agreement to determine the classification of direct costs in the accompanying condensed statements of operations.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company” as defined in 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 interim condensed financial statements for any interim period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations;
• 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 Report on this Form 10-Q 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 what 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 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 non-affiliates 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

There were no new accounting pronouncements that were issued or became effective since the issuance of our 2024 Annual Report that had, or are expected to have, a material impact on our unaudited condensed balance sheets, unaudited condensed statement of operations or unaudited condensed statement of cash flows.

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

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and Principal Accounting 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 fiscal quarter ended September 30, 2025. Based on this evaluation, our Chief Executive Officer and Principal Accounting Officer have concluded that, during the period covered by this Report, our disclosure controls and procedures were not effective due to our previously identified material weaknesses in internal control over financial reporting. As a result, we have performed additional analysis as deemed necessary to ensure that our financial statements were prepared in accordance with GAAP. Accordingly, notwithstanding the identified material weaknesses, management, including our Chief Executive Officer and Principal Accounting Officer, believes the condensed interim financial statements included in this Report are fairly presented, in all material respects, in accordance with GAAP.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated, communicated and discussed with our management, including our Chief Executive Officer and Principal Accounting Officer or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that controls and procedures, no matter how well designed and operated, can only provide reasonable, not absolute, assurance the desired control objectives will be met. In reaching a reasonable level of assurance, management has weighed the cost of contemplated controls against their intended benefits. The design of any system of controls is based on management’s assumptions about the likelihood of future events. We cannot assure you that our controls will achieve their stated goals under all possible conditions. Changes in future conditions may render our controls inadequate or may cause our degree of compliance with them to deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Previously Identified Material Weakness

As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, our management identified material weaknesses in our internal control over financial reporting related to our control environment. A material weakness is a deficiency, or combination of significant deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis.

Specifically, we have determined that we have not maintained adequate formal accounting policies, processes and controls related to complex transactions as a result of a lack of finance and accounting staff with the appropriate GAAP technical expertise needed to identify, evaluate and account for complex and non-routine transactions. We have also determined that we have not maintained sufficient staffing or written policies and procedures for accounting and financial reporting, which contributed to the lack of a formalized process or controls for management’s timely review and approval of financial information. More specifically, we have determined that our financial statement close process includes significant control gaps mainly driven by the small size of our accounting and finance staff and, as a result, a significant lack of appropriate segregation of duties. This includes the ability of users to create and post journal entries without adequate compensating review controls as well as review of system rights on the journal entry and financial close process. In addition, we did not have proper information technology general controls related to user access, including the performance of user access reviews, access to edit data in applications was not properly restricted, and formal approval of application access was not documented and retained.

The previously identified material weakness has not been remediated but we are in the process of implementing a number of measures to address the material weaknesses that has been identified including: (i) engaging additional accounting and financial reporting personnel with GAAP and SEC reporting experience, (ii) developing, communicating and implementing an accounting policy manual for our accounting and financial reporting personnel for recurring transactions and period-end closing processes, and (iii) establishing effective monitoring and oversight controls for non-recurring and complex transactions to ensure the accuracy and completeness of our financial statements and related disclosures.

These additional resources and procedures are designed to enable us to broaden the scope and quality of our internal review of underlying information related to financial reporting and to formalize and enhance our internal control procedures. With the oversight of senior management and our Audit Committee, we have begun taking steps and plan to take additional measures to remediate the underlying causes of the material weaknesses.

We intend to complete the implementation of our remediation plan when we have sufficient cash to remediate our material weaknesses. Although we believe that our remediation plan will improve our internal control over financial reporting, additional time may be required to fully implement it and to make conclusions regarding the effectiveness of our internal control over financial reporting. Our management will closely monitor and modify, as appropriate, the remediation plan to eliminate the identified material weaknesses.

Changes in Internal Control over Financial Reporting

Except for the material weaknesses noted above, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting since we filed our 2024 Annual Report.

An investment in our securities is speculative and involves a high degree of risk. You should carefully consider the risk factors below, as well as the other information in this Report, including our unaudited interim condensed financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other public filings in evaluating our business, including those risk factors included in our 2024 Annual Report. The occurrence of any of the events or developments described in our 2024 Annual Report, or summarized below or described elsewhere in this Report could harm our business, financial condition, results of operations, growth prospects or stock price. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risk Factors Summary

The following is a summary of principal factors and uncertainties that make investing in shares of our common stock risky and impact our ability to execute on our business strategy include risks regarding the following. This summary is not exhaustive, and readers are therefore encouraged to review the “Risk Factors” section and the “Risk Factors” section in our 2024 Annual Report in their entirety:

• 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 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 have incurred significant net losses in each period since inception, and we expect to continue to incur net losses until we receive FDA approval for our product candidate or until our commercial strategy for RenovoCath generates sufficient revenues.
• We are executing on a commercial strategy for selling our RenovoCath device on a standalone basis, which is a new activity for our company and subject to significant inherent risks. Our revenues from RenovoCath sales may fluctuate over time or may not meet our expectations.
• Our estimates of total addressable market, potential revenues and similar metrics related to our commercialization efforts for RenovoCath, as well as our estimates for the timing of completion and data readout from our clinical trials, may prove inaccurate, particularly given that our commercialization efforts are relatively new and are evolving and given the uncertainties associated with clinical trials.
• Revenue recognition from our RenovoCath commercialization activities could be complex and uncertain. We may be required to defer recognition of revenues under policies which we develop. Our inability to properly recognize revenue could have a material adverse effect on our estimates of our future revenue performance and on our actual financial results.
• Our revenues and results of operations may be difficult to predict and have and may continue to fluctuate from quarter to quarter, which could adversely affect our business and the market price of our common stock.
• If the manufacturers upon whom we rely fail to produce RenovoCath or product candidates in the volumes that we require on a timely basis or fail to comply with stringent regulations applicable to life science manufacturers, we may face delays in the development and commercialization of RenovoCath and our product candidates.

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• We will need to raise substantial additional capital 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 may force us to delay, reduce or eliminate our product development programs, commercial efforts or collaboration efforts.
• As of the date of this Report, our cash on hand will not be able to fund our planned operations for more the twelve months, and therefore there is a risk that we may be unable to continue as a going concern.
• We may consider strategic alternatives in order to maximize stockholder value, including financing, strategic alliances, and licensing arrangements. We may not be able to identify or consummate any suitable strategic alternatives, and any consummated strategic alternatives may not be successful.
• Our product candidates’ commercial viability 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 pharmaceutical product candidate. If we are unable to successfully advance or develop our product candidates, our business will be materially harmed.
• As our ongoing Phase III TIGeR-PaC trial is evaluating our most advanced drug-device combination product candidate to date, the failure of the trial to achieve results conducive to progressing the trial or filing and receiving NDA approval could cause our company significant harm.
• If we do not achieve our projected development goals in the timeframes we announce and expect, our stock price may decline.
• Our product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products or investigational new drugs, which may delay or preclude further development or regulatory approval or limit their use if approved.
• If the results of preclinical studies or clinical trials for our product candidates are negative, we could be delayed or precluded from the further development or commercialization of our product candidates, which could materially harm our business.
• If we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates.
• If our product candidates are unable to compete effectively with marketed drugs targeting similar indications as our product candidates, our commercial opportunity will be reduced or eliminated.
• We may delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business.
• Our future success depends on our ability to retain our key personnel and to attract, retain, and motivate qualified personnel, especially in light of an acute workforce shortage and hyper-competitive compensation environment.
• If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies, which would impair our competitive advantage.
• The patents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more effective technologies, designs, or methods without infringing our intellectual property rights and one or more of our competitors may design around our proprietary technologies.

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• The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our investors.
• If we fail to maintain compliance with or meet all applicable Nasdaq requirements, we could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.