10-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

Commission File Number: 001-40738

RENOVORX, INC.

(Exact name of registrant as specified in its charter)

2570 West El Camino Real, Suite 320, Mountain View, CA 94040

(Address of principal executive offices, including zip code)

(650) 284-4433

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, $0.0001 par value RNXT The Nasdaq Capital Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates on June 30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, based upon the closing price of the registrant’s common stock on such date as reported by The Nasdaq Capital Market, was approximately $26.6 million. Shares of voting stock held by each officer and director have been excluded in that such persons may be deemed to be affiliates. This assumption regarding affiliate status is not necessarily a conclusive determination for other purposes.

The number of outstanding shares of the registrant’s common stock, $0.0001 par value per share, as of March 23,2026, was 45,052,706.

DOCUMENTS INCORPORATED BY REFERENCE

None.

RENOVORX, INC.

ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2025

TABLE OF CONTENTS

Page

PART I

ITEM 1. BUSINESS 1

ITEM 1A. RISK FACTORS 25

ITEM 1B. UNRESOLVED STAFF COMMENTS 70

ITEM 1C. CYBERSECURITY 70

ITEM 2. PROPERTIES 71

ITEM 3. LEGAL PROCEEDINGS 71

ITEM 4. MINE SAFETY DISCLOSURES 71

PART II

ITEM 6. [RESERVED] 73

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 87

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 87

ITEM 9A. CONTROLS AND PROCEDURES 87

ITEM 9B. OTHER INFORMATION 89

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 89

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 90

ITEM 11. EXECUTIVE COMPENSATION 90

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 90

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 91

SIGNATURES 96

Solely for convenience, trademarks and trade names referred to in this Report may appear without the ® or TM symbols.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K, or Form 10-K (this “Report”), particularly in the sections captioned “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to significant risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control. All statements other than present and historical facts and conditions contained in this Report, including statements regarding our future revenues and other results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these terms or other comparable terminology. Actual events or results may differ from those expressed in these forward-looking statements, and these differences may be significant and adverse. Forward-looking statements include, but are not limited to, statements about:

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the sufficiency of our existing cash, cash equivalents, and investments to fund our future operating expenses and capital expenditure requirements;

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our estimates or expectations regarding future revenues, expenses, anticipated capital requirements to fund our future operating expenses, and our need for additional financing;

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our anticipated financial or operational performance;

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our anticipated use of our existing cash, cash equivalents, and investments;

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the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

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the progress and focus of our current and future clinical trials;

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projections for enrollment of our clinical trials and our expectations relating to the timing of the provision of updates on, public announcements (if any) for interim or top line data from, and completion of enrollment for and final results from our clinical trials (notably our ongoing Phase III TIGeR-PaC trial);

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our continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture of our product candidates;

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the beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates;

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our ability to advance product candidates into and successfully complete clinical trials;

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our ability to further develop and expand our therapy platform, both to use different chemotherapeutic agents, to include new indications, or to market our catheter on a standalone basis;

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our ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for various diseases;

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existing regulations and regulatory developments in the United States and other jurisdictions;

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our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our potential and ability to successfully commercialize our product candidates and generate revenue;

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the implementation of our strategic plans for our business and product candidates;

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the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with relevant and complementary expertise;

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our estimates of the number of patients in the United States who suffer from the diseases we target;

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our estimates of potential addressable market opportunities and our ability to successfully penetrate addressable markets;

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the success of competing therapies or devices that are or may become available;

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developments relating to our competitors and our industry, including competing product candidates, therapies and devices;

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our plans relating to the further development and manufacturing of our devices and product candidates, including for additional indications which we may pursue;

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our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;

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the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform and product candidates;

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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners;

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our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved;

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our ability to retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel;

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our ability to maintain compliance with the continuing listing requirements of the Nasdaq Stock Market; and

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our expectations regarding the impact of major domestic and geopolitical events on our business.

We have based the forward-looking statements contained in this Report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions and other factors described in the section titled “Risk Factors” and elsewhere in this Report. These risks are not exhaustive. Other sections of this Report include additional factors that could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Report. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

iii

The forward-looking statements made in this Report relate only to events as of the date on which such statements are made. We undertake no obligation to update any forward-looking statements after the date of this Report or to conform such statements to actual results or revised expectations, except as required by law.

This Report contains market data and industry forecasts that were obtained from industry publications. These data and forecasts involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this Report is generally reliable, such information is inherently imprecise.

In this Report, unless the context otherwise indicates, the terms “RenovoRx,” the “Company,” “we,” “our,” and “us” refer to RenovoRx, Inc., a Delaware corporation. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ended in December and the associated quarters, months and periods of those fiscal years.

PART I

ITEM 1. BUSINESS

Overview

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

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

We are actively commercializing the TAMP therapy platform and RenovoCath as a stand-alone device within its FDA cleared fields of use. We are a commercial-stage growth company commercializing RenovoCath in the United States, have received our first commercial purchase orders for RenovoCath devices in December 2024. For the year ended December 31, 2025, we generated an aggregate of $1.1 million in revenue from RenovoCath sales. These sales are from U.S. cancer centers that initiated repeat orders as well as new institutions adopting the device, including several esteemed, high-volume National Cancer Institute-designated centers. While we strive to meet and satisfy the anticipated demand, we continue to actively explore further revenue-generating activity, either on our own or in tandem with a medical device commercial partner.

In February 2026, we announced continued commercial progress, with 12 U.S. cancer centers utilizing the RenovoCath and 21 additional centers are evaluating the device, or have completed evaluation, or, are preparing for activation. As of the date of this Report, a total of 33 centers have requested access to RenovoCath, tripling the potential number of near-term commercial centers in RenovoRx’s sales pipeline since the first quarter of 2025. The growing adoption reflects increasing clinical demand for RenovoCath as it becomes integrated into overall cancer treatment paradigms and sets the stage potential revenue expansion in 2026. In addition, we built our sales and marketing infrastructure from scratch with our full sales and marketing team having been launched in late 2025. With this, we established the systems and processes needed to scale and believe having this team in place further bolsters our prospects.

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

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

We believe the initial target market for RenovoCath would be approximately $400 million in peak annual U.S. sales, based on our internal assumptions, which include: (i) pressure-mediated delivery catheters on market today, which are analogous to RenovoCath, have an average selling price of $6,500-$8,500 per unit; (ii) approximately 7,000 initial target patients at peak market penetration; and (iii) an average of at least 5 to 6 procedures per patient.

We also believe there are expansion opportunities across other clinical indications that could ultimately create a multi-billion-dollar total addressable market potential for RenovoCath. We believe that we can achieve meaningful market penetration with our sales and marketing team targeting the top 200 high-volume treatment centers. Furthermore, and importantly, there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering specialty pressure-mediated delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.

We continue to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials ("IITs") in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT trials achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP.

Intra-arterial Infusion of Gemcitabine with RenovoCath: IAG Clinical Process to Date

The current standard of care for pancreatic cancer treatment is primarily systemic IV gemcitabine and nab-paclitaxel or FOLFIRINOX chemotherapy; however, systemic chemotherapy is well known to cause debilitating side effects for patients. Unlike other tumors with extensive blood supply, pancreatic tumors have a limited vascular network so systemic chemotherapy may not adequately reach the tumor. Thus, the standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting systemic administration of chemotherapy to the tumor.

We have completed clinical studies and observational registry studies evaluating treatment with IAG, with 20 and 25 patients (including 2 patients who participated in both studies), respectively, who were diagnosed with locally advanced pancreatic cancer (“LAPC”). In the 43 unique pooled patients evaluable in these two studies, 9 patients pretreated with radiation followed by treatment with RenovoCath with gemcitabine experienced a median Overall Survival (“OS”) of 27.1 months. Based on previous large randomized clinical trials not sponsored by our company, the expected median overall survival of LAPC patients is 12.0 to 18.8 months in patients receiving only IV systemic chemotherapy or IV chemotherapy plus radiation (which are both considered standard of care). Unlike the randomized trials that established these standard of care results, our early clinical studies did not prospectively control the standard of care therapy received prior to administration of IAG and the results are subject to significant limitations and are not directly comparable to outcomes from randomized controlled trials. Based on FDA safety review of our prior clinical studies, the FDA allowed us to proceed to evaluate RenovoCath with gemcitabine (IAG) within our Phase III TIGeR-PaC clinical trial.

In a clinical trial, "enrollment" is the process of registering a participant into the trial, and "randomization" is a subsequent step where enrolled participants are assigned to comparative study groups by chance to avoid bias. Our ongoing TIGeR-PaC clinical trial is studying IAG to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares the treatment of LAPC using IAG versus systemic, standard of care, IV administration of gemcitabine and nab-paclitaxel. Our TIGeR-PaC protocol includes 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 our costs. We have had some interactions with the FDA regarding the Modified SAP, but we cannot provide any assurance that the FDA will agree with these modifications.

As of March 24, 2026, 104 patients had been randomized, and 72 events have occurred. We anticipate completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized. Final data in the study is anticipated in 2027.

The first interim analysis of the TIGeR-PaC trial at the 26th event (death) of the specified events was completed in March 2023, with the independent Data Monitoring Committee (“DMC”) recommending a continuation of the study. The interim analysis showed a 6-month median overall survival benefit (Figure 1) for patients (nearly a 60% improvement) versus the study control arm and current standard of care: IV administration of gemcitabine and nab-paclitaxel. Patients also had greater than 65% reduction in adverse events (Figure 2) with IAG versus the standard of care.

In the second quarter of 2025, the 52nd event triggered the second pre-planned interim analysis to be reviewed by the DMC. The DMC concluded its review and recommended that RenovoRx continue with the trial, without modification. To avoid compromising the integrity of the trial with the FDA, and after discussions with the DMC and consultation with our regulatory advisors, we elected to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion of the study as is common for Phase III trials.

TIGeR-PaC remains the cornerstone of our clinical development program, validating its mechanism of action and safety profile through rigorous, long-term evaluation.

Figure 1: TIGeR-PaC Phase III Update (1st Interim Analysis) showing 6-month median OS benefit with TAMP utilizing IAG delivered via the RenovoCath vs. IV/systemic gemcitabine and Abraxane (control).

Figure 2: TIGeR-PaC Phase III Update (1st Interim Analysis) showing that TAMP utilizing IAG observes fewer AEs and SAEs vs. IV gemcitabine and Abraxane (IV Gem + Abraxane).

Our TAMP Therapy Platform

Our patented TAMP therapy platform is focused on optimizing drug concentration in solid tumors by delivering oncology therapies with our RenovoCath device. TAMP is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. Specifically, our patented approach enables physicians to pre-treat patients with standard-of-care radiation therapy and utilize our RenovoCath device to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor.

Figure 3: Mechanism: Trans-Arterial Micro-Perfusion (TAMP)

We believe there are many advantages to our TAMP therapy platform, including:

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Application of Approved Chemotherapeutic Agents: Approved chemotherapeutic agents, with well-known safety and efficacy profiles have been used with our RenovoCath device. These include small molecule chemotherapy agents, and based on more recent animal studies, we believe that larger molecule agents could be utilized as well.

Targeted Approach: In a preclinical study published in the Journal of Vascular Interventional Radiology (July 2024 issue) using our therapy platform, we demonstrated up to 100 times higher local drug concentration compared to systemic chemotherapy. We believe our TAMP therapy platform allows for a targeted approach that can decrease systemic exposure and improve patient outcomes.

Delivery Method Independent of Tumor Vascularity: Our therapy platform is designed to deliver chemotherapeutic agents to solid tumors resistant to systemic chemotherapy due to lack of tumor feeder blood vessels. If approved, our product candidates utilizing our RenovoCath device have the potential to treat tumors that are not directly supplied by large blood vessels.

Broad Application for Solid Tumor Indications: Our therapy platform is not restricted to a single chemotherapeutic agent or solid tumor type. As such, it may be applied for use with additional therapeutic agents and/or in additional solid tumor indications, including in solid tumors with and without identifiable tumor feeder blood vessels.

Intellectual Property Protection: Our TAMP therapy platform and RenovoCath device are covered by 9 issued and 5 pending U.S. patents, and 10 issued and 7 pending patents outside of the U.S. We continue to explore additional opportunities to further bolster our intellectual property position, and if granted, our current applications would provide patent protection through 2045.

We received our first FDA 510(k) clearance for RenovoCath in 2014, a second clearance to use RenovoCath for infusion of chemotherapy agents in 2017, a further clearance to use RenovoCath with a power-injector in 2019, and a fourth clearance in 2021 to expand vessel diameter range to 3-11 mm, implement certain changes in the Instructions for Use (“IFU”), change the recommended saline to contrast solution ratio, among other changes and improvements.

We are also routinely in discussions regarding collaborations and potential out-licenses of our lead product candidate IAG, as we prepare for an FDA New Drug Application (“NDA”) filing in the coming years (assuming we meet our study endpoints) as well as other collaborations with our TAMP platform.

For further information regarding our RenovoCath Instructions for Use please see: https://renovorx.com/wp-content/uploads/2025/04/IFU-10004-Rev.-G-Universal-IFU.pdf.

Commercialization of RenovoCath

Until 2025, we focused our efforts primarily on progressing IAG through our ongoing Phase III TIGeR-PaC study for LAPC. The clinical efforts led to unsolicited (and subsequently solicited) feedback from oncologists, surgeons, and interventional radiologists regarding 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 device. We launched this effort with relatively little capital outlay, and in December 2024, we announced our receipt of our first commercial purchase orders for RenovoCath devices with over ten medical institutions initiating the process for RenovoCath purchase orders, and we were in discussions with more than twenty other institutions. Moreover, we believe that 17 centers that have used RenovoCath as part of the TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment, which is anticipated by the middle of 2026.

In February 2026, we announced continued progress with our sales and marketing efforts, with 12 U.S. cancer centers utilizing the RenovoCath device commercially and 21 additional centers are evaluating the device, or have completed evaluation, or, are preparing for activation.

A total of 33 centers have requested access to RenovoCath, tripling the potential number of near-term commercial centers in RenovoRx’s sales pipeline since the first quarter of 2025. The growing adoption reflects increasing clinical demand for RenovoCath as it becomes integrated into overall cancer treatment paradigms and sets the stage for Company revenue expansion in 2026. Increased numbers of cancer patients that have undergone multiple procedures using RenovoCath across RenovoRx’s existing commercial customer base has led to an increase in repeat purchase orders. This reflects strong physician satisfaction and demand growth. RenovoRx continues to engage with hundreds of physicians and key decision makers who have expressed commercial interest in adopting RenovoRx’s TAMP therapy platform, enabled by RenovoCath, for therapeutic drug-delivery in patients diagnosed with solid tumors.

The rise in clinical adoption is supported by both targeted commercialization efforts such as the launch of RenovoRx’s sales and marketing team in late 2025, and the growing body of real-world clinical evidence regarding the safety and effectiveness of RenovoCath in patients with solid tumors. Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 700 successful procedures.

Year-over-year utilization growth has been compelling. In the first quarter of 2025, three patients initiated treatment via TAMP across four cancer centers. In the first quarter of this year, we expect at least 10 new patients will begin treatment via TAMP in a customer base of 12 centers, and this is growing. One of the lessons we learned in 2025 was that when commercialization efforts start from zero, just a few patients can make a meaningful difference in revenue results, as a patient typically receives multiple procedures.

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

In February 2026, we established the RenovoCath Medical Advisory Board which brings together leading U.S. interventional radiology experts to provide strategic clinical insights that further advance the TAMP therapy platform in clinical indications of high unmet medical need. The MAB complements the Company’s esteemed and long-standing Scientific Advisory Board that provides specialized guidance on RenovoRx’s scientific research and clinical program strategy. The MAB will support RenovoRx’s ongoing clinical and market strategy and provide important insights into potential investigator-initiated trials supported by the Company. The MAB will also provide feedback to RenovoRx’s sales and marketing team as they work to bring RenovoCath to market as a standalone device within its FDA-cleared indications for use.

We have identified our initial target market for RenovoCath to be approximately $400 million in peak annual U.S. sales, based on our internal assumptions. Our current assumptions regarding our initial addressable market include: (i) pressure-mediated delivery catheters on market today, which are analogous to RenovoCath, have an average selling price of $6,500-$8,500 per unit; (ii) approximately 7,000 initial target patients at peak market penetration; and (iii) an average of at least 5 to 6 procedures per patient.

Moreover, expansion opportunities across other clinical indications could ultimately create multi-billion-dollar total addressable market potential for RenovoCath. We believe that we can achieve meaningful market penetration with a lean commercial team targeting the top 200 high-volume treatment centers. Furthermore, and importantly, there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering specialty pressure-mediated delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.

Figure 4: Illustration of local drug delivery of chemotherapy via the TAMP therapy platform enabled by the RenovoCath device.

RenovoCath Advantages

We believe that RenovoCath offers particular advantages versus the standard of care of IV systemic chemotherapy and other medical device technologies to both interventional oncology patients and physicians.

Research and Development Pipeline

While the oncology field has made progress with the treatment of cancers over the past few decades, the limited effectiveness of chemotherapy accompanied by debilitating side effects remains a barrier to the success of standard of care treatment. The common objective in chemotherapy treatment innovation is to enhance the dosing of the drug,

while minimizing systemic toxicity. The standard of care for most cancers is systemic (intravenous) chemotherapy, which delivers chemotherapy throughout the body.

Our proprietary TAMP therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead clinical development stage product candidate is IAG, a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway.

IAG utilizes RenovoCath, which is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. IAG is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA) (“CDER”). The TAMP therapy platform is currently being evaluated in the Phase III TIGeR-PaC clinical trial in LAPC. Depending on our clinical progress with IAG and our RenovoCath commercial efforts, we may look to expand our development pipeline into additional cancer tumors and explore new commercial and clinical business development opportunities with our therapeutic technology. IAG received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon New Drug Application approval.

Locally Advanced Pancreatic Cancer (LAPC)

Our ongoing Phase III TIGeR-PaC clinical trial is studying the 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, IV 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 our costs. 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.

The first interim analysis in the Phase III TIGeR-PaC study at the 26th event (death) of the specified events was completed in March 2023, with the DMC recommending a continuation of the study. The interim analysis showed a 6-month median overall survival benefit for patients (nearly a 60% improvement) versus the study control arm and current standard of care: IV administration of gemcitabine and nab-paclitaxel. Patients also had greater than 65% reduction in adverse events with RenovoCath with gemcitabine vs. standard of care.

In the second quarter of 2025, the 52nd event triggered the second pre-planned interim analysis to be reviewed by the DMC. The DMC concluded its review and recommended that RenovoRx continue with the trial, without modification. To avoid compromising the integrity of the trial with the FDA, and after discussions with the DMC and consultation with its regulatory advisors, we elected to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion of the study as is common for Phase III trials.

We continue advancing the TIGeR-PaC trial which remains on track. As of March 24, 2026, 104 patients had been randomized, and 72 events have occurred. We anticipate completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized. Final data in the study is anticipated in 2027.

TIGeR-PaC remains the cornerstone of our clinical development program, validating IAG’s mechanism of action and safety profile through rigorous, long-term evaluation. Subject to the continuing forward progress on our TIGeR-PaC trial and the success of our RenovoCath commercial efforts, we may pursue the investigation of IAG or other drug-device combinations using the TAMP therapy platform and in indications in addition to LAPC, as discussed further below.

Positive Early-Stage Clinical Data Published in International Peer-Reviewed Journal, The Oncologist®

In July 2024, we announced that promising early-stage clinical data relating to the TAMP therapy platform was published in the international peer-reviewed journal, The Oncologist. The Oncologist is an international peer-reviewed journal for practicing oncologists and hematologists. It is dedicated to translating the latest research developments into the best multidimensional care for cancer patients and is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments.

The scholarly article, titled “Treatment of Locally Advanced Pancreatic Cancer (LAPC) Using Localized Trans-Arterial Micro Perfusion (TAMP) of Gemcitabine: Combined Analysis of RR1 and RR2,” is a publication of early-stage clinical data, primarily procedure safety, overall survival (OS), and evaluation of factors associated with OS, in LAPC patients undergoing TAMP from the foundational studies we have previously conducted. The studies included the IA administration of gemcitabine utilizing the TAMP read in early Phase I/II dose escalation safety study (RR1) and acquired data from a post-marketing post-treatment observational registry study (RR2). The lead author, Hassan Hatoum, MD, is an oncologist and hematologist at the University of Oklahoma Health Sciences Center.

TAMP is designed to bypass traditional systemic delivery methods to provide precise drug-delivery through the artery near the tumor site to bathe the target tumor in chemotherapy. This approach creates the potential to minimize systemic toxicities. The RR1 and RR2 foundational studies investigated an unmet medical need for a more effective locoregional LAPC therapy to improve survival.

For purposes of this publication, data from RR1 and RR2 were pooled. The aims of the analysis were to assess TAMP procedure safety, OS, and evaluate factors associated with OS. The median OS for the 35 evaluable patients with LAPC disease was 12.6 months, TAMP-delivered chemotherapy in LAPC patients with prior radiation was associated with significantly longer median OS (27.1 months) compared to prior systemic chemotherapy (14.6 months) or no prior treatment (7.0 months). The most common side effects were gastrointestinal-related (abdominal pain, emesis, and vomiting); the most common Grade 3 toxicity was sepsis. Study results concluded that treatment with TAMP-mediated drug-delivery in patients with LAPC is potentially safe, feasible, and provides several potential clinical benefits.

TIGeR-PaC Phase III Trial (RR3)

With inclusion of data from prior completed clinical and registry studies within the IND submission package, the FDA permitted us to proceed with the Phase III TIGeR-PaC trial in February 2018 comparing TAMP with IA gemcitabine (IAG) to standard of care. In the FDA pre-IND meeting, the FDA confirmed the study design and endpoints and indicated that this Phase III study could serve as the basis for a New Drug Application approval if successful. In April 2018, we obtained Orphan Drug Designation for the use of our first clinical development stage product candidate, IAG in patients with pancreatic cancer.

The primary endpoint of the study is overall survival, from time of randomization until death. Secondary endpoints include but are not limited to progression free survival and quality of life questionnaire results. The study is a multi-center, open-label, randomized active-controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable according to NCCN guidelines. The study is currently enrolling patients in the U.S.

The study design is as follows: all patients receive an approximate 4-month induction phase of IV chemotherapy and radiation (SBRT per December 2021 amendment) prior to randomizing to 4 cycles (8 treatments) of TAMP or 4 cycles of continuation of IV chemotherapy, and follow-up until death. In March of 2024 we amended the protocol to extend the duration of follow-up from 3.5 years post-randomization to 5 years post-randomization.

A study flowchart is shown below (see Figure 9). Subjects with stable or responding disease after induction therapy and who are not surgical candidates will then be randomized 1:1.

Figure 6: TIGeR-PaC Study Flowchart. All subjects undergo a 4-month induction phase that includes IV gemcitabine + Abraxane (nab-paclitaxel) and radiation therapy. If the subjects are stable or responding with LAPC post-induction, they are randomized 1:1 into control group (IV gemcitabine + Abraxane) versus treatment group (IA gemcitabine via TAMP therapy). Subjects are then administered continuation therapy until disease progression and followed through survival.

Clinical Pharmacokinetic (PK) Data in Patients with LAPC Treated with Gemcitabine via TAMP

We expect IA gemcitabine delivered via TAMP to have a pharmacokinetic profile that is distinct from intravenous gemcitabine dosing. Furthermore, with local delivery of gemcitabine into the tissue via TAMP and drainage into the liver prior to systemic circulation, we anticipate lower systemic levels of gemcitabine.

In March 2024, pre-clinical data published in the Journal of Vascular Interventional Radiology (“JVIR”) showed a 100-fold (two orders of magnitude) increase in local tissue concentration of the therapy with TAMP compared to conventional intravenous (IV) delivery. TAMP also showed advantages compared to historically available IA delivery approaches. TAMP’s novel approach to treatment offers the potential to increase an oncology therapy’s efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue.

In January 2026, a pharmacokinetic data abstract was presented at ASCO GI 2026 by TIGeR-PaC Phase III clinical trial Investigator from the University of Pittsburgh Medical Center. The sub-study of the pivotal Phase III TIGeR-PaC clinical trial offers insight that supports the potential effectiveness of our TAMP therapy platform in LAPC. Of the 16 patients analyzed in this sub-study, 11 patients received IA gemcitabine via TAMP, and 5 patients received treatment via intravenous gemcitabine. Peak plasma gemcitabine concentrations were monitored in patients. Concentrations were lower with TAMP treatment despite a 50% higher drug concentration during infusion (1000 mg/m2 over 20 minutes vs 30 minutes for intravenous gemcitabine). Results of the sub-study showed our IA delivery of gemcitabine via TAMP decreased systemic levels of gemcitabine versus standard of care. In addition to providing increased local drug potency, the IA delivery of gemcitabine via TAMP approach may also be beneficial to decreasing gemcitabine-related systemic side effects. TAMP is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy.

In March 2025, an additional pharmacokinetic data abstract, titled “Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial,” authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by our founder, Executive Chairman and Chief Medical Officer Ramtin Agah, M.D., and others was presented at the Society of Surgical Oncology (SSO) 2025 Annual. PK analyses were performed on 19 patients with LAPC receiving IAG from six sites

as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.

Other Potential Clinical Indications

As noted above, beyond LAPC, we believe there are many clinical applications for the TAMP therapy platform to improve targeted delivery therapeutic agents. These potential applications are shown in the graphic below.

Figure 7: RenovoCath broad market opportunity in potential target cancer tumors including LAPC, cholangiocarcinoma, non-small cell lung cancer (NSCLC), glioblastoma, sarcomas, and uterine tumors.

Current Treatments and Limitations of Approaches

Currently, solid tumors are typically treated using one or a combination of treatment modalities: surgery, radiation, and pharmacological therapies (chemotherapy). For solid tumors, if the tumor is detected at an early stage and is localized to the affected organ, surgical removal of the entire tumor may be an effective and potentially curative treatment. In most cases, surgery is undertaken and/or completed prior to commencing additional treatment approaches. However, multiple solid tumor types, including pancreatic cancer, are diagnosed at advanced stages, which precludes surgery as a treatment approach. In many of these circumstances, the tumor has grown into adjacent anatomical structures making surgery difficult or impossible.

Intravenous (or IV), also known as systemic, chemotherapy is considered standard of care for most solid tumors, but limitations include less than acceptable efficacy, systemic toxicities, and other side effects. Leading chemotherapy regimens include (gemcitabine and nab-paclitaxel) which has a 7-week survival benefit over IV gemcitabine alone and FOLFIRINOX.

For the treatment of some localized solid tumors, targeted trans-arterial chemoembolization (TACE) is an established first line therapy. Many companies have developed therapeutic products for use in this approach to treat tumors of the liver, uterus, and prostate. Many solid tumors have a dedicated blood supply from small blood vessels, called tumor feeder blood vessels, that branch off of larger native arteries and terminate in the tumors to provide nutrition to the tumors. A key aspect of TACE is to identify and isolate these tumor feeder blood vessels during x-ray angiography and then deliver the desired therapy including chemotherapy and embolic agents. In patients with LAPC, no tumor feeder blood vessels are visible during angiography due to the hypovascular (lack of visible blood vessels) nature of these tumors. This limitation has rendered TACE ineffective in the treatment of patients with LAPC, extra-hepatic cholangiocarcinoma (eCCA), and a subset of other solid tumors. The limitations of TACE translate to low survival rates in these tumor subtypes. The use of TACE with or without immuno-oncology treatment approaches, which harness the body’s immune system to treat cancer, has not significantly improved survival rates in these subtypes. For example, due to the inability of immune cells to reach and penetrate the tumor tissue, early studies of targeted immunotherapies in pancreatic cancer have demonstrated limited success.

Intellectual Property

Our success depends in part on our ability to obtain patents and trademarks, maintain trade secret and know-how protection, enforce our proprietary rights against infringers, and operate without infringing on the proprietary rights of third parties. Because of the length of time and expense associated with developing new products and bringing them through the regulatory approval process, the health care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes, know-how, and methods.

Our intellectual property protection stems from several issued device and method patents on our RenovoCath device that optimizes delivery of the anti-cancer drug and the TAMP therapy platform. Our issued patents also provide exclusivity as it relates to utilizing RenovoCath with anti-cancer drugs.

We have developed and patented targeted combination therapies to improve therapeutic outcomes for cancer patients undergoing treatment. Our proprietary TAMP therapy platform enables physicians to isolate segments of the vascular anatomy closest to tumors and force chemotherapy across the blood vessel wall to bathe these difficult-to-reach solid tumors while minimizing the therapy’s toxicities versus systemic, e.g., intravenous therapy. This therapy may include pre-treatment of the local blood vessels and tissue with radiation therapy to decrease chemotherapy washout. TAMP may be performed using a dual-occlusion catheter system (e.g., the RenovoCath device) to control the application of a therapeutic agent to vascular regions to optimize drug concentrations. In December 2025, we published a new international patent application for our TAMP therapy platform to expand its IP portfolio. We already holds strong intellecutal property including coverage of our proprietary TAMP therapy platform and RenovoCath device, with 9 issued and 5 pending U.S. patents, and 10 issued and 9 pending patents outside of the US, including two international applications published in 2025. We continue to explore additional opportunities to further bolster our intellectual

property position, and if granted, our current applications would provide patent protection through 2045. The table below describes our issued patents, all of which have been assigned to us.

* Predicted earliest expiration date. The actual expiration date will depend on factors related to patent prosecution and issuance.

** Estimated expiration dates assume all maintenance fees are paid.

Orphan drug designation provides 7 years post-approval market exclusivity protection. While gemcitabine is generic, we have been awarded orphan drug designation from the FDA for the IA route of administration for both pancreatic cancer and bile duct cancer. IAG is regulated by the FDA as a new oncology drug product, and if approved, we will have exclusivity of the use of IAG as a drug-device combination product for this route of administration.

When appropriate, we actively pursue protection of our proprietary products, technologies, processes, and methods by filing United States and international patent and trademark applications. We seek to pursue additional patent protection for technology invented through research and development, manufacturing, and clinical use of our technology that will enable us to expand our patent portfolio around advances to our current systems, technology, and methods for our current applications as well as others.

There can be no assurance that the pending patent applications will result in the issuance of patents, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage.

To maintain our proprietary position, we also rely on trade secrets and proprietary technological experience to protect proprietary manufacturing processes, technology, and know-how relating to our business. We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and consultants to protect our trade secrets and proprietary technological expertise. In addition, we also seek to maintain our trade secrets through maintenance of the physical security of the premises where our trade secrets are located. There can be no assurance that these agreements will not be breached, that we will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets and proprietary knowledge.

In certain circumstances, United States patent law allows for the extension of a patent’s duration for a period of up to five years after FDA approval. We intend to seek extension for one of our patents after FDA approval if it has not expired prior to the date of approval. In addition to our proprietary protections, the FDA has granted us two orphan drug designations that provide us a seven-year period of exclusive marketing beginning on the date that our NDA is approved by the FDA for the designated orphan drug. While exclusivity only applies to the indication for which the drug has been approved, we believe that this exclusivity will provide us with added protection once commercialization of an orphan drug designated product begins.

There has been and continues to be substantial litigation regarding patent and other intellectual property rights in the pharmaceutical and medical device areas. If a third party asserts a claim against us, we may be forced to expend significant time and money defending such actions and an adverse determination in any patent litigation could subject us to significant liabilities to third parties, require us to redesign our product, require us to seek licenses from third parties, and, if licenses are not available, prevent us from manufacturing, selling or using our system. Additionally, we plan to enforce our intellectual property rights vigorously and may find it necessary to initiate litigation to enforce our patent rights or to protect our trade secrets or know-how. Patent litigation can be costly and time consuming and there can be no assurance that the outcome will be favorable to us.

Manufacturing and Supply

For the catheter component of IAG, as well as for standalone RenovoCath supply for our commercial efforts, we currently rely on a single-source contract U.S. manufacturer, Medical Murray, Inc. of North Barrington, IL. However, we engaged with an additional manufacturer as a backup supplier. We are subject to regulatory requirements of the FDA’s Quality System Regulation (QSR), for medical devices sold in the United States We have an agreement in place with Medical Murray to produce the RenovoCath which automatically renews on an annual basis until termination by either party with 12 months’ notice. While we believe Medical Murray has the capabilities to scale RenovoCath production to peak forecasted commercial volumes, manufacturing can be transferred to additional vendors if needed.

The FDA monitors compliance with QSR through periodic inspections of both our facility and the facility of our contact manufacturer.

Our failure or the failure of our contract manufacturer to maintain acceptable quality requirements could result in the shutdown of our manufacturing operations or the recall of products which could be detrimental to our company. If our contract manufacturer fails to maintain acceptable quality requirements, we may have to qualify a new contract manufacturer and could experience a material adverse effect to manufacturing and manufacturing delays as a result.

We do not own or operate and do not intend to establish our own gemcitabine manufacturing facilities.

Within our TIGeR-PaC Phase III trial, hospitals are sourcing generic gemcitabine labeled for IV use from their respective pharmacies to use in conjunction with the RenovoCath for the TAMP procedures. In the commercial setting, we expect to rely on contract manufacturing organizations for gemcitabine production, relabeling and co-packaging with the RenovoCath. The formulation of gemcitabine used in the TIGeR-PaC Phase III trial and in the commercial setting will be identical, however, the commercial labeling of gemcitabine will be IA gemcitabine post-approval to be used exclusively in conjunction with RenovoCath.

Enacted in December 2025, the BIOSECURE Act prohibits federal agencies from contracting with, or providing grants/loans to, entities that use biotechnology equipment or services from "Biotechnology Companies of Concern" (BCCs). While this law provides a five-year transition period for existing contracts, the Office of Management and Budget is expected to finalize the initial list of prohibited entities by late 2026. Although we don’t expect this law to impact our business, we are currently evaluating our reliance on third-party Contract Development and Manufacturing Organizations (CDMOs) and research partners. Any requirement to transition these services to alternative providers could result in significant operational delays, increased costs, and regulatory re-submission risks.

In addition, the Trump administration has proposed or implemented tariffs on active pharmaceutical ingredients and critical chemical intermediates imported from certain foreign jurisdictions. These trade barriers may increase our cost of goods sold or cause disruptions in our supply chain.

Government Regulation

Our products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. Foreign regulatory agencies, the FDA and regulatory agencies in state and local jurisdictions impose extensive requirements upon the clinical development, pre-market clearance and approval, manufacturing, labeling, marketing, advertising and promotion, pricing, storage and distribution of pharmaceutical and medical device products. Failure to comply with applicable foreign regulatory agency or FDA requirements may result in warning letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.

United States Regulatory Environment

In the U.S., the FDA regulates drug and device products, including combination, under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations. IAG is subject to FDA regulation in 21 CFR 3.2(e) as a combination product, which means it is composed of both a drug component and device component. Each component of a combination product is subject to the requirements established by FDA for that type of component and if marketed individually, each component would be subject to different regulatory pathways and reviewed by different centers within the FDA. In addition to our RenovoCath device, we are also evaluating our novel Phase III drug-device combination product candidate, known as IAG. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The IAG is currently being evaluated for the treatment of LAPC by CDER, the drug evaluation are of the FDA.

Our combination product candidate, IAG, which is enabled the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.

In the case of IAG, the primary mode of action is attributable to the drug component of the product, which means that CDER, has primary jurisdiction over its pre-market development and review. The underlying RenovoCath drug delivery device used in our clinical development stage product candidate has been separately cleared by CDRH as a standalone Class II medical device and not in combination of a specific drug product or part of a prepackaged combination product for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 3mm to 11mm in diameter.

The process required by the FDA before drug product candidates, including drug-led combination products, may be marketed in the United States generally involves the following:

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completion of extensive preclinical laboratory tests and animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;

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submission of an investigational new drug (IND) application, which must become effective before human clinical trials may begin and must be updated periodically;

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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;

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submission of a new drug application (NDA) after completion of all registrational or pivotal clinical trials;

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satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practices (cGMP) regulations; and

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FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.

The development and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted on a timely basis, if at all.

Clinical Trials

For purposes of NDA submission and approval, clinical trials are typically conducted in the following sequential phases, which may overlap:

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Phase I Clinical Trials. Studies are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, distribution, metabolism and excretion, typically in healthy humans, but in some cases in patients.

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Phase II Clinical Trials. Studies are generally conducted in a limited patient population to identify possible adverse effects and safety risks, explore the initial efficacy of the product for specific targeted indications and to determine dose range or pharmacodynamics. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials.

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Phase III Clinical Trials. These are commonly referred to as pivotal studies. When Phase II evaluations demonstrate that a dose range of the product is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, provide substantial evidence of clinical efficacy and further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial centers.

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Phase IV Clinical Trials. The FDA may approve an NDA for a product candidate but require that the sponsor conduct additional clinical trials to further assess the drug after NDA approval under a post-approval commitment. In addition, a sponsor may decide to conduct additional clinical trials after the FDA has approved an NDA. Post-approval trials are typically referred to as Phase IV clinical trials.

New Drug Applications (NDAs)

The results of drug development, preclinical studies and clinical trials are submitted to the FDA as part of an NDA. NDAs also must contain extensive chemistry, manufacturing and control information. An NDA must be accompanied by a significant user fee, which may be waived in certain circumstances. Once the submission has been accepted for filing, the FDA’s goal is to review applications within ten months of submission or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months from submission. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the

application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. For new oncology products, the FDA will often solicit an opinion from an Oncologic Drugs Advisory Committee, or ODAC, a panel of expert authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions. The ODAC panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. The FDA is not bound by the recommendation of an advisory committee.

Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will generally inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with cGMPs is satisfactory, and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied. After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter (“CRL”). A CRL generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. A CRL may require additional clinical data and/or an additional pivotal Phase III clinical trial(s), and/or other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaborators interpret data. Approval may be contingent on a Risk Evaluation and Mitigation Strategy (“REMS”) that limits the labeling, distribution or promotion of a drug product. Once issued, the FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the safety effects of approved products which have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs or other information.

There are three primary regulatory pathways for an NDA under Section 505 of the FDCA: Section 505 (b)(1), Section 505 (b)(2) and Section 505(j). A Section 505 (b)(1) application is used for approval of a new drug (for clinical use) whose active ingredients have not been previously approved. A Section 505 (b)(2) application is used for a new drug that relies on data not developed by the applicant. Section 505(b)(2) of the FDCA was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This statutory provision permits the approval of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The Hatch-Waxman Act permits the applicant to rely in part upon the FDA’s findings of safety and effectiveness for previously approved products. Section 505(j) application, also known as an abbreviated NDA, is used for a generic version of a drug that has already been approved.

An approval letter authorizes commercial marketing of the drug product with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a REMS to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

The NDA review process for drug-led combination includes a review of the device constituent. In this case, the device constituent for IAG is RenovoCath, which is cleared by the FDA.

Orphan Drug Exclusivity

Some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Pursuant to the Orphan Drug Act, the FDA grants orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. The orphan designation is granted for a combination of a drug entity and an indication and therefore it can be granted for an existing drug with a new (orphan) indication. Applications are made to the Office of Orphan Products Development at the FDA and a decision or request for more information is rendered in 60 days. NDAs for designated orphan drugs are exempt from user fees, obtain additional clinical protocol assistance, are eligible for tax credits up to 50% of research and development costs, and are granted a seven-year period of exclusivity upon approval. The FDA cannot approve the same drug for the same condition during this period of exclusivity, except in certain circumstances where a new product demonstrates superiority to the original treatment. Exclusivity begins on the date that the marketing application is approved by the FDA for the designated orphan drug, and an orphan designation does not limit the use of that drug in other applications outside the approved designation in either a commercial or investigational setting.

We have received orphan drug designations for IAG for pancreatic cancer and cholangiocarcinoma.

The granting of orphan drug designations does not mean that the FDA has approved a new drug. Companies must still pursue the rigorous development and approval process that requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted at all, or on a timely basis.

FDA Medical Device Regulation

Unless an exemption applies, each new or significantly modified drug delivery medical device that we develop based on the current 510(k)-cleared RenovoCath and which we seek to commercially distribute in the United States will require a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, unless addressed as part of a new drug application for a drug/device combination product. New medical devices without an applicable predicate device as well as higher-risk medical devices are subject to premarket approval by the FDA under a PMA or a de novo classification from the FDA. The 510(k) clearance, PMA approval, and de novo classification processes can be resource intensive, expensive, and lengthy, and require payment of significant user fees, unless an exemption is available.

Under the FDCA, medical devices are classified into one of three classes – Class I, Class II or Class III – depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. The RenovoCath catheter is classified as a Class II device.

Class II devices are those that are subject to the general controls and special controls, as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, patient registries, FDA guidance documents, and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process. The RenovoCath device received initial 510(k) clearance by FDA in 2014.

The 510(k) Clearance Process

Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent,” as defined in the statute, to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to 12 months but may take longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition, FDA collects user fees for certain medical device submissions and annual fees and for medical device establishments.

If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device. If the FDA determines that the device is not “substantially equivalent” to a predicate device, the device is automatically classified into Class III. The device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA approval process or seek risk-based reclassification of the device through the de novo process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. A manufacturer can also submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk.

After a device receives 510(k) clearance or de novo classification, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, could require a PMA or de novo classification. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many minor modifications are accomplished by ap letter-to-file in which the manufacturer documents the change in an internal letter-to-file. The letter-to-file is in lieu of submitting a new 510(k) to obtain clearance for such change. The FDA can always review these letters to file in an inspection. If the FDA disagrees with a manufacturer’s determination regarding whether a new premarket submission is required for the modification of an existing device, the FDA can require the manufacturer to cease marketing and/or recall the modified device until marketing authorization is obtained. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

Other FDA Regulatory Requirements

Products manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including recordkeeping, annual product quality review and reporting requirements. Adverse event experiences with the product, including both drug-related and device-related adverse events (including device malfunctions and medical device reporting), must be reported to the FDA in a timely fashion and pharmacovigilance programs to proactively look for these adverse events are mandated by the FDA. Drug and device manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP and QSR, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Following such inspections, the FDA may issue notices on Form 483, Untitled Letters or Warning Letters that could cause us or our third-party manufacturers to modify certain activities. A Form 483 Notice, if issued at the conclusion of an FDA inspection, list conditions the FDA investigators believe may have violated cGMP, QSR or other FDA regulations or guidelines. In addition to Form 483 Notices and Untitled Letters or Warning Letters, failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as suspension of manufacturing, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations, QSR and other ongoing FDA regulatory requirements. If we or our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may require us to recall our products from distribution or withdraw any potential approvals of an NDA for that product.

The FDA closely regulates the post-approval marketing and promotion of drugs and devices, including standards and regulations for direct-to-consumer advertising, dissemination of off-label information, industry-sponsored scientific and educational activities and promotional activities involving the Internet. Drugs and devices may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug or device, including changes in indications, labeling, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new or supplemental NDA or clearance or approval of the modified device, respectively, which may require us to develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these requirements can result in adverse publicity, Warning Letters, corrective advertising and potential civil and criminal penalties.

Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties, in particular in oncology. Physicians may believe that such off-label uses are the best treatment for many patients in

varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (“PDMA”), which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

Foreign Regulatory Environment

If we seek to market IAG in foreign jurisdictions, we could become subject to a variety of foreign regulations regarding development, approval, commercial sales, and distribution of our products in addition to regulations in the United States. Whether or not we obtain FDA approval for a product, we must obtain the necessary approvals by the regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and can involve additional product testing and additional review periods. The review process may take longer or shorter than that required to obtain FDA approval. The requirements governing, among other things, the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. If we fail to comply with applicable foreign regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and/or criminal prosecution.

Other United States Healthcare Laws

In addition to FDA restrictions on marketing of pharmaceutical and medical device products, including drug/device combination products, pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through which we research, as well as sell, market and distribute any products for which we obtain marketing authorization. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, data privacy and security, and transparency laws and regulations related to drug pricing and payments and other transfers of value made to physicians and other healthcare providers. If manufacturers’ operations, including activities engaged by their contractors or agents, are found to be in violation of any of such laws or any other governmental regulations that apply, they may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and imprisonment.

The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. The Affordable Care Act, or ACA, amended the intent element of the federal statute so that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to commit a violation. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers, among others, on the other. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain business activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

Federal civil and criminal false claims laws, including the federal civil False Claims Act, prohibit any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. This includes claims made to programs where the federal government reimburses, such as Medicare and Medicaid, as well as programs where the federal government is a direct purchaser, such as when it purchases off the Federal Supply Schedule. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly inflating

drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. Additionally, the ACA amended the federal Anti-Kickback Statute such that a violation of that statute can serve as a basis for liability under the federal False Claims Act. Most states also have statutes or regulations similar to the federal Anti-Kickback Statute and civil False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order a receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services.

In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, impose obligations on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business associates that perform certain services involving the storage, use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information. HITECH increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, many state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect and often are not preempted by HIPAA.

Further, pursuant to the ACA, the Centers for Medicare and Medicaid Services (“CMS”) has issued a final rule that requires applicable manufacturers of covered products, including prescription drugs and certain medical devices, to collect and annually report information on certain payments or transfers of value made in the previous year to physicians (defined to include doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others) and teaching hospitals, as well information regarding investment interests held by physicians and their immediate family members. The reported data is made available in searchable form on a public website on an annual basis. Failure to submit required information may result in civil monetary penalties. In addition, several states now require prescription drug companies to report certain expenses relating to the marketing and promotion of drug products and to report gifts and payments to individual healthcare practitioners in these states. Other states prohibit various marketing-related activities and/or require the posting of information relating to clinical studies and their outcomes. Some states require the reporting of certain pricing information, including information pertaining to and justifying price increases, or prohibit prescription drug price gouging. In addition, certain states require pharmaceutical companies to implement a healthcare compliance program or code of conduct. Certain states and local jurisdictions also require the registration of pharmaceutical sales representatives. Compliance with these federal and state laws is difficult and time consuming, and companies that do not comply with these state laws are exposed to liabilities and civil penalties.

Efforts to ensure that business arrangements with third parties comply with applicable healthcare laws and regulations involve substantial costs. If a drug company’s operations are found to be in violation of any such requirements, it may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, the curtailment or restructuring of its operations, loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other federal or state government healthcare programs, including Medicare and Medicaid, integrity oversight and reporting obligations, imprisonment, and reputational harm. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action for an alleged or suspected violation

can cause a drug company to incur significant legal expenses and divert management’s attention from the operation of the business, even if such action is successfully defended.

Of note, following the Supreme Court’s June 2024 reversal of the so-called “Chevron deference” doctrine, federal courts are increasingly exercising independent judgment in interpreting the FDCA rather than deferring to FDA expertise. This shift has introduced heightened legal uncertainty regarding FDA’s authority over drug sameness, exclusivity periods, and labeling. Additionally, ongoing restructuring within the Department of Health and Human Services may lead to shifts in enforcement priorities or delays in regulatory approvals. All of this makes complying with complex healthcare laws more difficult and uncertain for us.

Healthcare Reform

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended, collectively known as the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. The ACA contained a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws. Additionally, the ACA:

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increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price;

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required collection of rebates for drugs paid by Medicaid managed care organizations;

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required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and

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imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. For example, in June 2021 the U.S. Supreme Court held that Texas and other challengers had no legal standing to challenge the ACA, dismissing the case on procedural grounds without specifically ruling on the constitutionality of the ACA. Thus, the ACA will remain in effect in its current form. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and healthcare measures promulgated by the Biden administration will impact the ACA, our business, financial condition and results of operations.

Other legislative changes have been proposed and adopted since the ACA was enacted, including aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2031, with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through March 31, 2022, unless additional action is taken by Congress. Under current legislation, the actual reduction in Medicare payments can vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester.

Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have a material impact on our business. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all

Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. On June 30, 2023, CMS issued new guidance detailing the requirements and parameters of the first round of price negotiations, to take place during 2023 and 2024, for products subject to the “maximum fair price” provision that would become effective in 2026. On August 29, 2023, the U.S. Department of Health and Human Services (“HHS”) announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. CMS and HHS will continue to issue and update guidance as these programs are implemented. The impact of these regulations and any future healthcare measures and agency rules implemented by the Biden administration on us and the pharmaceutical industry as a whole is currently unknown, particularly in light of developments under the Trump administration.

For example, the Inflation Reduction Act, as modified by the One Big Beautiful Bill Act of 2025, also had an effect on drug pricing. While the initial maximum fair prices (MFPs) for the first ten Medicare Part D drugs took effect on January 1, 2026, recent legislative amendments have expanded the Orphan Drug Exclusion. This expansion now exempts drugs with multiple rare-disease designations from negotiation, provided they lack non-orphan approvals. However, the selection pool for 2027 and 2028 applicability years has been expanded to include Medicare Part B drugs, increasing the risk that IAG (even if approved) may be subject to government-mandated pricing.

In addition, in late 2025, the Trump administration initiated the GENEROUS (GENErating cost Reductions for U.S. Medicaid) Model, a Center for Medicare & Medicaid Innovation (CMMI) voluntary demonstration. This model seeks to align Medicaid net prices with international benchmarks from a basket of peer OECD nations. Furthermore, the launch of TrumpRx—a direct-to-consumer discount platform—requires participating manufacturers to offer deep discounts to American patients. If IAG is included in these models or if the administration mandates participation through future executive orders, our net price realization and gross margins could be materially adversely affected.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, a number of states are considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws once we begin commercialization after obtaining regulatory approval for any of our products.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product or product candidate for which we are developing or commercializing. Sales in the U.S. will depend, in part, on the availability of sufficient coverage and adequate reimbursement from third-party payors, which include government health programs such as Medicare, Medicaid, TRICARE and the Veterans Administration, as well as managed care organizations and private health insurers. Prices at which we or our customers seek reimbursement for our product candidates can be subject to challenge, reduction or denial by third-party payors.

The process for determining whether a third-party payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product. A third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be available. Additionally, in the U.S. there is no uniform policy among payors for coverage or reimbursement. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies, but also have their own methods and approval processes. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. If coverage and adequate reimbursement are not available, or are available only at limited levels, successful commercialization of, and obtaining a satisfactory financial return on, any product we develop may not be possible.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. In order to obtain coverage and reimbursement for any product that might be approved for marketing, we may need to conduct expensive studies in order to demonstrate the medical necessity and cost-effectiveness of any products, which would be in addition to the costs expended to obtain regulatory approvals. Third-party payors may not consider our product candidates to be medically necessary or cost-effective compared to other available therapies, or the rebate percentages required to secure favorable coverage may not yield an adequate margin over cost or may not enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development.

We are developing a new drug product, which is IA gemcitabine delivered via the proprietary RenovoCath device (IAG). If the drug is approved, it is expected to be sold together with the catheter used to administer the drug in the National Drug Code (NDC) created when the drug receives FDA approval. The reimbursement pathway involves separate payments for the drug product and for the occlusion procedure to administer it. As to the latter, it is anticipated that the procedure is accurately described by an existing code with existing payment levels. Given the expectation that the drug will be a novel, non-generic drug, a unique code and payment based on pricing information for the product should be established.

For the reasons discussed above, we believe there is a clear path to reimbursement for IAG and its related procedure in both the hospital outpatient and physician office settings (which may include freestanding entities such as catheterization laboratories). As is typical for a product still in clinical development, it is difficult to predict whether there would be any Medicare coverage obstacles, which there usually are not for FDA approved drugs being used for on-label use. We believe the most important step we can take to enhance reimbursement for our products is the development of published peer-reviewed clinical literature supporting their clinical benefit.

In addition, our efforts to commercialize RenovoCath as a standalone catheter, require its own insurance reimbursement arrangements.

Competition

The oncology biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies and strong competition. While we believe that our knowledge, leadership, experience, scientific resources, intellectual property, regulatory barriers, and the advanced stage of our clinical development provide us with competitive advantages, we may face competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies, worldwide. Many potential competitors have substantially greater scientific, research, financial, technical, and/or human resources than we do.

Many companies are active in the oncology market both in terms of commercially marketed products and products in development that could potentially compete with our products and product candidates for the treatment of solid tumors. Any product candidates that we successfully develop and commercialize may compete directly with approved and/or new therapies that may be approved in the future. Our competitors may also obtain FDA or foreign regulatory approval for their products more rapidly than we may obtain approval for our product candidates, which could result in our competitors establishing a strong market position prior to us entering the market. Key competitive factors affecting the success of our product candidates, if approved, are likely to be their safety, efficacy, convenience, price, and the availability of reimbursement from government and other third-party payors. Many companies are developing new therapeutics, and we cannot predict what the standard of care will be as our product candidate progresses through clinical development.

In February 2026, Novocure’s Optune Pax concomitant with gemcitabine and nab-paclitaxel was the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer after meeting its primary endpoint with a 2.04-month median overall survival difference compared to gemcitabine and nab-paclitaxel alone. Revolution Medicines also shared its Daraxonrasib plus Gemcitabine nab-Paclitaxel (GnP) Combination, with initial results in 1L Metastatic PDAC in late 2025 showing promising topline results. Both of these interventions were in combination with systemic gemcitabine and nab-paclitaxel. RenovoRx remains optimistic in the potential synergy with these interventions. FibroGen’s LAPC phase 3 did not reach its primary endpoint, failing to show an improvement in survival. We are aware of a number of companies in Phase I and Phase II clinical trials for the treatment of LAPC including one interventional company, TriSalus Life Sciences. LAP100 remains also active as a clinical trial, testing higher dose radiation therapy for LAPC in a Phase I clinical trial.

Many of our competitors have substantially greater financial, technological, research and development, marketing and personnel resources. In addition, some of our competitors have considerable experience in conducting clinical trials, regulatory, manufacturing and commercialization capabilities. Our competitors may develop alternative treatment methods, or achieve earlier product development, in which case the likelihood of us achieving meaningful revenues or profitability will be substantially reduced.

Employees and Human Capital Resources

As of the date of this Report, we have 17 employees. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We focus on employee engagement and believe our relationship with our employees is good. We have 9 key consultants in the areas of quality, regulatory, finance, legal, clinical, and marketing.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, and incentivizing our existing employees. The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

Facilities

We lease approximately 1,900 rentable square feet of office space as our administrative headquarters at 2570 West El Camino Real, Suite 320, Mountain View, CA 94040. The term of the lease expires on November 30, 2027, with a three-year option to renew. We believe that our facility is in good condition, well maintained, suitable and adequate for our current operations and purposes, and that additional or alternative space will be available in the future on commercially reasonable terms, if required.

Legal Proceedings

From time to time, we are engaged in various legal actions, claims and proceedings arising in the ordinary course of business, none of which are expected to be material.

Item 1A. Risk Factors

An investment in our securities is speculative and involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Report, including our 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. The occurrence of any of the events or developments described below 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. This summary is not exhaustive, and readers are therefore encouraged to review this Risk Factors section in its entirety.

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revenue generating company. These factors make it difficult to evaluate our current business and predict our future success and viability.

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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.

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We are executing on a commercial strategy for selling our RenovoCath device on a standalone basis, which is a relatively new activity for our company and subject to significant inherent risks.

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Our estimates of total addressable market, 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.

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Revenue recognition from our RenovoCath commercialization activities could be complex and uncertain. We may also 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.

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Our revenues and results of operations, particularly as 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.

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We face the risk that we may need to raise 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.

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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.

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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 drug-device product candidate. If we are unable to successfully advance or develop IAG or any other product candidate, our business will be materially harmed.

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As our ongoing TIGeR-PaC study is our most advanced clinical trial to date, the failure of the study to achieve results conducive to progressing the study or filing and receiving NDA approval would cause our company significant harm.

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If we do not achieve our projected commercial or development goals in the timeframes we announce and expect, our stock price may decline.

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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.

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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.

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If we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates.

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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.

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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.

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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.

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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.

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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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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 and continue to meet 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.

Risks Related to Our Business, Financial Condition and Capital Requirements

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 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 sale. While we have commenced generating revenue from RenovoCath commercial sales, our operating history as a revenue-generating 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.

Our first drug/device product candidate consists of IA gemcitabine in combination with RenovoCath (which we call IAG). The FDA has determined that IAG will be regulated as, and if approved we expect will be reimbursed as, a new oncology drug product. To date, we have not obtained marketing approval for IAG or any other drug/device combination product candidates, manufactured a commercial scale of our lead or any other drug/device product or arranged for a third-party to do so on our behalf, or conducted sales and marketing activities necessary for successful post FDA-approval product commercialization.

Alongside our Phase III clinical activities related to IAG, we commenced commercial sales of our FDA-cleared RenovoCath device on a standalone basis in late 2024 and have been generating revenue therefrom in 2025. While our commercial traction has grown, our operating experience in this business model remains limited and our commercialization efforts continue to evolve.

These factors make any assessment of our future success and viability subject to significant uncertainty. As a result, it may be more difficult for investors to accurately predict our likelihood of success and viability than it could be if we had a more mature operating history.

We will encounter expenses, difficulties, complications, delays, and other known and unknown factors and risks frequently experienced by clinical stage biopharmaceutical or early commercial stage medical device companies in rapidly evolving and competitive fields. We are also transitioning from a company with a research and clinical development focus to a company capable of supporting commercial activities. We have not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.

We are a clinical stage, early-revenue-stage company and have incurred significant losses since our formation. As of December 31, 2025, we have an accumulated deficit of approximately $61.4 million. For the fiscal years ended December 31, 2025 and 2024, we had net losses of approximately $11.2 million and $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 limited revenue from 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 to 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 cash flow positive or profitable operations, if ever. Investors in our securities must carefully consider the substantial challenges, risks and uncertainties inherent in our business plans. We may never receive regulatory approval for IAG 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, any 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 at 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 IAG or other drug/device product candidates, we expect that we will continue to incur substantial expenses and, 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.

With respect to the clinical development aspect of our business, we anticipate that our expenses will increase substantially if and as we:

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continue our research and discovery activities;

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continue the development of our proprietary technology platform;

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progress our current and any future product candidates through preclinical and clinical development;

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initiate and conduct additional preclinical, clinical, or other studies for our product candidates;

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work with our contract manufacturing organizations to manufacture RenovoCath and our other product candidates for our clinical trials;

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change or add additional contract manufacturers or suppliers;

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seek regulatory approvals and marketing authorizations for our product candidates;

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establish sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain approval;

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take steps to seek protection of our intellectual property and defend our intellectual property against challenges from third parties;

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obtain, expand, maintain, protect, and enforce our intellectual property portfolio;

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pursue any licensing or collaboration opportunities;

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attract, hire, and retain key and qualified personnel including clinical, scientific, management, and administrative personnel;

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provide additional internal infrastructure to support our continued research and development operations and any planned commercialization efforts;

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experience any delays or encounter other issues related to our operations;

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implement operations, financial, and management information systems;

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meet the requirements and demands of being a public company; and

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defend against any product liability claims or other lawsuits related to our products.

Our prior operating losses and expected future net losses have had and will continue to have an adverse effect on our stockholders’ equity, working capital, and our ability to fund our development efforts and achieve and maintain profitability. In any particular period, our operating results could be below the expectations of securities analysts or investors, or such analysts or investors could perceive these results to be negative, which could have a substantial adverse effect on the price of our common stock.

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.

Alongside our Phase III clinical activities related to IAG, in late 2024 we commenced commercial sales of our FDA-cleared RenovoCath device on a standalone basis, and we 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 begun to gain commercial traction, we nonetheless have limited 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-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.

Regardless of which commercial strategy, or combination of strategies, we choose to employ for RenovoCath, we will be required to execute our commercialization plan effectively and efficiently. If we are unable to do so in any material respect, and if, as a result, we are unable to generate meaningful or anticipated revenues from RenovoCath sales, this could cause a material adverse effect on our results of operations, cash flow, reputation, and stock price.

We have based our estimates of total addressable market size, peak annual sales projections and similar matters in this Report and elsewhere in our public filings or statements based on our market research, third-party reports and publicly available information which we consider reliable. However, our commercialization efforts for RenovoCath are relatively new and evolving. Therefore, readers are cautioned that our projections regarding revenues, peak annual sales potential, total addressable market and similar metrics are merely our current, preliminary estimates and are subject to change based on many factors, including factors which are out of our control. As such, no assurances are given that any such estimates will prove to be accurate.

We are in the relatively 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 commercial sales activities for our RenovoCath device are still relatively new. While our goal is to grow our revenues over time, at present our revenues and results of operations are difficult to predict and may fluctuate substantially from quarter to 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:

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our sales cycle per customer and in general may vary as a result of factors such as a customer’s familiarity with RenovoCath;

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the size of sales orders can vary significantly and may not be predicable on a customer-by-customer basis or generally;

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economic downturns are often characterized by decreased product demand, price erosion, technological shifts, work slowdowns and layoffs, which can substantially reduce contracting activity;

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customers may unexpectedly postpone or cancel orders due to changes in their strategic priorities, budgetary constraints or the existence of competitive technology;

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customer evaluations and purchasing processes vary significantly from company to company, and a customer’s internal approval and expenditure authorization process can be difficult and time consuming;

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changes in our pricing policies and discount plans may affect customer purchasing patterns;

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the number, timing and significance of our and our competitors’ product enhancements may affect purchasing decisions; and

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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.

As of March 23, 2026 (taking into account the net proceeds from our March 2026 private placement), we had cash and cash equivalents of approximately $13.0 million. Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we face the risk that we may be required to raise 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 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 financial statements as of December 31, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. If we fail to raise additional working capital, or do so on commercially unfavorable terms, it would materially and adversely affect our business, prospects, financial condition and results of operations, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, if at all. 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.

We may consider all strategic alternatives that may be available to us to maximize stockholder value, including financing, strategic alliances, and licensing arrangements, including a commercial sales partner as of our evolving RenovoCath commercial strategy. Our exploration of various strategic alternatives may not result in any specific action or transaction. To the extent that this engagement results in a transaction, our business objectives may change

depending upon the nature of the transaction. There can be no assurance that we will enter into any transaction as a result of the engagement. Furthermore, if we determine to engage in a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price. We also cannot predict the impact on our stock price if we fail to enter into a transaction.

In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our business activities because they may be deemed to be at too early of a stage of development for collaborative effort. Any delays in entering into new strategic partnership agreements harm our business prospects, financial condition and results of operations.

If we license or acquire products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following a strategic transaction, license, or acquisition, we will achieve the results, revenue or specific net income that justifies such transaction.

Risks Related to the Discovery, Development, and Commercialization of Our Product Candidates

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 IAG and future product candidates through preclinical studies and clinical trials (notably our Phase III TIGeR-PaC study with respect to IAG), have such 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.

Our product candidates must satisfy rigorous regulatory standards of safety and efficacy before we can advance or complete their clinical development, or before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy preclinical studies and clinical trials, develop acceptable manufacturing processes, and obtain regulatory approval. Despite these efforts, the FDA could delay, limit or deny approval of a product candidate for many reasons, including because the FDA:

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may not deem our product candidate to be safe and effective;

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determines that the product candidate does not have an acceptable benefit-risk profile;

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may not agree that the data collected from preclinical studies and clinical trials are acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval, and may impose requirements for additional preclinical studies or clinical trials;

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may determine that adverse events experienced by participants in our clinical trials represent an unacceptable level of risk;

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may determine that population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;

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may disagree regarding the formulation, labeling and/or the specifications;

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may not approve the manufacturing processes associated with our product candidate or may determine that a manufacturing facility does not have an acceptable compliance status;

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may conclude there are chemistry, manufacturing and controls issues that preclude approval of the NDA;

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may conclude that the drug substance or drug product manufacturing process is not in a state of control or does not meet cGMP or all the regulatory requirements;

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may conclude that the medical device manufacturing process for the drug/device combination product candidate is not in a state of control or does not meet all the regulatory requirements;

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may change approval policies or adopt new regulations; or

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may not file a submission due to, among other reasons, the content or formatting of the submission.

If we experience delays in obtaining approval or if we fail to obtain approval of our lead drug/device combination product candidate or any other product candidate, our commercial prospects will be harmed and our ability to generate revenues will be materially impaired which would adversely affect our business, prospects, financial condition and results of operations.

We cannot assure you that the results of late-stage clinical trials (notably our Phase III TIGeR-PaC study or IAG) will be favorable enough to support the continued development of our product candidates. A number of companies in the pharmaceutical and biopharmaceutical industries have experienced significant delays, setbacks and failures in all stages of development, including late-stage clinical trials, even after achieving promising results in preclinical testing or early-stage clinical trials. Accordingly, results from completed preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results we may obtain in later-stage trials. Furthermore, even if the data collected from preclinical studies and clinical trials involving our product candidates demonstrate a favorable safety and efficacy profile, such results may not be sufficient to support the submission of an NDA to obtain regulatory approval from the FDA in the U.S., or other similar regulatory agencies in other jurisdictions, which is required to market and sell the product. Even if we are successful in obtaining approval in one jurisdiction, we may not be successful in obtaining approval in any other jurisdictions. If we are unable to obtain approval for our product candidates in multiple jurisdictions, our business, financial condition, results of operations and our growth prospects could be negatively affected.

Our product candidates will require significant additional research and development efforts, the commitment of substantial financial resources, and regulatory approvals prior to advancing into further clinical development or being commercialized by us or collaborators. We cannot assure you that our product candidates will successfully progress through the drug development process or will result in commercially viable products. We do not expect our product candidates to be commercialized by us or collaborators for at least several years.

With respect to our ongoing Phase III TIGeR-PaC study of IAG in LAPC specifically, this study is our most advanced clinical trial to date and is therefore very important to us. While we have previously announced positive interim data from such study, and while the second interim analysis was completed in 2025 and the Data Monitoring Committee recommended continuation of the study, there can be no assurance that the final data will be positive or support an NDA submission or approval. We expect to complete enrollment in the TIGeR-PaC study by mid-2026 and anticipate final data readout in 2027, though there is a risk that enrollment or data completion could be delayed. In addition, for clinical or commercial reasons, we may be unable to, or may elect not to, even file an NDA for IAG. The failure of our TIGeR-PaC study to achieve results conducive to filing and receiving NDA approval would cause our company, and likely our stock price, significant harm. Some harm could occur if we are required to postpone, or elect not to, file an NDA for IAG in LAPC for any reason.

If we do not achieve our projected commercial or development goals in the timeframes we announce and expect, our stock price may decline.

From time to time, we estimate the timing of the anticipated accomplishment of various commercial, scientific, clinical, regulatory and product development goals, which we sometimes refer to as milestones. These milestones may include projected results (including revenue generation) from our RenovoCath commercialization activities as well as the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we may publicly announce the expected timing or results of some of these milestones. All of these milestones are and will be based on numerous assumptions and are subject to inherent known and unknown risks. For example, the revenues we generate from RenovoCath sales may be less than we anticipate or are projected by securities analysts who follow our company. Also, important milestones such as the actual timing for full enrollment in, or data readout from, our TIGeR-PaC study, or any related NDA submission, could change due to a variety of factors, some of which are beyond our control. Therefore, you are advised that the actual timing and results of these milestones can vary dramatically compared to our estimates or the estimates of securities analysts. If we do not meet these milestones as publicly announced, our stock price may decline and it may become more difficult to operate and finance our company.

RNXT US Equity

RNXT · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS

Item 1A. Risk Factors

RNXT US Equity☆

RNXT · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS

Item 1A. Risk Factors

RNXT US Equity