RenovoRx, Inc.

Previous wording

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

Current wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed interim financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2025, which is included in our 2025 Annual Report on Form 10-K, as amended.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Our patented Trans-Arterial Micro-Perfusion (TAMP™) platform, utilizing RenovoCath, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor locally, while potentially minimizing a therapy’s toxicities versus systemic intravenous chemotherapy. Our novel approach to targeted drug-delivery offers the potential for improved efficacy, safety, and tolerability, and our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of therapeutic agents.

Previous wording

The IAG combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath used with the approved chemotherapy 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.

Current wording

Until 2025, we primarily focused our efforts on progressingour novel drug-device combination oncology product candidate, intra-arterial gemcitabine (known as "IAG") delivered via RenovoCath, through our ongoing Phase III TIGeR-PaC study for locally advanced pancreatic cancer ("LAPC"). IAG is currently under investigation and has not been approved for commercial sale. IAG received Orphan Drug Designation ("ODD") for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. In the second quarter of 2026, we were granted an additional ODD for oxaliplatin for the treatment of pancreatic cancer.

Previous wording

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 the receipt of our first commercial purchase orders for RenovoCath devices with over ten medical institutions initiating the purchase process, while in discussions with more than twenty other institutions.

Current wording

As the TIGeR-PaC study progressed, we received unsolicited (and subsequently solicited) feedback from oncologists, surgeons, and interventional radiologists highlighting strong interest in our technology, indicating a demand and commercial opportunity for targeted delivery of diagnostic and/or therapeutic agents. As a result, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone medical device. We launched this effort with relatively little capital outlay, and in December 2024, we announced our first commercial purchase orders for RenovoCath devices with more than ten medical institutions initiating the purchasing process, while in discussions with more than twenty additional institutions.

Previous wording

We are actively commercializing the TAMP therapy platform and RenovoCath as a stand-alone device. In our first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales. We saw further acceleration in the commercial rollout of RenovoCath during the first quarter of 2026, achieving our strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase compared to the fourth quarter of 2025 and totaling more than 50% of our total revenue generated in 2025. This significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across our installed base. We define "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

Current wording

We are actively commercializing the TAMP platform and RenovoCath as a stand-alone device. In 2025, our first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales with effectively zero sales and marketing infrastructure for the majority of the year. In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth, commercial momentum, and expansion beyond locally advanced pancreatic cancer (LAPC). We generated record revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026 and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full-year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base. We define "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

Previous wording

Our commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. We began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026, we had 16 active centers. We are also advancing a robust pipeline of 32 additional centers in various stages of evaluation, approval, and onboarding, representing a significant expansion of our near-term commercial footprint. In total, these 48 centers have approximately quadrupled our near-term commercial sales pipeline compared to the first quarter of 2025, reflecting the rapid expansion of our commercial footprint year-over-year. Up to 15 TIGeR-PaC Phase III clinical trial sites that have previously utilized RenovoCath are expected to continue transitioning to commercial clinical use following completion of trial enrollment. These anticipated conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026. We continue to target 36 active commercial cancer centers by year-end 2026.

Current wording

Furthermore, we currently have 15 clinical trial sites under our Phase III TIGeR-PaC study that have previously utilized RenovoCath and are expected to continue transitioning to commercial clinical use. These anticipated commercial conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026.

Previous wording

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

Current wording

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

Previous wording

We continue to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications.

Current wording

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

Previous wording

We are also evaluating our novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as"IAG") in the 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 indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Current wording

We are evaluating IAG delivered via RenovoCath in the ongoing Phase III TIGeR-PaC clinical trial. IAG is being studied under a U.S. investigational new drug (IND) study regulated by the FDA's Center for Drug Evaluation and Research (CDER) pursuant to 21 CFR Part 312. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Previous wording

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 its cost. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.

Current wording

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

Previous wording

During the first quarter of 2026, we continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across our clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, we elected to defer publication of interim data until study completion.

Current wording

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

Previous wording

We expect that TIGeR-PaC trial sites will continue transitioning to commercial use following completion of enrollment, representing a meaningful potential driver of revenue growth in the second half of 2026. We continue to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that our current commercial strategy is independent of the trial’s ultimate outcome and timeline.

Current wording

We continue to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that our commercial strategy and revenue outlook are not dependent on the trial's ultimate outcome or timing. Importantly, we expect TIGeR-PaC trial sites will continue transitioning to commercial use, which we believe will serve as a meaningful driver of revenue growth in the second half of 2026.

Previous wording

The first interim analysis in the Phase III TIGeR-PaC study at the 26 th event (death) of the specified events was completed in March 2023, with the study's independent data monitoring committee (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.

Current wording

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

Previous wording

We continue to advance broader clinical programs by generating new data through our continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Our condensed interim financial statements as of June 30, 2026, have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs at least the next 12 months from the date of issuance of this report (i.e., into the second half of 2027), assuming our commercial strategy and our development programs advance as currently contemplated.

Previous wording

As a result, while we believe we do not need to raise new capital for at least a year, we are faced with the risk of requiring significant additional funding at some point to support our operations. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations, licenses or other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that could restrict our operations. We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future, we may have to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through private or public equity financings or debt financings when needed, we may be required to delay, limit, reduce or terminate development or future commercialization efforts, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed interim financial statements, and our shareholders may lose their entire investment in our common stock.

Current wording

As a result, while raising capital is not our current focus, wemay require additional funding in the futureto support our strategy. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations, licensing agreements or other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additional capital through equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that could restrict our operations. We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future, we may have to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through private or public equity financings or debt financings when needed, we may be required to delay, limit, reduce or terminate development or future commercialization efforts, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed interim financial statements, and our shareholders may lose their entire investment in our common stock.

Previous wording

In the fourth quarter of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025 and accelerated in the first quarter of 2026. We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. As of March 31, 2026 and December 31, 2025, we recorded nil of allowance for returns.

Current wording

In the fourth quarter of 2024, we began generating revenue through the sale of our RenovoCath device on a standalone basis directly to end user customers (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025 and accelerated in the first and second quarters of 2026, with the second quarter of 2026 being a record revenue quarter for us. We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which we expect to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. As of June 30, 2026 and December 31, 2025, we recorded nil of allowance for returns.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the common stock warrant liability for warrants issued under the registered direct offering. On April 3, 2023, we completed a registered direct offering financing issuing common shares and common stock warrants. The fair value of the common stock warrant per share was $0.36 and $0.31 on March 31, 2026, and December 31, 2025, respectively. The increase in the fair value was primarily due to the increase in our stock price combined with a shorter number of years remaining to the warrant expiration date.

Current wording

Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the common stock warrant liability for warrants issued under the registered direct offering. On April 3, 2023, we completed a registered direct offering financing issuing shares of common stock and common stock warrants. The fair value of the common stock warrant per share was $0.18 and $0.66 on June 30, 2026, and 2025, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date.

Previous wording

Cost of revenue was approximately $84,000 for the three months ended March 31, 2026, compared to approximately $94,000 of revenue for the same period last year. The decrease in costs of revenue is due to the costs of devices sold for the three months ended were manufactured under our Medical Murray supply agreement of approximately $1,200 per device. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials, approximately $8,300 per device.

Current wording

Cost of revenue was approximately $0.1 million for the three months ended June 30, 2026, compared to approximately $0.2 million cost of revenue for the same period last year, remaining relatively flat from the prior period last year. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials which resulted in higher manufacturing costs per device. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Previous wording

Selling, general and administrative expenses were approximately $2.7 million for the three months ended March 31, 2026, compared to $1.6 million for the same period last year, an increase of approximately $1.1 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $0.5 million as we increased our efforts on expanding our commercialization program of increasing pipeline and active customers and revenue. Professional and consulting increased by $0.2 million, including travel related expenses of $0.1 million primarily due to supporting the commercialization strategy including other selling, general and administrative expenses of $0.1 million. The increase was further impacted by a decrease in selling, general, and administrative expenses allocated to research and development expenses of $0.2 million. We anticipate selling, general and administrative expenses to increase during 2026 as we progress with our commercialization activities for our RenovoCath delivery system, due primarily to increase hiring of sales and marketing personnel which is expected to continue.

Current wording

Selling, general and administrative expenses were approximately $2.9 million for the three months ended June 30, 2026, compared to $1.5 million for the same period last year, an increase of approximately $1.4 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $0.8 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. Professional, and other expenses to include travel and marketing expenses increased by $0.4 million primarily due to supporting our RenovoCath commercialization strategy, including the decreased in selling, general, and administrative expenses allocated to research of $0.2 million. We anticipate selling, general and administrative expenses to increase during the second half of 2026 as we progress with our commercialization activities for RenovoCath.

Previous wording

Other expense was approximately $52,000 for the three months ended March 31, 2026, compared to other income of approximately $0.7 million for the same period last year. The increase in expense was primarily due to a $0.7 million change in the fair value of the common warrant liability.

Current wording

Other Income was approximately $0.4 million for the three months ended June 30, 2026, compared to other expense of approximately $0.2 million for the same period last year. The increase in other income was primarily due to a $0.7 million change in the fair value of common warrant liability, primarily due to a decrease in our stock price.

Previous wording

We recognized approximately $563,000 of revenue from sales of RenovoCath for the three months ended March 31, 2026, compared to $197,000 for the same period last year, representing a significant increase in sales volume. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Current wording

We recognized approximately $1.5 million of revenue from sales of RenovoCath for the six months ended June 30, 2026, compared to $0.6 million for the same period last year, representing a $0.9 million increase in sales volume. The significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across our active commercial cancer centers. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Previous wording

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

Current wording

Research and development expenses were approximately $2.4 million for the six months ended June 30, 2026, compared to $3.1 million for the same period last year, a decrease of $0.7 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.4 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system of $0.2 million, and selling, general, and administrative expenses allocated to research and development costs of $0.4 million. The decrease was off-set by an increase in employee and related benefit costs of $0.4 million primarily due to an increase in employees and salary changes associated with cost-of-living adjustments. We anticipate research and development expenses to increase in the second half of 2026 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Previous wording

From our inception through March 31, 2026, we had raised an aggregate of $81.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in public and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $72.4 million. As of March 31. 2026, we had cash and cash equivalents of $12.4 million.

Current wording

From our inception through June 30, 2026, we had raised an aggregate of $81.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in registered and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $72.5 million. As of June 30, 2026, we had cash and cash equivalents of $9.5 million.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. For the three months ended March 31, 2026, we recorded a net loss of $3.5 million and an accumulated deficit of $64.9 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the foreseeable future, although that is an important goal for our commercial efforts. We also expect to incur losses from our clinical activities until regulatory approval is granted for our first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements. No assurances can be made that we will pursue these strategies, and even if we do, there is a risk that we will be unable to generate revenue from such activities.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. For the six months ended June 30, 2026, we recorded a net loss of $6.4 million and an accumulated deficit of $67.8 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the near future, although that is an important goal for our commercial efforts. We also expect to incur losses from our clinical activities until revenues from RenovoCath sales grow and outpace cash and non-cash expenses. Losses may also continue until regulatory approval is granted for our lead product candidate, IAG, and until IAG is commercially launched and revenues are generated from sales of IAG, all of which, with respect to IAG, will not occur for several years. We face the risk that commercial sales of RenovoCath will not grow as anticipated, and regulatory approval of IAG is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements. No assurances can be made that we will pursue these strategies, and even if we do, there is a risk that we will be unable to generate revenue from such activities.

Previous wording

We have believe we will be able to continue to raise additional required capital as needed through debt financings, private or public equity financings (including our at the market offering program), potential exercises of outstanding warrants, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available as and when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and our ability to pursue our business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve cashflow positive operations or profitability, and we may never do so. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section of this Report and our 2025 Annual Report titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Current wording

We believe we will be able to continue to raise additional required capital as needed through debt financings, private or public equity financings (including our at the market offering program), potential exercises of outstanding warrants, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available as and when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and our ability to pursue our business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve cashflow positive operations or profitability, and we may never do so. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section of this Report and our 2025 Annual Report titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Previous wording

On March 20, 2026, we closed on a private placement offering to 15 accredited investors, of which 5 were insider investors, and issued 8,438,790 shares of common stock, 2,200,000 pre-funded warrants, and 5,319,392 revenue milestone warrants, representing 50% warrant coverage. The revenue milestone warrants have an exercise price equal to two times (2x) the purchase price paid for the shares of common stock in the offer, and they expire on the earlier of: (i) 30 days of our reporting $1.5 million in gross product sales in any fiscal quarter and (ii) March 30, 2029. We raised an aggregate gross proceeds of $10.0 million in this financing, before deducting placement agent fees and other legal and professional fees of approximately $0.7 million. In addition, we incurred approximately $0.3 million of issuance costs.

Current wording

On March 20, 2026, we closed on a private placement offering to 15 accredited investors, of which 5 were insider investors, and issued 8,438,790 shares of common stock, 2,200,000 pre-funded warrants, and 5,319,392 revenue milestone warrants, representing 50% warrant coverage. The revenue milestone warrants have an exercise price equal to two times (2x) the purchase price paid for the shares of common stock in the offer, and they expire on the earlier of: (i) 30 days of our reporting $1.5 million in gross product sales in any fiscal quarter and (ii) March 30, 2029. We raised aggregate gross proceeds of $10.0 million in this financing, before deducting placement agent fees and other legal and professional fees of approximately $0.7 million. In addition, we incurred approximately $0.3 million of issuance costs.

Previous wording

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

Current wording

As of the date of this Report, we believe that we have sufficient cash resources, including our private placement closing in March 2026 described above, to allow us to fund our operating, investing and financing cash flow needs through at least the next 12 months (i.e., into the second half of 2027). The accompanying unaudited condensed interim financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying unaudited condensed interim financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if we are unable to continue as a going concern.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

Cash used in operating activities for the three months ended March 31, 2025, reflected a net loss of $2.4 million, non-cash charges of $0.3 million, and a net change in our operating assets and liabilities of $0.7 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2026, reflected a net loss of $6.4 million, offset by non-cash charges of approximately $0.7 million, and a net change in our operating assets and liabilities of $0.8 million.

Previous wording

Cash used in operating activities for the three months ended March 31, 2026, reflected a net loss of $3.5 million, non-cash charges of $0.4 million, and a net change in our operating assets and liabilities of $0.6 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2025, reflected a net loss of $5.3 million, offset by non-cash charges of $0.4 million, and a net change in our operating assets and liabilities of $0.8 million.

Previous wording

Cash used in investing activities for the three months ended March 31, 2025, consisted of $2,000 for the purchase of property and equipment.

Current wording

Cash used in investing activities for the six months ended June 30, 2025, consisted of $2,000 for the purchase of property and equipment.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $9.0 million, consisting primarily of net proceeds from the public equity offering.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $9.1 million, consisting primarily of net proceeds from the March 2026 private placement.