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

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

Previous wording

We are a commercial and clinical stage life sciences company offeringRenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug delivery device, targeting high unmet medical needs, with a present focus on difficult to treat cancers. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted therapeutic delivery.

Current wording

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

Previous wording

Our RenovoCath device utilizes our patentedTrans-Arterial Micro-Perfusion (“TAMP™”) therapy platform, which is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy, including chemotherapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. We hold a robust portfolio of 19 issued patents and 12 pending patents covering our TAMP technology.

Current wording

Our RenovoCath device utilizes our patentedTrans-Arterial Micro-Perfusion (“TAMP™”) therapy platform, which is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration where it is needed. This targeted approach is designed to minimize systemic exposure and toxicities related to chemotherapy and addresses the longstanding challenge in cancer care of poor blood supply to tumor sites. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. We hold a robust portfolio of 19 issued patents and 12 pending patents covering our TAMP technology.

Previous wording

We will continue to gather important data about our market (such as sales cycles, activation times, individual customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders and position ourselves for commercial growth over the long term. In parallel, we have evaluated and may continue to evaluate potential collaborations with larger organizations who have established sales forces to accelerate our RenovoCath sales efforts.

Current wording

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

Previous wording

Readers are advised that our RenovoCath commercialization efforts are new, and we may not be able to achieve revenue growth on par with what have experienced to date for a variety of reasons. Thus, our efforts remain focused on the longer term. Moreover, revenue recognition under generally accepted accounting principles requires subjective judgments to be made by our management and could otherwise be complex and create uncertainties, including uncertainties arising from varying terms of sale we may offer to different customers. We may also be required to defer recognition of revenues until certain conditions are met. See “Components of Our Results of Operations – Revenue” below for further information.

Current wording

Readers are advised that our RenovoCath commercialization efforts are new and have experienced fluctuations in revenue, and we may not be able to achieve revenue growth for a variety of reasons. Thus, our efforts remain focused on the longer term. Moreover, revenue recognition under generally accepted accounting principles requires subjective judgments to be made by our management and could otherwise be complex and create uncertainties, including uncertainties arising from varying terms of sale we may offer to different customers. We may also be required to defer recognition of revenues until certain conditions are met. See “Components of Our Results of Operations – Revenue” below for further information.

Previous wording

In parallel to our RenovoCath commercialization efforts, we are completing enrollment in our ongoing Phase III randomized multi-center TIGeR-PaC clinical trial to investigate IAG for the treatment of LAPC. This trial is being conducted under a U.S. Investigational New Drug (“IND”) application that is regulated by the FDA’s 21 CFR 312 pathway. IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon approval by the FDA.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

The 52 nd event in our trial occurred during the quarter ended June 30, 2025, triggering the pre-planned second interim analysis and review by the independent Data Monitoring Committee (DMC) for the trial, which happened recently. The Data Monitoring Committee reviews the trial data and makes recommendations to our company, mainly whether the data support, form a third-party point of view, continuing the trial to completion.

Current wording

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

Previous wording

The TIGeR-PaC independent DMC has recently concluded its review and has recommended that we continue with the trial. We believe the independent DMC’s recommendation is an expression of confidence in the potential for a positive outcome in the trial overall. With a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions with the independent DMC, and consultation with our regulatory advisors, we have decided to defer publishing the detailed data from the second interim analysis. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment this year or early next year.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

In July 2025, we launched a RenovoCath Post-Marketing Registry Study calledPanTheR (NCT06805461). The initiation of this multi-center post-marketing registry study demonstrates our commitment to evaluating potential expansions of the use of RenovoCath for chemotherapy-delivery in several types of solid tumors. A registry study, sometimes called a post-approval study, is a type of clinical study that involves collecting data on the long-term use and performance of a medical device, in this case RenovoCath, after it has been cleared for market by the FDA. These trials can serve as a critical tool for understanding a product’s safety and effectiveness in a real-world setting and can provide valuable insights into long-term effectiveness, patient outcomes, and additional safety information that may emerge years after implantation or extended use.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of June 30, 2025, we had cash and cash equivalents of $12.3 million. We reported net losses of $2.9 million and $5.3 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2025, we had an accumulated deficit of $55.5 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. 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 September 30, 2025, we had cash and cash equivalents of approximately $10.0 million. We reported net losses of $2.9 million and $8.2 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $58.4 million. We expect to continue to incur significant expenses, operating losses and negative cash flows while we seek to grow our revenues from RenovoCath commercial sales. Further, we will not generate revenues from IAG sales unless and until we successfully complete development and obtain regulatory approval for IAG or another product candidate. Given economic and market conditions and timing of regulatory approval for IAG, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:

Previous wording

Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we will likely be required to raise additional capital at some point to continue the commercialization of RenovoCath and complete the development of and gain regulatory approval for IAG or any other of our future potential product candidates. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.

Current wording

Based on our current plans, our cash on hand is expected to fund both the RenovoCath commercial scale-up and continued progress of our Phase III TIGeR-PaC trial, as well as other activities, into the middle of 2026. Any increase in sales momentum beyond our current expectations could extend this timeline. However, due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we will be required to raise additional capital to fund our operations through at least the next 12 months from the issuance of this Report, continue the commercialization of RenovoCath and complete the development of and gain regulatory approval for IAG or any other of our future potential product candidates. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.

Previous wording

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

Current wording

However, we may not be able to obtain financing on favorable terms when needed, or at all. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operations.

Previous wording

Our condensed interim financial statements as of June 30, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs through at least the next 12 months, assuming our commercial strategy and our development programs advance as currently contemplated.

Current wording

Our condensed interim financial statements as of September 30, 2025 have been prepared under the assumption that the Company will continue as a going concern and, despite the Company’s findings to the contrary, do not include any adjustments that may result from the negative outcome of this uncertainty.

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, utilizing the service of third-party clinical trial sites and several clinical research vendors and consultants to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath delivery device, which comprises part of our IAG product candidate. Accordingly, we are able to charge our clinical trial sites for the RenovoCath delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices offset our research and development expenses. We expect our research and development expenses to increase for the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate our post marketing registry study called PanTheR 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. 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, utilizing the service of third-party clinical trial sites and several clinical research vendors and consultants to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath delivery device, which comprises part of our IAG product candidate. Accordingly, we are able to charge our clinical trial sites for the RenovoCath delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices offset our research and development expenses.

Previous wording

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

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 $0.66 and $0.73 on June 30, 2025 and 2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price.

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 common shares and common stock warrants. The fair value of the common stock warrant per share was $0.57 and $0.61 on September 30, 2025 and 2024, respectively. The decrease in the fair value of the liability from the prior year was primarily due to the decrease in our stock price combined with a shorter term to expiration.

Previous wording

We recognized approximately $0.4 million of revenue from sales of RenovoCath for the three months ended June 30, 2025, compared to no revenue for the same period last year as we launched initial commercial sales activity for RenovoCath during the fourth quarter of 2024. The quarter ended June 30, 2025 marked our second full quarter of revenue generation from RenovoCath sales. We expect to grow revenue from RenovoCath over time.

Current wording

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

Previous wording

Cost of revenue was approximately $0.2 million for the six months ended June 30, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party manufacturer. Prior to the commencement of our RenovoCath commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost for RenovoCath devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices from Medical Murray.

Current wording

Prior to the commencement of commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost for RenovoCath devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices from Medical Murray including costs for devices under the commercial supply agreement.

Previous wording

Research and development expenses were approximately $1.4 million for the three months ended June 30, 2025, compared to $1.5 million for the same period last year, a decrease of $0.1 million. The period-over-period decrease in research and development expenses is primarily driven by decrease in other clinical and regulatory expenses of $0.1 million including selling, general and administrative expense allocation of $0.1 million. This decrease was offset by an increase in non-recurring engineering costs to scale manufacturing and the development of our next generation RenovoCath delivery system by $0.1 million to support our commercial effort program. We expect research and development expenses to increase during 2025 as we continue to develop our next generation for our RenovoCath device, progress our Phase III TIGeR-PaC clinical trial study for IAG and to launch our new RenovoCath Post-Marketing Registry Study called PanTheR.

Current wording

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

Previous wording

Selling, general and administrative expenses were approximately $1.5 million for the three months ended June 30, 2025 and 2024, remaining relatively unchanged. Professional and consulting decreased by $0.1 million compared to the same period last year, primarily due to digital marketing expenses. This decrease was offset by selling, general and administrative allocation to research and development, of $0.1 million compared to the same period last year. We anticipate selling, general and administrative expenses to increase during 2025 as we progress with our commercialization activities for our RenovoCath device, due primarily to anticipated hiring of sales and marketing personnel.

Current wording

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

Previous wording

Other expense was approximately $0.2 million for the three months ended June 30, 2025, an increase in expense of approximately $0.9 million compared to other income of $0.6 million for the same period last year. The increase in other expense was primarily due to a $0.9 million change in the fair value of the common warrant liability primarily due to an increase in our stock price.

Current wording

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

Previous wording

We recognized approximately $0.6 million of revenue from sales of RenovoCath for the six months ended June 30, 2025, compared to no revenue for the same period last year as we launched initial commercial sales activity for RenovoCath during the fourth quarter of 2024. We expect to grow revenue from RenovoCath sales over time as we expand our commercial efforts.

Current wording

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

Previous wording

Cost of revenue was approximately $0.2 million for the three months ended June 30, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party manufacturer. Prior to the commencement of commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost for RenovoCath devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices from Medical Murray.

Current wording

Cost of revenue was approximately $0.3 million for the nine months ended September 30, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consists of costs associated with the sales of RenovoCath devices primarily from Medical Murray, our third-party manufacturer. Prior to the commencement of our RenovoCath commercial sales during the quarter ended December 31, 2024, all costs of manufacturing to produce RenovoCath devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost for devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices from Medical Murray including costs for devices under the commercial supply agreement.

Previous wording

Research and development expenses were approximately $3.1 million for the six months ended June 30, 2025, compared to $2.8 million for the same period last year, an increase of $0.3 million. The period-over-period increase in research and development expenses is primarily due to an increase in non-recurring engineering costs to scale manufacturing, including the development of the next generation of our RenovoCath delivery system by $0.3 million. Clinical, oncology and interventional radiology conferences and other scientific trade shows activities increased by $0.1 million including employee and related benefits costs of $0.1 million. This increase was offset by payments from clinical trial sites in consideration for RenovoCath delivery devices of $0.1 million including a decrease in selling, general and administration expenses allocated to research and development expenses of $0.1 million. We expect research and development expenses to increase during 2025 as we continue to incur non-recurring engineering activities for the next generation of our RenovoCath device, progress our Phase III TIGeR-PaC clinical trial study for IAG, and to launch our new RenovoCath Post-Marketing Registry Study called PanTheR.

Current wording

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

Previous wording

Selling, general and administrative expenses were approximately $3.1 million for the six months ended June 30, 2025, compared to $2.7 million for the same period last year, an increase of approximately $0.4 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 $0.1 million, professional and consulting fees of $0.1 million and a decrease in selling, general and administrative expenses allocated to research and development expenses of $0.1 million compared to the same period last year We anticipate selling, general and administrative expenses to increase during 2025 as we progress and expand our commercialization activities for our RenovoCath delivery system, due primarily to anticipated hiring of sales and marketing personnel.

Current wording

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

Previous wording

Other income was approximately $0.5 million for the six months ended June 30, 2025, a decrease of approximately $1.6 million compared to approximately $2.1 million for the same period last year. The decrease was primarily due to a $1.6 million in the fair value of the common warrant liability due to an increase in our stock price, offset by an increase in interest and dividend income of approximately $0.1 million.

Current wording

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

Previous wording

From our inception through June 30, 2025, we have raised an aggregate of $71.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in public and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $64.3 million. As of June 30, 2025, we had cash and cash equivalents of $12.3 million. Based on our operational 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 for at least the next twelve months, assuming our programs advance as currently contemplated, including fully funding both our RenovoCath scale-up and the development of our next generation RenovoCath delivery device system and the continued progress of our Phase III TIGeR-PaC clinical trial including the scale up of our new RenovoCath Post-Marketing Registry Study called PanTheR

Current wording

From our inception through September 30, 2025, we have raised an aggregate of $71.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in public and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $64.3 million. As of September 30, 2025, we had cash and cash equivalents of approximately $10.0 million. As discussed above under the caption “Cash Resources, History of Losses and Planned Activities”, based on our operational plans, we do not expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing needs for at least the next twelve months from the date of this Report. This raises a current substantial doubt about our ability to continue as a going concern.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. At June 30, 2025, we had an accumulated deficit of approximately $55.5 million. For the three and six months ended June 30, 2025, we reported a net loss of $2.9 million and $5.3 million, respectively. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations until we generate sufficient revenues from RenovoCath sales, which we may be unable to achieve. We also expect to incur losses from our clinical activities until regulatory approval is granted for our first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements or commercializing RenovoCath on a standalone basis. No assurances can be made that we will pursue these strategies, and even if it does, there is a risk that we will be unable to generate revenue from such activities.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. At September 30, 2025, we had an accumulated deficit of approximately $58.4 million. For the three and nine months ended September 30, 2025, we reported a net loss of $2.9 million and $8.2 million, respectively. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations until we generate sufficient revenues from RenovoCath sales, which we may be unable to achieve. We also expect to incur losses from our clinical activities until regulatory approval is granted for our first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements or commercializing RenovoCath on a standalone basis. No assurances can be made that we will pursue these strategies, and even if it does, there is a risk that we will be unable to generate revenue from such activities.

Previous wording

We believe we will be able to raise additional required capital when needed through debt financings, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and its ability to pursue its business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve positive cash flow or profitability, and we may never do so.

Current wording

We believe we will be able to raise additional required capital when needed through debt financings, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and the ability to pursue our business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve positive cash flow or profitability, and we may never do so.

Previous wording

Our ability to obtain additional financing we may need in the future will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors” in our 2024 Annual Report. Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Current wording

Our ability to obtain additional financing we may need in the future will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors” in this Report and in our 2024 Annual Report. Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Previous wording

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

Current wording

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

Previous wording

Cash used in operating activities for the six months ended June 30, 2024, reflected a net loss of $3.5 million and non-cash charges of $1.2 million, offset by net change in our operating assets and liabilities of $0.2 million.

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

There have been no material changes in our contractual obligations or other commitments since we filed our 2024 Annual Report.

Current wording

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