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 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 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”).

Previous wording

As used herein, the term “common stock” refers to our common stock, par value $0.0001 per share.

Current wording

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

Previous wording

We are a 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 transform the lives of cancer patients by providing innovative solutions to enable targeted therapeutic delivery.

Previous wording

We are both a clinical stage and a commercial stage enterprise. Our clinical stage lead product candidate is a novel drug-device combination product consisting of intra-arterial delivery of the chemotherapy gemcitabine via RenovoCath -- we refer to our lead product candidate herein as “IAG.” IAG is currently the subject of a Phase III clinical study for the treatment of locally advanced pancreatic cancer (“LAPC”). At the same time, we are commercializing RenovoCath for standalone use by interventional radiologists, oncologists, and other medical professionals who can use RenovoCath to treat patients within its FDA-cleared fields of use.

Current wording

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

Previous wording

Our RenovoCath device utilize 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, 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.

Previous wording

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

Current wording

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

Previous wording

Based on our internal assumptions, we believe that our initial total U.S. addressable market based solely on the initial clinical interest we have received for RenovoCath could represent an estimated $400 million peak annual U.S. sales opportunity. Our current assumptions regarding our initial addressable market include: (i) pressure-mediated delivery catheters on the market today, which are analogous to RenovoCath, have an average selling price of $6,500-$8,500 per unit; (ii) approximately 7,000 initial target patients at peak market penetration(meaning patients with whom we have experience through our clinical work, without the potential to expand indications beyond LAPC); and (iii) an average of approximately 8 annual procedures per patient. Beyond this initial market, we believe there are expansion opportunities across other indications that could create a several billion-dollar market potential for RenovoCath over time.

Current wording

Based on our internal assumptions, we believe that our initial total U.S. addressable market based solely on the initial clinical interest we have received for RenovoCath could represent an estimated $400 million peak annual U.S. sales opportunity. Beyond historical RenovoCath usage, RenovoRx commercial efforts are already indicating the adoption of RenovoCath technology for the treatment of other solid tumors. This serves as the basis for our belief in the potential for a several-billion-dollar TAM as we expand into additional cancer indications.

Previous wording

However, we are at the beginning of our RenovoCath commercialization efforts and have not had to recognize revenue from our operations in the past. A primary goal from these efforts is to generate and recognize revenue from RenovoCath sales. Revenue recognition under generally accepted accounting principles requires subjective judgements to be made by our management and could otherwise be complex and create uncertainties, including uncertainties arising from varying terms of sale we may offer to different customers. We may also be required to defer recognition of revenues until certain conditions are met. 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 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.

Previous wording

In parallel to our RenovoCath commercialization efforts, we are completing enrolment in our ongoing Phase III randomized multi-center clinical trial (called TIGeR-PaC) 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, 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.

Previous wording

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of May 2, 2025, 91 patients have been randomized and 56 events have occurred, triggering the second pre-planned interim analysis per the statistical analysis plan. We expect the study’s Data Monitoring Committee to review the data in the third quarter of 2025 and look forward to their recommendation regarding the continuation of the study and their guidance on interpretation and data-sharing of the second interim analysis.

Current 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.

Previous wording

We may also evaluate RenovoCath with gemcitabine and other agents as a potential therapy in other indications.

Current wording

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

Previous wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of March 31, 2025, we had cash and cash equivalents of $14.6 million. We reported net losses of $2.4 million and $1.1 million for the three months ended March 31, 2025, and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $52.6 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 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:

Previous wording

Our condensed interim financial statements as of March 31, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. 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 the second half of 2026, assuming our commercial strategy and our development programs advance as currently contemplated.

Current 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.

Previous wording

In December of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers). We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. We have not experienced any commercial product returns to date, and accordingly no allowance for returns was recorded for the period ended March 31, 2025.

Current wording

In December of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers). We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. We have not experienced any commercial product returns to date, and accordingly no allowance for returns was recorded as of June 30, 2025.

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 new clinical trials 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, 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.

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. 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 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.

Previous wording

Interest income is earned from cash deposited in our short-term marketable securities and money market account.

Current wording

Interest income is earned from cash deposited in our money market account.

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 $0.48 and $0.99 on March 31, 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 $0.66 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.

Previous wording

We recognized approximately $197,000 of revenue from sales of RenovoCath for the three months ended March 31, 2025, compared to no revenue for the same period last year as we only launched initial commercial sales activity for RenovoCath during the latter part of 2024. The quarter ended March 31, 2025 marked our first full quarter of revenue generation from RenovoCath sales, following an initial recognition of approximately $43,000 of RenovoCath-related revenue in the fourth quarter of 2024. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2025.

Current 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.

Previous wording

Cost of revenue was approximately $94,000 for the three months ended March 31, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consist of costs associated with the sales of RenovoCath devices and were disaggregated between the cost of devices expensed in prior periods as part of our clinical trial as research and development and the cost from our third-party CMO. Prior to our commercialization strategy, all costs of manufacturing to produce the devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost of revenue associated with the TIGeR-PaC study were recorded at zero-costs. The cost of revenue 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 at approximately $90,000 including shipping and handling fees of $4,000.

Current 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.

Previous wording

Cost of revenue consist of costs associated with the sales of RenovoCath devices and were disaggregated between the cost of devices expensed in prior periods as part of our clinical trial as research and development and the cost from our primary third-party manufacturer, Medical Murray, Inc. (the “CMO”). Prior to our commercialization strategy, all costs of manufacturing to produce the devices were allocated to our TIGeR-PaC Phase III clinical trial study in prior periods and expensed as research and development. The cost of revenue associated with the TIGeR-PaC study was recorded at zero-costs. The cost of revenue 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 including shipping and handling fees when applicable.

Current 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.

Previous wording

Research and development expenses were approximately $1.7 million for the three months ended March 31, 2025, compared to $1.3 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 driven by an increase in employee and related benefit costs of $0.1 million primarily due to an increase in salaries due to cost-of-living allowance. Manufacturing and non-recurring engineering costs to scale manufacturing increased by $0.1 million to support the commercial effort on our RenovoCath delivery system. Clinical, oncology and interventional radiology conferences and other scientific trade shows activities increased by $0.1 million including other research and development activities of $0.1 million. We expect research and development expenses to increase during 2025 as we continue our commercialization activities for our RenovoCath device and progress our Phase III TIGeR-PaC clinical trial study for IAG.

Current 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.

Previous wording

Selling, general and administrative expenses were approximately $1.6 million for the three months ended March 31, 2025, compared to $1.2 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 increased by $0.2 million compared to the same period last year, primarily due to support of the commercialization strategy including other selling, general and administrative expenses 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.

Current 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.

Previous wording

Other income was approximately $0.7 million for the three months ended March 31, 2025, a decrease of approximately $0.7 million compared to approximately $1.4 million for the same period last year. The decrease was primarily due to a $0.8 million in the fair value of the common warrant liability offset by an increase in interest and dividend income of $0.1 million.

Current 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.

Previous wording

From our inception through March 31, 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 March 31, 2025, we had cash and cash equivalents of $14.6 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 continued progress of our Phase III TIGeR-PaC clinical trial.

Current 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

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. For the three months ended March 31, 2025, we recorded a net loss of $2.4 million and an accumulated deficit of $52.6 million. 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 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.

Previous wording

Since our inception, we have been primarily a clinical stage company on our clinical development stage lead product candidate, novel drug-device combination product consists of IAG via RenovoCath for the treatment of LAPC. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we started to generate revenue in the fourth quarter of 2024. We anticipate continuing to generate revenue from RenovoCath sales in 2025 with anticipated sequential quarter over quarter increases in revenue during the year, which would support our liquidity. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generates meaningful revenues, of which no assurances can be given.

Current wording

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

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, 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

Previous wording

Cash used in operating activities for the three months ended March 31, 2024, reflected a net loss of $1.1 million, offset by non-cash charges of $0.9 million, and a net change in our operating assets and liabilities of $0.2 million.

Current 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.

Previous wording

Cash used in investing activities for the three months ended March 31, 2025, consisted of $0.2 million for the purchase of property and equipment.

Current 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $10.8 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, 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 three months ended March 31, 2024 was $5.4 million, consisting primarily of net proceeds from private placement offering.

Current 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.

Previous wording

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the three months ended March 31, 2025, from those previously disclosed in our 2024 Annual Report.

Current wording

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