RenovoRx, Inc.

Previous wording

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

Current wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed interim financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2025, which is included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 30, 2026 (as amended, the “2025 Annual Report”).

Previous wording

We are a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared local drug-delivery device, targeting high unmet medical needs.

Current wording

We are a life sciences company commercializing RenovoCath®, a novel, FDA-cleared device for local drug delivery designed to address significant unmet medical needs, with a focus on difficult-to-treat tumors. We are also evaluating intra-arterial gemcitabine (known as "IAG”) delivered via RenovoCath using RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) platform as a novel drug-device product candidate for difficult-to-treat locally advanced pancreatic cancer ("LAPC").

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

Our TAMP platform, enabled by RenovoCath, is a collaborative, localized drug-delivery platform, with two ways emerging therapies can strengthen our opportunity: 1. We can deliver established drugs locally sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed, and 2. As new drugs come to market, we believe many of them can be delivered directly via our RenovoCath device. And in both cases, our view is that novel improved therapies make our targeted drug-delivery platform even more valuable.

Current wording

We are actively commercializing the TAMP platform and RenovoCath as a stand-alone device. TAMP , enabled by RenovoCath, is a collaborative, localized drug-delivery platform, with two ways emerging therapies can strengthen our opportunity: (i) TAMP can deliver established drugs locally sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed, and (ii) as new drugs come to market, we believe many of these drugs can be delivered directly via our RenovoCath device. And in both cases, we believe that novel improved therapies could make the TAMP targeted drug-delivery platform even more valuable.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

The completion of enrollment in TIGeR-PaC is a significant milestone for our company which reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG as a novel drug-device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether our patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane).

Current wording

In August 2026, we achieved full enrollment in the TIGeR-PaC trial. This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether our patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care, systemic (intravenous) chemotherapy gemcitabine + Abraxane.

Previous wording

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

Current wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of September 30, 2026, we had cash and cash equivalents of $10.4 million. We reported net losses of $3.6 million and $10.1 million for the three and nine months ended September 30, 2026, respectively. As of September 30, 2026, we had an accumulated deficit of $71.5 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 and work towards our goal of cashflow positive operations. We will not generate revenues from IAG sales unless and until we successfully complete development, obtain regulatory approval for, and commercially launch IAG. Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:

Previous wording

Advance clinical development of IAG and our platform technology by continuing to enroll patients in our ongoing Phase III TIGeR-PaC clinical trial, expand the number of clinical trials, and advance IAG through other preclinical and clinical pipeline indication opportunities beyond LAPC;

Current wording

Advance our TAMP platform technology through expanded clinical trials, and advance IAG through other preclinical and clinical pipeline indication opportunities beyond LAPC;

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

expenses incurred under agreements with clinical trial sites, contract research organizations, and consultants that are involved in conducting our clinical trials;

Current wording

expenses incurred under agreements with clinical trial sites, including post marketing and IITs studies, contract research organizations, and consultants that are involved in conducting our clinical trials;

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 shares of common stock and common stock warrants. The fair value of the common stock warrant per share was $0.18 and $0.66 on June 30, 2026, and 2025, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date.

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 in our April 2023 registered direct offering.

Previous wording

We recognized record quarterly revenue of approximately $0.9 million from sales of RenovoCath for the three months ended June 30, 2026, compared to $0.4 million for the same period last year, representing a $0.5 million increase in sales volume. The growth was driven by continued expansion of active commercial cancer centers and repeat ordering from our existing commercial cancer center base. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Current wording

We recognized record quarterly revenue of approximately $1.1 million from sales of RenovoCath for the three months ended September 30, 2026, compared to $0.3 million for the same period last year, representing a $0.8 million increase in sales volume. The growth was driven by continued expansion of active commercial cancer centers and repeat ordering from our existing commercial cancer center base. We expect to continue to grow revenue from RenovoCath sales.

Previous wording

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

Current wording

Cost of revenue was approximately $0.2 million for the three months ended September 30, 2026, compared to approximately $53,000 cost of revenue for the same period last year, an increase of $0.1 million due to additional sales compared to the prior period last year. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Previous wording

Research and development expenses were approximately $1.2 million for the three months ended June 30, 2026, compared to $1.4 million for the same period last year, a decrease of $0.2 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.1 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease of $0.2 million in selling, general, and administrative expenses allocated to research and development expense. This decrease was off-set by an increase in employee and related benefit costs of $0.1 million. We anticipate research and development expenses to increase in the second half of 2026 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Current wording

Research and development expenses were approximately $1.2 million for the three months ended September 30, 2026, compared to $1.7 million for the same period last year, a decrease of $0.5 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical consulting expenses of $0.5 million due to costs associated with our ongoing TIGeR-PaC trial, including a decrease of $0.2 million in selling, general, and administrative overhead expenses allocated to research and development expense. This decrease was off-set by an increase in employees and related benefit costs of $0.2 million. We anticipate research and development expenses to continue to increase for the remainder of 2026 and into the first half of 2027 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the filing of a 510(k) with the FDA next year at least 90 days before the device is offered for sale.

Previous wording

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

Current wording

Selling, general and administrative expenses were approximately $2.9 million for the three months ended September 30, 2026, compared to $1.7 million for the same period last year, an increase of approximately $1.2 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $0.8 million including an increase in marketing and travel related expenses of $0.2 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and increase in revenue. In addition, selling, general, and administrative overhead expenses allocated to research and development expenses decreased by $0.2 million, offset by a decrease in professional and other expenses of $0.1 million. We anticipate selling, general and administrative expenses to continue to increase as we progress with our commercialization activities for RenovoCath.

Previous wording

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

Current wording

Other expense was approximately $0.4 million for the three months ended September 30, 2026, compared to other income of approximately $0.3 million for the same period last year. The increase in other expense was primarily due to a $0.7 million change in the fair value of common warrant liability, primarily due to an increase in our stock price.

Previous wording

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

Current wording

We recognized approximately $2.5 million of revenue from sales of RenovoCath for the nine months ended September 30, 2026, compared to $0.9 million for the same period last year, representing a $1.6 million increase in sales volume. The significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across our active commercial cancer centers. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2026.

Previous wording

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

Current wording

Cost of revenue was approximately $0.4 million for the nine months ended September 30, 2026, compared to approximately $0.3 million, remaining relatively flat for the same period last year. Prior to the Medical Murray supply agreement, devices sold for the same period as last year were manufactured based on time and materials which resulted in higher manufacturing costs per device. We expect costs of revenue to increase as we increase our revenue from RenovoCath sales.

Previous wording

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

Current wording

Research and development expenses were approximately $3.7 million for the nine months ended September 30, 2026, compared to $4.8 million for the same period last year, a decrease of $1.1 million. The period-over-period decrease in research and development expenses is primarily driven by a decrease in regulatory and clinical development of $0.9 million due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC, including a decrease in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system of $0.1 million, and selling, general, and administrative overhead expenses allocated to research and development costs of $0.6 million. These decreases were offset by an increase in employees and related benefit costs of $0.5 million primarily due to increased headcount and personnel-related expenses. We anticipate research and development expenses to increase for the remainder of 2026 and into the first half of 2027 as we advance our clinical development of IAG and the development of our next generation RenovoCath device including incurring expenses for the anticipated potential filing of a New Drug Application with the FDA for IAG.

Previous wording

Selling, general and administrative expenses were approximately $5.6 million for the six months ended June 30, 2026, compared to $3.1 million for the same period last year, an increase of approximately $2.5 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 $1.3 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. Professional, and other expenses to include travel and marketing expenses increased by $0.7 million primarily due to supporting our RenovoCath commercialization strategy. Legal expenses increased $0.1 million, including a decrease in selling, general, and administrative expenses of $0.4 million. We anticipate selling, general and administrative expenses to increase during the second half of 2026 as we progress with our commercialization activities for our RenovoCath delivery system.

Current wording

Selling, general and administrative expenses were approximately $8.5 million for the nine months ended September 30, 2026, compared to $4.8 million for the same period last year, an increase of approximately $3.7 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 $2.0 million including an increase in travel and marketing related expenses of $0.5 million as we made targeted investments in expanding our RenovoCath commercialization program, resulting in an increased commercial pipeline, additional active cancer center customers and a resulting increase in revenue. Professional, and other expenses increased $0.6 million, including a decrease in selling, general, and administrative overhead expenses allocated to research and development expenses of $0.6 million. We anticipate selling, general and administrative expenses to increase as we progress with our commercialization activities for RenovoCath.

Previous wording

Other Income (expense), net was approximately $0.4 million for the six months ended June 30, 2026, compared to approximately $0.5 million for the same period last year. The decrease in other income was primarily due to a decrease in interest income of approximately $0.1 million.

Current wording

Other expense was approximately $25,000 for the nine months ended September 30, 2026, compared to other income of approximately $0.8 million for the same period last year. The decrease in other income was primarily due to a $0.6 million change in the fair value of common warrant liability, due to an increase of the warrant liability expense attributed by an increase in our stock price and a decrease in interest income including other miscellaneous expenses of approximately $0.2 million.

Previous wording

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

Current wording

From our inception through September 30, 2026, we had raised an aggregate of $84.9 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in registered and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $76.0 million. As of September 30, 2026, we had cash and cash equivalents of $10.4 million.

Previous wording

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

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. For the nine months ended September 30, 2026, we recorded a net loss of $10.1 million and an accumulated deficit of $71.5 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the near future, although that is an important goal for our commercial efforts. We also expect to incur losses from our clinical activities until revenues from RenovoCath sales grow and outpace cash and non-cash expenses. Losses may also continue until regulatory approval is granted for our lead product candidate, IAG, and until IAG is commercially launched and revenues are generated from sales of IAG, all of which, with respect to IAG, will not occur for several years. We face the risk that commercial sales of RenovoCath will not grow as anticipated, and regulatory approval of IAG is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements. No assurances can be made that we will pursue these strategies, and even if we do, there is a risk that we will be unable to generate revenue from such activities.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Since our inception, we have been primarily a clinical stage company working on the development of IAG, and our principal sources of liquidity have been for the financing transactions we have undertaken as described above. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we generated revenue in the fourth quarter of 2024. We have since grown our RenovoCath revenues, and our goal is to grow revenues from our RenovoCath commercialization efforts over time. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generate meaningful revenues, of which no assurances can be given.

Previous wording

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

Current wording

Our primary uses of cash are to fund our operations including research and development, commercialization of our RenovoCath as a standalone device and selling, general and administrative expenses. We will continue to incur operating losses in the future and expect that our research and development and selling, general and administrative expenses will continue to increase as we continue our research and development efforts with respect to clinical development of IAG and further develop our technology platform, commercializing RenovoCath and ensuring we are complying with the requirements of being a public company (including following our loss of emerging growth company status as of December 31, 2026). The cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

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

Current wording

Cash used in operating activities for the nine months ended September 30, 2026, reflected a net loss of $10.1 million, offset by non-cash charges of approximately $1.7 million, and a net change in our operating assets and liabilities of $0.7 million.

Previous wording

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

Current wording

Cash used in operating activities for the nine months ended September 30, 2025, reflected a net loss of $8.2 million, offset by non-cash charges of $0.6 million, and a 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, 2026, consisted of $71,000 for the purchase of property and equipment.

Current wording

Cash used in investing activities for the nine months ended September 30, 2026, consisted of $90,000 for the purchase of property and equipment.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $12.6 million, consisting primarily of net proceeds from the March 2026 private placement and proceeds of $3.5 million from warrant exercises in August and September 2026.

Previous wording

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

Previous wording

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our 2025 Annual Report.

Current wording

The accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed interim financial statements and the related disclosures, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed interim financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Previous wording

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the six months ended June 30, 2026, from those previously disclosed in our 2025 Annual Report.

Current wording

There have been no significant changes to our critical accounting policies or significant judgments and estimates for the nine months ended September 30, 2026, from those previously disclosed in our 2025 Annual Report.