RenovoRx, Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations for our fiscal year ended December 31, 2024 should be read in conjunction with the financial statements and related notes thereto included in Part II, Item 8, “Financial Statements and Supplementary Data,” of this Report. All information presented herein is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ended December 31 and the associated quarters, months and periods of those fiscal years.

Current wording

The following discussion and analysis of our financial condition and results of operations for our fiscal year ended December 31, 2025 should be read in conjunction with Item 1. Business and our financial statements and related notes thereto included in Part II, Item 8, “Financial Statements and Supplementary Data,” included elsewhere in this Annual Report on Form 10-K. All information presented herein is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ended December 31 and the associated quarters, months and periods of those fiscal years.

Previous wording

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc.

Current wording

Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. As used herein, the term “common stock” refers toour common stock, par value $0.0001 per share.

Previous wording

IAG our RenovoCath device utilize our patented Trans-Arterial Micro-Perfusion (‘TAMP™”) therapy platform, which is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy, Including traditional chemotherapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted therapeutic delivery RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

Current wording

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

Previous wording

We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of December 31, 2024, we had cash and cash equivalents of $7.2 million (although we raised an additional $10.9 million in net proceeds through a public offering completed in February 2025). We had net losses of $8.8 million and $10.2 million for the years ended December 31, 2024, and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $50.2 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 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 December 31, 2025, we had cash and cash equivalents of $7.0 million (although we raised an additional $10.0 million in gross proceeds through a private placement offering completed in March 2026). We had net losses of $11.2 million and $8.8 million for the years ended December 31, 2025, and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $61.4 million. We expect to continue to incur significant expenses as we seek to grow our revenues from RenovoCath commercial sales, reduce cash burn, and advance toward the goal of achieving cash-flow breakeven operations. As we work to achieve these goals, we expect to continue to incur operating losses. 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 could increase, particularly if and when we decide to:

Previous wording

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

Current wording

In addition to the variables described above, if and when IAG or any of our product candidates successfully complete development and FDA approval, we will incur substantial additional costs associated with establishing a distribution infrastructure and incur other expense needed to commercialize IAG as its own product, which will be in addition to the costs incurred and to be incurred in commercializing RenovoCath as a standalone device. We cannot reasonably estimate these costs at this time as we will not even achieve final results from our Phase III TIGeR-PaC clinical trial for IAG until 2027.

Previous wording

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

Current wording

Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, even after taking into account the $10.0 million in gross proceeds we received from our recent March 2026 private placement (the “March 2026 Private Placement”), we will likely be required to raise additional capital to complete the development of IAG (or any other product candidates) and expand commercialization of RenovoCath. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.

Previous wording

Our financial statements as of December 31, 2024 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 first half of 2026, assuming our programs advance as currently contemplated.

Current wording

Our financial statements as of December 31, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report (after taking into account the March 2026 Private Placement) will be sufficient to fund our operating, investing and financing cash flow needs for at least the next 12 months from the date of issuance of the report, assuming our programs advance as currently contemplated.

Previous wording

As a result, we will likely require significant additional funding to support our continuing operations. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations, licenses or other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would 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 financial statements, and our shareholders may lose their entire investment in our common stock.

Current wording

However, until such time, if ever, as we can generate substantial product revenue and generate positive cash flows, there is a risk that we may need to again finance our cash needs through private or public equity financings, debt financings and collaborations, licenses or other similar arrangements. We currently have no credit facility or committed sources of capital other than our “at-the-market” offering program through Jones Trading as sales agent (however, pursuant to the terms of the March 2026 Private Placement, we are prohibited from using such offering program 275 days from the effectiveness of the registration statement registering the securities issued in the March 2026 Private Placement). To the extent that we raise additional capital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would 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 financial statements, and our shareholders may lose their entire investment in our common stock.

Previous wording

In the fourth quarter of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers). 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 product returns to date, and accordingly no allowance for returns was recorded for the year ended December 31, 2024.

Current wording

In the fourth quarter of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers), and revenue generation from such activity continued for the entire year ended December 31, 2025. 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 product returns to date, and accordingly no allowance for returns was recorded for the year ended December 31, 2025.

Previous wording

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

Previous wording

Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and preclinical studies, are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by third party vendors.

Current wording

Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and animal studies, are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by third party vendors.

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 $0.78 and $1.69 on December 31, 2024 and 2023, 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 $0.31 and $0.78 on December 31, 2025 and 2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price combined with a shorter number of years remaining to the warrant expiration date,

Previous wording

Research and development expenses were $6.0 million for the year ended December 31, 2024 compared to $5.7 million for the year ended December 31, 2023, an increase of $0.3 million. The period-over-period increase in research and development expenses is primarily driven by $0.3 million increase in manufacturing and non-recurring engineering costs to scale manufacturing to support the commercial effort on our RenovoCath delivery system. Clinical development expenses decreased by $0.2 million, which includes a decrease in professional and consulting fees and our Phase III clinical trial study. Personnel expenses for employees and benefits increased by $0.3 million, which is primarily due to an increase in employee incentive compensation of $0.2 million. Regulatory expense decreased by $0.1 million primarily due to the reduction in consulting expenses. Cash payments made for use of RenovoCath delivery devices used in our Phase III clinical trial were relatively flat for the year ended December 31, 2024 compared to the previous year. Payments received from clinical trial sites for the devices have been adequate to cover our direct costs of manufacturing the RenovoCath delivery devices and to offset research and development expenses. 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 $6.3 million for the year ended December 31, 2025 compared to approximately $6.0 million for the year ended December 31, 2024, an increase of approximately $0.3 million. The period-over-period increase in research and development expenses is primarily driven by an increase in non-recurring engineering costs for the development of the next generation of our RenovoCath delivery system of $0.5 million and other research and development costs, primarily animal studies, of $0.1 million. This increase was offset by a decrease in selling, general and administrative expenses allocated to research and development of approximately $0.4 million. Clinical development increased $0.2 million from the same period in 2024 due to costs associated with our ongoing Phase III clinical trial study TIGeR-PaC and costs for our RR5 Registry study. Personnel expenses for employees and benefits increased by $0.1 million, which is primarily due to an increase in the number of employees. Regulatory expenses remained relatively unchanged from the same period last year. Cash payments made for use of RenovoCath delivery devices used in our Phase III clinical trial increase $0.2 million compared to the previous year. Payments received from clinical trial sites for the devices have been adequate to cover our direct costs of manufacturing the RenovoCath delivery devices and to offset research and development expenses. We anticipate research and development expenses to increase next year as we advance our clinical development of IAG and develop our next generation of RenovoCath device.

Previous wording

Selling, general and administrative expenses were $5.0 million for the year ended December 31, 2024 compared to $5.7 million for the year ended December 31, 2023, a decrease of $0.7 million. The period-over-period decrease in selling, general and administrative expenses was primarily attributable to a decrease in professional and consulting fees of $0.5 million, a decrease in directors and officers insurance of $0.2 million, and a $0.1 million increase in the allocation of selling, general and administrative expenses to research and development. Personnel expenses for employees and benefits increased by $0.2 million, which is primarily due to an increase in employee incentive compensation. Legal fees decreased by $0.2 million for the year ended December 31, 2024 compared to the previous year. The decrease was primarily due to transitioning to a new firm to lower expenses. We anticipate selling, general and administrative expenses to increase next year as we progress with our commercialization activities for our RenovoCath device.

Current wording

Selling, general and administrative expenses were approximately $7.0 million for the year ended December 31, 2025 compared to approximately $5.0 million for the year ended December 31, 2024, an increase of approximately $2.1 million. The period-over-period increase in selling, general and administrative expenses was primarily attributable to an increase in professional services and other of $1.3 million, comprising of $0.2 million in consulting services adopting policies and controls to remediate the material weakness; including increases in audit services in relation to registration statements and other professional expenses of $0.4 million; investor and public relations of $0.1 million; travel related expenses of $0.2 million; office and other expenses of $0.2 million; a decrease of $0.4 million in the allocation of selling, general and administrative expenses to research and development, offset by a decrease in directors and officers insurance of $0.2 million. Personnel expenses for employees and benefits increased by $0.6 million due to an increase in employee head count. Legal fees increased by $0.2 million for the year ended December 31, 2025 compared to the previous year. We anticipate selling, general and administrative expenses to increase next year as we progress with our commercialization activities for our RenovoCath delivery system, due primarily to increased hiring of sales and marketing personnel which is expected to continue.

Previous wording

Interest (Expense) Income, Net (in thousands)

Current wording

Interest Income, Net (in thousands)

Previous wording

Interest income was $0.4 million and $0.1 million for the years ended December 31, 2024 and 2024, respectively. Interest income represents income earned on excess operating cash invested in short-term U.S. Treasury bills. The increase of $0.3 million in interest income was due to an increase in our average cash balance held in U.S. Treasury bills primarily from the closing of two financings in early 2024.

Current wording

Interest income was approximately $0.4 million for the years ended December 31, 2025 and 2024. Interest income represents income earned on excess operating cash invested in short-term U.S. Treasury bills.

Previous wording

From our inception through December 31, 2024, we have raised an aggregate of $59.2 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 $53.5 million. As of December 31, 2024, the Company had cash and cash equivalents of $7.2 million (although we raised an additional $10.9 million in net proceeds through a public offering completed in February 2025). As used herein, the term “common stock” refers to the Company’s common stock, par value $0.0001 per share.

Current wording

From our inception through December 31, 2025, we had 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 December 31, 2025, the Company had cash and cash equivalents of $7.0 million (although we raised an additional $10.0 million in gross proceeds through the March 2026 Private Placement).

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. For the year ended December 31, 2024, we recorded a net loss of $8.8 million and an accumulated deficit of $50.2 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the foreseeable future. We also expect to incur losses from our clinical activities until regulatory approval is granted for its 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 marketing its proprietary catheter device 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. For the year ended December 31, 2025, we recorded a net loss of $11.2 million and an accumulated deficit of $61.4 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations in the foreseeable future. We also expect to incur losses from our clinical activities until regulatory approval is granted for its 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 marketing its proprietary catheter device 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

On November 10, 2022, we filed an omnibus shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules. On February 10, 2025, we closed a public offering subject to the baby-shelf limitations rules and raised an aggregate of $12.1 million (see “Note 14. Subsequent Events” in notes to the accompanying financial statements). As a result of such offering, we presently have very little capacity under such omnibus shelf registration statement.

Current wording

On November 14, 2025, we filed a shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million of our securities subject to various limitations, including limited sales in any twelve-month period while the Company is subject to the “baby-shelf” rules.

Previous wording

On January 26, 2024, we completed a private placement to 92 accredited investors with gross proceeds of $6.1 million before deducting placement agent fees and other offering expenses of approximately $0.7 million. In this private placement, we issued 6,133,414 shares of common stock and common stock warrants to purchase up to an aggregate of 6,133,414 shares of common stock, which expire five years on January 26, 2029. In connection with such private placement, we entered into a placement agent agreement as additional compensation to the placement agent, and issued common stock warrants to purchase up to an aggregate of 511,940 shares of common stock (the “January 2024 PA Warrants”), which warrants expire five years from the issuance date. The significant majority of the warrants issued in this private placement have an exercise price of $0.99 per share. The warrants purchased by our directors, officers, employees and consultants in this private placement have an exercise price of $1.22 per share.

Current wording

On January 26, 2024, we completed a private placement to 92 accredited investors with gross proceeds of $6.1 million before deducting placement agent fees and other offering expenses of approximately $0.7 million. In this private placement, we issued 6,133,414 shares of common stock and common stock warrants to purchase up to an aggregate of 6,133,414 shares of common stock, which expire five years on January 26, 2029. In connection with such private placement, we entered into a placement agent agreement as additional compensation to the placement agent, and issued common stock warrants to purchase up to an aggregate of 511,940 shares of common stock, which warrants expire five years from the issuance date. The significant majority of the warrants issued in this private placement have an exercise price of $0.99 per share. The warrants purchased by our directors, officers, employees and consultants in this private placement have an exercise price of $1.22 per share.

Previous wording

On April 11, 2024, we completed another private placement offering to 172 accredited investors, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offering were $11.1 million, and the net offering proceeds were $9.6 million after deducting placement agent fees of $1.3 million and other professional expenses of $0.2 million. In conjunction with the issuance of 6,960,864 shares of common stock, we bundled the offering with: (i) a pre-funded warrant exercisable for 951,500 shares of common stock at an exercise price of $0.0001 per share, with an unlimited term and immediate exercisability upon issuance, subject to specific beneficial ownership limitations; (ii) Series A warrants exercisable for 7,912,364 shares of common stock at $1.22 per share, valid for 5 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations; (iii) Series B warrants exercisable for 3,956,182 shares of common stock at $1.22 per share, valid for 2 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations. We have the right to call the Series B warrants under certain conditions. Additionally, as compensation to the placement agent, we issued warrants on the same date to purchase up to an aggregate of 701,243 shares of common stock (the “April 2024 PA Warrants”) at $1.69 per share over a 5-year term, with provisions for cashless exercise if the shares are unregistered or no current prospectus is available for resale. The April 2024 PA Warrants become exercisable on October 11, 2024, subject to specific beneficial ownership limitations and customary adjustments.

Current wording

On April 11, 2024, we completed another private placement offering to 172 accredited investors, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offering were $11.1 million, and the net offering proceeds were $9.6 million after deducting placement agent fees of $1.3 million and other professional expenses of $0.2 million. In conjunction with the issuance of 6,960,864 shares of common stock, we bundled the offering with: (i) a pre-funded warrant exercisable for 951,500 shares of common stock at an exercise price of $0.0001 per share, with an unlimited term and immediate exercisability upon issuance, subject to specific beneficial ownership limitations; (ii) Series A warrants exercisable for 7,912,364 shares of common stock at $1.22 per share, valid for 5 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations; and (iii) Series B warrants exercisable for 3,956,182 shares of common stock at $1.22 per share, valid for 2 years and immediately exercisable subject to customary adjustments and beneficial ownership limitations. We have the right to call the Series B warrants under certain conditions. Additionally, as compensation to the placement agent, we issued warrants on the same date to purchase up to an aggregate of 701,243 shares of common stock (the “April 2024 PA Warrants”) at $1.69 per share over a 5-year term, with provisions for cashless exercise if the shares are unregistered or no current prospectus is available for resale. The April 2024 PA Warrants become exercisable on October 11, 2024, subject to specific beneficial ownership limitations and customary adjustments.

Previous wording

On February 6, 2025, we entered into an underwriting agreement to investors pursuant to our shelf registration while subject to the baby-shelf rules. The financing closed on February 10, 2025, and we raised aggregate gross proceeds of $12.1 million. In connection with the offering, we sold to investors an aggregate of 11,523,810 shares of common stock. In connection with the closing of the offering, we issued to the underwriter warrants, as partial compensation for the underwriter’s services, and issued 576,191 common stock warrants expiring five years from the closing date. See “Note 14. Subsequent Events” in Notes to Financial Statements.

Current wording

On February 10, 2025, we completed an underwriting offering to investors pursuant to our shelf registration while subject to the baby-shelf rules. The aggregate gross proceeds from the offering were $12.1 million after deducting underwriter's fees and other professional expenses of $1.3 million. In connection with the offering, we sold to investors and aggregate of 11,523,810 shares of common stock and we issued 576,191 common warrants, as partial compensation for the underwriter's services, expiring five years from the closing date.

Previous wording

As of the date of this Report, we believe that we have sufficient cash resources, including our shelf closing in February 2025 as described below, to allow us to fund our operating, investing and financing cash flow needs at least through the first half of 2026. The accompanying audited 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 audited financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if we are unable to continue as a going concern.

Current wording

As of the date of this Report, we believe that we have sufficient cash resources, including our private placement closing in March 2026 described above, to allow us to fund our operating, investing and financing cash flow needs through at least the next 12 months. The accompanying audited 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 audited 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

We have (including our public offering closing in February 2025 as described under Sources of Liquidity below) and believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials 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 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 have and believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances that such financing will be available if and when needed, or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials 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 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

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 intra-arterial delivery of gemcitabine (“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 generated revenue in the fourth quarter of 2024. We anticipate generating revenues from our RenovoCath commercialization efforts in 2025 with an anticipated quarter over quarter increase in revenue during the year. 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 IAG, our clinical development stage lead product candidate, a novel drug-device combination product for the treatment of LAPC. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we generated revenue in the fourth quarter of 2024. Our goal is to grow revenues from our RenovoCath commercialization efforts in 2026. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generate meaningful revenues, of which no assurances can be given.

Previous wording

Net cash used in operating activities was $9.1 million for the year ended December 31, 2024, which was primarily attributable to our net loss of $8.8 million and non-cash charges of $0.6 million, adjusted for net changes in operating assets and liabilities of $0.3 million. Noncash charges included primarily stock-based compensation expense, and gain on the fair value of common stock warrants. Net cash used in operating activities for the year ended December 31, 2023 reflected a net loss of $10.2 million and noncash charges of $0.6 million, adjusted for net changes in operating assets and liabilities of $0.6 million. Noncash charges included primarily of stock-based compensation expense, and a gain on the fair value of common stock warrants.

Current wording

Net cash used in operating activities was $11.0 million for the year ended December 31, 2025, which was primarily attributable to our net loss of $11.2 million and non-cash charges of $0.4 million, adjusted for net changes in operating assets and liabilities of $0.2 million. Noncash charges included primarily stock-based compensation expense, gain on the fair value of common stock warrants and lease expense. Net cash used in operating activities for the year ended December 31, 2024 reflected a net loss of $8.8 million and noncash charges of $0.6 million, adjusted for net changes in operating assets and liabilities of $0.3 million. Noncash charges included primarily stock-based compensation expense, and a gain on the fair value of common stock warrants.

Previous wording

Net cash used in investing activities for the year ended December 31, 2024 was $12,000 consisting of purchase of property and equipment. Net cash provided by investing activities for the year ended December 31, 2023 was $2.0 million consisted of proceeds of U.S. Treasury bills, which are classified as available-for-sale securities.

Current wording

Net cash used in investing activities for the year ended December 31, 2025 was 2,000 compared to $12,000 consisting of purchase of property and equipment for the year ended December 31, 2024.

Previous wording

Net cash provided by financing in the year ended December 31, 2024 was $15.1 million, consisting primarily of the two private placements for net proceeds of approximately $15.0 million and proceeds from exercise of stock options and common stock warrants of $0.1 million. Net cash provided by financing in the year ended December 31, 2023 was $5.0 million, consisting primarily of proceeds of $5.0 million from the issuance of common stock in our RDO.

Current wording

Net cash provided by financing for the year ended December 31, 2025 was $10.8 million, consisting primarily of gross proceeds of approximately $12.1 from investors pursuant to our shelf registration less issuance costs of $1.3 million. Net cash provided by financing in the year ended December 31, 2024 was $15.1 million, consisting primarily of the two private placements for net proceeds of approximately $15.0 million and proceeds from exercise of stock options and common stock warrants of $0.1 million.

Previous wording

In October 2024, we entered into a 36-month lease agreement, commencing on December 1, 2024, non-cancelable operating lease consisting of approximately 1,900 rentable square feet of office space in Mountain View, California. The lease has a one-time option to renew the term for an extension period of 36 months, see “Note 6. Leases, Commitments and Contingencies” in Notes to Financial Statements. Other than the new lease in October 2024, there have been no significant changes in our contractual obligations or other commitments as of December 31, 2024.

Current wording

In October 2024, we entered into a 36-month lease agreement, commencing on December 1, 2024, non-cancelable operating lease consisting of approximately 1,900 rentable square feet of office space in Mountain View, California. The lease has a one-time option to renew the term for an extension period of 36 months, see “Note 6. Leases, Commitments and Contingencies” in Notes to Financial Statements.

Previous wording

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.07 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

Current wording

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of (1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,