RenovoRx, Inc.
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001493152-24-045137
Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001641172-25-010935
Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 104 previous paragraphs and 98 current paragraphs.
33 unchanged; 27 reworded; 36 added; 42 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 8 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (36)
Current report
As used herein, the term “common stock” refers to our common stock, par value $0.0001 per share.
Current report
We are both a clinical stage and a commercial stage enterprise. Our clinical stage lead product candidate is a novel drug-device combination product consisting of intra-arterial delivery of the chemotherapy gemcitabine via RenovoCath -- we refer to our lead product candidate herein as “IAG.” IAG is currently the subject of a Phase III clinical study for the treatment of locally advanced pancreatic cancer (“LAPC”). At the same time, we are commercializing RenovoCath for standalone use by interventional radiologists, oncologists, and other medical professionals who can use RenovoCath to treat patients within its FDA-cleared fields of use.
Current report
Commercialization of RenovoCath
Current report
For the past several years, we have focused our efforts on progressing IAG through clinical trials. However, based on organic demand from doctors in the field who have become familiar with our technology, in 2024, we made the decision to launch an effort to commercialize our RenovoCath delivery device as a standalone device within its FDA cleared uses. Commenced in the field in the fourth quarter of 2024, this commercial effort has already begun to achieve positive results, including our first commercial sales revenue. To accommodate increased need for RenovoCath supply, we expanded our relationship with our U.S.-based third-party RenovoCath manufacturer, Medical Murray, Inc.
Current report
We are encouraged by the strong organic demand we are seeing for RenovoCath. In December 2024, we announced that over ten medical institutions had initiated the process for RenovoCath purchase orders, and in February 2025, we announced additional purchase orders received from several esteemed, high volume National Cancer Institute-designated centers and that utilization of RenovoCath devices by our initial customers led to repeat purchase orders. Further, we believe the approximately twenty cancer centers that have used RenovoCath as part of our ongoing Phase II trial could also be potential customers for RenovoCath after completion of trial enrollment, anticipated for later in 2025.
Current report
We have begun to generate revenue through sales of our RenovoCath devices, and our goal is to significantly increase these revenues over time. Importantly, we believe our current commercial strategy can be accomplished without a material increase in our capital expenditures, regardless of whether we self-commercialize or choose to partner with a larger organization with an existing sales force. We are actively exploring potential commercial sales partners for RenovoCath, which will allow us to determine in the coming quarters which RenovoCath sales strategy, or combination of strategies, will be most beneficial to us.
Current report
Following our late 2024 commercial launch, we continued to generate revenues from RenovoCath sales. In the first quarter ended March 31, 2025 we generated revenue of $197,000 from RenovoCath sales and anticipate sequential quarter over quarter increases in revenue during the remainder of 2025.
Current report
However, we are at the beginning of our RenovoCath commercialization efforts and have not had to recognize revenue from our operations in the past. A primary goal from these efforts is to generate and recognize revenue from RenovoCath sales. Revenue recognition under generally accepted accounting principles requires subjective judgements to be made by our management and could otherwise be complex and create uncertainties, including uncertainties arising from varying terms of sale we may offer to different customers. We may also be required to defer recognition of revenues until certain conditions are met. See “Components of Our Results of Operations – Revenue” below for further information.
Current report
Based on our internal assumptions, we believe that our initial total U.S. addressable market based solely on the initial clinical interest we have received for RenovoCath could represent an estimated $400 million peak annual U.S. sales opportunity. Our current assumptions regarding our initial addressable market include: (i) pressure-mediated delivery catheters on the market today, which are analogous to RenovoCath, have an average selling price of $6,500-$8,500 per unit; (ii) approximately 7,000 initial target patients at peak market penetration(meaning patients with whom we have experience through our clinical work, without the potential to expand indications beyond LAPC); and (iii) an average of approximately 8 annual procedures per patient. Beyond this initial market, we believe there are expansion opportunities across other indications that could create a several billion-dollar market potential for RenovoCath over time.
Current report
Our Ongoing Pivotal Phase III Trial for IAG
Current report
In parallel to our RenovoCath commercialization efforts, we are completing enrolment in our ongoing Phase III randomized multi-center clinical trial (called TIGeR-PaC) to investigate IAG for the treatment of LAPC. This trial is being conducted under a U.S. Investigational New Drug (“IND”) application that is regulated by the FDA’s 21 CFR 312 pathway. IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon approval by the FDA.
Current report
Our initial interim data from the TIGeR-PaC study, announced in March 2023, showed that patients experienced a median overall survival of 16 months, compared to 10 months from the time of randomization following a 5.5 month induction phase prior to randomization, for patients receiving standard systemic chemotherapy. Moreover, we observed a 65% reduction in adverse events such as nausea and fatigue, significantly improving patient quality of life. These results strengthen our conviction that TAMP can redefine outcomes for patients facing some of the most difficult-to-treat cancers.
Current report
The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of May 2, 2025, 91 patients have been randomized and 56 events have occurred, triggering the second pre-planned interim analysis per the statistical analysis plan. We expect the study’s Data Monitoring Committee to review the data in the third quarter of 2025 and look forward to their recommendation regarding the continuation of the study and their guidance on interpretation and data-sharing of the second interim analysis.
Current report
Cash Resources, History of Losses and Planned Activities
Current report
Due to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we will likely be required to raise additional capital at some point to continue the commercialization of RenovoCath and complete the development of and gain regulatory approval for IAG or any other of our future potential product candidates. We have historically financed our operations primarily through private and public sales of our equity (including warrants to purchase common stock). To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms, or at all.
Current report
As a result, we are faced with the risk of requiring 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 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 report
In December of 2024, we began to derive revenue through the sale of our RenovoCath device on a standalone basis directly to end users (i.e., hospitals and cancer treatment centers). We consider customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. Our contracts with customers typically contain a single performance obligation, which is the delivery of the RenovoCath device. We recognize revenue from sales of products at the point in time that the customer obtains control, which is typically based upon the terms of delivery. In determining the transaction price, we evaluate whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The only type of variable consideration we offer is limited return rights relating primarily to product damage or defects identified upon receipt, and therefore we expect minimal returns. Returns are estimated taking into consideration several factors including these limited product return rights, historical return activity, and other relevant factors. We have not experienced any commercial product returns to date, and accordingly no allowance for returns was recorded for the period ended March 31, 2025.
Current report
Cost of Revenue
Current report
Cost of revenue consist of costs associated with the sales of RenovoCath devices and were disaggregated between the cost of devices expensed in prior periods as part of our clinical trial as research and development and the cost from our primary third-party manufacturer, Medical Murray, Inc. (the “CMO”). Prior to our commercialization strategy, all costs of manufacturing to produce the devices were allocated to our TIGeR-PaC Phase III clinical trial study in prior periods and expensed as research and development. The cost of revenue associated with the TIGeR-PaC study was recorded at zero-costs. The cost of revenue for devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices including shipping and handling fees when applicable.
Current report
Research and Development
Current report
Selling, General and Administrative
Current report
Other Income
Current report
Revenue
Current report
We recognized approximately $197,000 of revenue from sales of RenovoCath for the three months ended March 31, 2025, compared to no revenue for the same period last year as we only launched initial commercial sales activity for RenovoCath during the latter part of 2024. The quarter ended March 31, 2025 marked our first full quarter of revenue generation from RenovoCath sales, following an initial recognition of approximately $43,000 of RenovoCath-related revenue in the fourth quarter of 2024. We expect to grow revenue from RenovoCath sales on a sequential quarter-by-quarter basis for the remainder of 2025.
Current report
Cost of Revenue
Current report
Cost of revenue was approximately $94,000 for the three months ended March 31, 2025, compared to no cost of revenue for the same period last year. Cost of revenue consist of costs associated with the sales of RenovoCath devices and were disaggregated between the cost of devices expensed in prior periods as part of our clinical trial as research and development and the cost from our third-party CMO. Prior to our commercialization strategy, all costs of manufacturing to produce the devices were allocated to our TIGeR-PaC clinical trial study in prior periods and expensed as research and development. The cost of revenue associated with the TIGeR-PaC study were recorded at zero-costs. The cost of revenue for devices not associated with the TIGeR-PaC study represents the total costs to manufacture the device based on time and materials to produce the devices at approximately $90,000 including shipping and handling fees of $4,000.
Current report
Research and Development
Current report
Research and development expenses were approximately $1.7 million for the three months ended March 31, 2025, compared to $1.3 million for the same period last year, an increase of $0.4 million. The period-over-period increase in research and development expenses is primarily driven by an increase in employee and related benefit costs of $0.1 million primarily due to an increase in salaries due to cost-of-living allowance. Manufacturing and non-recurring engineering costs to scale manufacturing increased by $0.1 million to support the commercial effort on our RenovoCath delivery system. Clinical, oncology and interventional radiology conferences and other scientific trade shows activities increased by $0.1 million including other research and development activities of $0.1 million. We expect research and development expenses to increase during 2025 as we continue our commercialization activities for our RenovoCath device and progress our Phase III TIGeR-PaC clinical trial study for IAG.
Current report
Selling, General and Administrative
Current report
Selling, general and administrative expenses were approximately $1.6 million for the three months ended March 31, 2025, compared to $1.2 million for the same period last year, an increase of approximately $0.4 million. The period-over-period increase in selling, general and administrative expenses is primarily driven by an increase in head count and employee and related benefit costs of $0.1 million. Professional and consulting increased by $0.2 million compared to the same period last year, primarily due to support of the commercialization strategy including other selling, general and administrative expenses of $0.1 million. We anticipate selling, general and administrative expenses to increase during 2025 as we progress with our commercialization activities for our RenovoCath device.
Current report
Other Income
Current report
We have incurred significant losses and negative cash flows from operations since our inception. For the three months ended March 31, 2025, we recorded a net loss of $2.4 million and an accumulated deficit of $52.6 million. Depending on our commercialization efforts with RenovoCath, we do not expect to generate positive cash flows from operations until we generate sufficient revenues from RenovoCath sales, which we may be unable to achieve. We also expect to incur losses from our clinical activities until regulatory approval is granted for our first product candidate, IAG. Regulatory approval is not guaranteed and may never be obtained. We may also pursue other revenue-generating strategies such as licensing or collaboration agreements or commercializing RenovoCath on a standalone basis. No assurances can be made that we will pursue these strategies, and even if it does, there is a risk that we will be unable to generate revenue from such activities.
Current report
We believe we will be able to raise additional required capital when needed through debt financings, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. There can be no assurance that such financing will be available when needed or will be at terms acceptable to us. The inability to raise capital as and when needed would have a negative impact on our liquidity, financial condition and its ability to pursue its business strategy. We will need to generate significant revenue from commercial sales of RenovoCath or otherwise to achieve positive cash flow or profitability, and we may never do so.
Current report
On February 10, 2025, we closed the February 2025 Offering and received gross proceeds of approximately $12.1 million. The net proceeds were $10.8 million after deducting underwriting fees of $0.8 million and other professional expenses of $0.5 million. In connection with the offering, we issued an aggregate 11,523,810 shares of common stock and underwriter warrants to purchase 576,191 shares of common stock at $1.21 per share over a 5-year term.
Current report
Since our inception, we have been primarily a clinical stage company on our clinical development stage lead product candidate, novel drug-device combination product consists of IAG via RenovoCath for the treatment of LAPC. In 2024, we made the decision to launch an effort to commercialize our RenovoCath device as a standalone product within its FDA-cleared fields of use and upon our initial commercialization launch of RenovoCath, we started to generate revenue in the fourth quarter of 2024. We anticipate continuing to generate revenue from RenovoCath sales in 2025 with anticipated sequential quarter over quarter increases in revenue during the year, which would support our liquidity. However, we have incurred significant operating losses and negative cash flows from operations and we anticipate that we will continue to incur net losses until our RenovoCath commercial efforts generates meaningful revenues, of which no assurances can be given.
Current report
Cash Used in Investing Activities
Removed paragraphs (42)
Previous report
Our lead product candidate is a novel oncology drug-device combination product and is being investigated under a U.S. Investigational New Drug (“IND”) application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath®, our FDA-cleared device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
Previous report
The intra-arterial infusion of the chemotherapy, gemcitabine, utilizing RenovoCath is currently being evaluated for the treatment of locally advanced pancreatic cancer (“LAPC”) by the Center for Drug Evaluation and Research (the drug division of FDA) in our ongoing Phase III TIGeR-PaC randomized multi-center clinical trial.
Previous report
Further, as described further below under “Other Potential Opportunities for RenovoCath,” we are also actively exploring other commercialization strategies utilizing our TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device.
Previous report
Intra-arterial Infusion of Gemcitabine with RenovoCath: Clinical Process to Date
Previous report
Systemic (IV gemcitabine and nab-paclitaxel) chemotherapy is currently the standard of care for pancreatic cancer treatment. However, it is known to cause debilitating side effects for patients diagnosed with this disease. Unlike other tumors with extensive blood supply, pancreatic tumors have poor blood supply so systemic chemotherapy may not adequately reach the tumor. Thus, the standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting systemic administration of chemotherapy to the tumor.
Previous report
We have completed our RR1 Phase I/I and RR2 observational registry studies for RenovoCath with gemcitabine, with 20 and 25 patients respectively, in LAPC. In the 35 pooled patients evaluable in these two studies, 9 patients pretreated with radiation followed by treatment with RenovoCath with gemcitabine experienced a median Overall Survival (“OS”) of 27.1 months. Based on previous large randomized clinical trials, the expected survival of LAPC patients is 12.0 to 18.8 months in patients receiving only IV systemic chemotherapy or IV chemotherapy plus radiation (which are both considered standard of care). Unlike the randomized trials that established these standard of care results, our RR1 and RR2 clinical trials did not prospectively control the standard of care therapy received prior to administration of RenovoCath with gemcitabine. Based on FDA safety review of our Phase I/II study, the FDA allowed us to proceed to evaluate RenovoCath with gemcitabine within our Phase III TIGeR-PaC clinical trial.
Previous report
Ourongoing Phase III TIGeR-PaC clinical trial, a randomized, multi-center study, is evaluating RenovoRx’s first product candidate, using TAMP, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of gemcitabineto treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares the treatment of LAPC using RenovoCath with gemcitabine versus systemic IV administration of gemcitabine and nab-paclitaxel.
Previous report
Our protocol for TIGeR-PaC involves systemic chemotherapy and SBRT during the induction phase of the study (prior to randomization). Patients receiving SBRT during the induction phase are required to complete 5 treatments, over 5 consecutive days, and do not receive oral chemotherapy vs. previously utilized intensity-modulated radiation therapy (“IMRT”) where patients must complete 25 radiation treatments in combination with oral chemotherapy during the induction phase of the study, which takes between 35 and 56 days to complete. In December 2021, we amended our protocol and statistical analysis plan for TIGeR-PaC (the “Modified SAP”) to (i) enroll and analyze only patients receiving SBRT during the induction phase, (ii) include a second interim analysis, (iii) change the total number of patients randomized in the study to 114 with a total of 86 deaths from SBRT patients, and (iv) repower the study from 90% to 80%,The change to the 80% power calculation aligns with common practice for clinical trials and, we believe this design will shorten the timeframe needed to complete the study, as well as significantly decrease our costs. We have not discussed the protocol amendment or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will agree with these modifications, but these modifications have been submitted to the FDA.
Previous report
The first interim analysis in the TIGeR-PaC study at the 26 th event of the specified events (deaths), was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study’s primary endpoint is an OS benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52 nd event, which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. We are also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.
Previous report
Our TAMP Therapy Platform
Previous report
Our patented TAMP therapy platform is focused on optimizing drug concentration in solid tumors by delivering oncology therapies with our RenovoCath delivery system. TAMP is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. Specifically, our patented approach enables physicians to pre-treat patients with standard-of-care radiation therapy and utilize our RenovoCath delivery system to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor.
Previous report
We believe there are many advantages to our TAMP therapy platform, including:
Previous report
We received our first FDA 510(k) clearance for RenovoCath in 2014, a second clearance to use the RenovoCath for infusion of chemotherapy agents in 2017, a further clearance to use RenovoCath with a power-injector in 2019, and a fourth clearance in 2021 to expand vessel diameter range to 3-11 mm, implement certain changes in the Instructions for Use, change the recommended saline to contrast solution ratio, among other changes and improvements.
Previous report
In a further validation of our TAMP platform, last year, we announced a collaboration with Imugene(ASX: IMU)to explore expansion of our TAMP product pipeline with Imugene’s CF33 oncolytic virus therapy for the treatment of difficult-to-access tumors. We are continually in discussions regarding similar collaborations and potentially out-licenses of RenovoCath with gemcitabine as we prepare for the NDA filing (assuming we meet our study endpoints) and commercialization of RenovoCath (if approved by FDA) as well as other collaborations with our TAMP platform.
Previous report
For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
Previous report
Other Potential Commercial Opportunities for RenovoCath
Previous report
In recent years, we have focused our efforts primarily on progressing RenovoCath with gemcitabine through our ongoing Phase III TIGeR-PaC study for LAPC. During this process, we have begun to explore other opportunities for our TAMP therapy platform.
Previous report
As a result of the introduction of our FDA-cleared RenovoCath delivery system as part of the TIGeR-PaC study and the resulting unsolicited (and subsequently solicited) feedback we have received from oncologists, surgeons, and interventional radiologists indicating increased demand for targeted delivery of diagnostic and/or therapeutic agents, during the first half of 2024, we began to actively explore a new opportunity to market and sell RenovoCath as a standalone device. RenovoCath is FDA-cleared and indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. We will engage in this potential revenue-generating activity either on our own or, more likely, in tandem with a commercial partner.
Previous report
In September 2024, we announced the signing of a new project work order with our RenovoCath contract manufacturing organization partner, Medical Murray Inc. of North Barrington, IL (the “CMO”), for an expanded relationship as we continue our exploration of commercial opportunities for RenovoCath beyond our currently ongoing clinical programs. To create performance incentives for our CMO, we have issued a warrant to purchase up to 709,500 shares of our common stock. This warrant vests and is only exercisable over time in tranches and only if the CMO achieves certain manufacturing milestones.
Previous report
Beyond LAPC, we believe there are many clinical applications for RenovoCath to improve targeted delivery of diagnostic and therapeutic agents. This leads us to a business development opportunity that would also likely engage in Phase IV post-market “registry” clinical studies of the RenovoCath delivery system to gather additional data to support both our clinical and commercial efforts. Securing the manufacturing capacity for this strategy with our CMO partner is a great first step. We are also in active discussions with many interested customers to purchase supplies of RenovoCath as well as potential distribution partners.
Previous report
We are increasing production of RenovoCath supplies through our CMO, and if we launch our commercial strategy as planned, we anticipate potential for near-term revenue in 2025. Without incremental revenues from this commercial strategy, we maintain sufficient cash on hand to achieve both our next interim read-out of our Phase III TIGeR-PaC study, which will be triggered by the 52nd event, estimated to occur in late 2024 or early 2025, and fund our current efforts for our RenovoCath go to market activities. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. We are also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.
Previous report
In parallel, we remain fully engaged and committed to the ongoing pivotal Phase III TIGeR-PaC clinical trial in LAPC. During 2024, we announced that additional renowned clinical oncology sites are now participating in the study with the goal of accelerating patient enrollment. We are progressing towards data, which could allow for a second interim readout in the trial and the potential filing of NDA with the FDA for RenovoCath with gemcitabine as a drug-device treatment in LAPC.
Previous report
Previous Fundraising and Anticipated Future Spending
Previous report
Since our inception, we have devoted substantially all our efforts to developing our cancer therapy platform and product candidates, raising capital and organizing and staffing our company. In January and April 2024, we raised additional funding in two private placements, offering shares of common stock and warrants to purchase shares of common stock for aggregate gross proceeds of $17.2 million. As of September 30, 2024, we have received over $59.2 million in aggregate gross proceeds and have financed our operations primarily through issuance of convertible preferred stock and convertible notes prior to our initial public offering, and securities issued in our August 2021 initial public offering, a registered direct offering with a single institutional investor in April 2023 (the “RDO”), common stock purchase warrants, the aforementioned January and April 2024 private placements, and a loan pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”). After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $5.8 million, our net offering proceeds to date are $53.4 million.
Previous report
Currently, we have not generated any revenue from product sales of our patented RenovoCath device or as a result of our TIGeR-PaC clinical study or any other clinical or sales efforts. If our development efforts for our current or future product candidates are successful and result in marketing approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration or license agreements. We may also pursue a strategy of commercializing our RenovoCath, as a standalone device as a means of generating revenue.
Previous report
Other Income (Expenses), Net
Previous report
Interest and Dividend Income (Expense), Net
Previous report
Interest expense consists of financing interest for the Directors and Officers liability insurance premiums.
Previous report
Change in Fair Value of Common Warrant Liability
Previous report
On March 27, 2020, the CARES Act was enacted. The CARES Act includes several significant provisions for corporations, including the usage of net operating losses (“NOLs”), interest deductions and payroll benefits. Corporate taxpayers may carryback NOLs originating during 2018 through 2020 for up to five years.
Previous report
Research and development expenses were approximately $1.7 million for the three months ended September 30, 2024, remaining relatively flat compared to the same period last year. Employee and related benefit costs increased $0.1 million including an increase of $0.1 million in clinical conferences and trade shows activities. This increase was partially offset by lower regulatory and clinical consulting costs and manufacturing for our proprietary catheter delivery device. We anticipate research and development expenses to increase as we increase manufacturing costs for our device and continue advancing our Phase III clinical trial study throughout the remainder of the year.
Previous report
General and administrative expenses were approximately $1.2 million for the three months ended September 30, 2024, a decrease of approximately $0.2 million compared to approximately $1.4 million for the same period last year. The decrease was primarily due to decreases of $0.2 million in professional and consulting fees, and legal fees, partially offset by an increase of $0.1 million in investor and public relations costs. We anticipate general and administrative expenses increasing moderately throughout the remaining year as we progress our commercialization activities for our RenovoCath device.
Previous report
Other Income/(Expense), Net
Previous report
Research and development expenses were approximately $4.4 million for the nine months ended September 30, 2024, a decrease of approximately $0.5 million, compared to approximately $4.9 million for the prior year period. The decrease was primarily due lower costs of $0.6 million on clinical, regulatory and clinical consulting costs from our ongoing Phase III clinical trial cost as we reduced expenses to conserve our cash runway in the first quarter and a decrease of $0.1 million in clinical conferences and trade shows, partially offset by an increase of $0.3 million in employee and related benefits costs. Our primary manufacturer company of our RenovoCath device commenced production this year as we implemented our commercialization and sale of our product candidate’s strategy. Allocated general and administrative support costs for personnel, facility and office supply expenses decreased by $0.1 million compared to the same period last year. We anticipate research and development expenses to increase as we progress our commercialization strategy, including our ongoing Phase III clinical trial study throughout the remainder of the year.
Previous report
General and administrative expenses were approximately $3.9 million for the nine months ended September 30, 2024, a decrease of approximately $0.8 million compared to approximately $4.7 million for the prior year period. The decrease was primarily due to a $0.3 million reduction in professional and consulting fees, a $0.1 million decrease in recruitment fees, a $0.2 million decrease in investor and public relations costs, a $0.2 million decrease in directors’ and officers’ liability insurance expense and a $0.1 million decrease in legal fees. The decrease was partially offset by lower allocated general and administration expenses to research and development of $0.1 million. We anticipate general and administrative expenses to increase slightly throughout the remaining year as we progress with our commercialization activities for our RenovoCath device.
Previous report
Other Income/(Expense), Net
Previous report
Other income/(expense), net was approximately $2.4 million for the nine months ended September 30, 2024, a decrease of approximately $0.2 million compared to approximately $2.6 million for the prior year period. The decrease was primarily due to a $1.0 million change in the fair value of the common warrant liability due to a decline in our common stock price during the nine months ended September 30, 2023 as compared to September 30, 2024. The decrease was offset by a $0.2 million increase in interest and dividend income from an increase in cash and cash equivalents related to the completion of two private placement financings completed earlier in the year and $0.6 million of transaction costs allocated to common warrant liability in the previous period.
Previous report
For the nine months ended September 30, 2024, we incurred a net loss of $5.9 million. As of September 30, 2024, our accumulated deficit stood at $47.3 million. We anticipate incurring further losses and increasing operating expenses in future periods.
Previous report
As of September 30, 2024, we have received over $59.2 million in gross proceeds through various financial arrangements to include the issuance of preferred stock, convertible debt, securities in our IPO, the RDO, private placements and various loans. After deducting underwriting discounts, commissions, placement fees, legal fees, and other professional expenses of $5.8 million, our net offering proceeds from these activities were $53.4 million.
Previous report
Based on our operational plans, we do not expect that our current cash and cash equivalents as of the date of this filing, will be sufficient to fund our operating, investing and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated. Based upon this review and the Company’s current financial condition, the Company has concluded that substantial doubt exists as to the Company’s ability to continue as a going concern. We believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, obtain a credit facility or other loan or at-the-market offering, collaborative agreements or other arrangements with other companies, or other sources of financing.
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Reworded paragraphs (27)
Previous wording
Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this Report, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023, which is included in our 2023 Annual Report.
Current wording
Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed interim condensed financial statements and related notes included elsewhere in this Report, our management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2024, which is included in our 2024 Annual Report.
Previous wording
We are a life sciences company developing novel targeted oncology therapies and offeringRenovoCath, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug-delivery platform, targeting high unmet medical needs. Our patentedTAMP therapy platform 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. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
Current wording
We are a life sciences company offeringRenovoCath®, a novel, U.S. Food and Drug Administration (“FDA”)-cleared local drug delivery device, targeting high unmet medical needs, with a present focus on difficult to treat cancers. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted therapeutic delivery.
Previous wording
We may also evaluate RenovoCath with gemcitabine as a potential therapy in other indications. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon NDA approval by the FDA.
Current wording
We may also evaluate RenovoCath with gemcitabine and other agents as a potential therapy in other indications.
Previous wording
We have incurred significant operating losses and generated negative cash flows from operations since our inception. As of September 30, 2024, we had cash and cash equivalents of $9.6 million. As of September 30, 2024, we had an accumulated deficit of $47.3 million. We expect to continue to incur significant expenses, increasing operating losses and negative cash flows for the foreseeable future. At the time we launch our commercial strategy, we anticipate to generate revenue from RenovoCath device sales via either on our own or, more likely, in tandem with a commercial partner our direct channel and/or collaborations, licensing arrangements or other strategic or commercial activities. Given economic and market conditions and the timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing research, development and potential commercialization 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 March 31, 2025, we had cash and cash equivalents of $14.6 million. We reported net losses of $2.4 million and $1.1 million for the three months ended March 31, 2025, and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $52.6 million. We expect to continue to incur significant expenses, operating losses and negative cash flows while we seek to grow our revenues from RenovoCath commercial sales. We will not generate revenues from IAG sales unless and until we successfully complete development and obtain regulatory approval for IAG or another product candidate. Given economic and market conditions and timing of regulatory approval, we expect that our expenses will increase in connection with our ongoing commercial, research and development activities, particularly if and when we decide to:
Previous wording
As a result, we will require significant additional funding to support our continuing operations. 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 our products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition to other commercial costs. We cannot reasonably estimate these costs at this time.
Current wording
In addition to the variables described above, if and when IAG or any of our other potential future product candidates successfully complete development and receive regulatory approval, we will incur substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition to other commercial costs. We cannot reasonably estimate these costs at this time.
Previous wording
Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operations. As a result, there is substantial doubt about our ability to operate as a going concern.
Current wording
Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material and adverse impact on our operations.
Previous wording
Our financial statements as of September 30, 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 do not expect that our current cash and cash equivalents as of the date of this filing, will be sufficient to fund our operating, investing and financing cash flow needs, assuming our programs advance as currently contemplated.
Current wording
Our condensed interim financial statements as of March 31, 2025 have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of this uncertainty. Based on our operating plans, we expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs through the second half of 2026, assuming our commercial strategy and our development programs advance as currently contemplated.
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 third-party vendors to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for our proprietary catheter delivery device RenovoCath, which comprises part of the RenovoGem product. 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 a portion of our research and development expenses. We expect our research and development expenses to increase for the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate new clinical trials and pursue regulatory approval of our product candidates. It is difficult to predict with any certainty the duration and costs of completing our current or future clinical trials of our product candidates or if, when or to what extent we will achieve regulatory approval and generate revenue from the commercialization and sale of our product candidates. The duration, costs and timing of clinical trials and other development of our product candidates will depend on a variety of factors, including uncertainties in clinical trial enrollment, timing and extent of future clinical trials, development of new product candidates and significant and changing government regulation. We may never succeed in achieving regulatory approval for any of our product candidates.
Current wording
Research and development expenses consist of costs related to the research and development of our TAMP technology and our ongoing clinical trial. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors and consultants. We outsource a substantial portion of our clinical trial activities, utilizing the service of third-party clinical trial sites and several clinical research vendors and consultants to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath delivery device, which comprises part of our IAG product candidate. Accordingly, we are able to charge our clinical trial sites for the RenovoCath delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices offset our research and development expenses. We expect our research and development expenses to increase for the foreseeable future as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate 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.
Previous wording
General and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrative functions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property other matters, consulting costs, conferences, travel, and allocated expenses for rent, insurance, and other general overhead costs. We expect to continue to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations of the Securities and Exchange Commission, or SEC, and Nasdaq listing standards and increased expenses in the areas of insurance, professional services and investor relations. As a result, we expect our general and administrative expenses to increase in the foreseeable future. General and administrative expenses are expensed as incurred.
Current wording
Selling, general and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance, commercial and administrative functions, professional services and associated costs related to accounting, tax, audit, legal, intellectual property and other matters, consulting costs, conferences, travel and allocated expenses for rent, insurance and other general overhead costs. We expect to continue to incur additional expenses as a result of operating as a public company, including costs to comply with the rules and regulations of the Securities and Exchange Commission, or SEC, and Nasdaq listing standards and increased expenses in the areas of insurance, professional services and investor relations. As a result, we expect our selling, general and administrative expenses to increase in the foreseeable future. Selling, general and administrative expenses are expensed as incurred.
Previous wording
Interest income and dividend income are earned from cash deposited in our short-term marketable securities and money market accounts.
Current wording
Interest income is earned from cash deposited in our short-term marketable securities and money market account.
Previous wording
Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the warrant liability associated with the April 2023 Warrant. The fair value per share of the April 2023 Warrant was $0.61 and $1.69 on September 30, 2024 and December 31, 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 $0.48 and $0.99 on March 31, 2025 and 2024, respectively. The decrease in the fair value was primarily due to the decrease in our stock price.
Previous wording
Other income/(expense), net was approximately $0.4 million for the three months ended September 30, 2024, a decrease of approximately $1.2 million compared to approximately $1.6 million for the in the same period last year. The decrease was primarily due to a $1.3 million change in the fair value of the common warrant liability offset by interest and dividend income of $0.1 million.
Current wording
Other income was approximately $0.7 million for the three months ended March 31, 2025, a decrease of approximately $0.7 million compared to approximately $1.4 million for the same period last year. The decrease was primarily due to a $0.8 million in the fair value of the common warrant liability offset by an increase in interest and dividend income of $0.1 million.
Previous wording
We have financed our operations from inception through the date of this Report primarily through the issuance and sale of an aggregate of $59.2 million from private placements of our convertible preferred stock, convertible debt securities prior to our August 2021 initial public offering, and the issuance of securities in our initial public offering, our RDO and other private placement offerings, various loans and the exercise of warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, net offerings were $53.8 million. During the first four months of 2024 alone, we raised new capital for aggregate gross proceeds of $17.2 million, to further advance our programs.
Current wording
From our inception through March 31, 2025, we have raised an aggregate of $71.4 million, primarily from private placements of convertible preferred stock, convertible debt securities, the issuance of securities in public and private placement offerings and the exercise of common stock warrants and common stock options. After deducting underwriting discounts and commissions, placement agent fees and other offering expenses, our net proceeds from these offerings were $64.3 million. As of March 31, 2025, we had cash and cash equivalents of $14.6 million. Based on our operational plans, we expect that our current cash and cash equivalents as of the date of this Report will be sufficient to fund our operating, investing and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated, including fully funding both our RenovoCath scale-up and the continued progress of our Phase III TIGeR-PaC clinical trial.
Previous wording
On April 3, 2023, we completed a RDO under our shelf registration statement on Form S-3 for the purchase and sale of 1,557,632 shares of common stock (or pre-funded common warrants) at a purchase price of $3.21 per share of common stock (or pre-funded warrants) to a certain institutional investor. Additionally, in a concurrent private placement, we issued to the investor common warrants to purchase up to 1,947,040 shares of our common stock. The aggregate gross proceeds from this RDO were $5.0 million, and the net offering proceeds were $4.4 million after deducting placement agent fees and placement agent’s expenses of $0.4 million and other professional expenses of $0.2 million.
Current wording
On April 3, 2023, we completed a registered direct offering (“RDO”) under our Shelf Registration Statement on Form S-3 for the purchase and sale of 1,557,632 shares of common stock (or pre-funded common warrants) at a purchase price of $3.21 per share of common stock (or pre-funded warrants) to a certain institutional investor. Additionally, in a concurrent private placement, we issued to the investor common warrants to purchase up to 1,947,040 shares of our common stock. The aggregate gross proceeds from this RDO were $5.0 million, and the net offering proceeds were $4.3 million after deducting placement agent fees and placement agent’s expenses of $0.4 million and other professional expenses of $0.3 million.
Previous wording
On April 11, 2024, we completed a second private placement offering, issuing common stock, pre-funded warrants, Series A warrants, and Series B warrants. The aggregate gross proceeds from this offer were $11.1 million, and the net offering proceeds were $9.7 million after deducting placement agent fees of $1.2 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, with us retaining the right to call these warrants under certain conditions. Additionally, we issued the April 2024 PA Warrants on the same date, exercisable for 701,243 shares of common stock 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 a second private placement offering, 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, with us retaining the right to call these warrants under certain conditions. Additionally, we issued the April 2024 PA Warrants on the same date, exercisable for 701,243 shares of common stock 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
Our ability to obtain additional required financing will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors in Part I item 1A on Form 10-K on our 2023 Annual Report.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.
Current wording
Our ability to obtain additional financing we may need in the future will be subject to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials, discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors” in our 2024 Annual Report. Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.
Previous wording
Our primary uses of cash are to fund our operations including research and development and general and administrative expenses. We will continue to incur operating losses in the future and expect that our research and development and general and administrative expenses will continue to increase as we continue our research and development efforts with respect to clinical development of our product candidates, further develop our therapy platform and ensure that 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 and selling, general and administrative expenses. We will continue to incur operating losses in the future and expect that our research and development and selling, general and administrative expenses will continue to increase as we continue our research and development efforts with respect to clinical development of our product candidates, further develop our therapy platform and ensure that we are complying with the requirements of being a public company. The cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Previous wording
The following table summarizes our cash flows for the period indicated (in thousands):
Current wording
The following table summarizes our cash flows for the periods indicated (in thousands):
Previous wording
Cash used in operating activities for the nine months ended September 30, 2024, reflected a net loss of $5.9 million and non-cash charges of $1.2 million, and offset by net change in our operating assets and liabilities of $0.4 million.
Current wording
Cash used in operating activities for the three months ended March 31, 2025, reflected a net loss of $2.4 million, non-cash charges of $0.3 million, and a net change in our operating assets and liabilities of $0.7 million.
Previous wording
Cash used in operating activities for the nine months ended September 30, 2023, reflected a net loss of $7.0 million and non-cash charges of $2.2 million, offset by a net change in our operating assets and liabilities of $1.0 million.
Current wording
Cash used in operating activities for the three months ended March 31, 2024, reflected a net loss of $1.1 million, offset by non-cash charges of $0.9 million, and a net change in our operating assets and liabilities of $0.2 million.
Previous wording
Cash provided by investing activities for the nine months ended September 30, 2023, consisted of $2.0 million from the sale of investments.
Current wording
Cash used in investing activities for the three months ended March 31, 2025, consisted of $0.2 million for the purchase of property and equipment.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $5.0 million, consisting primarily of proceeds from common stock and pre-funded common warrants.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $10.8 million, consisting primarily of net proceeds from the public equity offering.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.1 million, consisting primarily of net proceeds from two private placement offerings.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $5.4 million, consisting primarily of net proceeds from private placement offering.
Previous wording
There have been no significant changes in our contractual obligations or other commitments as of September 30, 2024.
Current wording
There have been no material changes in our contractual obligations or other commitments since we filed our 2024 Annual Report.
Previous wording
There have been no significant changes to our critical accounting policies or significant judgments and estimates for the nine months ended September 30, 2024, from those previously disclosed in our 2023 Annual Report.
Current wording
There have been no significant changes to our critical accounting policies or significant judgments and estimates for the three months ended March 31, 2025, from those previously disclosed in our 2024 Annual Report.
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 $1.235 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,
Current wording
We are an “emerging growth company” as defined in 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,
Previous wording
We have elected to take advantage of certain of the reduced disclosure obligations in this Quarterly Report on Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.
Current wording
We have elected to take advantage of certain of the reduced disclosure obligations in this Report on Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than what you might receive from other public reporting companies in which you hold equity interests.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Our RenovoCath device utilize our patentedTrans-Arterial Micro-Perfusion (“TAMP™”) therapy platform, which is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy, including chemotherapy. Our novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. RenovoCath is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. We hold a robust portfolio of 19 issued patents and 12 pending patents covering our TAMP technology.
Current report — wording carried from elsewhere
Change in Fair Value of Warrant Liability
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Comparison of the Nine Months Ended September 30, 2024, and 2023
Previous report — wording carried elsewhere
The following table summarizes the significant components of our results of operations for the periods presented (in thousands, except percentages):