Core Insights - RenovoRx, Inc. reported a quarterly loss of $0.08 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.10 per share a year ago [1] - The company generated revenues of $0.27 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 35.12%, while revenues were zero a year ago [2] - RenovoRx shares have declined approximately 22.5% year-to-date, contrasting with the S&P 500's gain of 16.5% [3] Company Performance - The earnings outlook for RenovoRx is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.08 on revenues of $0.48 million, and -$0.31 on revenues of $1.51 million for the current fiscal year [7] - The company has surpassed consensus EPS estimates only once in the last four quarters [1] Industry Context - The Medical - Biomedical and Genetics industry, to which RenovoRx belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact RenovoRx's stock performance [5]

Financial Data and Key Metrics Changes - For Q3 2025, RenovoRx reported revenues of approximately $266,000, contributing to a total of approximately $900,000 for the first nine months of 2025 [20][21] - Research and development expenses were $1.7 million, reflecting ongoing investment in the TIGeR-PaC trial and other studies [20] - Selling, general, and administrative expenses were also $1.7 million, indicating stable operating expenses while expanding commercial capabilities [20] Business Line Data and Key Metrics Changes - The RenovoCath device has seen a significant increase in adoption, expanding from five approved centers at the beginning of 2023 to 14 centers by Q3 2025, with five centers already using the device and making repeat orders [9][10] - The company anticipates a peak U.S. market opportunity of approximately $400 million annually for RenovoCath as a standalone device, with potential for several billion dollars as it expands into other tumor types [12] Market Data and Key Metrics Changes - The company has established a geographically diverse network of clinical institutions using and interested in TAMP, including leading academic institutions and high-volume community hospitals [10] - Physician feedback indicates benefits of targeted drug delivery with TAMP, including reduced systemic chemotherapy toxicity and improved patient quality of life [10] Company Strategy and Development Direction - RenovoRx aims to integrate its TAMP technology into the standard of care for cancer treatment, focusing on improving patient outcomes through targeted and tolerable treatment options [6][12] - The company is committed to maintaining fiscal discipline while scaling its commercial foundation and preparing for broader adoption [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early signs of clinical adoption and the potential for revenue growth, emphasizing the importance of a lean operating structure [8][12] - The company is focused on strategic data-driven expansion and believes that its commercial growth strategy positions it for long-term success [12] Other Important Information - As of September 30, 2025, RenovoRx had over $10 million in cash and cash equivalents, which is expected to fund ongoing commercialization efforts and the completion of the TIGeR-PaC trial [13][21] - The company is exploring multiple financing options to strengthen its balance sheet, including debt and equity financing [14] Q&A Session Summary Question: Has the company considered international expansion given the positive reception? - Management indicated that while international expansion has been considered, the focus remains on the U.S. market due to favorable reimbursement and significant interest [23] Question: How quickly can the supply chain ramp up if demand exceeds expectations? - Management noted a strong partnership with their contract manufacturer, which has already begun ramping production and reducing costs, allowing for quick scalability [24] Question: Is the supply chain based in the U.S.? - Yes, the contract manufacturer is based outside of Chicago, and most components are sourced from the U.S., insulating the company from global supply chain issues [25] Question: What are the expected outcomes from the new Senior Director of Sales? - The new hire is expected to enhance the commercial strategy and increase market adoption, with early signs of success already being observed [29] Question: What is the typical timeline for hospitals to get approval after requesting it? - The sales cycle varies widely, but management anticipates that with local representation, the timeline can be shortened significantly [32] Question: Can you provide updates on patient enrollment and events for the TIGeR-PaC study? - As of the last update, 95 patients had been randomized, with 61 events reported, and final enrollment is expected to be completed early next year [34]

Financial Performance - Year-to-date revenue for RenovoRx reached approximately $900,000 as of September 30, 2025, reflecting growing clinical need and market demand for targeted drug-delivery solutions [2] - RenovoRx reported third quarter revenues of approximately $266,000, marking the company's third full quarter of revenue generation from RenovoCath sales [14] - The net loss for the third quarter was $2.9 million, compared to a net loss of $2.5 million for the same period in 2024 [17] - Cash and cash equivalents stood at $10 million as of September 30, 2025, sufficient to fund ongoing commercialization efforts and complete enrollment in the Phase III TIGeR-PaC clinical trial [15] Market Expansion - The number of approved cancer centers purchasing RenovoCath increased from 5 at the beginning of 2025 to 14 by November 7, 2025, with additional quotes requested from 10 more centers [4] - The initial total addressable market (TAM) for RenovoCath is estimated at approximately $400 million, with long-term potential in the several billion-dollar range as the platform expands [8] - RenovoRx has engaged with numerous physicians expressing interest in utilizing RenovoCath, indicating strong market interest and advocacy for the TAMP platform [4] Clinical Development - The Phase III TIGeR-PaC trial is on track for enrollment completion in early 2026, with final data readout expected in 2027 [10] - The company is focused on commercializing its RenovoCath and TAMP technology, with ongoing clinical trials and studies aimed at treating specific medical conditions [32] Expenses and Financial Management - Research and development expenses for the third quarter were $1.7 million, while selling, general, and administrative expenses were approximately $1.7 million [16] - There are concerns regarding the sufficiency of existing cash and cash equivalents to fund future operating expenses and capital requirements [32] Strategic Planning and Risks - There are inherent risks and uncertainties associated with the company's forward-looking statements, including the potential for clinical trials to not demonstrate sufficient safety and efficacy for regulatory approval [32] - The company emphasizes the importance of regulatory approvals and the potential impact of regulatory authorities on its clinical development plans and timelines [32] - The company is exploring commercial opportunities for its TAMP technology, but there is a risk that this may not lead to viable revenue-generating operations [32] - The company is assessing the commercialization potential of its product candidates, contingent upon regulatory approval [32] - The ability to manufacture and supply product candidates for clinical trials and commercial use is a key focus area for the company [32] - The company acknowledges the competitive landscape and the need to monitor developments related to competitors and industry trends [32] - Future strategic arrangements and collaborations are being considered to enhance the company's operational capabilities and market position [32] Team Development - The company strengthened its commercial team by hiring Philip Stocton as Senior Director of Sales & Market Development and plans to add a marketing director by the end of the year [7]

Financial Performance - Revenues for the three months ended September 30, 2025, were $266,000, compared to $0 for the same period in 2024, indicating a significant increase [22]. - Gross profit for the nine months ended September 30, 2025, was $586,000, compared to $0 for the same period in 2024, reflecting successful revenue generation [22]. - The net loss for the three months ended September 30, 2025, was $2,912,000, compared to a net loss of $2,471,000 for the same period in 2024, indicating a 17.8% increase in losses [22]. - For the nine months ended September 30, 2025, the company reported a net loss of $8.2 million, compared to a net loss of $5.9 million for the same period in 2024 [29]. - The company reported a net loss of $8,227,000 for the nine months ended September 30, 2025, compared to a net loss of $5,936,000 for the same period in 2024, representing a 38.6% increase in net loss [89]. - The company anticipates continued operating losses until significant revenue is generated from the commercialization of the RenovoCath device [166]. Assets and Liabilities - Total assets increased to $11,206,000 as of September 30, 2025, up from $8,118,000 on December 31, 2024, representing a 37.5% growth [17]. - Cash and cash equivalents increased to $10,044,000 as of September 30, 2025, up from $7,154,000 on December 31, 2024, a growth of 40.5% [17]. - Total liabilities decreased to $3,128,000 as of September 30, 2025, down from $3,640,000 on December 31, 2024, a reduction of 14.0% [18]. - The accumulated deficit as of September 30, 2025, was $(58,446,000), compared to $(50,219,000) as of December 31, 2024, indicating an increase in the deficit of 16.4% [19]. Expenses - Operating expenses for the three months ended September 30, 2025, totaled $3,413,000, an increase from $2,828,000 in the same period of 2024, marking a 20.6% rise [22]. - Research and development expenses for the nine months ended September 30, 2025, were $4,768,000, compared to $4,449,000 for the same period in 2024, a 7.2% increase [22]. - Selling, general and administrative expenses increased by 47% to approximately $1.7 million for the three months ended September 30, 2025, compared to $1.2 million for the same period in 2024 [154]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, were approximately $4.8 million, a 24% increase from $3.9 million in the same period in 2024 [156]. Financing Activities - The company raised an aggregate of $71.4 million since its inception, with net proceeds of $64.3 million after deducting offering expenses [35]. - The company completed a registered direct offering in April 2023, raising gross proceeds of $5.0 million [40]. - The February 2025 public offering generated approximately $12.1 million in gross proceeds, with net proceeds of $10.8 million after deducting underwriting fees and expenses [43]. - The company anticipates needing additional funding to support operations if commercial sales of RenovoCath do not significantly increase during 2026 [45]. Commercialization and Market Potential - The company expanded its commercial efforts for the RenovoCath device, achieving its first commercial sales revenue in Q4 2024 and increasing the number of approved centers from 5 to 14 by early 2025 [105]. - The initial peak U.S. market opportunity for RenovoCath is estimated at approximately $400 million annually, with potential for several billion dollars as the company expands into other tumor types [111]. - As of September 30, 2025, RenovoCath sales totaled approximately $900,000, with expectations for revenue growth over time [106]. Clinical Trials and Research - The ongoing Phase III TIGeR-PaC clinical trial for IAG is expected to complete enrollment in early 2026, with final data anticipated in 2027 [114]. - The company launched the RR5 Post-Marketing Registry Study in July 2025 to evaluate the safety and effectiveness of RenovoCath across a range of solid tumors [121]. - The independent Data Monitoring Committee recommended continuing the TIGeR-PaC trial after their second interim analysis in August 2025 [117]. Internal Controls and Governance - The company has identified material weaknesses in its accounting policies and controls, primarily due to insufficient staffing and lack of GAAP expertise [189]. - The remediation plan includes hiring additional accounting personnel with GAAP and SEC reporting experience and developing an accounting policy manual [190]. - The company plans to enhance internal control procedures and monitoring for complex transactions to ensure financial statement accuracy [191]. - There have been no changes in internal control over financial reporting that materially affect the company since the filing of the 2024 Annual Report [193]. Stock and Shareholder Information - The company reported a weighted-average share count of 36,646,278 for the three months ended September 30, 2025, compared to 24,940,746 for the same period in 2024, reflecting a 46.0% increase in shares outstanding [22]. - The common stock warrant liability was valued at $1.1 million as of September 30, 2025, compared to $1.5 million as of December 31, 2024 [59]. - The market price of the company's common stock may be volatile, and failure to comply with Nasdaq requirements could lead to delisting [202].

Core Insights - RenovoRx reported a year-to-date revenue of approximately $900,000 as of the end of Q3 2025, indicating strong commercial progress and increasing market demand for its RenovoCath device [2][3][14] - The company has expanded its customer base from five to 14 approved cancer centers for RenovoCath, with additional quotes requested from 10 more centers, reflecting growing physician interest and satisfaction [4][5][8] - RenovoRx's cash position as of September 30, 2025, was $10 million, which is expected to support ongoing commercialization efforts and the completion of its Phase III clinical trial [15][21] Commercialization Update - The commercialization strategy for RenovoCath has shown progress, with Q3 2025 revenues reaching approximately $266,000, driven by new customer orders and repeat purchases [14][3] - The company has engaged with numerous physicians and medical institutions, indicating a strong interest in utilizing RenovoCath for targeted drug delivery [4][5] - RenovoRx aims to integrate its TAMP™ therapy into standard care practices to improve patient outcomes [2][10] Clinical Research and Development - The Phase III TIGeR-PaC trial is on track for enrollment completion in early 2026, with final data expected in 2027 [10][12] - A new post-marketing registry study has been launched to gather real-world evidence on the use of RenovoCath, with initial patient procedures already initiated [12][10] - The company has strengthened its Scientific Advisory Board with the addition of experts in oncology, enhancing its clinical development capabilities [11] Financial Highlights - For Q3 2025, RenovoRx reported a net loss of $2.9 million, compared to a net loss of $2.5 million in Q3 2024, reflecting ongoing investments in R&D and commercialization [17][24] - Research and development expenses were $1.7 million for the quarter, consistent with the previous year, indicating continued commitment to clinical trials [16][24] - Selling, general, and administrative expenses increased to approximately $1.7 million, up from $1.2 million in the prior year, reflecting the company's growth efforts [17][24] Market Potential - The initial total addressable market (TAM) for RenovoCath is estimated at approximately $400 million in peak annual U.S. sales, with potential for several billion dollars as the platform expands into additional indications [9][26] - The company is actively exploring further revenue-generating activities to meet anticipated demand for RenovoCath [29]

Core Insights - RenovoRx has appointed Dr. Timothy Donahue, a distinguished UCLA surgeon and expert in pancreatic cancer, to its Scientific Advisory Board, enhancing the company's expertise in surgical oncology and translational research aimed at improving treatment strategies for complex cancers [1][5][6] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, an FDA-cleared drug-delivery device designed to address high unmet medical needs in cancer treatment [6][9] - The company's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform aims to deliver therapeutic agents directly to tumor sites while minimizing systemic toxicity [6][9] Dr. Timothy Donahue's Role - Dr. Donahue is the Director of UCLA's Agi Hirshberg Center for Pancreatic Diseases and Chief of the Division of Surgical Oncology, bringing extensive clinical and research experience to RenovoRx [2][3] - His leadership in translational oncology and clinical research is expected to inform the development of localized therapies to improve patient outcomes [5][6] Research and Development - Dr. Donahue leads a National Institutes of Health-funded research laboratory focused on advancing treatment strategies for pancreatic cancer through mechanistic investigations [4] - RenovoRx is currently evaluating its intra-arterial gemcitabine product candidate (IAG) in the Phase III TIGeR-PaC trial, utilizing the RenovoCath device [7][8] Commercialization Efforts - RenovoRx has received its first commercial purchase orders for RenovoCath devices and is expanding its customer base, including high-volume National Cancer Institute-designated centers [9] - The company is exploring further revenue-generating activities to meet anticipated demand for its products [9]

Core Insights - RenovoRx, Inc. is participating in the Canaccord Genuity MedTech, Diagnostics & Digital Health & Services Forum on November 20, 2025, where CEO Shaun Bagai will discuss the company's commercialization progress and ongoing clinical trials [1][2][3] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, a patented FDA-cleared drug-delivery device aimed at addressing high unmet medical needs [4] - The company's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform allows for targeted therapeutic delivery near tumor sites, potentially reducing toxicities compared to systemic intravenous therapy [4] Clinical Trials and Studies - The ongoing Phase III TIGeR-PaC clinical trial is evaluating RenovoRx's drug-device combination product candidate, intra-arterial gemcitabine (IAG), for locally advanced pancreatic cancer [2][5] - A post-marketing observational registry study has been launched to assess long-term safety signals and survival outcomes for patients treated with RenovoCath [2] Commercialization Efforts - RenovoRx has received its first commercial purchase orders for RenovoCath devices as of December 2024, with several customers placing repeat orders [7] - The company is expanding its customer base, including high-volume National Cancer Institute-designated centers, to meet anticipated demand [7] Regulatory Status - IAG, the combination product candidate, is under investigation and has not yet been approved for commercial sale [6] - RenovoCath with gemcitabine has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, granting seven years of market exclusivity upon FDA approval [6]

Core Insights - RenovoRx, Inc. is set to host its third quarter 2025 financial results and business highlights conference call on November 13, 2025, at 4:30 p.m. ET [1][3] - The management will discuss developments related to the RenovoCath device commercialization and ongoing clinical trials, including the Phase III TIGeR-PaC trial for locally advanced pancreatic cancer [2][5] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing the RenovoCath device, which is FDA-cleared for local drug delivery [4][6] - The company utilizes a patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform designed to deliver therapeutics directly to tumor sites, potentially reducing systemic toxicity [4][6] Clinical Trials and Product Development - The company is evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine (IAG), in the ongoing Phase III TIGeR-PaC trial [5][6] - IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, granting seven years of market exclusivity upon FDA approval [6] Commercialization Efforts - RenovoRx is actively commercializing its TAMP technology and has received its first commercial purchase orders for RenovoCath devices as of December 2024 [7] - The company is expanding its customer base, including high-volume National Cancer Institute-designated centers, and is exploring further revenue-generating activities [7]

Core Insights - RenovoRx has appointed Dr. Thierry de Baère, a leading expert in interventional oncology, to its Scientific Advisory Board, enhancing its expertise in targeted drug-delivery and locoregional cancer therapies [1][5]. Company Overview - RenovoRx, Inc. is a life sciences company focused on developing innovative targeted oncology therapies and commercializing RenovoCath, an FDA-cleared drug-delivery device [6]. - The company's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform aims to optimize targeted drug delivery while minimizing toxicities compared to systemic intravenous therapy [6]. Expertise and Contributions - Dr. de Baère is the Head of the Interventional Radiology Unit at Gustave Roussy Cancer Centre and has extensive experience in minimally invasive therapies for various cancers [3][4]. - He has over 400 peer-reviewed publications and has received numerous awards, including the 2019 CIRSE Gold Medal [4]. Clinical Development - RenovoRx is evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine delivered via RenovoCath (IAG), in the ongoing Phase III TIGeR-PaC trial [7]. - IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon FDA approval [8]. Commercialization Efforts - The company is actively commercializing its TAMP technology and has received its first commercial purchase orders for RenovoCath devices [9]. - Several customers have initiated repeat orders, indicating growing demand, particularly from National Cancer Institute-designated centers [9].

Core Insights - The first registry-eligible patient procedure in the PanTheR Post-Marketing Registry Study has been successfully completed at the University of Vermont Cancer Center, marking a significant milestone for RenovoRx and its RenovoCath device [1][2][3] - Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center have joined the University of Vermont Cancer Center as participating clinical sites in the PanTheR study, which aims to gather expanded safety and performance data on RenovoCath [2][3] - The PanTheR study is designed to evaluate the long-term safety and survival outcomes for patients with solid tumors treated using RenovoCath, capturing real-world data that may inform future clinical trial designs [5][8] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing innovative targeted oncology therapies and commercializing the RenovoCath device, which is FDA-cleared for targeted drug delivery [7][8] - The RenovoCath device utilizes a patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, aiming to improve therapeutic delivery while minimizing toxicities compared to systemic intravenous therapy [8][9] - RenovoRx is also evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine delivered via RenovoCath, in the ongoing Phase III TIGeR-PaC trial [9][10] Study Details - The PanTheR study is a multi-center, post-marketing observational registry study that will collect data on the long-term use and performance of RenovoCath after its FDA clearance [5] - The study aims to generate meaningful real-world data that can guide future treatment decisions for patients with difficult-to-treat cancers, potentially improving survival and quality of life outcomes [4][5] - Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, reinforcing the company's commitment to innovation and patient outcomes [5][11]