Core Viewpoint - RenovoRx, Inc. is actively commercializing its innovative targeted oncology therapies, particularly focusing on the RenovoCath device, which has shown growing clinical demand and market traction [1][2][6] Group 1: Company Updates - CEO Shaun Bagai will present at the iAccess Alpha Virtual Best Ideas Winter Investment Conference on December 9, 2025, to discuss the company's commercial efforts and market traction [1][4] - Year-to-date revenue for RenovoRx reached approximately $900,000 by the end of September 30, 2025, indicating progress in its commercialization efforts [2][7] - The company has received its first commercial purchase orders for RenovoCath devices and has seen repeat orders from several customers, including high-volume National Cancer Institute-designated centers [7] Group 2: Clinical Research and Development - The ongoing Phase III TIGeR-PaC clinical trial is evaluating intra-arterial gemcitabine delivered via RenovoCath in patients with locally advanced pancreatic cancer [3][8] - RenovoRx is also conducting a post-marketing registry study to capture real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors [3] - The company supports investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer, which may broaden the application of its TAMP™ therapy platform [3][6] Group 3: Product Information - RenovoCath is an FDA-cleared drug-delivery device designed for targeted therapeutic delivery, aiming to minimize toxicities compared to systemic intravenous therapy [5][6] - The device is indicated for temporary vessel occlusion and the delivery of fluids, including therapeutic agents, to specific sites in the peripheral vascular system [5][9] - RenovoCath with gemcitabine has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing seven years of market exclusivity upon FDA approval [10]

Summary of RenovoRx Conference Call (November 20, 2025) Company Overview - **Company**: RenovoRx (NasdaqCM:RNXT) - **Market Cap**: Approximately $30 million - **Focus**: Interventional oncology with a late-stage product in development and a commercial catheter device - **Current Stock Price**: Approximately $0.75 - **Analyst Rating**: Buy rating with a price target of $3 per share [1][17] Core Business and Product Development - **Product**: RenovoCath, a catheter device for localized chemotherapy - **Revenue**: Achieved $900,000 in revenue through Q3 2025 without a dedicated sales and marketing team [3][13] - **Market Potential**: Estimated peak sales potential for the catheter is about $400 million [3][8] - **Commercialization Strategy**: Initiated in early 2025, focusing on understanding market dynamics and barriers to adoption [3][9] Technology and Treatment Approach - **Innovative System**: Developed a new treatment method called TransArterial Microperfusion (TAMP) for localized chemotherapy [2][5] - **Mechanism of Action**: Allows for a hundred-fold increase in tissue concentration of chemotherapy compared to systemic delivery [7][8] - **Targeted Conditions**: Primarily focused on locally advanced pancreatic cancer, with ongoing phase III trials [4][10] Clinical Trials and Efficacy - **Phase III Trial**: Enrollment expected to complete early next year, with final data anticipated in 2027 [4][14] - **Survival Benefits**: Interim analysis shows a six-month survival benefit, with patients living approximately 21.5 months compared to 15.5 months in the control group [10][40] - **Quality of Life**: Notable 65% reduction in systemic toxicities and adverse events compared to traditional therapies [11][40] Market Dynamics and Sales Strategy - **Target Market**: Approximately 200 hospitals in the U.S. with specialized cancer centers [9] - **Sales Force**: Currently expanding with the hiring of a Senior Director of Sales and Marketing, along with additional sales representatives [9][20] - **Revenue Model**: Each patient may require multiple procedures, potentially generating $50,000 to $100,000 in revenue per patient [19][22] Financial Overview - **Cash Position**: $10 million in cash as of Q3 2025, with a monthly burn rate of $800,000 [16][44] - **Profitability Outlook**: Positive contribution margin on the device, with a goal to reach break-even with 25-50 hospitals actively using the device [22][23] Future Prospects and Strategic Initiatives - **Post-Marketing Registry Study**: Launched to track data on the use of RenovoCath across various cancers [12][13] - **Expansion Plans**: Exploring additional indications and potential partnerships with other biotech firms for drug-device combinations [42][43] - **Regulatory Strategy**: Aiming for a J-code drug reimbursement for the drug-device combination, which could significantly increase market potential [17] Key Takeaways - RenovoRx is positioned to disrupt traditional cancer treatment paradigms with its innovative localized chemotherapy approach - The company is on track to expand its market presence and revenue generation capabilities through strategic hiring and commercialization efforts - Clinical trial results and a strong focus on quality of life improvements are expected to drive adoption among oncologists and patients alike [10][11][40]

Core Insights - RenovoRx, Inc. is participating in the Alliance Global Partners Emerging AgBiotech/Bio-Solutions Virtual Showcase on November 20, 2025, where CEO Shaun Bagai will provide updates on the company's commercial efforts and market traction [1][2] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, an FDA-cleared drug-delivery device [6][8] - The company aims to address high unmet medical needs through its patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which allows for targeted therapeutic delivery while minimizing toxicities associated with systemic intravenous therapy [6][8] Financial Performance - For the third quarter of 2025, RenovoRx reported year-to-date revenue of approximately $900,000, indicating progress in its commercial efforts [2] Clinical Research and Development - The ongoing Phase III TIGeR-PaC clinical trial is evaluating intra-arterial gemcitabine delivered via RenovoCath in patients with locally advanced pancreatic cancer [3][7] - The company is also conducting a post-marketing registry study to gather real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors [3] - Investigator-initiated trials are being supported for borderline resectable and oligometastatic pancreatic cancer, designed to be cost-neutral while providing meaningful data [3] Product Information - RenovoCath is designed for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, with applications including arteriography and chemotherapeutic drug infusion [5][6] - The combination product candidate, intra-arterial gemcitabine (IAG), is under investigation and has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon FDA approval [8][9] Market Activity - RenovoRx has received its first commercial purchase orders for RenovoCath devices and is seeing repeat orders from customers, 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]

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]

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].

Summary of RenovoRx Conference Call Company Overview - **Company**: RenovoRx (NasdaqCM:RNXT) - **Industry**: Medical Technology, specifically focused on cancer treatment and drug-device combinations Key Points and Arguments 1. **Advancements in Cancer Care**: RenovoRx is advancing medicine through innovative technologies aimed at reducing toxicity in cancer treatments while effectively targeting tumors [2][3] 2. **RenovoCath Device**: The FDA-cleared RenovoCath device has been commercialized, with revenues in the first half of the year exceeding expectations despite having no sales force in place [3][4] 3. **Market Opportunity**: The initial market opportunity for the RenovoCath device is estimated at $400 million, with potential for significant growth as the device is used in various cancer treatments [4][13] 4. **Clinical Trials**: The TIGeR-PaC phase III trial is focused on treating locally advanced pancreatic cancer, with enrollment nearing completion [4][16] 5. **Mechanism of Action**: The RenovoCath device utilizes Transarterial Microperfusion (TAMP) to deliver chemotherapy directly to tumors, particularly those that are hypovascular and resistant to systemic treatments [5][6][12] 6. **Patient Experience**: The treatment procedure is outpatient, takes about 90 minutes, and does not require general anesthesia, leading to a better quality of life for patients [10][11] 7. **Survival Benefits**: Interim analysis from the TIGeR-PaC trial shows a six-month survival benefit for patients treated with the RenovoCath device compared to standard treatments, along with a 65% reduction in adverse events [22][23] 8. **Commercial Strategy**: RenovoRx plans to expand its commercial efforts with a small, efficient sales team targeting high-volume surgical centers and academic institutions [15][16] 9. **Financial Health**: The company reported $600,000 in revenue in the first half of the year and has a cash reserve of $12.3 million, which is expected to last into late 2026 [16][28] 10. **Patent Protection**: RenovoRx holds over 19 issued patents worldwide, ensuring protection for its technology and innovations [14] Additional Important Content 1. **Future Trials and Indications**: There is interest in expanding the use of the RenovoCath device to other cancers, including cholangiocarcinoma and non-small cell lung cancer [30][32] 2. **Metrics for Commercial Traction**: The company is focusing on the number of centers approved to use the device and the volume of patients treated, rather than just revenue figures [32][33] 3. **Partnership Opportunities**: RenovoRx is in discussions with potential partners, including Boston Scientific, to scale commercial efforts and explore acquisition possibilities [37][39] 4. **Regulatory Pathway**: The company anticipates engaging with the FDA for an accelerated approval pathway based on the positive survival and safety signals from the TIGeR-PaC trial [40] This summary encapsulates the key insights from the RenovoRx conference call, highlighting the company's innovative approach to cancer treatment, market potential, and strategic plans for growth and commercialization.