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]

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.

Core Viewpoint - RenovoRx, Inc. is actively commercializing its FDA-cleared drug-delivery device, RenovoCath, and is presenting at the iAccess Alpha Virtual Best Ideas Fall Investment Conference to discuss its commercialization efforts and ongoing clinical trials [1][2][3] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, a patented drug-delivery device that addresses high unmet medical needs [6] - The company utilizes its Trans-Arterial Micro-Perfusion (TAMP™) therapy platform for targeted therapeutic delivery, aiming to improve safety and efficacy compared to traditional systemic therapies [6] Commercialization Efforts - The company has received its first commercial purchase orders for RenovoCath devices as of December 2024, with several customers initiating repeat orders [9] - RenovoRx is expanding its customer base, including high-volume National Cancer Institute-designated centers, to meet anticipated demand for RenovoCath [10] Clinical Trials - The ongoing Phase III TIGeR-PaC clinical trial is evaluating the intra-arterial gemcitabine delivered via RenovoCath for treating locally advanced pancreatic cancer (LAPC) [3][7] - The Data Monitoring Committee has recommended continuing the trial after reviewing a second pre-planned interim analysis triggered by 52 deaths [3] Product Information - RenovoCath is designed for isolating blood flow and delivering fluids to specific sites in the peripheral vascular system, with applications including temporary vessel occlusion and chemotherapeutic drug infusion [5] - The combination product candidate, IAG, which uses RenovoCath, has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing seven years of market exclusivity upon FDA approval [8]

Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]