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]

MOUNTAIN VIEW, Calif., Nov. 19, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (Nasdaq: RNXT) (“RenovoRx” or “the Company”), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, today announced that Chief Executive Officer Shaun Bagai will participate in the Alliance Global Partners (AGP) Emerging AgBiotech/Bio-Solutions Virtual Showcase. The event will be hosted by Scott Henry, Managing Director and Healthcare Analyst ...

The after-hours session on Friday, November 14, 2025, brought notable moves across several biotech and therapeutics names, as corporate updates, financial results, and strategic announcements drove sharp price reactions. From acquisition agreements to pivotal trial milestones, these developments shaped trading momentum well beyond the regular market close.Repare Therapeutics Inc. (RPTX) surged in after-hours trading, closing at $2.15, up 30.32% or $0.50. The company announced that it has entered into a def ...

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]

Exhibit 99.1 RenovoRx Reports Third Quarter 2025 Financial Results, Including Approximately $900,000 in Year-to-Date Revenue, and Provides Business Update September 30, 2025 Cash and Cash Equivalents at $10 million Revenue Expected to Grow in 2026 and Continue to Of set Cash Burn Management to Host Conference Call Today at 4:30 p.m. ET MOUNTAIN VIEW, Calif. – November 13, 2025 – RenovoRx, Inc. (Nasdaq: RNXT) ("RenovoRx" or the "Company"), a life sciences company developing innovative targeted oncology thera ...

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]