Core Perspective - The company is focused on innovating cancer treatment by prioritizing patient well-being alongside tumor destruction, aiming to localize therapy for better outcomes [2]. Company Background and Progress - The company is making significant strides in both commercial and clinical aspects, laying a strong foundation for growth in 2026 [1][2]. - A two-pronged approach to market potential has been initiated, with the commercialization of their therapeutic solutions underway [3].

Summary of RenovoRx Conference Call - December 09, 2025 Company Overview - **Company**: RenovoRx Inc. (NasdaqCM:RNXT) - **Industry**: Cancer therapeutics and medical devices Key Points and Arguments 1. **New Approach to Cancer Treatment**: RenovoRx is focusing on localizing therapy for cancers rather than solely targeting tumors, aiming to minimize patient toxicity while effectively treating cancer [2][3] 2. **Commercialization of RenovoCath Device**: The company has initiated the commercialization of its FDA-cleared RenovoCath device, generating over $900,000 in revenue year-to-date through Q3 2025 without a dedicated sales infrastructure [3][4] 3. **Market Potential**: The peak revenue potential for the RenovoCath device in the U.S. is estimated at over $400 million, based on indications and areas of use [4][12] 4. **TAMP Mechanism**: The proprietary Trans-Arterial Micro-Perfusion (TAMP) mechanism allows for localized chemotherapy delivery, significantly increasing drug concentration at the tumor site while reducing systemic exposure [5][8][9] 5. **Clinical Trials**: The pivotal phase III TIGeR-PaC study for locally advanced pancreatic cancer is progressing, with enrollment expected to complete in early 2026 and final data anticipated in 2027 [5][18] 6. **Patient Experience**: The TAMP procedure is outpatient, requiring only conscious sedation, and allows patients to receive treatment in about 90 minutes, contrasting with traditional chemotherapy that often requires longer hospital stays [10][11] 7. **Market Expansion**: Beyond pancreatic cancer, the device is applicable to other hypovascular tumors, including cholangiocarcinoma and non-small cell lung cancers, which could further expand the market [11][34] 8. **Sales Infrastructure**: A lean sales team has been established, with 14 centers approved to purchase the device and five actively using it, indicating strong initial market interest [14][15][26] 9. **Financial Position**: As of Q3 2025, RenovoRx reported over $10 million in cash and anticipates revenue growth in 2026, with a current cash burn of approximately $800,000 per month [24][34] 10. **Reimbursement and Margins**: The company has established reimbursement rates allowing for device pricing between $6,000 and $8,500, with current margins around 80%, expected to improve as manufacturing scales [12][35] Additional Important Content - **Regulatory Pathway**: The device was approved through the 510(k) pathway, allowing for a faster and simpler regulatory process compared to more invasive technologies [28][29] - **International Market Considerations**: While there is potential for international expansion, the focus remains on the U.S. market due to higher reimbursement rates and lower regulatory hurdles [28][29] - **Future Collaborations**: Ongoing discussions with medical device companies for potential partnerships or distribution arrangements are in place, indicating interest in the device's unique capabilities [37][38] - **Scientific Advisory Board**: The company has a strong advisory board with notable experts in oncology, enhancing its credibility and potential for clinical success [22] 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.

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]

Core Insights - The after-hours trading session on November 14, 2025, saw significant movements in biotech and therapeutics stocks due to various corporate updates and financial results [1] Company Summaries - Repare Therapeutics Inc. (RPTX) experienced a 30.32% increase, closing at $2.15, following the announcement of a definitive agreement for acquisition by XenoTherapeutics, with shareholders set to receive $1.82 per share plus a contingent value right. The company reported cash and cash equivalents of $112.6 million as of September 30, 2025, up from $109.5 million at the end of June [2] - Senti Biosciences, Inc. (SNTI) rose 7.45% to $1.73 after reporting a net loss of $18.1 million, or $0.69 per share, for Q3 2025. Cash and cash equivalents decreased to $12.2 million from $48.3 million at year-end 2024 [3] - Applied Therapeutics, Inc. (APLT) advanced 8.15% to $0.24, reporting a net loss of $19.0 million, or $0.13 per share, for Q3 2025, an improvement from a net loss of $68.6 million, or $0.48 per share, in the same period of 2024. Cash and cash equivalents totaled $11.9 million, down from $79.4 million at the end of 2024 [4] - RenovoRx, Inc. (RNXT) climbed 6.28% to $0.80, reporting revenues of approximately $266,000 for Q3 2025, with a net loss of $2.9 million compared to $2.5 million in the same period of 2024 [5] - Nuvalent, Inc. (NUVL) gained 9.33%, closing at $105.50, and announced plans for a webcast to discuss pivotal data for its investigational ALK-selective inhibitor in patients with advanced ALK-positive non-small cell lung cancer [6]

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].