Core Viewpoint - RenovoRx, Inc. is conducting its Q1 2025 earnings conference call, highlighting its financial and operational performance, with key leadership present to discuss the company's progress and future outlook [1][2]. Group 1: Company Leadership and Structure - The conference call features RenovoRx's leadership team, including Dr. Ramtin Agah (Founder and Chief Medical Officer), Shaun Bagai (CEO), and Ronald Kocak (VP Controller and Principal Accounting Officer) [2]. Group 2: Forward-Looking Statements - The company emphasizes that statements made during the call may be considered forward-looking, reflecting management's current views on market conditions and potential outcomes of clinical trials [3][4]. - Management's forward-looking statements are based on current plans and assumptions, which are subject to various risks and uncertainties [3].

Company Performance - RenovoRx, Inc. reported a quarterly loss of $0.08 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.07 per share a year ago [1] - The company posted revenues of $0.2 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 1.50%, and this is an increase from zero revenues a year ago [2] - RenovoRx shares have declined approximately 18.6% since the beginning of the year, while the S&P 500 has gained 0.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $0.32 million, and for the current fiscal year, it is -$0.30 on revenues of $1.55 million [7] - The estimate revisions trend for RenovoRx is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which RenovoRx belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of approximately $200,000 from commercial sales of its FDA cleared RenovoCast device, exceeding initial expectations [22] - Research and development expenses increased to $1,700,000 from $1,300,000 in Q1 2024, primarily due to higher employee compensation and increased manufacturing costs [22] - Selling, general and administrative expenses rose to approximately $1,600,000 from $1,200,000 in the prior year period, attributed to increased personnel costs and professional fees [22] - As of March 31, 2025, the company had $14,600,000 in cash and cash equivalents [23] Business Line Data and Key Metrics Changes - The company generated its first revenue from commercial sales of Renovocath, with $43,000 in revenue recorded in December 2024 and approximately $200,000 in Q1 2025 [12][22] - There is strong organic demand for Renovocath, with over 10 medical institutions initiating purchase orders [13] - The initial total addressable market for Renovocath is estimated at $400,000,000 in peak U.S. annual sales opportunity [14] Market Data and Key Metrics Changes - The company anticipates sequential quarter-over-quarter revenue growth for Renovocath throughout the year, driven by demand from oncology centers [13][21] - The company is exploring international markets but currently lacks a CE mark, focusing on the U.S. market first due to favorable reimbursement landscapes [28] Company Strategy and Development Direction - The company is focused on implementing a commercial strategy for Renovocath alongside ongoing clinical trials, aiming to establish a new standard of care for locally advanced pancreatic cancer [12][10] - The company plans to target the top 200 high-volume treatment centers for market penetration, potentially partnering with larger organizations for distribution [17][31] - The company is also exploring expansion opportunities across other cancer indications, which could significantly increase the total addressable market [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase III TIGER PACT clinical trial, with expectations for full enrollment in 2025 [18] - The company is encouraged by the positive feedback from clinical investigators regarding the potential benefits of the Renovocath device [10] - Management believes that growing revenues from Renovocath will reduce the company's burn rate and support ongoing clinical trials [17] Other Important Information - The company announced the issuance of a new U.S. patent for its TAMP therapy platform, enhancing its intellectual property portfolio [19][20] - Management and board members purchased approximately 143,000 shares of Renovo Rx stock, signaling confidence in the company's future [20] Q&A Session Summary Question: Plans for Renovocast in international markets - The company is looking into obtaining a CE mark for future international markets, with high demand noted in Europe and Asia [28] Question: Sales strategy for targeting top cancer centers - The company is exploring both hiring a small sales force and partnering with strategic partners that have existing distribution channels [31]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of approximately $200,000 from commercial sales of its FDA cleared RenovoCast device, exceeding initial expectations [22] - Research and development expenses increased to $1,700,000 from $1,300,000 in Q1 2024, primarily due to higher employee compensation and increased manufacturing costs [22] - Selling, general and administrative expenses rose to approximately $1,600,000 from $1,200,000 in the prior year period, attributed to increased personnel costs and professional fees [22] - As of March 31, 2025, the company had $14,600,000 in cash and cash equivalents [23] Business Line Data and Key Metrics Changes - The company began generating revenue from commercial sales of Renovocath in Q1 2025, with purchase orders received ahead of schedule [12] - Revenue from Renovocath exceeded internal expectations, with approximately $200,000 generated in the first quarter [13] - The company anticipates sequential quarter-over-quarter revenue growth for Renovocath for the foreseeable future [13] Market Data and Key Metrics Changes - The initial total addressable market for Renovocath is estimated at $400,000,000 in peak U.S. annual sales opportunity [14] - The company expects expansion opportunities across other cancer indications, potentially leading to a multi-billion dollar U.S. total addressable market over time [15] Company Strategy and Development Direction - The company is focusing on implementing a commercial strategy for Renovocath alongside ongoing clinical trials [12] - Plans to target the top 200 high-volume treatment centers with a small yet focused commercial team [16] - The company is exploring partnerships with larger organizations that have established sales forces to enhance market penetration [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Renovocath device and the positive reception from the physician community [10] - The company aims to achieve full enrollment in the TIGER PACT trial during 2025, with ongoing efforts to target additional clinical sites [18] - Management highlighted the importance of the new U.S. patent for the TANF therapy platform in strengthening the company's competitive position [20] Other Important Information - The company announced that members of the management team and board purchased approximately 143,000 shares of Renovo Rx stock, signaling confidence in the company's future [20] - The company is actively exploring international market opportunities, particularly in Europe and Asia, but is currently focused on the U.S. market [29][30] Q&A Session Summary Question: Plans for Renovocast in international markets - The company is looking into obtaining a CE mark for future international markets, with high demand noted in Europe and Asia [29][30] Question: Plans for partnering with cancer centers - The company is considering both hiring a small sales force and partnering with strategic companies that have existing distribution channels to target top cancer centers [32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ COMMISSION FILE NUMBER: 001-40738 RENOVORX, INC. (Exact name of registrant as specified in its charter) Delaware 27-1448452 (State or oth ...

[Business and Commercialization Update](index=1&type=section&id=Business%20and%20Commercialization%20Update) RenovoRx launched RenovoCath commercial sales in Q1 2025, exceeding expectations with initial revenue and projecting significant market expansion - Q1 2025 marked the first full quarter of RenovoCath commercial sales, generating approximately **$200,000** in revenue and surpassing internal forecasts[3](index=3&type=chunk)[4](index=4&type=chunk) - Over **ten** medical institutions have placed initial and repeat purchase orders for RenovoCath[5](index=5&type=chunk) - The initial U.S. total addressable market for RenovoCath is estimated at **$400 million** in peak annual sales, with potential to expand into a multi-billion-dollar market[6](index=6&type=chunk)[7](index=7&type=chunk) - Intellectual property strengthened with a new U.S. patent for the TAMP therapy platform, expanding the global portfolio to **19** patents[11](index=11&type=chunk) [Ongoing Pivotal Phase III TIGeR-PaC Trial Update](index=2&type=section&id=Ongoing%20Pivotal%20Phase%20III%20TIGeR-PaC%20Trial%20Update) The Phase III TIGeR-PaC trial is on track for full enrollment in 2025, with 91 patients randomized and a second interim analysis triggered - The Phase III TIGeR-PaC trial is on track for full enrollment in **2025**, with Johns Hopkins Medicine joining as a clinical site[8](index=8&type=chunk) TIGeR-PaC Trial Enrollment and Analysis Status (as of May 2, 2025) | Metric | Status | | :--- | :--- | | **Target Randomized Patients** | 114 | | **Patients Randomized** | 91 | | **Target Events for Final Analysis** | 86 | | **Events Occurred** | 56 | - The second interim analysis has been triggered, with Data Monitoring Committee review anticipated in **Q3 2025**[9](index=9&type=chunk) - Supportive pre-clinical and pharmacokinetic data for the TAMP therapy platform were presented at major oncology conferences including ASCO GI, SIO, and SSO[10](index=10&type=chunk) [Financial Highlights for the First Quarter Ended March 31, 2025](index=3&type=section&id=Financial%20Highlights%20for%20the%20First%20Quarter%20Ended%20March%2031%2C%202025) Q1 2025 saw RenovoRx's first commercial revenue of $200,000, a cash balance of $14.6 million, and an increased net loss due to commercialization and R&D investments Q1 2025 Key Financial Metrics | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Revenue** | ~$200 thousand | $0 | | **R&D Expenses** | $1.7 million | $1.3 million | | **SG&A Expenses** | $1.6 million | $1.2 million | | **Net Loss** | $2.4 million | $1.1 million | | **Cash & Cash Equivalents** | $14.6 million | N/A | - Cash balance of **$14.6 million** as of March 31, 2025, is expected to fund RenovoCath commercial scale-up and TIGeR-PaC trial completion[1](index=1&type=chunk)[16](index=16&type=chunk) Selected Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $14,582 | $7,154 | | **Total assets** | $16,014 | $8,118 | | **Total liabilities** | $2,857 | $3,640 | | **Total stockholders' equity** | $13,157 | $4,478 | Selected Statement of Operations Data (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Revenues** | $197 | $ - | | **Gross profit** | $103 | $ - | | **Research and development** | $1,642 | $1,257 | | **Selling, general and administrative** | $1,571 | $1,219 | | **Loss from operations** | $(3,110) | $(2,476) | | **Net loss** | $(2,420) | $(1,076) | | **Net loss per share, basic and diluted** | $(0.08) | $(0.07) | [Corporate Overview and Conference Call](index=1&type=section&id=Corporate%20Overview%20and%20Conference%20Call) RenovoRx is a life sciences company advancing targeted oncology therapies and commercializing RenovoCath, with management demonstrating confidence through open market share purchases - RenovoRx is a life sciences company focused on developing targeted oncology therapies via its TAMP™ platform and commercializing the FDA-cleared RenovoCath device[2](index=2&type=chunk)[23](index=23&type=chunk) - Management and Board members purchased approximately **143,000** shares in open market transactions during Q1 2025[12](index=12&type=chunk) Conference Call Details | Event: | RenovoRx First Quarter 2025 Financial Results Conference Call | | :--- | :--- | | **Date:** | Thursday, May 15, 2025 | | **Time:** | 4:30 p.m. ET | | **Live Call:** | 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International) |

Summary of RenovoRx (RNXT) Fireside Chat - April 29, 2025 Company Overview - **Company**: RenovoRx (RNXT) - **Product**: Renovocath, a novel FDA-cleared drug delivery device for cancer treatment, particularly for locally advanced pancreatic cancer - **Key Personnel**: Sean Beguy (CEO), Gregory Tisi (Medical Director at Hackensack Meridian) Industry Context - **Industry**: Cancer treatment and drug delivery devices - **Market Potential**: Estimated peak U.S. revenue of $400 million for Renovocath alone, with a focus on pancreatic cancer treatment Core Points and Arguments 1. **Commercialization Strategy**: The company has initiated commercialization efforts for Renovocath, with first purchase orders received in 2024 and expectations for strong demand in 2025 [8][10][22] 2. **Clinical Trial Progress**: Ongoing Phase III TIGER PACT trial for locally advanced pancreatic cancer, with interim analysis showing increased overall survival and reduced side effects [10][19][21] 3. **Mechanism of Action**: Renovocath utilizes a proprietary method called transarterial microperfusion to deliver chemotherapy directly to tumors, resulting in a 100 times increase in drug concentration at the tumor site compared to systemic delivery [12][13] 4. **Patient Outcomes**: Initial data indicates a six-month increase in survival compared to standard care, with a 65% reduction in side effects, leading to improved quality of life for patients [20][21] 5. **Financial Performance**: Reported initial revenues of $43,000 in Q4 2024, with guidance for low six-figure revenue in Q1 2025 and expectations for sequential growth [22][23] 6. **Reimbursement Landscape**: Recent changes in reimbursement codes have increased the potential revenue per procedure from $10,000 to $17,000, enhancing the business opportunity for RenovoRx [53] 7. **Market Demand**: High physician demand for the device has been noted, with hospitals expressing interest in purchasing Renovocath for patient treatment [10][26] Additional Important Insights 1. **Sales Strategy**: The company plans to operate with a lean sales force of 3-5 people, leveraging existing physician demand and partnerships with established distribution channels [30][31][17] 2. **Supply Chain Stability**: The device is manufactured in the U.S., mitigating risks associated with global supply chain issues [60][62] 3. **Future Opportunities**: The technology is adaptable for various drugs, including immunotherapies and gene editing therapies, which could expand its application in cancer treatment [40][42] 4. **Investor Sentiment**: The CEO expressed confidence that the stock is undervalued due to a lack of understanding of the commercial opportunity and anticipated growth in revenue as the company transitions to a commercial phase [69][72] Conclusion - RenovoRx is positioned to capitalize on a significant market opportunity in cancer treatment with its innovative Renovocath device, backed by promising clinical trial results and a strong commercialization strategy. The company aims to enhance patient care while achieving substantial revenue growth in the coming years.

RenovoRx Investment Highlights - RenovoRx is developing combination therapies based on its proprietary Trans-Arterial Micro-Perfusion (TAMP) platform[4] - The FDA granted Orphan Drug Designation to RenovoRx's lead device/drug combination product candidate (RenovoCath plus Gemcitabine) in pancreatic and bile duct cancers[4] - RenovoCath, an FDA 510(k) cleared device, is being commercialized with first purchase orders received in Q4 2024[4] - RenovoRx anticipates initial revenues from RenovoCath in Q1 2025[45] TIGeR-PaC Phase III Clinical Trial - RenovoRx is advancing its pivotal Phase III TIGeR-PaC study for the treatment of locally advanced pancreatic cancer (LAPC)[5] - The first interim analysis of the TIGeR-PaC study showed a 65% reduction in adverse effects[5] - The second interim analysis of the TIGeR-PaC study is anticipated by the end of 1H 2025[5, 63] Market Opportunity - RenovoRx is pursuing a ~$400 million potential peak annual United States revenue opportunity for RenovoCath with initial clinical interest[5] - The company sees an opportunity to expand potential RenovoCath indications of use and estimated total addressable market for RenovoCath to several billion dollars with patent protection to 2038[5, 35] - Approximately 67,000 patients across areas of expressed interest in the US could benefit from RenovoCath[40]

Financial Performance - RenovoRx reported initial revenues of approximately $43,000 from RenovoCath sales in Q4 2024, marking the first revenue generation from the device [5][16]. - The company has a cash position of $7.2 million as of December 31, 2024, and raised an additional $12.1 million in gross proceeds from a public offering in February 2025 [3][16]. - The net loss for 2024 was $8.8 million, an improvement from a net loss of $10.2 million in 2023 [16]. - Selling, general, and administrative expenses decreased to $5.0 million in 2024 from $5.7 million in 2023, attributed to lower professional and consulting costs [16]. - Research and development expenses for 2024 were $6.0 million, an increase from $5.7 million in 2023, primarily due to manufacturing and personnel costs [16]. Market Potential - The total addressable market (TAM) for RenovoCath is estimated at $400 million for peak annual U.S. sales, with potential expansion opportunities leading to a multi-billion dollar TAM over time [4][7]. - RenovoRx expects revenue to increase to the low six-figure range in Q1 2025, followed by sequential quarter-over-quarter growth throughout the year [4]. - More than ten medical institutions have initiated purchase orders for RenovoCath, with repeat orders already received from initial customers [6][24]. - RenovoRx's commercialization strategy aims to penetrate the market with a small team targeting the top 200 high-volume treatment centers [7]. Clinical Trials - The ongoing Phase III TIGeR-PaC clinical trial is on track for full enrollment in 2025, with 90 patients randomized and 50 events recorded as of March 28, 2025 [10][11]. - RenovoRx is conducting the TIGeR-PaC Phase III clinical trial study in LAPC, with ongoing efforts to achieve full enrollment and interim data readouts [26]. - The company faces uncertainties regarding the timing and results of clinical trials, including the potential for interim results to not predict final outcomes [26]. - RenovoRx estimates the number of patients suffering from targeted diseases, which will influence clinical trial enrollment [26]. Commercialization Strategy - RenovoRx is exploring commercialization strategies utilizing its TAMP technology, aiming for clinically meaningful outcomes for targeted medical conditions [26]. - The execution of the commercial strategy for RenovoCath may not lead to viable revenue-generating operations, highlighting inherent risks [26]. - The company anticipates revenue generation from RenovoCath sales, although specific timing and levels remain uncertain [26]. - Future strategic arrangements and collaborations may provide potential benefits, although their success is not guaranteed [26]. - Regulatory authorities may disagree with the company's data interpretations, impacting the approval process for product candidates [26]. - The sufficiency of existing cash and cash equivalents to fund future operating expenses and capital requirements remains a concern [26].

Revenue Generation and Market Potential - The company generated approximately $43,000 in initial revenues from RenovoCath sales in Q4 2024, with expectations to increase revenues to the low six-figure range in Q1 2025[24]. - The initial target market for RenovoCath is estimated to be approximately $400 million in peak annual U.S. sales, based on an average selling price of $6,500-$8,500 per unit and approximately 7,000 target patients[25][49]. - The company believes that expansion opportunities across other clinical indications could create a several billion-dollar total addressable market potential for RenovoCath over time[26][49]. - The company is in discussions with over twenty institutions for potential purchase orders of RenovoCath devices[46]. - The company plans to penetrate the market by expanding relationships with 200 high-volume cancer treatment centers and engaging with surgical oncologists, medical oncologists, and interventional radiologists[50]. Clinical Trials and Efficacy - The ongoing pivotal Phase III clinical trial (TIGeR-PaC) for IAG has shown a 6-month median overall survival benefit of nearly 60% compared to the standard of care[32]. - The TIGeR-PaC trial has enrolled 90 patients as of March 31, 2025, with 50 events (deaths) recorded, and a second interim analysis is anticipated in Q2 2025[37]. - The first interim analysis of the TIGeR-PaC study indicated a greater than 65% reduction in adverse events with IAG compared to standard care[32]. - The Phase III TIGeR-PaC clinical trial showed a 6-month median overall survival benefit of nearly 60% for patients using RenovoCath compared to standard IV administration of gemcitabine and nab-paclitaxel[62]. - Patients experienced over a 65% reduction in adverse events with RenovoCath compared to standard care[62]. - The ongoing Phase III trial protocol was amended to include 114 patients, with a total of 86 events required for final analysis, aiming to reduce costs and timeframe[59]. - The company is exploring additional cancer tumors for development and potential commercial opportunities with the RenovoCath technology[58]. Regulatory Designations and Approvals - The company has received Orphan Drug Designation for IAG, providing 7 years of market exclusivity upon FDA approval[27]. - The company received FDA Orphan Drug Designation for IAG, providing 7 years of market exclusivity upon New Drug Application approval[58]. - The FDA has granted Orphan Drug Designation for the IAG product candidate in patients with pancreatic cancer, indicating potential for expedited development[102]. - The FDA has granted the company two orphan drug designations for pancreatic cancer and bile duct cancer, which will provide added protection upon commercialization[137]. - The RenovoCath device received initial 510(k) clearance from the FDA in 2014, classified as a Class II device, which requires premarket review and clearance[152]. Product Development and Technology - The TAMP therapy platform allows for targeted delivery of chemotherapy, potentially improving patient outcomes by delivering up to 100 times higher local drug concentration compared to systemic chemotherapy[45]. - The TAMP therapy platform allows for precise therapeutic delivery, potentially minimizing toxicities compared to systemic intravenous therapy[57]. - The TAMP platform has been under development for over 15 years, focusing on delivering chemotherapy to poorly vascularized tumors[75]. - The company is currently conducting a Phase III trial using generic gemcitabine labeled for IV use in conjunction with RenovoCath[133]. - The RenovoCath device is intended for use in arteries ranging from 3mm to 11mm in diameter for various applications, including chemotherapy drug infusion[138]. Financial Position and Future Outlook - As of December 31, 2024, the company has an accumulated deficit of approximately $50.2 million, with net losses of approximately $8.8 million and $10.2 million for the fiscal years ended 2024 and 2023, respectively[201]. - The company expects to continue incurring net losses until FDA approval for its product candidate or until the RenovoCath strategy generates sufficient revenues[201]. - The company has approximately $15.8 million in cash and cash equivalents as of March 1, 2025, and will need to raise substantial additional capital to develop and commercialize its products[213]. - The company has not recognized any revenue from its RenovoCath commercialization efforts to date, and revenue recognition may be complex and uncertain[209]. - The company expects fluctuations in revenues and results of operations, which may adversely affect its business and stock price[211]. Competition and Market Challenges - The oncology biotechnology and pharmaceutical industries are characterized by strong competition, with many companies having greater resources[182]. - The company may face competition from major pharmaceutical and biotechnology companies in the oncology market, affecting market entry and positioning[183]. - The company faces significant competition in establishing strategic partnerships, which may delay its business prospects[217]. - Third-party payors are increasingly challenging product pricing and examining medical necessity and cost-effectiveness, impacting reimbursement rates[179]. Regulatory Compliance and Risks - The company is subject to extensive FDA regulations, including compliance with Quality System Regulation (QSR) for medical devices[134][136]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of NDA approval, which can affect market potential and profitability[144]. - The FDA conducts inspections of clinical sites and manufacturing facilities before approving an NDA to ensure compliance with Good Clinical Practices (GCP) and current Good Manufacturing Practices (cGMP)[141]. - Regulatory approval processes vary by country, and failure to comply with foreign regulations may lead to fines or product recalls[161]. - Compliance with federal and state healthcare laws involves substantial costs and risks, including potential penalties and operational restructuring[170]. Strategic Planning and Management - The company may consider strategic alternatives, including financing and licensing arrangements, to maximize stockholder value[193]. - Future success depends on the ability to retain key personnel and attract qualified staff amid a competitive environment[200]. - The commercialization strategy for the RenovoCath device is new and evolving, with significant inherent risks related to manufacturing, supply chain, and sales efforts[205]. - The ongoing TIGeR-PaC study is the most advanced clinical trial, and its failure could significantly harm the company[193].