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.

Investor Presentation Delivering therapy where it matters® March 2025 © RenovoRx, Inc. All rights reserved. NASDAQ | RNXT Cautionary Note Regarding Forward-Looking Statements This presentation and statements of the Company's management made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) the potential of RenovoCath® or TAMP ...

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].

Group 1 - Stephen Read is the manager and founder of HIT Capital, which has a beneficial long position in RNXT through stock ownership [1][2] - HIT Capital was launched after Stephen Read's tenure at ConocoPhillips, where he worked before focusing on his investment firm [1] - The firm emphasizes the importance of generous investment strategies, as reflected in Stephen Read's favorite quote from 2 Corinthians 9:6 [1] Group 2 - HIT Investments serves as the general partner of HIT Capital, further solidifying its investment strategy and positioning [2] - Additional disclosures regarding HIT Capital's investment strategies and positions can be found on their official website [2]

Financial Position - As of September 30, 2024, the company had $9.6 million in cash, sufficient to fund operations for the next interim read-out and current commercialization efforts for RenovoCath[1]. - General and administrative expenses decreased to approximately $1.2 million for Q3 2024, down from $1.4 million in the same period last year[11]. - The net loss for Q3 2024 was $2.5 million, compared to a net loss of $1.4 million for Q3 2023[12]. Research and Development - Research and development expenses for Q3 2024 were approximately $1.7 million, remaining flat compared to the same period last year[10]. - RenovoRx signed a new work order with Medical Murray to increase production of RenovoCath devices[4]. Clinical Trials - The ongoing pivotal Phase III TIGeR-PaC clinical trial is expected to complete patient enrollment in the first half of 2025[2]. - The first patient was enrolled at the University of Nebraska Medical Center for the TIGeR-PaC trial, which is anticipated to drive enrollment completion[7]. - The second interim analysis for the TIGeR-PaC study will be triggered by the 52 event, estimated to occur in late 2024 or early 2025[15]. Commercial Strategy - The company expects its RenovoCath commercial strategy to potentially generate revenue in 2025[5]. - RenovoCath received Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing 7 years of market exclusivity upon NDA approval by the FDA[18].

Core Insights - RenovoRx is making significant progress in its pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer, with patient enrollment expected to complete in the first half of 2025 [2][15] - The company has a commercialization plan for its FDA-cleared RenovoCath delivery system, which is anticipated to generate near-term revenue in 2025 [2][5] - As of September 30, 2024, RenovoRx has $9.6 million in cash, sufficient to fund operations and the next interim analysis of the clinical trial [2][9] Financial Highlights - Cash Position: The company reported cash and cash equivalents of $9.6 million as of September 30, 2024 [9] - R&D Expenses: Research and development expenses were approximately $1.7 million for the third quarter of 2024, remaining flat compared to the same period last year [10] - G&A Expenses: General and administrative expenses were approximately $1.2 million for the third quarter of 2024, a decrease of approximately $0.2 million compared to the same period last year [11] - Net Loss: The net loss for the quarter ended September 30, 2024, was $2.5 million, compared to a net loss of $1.4 million for the same quarter in 2023 [12] Clinical and Operational Developments - The company has signed a new work order with Medical Murray to increase production of RenovoCath devices in response to growing demand from healthcare professionals [4] - The first patient has been enrolled at the University of Nebraska Medical Center for the ongoing TIGeR-PaC clinical trial, which is expected to drive enrollment completion [7] - Positive early-stage clinical data has been published in an international peer-reviewed journal, highlighting the safety and overall survival of patients undergoing treatment with the RenovoCath system [8] Management and Strategy - Robert Strasser has been promoted to Vice President of R&D and Operations, bringing extensive experience in operations and product commercialization [6] - The company is exploring various commercialization strategies for the RenovoCath delivery system, which may include direct sales or partnerships [4][18]

Core Viewpoint - RenovoRx, Inc. is increasing production of its FDA-cleared RenovoCath catheter-based delivery system due to rising demand from oncologists and interventional radiologists for targeted delivery of diagnostic and therapeutic agents [1] Group 1: Production and Manufacturing - RenovoRx has signed a new project work order with Medical Murray to expand their manufacturing relationship and explore commercial opportunities for RenovoCath beyond current clinical programs [2] - To incentivize Medical Murray, RenovoRx will issue a warrant for up to 709,500 shares of common stock, contingent on achieving certain manufacturing milestones [2] Group 2: Clinical Trials and Research - The company is committed to its ongoing pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC), with additional clinical sites joining to accelerate patient enrollment [3] - The TIGeR-PaC trial is evaluating the TAMP™ therapy platform using RenovoCath for intra-arterial infusion of gemcitabine HCl, comparing it to the current standard of care [3][7] - The primary endpoint of the trial is a 6-month overall survival benefit, with secondary endpoints including reduced side effects compared to standard treatment [8] Group 3: Market Strategy and Leadership - Feedback from physicians indicates a desire to purchase RenovoCath as a standalone device, which has been used in over 500 procedures [4] - The company is exploring commercial opportunities to meet growing demand for RenovoCath technology and expects to generate revenue during 2025 [4] - Robert Strasser has been promoted to Vice President of R&D and Operations, playing a key role in the company's manufacturing and commercial strategy [4] Group 4: Product Information - RenovoCath is designed for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, indicated for temporary vessel occlusion and chemotherapeutic drug infusion [5][9] - The device is intended for use in arteries with diameters ranging from 3mm to 11mm [5]