RenovoRx(RNXT) - 2025 Q1 - Quarterly Results

Business and Commercialization Update 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][4] - Over ten medical institutions have placed initial and repeat purchase orders for RenovoCath[5] - 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][7] - Intellectual property strengthened with a new U.S. patent for the TAMP therapy platform, expanding the global portfolio to 19 patents[11] Ongoing Pivotal Phase III TIGeR-PaC Trial Update 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] 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] - Supportive pre-clinical and pharmacokinetic data for the TAMP therapy platform were presented at major oncology conferences including ASCO GI, SIO, and SSO[10] Financial Highlights for the First Quarter Ended March 31, 2025 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][16] 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 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][23] - Management and Board members purchased approximately 143,000 shares in open market transactions during Q1 2025[12] 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) |