RenovoRx(RNXT) - 2025 Q2 - Quarterly Results

Business Highlights and Operational Updates RenovoRx reported significant progress in the second quarter of 2025, highlighted by initial commercial revenue from its RenovoCath device and a positive recommendation from the Data Monitoring Committee (DMC) to continue its pivotal Phase III TIGeR-PaC trial RenovoCath Commercialization The company achieved over $400,000 in revenue from RenovoCath sales in Q2 2025, marking its second full quarter of commercial activity, expanding its customer base and sales team | Metric | Value | Period | | :--- | :--- | :--- | | Commercial Revenue | > $400,000 | Q2 2025 | - The number of cancer centers approved to purchase RenovoCath increased to thirteen, up from five in the first quarter of 2025, with all four centers that have used the device making repeat purchase orders[5][11] - The initial total addressable market (TAM) for RenovoCath is estimated at a $400 million peak annual U.S. sales opportunity, with potential to expand into a multi-billion dollar market with additional applications[6] - Hired Philip Stocton as Senior Director of Sales and Market Development to expand commercial efforts[2][13] Pivotal Phase III TIGeR-PaC Trial Update The independent Data Monitoring Committee (DMC) recommended the continuation of the Phase III TIGeR-PaC trial, with 95 of 114 patients randomized as of August 12, 2025 - The independent Data Monitoring Committee (DMC) recommended the continuation of the Phase III TIGeR-PaC trial following a review of the second pre-planned interim analysis[3][9] - The company will defer publishing the second interim data to preserve the integrity of the trial, with plans to revisit publication upon study completion[4][9] | Trial Progress | Current Status (as of Aug 12, 2025) | Target for Final Analysis | | :--- | :--- | :--- | | Randomized Patients | 95 | 114 | | Events (Deaths) | 61 | 86 | Other Key Developments RenovoRx expanded its patent protection for the TAMP therapy platform, initiated a post-marketing registry study, and added Johns Hopkins Medicine as a new clinical trial site - Received U.S. patent No. 12,290,564, titled "Methods for Treating Tumors," which expands protection for the TAMP therapy platform through November 2037[15] - Launched the PanTheR study, a multi-center post-marketing observational registry to evaluate the safety and effectiveness of RenovoCath in real-world clinical settings[16] - Initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial[14] Financial Performance For the second quarter of 2025, RenovoRx reported revenues of $422,000 and a net loss of $2.9 million, ending the quarter with a strong cash position of $12.3 million Financial Highlights (Q2 2025) RenovoRx generated $422,000 in revenue from RenovoCath sales, maintained stable operating expenses, and reported a net loss of $2.9 million, primarily due to a change in warrant liability fair value - As of June 30, 2025, the company had $12.3 million in cash and cash equivalents, believed to be sufficient to fund ongoing RenovoCath scale-up and progress in the TIGeR-PaC trial[1][18] | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $422,000 | $0 | +$422,000 | | R&D Expenses | $1.4 million | $1.5 million | -$0.1 million | | SG&A Expenses | $1.5 million | $1.5 million | Unchanged | | Net Loss | $2.9 million | $2.4 million | +$0.5 million | - The increase in net loss was primarily driven by a $0.9 million change in the fair value of the warrant liability, offset by a $0.4 million decrease in loss from operations[21] Financial Statements The unaudited financial statements show total assets of $13.6 million and total liabilities of $3.0 million as of June 30, 2025, with revenues of $422,000 and a net loss per share of ($0.08) for the quarter Selected Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,314 | $7,154 | | Total assets | $13,643 | $8,118 | | Total liabilities | $3,002 | $3,640 | | Total stockholders' equity | $10,641 | $4,478 | Selected Statement of Operations Data (in thousands, except per share) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $422 | $0 | | Gross profit | $270 | $0 | | Loss from operations | ($2,678) | ($3,034) | | Net loss | ($2,895) | ($2,389) | | Net loss per share | ($0.08) | ($0.10) | Corporate Information This section provides details about RenovoRx's products, business focus, and standard legal disclaimers, including a cautionary note on forward-looking statements About RenovoRx and RenovoCath RenovoRx is a life sciences company commercializing the FDA-cleared RenovoCath device and developing targeted oncology therapies via its patented Trans-Arterial Micro-Perfusion (TAMP™) platform - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing its FDA-cleared drug-delivery device, RenovoCath[30] - The TAMP™ therapy platform is designed for targeted therapeutic delivery across the arterial wall near a tumor, potentially minimizing systemic toxicities[30] - RenovoCath is FDA-cleared for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, including for chemotherapeutic drug infusion[29] Forward-Looking Statements This section contains a standard cautionary note advising that the press release includes forward-looking statements concerning clinical trials, commercialization plans, revenue generation, and product potential - The press release contains forward-looking statements regarding clinical trials, commercialization plans, and financial projections[35] - These statements are subject to numerous risks and uncertainties, including those related to clinical trial outcomes, regulatory approvals, commercial success, and financing needs[35]