RNXT RenovoRx Inc

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced that Ripal Gandhi, M.D., FSIR, FSVM will present at the Symposium on Clinical Interventional Oncology (“CIO”) which is being held September 20-22, 2024, at the Loews Hotel in Miami Beach, Florida. Dr. Gandhi’s presentation will highlight RenovoRx’s TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (“LAPC”) and recent publications of clinical data.

Dr. Gandhi, professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine, is a Course Director for the Symposium on CIO. Since 2018, Dr. Gandhi has been instrumental as a principal investigator for the Miami Cancer Institute in RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial in LAPC.

Dr. Gandhi’s presentation will provide an overview of the clinical challenges of the standard of care treatment available to LAPC patients. Systemic (intravenous) chemotherapy, while considered the standard-of-care for LAPC, is often associated with debilitating side effects, and may have limited effectiveness in treating this type of cancer due to tumors lacking dedicated blood vessels critical for delivering chemotherapy. Dr. Gandhi will highlight the TAMP therapy platform and the opportunity it may give to LAPC patients as a potential targeted oncology option for treatment.

Dr. Gandhi will also discuss the status of the Company’s ongoing Phase III TIGeR-PaC study, which is evaluating the use of the TAMP therapy platform with gemcitabine HCl in patients with LAPC. Additionally, he will review a recent publication in the international peer-reviewed journal, The Oncologist®, of early-stage clinical data on the intra-arterial administration of gemcitabine HCl utilizing the TAMP including Phase I/II dose escalation safety study (RR1) and acquired data from a post-marketing post-treatment observational registry study (RR2).

Presentation Details:Date: Saturday, September 21, 2024Title: New Frontiers in Pancreatic Cancer: Transarterial and Transvenous ApproachesTime: 9:30am ETLocation: Loews Hotel in Miami Beach, FloridaSpeaker: Ripal Gandhi, M.D., FSIR, FSVMEvent Website: Home | Symposium on Clinical Interventional Oncology (hmpglobalevents.com)

About the TIGeR-PaC Clinical Trial TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first product candidate using the TAMP technology is a novel investigational oncology drug-delivery combination utilizing the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine HCl.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Independent Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study's primary endpoint is a 6-month Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event, which is estimated to occur in late 2024 or early 2025.

About RenovoRx, Inc.RenovoRx is a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel and patented approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Its Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine HCl by the RenovoCath catheter is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and Research (the drug division of FDA).

RenovoRx is also actively exploring other commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath delivery system as a stand-alone device.

RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. The intra-arterial infusion of gemcitabine HCl by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Cautionary Note Regarding Forward-Looking StatementsThis press release and statements made in connection therewith and at the Symposium on CIO described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding (i) our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath® or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; (vi) research and clinical development plans and timelines, and the regulatory process for our product candidates; (vii) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (viii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (ix) our ability to advance product candidates into, and successfully complete, clinical trials; (x) the timing or likelihood of regulatory filings and approvals; (xi) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xii) the commercialization potential of our product candidates, if approved; (xiii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiv) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xvi) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvii) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xviii) the implementation of our strategic plans for our business and product candidates; (xix) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xx) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xxi) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxii) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT:212-896-1254RenovoRX@KCSA.com