Ms. Gentry, an Industry Expert in Clinical Trials Management, Adds Valuable Leadership Experience to Advance Studies in Cancer Treatment.
Los Altos, CA, April 11, 2023 – RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, announced today that Leesa Gentry has joined the Company as Senior Vice President of Clinical Operations. Ms. Gentry, an industry expert in clinical trials management, brings the RenovoRx team valuable leadership experience to further advance studies in cancer treatment. In the past year, Ms. Gentry is the fourth addition to the Company’s executive management team following COO, Angela Gill Nelms, CFO, James Ahlers, and Vice President and Controller, Ron Kocak.
Ms. Gentry brings 29 years of experience focused on improving clinical research programs in Contract Research Organization (CRO), pharmaceutical, and biotech industries. Past employers include IQVIA (Quintiles), PPD, OmnicareCR and Otsuka. Prior to RenovoRx, she was Senior Vice President (SVP) of Clinical Operations at Evotec. (NASDAQ: EVO). At PPD, Ms. Gentry was Global Project Manager and Senior Research Specialist for Clinical Systems where her team developed one of the pharmaceutical industry’s first clinical trial management systems.
At Omnicare, Ms. Gentry grew the clinical research site network within long-term care; her work was featured in the Good Clinical Practice Journal. During her tenure at Otsuka, Ms. Gentry developed novel methods for improved, streamlined trial implementation in clinical operations, data management and third-party collaboration. Her work on registration trial implementation within resource-constrained environments was featured in the Bulletin of the World Health Organization.
“Leesa is an outstanding clinical operations leader with decades of diverse experience that will make an immediate impact to enhance our clinical trials,” said RenovoRx CEO, Shaun Bagai. “As we continue to build momentum on the heels of our positive, Phase III interim analysis data in pancreatic cancer treatment, we will look to her guidance to enhance our current and future trials. We are confident in Leesa’s track record for successful regulatory submissions, late-stage trial preparation, and clinical execution. She will be invaluable in our quest to increase patient lifespans and improve quality of life by developing innovative oncology therapies.”
Ms. Gentry added, “RenovoRx is changing the current standard of care for Locally Advanced Pancreatic Cancer (LAPC), and I am excited to be a part of the team’s mission,” said Ms. Gentry. “With interim data demonstrating clinically significant improvement in overall survival and quality of life for patients undergoing RenovoGemTM treatment, the team’s progress is impressive. Based on the Company’s pipeline and expected clinical milestones, RenovoRx has tremendous potential for helping patients with difficult-to-treat cancers.”
About RenovoRx, Inc.
RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. Our mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP®) therapy platform aims to avoid the harsh side effects typical of the current standard of care, or systemic delivery methods, thus improving patient well-being and, potentially extension of life, so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and clinical use, with the goal of improving their safety, tolerance, and widening their therapeutic window by providing more targeted delivery at the location of the tumor tissue. RenovoRx’s lead product candidate, RenovoGemTM, is a combination of gemcitabine and its patented delivery system, RenovoCath®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase III TIGeR-PaC clinical trial for the treatment of LAPC.
RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued U.S. patents, one issued European patent, and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma).
This press release contains 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 our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoTAMP®, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and our preliminary financial results, cash position and related ability to continue as a going concern. 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, clinical trials, therapy platform, business 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 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: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; the interim results may not be predictive of the outcome of our clinical trial, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, or the regulatory authority may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; 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; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. 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.