Study Results Validate Potential for Intra-arterial Chemotherapy Delivery for the Treatment of Pancreatic Cancer

RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that it will be presenting an ePoster at the 2021 Pancreas Club Annual Meeting being held virtually on November 11-12, 2021.

The poster describes the RR2 Observational Registry Study, which used RenovoRx’s novel therapy platform, RenovoTAMP™ (RenovoRx Trans-Arterial Micro-Perfusion), to deliver gemcitabine, an approved chemotherapeutic agent, intra-arterially to the pancreatic tumor. The results of this study along with the prior Phase 1 study form the foundation of RenovoRx’s ongoing randomized, multi-center Phase 3 clinical trial (TIGeR-PaC) of its lead product candidate, RenovoGem™, for the treatment of unresectable, locally advanced pancreatic cancer (LAPC).

The Registry Study, which was designed to assess the effectiveness and feasibility of intra-arterial therapeutic treatment of patients with LAPC, validated prior radiation and treatment location as predictors of overall survival. It included 25 patients (10 treatment naïve, 6 with prior chemotherapy, 8 with prior chemotherapy and radiation, and 1 that had undergone prior Whipple surgery). Patients with prior radiation treatment demonstrated increased survival benefit from RenovoTAMP (median overall survival of 23.1 months) when compared to patients with prior chemotherapy (median overall survival of 16.6 months) and treatment naïve patients (median overall survival of 5.7 months). In addition, treatment via the superior mesenteric artery (SMA) delivered greatest survival benefits, with median overall survival of 31.7 months when compared with treatment via other arteries. The survival benefit for patients treated with RenovoTAMP supports the rationale underlying the potential for intra-arterial, targeted chemotherapy delivery as a treatment for LAPC.

“Standard of care for patients diagnosed with unresectable LAPC is intravenous (IV) systemic chemotherapy, which both has significant side effects and is limited in its effectiveness by the lack of visible tumor feeders to pancreatic tumors,” said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx. “Based on the results of our foundational clinical trials, intra-arterial delivery of chemotherapy via RenovoTAMP not only reduced the tolerability issues associated with systemic chemotherapy, but by targeting delivery of treatment in close proximity to the tumor and pancreatic tissue, it also demonstrated improved patient survival rate.”

The details of the presentation are as follows:

Title: Treating locally advanced pancreatic cancer with a novel, dual-occlusion balloon catheter

Poster Number: P108

Authors: H. Charles Li; Carter Hultman; Alexander Rosemurgy, MD; J. Augusto Bastidas, MD; Reza Malek, MD; Emmanuel Zervos, MD; Steven Goldin, MD; Peter Muscarella, MD; Charles Nutting, DO; Barish Edil, MD; Ramtin Agah, MD

A recording of the presentation will be available on RenovoRx’s website.

About the Phase 3 TIGeR-PaC Clinical Trial

The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMP^™ platform to evaluate RenovoRx’s first product candidate, RenovoGem^™ to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP™) therapy platform. RenovoTAMP delivers approved small molecule chemotherapeutic agents locally to the solid tumors. RenovoRx’s lead product candidate, RenovoGem™, uses intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable locally advanced pancreatic cancer (LAPC) and is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

RenovoRx’s patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

Forward-looking statements

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 Phase 1 (RR1) and Observational Registry (RR2) studies, statements regarding the potential of RenovoTAMP™, RenovoCath^® or RenovoGem™ or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. 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; 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 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.

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