RenovoRx Announces Second Quarter 2022 Financial Results

LOS ALTOS, Calif.–(BUSINESS WIRE)– RenovoRx Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on localized treatment of difficult-to-treat solid tumors with its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) technology.MT) therapy platform, today announced its financial results for the three months ended June 30, 2022.

“Over the past decade, our team has developed and refined a unique therapeutic platform for hard-to-treat solid tumors by localizing and targeting chemotherapy to minimize systemic side effects, improve quality of life and potentially prolong life. We started with one of the most aggressive tumor types – pancreatic cancer,” said Shaun Bagai, CEO of RenovoRx. “Innovation and success in pancreatic cancer treatment options are rare. Through our TIGeR-PaC Phase 3 clinical study, we have the potential to revolutionize the treatment of pancreatic cancer, shifting the focus of patients from managing treatment and its side effects to spending more time with their family and loved ones.

Mr. Bagai continued, “The most significant milestone to date for our therapeutic platform is expected in the fourth quarter of this year: the first prospective interim analysis for this pivotal Phase 3 study. on the potential of RenovoTAMP at a stage of the trial equivalent to a solid phase 2 oncology study, with the rigor of having randomized it. We also submitted a protocol to the FDA for a Phase 2/3 clinical trial in extrahepatic (or extrahepatic) cholangiocarcinoma, advancing our therapeutic platform into other indications. We expect to begin the study and enroll the first patient in the fourth quarter of 2022, assuming the protocol is acceptable to the FDA.

“To support our growth and infrastructure, in July we appointed James Ahlers, an accomplished life sciences finance leader, as Chief Financial Officer, and expanded our finance team with the addition of Ron Kocak, a seasoned financial reporting and accounting professional, serving as Vice President and Controller,” Mr. Bagai said. “With the addition of James and Ron, we continue to lay the foundation to support the evolution of our clinical pipeline.”

Financial Highlights for the Quarter Ended June 30, 2022

  • As of June 30, 2022, the Company had cash and cash equivalents and short-term marketable securities of $10.8 million.
  • Research and development expenses were $1.4 million for the three months ended June 30, 2022, compared to $0.5 million for the three months ended June 30, 2021. The increase of $0.9 million dollars is primarily due to a $0.5 million increase in preclinical and regulatory research and development expenditures, and a $0.2 million increase in clinical consultation to support the ongoing Phase 3 trial.
  • General and administrative expenses were $1.2 million for the quarter ended June 30, 2022, compared to $0.3 million for the quarter ended June 30, 2021. This increase of $0.9 million is mainly attributable to an increase of $0.4 million in professional and consulting services related to IPO support and an increase of $0.2 million for higher personnel costs.
  • Net loss was $2.6 million for the quarter ended June 30, 2022, compared to a net loss of $1.3 million for the quarter ended June 30, 2021.
  • As of June 30, 2022, the Company had 9,066,863 common shares outstanding.

About the TIGeR-PaC Phase 3 Clinical Trial

TIGeR-PaC is a randomized, multicenter Phase 3 study using RenovoRx’s innovative therapeutic platform, RenovoTAMPMT (RenovoRx trans-arterial micro-infusion). The study evaluates the company’s first product candidate, RenovoGemMT, to treat locally advanced pancreatic cancer (LAPC) by intra-arterial administration of gemcitabine (a chemotherapy approved by the FDA). The primary endpoint of the study is overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently recruiting unresectable LAPC patients at multiple sites across the United States. To learn more about the study and 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 through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) technology.MT) therapy platform. RenovoTAMP uses approved chemotherapeutic agents with validated mechanisms of action and well-established safety and side-effect profiles, with the goal of increasing their efficacy, improving their safety and expanding their therapeutic window. RenovoRx’s lead product candidate, RenovoGemMTis a combination of gemcitabine and our proprietary delivery system, RenovoCath®, and is regulated by the FDA as a new oncology drug to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

RenovoRx’s patent portfolio for its therapeutic platform and product candidates includes seven US patents, one European patent and several additional patents pending in the US, EU and Asia. RenovoRx has received Orphan Drug Designation for the intra-arterial administration of gemcitabine for the treatment of pancreatic cancer and biliary tract 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 follow 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 clinical trials and studies, including expected timeline, statements regarding the potential of RenovoTAMPMTRenovoCath® or RenovoGemMT or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential of our product candidates to treat or provide clinically meaningful results for certain medical conditions or diseases. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based on our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, beyond our control, and involve assumptions that may never materialize or occur. turn out to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapeutic 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 such forward-looking statements. These statements can be identified by words such as “may”, “expects”, “plans”, “aims”, “anticipates”, “believes”, “expects”, “estimates”, “has intention” and “potential”. or negative of these or other comparable terms regarding RenovoRx’s strategy, plans or intentions of expectations, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, which could cause actual events to differ materially from those projected or indicated by such statements, including, among others: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and research programs; our ability to use and expand our therapeutic 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 target and the number of patients likely to participate in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and potential to successfully manufacture and supply our product candidates for clinical trials and for commercial purposes, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenues, capital requirements and additional financing needs 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 needs; 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 businesses and product candidates; the extent of protection we are able to establish and maintain for intellectual property rights, including our therapeutic platform, product candidates and research programs; our ability to enter into contracts with third-party suppliers and manufacturers and their ability to operate adequately; pricing, coverage and reimbursement for our product candidates, if approved; developments related to our competitors and our industry, including competing product candidates and therapies; the negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. Information regarding the foregoing and additional risks can be found in the section titled “Risk Factors” in our filings from time to time with the Securities and Exchange Commission.

The forward-looking statements included herein are made as of the date hereof, and RenovoRx undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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