LOS ALTOS, Calif.–(BUSINESS WIRE)–August 15, 2022–
RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP TM ) therapy platform, today reported its financial results for the quarter ended June 30, 2022.
“Over the past decade, our team has developed and refined a unique therapy platform for difficult-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 Phase 3 TIGeR-PaC clinical study, we have the potential to revolutionize the treatment of pancreatic cancer, changing the way patients approach to cope with treatment and its side effects, to enjoy more time with family and loved ones.”
Mr. Bagai continued: “The most significant milestone to date for our therapy platform is expected in the fourth quarter of this year: the first prospective interim analysis of this pivotal Phase 3 study. These data will provide us with insight into significant of RenovoTAMP’s potential at a trial point equivalent to a robust phase 2 oncology study, with the rigor of having it randomized.We have also submitted a protocol to the FDA for a phase 2/3 clinical trial in extrahepatic (or outside the liver) cholangiocarcinoma, advancing our therapy platform to other indications. We plan 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 added James Ahlers, an accomplished life sciences finance leader, as CFO, and expanded our finance team with the addition of Ron Kocak, an experienced accounting and financial reporting professional, as Vice President, President and Controller,” said Mr. Bagai. “With the addition of James and Ron, we continue to build 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 quarter ended June 30, 2022, compared to $0.5 million for the quarter ended June 30, 2022. , 2021. The $0.9 million increase was primarily due to a $0.5 million increase in preclinical research and development and regulatory expenses, and a $0.2 million increase in clinical consultancy to support 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 was primarily due to a $0.4 million increase in professional and consulting services related to post-IPO support and a $0.2 million increase in costs related to the staff Net loss was $2.6 million for the quarter ended June 30, 2022, compared to net loss of $1.3 million for the quarter ended June 30, 2021. At 30 of June 2022, the Company had 9,066,863 ordinary shares in circulation.
About the TIGeR-PaC phase 3 clinical trial
TIGeR-PaC is a randomized, multicenter Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMP TM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the company’s first product candidate, RenovoGem TM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (an FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.
TIGeR-PaC is currently enrolling patients with unresectable LAPC at multiple sites in the US. For more information 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 using its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP TM ) therapy platform. RenovoTAMP uses approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the aim of increasing their efficacy, improving their safety and expanding their therapeutic window. RenovoRx’s lead product candidate, RenovoGem TM, is a combination of gemcitabine and our proprietary delivery system, RenovoCath ® , and is FDA-regulated as a new oncology product 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 therapy 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 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.
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, without limitation, statements about our trials and clinical studies , including the expected timing, statements regarding the potential of RenovoTAMP TM, RenovoCath ® or RenovoGem TM or with respect to our ongoing Phase 3 TIGeR-PaC clinical trial at 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 about future events, many of which, by their nature, are inherently uncertain, beyond our control and involve assumptions that may never materialize or may turn out to be incorrect. These may include estimates, projections and statements related 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 risks and known and unknown uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements can be identified by words such as “may”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “forecasts”, “estimates”, “intends” and “potential”. or the negative of these terms or other comparable terminology with respect to RenovoRx’s strategy, plans or expectations intentions, although not all forward-looking statements contain such 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 other things: the timing of commencement, progress and results potentials from our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a portfolio 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 suffering from the diseases we target and the number of patients who may be enrolled 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 use, if approved; future strategic agreements and/or collaborations and the potential benefits of such agreements; our estimates of 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 requirements; our ability to maintain 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 can 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 function properly; the price, coverage and reimbursement of our product candidates, if approved; developments related to our competitors and our industry, including product candidates and competing therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. Information about the above and additional risks can be found in the section entitled “Risk Factors” in the documents we file with the Securities and Exchange Commission from time to time.
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.
View the activated source version businesswire.com:https://www.businesswire.com/news/home/20220815005195/ca/
CONTACT: Company contact:
Shaun R. Bagai, CEO
James Ahlers, CFOInversor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
email@example.comContact with the media:
Knight Marketing Communications, Ltd.
KEYWORD: CALIFORNIA NEW YORK UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: RESEARCH FDA Clinical Trials BIOTECHNOLOGY HEALTH PHARMACEUTICALS GENERAL HEALTH SCIENCE ONCOLOGY
SOURCE: RenovoRx, Inc.
Copyright Business Wire 2022.
PUB: 15/08/2022 08:00/DISC: 15/08/2022 08:02