On March 30, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its financial results for the year ended December 31, 2021 (Press release, Renovorx, MAR 30, 2022, View Source [SID1234611206]).
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"2021 was a transformative year for RenovoRx. We successfully closed on our initial public offering and listed on the NASDAQ under ‘RNXT,’" said Shaun Bagai, CEO of RenovoRx. "Importantly, despite challenges created by the COVID-19 pandemic, we maintained steady enrollment in our Phase 3 clinical trial in locally advanced pancreatic cancer. We recently achieved approximately 50% of the target enrollment under the current statistical analysis plan. One of the issues with systemic chemotherapy is the significant side effects to the entire body. RenovoRx is addressing this problem by localizing therapy to treat tumors via our proprietary RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapeutic platform. Today, we have the strategy and team to build on our progress in treating pancreatic cancer with the opportunity to extend the RenovoTAMP platform to other cancers. We are challenging the bounds typically associated with treating solid tumors to improve survival and quality of life for patients undergoing chemotherapy."
2021 Operational Highlights:
Issuance of seventh U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform.
Closed on IPO and listed on the Nasdaq Capital Market under the ticker symbol, "RNXT."
Received new 510(k) clearance for the RenovoCath delivery system (the device component of the Company’s initial product, RenovoGem). RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.
Announced final data from RR2 observational registry study. Phase 1/2 trials demonstrated that prior radiation treatment, together with targeted chemotherapy delivered via RenovoTAMP, reduced the tolerability issues typically associated with systemic chemotherapy and improved survival.
2022 Operational Highlights and Upcoming Targeted Milestones:
Began enrolling patients at Columbia University’s New York-Presbyterian Hospital Irving Medical Center in ongoing TIGeR-PaC Phase 3 Clinical Trial.
TIGeR-PaC achieved approximately 50 percent of the target enrollment under the current statistical analysis plan.
Plans to meet with the FDA to discuss trial design for a second indication, extrahepatic (or outside the liver) cholangiocarcinoma (bile duct cancer), or eCCA. Pending the outcome of that meeting and protocol submission, Phase 2 trial in eCCA may be launched in 2H 2022.
Expects to conduct TIGeR-PaC interim analysis.
Financial Highlights for the Fiscal Year Ended December 31, 2021
Cash and cash equivalents as of December 31, 2021, were $15.2 million.
Research and development expenses were $3.0 million for the year ended December 31, 2021, compared to $2.4 million for the year ended December 31, 2020. The increase was primarily due to higher clinical development employee-related costs.
General and administrative expenses were $2.6 million for the year ended December 31, 2021, compared to $0.8 million for the year ended December 31, 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including employee-related costs and insurance costs for Directors and Officers Liability Insurance.
Net loss was $6.3 million for the ended December 31, 2021, compared to net loss of $3.8 million for year ended December 31, 2020.
As of March 25, 2022 the Company had 9,029,305 common shares outstanding.
About the Phase 3 TIGeR-PaC Clinical Trial
TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMP (RenovoRx Trans-arterial Micro-perfusion). The study is evaluating the Company’s first product candidate, RenovoGem, 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 unresectable LAPC patients at several sites across the U.S. To learn more about the study and the participating clinical trial sites, visit View Source