On November 15, 2021 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its unaudited financial results for the third quarter ended September 30, 2021 (Press release, Renovorx, NOV 15, 2021, View Source [SID1234595643]).
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"The third quarter of 2021 marked an important juncture in the growth of our company as we completed our IPO in late August and our seventh U.S. patent was issued for our RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform. Our team remains patient-focused, supporting the clinical sites, their patients and families enrolled in our Phase 3 TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC)," said Shaun Bagai, Chief Executive Officer of RenovoRx.
Mr. Bagai added, "At two recent pancreatic cancer-focused meetings, we presented incremental positive study data from our foundational clinical trials that support the potential for more tolerable and targeted treatment of LAPC through intra-arterial delivery of chemotherapy. Through preliminary pharmacokinetic data (data describing the absorption, distribution, metabolism, and excretion of chemotherapy) from five patients in the TIGeR-PaC study, we found an approximate two-thirds reduction in systemic gemcitabine, when compared to systemic levels in historical control patients receiving traditional IV infusion of gemcitabine. This finding reinforces the potential for intra-arterial delivery to improve tolerability, reduce typical, and often debilitating, side effects associated with systemic chemotherapy, and ultimately improve quality of life. In addition, the final data we presented from our RR2 Observational Registry Study suggests that when RenovoTAMP is used in combination with radiation therapy, it may reduce arterial microvasculature, which minimizes leakage during chemotherapy delivery, and thereby increases the chemotherapy directly reaching the tumor."
GAAP Financial Results
For the Third Quarter Ended September 30, 2021 (Unaudited)
Net loss for the third quarter of 2021 was $1.5 million, compared to $1.1 million for the third quarter of 2020.
Research and development expenses for the third quarter of 2021 were $0.8 million, compared to $0.7 million for the same period in 2020. The increase was primarily due to higher clinical development personnel costs.
General and administrative expenses for the third quarter of 2021 were $0.6 million, compared to $0.2 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.
For the Nine Months Ended September 30, 2021 (Unaudited)
Net loss for the nine months ended September 30, 2021 was $4.0 million, compared to $2.9 million for the same period in 2020.
Research and development expenses for the nine months ended September 30, 2021 and 2020 were each $1.9 million. Research and development expenses during the 2021 period were higher overall, primarily due to higher clinical development personnel costs, but were offset by lower leased software expenses and payments received from clinical sites for the use of our RenovoCath delivery system in our Phase 3 clinical trial.
General and administrative expenses for the nine months ended September 30, 2021 were $1.4 million, compared to $0.6 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.
As of September 30, 2021, the Company had cash and cash equivalents of $17.7 million and no outstanding debt obligations.
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 View Source