On January 29, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported that it has closed a private placement (the "private placement" or the "financing") resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses (Press release, Renovorx, JAN 29, 2024, View Source [SID1234639685]).
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The closing of this private placement extends RenovoRx’s cash runway as RenovoRx continues its ongoing pivotal TIGeR-PaC Phase III clinical trial, with a second interim analysis for this study to occur at the 52nd event (death), which is expected in late 2024.
RenovoRx insiders, including members of the management team and Board of Directors, participated in the private placement. Through the execution of this financing, RenovoRx sold an aggregate of 6,133,414 shares of common stock and warrants exercisable for up to an aggregate of 6,133,414 shares of common stock. Investors who are not insiders of RenovoRx paid $0.99 per share for the common stock and associated warrants, but RenovoRx’s management team and directors purchased shares and warrants at the market price for Nasdaq Stock Market purposes at $1.22 per share and associated warrant, reflecting their strong belief in the Company. The warrants are exercisable at a price equal to the per share price paid by the applicable investor and are exercisable for a period of five years following the closing of the private placement.
Shaun Bagai, CEO of RenovoRx, stated, "We are thrilled to start the new year with the closing of this important financing, especially in a challenging market climate. The net proceeds bolster our balance sheet and will allow us to drive our pivotal trial towards what we hope will be another positive interim analysis by the end of this year. We are particularly grateful for the participation in this financing from members of our board and management team as well as existing and new investors. With the net proceeds of this financing, in alignment with our consistent focus on efficient use of capital, we anticipate that we will be able to fund our operations through late 2024, even as we continue to explore additional capital raising opportunities. We are at a critical inflection point, and our efforts are laser focused on advancing multiple late-stage programs, reaching clinical milestones, and helping cancer patients live a longer, fuller life."
"Last year, I joined RenovoRx’s Board as a Director," said Dr. Robert J. Spiegel. "I have now chosen to join as an investor in this private placement financing. RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) platform has the possibility to extend across a variety of high unmet needs by expanding our pipeline into other difficult-to-treat solid tumor cancers with additional therapeutics."
The first interim analysis in RenovoRx’s pivotal Phase III TIGeR-PaC clinical trial at the 26th specified event, was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The second interim analysis will occur at the 52nd of the specified events. The 52nd event is estimated to occur in late 2024. TIGeR-PaC is an ongoing randomized multi-center study in locally advanced pancreatic cancer (LAPC) using RenovoRx’s proprietary TAMP therapy platform to evaluate its first product candidate, RenovoGemTM, a novel oncology drug-device combination product. The study is comparing treatment with TAMP to the current standard of care of systemic intravenous chemotherapy.
The TIGeR-PaC study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care. Interim analysis data was presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and as a Late Breaker Oral Presentation at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer.
The financing will also allow RenovoRx to begin to engage additional clinical trial sites in preparation for the Company’s Phase III CouGar study in bile duct cancer, which is the second late-stage clinical trial to evaluate RenovoGem in a difficult-to-access solid tumor cancer. RenovoRx has also identified other potential pipeline indication opportunities in non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma. The Company will require additional funding to fully pursue these opportunities.
Paulson Investment Company, LLC acted as the exclusive placement agent in connection with this financing.
"We are excited to assist RenovoRx in securing funding with Paulson’s high-net-worth clients for the Phase III study on its TAMP therapy for LAPC treatment," said Marta Wypych, Head of Investment Banking at Paulson Investment Company. "By doing so, we aim to facilitate the Company’s journey towards FDA approval, bringing forth this innovative combination therapy to the market for the well-being of pancreatic cancer patients."
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.