Renibus Therapeutics – a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases – recently announced the close of an extension to its Series B financing round, bringing the total amount raised to $72 million. And Renibus’ investors are comprised of existing and new investors, including leaders in the cardiac surgery community.
The proceeds from the Series B financing will be used to advance RBT-1 through a pivotal Phase 3 trial for its lead indication of reducing the risk of postoperative complications following cardiothoracic surgery. And RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant, and iron scavenging pathways that acts as a preconditioning agent, initially being studied in cardiac surgery patients. And in February 2023, Renibus completed Phase 2 development of RBT-1 and presented the data at the American Association for Thoracic Surgery Meeting during a late-breaking session in May 2023.
The Phase 2 study of RBT-1 (NCT04564833), which was completed in February 2023, was a randomized, double-blind, multi-center, placebo-controlled trial evaluating the effect of RBT-1 in patients undergoing elective coronary artery bypass graft (CABG) and cardiac valve surgery. And Renibus announced positive final results from this study in May 2023, which supports the advancement of RBT-1 into a pivotal Phase 3 study.
In June 2023, RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. In July 2023, Renibus reached an agreement with the FDA on the Phase 3 program for RBT-1.
KEY QUOTES:
“Closing an upsized round with $72 million in demand is a testament to the experience and track record of the Renibus team and the unique potential of RBT-1 to act as a preconditioning agent, bringing long-overdue innovation to patients undergoing cardiac surgery. We remain highly encouraged by our opportunity with RBT-1 and are well positioned to execute our pivotal Phase 3 development plans. In addition, the FDA’s alignment on our Phase 3 pivotal study and our recent Breakthrough Therapy Designation, give us great confidence to advance RBT-1 towards patients in need with the potential to create a transformative new drug category.”
– Frank Stonebanks, Co-CEO of Renibus
“We are pleased with the tremendous enthusiasm and commitment from our investors in deploying this additional capital. The funding provides sufficient runway to advance RBT-1 through the planned Phase 3 trial and preparation for an NDA filing. The upsized round is also expected to enable us to selectively fund additional pipeline programs with the potential for further value creation.”
– Jamie A. Donadio, Chief Financial Officer of Renibus
