Renibus Therapeutics Announces $47 Million Financing to Advance Lead Program RBT-1 Through Pivotal Phase 3 Trial

2023-07-18

临床2期临床3期临床结果突破性疗法

-Financing follows positive final Phase 2 results of RBT-1 presented at AATS 2023- -Proceeds fund pivotal Phase 3 trial of RBT-1; on track to initiate in Q3 2023- SOUTHLAKE, Texas, July 18, 2023 /PRNewswire/ -- Renibus Therapeutics, Inc., ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal diseases, today announced raising $47 million from the initial closings of a Series B financing. Proceeds from the financing will be used to advance RBT-1 through a pivotal Phase 3 trial for its lead indication of reducing the risk of post-operative complications following cardiothoracic surgery. 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. 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 last few months have been transformational for Renibus, highlighted by the completion of the RBT-1 Phase 2 study demonstrating RBT-1's potential to prevent organ damage and minimize post-operative complications after cardiac surgery. These results, and the FDA's Breakthrough Designation, catalyzed the $47 million financing announced today," said Frank Stonebanks, Co-CEO of Renibus. "These funds, from existing and new investors, including leaders in the cardiac surgery community, will be used to advance RBT-1 through the planned Phase 3 trial, which is designed to be a standalone pivotal study for submission of a new drug application. Our investor base remains strong, and we thank them for supporting our shared commitment to advancing RBT-1 and improving patient healthcare." About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways that is advancing toward Phase 3 development for its lead indication to reduce post-operative complications following cardiothoracic surgery. 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/or cardiac valve surgery. 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. About Renibus Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardiorenal diseases and complex surgeries. The Company has developed a robust portfolio of products that activate multiple cytoprotective pathways, including organ protection via preconditioning. Renibus' first-in-class lead program is RBT-1. RBT-2 is an antioxidant and anti-fibrotic drug that has been shown in pre-clinical models to have the potential to reduce the risk of CKD progression. RBT-3 is a novel, low molecular weight iron nanoparticle that has the potential to rapidly resolve anemia and reduce the risk of cisplatin-induced nephrotoxicity. RBT-9 (stannic protoporfin) is a potent anti-inflammatory and antioxidant drug with broad spectrum anti-viral properties. It has been investigated in a 42-patient Phase 2, randomized, placebo-controlled trial in high-risk patients with COVID-19. The data from this trial indicated the RBT-9 has the potential to significantly improve clinical outcomes in life threatening viral infections. Additional pre-clinical work is underway to help inform the clinical development strategy. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point amy@juniper-point.com 858-914-1962 Business Development Contact Frank Stonebanks Co-CEO, Renibus fstonebanks@renibus.com