Renibus Therapeutics is a clinical-stage biopharmaceutical company focused on preventing and treating cardio-renal and metabolic diseases. Its lead candidate, RBT-1 (stannic protoporfin/iron sucrose), is being developed as a preconditioning agent that induces anti-inflammatory, antioxidant, and iron-scavenging pathways and is initially studied in cardiac surgery patients. Renibus completed a randomized, double-blind, multi-center, placebo-controlled Phase 2 study of RBT-1 in February 2023 and announced positive final results in May 2023. RBT-1 received Breakthrough Therapy designation from the U.S. FDA in June 2023, and Renibus reached agreement with the FDA on the Phase 3 program in July 2023. The company intends to advance RBT-1 into a pivotal Phase 3 trial to reduce postoperative complications following cardiothoracic surgery and to prepare for an NDA filing. Renibus recently closed a Series B financing extension that brings total proceeds to $72 million to support the Phase 3 program and selective funding of additional pipeline programs. Renibus Therapeutics, based in Southlake, TX, is a clinical-stage biopharmaceutical company led by Co-CEOs Frank Stonebanks and D. Jeff Keyser. The company has developed a portfolio of products that activate multiple cytoprotective pathways, including organ protection via preconditioning. Its lead program, RBT-1, is a potent inducer of anti-inflammatory, antioxidant and iron-scavenging pathways and is being advanced for reducing the risk of post-operative complications following cardiothoracic surgery. RBT-2 is an antioxidant and anti-fibrotic candidate with preclinical data suggesting potential to reduce CKD progression. RBT-3 is a low molecular weight iron nanoparticle aimed at rapidly resolving anemia and reducing cisplatin-induced nephrotoxicity. RBT-9 (stannic protoporphyrin) is an anti-inflammatory and antioxidant drug with reported broad-spectrum antiviral properties and was investigated in a 42-patient Phase 2 randomized, placebo-controlled trial in high-risk COVID-19 patients. Renibus Therapeutics develops a portfolio of products that activate multiple cytoprotective pathways to prevent disease progression and protect organs in cardiorenal diseases. Its lead program, RBT-1 (SnPP/FeS), is a potent inducer of Nrf2, IL-10, and ferritin and is in Phase 2 development in cardiac surgery, with plans to enter a Phase 3 registration study for its lead indication to reduce postoperative complications after cardiothoracic surgery. RBT-2 (tetrahydrocurmin) is an antioxidant and anti-fibrotic intended to inhibit CKD progression and is slated for IND-enabling and clinical development in 2023. RBT-3 (FeS), a low molecular weight iron nanoparticle and component of RBT-1, is targeted at reducing cisplatin-induced nephrotoxicity and will enter clinical development in 2023. RBT-9 (SnPP), the other component of RBT-1, has anti-inflammatory, antioxidant, and antiviral properties and was studied in a 42-patient Phase 2 RCT in COVID pneumonia, where it reportedly reduced hospital length of stay by ~70%. The company, led by Chairman and CEO Frank Stonebanks and based in South Lake, Texas, recently secured bridge financing to support these development plans. Renibus Therapeutics is a Southlake, TX–based clinical-stage biotech focused on advancing the cardiorenal disease treatment paradigm by preventing and treating kidney disease. Its portfolio includes RBT-1 (prevention of acute kidney injury), RBT-2 (treatment of chronic kidney disease) and RBT-3 (treatment of iron deficiency anemia and platinum-based kidney toxicity). RBT-1 is in a large (126-patient), randomized, double-blind study in AKI in a cardiac surgery setting. RBT-2 is scheduled to begin Phase I later this year. RBT-3 may commence Phase III development in Q3 2022 and is described as having a differentiated profile versus the current standard of care. The company completed a Series A financing that closed at $35M and intends to use the funds to advance its pipeline and lead candidates.

Total raised

$167M

Funding rounds

5

Latest round

Series B

Latest activity

Sep 2023