BIVI

BioVie Inc. is a clinical-stage biopharmaceutical company developing innovative drug therapies for chronic and debilitating liver diseases and neurological disorders. Headquartered in Carson City, Nevada, BioVie is advancing a pipeline of therapies targeting conditions with significant unmet medical needs where current treatment options are limited or inadequate. The company's lead programs address liver cirrhosis and Alzheimer's disease, two conditions affecting millions globally and representing substantial commercial opportunities. BioVie's lead candidate for liver disease is BIV201 (continuous infusion terlipressin), being developed for patients with ascites due to liver cirrhosis. Terlipressin has been used in Europe for hepatorenal syndrome and variceal bleeding, but BioVie is developing a novel continuous infusion formulation designed to be safer and more effective for managing ascites in cirrhotic patients. The company has completed Phase 2 studies and is advancing toward pivotal trials. For Alzheimer's disease, BioVie is developing NE3107, an oral small molecule that inhibits inflammatory signaling pathways implicated in neurodegeneration and insulin resistance. NE3107 has shown encouraging signals in clinical studies for both Alzheimer's and potentially other conditions involving neuroinflammation. The company's differentiation stems from repositioning existing compounds with known safety profiles into new indications where they may provide clinical benefits. This approach potentially reduces development risk and timelines compared to developing novel chemical entities. BioVie addresses large patient populations with serious conditions where effective therapies are lacking. Success depends on demonstrating clinical efficacy and safety in rigorous trials, securing regulatory approvals, establishing commercial partnerships, and ultimately reaching patients who could benefit from these therapies. The company continues advancing its clinical programs while managing capital efficiently through this development-stage phase.