Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella addresses serious diseases with significant morbidity and mortality for which there are currently no approved drug therapies.

We recently completed a phase 2A multi-center dose-escalation clinical trial for our lead product, LP-10, which focuses on cancer survivors who acquire hemorrhagic cystitis, (HC), also called radiation cystitis, that occurs after pelvic radiation. We are developing LP-10 and our Platform to be, to our knowledge, the first drug candidate and drug delivery technology to successfully treat cancer survivors who acquire HC.

In a second program, we are developing LP-310, a product candidate which employs a formulation similar to LP-10, for the treatment of oral lichen planus (“OLP”). OLP is a chronic, T-cell-mediated, autoimmune oral mucosal disease, and LP-310 contains tacrolimus which inhibits T-lymphocyte activation. LP-310 is specifically optimized for local delivery to oral mucosa. We believe there are no other liposomal products developed to treat such disease and that our approach of using metastable liposomal tacrolimus as a treatment for OLP is novel.