Lipella Pharmaceuticals Inc. announced top line results of the Company's recently completed Phase 2 a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for Hemorrhagic Cystitis, a rare but highly morbid disease for which there are currently no FDA approved treatments. The LP-10 Phase 2a clinical trial was a multi-center, dose-escalation study The study recruited 13 subjects with moderate to severe refractory hemorrhagic cystitis. These subjects were treated with up to two courses of LP-10 intravesical bladder instillations.

The top line results indicated: · All subjects tolerated LP-10 instillations and completed the study without report of product related serious adverse events. LP-10 pharmacokinetic analysis demonstrated short duration of systemic uptake. A dose response was noted and there were · Decreased hematuria · Decreased cystoscopic bleeding and ulceration sites · Improved patients' urinary symptoms · Responder analysis noted complete response in 3 subjects, partial response in 7 subjects and no response in 3 subjects.