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Lipella Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing treatments for serious diseases for which there are currently no approved drug therapies. Our proprietary drug delivery technology has potential applications in addressing diseases of the mucosal tissue including the bladder, urethra, oral cavity, esophagus and colon. We see strong potential for our technology in partnerships and commercial licensing agreements.

We have successfully completed a Phase 2a multi-center dose-escalation clinical trial for our lead product candidate, LP-10 (liposomal tacrolimus), in the treatment of hemorrhagic cystitis. Lipella expects to have a Type C meeting with the FDA in H1 2024 to discuss our proposed Phase 2b clinical trial design for the evaluation of LP-10. We believe LP-10 has the potential to be the first drug candidate and drug delivery technology to treat cancer survivors who acquire hemorrhagic cystitis.

Our broad pipeline also includes LP-310, an oral formulation of LP-10, for the treatment of oral lichen planus, LP-410 for the treatment of oral Graft-versus-Host disease (GvHD), and LP-50, which has shown promise in preclinical studies as a potential treatment for non-muscle invasive bladder cancer (NMIBC).