Lipella Pharmaceuticals Secures Extended Market Exclusivity with Issuance of U.S. Patent for Liposomal Delivery Platform

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing innovative therapies for serious diseases with unmet medical needs, today announced that U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform will be officially issued by the U.S. Patent and Trademark Office (USPTO) on November 12, 2024. This patent, titled "Delivery of Agents Using Metastable Liposomes," covers key technological innovations that enable the targeted delivery of therapeutic agents using liposome-based vehicles.

The patent’s claims cover Lipella’s method of using metastable liposomes to deliver therapeutic agents, providing broad intellectual property protection for the company’s drug delivery platform. This protection extends market exclusivity for Lipella’s two lead clinical assets, LP-10 and LP-310, which are currently in Phase 2 clinical trials. LP-10, a liposomal formulation of tacrolimus for treating hemorrhagic cystitis, and LP-310, an oral rinse for managing oral lichen planus, represent promising new approaches to addressing diseases with limited treatment options.

“We believe our proprietary liposomal drug delivery platform holds significant potential to enhance efficacy and tolerability across various therapeutic areas, including oncology, cancer survivorship and immunotherapy. This platform offers a safer, more effective way to administer therapeutics like tacrolimus, providing patients with targeted treatment options that minimize side effects,” said Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals. “The official issuance of this strategically important patent marks a pivotal advancement for Lipella, strengthening our intellectual property portfolio and supporting our commitment to advancing treatments for critical conditions such as hemorrhagic cystitis and oral lichen planus.”

With additional patents in the United States, Australia and Canada extending exclusivity until 2035, Lipella Pharmaceuticals is committed to providing value as it advances its clinical pipeline and explores new therapeutic applications.

About Lipella’s Lead Clinical Assets: LP-10 and LP-310

• LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare but severe condition characterized by bleeding from the bladder. LP-10 has shown promising safety and efficacy results in a multicenter Phase 2a trial, where it improved urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, further underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.
• LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mucous membranes of the mouth. LP-310 offers a promising new approach to treating OLP, which affects millions of Americans and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway with anticipated top-line data by year-end and trial completion by mid-2025. To find out more about our clinical trial visit: https://lipella.com/oral-lichen-planus-treatment/

About Lipella Pharmaceuticals Inc.Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in December 2022. Learn more at lipella.com and follow us on X and LinkedIn.

CONTACTJeff RamsonPCG [e-mail]646-863-6893