Lipella Pharmaceuticals Inks Manufacturing Partnership Agreement With Cook MyoSite

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has signed a manufacturing collaboration agreement with Cook MyoSite, Inc. (Cook MyoSite) to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), which is intended to treat hemorrhagic cystitis. The US Food and Drug Administration has designated LP-10 as an orphan drug. Lipella recently announced positive topline results from its Phase 2a clinical trial evaluating LP-10 as a drug candidate for hemorrhagic cystitis, a rare and debilitating disease for which there are currently no FDA-approved treatments.

Lipella's collaboration with Cook MyoSite, a company with 19 years of Good Manufacturing Practise ("GMP") manufacturing experience, is expected to significantly accelerate Lipella's ability to bring new treatments to patients with unmet needs. Lipella's Chief Medical Officer, Dr. Michael Chancellor, expressed his excitement about the collaboration, saying, "Cook MyoSite's reputation for quality and safety standards, as well as their extensive experience in GMP manufacturing, will be invaluable as we develop our IND application for LP-10."

We are confident that this collaboration will accelerate our efforts to develop clinical supplies and research products for LP-10, benefiting patients in the long run." Lipella's Chief Executive Officer, Dr. Jonathan Kaufman, emphasised the importance of CMC documentation in the regulatory approval process, particularly for products developed through the FDA's 505(b)(2) pathway, such as LP-10. He emphasised that the collaboration with Cook MyoSite will be critical in advancing LP-10's commercial approval.

Cook MyoSite's Managing Vice President, Ryan Pruchnic, who is also a member of Lipella's board of directors, stated Cook MyoSite's commitment to Lipella's investigational products. "LP-10 is a fantastic drug candidate with enormous potential to help patients in need." Mr. Pruchnic stated, "We are excited to share our knowledge and expertise in GMP manufacturing and contribute to the advancement of this promising therapeutic."

With this collaboration, Lipella and Cook MyoSite will be able to make a greater impact in addressing the significant unmet need for effective hemorrhagic cystitis treatments, as well as move LP-10 closer to regulatory approval. Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. In addition to operating several regulated clinical studies, Cook MyoSite provides a range of custom services, including modified cell samples to contract manufacturing arrangements, procurement and processing of muscle cells from specific donor populations, custom media formulations, CMO/CDMO arrangements, and QC analytical testing and assay development.