Lipella Pharmaceuticals Inc.

The company focuses on developing new drugs by reformulating active agents found in existing generic drugs and optimizing these reformulations for new applications. This strategy aims to combine cost efficiencies and reduced risks from using existing generic drugs with potential patent protections for its proprietary formulations, allowing the company to expedite, protect, and monetize its product candidates. The company therapeutically focuses on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. The company has not yet commercialized any products and does not expect to generate revenue from sales of any product candidates for several years. Its product candidates include LP-10, LP-310, LP-410, and LP-50. The company is currently addressing two indications through the development of its product candidates: LP-10 for hemorrhagic cystitis ("HC") and LP-310 for oral lichen planus ("OLP"). HC is chronic, uncontrolled urinary blood loss resulting from certain chemotherapies or pelvic radiation therapy, also known as "radiation cystitis." Many radiation cystitis patients experience severe morbidity, and in some cases, mortality, with no FDA-approved therapy or, to the company's knowledge, any other regulatory body-approved therapy currently available. LP-310, which employs a formulation similar to LP-10, is for the treatment of OLP. OLP is a chronic, T-cell-mediated, autoimmune oral mucosal disease, and LP-310 contains tacrolimus, which inhibits T-lymphocyte activation. OLP symptoms include painful burning sensations, bleeding, irritation with tooth brushing, painful, thickened patches on the tongue, and discomfort when speaking, chewing, or swallowing. OLP can also be a precursor to cancer, predominantly squamous cell carcinoma, with a malignant transformation rate of approximately one percent.