LIPO Lipella Pharmaceuticals Inc

Lipella Pharmaceuticals Inc. (Nasdaq: “LIPO”) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate to severe hemorrhagic cystitis (HC). Lipella expects to meet with the FDA on May 21, 2024.

HC is a serious, life-threatening form of gross hematuria (i.e. visible blood in urine) caused by cancer treatments including pelvic radiation therapy, and certain chemotherapies including cyclophosphamide and ifosfamide, which are most commonly used for the treatment of breast cancer.

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, expressed anticipation for advancing the LP-10 program, stating, “We are eager to advance our LP-10 program efficiently, and our scheduled FDA meeting in the second quarter of 2024 will play a pivotal role in enhancing the regulatory prospects of LP-10.”

Lipella successfully completed a Phase-2a open-label, dose-escalation clinical trial in early 2023 demonstrating the safety, and the potential efficacy of LP-10 in 13 patients with a history of HC. The study demonstrated preliminary efficacy in multiple measures, including urine microscopy, urinalysis, urinary urgency, as well as a potential dose response in the reduction of bleeding sites observed during bladder cystoscopy. Lipella published these results in the peer-reviewed journal, International Urology and Nephrology, in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.

The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

About LP-10, LP-310 and LP-410

LP-10 is a liposomal tacrolimus formulation for intravesical administration to treat hemorrhagic cystitis (HC). LP-10 has been evaluated in a multicenter Phase 2a dose escalation trial of 13 subjects with moderate to severe refractory HC, with positive top line results demonstrating safety and efficacy, short duration of systemic uptake of LP-10, and a dose response including decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients. Lipella has been granted Orphan Disease Designation by the FDA for LP-10 in the treatment of moderate to severe hemorrhagic cystitis. LP-310/LP-410 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella’s lead drug candidate, LP-10, for the indications of oral lichen planus (OLP) and oral Graft-versus-Host Disease (GvHD). Lipella has been granted orphan drug designation by the FDA for LP-310 in the treatment of GvHD.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements

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CONTACTDr. Jonathan Kaufman, CEOLipella PharmaceuticalsInfo@Lipella.com 1-412-894-1853

PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com