On March 31, 2023 Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, reported a business update and provided financial results for the year ended December 31, 2022 (Press release, Lipella Pharmaceuticals, MAR 31, 2023, View Source [SID1234629802]).
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Jonathan Kaufman, Co-founder and CEO of Lipella Pharmaceuticals, commented, "Last year we focused on developing our corporate profile and scientific mission to address serious diseases with significant unmet need. During 2022, Lipella achieved several important milestones including the Company’s completion of its Initial Public Offering in late December.
"Subsequent to the year end in early 2023, we announced the successful top line results of our Phase 2a clinical trial evaluating LP-10, our lead product candidate in 13 subjects with moderate to severe refractory hemorrhagic cystitis (HC). HC is a potentially fatal disease with great unmet need and no currently approved drug treatment.
"The results of the trial demonstrated no serious adverse events, very short duration of systemic uptake, and decreased hematuria, cystoscopic bleeding and ulceration sites, resulting in improved patients’ urinary symptoms. We’re excited to have the results presented by study leader Dr. Jason Hafron, from the Michigan Institute of Urology, at the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.
"Following our IPO and other initial expenses, we ended the year with $5.1 million in cash. We anticipate this will provide Lipella with an operating runway into 2024," concluded Dr. Kaufman.
Lipella Co-Founder and Chief Medical Officer, Dr. Michael Chancellor said, "Looking ahead, we are anticipating a number of significant milestones in 2023. We expect to meet with the FDA to discuss the results of our Phase 2a clinical study and the pathway to regulatory approval.
"This year we established an Oral Health Scientific Advisory Board comprising a group of highly respected professionals. These advisors will guide us in the development of Lipella’s second product candidate, LP-310, for the treatment of symptomatic oral lichen planus (OLP)."
For Lipella’s complete financial results for the twelve-month period ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.