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 the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP). With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.

Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic OLP. Approximately 24 subjects will be enrolled across five study sites in the United States. LP-310, Lipella's proprietary liposomal-tacrolimus (LP-10) oral rinse formulation, will be evaluated for safety, tolerability, and efficacy at doses of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. The trial, registered on ClinicalTrials.gov (NCT06233591), aims to address the unmet need for an effective treatment for OLP, a condition that currently lacks FDA-approved therapies.

Participants in the study will undergo screening, treatment, and follow-up phases. During the treatment phase, they will use a 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks, followed by a single post-treatment visit 2 weeks after the last dose. The study is anticipated to conclude in mid-2025.

Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm, stating, “We are extremely pleased to announce the completion of the Site Initiation Visit for our Phase 2a trial of LP-310. This milestone brings us one step closer to providing a potential treatment for the estimated 6 million Americans affected by OLP, a condition that causes significant pain and has no approved therapies.”

Dr. Michael Chancellor, Chief Medical Officer of Lipella, highlighted the significance of the trial, noting, “OLP presents as a painful oral mucosal disease with no approved therapy. We are optimistic that Lipella's proprietary oral rinse formulation of liposomal tacrolimus offers significant potential in treating OLP while minimizing systemic toxicity. I eagerly anticipate collaborating with the principal investigators to ensure a safe and seamless trial process.”

About Oral Lichen Planus Oral Lichen Planus (OLP) is a serious and debilitating condition characterized by oral mucosal lesions. It affects millions of individuals worldwide and presents significant challenges in terms of management and treatment. Current therapeutic options are limited, underscoring the critical need for innovative approaches like LP-310 in addressing this unmet medical need.

About Lipella PharmaceuticalsLipella 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 StatementsThis press release includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,” “could,” “continue,” “would,” “should,” “potential,” “target,” “goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “predicts,” “expects,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACTDr. Jonathan Kaufman, CEOLipella PharmaceuticalsInfo@Lipella.com1-412-894-1853

Jeff RamsonPCG Advisoryjramson@pcgadvisory.com