• Lipella to collaborate in anticipation of forthcoming Investigational New Drug (IND) application
• LP-10 is a promising potential treatment for hemorrhagic cystitis that has received Orphan Drug Designation from the FDA
• Lipella has successfully completed a Phase 2a clinical trial evaluating LP-10

PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into 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), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.

Lipella recently released positive topline results from its Phase 2a clinical trial evaluating LP-10 as a drug candidate for hemorrhagic cystitis, a rare and debilitating disease with no FDA approved treatments currently available. The collaboration with Cook MyoSite, a company with 19 years of Good Manufacturing Practice ("GMP") manufacturing expertise, is expected to greatly accelerate Lipella's ability to bring new treatments to patients with unmet needs.

Dr. Michael Chancellor, Chief Medical Officer of Lipella, expressed his enthusiasm about the partnership, stating, "Cook MyoSite's reputation for quality and safety standards, along with 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 expedite our efforts to produce clinical supplies and research products for LP-10, ultimately benefiting patients."

Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, highlighted the importance of CMC documentation in the regulatory approval process, particularly for products developed via the FDA's 505(b)(2) pathway, such as LP-10. He emphasized that the collaboration with Cook MyoSite will play a crucial role in advancing the commercial approval of LP-10.

Ryan Pruchnic, Managing Vice President of Cook MyoSite, who is also a member of Lipella's board of directors, expressed Cook MyoSite's commitment to supporting Lipella's investigational products.

"LP-10 is an outstanding drug candidate with immense potential to treat patients in need. We are excited to share our knowledge and expertise in GMP manufacturing and contribute to the advancement of this promising therapeutic," said Mr. Pruchnic.

With this collaboration, Lipella and Cook MyoSite are poised to make a greater impact in addressing the significant unmet need for effective treatments for hemorrhagic cystitis, and further advance LP-10 towards regulatory approval.

ABOUT COOK MYOSITE

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. Learn more about Cook MyoSite at www.cookmyosite.com.

ABOUT LIPELLA PHARMACEUTICALS INC.

Lipella 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, often referred to as the 505(b)(2) regulatory pathway (in the US). 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 and its common stock trades on Nasdaq under the ticker "LIPO". For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements

This 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 collaboration with Cook MyoSite and any advancement of LP-10's development and regulatory approval as a result, 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.