Lipella Pharmaceuticals Re-signs Manufacturing Collaboration Agreement with Cook MyoSite to Support LP-310 Clinical Development
- Partnership renewal ensures continued manufacturing support for clinical pipeline development
- Collaboration focuses on commercialization path for LP-310, targeting an unmet medical need
- Manufacturing partner's executive serves on Lipella's Board, indicating strong strategic alignment
- No specific timeline provided for product development or commercialization
- Financial terms of the manufacturing agreement not disclosed
Supports late-stage development and scalable manufacturing for LP-310, a non-steroidal oral rinse therapy for Oral Lichen Planus, a condition with no approved treatments
PITTSBURGH, June 04, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet need, today announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite, Inc. (“Cook MyoSite”) to support Chemistry, Manufacturing and Control (CMC) documentation supporting our clinical products LP-10 and LP-310.
Dr. Jonathan Kaufman, Chief Executive Officer and Co-Founder of Lipella, said, “We are pleased to renew our collaboration with Cook MyoSite, a trusted partner with a strong track record in high-quality manufacturing. This CMC collaboration is increasingly valuable to Lipella as our clinical pipeline matures toward commercializable assets.”
Ryan Pruchnic, Managing Vice President of Cook MyoSite and a member of Lipella’s Board of Directors, added, “Our team is committed to ensuring high standards of safety, quality and execution, to support Lipella's clinical progress.”
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 Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at lipella.com and follow us on X and 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 strategy, future operations, financial position, prospects, clinical trials, including the statistically significant safety and efficacy data presented above for LP-310, regulatory approvals, 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, market and other conditions, 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, risks related to the current clinical trial for LP-310, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other risks that may be included in the periodic reports and other filings that the Company files from time to time with the U.S. Securities and Exchange Commission. 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.
CONTACT:
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
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