• Presentation Focused on Positive Results from Recent Phase 2a Study

PITTSBURGH, May 1, 2023 /PRNewswire/ -- 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 it has delivered a late-breaking presentation at the annual meeting of the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.

The Phase 2a study data was presented by Dr. Jason Hafron, Principal Investigator for Lipella's national trial, and a urologist specializing in the minimally invasive treatment of cancers involving the prostate, kidney and bladder, utilizing robotic surgery.

Dr. Hafron commented, "The clinical trial was a multi-center, dose-escalation Phase 2a study of 13 subjects with moderate to severe refractory hemorrhagic cystitis. Subjects were treated with up to two courses of LP-10 intravesical bladder instillations, which were tolerated without report of product related serious adverse events.

"The treatment response was fast and patients were able to tolerate LP-10. The study demonstrated decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients.

"These results are very encouraging. Having a safe and effective drug to treat hemorrhagic cystitis would be a major service to the field of urology."

Lipella Pharmaceuticals CEO, Dr. Jonathan Kaufman, added, "We are very pleased to have successfully completed our Phase 2a clinical trial. The study's positive results bring us closer to bringing a first-in-class hemorrhagic cystitis treatment to the cancer survivor community."

Lipella anticipates scheduling a Type B meeting with the FDA regarding this program in the next few months.

ABOUT HEMORRHAGIC CYSTITIS

Lipella received Orphan Disease Designation LP-10 for the treatment of moderate to severe hemorrhagic cystitis, a disease with great unmet need and no currently approved drug treatment.  Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called radiation hemorrhagic cystitis. Certain chemotherapies (such as cyclophosphamide) can also cause this painful form of urinary bleeding. The blood loss associated with hemorrhagic cystitis can lead to surgery and can be fatal.

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. 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

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, 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.

CONTACT

Chuck Harbey
PCG Advisory
This email address is being protected from spambots. You need JavaScript enabled to view it. 
646.863.6341