• Article highlights results from successful Phase 2a clinical trial for lead candidate, LP-10
• Lipella expects to initiate Phase 2b clinical trial in LP-10 in early 2024

PITTSBURGH, Pa., Sept. 21, 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 announces that the results of its successful Phase 2a clinical trial have been the published in the peer-reviewed Journal of Urology and Nephrology.

The article, titled "Intravesical liposomal tacrolimus for hemorrhagic cystitis: a phase 2a multicenter dose-escalation study," highlights the clinically meaningful efficacy and safety profile of Lipella's lead product candidate, LP-10 as a potential treatment for hemorrhagic cystitis.

Jonathan Kaufman, Ph.D., Lipella's Chief Executive Officer, said, "The peer-reviewed publication of our Phase 2a study results is a milestone achievement for Lipella. It underscores the significance of our clinical program and LP-10's potential as a first-in-class treatment for the cancer survivor community with hemorrhagic cystitis."

Dr. Michael Chancellor, Chief Medical Officer at Lipella, said, "LP-10 has received Orphan Disease Designation from the US Food and Drug Administration (FDA) for the treatment of hemorrhagic cystitis, a potentially fatal disease with great unmet need and no currently approved drug treatment. We are scheduled to have a Type-C meeting with FDA in Q4 and plan to share details on those discussions shortly thereafter. We currently expect to initiate our Phase 2b clinical trial for LP-10 in January 2024."

Clinical Trial Highlights

Lipella's multi-center, dose-escalation study was led by Dr. Jason Hafron of Michigan Institute of Urology.

• 13 patients with moderate to severe refractory hemorrhagic cystitis were treated with up to two courses of LP-10 intravesical bladder instillations.
• Pharmacokinetic analysis demonstrated a very short duration of systemic uptake and symptomatic improvements including:
  • decreased hematuria
  • decreased cystoscopic bleeding
  • a reduced number of ulceration sites, and,
  • improved urinary symptoms.

ABOUT HEMORRHAGIC CYSTITIS

Hemorrhagic cystitis is a disease with great unmet need and no currently approved drug treatment. Radiation used to treat various cancers can cause chronic, painful urinary inflammation and blood loss, known as radiation hemorrhagic cystitis. Certain chemotherapies can also cause this painful form of urinary bleeding. The blood loss associated with hemorrhagic cystitis can lead to surgery and can be fatal. There are currently no adequate therapies available for the treatment of moderate to severe hemorrhagic cystitis patients.

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.

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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
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1-412-894-1853

Chuck Harbey
PCG Advisory
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646.863.6341