PITTSBURGH - Lipella Pharmaceuticals Inc. (NASDAQ:LIPO), a biotech firm specializing in treatments for diseases with significant unmet needs, has announced an upcoming meeting with the U.S. Food and Drug Administration (FDA) to discuss its Phase-2b clinical trial for LP-10, a treatment aimed at moderate to severe hemorrhagic cystitis (HC). The meeting, set for May 21, 2024, is a critical step for the company as it seeks to advance the regulatory process for LP-10.
HC, a severe form of hematuria caused by certain cancer treatments, has limited therapeutic options available. Lipella’s LP-10, an intravesical liposomal formulation of tacrolimus, has shown promise in a Phase-2a clinical trial, demonstrating safety and potential efficacy in reducing symptoms and bleeding in patients with HC. This trial included 13 patients and yielded positive preliminary results, which were published in the International Urology and Nephrology journal in September 2023.
Dr. Michael Chancellor, Lipella’s Chief Medical Officer, stated, "We are eager to advance our LP-10 program efficiently, and our scheduled FDA meeting in the second quarter of 2024 will play a pivotal role in enhancing the regulatory prospects of LP-10."
The proposed Phase-2b trial is expected to be a 36-subject, double-blind, placebo-controlled study, with primary efficacy based on the reduction of patient-reported gross hematuria episodes over a week. Lipella has received Orphan Disease Designation for LP-10 in treating moderate to severe HC, highlighting the drug's potential significance.
Lipella Pharmaceuticals, which completed its initial public offering in December 2022, is also working on LP-310 and LP-410, oral rinse formulations of tacrolimus for oral lichen planus (OLP) and oral Graft-versus-Host Disease (GvHD), respectively. The FDA has granted orphan drug designation for LP-310 in GvHD treatment.
This announcement is based on a press release statement from Lipella Pharmaceuticals Inc., without endorsement of the claims. The information provided offers a factual overview of the company's ongoing efforts to address HC and the regulatory milestones ahead.
InvestingPro Insights
Lipella Pharmaceuticals Inc. (NASDAQ:LIPO) has been navigating a challenging financial landscape, as reflected in its recent metrics. The company holds a market capitalization of around $4.93 million, indicating its relatively small size within the biotech sector. Despite significant revenue growth over the last twelve months, as of Q4 2023, with an impressive 144.15% increase, the company has faced difficulties with profitability. Gross profit margins have been substantially negative, at -575.87%, suggesting that Lipella's costs far exceed its revenue.
Investors should note that Lipella's stock has experienced significant volatility. Over the last month, the price total return has decreased by 33.33%, and over the last six months, the decline has been even steeper at 54.55%. This could be indicative of market reactions to the company's financial performance and its ongoing clinical trials. Despite these challenges, Lipella's liquid assets exceed its short-term obligations, providing some financial stability in the near term.
For those considering an investment in Lipella, it's important to consider these InvestingPro Tips: The company does not pay a dividend to shareholders, which may be a consideration for income-focused investors. Additionally, the company is not profitable over the last twelve months, highlighting the risks associated with investing in early-stage biotech firms.
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