Lipella Pharmaceuticals Inc Stock Price, News & Analysis

Lipella Pharmaceuticals (NASDAQ: LIPO) announced positive topline results from its Phase 2a trial of LP-310, a liposomal-tacrolimus oral rinse for treating oral lichen planus (OLP). The trial demonstrated statistically significant improvements across multiple endpoints with a strong safety profile.

The study's first cohort, involving eight participants receiving 0.25 mg twice-daily doses, showed significant improvements in key metrics including:

• Investigator Global Assessment improved from 3.50 to 1.75 at week 4
• REU Score reduced from 27.75 to 12.69 at week 4
• Pain scores decreased from 6.63 to 2.38 at week 4

The trial has progressed to a higher dose cohort of 0.5 mg/10 mL across seven U.S. sites, with completion expected by mid-2025. The company plans to submit a Phase 2b trial application and request Breakthrough Therapy designation in the second half of 2025.

Lipella Pharmaceuticals (Nasdaq: LIPO) has received FDA approval for an Expanded Access Program (EAP) for LP-310, an oral rinse treatment for oral lichen planus (OLP). LP-310 is designed to provide targeted relief for OLP, a chronic inflammatory condition affecting mouth mucous membranes that impacts approximately 6 million Americans.

The EAP approval allows patients with serious or life-threatening conditions to access LP-310 outside of clinical trials before FDA approval. This is particularly significant as there are currently no FDA-approved therapies for OLP, which causes burning pain, white patches, swollen tissue, and open sores.

The company views this approval as a key milestone in addressing the unmet medical need in OLP treatment, supporting their ongoing clinical development efforts.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced the publication of a peer-reviewed paper in CUREUS focusing on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs). The paper discusses the company's investigational therapy LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) designed for localized therapeutic effects while minimizing systemic exposure. LP-310 is currently in a Phase 2a multicenter clinical trial evaluating safety, tolerability, and efficacy in adult OLP patients. The publication explores TCIs as alternatives to traditional corticosteroid treatments, aiming to reduce undesirable side effects associated with long-term steroid use.

Lipella Pharmaceuticals has completed dosing for the first cohort in its Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse for Oral Lichen Planus (OLP). Eight participants received a 0.25 mg dose, showing promising initial results with no product-related serious adverse events. Blood tacrolimus levels were minimal or undetectable, indicating localized therapeutic effects. The trial has advanced to testing a higher 0.5 mg dose. The study spans seven U.S. sites, with top-line data expected by year-end 2024 and trial completion by mid-2025. OLP affects approximately 6 million Americans and currently lacks FDA-approved therapies.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced the issuance of U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform. The patent, titled 'Delivery of Agents Using Metastable Liposomes,' extends market exclusivity for the company's lead clinical assets, LP-10 and LP-310, currently in Phase 2 trials. LP-10 is a liposomal formulation of tacrolimus for hemorrhagic cystitis, while LP-310 is an oral rinse for oral lichen planus. The company holds additional patents in the United States, Australia, and Canada, providing exclusivity until 2035.

Lipella Pharmaceuticals (Nasdaq: LIPO) announced a 1-for-8 reverse stock split effective November 7, 2024, with split-adjusted trading beginning November 8, 2024. The measure aims to comply with Nasdaq Capital Market's minimum bid price requirement. The split was approved by stockholders on September 10, 2024. The company's authorized shares will remain at 200,000,000, with a par value of $0.0001 per share. Nevada Agency and Transfer Company will serve as the exchange agent, with stockholders receiving transition information directly.

Lipella Pharmaceuticals (Nasdaq: LIPO), a clinical-stage biotechnology company, has announced its participation in the 2024 Spartan Capital Investor Conference. CEO Jonathan Kaufman, PhD, will deliver a presentation on November 4th, 2024, at 9:25 am EST at the Pierre Hotel in New York. The company, which focuses on addressing serious diseases with significant unmet needs, will also offer one-on-one meetings with registered conference investors.

Lipella Pharmaceuticals (Nasdaq: LIPO) has received a notice of allowance from the USPTO for its proprietary liposomal drug delivery platform. The patent application, titled 'Delivery of Agents Using Metastable Liposomes,' covers key innovations in Lipella's technology for delivering therapeutic agents via liposome-based vehicles.

This breakthrough enables precise, targeted delivery, improving safety and efficacy across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy. The patent provides broad IP protection for Lipella's drug delivery platform, which optimizes delivery to epithelial tissues. It extends market exclusivity for two lead clinical assets currently in Phase 2 trials.

Dr. Michael Chancellor, CMO of Lipella, highlighted the significance of this milestone in advancing therapies for conditions such as hemorrhagic cystitis and oral lichen planus. The company's liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing systemic side effects.

Lipella Pharmaceuticals (Nasdaq: LIPO), a clinical-stage biotechnology company, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Jonathan Kaufman, PhD, will be presenting at the event on Thursday, October 17th, 2024, at 10:30am.

The summit is scheduled to take place from October 15-17, 2024. Interested parties can access the webcast of Lipella's presentation at https://m-vest.com/events/healthcare-10152024. Additionally, Dr. Kaufman will be available for one-on-one meetings with registered investors attending the conference.

Lipella Pharmaceuticals focuses on developing treatments for serious diseases with significant unmet needs, positioning itself as a key player in the biotechnology sector.