Lipella Pharmaceuticals Inc Stock Price, News & Analysis

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.

Lipella Pharmaceuticals (Nasdaq: LIPO) has reported encouraging early tolerability results in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP). Three participants have completed the four-week treatment with the oral rinse, showing good tolerability and no unpleasant taste. The multi-center study is evaluating the safety, tolerability, and efficacy of LP-310 at various doses.

LP-310 is a proprietary liposomal-tacrolimus formulation targeting the underlying causes of OLP. It aims to provide a more effective alternative to current palliative treatments by delivering concentrated therapeutic effects directly in the oral cavity while minimizing systemic toxicity. Notably, LP-310 is the only topical treatment in development for OLP, a condition with no FDA-approved pharmacotherapies.

The trial is being conducted at five active sites across the U.S. and is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. These early results suggest LP-310's potential as a breakthrough treatment for OLP, a condition that significantly impacts patients' quality of life.

Lipella Pharmaceuticals (Nasdaq: LIPO) is set to participate in H.C. Wainwright's 26th Annual Global Investment Conference in New York City from September 9-11, 2024. The company will deliver a virtual presentation and offer one-on-one meetings for qualified investors at the Lotte New York Palace Hotel.

Lipella has two lead drug candidates in IND-approved phase 2 clinical trials for rare diseases, using the 505(b)(2) pathway:

• LP-310: A liposomal-tacrolimus oral rinse for oral lichen planus (OLP), with topline data expected by year-end 2024.
• LP-10: Liposomal tacrolimus for hemorrhagic cystitis (HC), with a phase 2b trial anticipated to start in the first half of 2025.

Both treatments target conditions with or no current therapeutic options in development, positioning Lipella as a potential leader in these rare disease markets.

Lipella Pharmaceuticals (NASDAQ: LIPO) has launched an Oral Lichen Planus (OLP) Patient Registry to advance research and treatment development for this chronic inflammatory disease affecting approximately 6 million Americans. OLP, which impacts the mouth's mucous membranes, currently has no FDA-approved therapies.

The company is also conducting an investigational study of LP-310, an oral rinse derived from their lead candidate LP-10. LP-310 has received FDA approval for clinical evaluation in treating OLP. This initiative aligns with Lipella's mission to improve treatment approaches for OLP, a condition characterized by burning pain, white patches, swollen tissue, and open sores.

Lipella Pharmaceuticals (Nasdaq: LIPO) is set to present clinical data on LP-20, a novel MRI contrast agent, at the 5th International Consultation on Interstitial Cystitis Japan (ICICJ) in Kyoto, August 21-23, 2024. LP-20 is designed to diagnose interstitial cystitis and detect bladder cancer using advanced MRI technology to identify bladder permeability defects.

The contrast agent, which has completed preclinical and proof-of-concept human trials, is administered via catheter into the bladder. It shows promise as a rapid and cost-effective diagnostic solution for these conditions. LP-20's development was partially funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Lipella Pharmaceuticals (Nasdaq: LIPO) has dosed the first two patients in its Phase 2a clinical trial for LP-310, a novel liposomal-tacrolimus oral rinse targeting Oral Lichen Planus (OLP). OLP is a chronic inflammatory condition affecting about 6 million Americans, with no FDA-approved therapies currently available. The multicenter, dose-ranging study involves adult subjects with symptomatic OLP and is expected to conclude in mid-2025. Lipella anticipates reporting top-line data by the end of 2024. LP-310 aims to address the underlying mechanisms of OLP, potentially offering substantial symptom relief and reduced complication risks. This trial represents a significant step towards developing the first approved drug treatment for OLP, addressing a critical unmet medical need.

Lipella Pharmaceuticals (Nasdaq: LIPO), a clinical-stage biotech company, has announced a $1.28 million registered direct offering of common stock priced at-the-market under Nasdaq rules. The offering includes 2,066,000 shares at $0.62 per share or pre-funded warrants. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close around August 1, 2024, subject to customary conditions. Lipella plans to use the net proceeds for working capital and general corporate purposes. The securities are being offered through a previously filed and effective shelf registration statement on Form S-3.