Announcement • Mar 31
Lipella Pharmaceuticals Inc. Filed for Bankruptcy Lipella Pharmaceuticals Inc. filed a voluntary petition for reorganization under Chapter 11 in the US Bankruptcy Court for the Western District of Pennsylvania on March 30, 2026. The debtor listed its assets in the range of $1 million to $10 million and liabilities in the range of $0.5 million to $1 million. The debtor is represented by Michael A. Shiner of Tucker Arensberg, P.C. as its legal counsel. BDO USA, LLP is appointed as financial advisor to debtor. Announcement • Sep 18
Lipella Pharmaceuticals Announces Positive Final Results from Phase 2a Study of LP-10 in Oral Lichen Planus Lipella Pharmaceuticals Inc. announced positive final results from its completed Phase 2a multicenter, dose-ranging study evaluating LP-10, a proprietary liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus (OLP). The study met its primary safety endpoint and achieved statistically significant improvements across all efficacy measures at the 4-week timepoint. These results support LP-10‘s potential to become the first FDA-approved therapy for OLP, a chronic inflammatory condition that affects an estimated 6 million Americans, with no approved treatment options. Key Study Results: Safety Profile: All 27 patients completed the full 4-week treatment course No serious adverse events reported Minimal systemic exposure: 76% of tacrolimus blood measurements were below detection limits (<1.0 ng/mL) Well-tolerated, with only mild to moderate treatment-related adverse events; dry mouth being the most common, occurring in 18.5% of patients Efficacy Outcomes: All three dose groups (0.25 mg, 0.5 mg, and 1.0 mg) demonstrated statistically significant improvements at Week 4 (all p<0.05) on the secondary efficacy endpoints: Investigator Global Assessment (IGA) showed clear reductions in ulceration and erythema scores Pain and Sensitivity improved significantly, with patients reporting meaningful reductions on numerical rating scales,Patient symptoms, as measured by the OLP Symptom Severity Measure (OLPSSM), demonstrated meaningful improvement in overall symptom burden,Sustained efficacy was observed, with all patients maintaining clinical benefit and no evidence of worsening through the 2-week follow-up period. Study Design: The Phase 2a study was a multicenter, dose-ranging trial conducted at five leading U.S. clinical sites. Twenty-seven adults with biopsy-confirmed symptomatic OLP were sequentially enrolled into three dose cohorts. Patients used a 3-minute LP-10 oral rinse twice daily for 4 weeks, followed by a 2-week safety follow-up. The study population was representative of typical OLP patients: 81.5% were female, the median age was 62 years, and disease duration ranged from 1 to 28 years. All participants had previously failed standard therapies, including topical corticosteroids. Next Steps: Based on these positive results, Lipella is advancing LP-10 into late-stage development: Preparation of Phase 2b protocol incorporating FDA feedback, Scaling manufacturing capabilities to support larger clinical trials . Exploring strategic partnerships and collaborations. Announcement • Jun 22
Lipella Pharmaceuticals Announces Delisting from Nasdaq Capital Market Lipella Pharmaceuticals Inc. announced that the Nasdaq Hearings Panel has determined to delist the Company’s common stock from The Nasdaq Capital Market. Trading in the common stock was suspended at the open of business on June 20, 2025. The delisting follows Nasdaq’s determination that certain private placement transactions completed between December 2024 and March 2025 did not comply with Listing Rules 5100 (Public Interest Concern), 5635 (Shareholder Approval), and 5640 (Voting Rights). Specifically, Nasdaq cited the issuance of Series C voting convertible preferred stock and warrants to the Company’s placement agent and advisor to those transactions, as having been structured in a way that triggered these rule violations. The Company was notified by the Hearings Panel of its determination to delist the Company’s common stock effective today. Lipella is disappointed by this decision—particularly in light of the fact that it was taking immediate steps to obtain stockholder approval and address the concerns raised by Nasdaq. Lipella remains operationally sound, and its business fundamentals are intact. The Company is executing on its strategic and clinical development plans, including continued advancement of its lead product candidates LP-10 for hemorrhagic cystitis and LP-310 for oral lichen planus. In parallel, Lipella is actively exploring other markets to list its common stock and is committed to relisting its shares on a trading venue that provides the best possible liquidity and access for investors. The Company’s common stock is currently quoted on the OTC Markets under the symbol “LIPO.” “We acknowledge Nasdaq’s decision and are focused on taking swift, constructive steps accordingly,” said Dr. Jonathan Kaufman, Chief Executive Officer of Lipella. “Our commitment to our shareholders, our mission, and our clinical goals has not changed.” The Company remains a reporting company under the Securities Exchange Act of 1934 and will continue to file periodic reports and disclosures with the U.S. Securities and Exchange Commission. Lipella will keep its stockholders informed of all material developments as it continues to assess its options. 
