UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure
Press Release
On September 18, 2025, Lipella Pharmaceuticals Inc. (the “Company”) issued a press release announcing 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”). A copy of the press release is attached hereto as Exhibit 99.1.
Corporate Presentation
The Company updated its presentation used by management to describe its business. A copy of the presentation is attached hereto as Exhibit 99.2.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1 and 99.2, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item 8.01 Other Events.
On September 18, 2025, the Company 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 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.
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.
All 27 patients completed the full four-week treatment course, and no serious adverse events were reported. Systemic exposure was minimal, with 76% of tacrolimus blood measurements below detection limits (<1.0 ng/mL). Treatment-related adverse events were mild to moderate, with dry mouth being the most common, occurring in 18.5% of patients.
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 secondary efficacy endpoints. Investigator Global Assessment scores showed clear reductions in ulceration and erythema, pain and sensitivity improved significantly with patients reporting meaningful reductions on numerical rating scales, and patient-reported symptoms, measured by the OLP Symptom Severity Measure (OLPSSM), showed meaningful improvement in overall symptom burden. Sustained efficacy was observed, with all patients maintaining clinical benefit and no evidence of worsening through the two-week follow-up.
Based on these results, the Company is advancing LP-10 into late-stage development, including preparation of a Phase 2b protocol incorporating FDA feedback, scaling manufacturing to support larger clinical trials, and exploring strategic partnerships and collaborations.
Item 9.01 Financial Statements and Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release, dated September 18, 2025 | |
| 99.2 | Investor Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 18, 2025 | Lipella Pharmaceuticals Inc. | ||
| By: | /s/ Jonathan Kaufman | ||
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Name: Jonathan Kaufman Title: Chief Executive Officer |
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