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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
September 18, 2025
Lipella
Pharmaceuticals Inc.
(Exact name of registrant as specified in
its charter)
| Delaware |
|
001-41575 |
|
20-2388040 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
| |
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7800 Susquehanna St., Suite 505
Pittsburgh, PA |
|
15208 |
| (Address of registrant’s principal executive office) |
|
(Zip code) |
Registrant’s telephone number, including
area code: (412) 894-1853
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
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| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share |
|
LIPO |
|
The Nasdaq Stock Market LLC * |
*Trading of the registrant’s common
stock on Nasdaq was suspended on June 20, 2025. The registrant’s common stock is currently quoted on the OTCID Market operated
by OTC Markets Group Inc. under the symbol “LIPO.”
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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. |
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By: |
/s/ Jonathan Kaufman |
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Name: Jonathan Kaufman
Title: Chief Executive Officer |
|
