UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
Reference is made to the disclosure in Item 8.01 of this Current Report on Form 8-K (this “Form 8-K”), which disclosure is incorporated herein by reference. The Press Release (as defined below) is filed herewith as Exhibit 99.1 and incorporated herein by reference.
The information contained in this Form 8-K under Item 7.01, including Exhibit 99.1 attached hereto, shall be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof. The information set forth in this Item 7.01 of this Form 8-K and Exhibit 99.1 attached hereto shall not be deemed an admission as to the materiality of any information in this Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 8.01 Other Events.
On May 15, 2025, Lipella Pharmaceuticals Inc. (the “Company”), issued a press release (the “Press Release”) announcing that topline data from the first two dose cohorts of its ongoing Phase 2a trial of LP-310 (liposomal tacrolimus oral rinse) for the treatment of Oral Lichen Planus (“OLP”) will be presented at the 2025 joint international meeting of the American Academy of Oral Medicine and the European Association of Oral Medicine in Las Vegas. The data to be presented includes safety and efficacy findings from the 0.25 mg and 0.50 mg dose cohorts of LP-310, administered once daily over four weeks in adults with symptomatic OLP.
The Press Release is attached hereto as Exhibits 99.1 and incorporated herein by reference.
Cautionary Statement Regarding Forward-Looking Statements
This Form 8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Such forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company’s future activities, or future events or conditions, including, but not limited to those related to the latest clinical trial results for LP-310, which can be identified by terminology such as “may,” “will,” “expects,” “anticipates,” “aims,” “potential,” “future,” “intends,” “plans,” “believes,” “estimates,” “continue,” “likely to” and other similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not historical facts and are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by its management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict, many of which are beyond the Company’s control, including risks related to the Company’s ability to regain and/or maintain compliance with the listing standards of The Nasdaq Stock Market LLC, the Company’s current liquidity position and the need to obtain additional financing to support ongoing operations, and other risks that may be included in the periodic reports and other filings that the Company files from time to time with the U.S. Securities and Exchange Commission. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in the forward-looking statements. Any forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this Form 8-K, except as required by applicable law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description | |
| 99.1 | Press Release, dated May 15, 2025. | |
| 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: May 15, 2025 | Lipella Pharmaceuticals Inc. | |
| By: | /s/ Jonathan Kaufman | |
Name: Jonathan Kaufman Title: Chief Executive Officer | ||
Exhibit 99.1
Lipella Pharmaceuticals to Present Phase 2a Data for LP-310 in Oral Lichen Planus at 2025 AAOM/EAOM International Meeting
Statistically significant safety and efficacy data from 0.25 mg and 0.50 mg cohorts to be presented
Presentation scheduled for Thursday, May 15, 2025, at 11:36 a.m. PT
PITTSBURGH, May 15, 2025 – Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “we,” “our,” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, today announced that topline data from the first two dose cohorts of its ongoing Phase 2a trial of LP-310 (liposomal tacrolimus oral rinse) for the treatment of Oral Lichen Planus (OLP) will be presented at the 2025 joint international meeting of the American Academy of Oral Medicine (AAOM) and the European Association of Oral Medicine (EAOM) in Las Vegas.
Presentation Details
| ● | Title: Liposomal Tacrolimus (LP-310) Oral Rinse for the Treatment of Oral Lichen Planus: Topline Analysis of a Phase 2a Multicenter Dose-Ranging Trial |
| ● | Presenter: Dr. Alessandro Villa, Chief of Oral Medicine, Oral Oncology, and Dentistry, Miami Cancer Institute |
| ● | Date & Time: Thursday, May 15, 2025, at 11:36 a.m. PT |
| ● | Location: 2025 AAOM/EAOM International Meeting, Las Vegas, NV |
Presentation
Highlights:
The data to be presented includes safety and efficacy findings from the 0.25 mg and 0.50 mg dose cohorts of LP-310, administered
once daily over four weeks in adults with symptomatic OLP. The primary endpoint was assessed at Week 4, with follow-up at Week
6.
Treatment at the 0.50 mg dose demonstrated statistically significant improvements in multiple endpoints:
| ● | Investigator Global Assessment (IGA): Improved from 3.42 at baseline to 1.71 at Week 4 (p=0.007) |
| ● | REU Score (Reticulation, Erythema, Ulceration): Reduced from 26.91 to 11.88 at Week 4 (p=0.003) |
| ● | Oral Lichen Planus Symptom Severity Measure (OLPSSM): Dropped from 14.92 to 4.88 at Week 4 (p=0.003) |
| ● | Pain Numerical Rating Scale (NRS): Improved from 6.42 to 2.25 at Week 4 (p=0.003) |
Visible lesion resolution was observed during treatment. A return toward baseline following cessation of dosing supports localized on-treatment activity.
LP-310 was well tolerated, with no treatment-related serious adverse events (SAEs), no patient discontinuations, and no detectable systemic tacrolimus levels. All participants adhered to the once-daily regimen.
“The positive data from the 0.50 mg cohort showed consistent improvements across patient-reported and clinician-assessed measures. We’re encouraged by the reductions in pain, inflammation, and ulceration,” said Dr. Michael Chancellor, Chief Medical Officer and Co-Founder of Lipella Pharmaceuticals. “These findings support LP-310’s potential as a localized, non-steroidal treatment for Oral Lichen Planus. We look forward to sharing final topline data from the fully enrolled trial in the second quarter of 2025.”
About
the Study
The Phase 2a trial is a multicenter, dose-ranging study evaluating the safety, tolerability, and efficacy of LP-310 in adults (18
years and older) with symptomatic Oral Lichen Planus. Three dose levels—0.25 mg, 0.5 mg, and 1.0 mg—are being assessed.
LP-310 was administered once daily for four weeks. The primary endpoint was measured at Week 4, with follow-up at Week 6 to assess
durability of response.
About
Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology
company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations
for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist.
The company completed its initial public offering in 2022. Learn more at lipella.com and follow us on X and LinkedIn.
Forward-Looking
Statements
This press release includes certain “forward-looking statements.” All statements, other than statements of historical
fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects,
clinical trials, including the statistically significant safety and efficacy data presented above for LP-310, regulatory approvals,
pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are
forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,”
“could,” “continue,” “would,” “should,” “potential,” “target,”
“goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,”
“estimates,” “predicts,” “expects,” “projects” and similar references to future
periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial
trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations,
business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict.
Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore,
against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances
of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results
to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the
current clinical trial for LP-310, general capital market risks, regional, national or global political, economic, business, competitive,
market and regulatory conditions, and other risks that may be included in the periodic reports and other filings that the Company
files from time to time with the U.S. Securities and Exchange Commission. Any forward-looking statement made by us is based upon
the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made.
Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to
predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied
upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is
as of the date hereof, and the Company has no obligation to update such information, including in the event that such information
becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal
and related matters concerning the matters described herein.
CONTACT:
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
[email protected]
1-412-894-1853
PCG
Advisory
Jeff Ramson
[email protected]