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. Each of the Press Releases (as defined below) and the Investor Presentation (as defined below) are filed herewith as Exhibits 99.1, 99.2 and 99.3, respectively, and incorporated herein by reference.
The information contained in this Form 8-K under Item 7.01, including Exhibits 99.1, 99.2 and 99.3 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, 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 Exhibits 99.1, 99.2 and 99.3 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 February 6, 2025, Lipella Pharmaceuticals Inc. (the “Company”), issued a press release (the “February 6th Press Release”) announcing that the Company received approval from the U.S. Food and Drug Administration (“FDA”) to use one of the Company’s product candidates, LP-310, an oral rinse formulation designed to treat oral lichen planus (“OLP”), in an expanded access program, which allows patients to access certain treatments outside of clinical trials that are not yet approved by the FDA.
On February 11, 2025, the Company issued a press release (the “February 11th Press Release”, and together with the February 6th Press Release, the “Press Releases”) announcing that the Company intends to report positive topline Phase 2a results for LP-310 in the treatment of OLP during the BIO CEO & Investor Conference on February 11, 2025. The Company intends to use an investor presentation (the “Investor Presentation”) at such conference to provide further details regarding such topline results and the Company’s other product candidates to prospective investors, analysts and others. Each of the Press Releases and the Investor Presentation are attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 current regulatory status and clinical trial results for LP-310 and the Company’s other product candidates, 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 February 6, 2024. | |
| 99.2 | Press Release, dated February 11, 2024. | |
| 99.3 | 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: February 11, 2025 | Lipella Pharmaceuticals Inc. | |
| By: | /s/ Jonathan Kaufman | |
Name: Jonathan Kaufman Title: Chief Executive Officer |
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