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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): February 11, 2025

 

Lipella Pharmaceuticals Inc. 

(Exact name of registrant as specified in its charter)

 

Delaware   005-93847   20-2388040
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

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)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
  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

 

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.

 

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