UNITED
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 11, 2023, Lipella Pharmaceuticals Inc. (the “Company”) presented at the H.C. Wainwright 25th Annual Global Investment Conference in New York City, New York to prospective investors, analysts, industry participants and other attendees in order to provide an update on its product pipeline and discuss recent business developments, including its Phase 2a clinical trial results for its drug candidate, LP-10. The presentation materials furnished herewith as Exhibit 99.1 (the “Presentation Materials”) were used in connection with such presentation, are incorporated into this Item 7.01 by reference and will be posted on the Company’s website at https://lipella.com. Information contained on the Company’s website is not incorporated by reference into and should not be considered to be part of this Current Report on Form 8-K (this “Form 8-K”).
The information contained in this Form 8-K under Item 7.01, including Exhibit 99.1 attached hereto, is deemed to be ”furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not 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, except as shall be expressly set forth by specific reference to this Form 8-K in such filing. 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.
Forward-Looking Statements
Exhibit 99.1 attached hereto contains, and may indicate, forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and as defined in the U.S. Private Securities Litigation Reform Act of 1995. 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 without limitation, those statements relating to the Company’s product pipeline, anticipated timing and clinical trial results for LP-10 in the Presentation Materials, and the Company’s clinical trials and/or trial results for its other products now or in the future, 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. 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 | Lipella Pharmaceuticals Inc. September 2023 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 11, 2023 | Lipella Pharmaceuticals Inc. | |
| By: | /s/ Jonathan Kaufman | |
| Name: Jonathan Kaufman Title: Chief Executive Officer |
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