UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On June 20, 2025, Lipella Pharmaceuticals Inc., a Delaware corporation (the “Company”, “we”, “us” or “our”), received a letter (the “Letter”) from the Hearings Panel (the “Panel”) of The Nasdaq Stock Market LLC (“Nasdaq”), dated June 17, 2025, indicating that the Panel has determined to delist the Company’s common stock, par value $0.0001 per share (the “Common Stock”), from the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5100, which permits Nasdaq to use its discretionary authority for public interest concerns, due to the Company’s non-compliance with (i) Nasdaq Listing Rule 5635(d), which requires prior shareholder approval for the issuance, other than in a public offering, of 20% or more of a company’s outstanding shares at a per share price less than the Minimum Price (as defined in such rule), and (ii) Nasdaq Listing Rule 5640, which prohibits voting rights of existing shareholders from being disparately reduced or restricted. The Letter cited the Company’s issuance of shares of its Series C voting convertible preferred stock and warrants to the Company’s placement agent, consultant and advisor in connection with certain private placement transactions completed between December 2024 and March 2025 as the reason for such non-compliance and Nasdaq’s determination.
The Common Stock has been suspended as of the open of trading on June 20, 2025. The Company expects that a Form 25 will be filed with the U.S. Securities and Exchange Commission (the “SEC”) to remove the Common Stock from listing on the Nasdaq Capital Market. The Common Stock is currently quoted on the Pink Market operated by OTC Markets Group Inc. under its existing symbol “LIPO” as of June 20, 2025.
Item 7.01 Regulation FD Disclosure
On June 20, 2025, the Company issued a press release announcing the Panel’s decision to delist the Common Stock from the Nasdaq Capital Market. A copy of such press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference.
The information set forth in Item 7.01 of this Form 8-K shall not be deemed to be “filed” for 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 in any of the Company’s filings with the SEC under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except as expressly set forth by specific reference in such a filing.
Cautionary Statement Regarding Forward-Looking Statements
This Form 8-K contains forward-looking statements. 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 those related to Nasdaq’s determination to delist the Common Stock or with respect to the Company’s exploration of all markets and commitment to list its Common Stock, 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 such delisting determination and the Company’s ability to list its Common Stock, and other risks that may be included in the periodic reports and other filings that the Company files from time to time with the SEC. 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.
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Item 9.01 Financial Statements and Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release, dated June 20, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: June 20, 2025 |
Lipella Pharmaceuticals Inc. |
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By: |
/s/ Jonathan Kaufman |
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Name: Jonathan Kaufman Title: Chief Executive Officer |
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Exhibit 99.1
Lipella Pharmaceuticals Announces Delisting from Nasdaq Capital Market
PITTSBURGH, PA – June 20, 2025 – Lipella Pharmaceuticals Inc. (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, today announced that the Nasdaq Hearings Panel has determined to delist the Company’s common stock from The Nasdaq Capital Market. Trading in the common stock was suspended at the open of business today.
The delisting follows Nasdaq’s determination that certain private placement transactions completed between December 2024 and March 2025 did not comply with Listing Rules 5100 (Public Interest Concern), 5635 (Shareholder Approval), and 5640 (Voting Rights). Specifically, Nasdaq cited the issuance of Series C voting convertible preferred stock and warrants to the Company’s placement agent and advisor to those transactions, as having been structured in a way that triggered these rule violations.
The Company was notified by the Hearings Panel of its determination to delist the Company’s common stock effective today. Lipella is disappointed by this decision—particularly in light of the fact that it was taking immediate steps to obtain stockholder approval and address the concerns raised by Nasdaq.
Lipella remains operationally sound, and its business fundamentals are intact. The Company is executing on its strategic and clinical development plans, including continued advancement of its lead product candidates LP-10 for hemorrhagic cystitis and LP-310 for oral lichen planus.
In parallel, Lipella is actively exploring other markets to list its common stock and is committed to relisting its shares on a trading venue that provides the best possible liquidity and access for investors. The Company’s common stock is currently quoted on the OTC Markets under the symbol “LIPO.”
“We acknowledge Nasdaq’s decision and are focused on taking swift, constructive steps accordingly,” said Dr. Jonathan Kaufman, Chief Executive Officer of Lipella. “Our commitment to our shareholders, our mission, and our clinical goals has not changed.”
The Company remains a reporting company under the Securities Exchange Act of 1934 and will continue to file periodic reports and disclosures with the U.S. Securities and Exchange Commission. Lipella will keep its stockholders informed of all material developments as it continues to assess its options.
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, including with respect to the Company’s exploration of all markets and its commitment to list its common stock, future operations, financial position, prospects, clinical trials, 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, 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.
1-412-894-1853
PCG Advisory
Jeff Ramson