UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On March 31, 2023, Lipella Pharmaceuticals Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial and business results for the fiscal year ended December 31, 2022 to discuss such results and update shareholders on general corporate developments. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference.
The information contained in Items 2.02 and 7.01 of this Form 8-K and Exhibit 99.1 attached hereto are furnished to, but shall not be deemed filed with, the U.S. Securities and Exchange Commission or incorporated by reference into the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Item 7.01 Regulation FD Disclosure.
Reference is made to the disclosure in Item 2.02 of this Form 8-K, which disclosure is incorporated herein by reference. 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 clinical trial results for LP-10 and regulatory approval in its press release attached hereto, or the Company’s clinical trials and/or trial results and regulatory approval 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 | Press release, dated March 31, 2023. | |||
| 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: April 3, 2023 | Lipella Pharmaceuticals Inc. | ||
| By: | /s/ Jonathan Kaufman | ||
Name: Jonathan Kaufman Title: Chief Executive Officer |
|||
Exhibit 99.1
Lipella Provides Business Update and Reports 2022 Financial Results
Company Successfully Completes Phase 2a Clinical Trial
Fourth Quarter or Full Year Highlights
● Appointed Douglas Johnston as CFO in November 2022
● Successfully completed Initial Public Offering, attained NASDAQ CM listing
● Year-end cash balance in excess of $5 million
Subsequent Events
● Attended Biotech Showcase announcing successful top line results for lead candidate LP-10 during Phase 2A clinical trial
● Created Oral Health Scientific Advisory Board to focus on development of LP-310 for oral lichen planus
● Announced the successful completion of Phase 2A clinical trial of LP-10
● Dr. Jason Hafron of the Michigan institute of Urology will present the Phase 2A results at the American Urological Association Annual Meeting on April 30
PITTSBURGH, PA -- March 31, 2023 -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today provided a business update and reported financial results for the year ended December 31, 2022.
Jonathan Kaufman, Co-founder and CEO of Lipella Pharmaceuticals, commented, “Last year we focused on developing our corporate profile and scientific mission to address serious diseases with significant unmet need. During 2022, Lipella achieved several important milestones including the Company’s completion of its Initial Public Offering in late December.
“Subsequent to the year end in early 2023, we announced the successful top line results of our Phase 2a clinical trial evaluating LP-10, our lead product candidate in 13 subjects with moderate to severe refractory hemorrhagic cystitis (HC). HC is a potentially fatal disease with great unmet need and no currently approved drug treatment.
“The results of the trial demonstrated no serious adverse events, very short duration of systemic uptake, and decreased hematuria, cystoscopic bleeding and ulceration sites, resulting in improved patients' urinary symptoms. We’re excited to have the results presented by study leader Dr. Jason Hafron, from the Michigan Institute of Urology, at the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.
“Following our IPO and other initial expenses, we ended the year with $5.1 million in cash. We anticipate this will provide Lipella with an operating runway into 2024,” concluded Dr. Kaufman.
Lipella Co-Founder and Chief Medical Officer, Dr. Michael Chancellor said, “Looking ahead, we are anticipating a number of significant milestones in 2023. We expect to meet with the FDA to discuss the results of our Phase 2a clinical study and the pathway to regulatory approval.
“This year we established an Oral Health Scientific Advisory Board comprising a group of highly respected professionals. These advisors will guide us in the development of Lipella’s second product candidate, LP-310, for the treatment of symptomatic oral lichen planus (OLP).”
For Lipella’s complete financial results for the twelve-month period ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.
About Lipella Pharmaceuticals Inc.
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.
Forward-Looking Statements
This press release includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this presentation regarding, among other things, our strategy, future operations, financial position, anticipated dividends, projected costs, prospects, 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 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, regional, national or global political, economic, business, competitive, market and regulatory conditions, and otherfactors. 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. The Company expressly disclaims any and all liability relating to or resulting from the use of this presentation. 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.
CONTACTS
Jonathan Kaufman
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Chuck Harbey
PCG Advisory
charbey@pcgadvisory.com
646.863.6341
| - | Tables Follow – |
Lipella Pharmaceuticals Inc.
Consolidated Balance Sheets
| December 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | 5,121,743 | $ | 1,413,828 | |||||
| Grants receivable | 113,655 | — | ||||||
| Short term investments | — | 300,546 | ||||||
| Prepaid expenses | 563,891 | 93,715 | ||||||
| Total Current Assets | 5,799,289 | 1,808,089 | ||||||
| Operating lease right of use asset | 150,821 | $ | 204,800 | |||||
| Total Assets | $ | 5,950,110 | $ | 2,012,889 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | 384,357 | 46,900 | ||||||
| Accrued expenses | 389,209 | 151,521 | ||||||
| Operating lease liability | 58,262 | 39,598 | ||||||
| Payroll liability | 67,832 | 50,161 | ||||||
| Notes payable, current | 25,000 | — | ||||||
| Related party loan | 250,000 | 25,000 | ||||||
| Related party interest | 3,596 | 27,445 | ||||||
| Total Current Liabilities | 1,178,256 | 340,625 | ||||||
| Operating lease liability, net of current portion | 96,258 | 168,363 | ||||||
| Related party interest, net of current portion | — | 30,349 | ||||||
| Related party loan, net of current portion | — | 50,000 | ||||||
| Total Liabilities | 1,274,514 | 589,337 | ||||||
| Stockholders' equity: | ||||||||
| Convertible preferred stock, $.0001 par value; 20,000,000 shares authorized; -0- and 1,592,447 shares issued and outstanding at December 31, 2022 and December 31, 2021 | $ | — | $ | 159 | ||||
| Common stock, $.0001 par value; 200,000,000 shares authorized; 5,743,945 shares issued and outstanding at December 31, 2022 and 3,866,625* at December 31, 2021 | 574 | 387 | ||||||
| Additional paid-in capital* | 10,379,900 | 4,530,193 | ||||||
| Accumulated deficit | (5,704,878 | ) | (3,107,187 | ) | ||||
| Total Shareholders’ equity | 4,675,596 | 1,423,552 | ||||||
| Total liabilities and stockholders' equity | $ | 5,950,110 | $ | 2,012,889 | ||||
*As re-stated to reflect the impact of the reverse stock split that occurred on December 19, 2022
Lipella Pharmaceuticals Inc.
Consolidated Statements of Operations
| For the year ended | ||||||||
| December 31, 2022 | December 31, 2021 | |||||||
| Grant revenues | $ | 184,156 | $ | 259,347 | ||||
| Contract revenues | — | — | ||||||
| Total revenues | 184,156 | 259,347 | ||||||
| Cost and expenses | ||||||||
| Research and development | 2,547,677 | 1,456,791 | ||||||
| General and administrative | 226,192 | 718,384 | ||||||
| Total costs and expenses | 2,773,869 | 2,175,175 | ||||||
| Loss from operations | (2,589,713 | ) | (1,915,828 | ) | ||||
| Other income (expense) | ||||||||
| Other income | (45 | ) | 57,085 | |||||
| Interest income | 1,678 | 104 | ||||||
| Interest expense related party | (9,612 | ) | (6,834 | ) | ||||
| Total other income/(expense) | (7,979 | ) | 50,355 | |||||
| Loss before income taxes | (2,597,692 | ) | (1,865,473 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net Loss | $ | (2,597,692 | ) | $ | (1,865,473 | ) | ||
| Loss per common share | ||||||||
| Basic* | (0.64 | ) | (0.55 | ) | ||||
| Dillutive* | (0.64 | ) | (0.55 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||
| Basic* | 4,060,624 | 3,408,051 | ||||||
| Dillutive* | 4,060,624 | 3,408,051 | ||||||
*As re-stated to reflect the impact of the reverse stock split that occurred on December 19, 2022