Full Press Release Details
Provides Business Update and Reports 2022 Financial Results
Successfully Completes Phase 2a Clinical Trial
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
Attended Biotech Showcase announcing successful top line results for lead candidate LP-10 during Phase
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
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.
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.
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.
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.
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.
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
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
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.
Lipella Pharmaceuticals Inc.
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
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.
Pharmaceuticals Inc.
| 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 |
re-stated to reflect the impact of the reverse stock split that occurred on December 19, 2022
Pharmaceuticals Inc.
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 |
re-stated to reflect the impact of the reverse stock split that occurred on December 19, 2022