Successful top line results from Phase 2a
clinical trial for lead candidate LP-10
Oral Health Scientific Advisory Board
established to focus on development of LP-310 for oral lichen
planus
Late-breaking presentation of Phase 2a study
results at the American Urological Association Annual
Meeting
Manufacturing collaboration agreement with
Cook MyoSite in anticipation of Lipella's forthcoming
Investigational New Drug (IND) application
PITTSBURGH, May 15, 2023
/PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO")
("Lipella," "our, "us" or the "Company"), a clinical-stage
biotechnology company addressing serious diseases with significant
unmet need, today provides a corporate update and announces its
first quarter 2023 financial results.
Dr. Jonathan Kaufman, CEO of
Lipella, said, "Lipella has had a strong start to 2023 with the
release of positive top line results from our Phase 2a clinical
trial evaluating the safety and efficacy of LP-10 as a treatment
for hemorrhagic cystitis. The results have been presented at
prestigious meetings including the 2023 Biotech Showcase and as
part of a late-breaking presentation at the Annual Meeting of the
American Urological Association. We expect to schedule a Type B
meeting with the FDA regarding this program in the coming
months.
"We were also delighted to enter a manufacturing collaboration
agreement with Cook MyoSite to facilitate Chemistry, Manufacturing,
and Control documentation for LP-10 in anticipation of Lipella's
forthcoming IND application."
Operational Highlights
- In March 2023, Lipella created a
Scientific Advisory Board in oral health to focus on the
development of LP-310, the company's product candidate for the
treatment of symptomatic oral lichen planus. The five-member board
is made up of a group of highly regarded experts in oral
medicine.
- In January 2023, Lipella
presented successful top line results of its Phase 2a clinical
trial for LP-10 in hemorrhagic cystitis at the 2023 Biotech
Showcase.
Financial Highlights
- Lipella had approximately $4.0
million in cash, cash equivalents and marketable securities
as of March 31, 2023.
- Net loss for the quarter ended March 31,
2023 was approximately $1.1
million.
- Investors are encouraged to read the Company's Quarterly Report
on Form 10-Q when it is filed with the Securities and Exchange
Commission (the "SEC"), which will contain additional details about
Lipella's financial results as of and for the period ended
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 press release
regarding, among other things, our strategy, future operations,
financial position, 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 among
other things, 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 other factors. 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
Dr. Jonathan
Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Chuck Harbey
PCG Advisory
charbey@pcgadvisory.com
646.863.6341
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SOURCE Lipella Pharmaceuticals Inc.