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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February 11, 2025
Lipella
Pharmaceuticals Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
005-93847 |
|
20-2388040 |
(State or other jurisdiction
of incorporation) |
|
(Commission File
Number) |
|
(IRS Employer
Identification No.) |
7800
Susquehanna St., Suite 505
Pittsburgh,
PA |
|
15208 |
| (Address
of registrant’s principal executive office) |
|
(Zip
code) |
Registrant’s
telephone number, including area code: (412) 894-1853
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which
registered |
| Common
Stock, par value $0.0001 per share |
|
LIPO |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item
7.01 |
Regulation
FD Disclosure. |
Reference
is made to the disclosure in Item 8.01 of this Current Report on Form 8-K (this “Form 8-K”), which disclosure is incorporated
herein by reference. Each of the Press Releases (as defined below) and the Investor Presentation (as defined below) are filed
herewith as Exhibits 99.1, 99.2 and 99.3, respectively, and incorporated herein by reference.
The
information contained in this Form 8-K under Item 7.01, including Exhibits 99.1, 99.2 and 99.3 attached hereto, shall be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
and shall be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act,
whether made before or after the date hereof. The information set forth in this Item 7.01 of this Form 8-K and Exhibits 99.1,
99.2 and 99.3 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.
Item
8.01 Other Events.
On
February 6, 2025, Lipella Pharmaceuticals Inc. (the “Company”), issued a press release (the “February 6th
Press Release”) announcing that the Company received approval from the U.S. Food and Drug Administration (“FDA”)
to use one of the Company’s product candidates, LP-310, an oral rinse formulation designed to treat oral lichen planus (“OLP”),
in an expanded access program, which allows patients to access certain treatments outside of clinical trials that are not yet
approved by the FDA.
On
February 11, 2025, the Company issued a press release (the “February 11th Press Release”, and together
with the February 6th Press Release, the “Press Releases”) announcing that the Company intends to report
positive topline Phase 2a results for LP-310 in the treatment of OLP during the BIO CEO & Investor Conference on February
11, 2025. The Company intends to use an investor presentation (the “Investor Presentation”) at such conference to
provide further details regarding such topline results and the Company’s other product candidates to prospective investors,
analysts and others. Each of the Press Releases and the Investor Presentation are attached hereto as Exhibits 99.1, 99.2 and 99.3,
respectively, and incorporated herein by reference.
Cautionary
Statement Regarding Forward-Looking Statements
This
Form 8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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, but not limited
to those related to the current regulatory status and clinical trial results for LP-310 and the Company’s other product
candidates, 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 the Company’s
ability to regain and/or maintain compliance with the listing standards of The Nasdaq Stock Market LLC, the Company’s current
liquidity position and the need to obtain additional financing to support ongoing operations, 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.
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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
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: February 11, 2025 |
Lipella Pharmaceuticals Inc. |
| |
|
|
| |
By: |
/s/ Jonathan
Kaufman |
| |
|
Name:
Jonathan Kaufman
Title:
Chief Executive Officer |
Exhibit
99.1
Lipella
Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus
PITTSBURGH,
Feb. 06, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”),
a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced that
the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310, an oral rinse
formulation designed to treat oral lichen planus (OLP).
LP-310
is an innovative, localized therapy formulated to provide targeted relief for OLP patients while minimizing systemic exposure.
Oral lichen planus is a chronic inflammatory condition affecting the mucous membranes inside the mouth, often causing burning
pain, white patches, swollen tissue and open sores. The condition impacts approximately 6 million Americans and currently has
no FDA-approved therapies.
Expanded
Access Programs allow patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside
of a clinical trial that are not yet approved by the FDA.
“Receiving
FDA approval for expanded use of LP-310 represents a key milestone in our mission to address the significant unmet need in oral
lichen planus treatment,” said Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. “We
are pleased to make LP-310 available to patients beyond our Phase 2a clinical trial through this expanded access program. With
no approved therapies currently available, this approval strengthens our commitment to advancing LP-310 as a potential solution
for patients living with this painful and often debilitating condition.”
The
FDA’s approval for expanded use reinforces LP-310’s potential as a new therapeutic option for OLP and supports ongoing
clinical development efforts.
About
LP-310
LP-310 is an oral rinse formulation of LP-10 (tacrolimus) developed to target inflammation and immune response in OLP patients.
Designed for localized therapeutic effects, LP-310 minimizes systemic exposure, reducing the risks associated with long-term steroid
use. A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy
of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus)
and is being conducted across seven active U.S. sites, which are now recruiting participants.
About
Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology
company focused on developing innovative therapies by reformulating active agents in existing generic drugs. Lipella targets diseases
with significant unmet needs, where no approved treatments currently exist.
For more information, visit lipella.com or
follow us on LinkedIn and X .
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,
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, risks related to the
effective application of the use of proceeds from the private placement, general capital market risks, 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:
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
PCG
Advisory
Jeff Ramson
jramson@pcgadvisory.com
Exhibit
99.2
Lipella
Pharmaceuticals Reports Positive Topline Phase 2a Results for LP-310 in the Treatment of Oral Lichen Planus
LP-310
Treatment Demonstrates Clinically Meaningful Reductions in Pain, Ulceration, and
Inflammation Across All Key Metrics
Findings
Highlight Favorable Safety Profile and Tolerability of Twice-Daily Oral Rinse
Multicenter
Phase 2a Trial Advancing to Higher Treatment Dose with
Recruitment Expected to Conclude the First Half of 2025
Lipella
Leadership to Present Findings at BIO CEO & Investor Conference
on Tuesday, February 11, 2025, at 2:30 p.m. EST
PITTSBURGH,
Feb. 11, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us,”
or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet needs, today
shared topline analysis of its Phase 2a multicenter dose-ranging trial examining LP-310, a liposomal-tacrolimus oral rinse formulation
of LP-10 being developed to treat oral lichen planus (“OLP”).
LP-310
demonstrated a strong safety profile, with no product-related serious adverse events (SAEs) and no patient dropouts. The trial showed
statistically significant improvements across multiple patient-reported and investigator-measured efficacy endpoints at weeks 1, 4, and
6. LP-310 is the only oral rinse topical treatment currently in development for OLP.
Lipella
Pharmaceuticals’ management will provide an overview of the Company and present results from the study during the BIO CEO &
Investor Conference at The New York Marriott Marquis in New York City on Tuesday, Feb. 11, 2025, at 2:30 p.m. EST in the Plymouth Room.
Affecting
about 6 million Americans, OLP is a chronic inflammatory condition that targets mucous membranes in the mouth, which can cause pain and
make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue
and open sores, OLP has no FDA-approved therapies.
“OLP
represents a significant unmet need, and these remarkable results are highly encouraging, underscoring the meaningful value LP-310 can
bring to both patients and the broader healthcare system,” added Jonathan Kaufman, Co-Founder and CEO of Lipella Pharmaceuticals.
“With a chronic condition like OLP, delivering a targeted, effective treatment that overcomes the challenges of current options
is vital. We are thrilled to advance its development and unlock its full potential.”
In
the study’s first cohort, eight participants received a twice-daily dose of 0.25 mg of LP-310. Follow-up visits occurred at one
and four weeks as well as two weeks post-treatment. The trial showed significant improvements across multiple efficacy endpoints while
suggesting the safety and tolerability of LP-10 in adult patients with symptomatic OLP at the 0.25 mg/10 mL dose. The trial, which is
active across seven U.S. sites, has progressed to the next higher dose cohort of 0.5 mg/10 mL.
Topline
Findings:
- Investigator
Global Assessment (IGA): Improved from 3.50 ± 0.19 at baseline to 2.75 ± 0.31 at week 1 (p=0.031), 1.75 ±
0.45 at week 4 (p=0.008), and 2.80 ± 0.37 at week 6 (p=0.125).
- Reticulation,
Erythema, and Ulceration (REU) Score: Reduced from 27.75 ± 2.71 at baseline to 17.56 ± 2.51 at week 1 (p=0.004),
12.69 ± 3.06 at week 4 (p=0.004), and 19.60 ± 4.31 at week 6 (p=0.031).
- Oral
Lichen Planus Symptom Severity Measure (OLPSSM): Decreased from 15.38 ± 2.20 at baseline to 10.13 ± 2.34 at week
1 (p=0.035), 5.00 ± 2.28 at week 4 (p=0.004), and 8.60 ± 4.06 at week 6 (p=0.031).
- Pain
Numerical Rating Scale (NRS): Improved from 6.63 ± 0.80 at baseline to 4.38 ± 0.96 at week 1 (p=0.004), 2.38 ±
1.15 at week 4 (p=0.004), and 3.60 ± 1.63 at week 6 (p=0.031).
- Global
Response Assessment (GRA): Significant improvement was observed at week 4 (p=0.031).
“The
statistically significant reductions in pain, ulceration, and inflammation observed in this trial provide strong grounds for the scientific
validation of LP-310’s efficacy,” said Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals.
“These results, combined with the treatment’s favorable safety profile, highlight the potential of LP-310 to deliver a highly
targeted and tolerable therapy for OLP. We are deeply grateful to the patients and investigators for their contributions to this critical
study and inspired by the marked improvements we’ve seen in patients’ lives. We look forward to advancing the trial to the
next dose cohort and expanding recruitment across seven active U.S. sites as we continue to build on these promising findings.”
Safety
and Tolerability
LP-310 was well tolerated with no product-related serious adverse events reported. All patients adhered to the twice-daily 10 mL rinse
regimen, with no dropouts during the study. Pharmacokinetic analysis showed that tacrolimus blood levels were undetectable or minimal
in all patients, underscoring LP-310’s potential to deliver localized benefits without systemic toxicity.
Next
Steps in Development
Lipella continues to recruit for the trial, with plans to activate additional sites and complete the trial by mid-2025. The company is
preparing for key milestones, including the submission of a Phase 2b clinical trial investigational new drug application in the second
half of 2025 and a Breakthrough Therapy designation request to the FDA during the same period.
About
LP-310
LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address OLP. Designed to provide localized therapeutic
effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition.
A
Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in
adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus) and is being
conducted across seven active U.S. sites, which are now recruiting participants. The study has reported topline data from its first cohort,
with the second cohort currently dosing and topline data expected in the first half of 2025.
For
more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
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" which are not historical facts, within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other
than statements of historical fact, included in this press release regarding, among other things, our strategy, 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, the current clinical trial results for LP-310 and our other products general capital market risks,
our ability to regain and maintain compliance with the listing standards of The Nasdaq Stock Market LLC, regional, national or global
political, economic, business, competitive, market and regulatory conditions, our current liquidity position and the need to obtain additional
financing to support ongoing operations, and other risks as more fully described in our filings 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 or investment advice and
should consult with your own advisors as to the matters described herein, as applicable.
CONTACT
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
PCG
Advisory
Jeff Ramson
jramson@pcgadvisory.com
Exhibit 99.3
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Lipella Pharmaceuticals (NASDAQ:LIPO)
과거 데이터 주식 차트
부터 1월(1) 2025 으로 2월(2) 2025
Lipella Pharmaceuticals (NASDAQ:LIPO)
과거 데이터 주식 차트
부터 2월(2) 2024 으로 2월(2) 2025
