Filed
pursuant to Rule 424(b)(5)
Registration
Statement No. 333-276815
Prospectus
Supplement
(To
Prospectus dated February 8, 2024)

LIPELLA
PHARMACEUTICALS INC.
399,000
Shares of Common Stock
Pre-Funded
Warrants to purchase up to 1,667,000 Shares of Common Stock
Up
to 1,667,000 Shares of Common Stock Underlying the Pre-Funded Warrants
We
are offering 399,000 shares of our common stock, par value $0.0001 per share (“common stock”), to an institutional
investor at an offering price of $0.62 per share, pursuant to this prospectus supplement and the accompanying base prospectus.
We
are also offering pre-funded warrants to purchase 1,667,000 shares of our common stock (“pre-funded warrants”) in
lieu of shares of common stock to the same institutional investor whose purchase of shares of common stock in this offering would
otherwise result in the investor, together with its affiliates, beneficially owning more than 4.99% (or, at the election of the
investor, 9.99%) of our common stock. Each pre-funded warrant will be sold in this offering at a purchase price equal to $0.619
(equal to the purchase price per share of common stock sold in this offering, minus $0.001). The per share exercise price for
the pre-funded warrants will be $0.001, and the pre-funded warrants are immediately exercisable and may be exercised at any time
until all of the pre-funded warrants are exercised in full. This offering also relates to the shares of common stock issuable
upon exercise of the pre-funded warrants sold in this offering.
Our
common stock is listed and trades on the Nasdaq Capital Market under the symbol “LIPO.” The last sale price of our
shares of common stock on July 30, 2024 was $0.8967 per share. There is no established trading market for the pre-funded warrants,
and we do not expect a market to develop. We do not intend to apply for a listing for such pre-funded warrants on any securities
exchange or other nationally recognized trading system.
As
of the date of this prospectus supplement, the aggregate market value of our outstanding common stock held by non-affiliates,
computed by reference to the price at which our common stock was last sold on the Nasdaq Capital Market on July 30, 2024, which
was $0.8967 per share, was $5,226,998.80, based on 7,605,636 shares of our outstanding common stock as of the date of this prospectus
supplement, of which 5,829,150 shares were held by non-affiliates. Pursuant to General Instruction I.B.6 of Form S-3, in no event
will we sell securities in a public primary offering with a value exceeding one-third of our public float in any 12-month period
so long as our public float remains below $75 million. During the 12 calendar months prior to and including the date of this prospectus
supplement (excluding this offering), we have not sold any securities pursuant to General Instruction I.B.6 of Form S-3.
We
have engaged H.C. Wainwright & Co., LLC (“Wainwright” or the “placement agent”) to act as our exclusive
placement agent for this offering. The placement agent has agreed to use its “reasonable best efforts” to arrange
for the sale of shares of our common stock and pre-funded warrants offered by this prospectus supplement and the accompanying
base prospectus, but the placement agent has no obligation to purchase or sell any of such securities or to arrange for the purchase
or sale of any specific number or dollar amount of such securities. There is no required minimum number of securities that must
be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to
closing this offering, the actual offering amount, placement agent fees, and proceeds to us, if any, are not presently determinable
and may be substantially less than the total maximum offering amounts set forth below. We have not arranged to place the funds
from investors in an escrow, trust or similar account. We have agreed to pay the placement agent the fees set forth in the table
below in connection with this offering, which assumes that we sell all of the shares of common stock and pre-funded warrants we
are offering hereby.
|
|
Per
Share |
|
|
Per
Pre-Funded Warrant |
|
|
Total |
|
Offering price |
|
$ |
0.6200 |
|
|
$ |
0.6190 |
|
|
$ |
1,280,920.00 |
|
Placement agent’s fees (1) |
|
$ |
0.0465 |
|
|
$ |
0.0465 |
|
|
$ |
96,069.00 |
|
Proceeds, before expenses, to us (2) |
|
$ |
0.5735 |
|
|
$ |
0.5725 |
|
|
$ |
1,184,851.00 |
|
(1) |
Represents a cash fee equal to 7.5% of the aggregate purchase price paid by the investor in this offering. In addition, we have agreed to pay the placement agent a management fee, reimbursement for certain of its offering-related expenses and to issue warrants to purchase shares of common stock to the placement agent or its designees (the “placement agent warrants”). Neither the placement agent warrants nor the shares of our common stock issuable upon exercise of the placement agent warrants are being registered hereby. See “Plan of Distribution” beginning on page S-8 of this prospectus supplement for more information. |
|
|
(2) |
Does not include proceeds from the exercise of the placement agent warrants to be issued to the placement agent in cash, if any. |
Delivery
of the shares of common stock and pre-funded warrants offered hereby is expected to be made on or about August 1, 2024, subject
to satisfaction of customary closing conditions.
Investing
in our securities involves a high degree of risk. Before making any investment decision, you should carefully review and consider
all the information in this prospectus supplement, the accompanying base prospectus and the documents incorporated by reference
herein and therein, including the risks and uncertainties described under “Risk Factors” beginning on page S-8 of
this prospectus supplement and the risk factors incorporated by reference into this prospectus supplement and the accompanying
base prospectus.
Neither
the U.S. Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved
of these shares or determined if this prospectus supplement or the accompanying base prospectus is truthful or complete. Any representation
to the contrary is a criminal offense.
H.C.
Wainwright & Co.
The
date of this prospectus supplement is July 31, 2024.
TABLE
OF CONTENTS
You
should rely only on the information incorporated by reference or provided in this prospectus supplement and the accompanying base
prospectus. Neither we nor the placement agent have authorized anyone to provide you with different information. If anyone provides
you with different or inconsistent information, you should not rely on it. This prospectus supplement and the accompanying base
prospectus do not constitute an offer to sell, or a solicitation of an offer to purchase, the securities offered by this prospectus
supplement and the accompanying base prospectus in any jurisdiction where it is unlawful to make such offer or solicitation. You
should assume that the information contained in this prospectus supplement or the accompanying base prospectus, or any document
incorporated by reference in this prospectus supplement or the accompanying base prospectus, is accurate only as of the date of
those respective documents. Neither the delivery of this prospectus supplement nor any distribution of securities pursuant to
this prospectus supplement shall, under any circumstances, create any implication that there has been no change in the information
set forth or incorporated by reference into this prospectus supplement or in our affairs since the date of this prospectus supplement.
Our business, financial condition, results of operations and prospects may have changed since that date.
ABOUT
THIS PROSPECTUS SUPPLEMENT
A
registration statement on Form S-3 (File No. 333-276815) utilizing a shelf registration process relating to the securities described
in this prospectus supplement was initially filed with the SEC on February 1, 2024 and was declared effective on February 8, 2024.
This
document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering of
securities. The second part is the accompanying base prospectus, which provides more general information, some of which may not
apply to this offering. The information included or incorporated by reference in this prospectus supplement also adds to, updates
and changes information contained or incorporated by reference in the accompanying base prospectus. It is also important for you
to read and consider all information contained in this prospectus supplement and the accompanying base prospectus, including the
documents we have referred you to in the section entitled “Where You Can Find More Information” below in this prospectus
supplement. If information included or incorporated by reference in this prospectus supplement is inconsistent with the accompanying
base prospectus or the information incorporated by reference therein, then this prospectus supplement or the information incorporated
by reference in this prospectus supplement will apply and will supersede the information in the accompanying base prospectus and
the documents incorporated by reference therein. You should assume that the information contained in this prospectus supplement,
the accompanying base prospectus and the documents incorporated by reference is accurate only as of their respective dates.
We
have not, and the placement agent has not, authorized any person to provide you with any information or to make any representation
other than as contained in this prospectus supplement or in the accompanying base prospectus and the information incorporated
by reference herein and therein. We and the placement agent do not take any responsibility for, and can provide no assurance as
to the reliability of, any information that others may provide you. The information appearing or incorporated by reference in
this prospectus supplement and the accompanying base prospectus is accurate only as of the date of this prospectus supplement
or the date of the document in which incorporated information appears unless otherwise noted in such documents. Our business,
financial condition, results of operations and prospects may have changed since those dates.
The
distribution of this prospectus supplement and the accompanying base prospectus and the offering of the securities in certain
jurisdictions may be restricted by law. We are not, and the placement agent is not, making an offer of the securities in any jurisdiction
where the offer is not permitted. Persons who come into possession of this prospectus supplement and the accompanying base prospectus
should inform themselves about and observe any such restrictions. This prospectus supplement and the accompanying base prospectus
do not constitute, and may not be used in connection with, an offer or solicitation by anyone in any jurisdiction in which such
offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or
to any person to whom it is unlawful to make such offer or solicitation.
Unless
the context indicates otherwise, in this prospectus supplement and the accompanying base prospectus the terms, the terms “Lipella,”
the “Company,” “we,” “our” or “us” in this prospectus supplement refer to Lipella
Pharmaceuticals Inc.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus supplement and the documents incorporated by reference in this prospectus supplement include forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that relate to future events or our future
operations or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements
by terminology such as “may”, “should”, “intends”, “expects”, “plans”,
“targets”, “anticipates”, “believes”, “estimates”, “will”, “would”,
“predicts”, “potential”, or “continue” or the negative of these terms or other comparable
terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors. The Private
Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to
comply with the terms of the safe harbor, we note that a variety of factors could cause actual results and experience to differ
materially from the anticipated results or other expectations expressed in the forward-looking statements.
Such
statements include, but are not limited to, statements about the following:
● |
the
initiation, timing, progress preclinical and clinical trials for other product candidates, including statements regarding
the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results
of the trials will become available and our research and development programs; |
● |
the
timing, scope or results of regulatory filings and approvals for our product candidates, including timing of final U.S. Food
and Drug Administration (“FDA”) marketing and other regulatory approvals of our lead product candidate, LP-10;
and our other product candidates, including, but not limited to, LP-310; |
● |
our
ability to achieve certain accelerated or “orphan drug” designations from the FDA; |
● |
our
estimates regarding the potential market opportunity for LP-10 or any of our other product candidates; |
● |
our
research and development programs for our product candidates; |
● |
our
plans and ability to successfully develop and commercialize LP-10 or any of our other product candidates; |
● |
our
ability to identify and develop new product candidates; |
● |
our
ability to identify, recruit and retain key personnel; |
● |
our
commercialization, marketing and manufacturing capabilities and strategy; |
● |
the
implementation of our business model, strategic plans for our business, product candidates and technology; |
● |
the
scalability and commercial viability of our proprietary manufacturing methods and processes; |
● |
the
rate and degree of market acceptance and clinical utility of our product candidates and gene therapy, in general; |
● |
our
competitive position; |
● |
our
intellectual property position and our ability to protect and enforce our intellectual property; |
● |
our
financial performance; |
● |
developments
and projections relating to our competitors and our industry; |
● |
our
ability to establish and maintain collaborations or obtain additional funding; |
● |
our
estimates regarding expenses, future revenue, capital requirements and needs for or ability to obtain additional financing; |
● |
the
impact of laws and regulations; |
● |
our
expectations regarding the time during which an emerging growth company under the JOBS Act; and the
impact of global economic and political developments on our business, including high inflation and capital market disruptions,
the Ukraine-Russia and Israel-Hamas wars, economic sanctions and economic slowdowns or recessions, including any that may
result from such developments and public health concerns, which could harm our commercialization efforts as well as the value
of our common stock and our ability to access capital markets. |
We
have based these forward-looking statements on our current expectations and projections about future events. We believe that the
assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to us
on the date hereof, but we cannot assure you that these assumptions and expectations will prove to have been correct or that we
will take any action that we may presently be planning. These forward-looking statements are inherently subject to known and unknown
risks and uncertainties. We have included important cautionary statements in this prospectus supplement, in the documents incorporated
by reference in this prospectus supplement, and in the sections in our periodic reports, including our most recent Annual Report
on Form 10-K, entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” as supplemented by our subsequent Quarterly Reports on Form 10-Q or our
Current Reports on Form 8-K, discussing some of the factors that we believe could cause actual results or events to differ materially
from the forward-looking statements that we are making including, but are not limited to, research and product development uncertainties,
regulatory policies and approval requirements, competition from other similar businesses, market and general economic factors.
In
light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained
in this prospectus supplement or in any document incorporated herein by reference might not occur. Investors are cautioned not
to place undue reliance on the forward-looking statements, which speak only as of the date of this prospectus supplement or the
date of the document incorporated by reference in this prospectus supplement. We are not under any obligation, and we expressly
disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events
or otherwise. All subsequent forward-looking statements attributable to us or to any person acting on our behalf are expressly
qualified in their entirety by the cautionary statements contained or referred to in this section.
PROSPECTUS
SUPPLEMENT SUMMARY
The
following summary of our business highlights some of the information contained elsewhere in or incorporated by reference into
this prospectus supplement. Because this is only a summary, however, it does not contain all of the information that may be important
to you. You should carefully read this prospectus supplement and the accompanying base prospectus, including the documents incorporated
by reference, which are described under “Where You Can Find Additional Information” and “Incorporation of Certain
Information by Reference” in this prospectus supplement. You should also carefully consider the matters discussed in the
section in this prospectus supplement entitled “Risk Factors.”
Overview
We
are 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. We believe that this strategy combines many of the cost efficiencies
and risk abatements derived from using existing generic drugs with potential patent protections for our proprietary formulations;
this strategy allows us to expedite, protect, and monetize our product candidates. Additionally, we maintain a therapeutic focus
on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. We believe
that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval.
LP-10
is the development name of our reformulation of tacrolimus (an approved generic active agent) specifically optimized for topical
deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery platform that we have developed
and that we refer to as our metastable liposome drug delivery platform (our “Platform”). We are developing LP-10 and
our Platform to be, to our knowledge, the first drug candidate and drug delivery technology that could be successful in treating
cancer survivors who acquire hemorrhagic cystitis. We have received U.S. Food and Drug Administration (“FDA”) “orphan
drug” designation covering LP-10 and plan to apply for additional regulatory designations in the event we achieve qualifying
results in the current phase 2a clinical trial for LP-10. Market data exclusivity may be available in the U.S. and other jurisdictions
in which regulatory approval is obtained for the Company’s product, regardless of patent status.
The
safety and efficacy of LP-10 was evaluated in a 13-subject, open-label, multi-center, dose-escalation, phase 2a clinical trial
in patients experiencing complications associated with a rare but highly morbid disease called “radiation-induced hemorrhagic
cystitis” or “radiation cystitis.” This phase 2a clinical trial commenced on February 15, 2021, and we reported
the trial’s summary results in the first quarter of 2023. We met with the FDA in the fourth quarter of 2023 regarding the
LP-10 clinical trial results, and expect to receive their response to our proposed phase 2b trial design in the fourth quarter
of 2024. There is currently no FDA approved drug therapy available for radiation cystitis patients, who are all cancer survivors
who received pelvic radiation therapy to treat solid pelvic tumors, including prostate and ovarian cancers, and who are now dealing
with therapy-associated complications, including urinary bleeding (a radiation cystitis symptom). LP-10’s active ingredient,
tacrolimus, which has a well-known pharmacology and toxicology, addresses a reduction (or cessation) of uncontrolled urinary bleeding.
In
the fourth quarter of 2023, we received IND approval from the FDA for LP-310, our product for the treatment of oral lichen planus
(“OLP”). We have begun the clinical trial process for LP-310, and we initiated the first clinical site in the second
quarter of 2024 and expect to treat the first patient by the third quarter of 2024. OLP is a chronic, T-cell-mediated, autoimmune
oral mucosal disease, and LP-310 contains tacrolimus which inhibits T-lymphocyte activation. To date, upon review of relevant FDA
public data resources on approved drugs and biologics, we are not aware of any other liposomal products developed to treat such
disease.
In
the first quarter of 2024, we received IND approval from the FDA for LP-410, our phase-1/2a product, for the treatment of oral
graft-versus-host disease (“GVHD”). LP-410 is an oral rinse, similar to LP-310, but will have a different containment
system. Hematopoietic cell transplantation (“HCT”) is used to treat a wide range of malignancies, hematologic and
immune deficiency states, and autoimmune diseases. GVHD is a clinical syndrome where donor-derived immunocompetent T-cells react
against patient tissues directly or through exaggerated inflammatory responses following HCT. Lipella has developed LP-410 for
the topical delivery directly to the mouth surface. LP-410 targets the underlying mechanisms of oral GVHD, potentially providing
a safe and effective treatment option for affected individuals. Lipella received “orphan drug” designation approval
on November 11, 2023 for tacrolimus for the treatment of oral GVHD. An IND application for LP-410’s treatment of oral GVHD
was submitted to the FDA on January 30, 2024.
Since
our inception in 2005, we have focused primarily on business planning and progressing our lead product candidates, including progressing
LP-10 through clinical development, raising capital, organizing and staffing the Company.
Additional
Information
For
additional information related to our business and operations, please refer to the reports incorporated herein by reference, including
our Annual Report on Form 10-K for the year ended December 31, 2023 as described under the caption “Incorporation of Documents
by Reference” on page S-19 of this prospectus supplement.
Corporate
Information
We
were incorporated under the laws of the state of Delaware in February 2005. Our principal executive offices are located at 7800
Susquehanna Street, Suite 505, Pittsburgh, PA 15208, and our telephone number is (412) 894-1853. We have approximately 6,000 square
feet of combined laboratory, office and warehouse space at our principal executive offices that we use in our research and development
efforts, including a sterile pharmaceutical pilot plant for manufacturing liposomal and other formulations, as well as relevant
analytical facilities. Our corporate website address is www.lipella.com. The
information contained on, connected to or that can be accessed via our website is not part of this prospectus supplement. We have
included our website address in this prospectus supplement as an inactive textual reference only and not as an active hyperlink.
Our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports filed
or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are available free of charge through the investor relations
page of our internet website as soon as reasonably practicable after we electronically file such material with, or furnish it
to, the SEC.
Implications
of Being an Emerging Growth Company and a Smaller Reporting Company
We
qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”). An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that
are otherwise applicable generally to public companies. These provisions include:
● reduced
obligations with respect to financial data;
● an
exception from compliance with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley
Act”);
● reduced
disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements;
and
● exemptions
from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements.
We
may take advantage of these provisions for up to five years following our December 2022 initial public offering (our “IPO”)
or such earlier time that we no longer qualify as an emerging growth company. We would cease to be an emerging growth company
upon the earliest of:
● the
last day of the fiscal year on which we have $1.235 billion or more in annual revenue,
● the
date on which we become a “large accelerated filer” (i.e., as of our fiscal year end, the total market value of our
common equity securities held by non-affiliates is $700 million or more as of June 30),
● the
date on which we issue more than $1.0 billion of non-convertible debt over a three-year period, or
● the
last day of our fiscal year following the fifth anniversary of the date of the completion of our IPO.
We
may choose to take advantage of some but not all of these reduced reporting burdens.
In
addition, under the JOBS Act, emerging growth companies can take advantage of an extended transition period and delay adopting
new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this
extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which
adoption of such standards is required for private companies. If we were to subsequently elect instead to comply with public company
effective dates, such election would be irrevocable pursuant to the JOBS Act.
Also,
we are a “smaller reporting company” (and may continue to qualify as such even after we no longer qualify as an emerging
growth company). For as long as we qualify as a “smaller reporting company,” we may provide reduced disclosure in
the public filings that we make with the SEC than larger public companies, such as the inclusion of only two years of audited
financial statements and only two years of management’s discussion and analysis of financial condition and results of operations
disclosure.
As
a result of qualifying as an emerging growth company and a smaller reporting company, to the extent we take advantage of the allowable
reduced reporting burdens, the information that we provide to our stockholders may be different than what you might receive from
other public reporting companies in which you hold equity interests.
THE
OFFERING
Common Stock Offered in This Offering |
399,000 shares of
our common stock, par value $0.0001 per share |
|
|
Pre-Funded Warrants Offering in This Offering |
We are offering
pre-funded warrants to purchase 1,667,000 shares of common stock in lieu of shares of common stock to the investor whose purchase
of shares of common stock in this offering would otherwise result in the investor, together with its affiliates, beneficially
owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following
the consummation of this offering. The purchase price of each pre-funded warrant is equal to the price at which a share of
common stock is sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant is $0.001
per share. Each pre-funded warrant will be exercisable immediately and may be exercised at any time until all of the pre-funded
warrants are exercised in full. |
|
|
|
This prospectus
supplement and accompanying base prospectus also relate to the offering of the shares of common stock issuable upon exercise
of the pre-funded warrants. |
|
|
Common Stock Outstanding Before This Offering |
7,605,636 shares. |
|
|
Common Stock to be Outstanding After This Offering |
8,004,636 shares,
assuming no exercise of the pre-funded warrants or the placement agent warrants (9,671,636 shares, assuming full exercise of the pre-funded warrants). |
|
|
Use of Proceeds |
We estimate the
net proceeds from this offering will be approximately $1.0 million after deducting estimated offering expenses payable by
us. We currently intend to use the net proceeds from this offering for working capital and general corporate purposes. See
“Use of Proceeds” on page S-12. |
|
|
Risk Factors |
Investing in our
securities involves a high degree of risk. Before you decide to invest in our common stock, you should carefully read this
prospectus supplement in its entirety and carefully consider the risks and uncertainties described in “Risk Factors”
beginning on page S-8 of this prospectus supplement, beginning on page 8 of the accompanying base prospectus and in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as such risk factors may be amended, updated or modified
periodically in our reports filed with the SEC, and the financial data and related notes and the reports incorporated by reference
herein and therein. |
|
|
Nasdaq Capital Market Symbol |
“LIPO”.
There is no established public trading market for the pre-funded warrants, and we do not expect a market to develop. We do
not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading system. Without an
active trading market, the liquidity of the pre-funded warrants will be limited. |
The
number of shares of common stock to be outstanding immediately after this offering is based on 7,605,636 shares of our common
stock outstanding as of July 30, 2024 and excludes the following securities outstanding on July 30, 2024:
● |
2,893,000 shares
of our common stock issuable upon the exercise of outstanding stock options, at a weighted average exercise price of $2.43
per share with a weighted average remaining contractual life of 5.70 years; |
|
|
● |
1,025,000 shares
of our common stock reserved for future grant under our 2020 Stock Incentive Plan; and |
|
|
● |
1,558,467 shares
of our common stock issuable upon the exercise of outstanding warrants. |
|
|
Unless
otherwise indicated, this prospectus supplement assumes the full exercise of the pre-funded warrants and no exercise of any placement agent warrants.
RISK
FACTORS
Investing in our
shares of common stock involves a high degree of risk. You should carefully consider the risks, uncertainties and other factors
described in our most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K that we have filed or will filed with the SEC, and in other documents incorporated by reference
to our filings with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act and all other information contained
or incorporated by reference in this prospectus supplement and the accompanying base prospectus, including our consolidated financial
statements and the related notes, before investing in our common stock. If any of these risks materialize, our business, financial
condition or results of operations could be materially harmed. In that case, the trading price of our common stock could decline,
and you may lose some or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional
risks not presently known to us, or that we currently deem immaterial, may also impair our business operations. If any of these
risks were to occur, our business, financial condition, or results of operations would likely suffer. In that event, the trading
price of our common stock could decline, and you could lose all or part of your investment.
Risks Related to this Offering
If you purchase securities sold in
this offering, you will incur immediate dilution.
Since the price per
share of our common stock being offered is higher than the pro forma as adjusted net tangible book value per share of our common
stock after giving effect to this offering, you will suffer dilution with respect to the pro forma as adjusted net tangible book
value of the shares of common stock you purchase in this offering. Based on an offering price of $0.62 per share and our pro forma
net tangible book value as of March 31, 2024, if you purchase securities in this offering, you will suffer immediate dilution of
$0.25 per share with respect to the net tangible book value of the common stock. You may experience additional dilution upon exercise
of the outstanding stock options and other equity awards that may be granted under our equity incentive plans, exercise of outstanding
warrants and when we otherwise issue additional shares of our common stock. For more information, see “Dilution.”
We will have broad discretion in
the use of the net proceeds from this offering and may not use them effectively, including in connection with pending litigation.
Our management will
have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in
the section entitled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to
assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine
our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our
management may not apply the net proceeds from this offering in ways that ultimately increase the value of your investment. The
failure by our management to apply these funds effectively could harm our business. These investments may not yield a favorable
return to our stockholders.
We have
been notified by The Nasdaq Stock Market LLC (“Nasdaq”) of our failure to comply with certain continued listing requirements
and, if we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq, our Common
Stock could be delisted from Nasdaq.
Our
Common Stock is currently listed on the Nasdaq Capital Market. In order to maintain that listing, we must satisfy minimum financial
and other continued listing requirements and standards, including those regarding director independence and independent committee
requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.
As
disclosed in our Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on April 19, 2024, on
April 17, 2024, we received a written notification from Nasdaq’s Listing Qualifications Department notifying us that we were
not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth under
Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”), because the closing bid price of our Common Stock
was below $1.00 per share for the previous thirty (30) consecutive business days. We were granted 180 calendar days, or until October
14, 2024, to regain compliance with the Minimum Bid Price Requirement. In the event we do not regain compliance with the Minimum
Bid Price Requirement by October 14, 2024, we may be eligible for an additional 180-calendar day grace period. To qualify, we will
be required to meet the continued listing requirement for market value of publicly held shares and all other listing standards
for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice
to Nasdaq of our intent to regain compliance with such requirement during such second compliance period. If we do not regain compliance
within the allotted compliance period(s), including any extensions that may be granted, Nasdaq will provide notice that our Common
Stock will be subject to delisting from the Nasdaq Capital Market. At that time, we may appeal Nasdaq’s determination to
a hearings panel.
We intend to monitor
the closing bid price of our Common Stock and assess potential actions, including effecting a reverse stock split, to regain compliance,
but there is no assurance that we will be able to regain compliance, including under the specified grace period or any extensions
thereof. Even if we were to regain compliance with the deficiency noted above, we may, again, in the future fall out of compliance
with such standards. A delisting of our Common Stock could have an adverse effect on the market price of, and the efficiency of
the trading market for, our Common Stock, not only in terms of the number of shares that can be bought and sold at a given price,
but also through delays in the timing of transactions and less coverage of us by securities analysts, if any.
There can be no
assurances that we will be able to regain compliance with the Minimum Bid Price Requirement or if we do later regain compliance
with the Minimum Bid Price Requirement, that we will be able to continue to comply with all applicable Nasdaq listing requirements
now or in the future. If we are unable to maintain compliance with these Nasdaq requirements, our Common Stock will be delisted
from the Nasdaq Capital Market.
In the event that
our Common Stock is delisted from the Nasdaq Capital Market, as a result of our failure to comply with the Minimum Bid Price Requirement,
or due to our failure to continue to comply with any other requirement for continued listing on the Nasdaq Capital Market, and
is not eligible for listing on another exchange, trading in the shares of our Common Stock could be conducted in the over-the-counter
market or on an electronic bulletin board established for unlisted securities such as the Pink Market or another over-the-counter
market operated by the OTC Markets Group Inc. In such event, it could become more difficult to dispose of, or obtain accurate price
quotations for, our Common Stock, and it would likely be more difficult to obtain coverage by securities analysts and the news
media, which could cause the price of our Common Stock to decline further. Also, it may be difficult for us to raise additional
capital if we are not listed on a national exchange.
There may be future sales of our
securities or other dilution of our equity, which may adversely affect the market price of our common stock.
We are generally not
restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that
represent the right to receive, common stock; however, we agreed as part of this offering to not issue any common stock or common
stock equivalents, or file any registration statement or amendments or supplements thereto, other than this prospectus supplement
or filing a registration statement on Form S-8 in connection with any equity incentive plan for a period of thirty (30) days from
the closing of this offering. The market price of our common stock could decline as a result of sales of common stock or securities
that are convertible into or exchangeable for, or that represent the right to receive, common stock after this offering or the
perception that such sales could occur.
Even if this offering is successful,
we will need to raise additional capital in the future to remain a going concern, which may not be available on acceptable terms,
or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development
efforts or other operations.
We have had significant
recurring losses from operations and we have not established a source of revenues sufficient to cover our operating costs and must
raise additional funds in order to continue operating our business. We expect to continue to fund our operations in the future
primarily through equity and debt financings. If additional capital is not available to us when needed or on acceptable terms,
we may not be able to continue to operate our business pursuant to our business plan or we may have to discontinue our operations
entirely. Based on our cash balance and recurring losses since inception and inadequacy of existing capital resources to fund planned
operations during the next 12 months, we will require significant additional funding to continue operations. We will receive net
proceeds of approximately $1.0 million from the sale of the securities offered by us in this offering, after deducting the placement
agent fees and estimated offering expenses payable by us. We cannot provide assurances that our plans will not change or that changed
circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. Moreover, if
we are unable to continue as a going concern, we may be forced to liquidate our assets and the values we receive for our assets
in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
Any additional fundraising
efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize
our product candidates. Our ability to raise additional funds will depend, in part, on the success of our product development activities,
any clinical trials, regulatory events, our ability to identify and enter into in-licensing or other strategic arrangements, and
other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market
conditions, many of which are beyond our control. There can be no assurances that sufficient funds will be available to us when
required or on acceptable terms, if at all.
If we are unable to
secure additional funds when needed or on acceptable terms, we may be required to defer, reduce or eliminate significant planned
expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of technology
or assets, pursue an acquisition of our company by a third party at a price that may result in a loss on investment for our stockholders,
enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential
markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business,
financial condition and results of operations. Moreover, if we are unable to obtain additional funds on a timely basis, there will
be substantial doubt about our ability to continue as a going concern and increased risk of insolvency and up to a total loss of
investment by our stockholders.
We do not anticipate paying dividends
on our common stock in the foreseeable future.
We currently plan to
invest all available funds, including the proceeds from this offering, and future earnings, if any, in the development and growth
of our business. We currently do not anticipate paying any cash dividends on our common stock in the foreseeable future. As a result,
a rise in the market price of our common stock, which is uncertain and unpredictable, will be your sole source of potential gain
in the foreseeable future and you should not rely on an investment in our common stock for dividend income.
The market price and trading volume
of our Common Stock may experience rapid and substantial volatility, which could cause purchasers of our Common Stock to incur
substantial losses.
The market price
of our Common Stock may fluctuate dramatically, and may decline rapidly, regardless of any developments in our business. Overall,
there are various factors, many of which are beyond our control, that could negatively affect the market price of our Common Stock
or result in fluctuations in the price or trading volume of our Common Stock, including:
|
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actual or anticipated variations in our annual or quarterly results of operations, including our earnings estimates and whether we meet market expectations with regard to our earnings; |
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|
|
|
● |
our current inability to pay dividends or other distributions; |
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|
|
|
● |
publication of research reports by analysts or others about us or the industry in which we operate, including the pharmaceutical or biotechnology industry which may be unfavorable, inaccurate, inconsistent or not disseminated on a regular basis; |
|
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|
● |
changes in market valuations of similar companies; |
● |
market reaction to any additional equity, debt or other securities that we may issue in the future, and which may or may not dilute the holdings of our existing stockholders; |
● |
additions or departures of key personnel; |
● |
actions by institutional or significant stockholders; |
● |
short interest in our Common Stock or our other securities and the market response to such short interest; |
● |
the dramatic increase in the number of individual holders of our Common Stock and their participation in social media platforms targeted at speculative investing; |
● |
speculation in the press or investment community about our company or industries in which we operate; |
● |
strategic actions by us or our competitors, such as acquisitions or other investments; |
● |
legislative, administrative, regulatory or other actions affecting our business, our industry, including positions taken by the FDA; |
● |
investigations, proceedings, or litigation that involve or affect us; and |
● |
the occurrence of any of the other risk factors included in this Report; and |
● |
general market and economic conditions. |
|
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|
We are selling the securities offered
in this prospectus on a “best efforts” basis and may not be able to sell any of the securities offered herein.
We have engaged Wainwright
to act as placement agent in connection with this offering. While Wainwright will use its reasonable best efforts to arrange for
the sale of the securities, they are under no obligation to purchase any of the securities. As a result, there are no firm commitments
to purchase any of the securities in this offering. Consequently, there is no guarantee that we will be capable of selling all,
or any, of the securities being offered hereby.
Risks Related to the Pre-Funded Warrants
We do not intend to apply for any
listing of the pre-funded warrants on any exchange or nationally recognized trading system, and we do not expect a market to develop
for the pre-funded warrants.
We do not intend to
apply for any listing of either of the pre-funded warrants on the Nasdaq Capital Market or any other securities exchange or nationally
recognized trading system, and we do not expect a market to develop for the pre-funded warrants. Without an active market, the
liquidity of the pre-funded warrants will be limited. Further, the existence of the pre-funded warrants may act to reduce both
the trading volume and the trading price of our common stock.
Except as otherwise provided in the
pre-funded warrants, holders of pre-funded warrants purchased in this offering will have no rights as stockholders of common stock
until such holders exercise their pre-funded warrants and acquire our common stock.
The pre-funded warrants
offered in this offering do not confer any rights of common stock ownership on their holders, such as voting rights, but rather
merely represent the right to acquire shares of our common stock at a fixed price. A holder of a pre-funded warrant may exercise
the right to acquire a share of common stock and pay a nominal exercise price of $0.001 at any time. Upon exercise of the pre-funded
warrants, the holders thereof will be entitled to exercise the rights of a holder of common stock only as to matters for which
the record date occurs after the exercise date.
We may not receive any additional
funds upon the exercise of the pre-funded warrants.
Each pre-funded warrant
may be exercised by way of a cashless exercise, meaning that the holder may not pay a cash purchase price upon exercise, but instead
would receive upon such exercise the net number of shares of our common stock determined according to the formula set forth in
the pre-funded warrant. Accordingly, we may not receive any additional funds upon the exercise of the pre-funded warrants.
USE
OF PROCEEDS
We
estimate the net proceeds to us from the sale of our common stock in this offering, if any, will be approximately $1.0 million
after deducting the placement agent fees and estimated offering expenses payable by us, assuming full exercise of the pre-funded
warrants and excluding any proceeds we may receive upon exercise of the placement agent warrants.
We currently intend
to use the net proceeds from this offering for working capital and general corporate purposes. As a result, our management will
retain broad discretion in the allocation and use of the net proceeds of this offering, and investors will be relying on the judgment
of our management with regard to the use of these net proceeds.
DILUTION
If you invest in our
securities, you will experience immediate and substantial dilution to the extent of the difference between the amount per share
paid in this offering and the net tangible book value per share of our common stock immediately after the offering.
Our net tangible book
value per share is determined by subtracting our total liabilities from our total tangible assets, which is total assets less intangible
assets, and dividing this amount by the number of shares of common stock outstanding. The historical net tangible book value of
our common stock as of March 31, 2024 was approximately $2,561,279, or $0.36 per share, based on 7,039,846 shares of our common
stock outstanding at March 31, 2024.
Our pro forma net tangible
book value as of March 31, 2024, was approximately $2,561,279, or approximately $0.34 per share, on a pro forma basis to give effect
to the issuance of 565,790 shares of common stock upon exercise of certain pre-funded warrants on May 3, 2024.
After giving effect to the issuance
and sale in this offering of 399,000 shares of common stock at the offering price of $0.62 per share and pre-funded warrants to purchase
up to 1,667,000 shares of common stock at the offering price of $0.619 per pre-funded warrant, assuming full exercise of the pre-funded
warrants and no exercise of any placement agent warrants, after deducting the estimated placement agent’s fees and estimated offering
expenses payable by us, our pro forma as adjusted net tangible book value on March 31, 2024,
would have been approximately $3,561,279 or $0.37 per share. This represents an immediate increase in the net tangible book value of $0.03
per share attributable to this offering and an immediate dilution of $0.25 per share to the new investors in this offering.
The following table
illustrates the immediate dilution to new investors:
Offering price per share |
|
|
|
|
|
$ |
0.62 |
|
Historical net tangible book value per share on March 31, 2024 |
|
$ |
0.36 |
|
|
|
|
|
Pro forma net tangible book value per share on March 31, 2024 |
|
|
0.34 |
|
|
|
|
|
Increase in pro forma net tangible book value per share attributable to this offering |
|
|
0.03 |
|
|
|
|
|
Pro forma as adjusted net tangible book value per share as of March 31, 2024, after giving effect to this offering |
|
|
|
|
|
|
0.37 |
|
Dilution per share to new investors in this offering |
|
|
|
|
|
$ |
0.25 |
|
The foregoing discussion
and table do not take into account further dilution to the new investor that could occur upon the exercise of outstanding options
or warrants. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if
we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised
through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to
our stockholders.
The above discussion
and table are based on 7,039,846 shares of our common stock outstanding as of March 31, 2024, respectively, and excludes the following
securities outstanding on March 31, 2024:
|
● |
2,893,000 shares of our common stock issuable upon the exercise of outstanding stock options, at a weighted average exercise price of $2.73 per share with a weighted average remaining contractual life of 5.7 years; |
|
|
|
|
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1,025,000 shares of our common stock reserved for future grant under our 2020 Stock Incentive Plan; |
|
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|
● |
1,558,467 shares of our common stock issuable upon the exercise of outstanding warrants; and |
|
|
|
|
● |
565,590 shares of our common stock issuable upon the exercise of outstanding pre-funded warrants. |
Unless otherwise indicated, this prospectus
supplement assumes full exercise of the pre-funded warrants and no exercise of the placement agent warrants.
DESCRIPTION
OF THE SECURITIES THAT WE ARE OFFERING
We are offering 399,000
shares of common stock and the pre-funded warrants to purchase up to 1,667,000 shares of our common stock. The following description
of our shares of common stock and such pre-funded warrants summarizes the material terms and provisions thereof.
Common Stock
For a description of
the rights associated with the common stock, see “Description of Capital Stock” in the accompanying base prospectus.
Our common stock is listed on the Nasdaq Capital Market under the symbol “LIPO.” Our transfer agent is Nevada Agency
and Transfer Company.
Pre-Funded Warrants
The following summary
of certain terms and provisions of the pre-funded warrants that are being offered hereby is not complete and is subject to, and
qualified in its entirety by, the provisions of the pre-funded warrant, the form of which will be filed as an exhibit to our Current
Report on Form 8-K filed with the SEC on August 1, 2024. Prospective investors should carefully review the terms and provisions of the form
of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.
Each pre-funded warrant
will be sold in this offering at a purchase price equal to $0.619 (equal to the purchase price per share of common stock sold in
this offering, minus $0.001). The purpose of the pre-funded warrants is to enable investors that may have restrictions on their
ability to beneficially own more than 4.99% (or, upon election of the holder, 9.99%) of our outstanding common stock following
the consummation of this offering the opportunity to make an investment in the Company without triggering their ownership restrictions,
by receiving pre-funded warrants in lieu of our common stock which would result in such ownership of more than 4.99% (or 9.99%),
and receive the ability to exercise their option to purchase the shares underlying the pre-funded warrants at such nominal price
at a later date.
Exercise Price and Duration
The pre-funded warrants
will have an exercise price of $0.001 per share. The pre-funded warrants are exercisable immediately upon issuance, and may be
exercised at any time until all of the pre-funded warrants are exercised in full. The exercise price is subject to appropriate
adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar
events affecting our shares of common stock and also upon any distributions of assets, including cash, stock or other property
to our shareholders.
Exercisability
The pre-funded warrants
will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and,
at any time a registration statement registering the issuance of the shares of common stock underlying the pre-funded warrants
under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the
Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of
shares of common stock purchased upon such exercise.
Cashless Exercise
In lieu of making the
cash payment otherwise contemplated to be made to us upon exercise of a pre-funded warrant in payment of the aggregate exercise
price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common
stock determined according to a formula set forth in the pre-funded warrant.
Exercise Limitation
A holder will not have
the right to exercise any portion of the pre-funded warrant if the holder (together with its affiliates) would beneficially own
in excess of 4.99% (or 9.99% upon the request of the holder) of the number of common shares outstanding immediately after giving
effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. However,
any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after
such election.
Transferability
Subject to applicable
laws, the pre-funded warrants may be offered for sale, sold, transferred or assigned without our consent.
Fractional Shares
No fractional common
shares will be issued upon the exercise of the pre-funded warrants. Rather, the Company, at its election, either may pay a cash
adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the exercise price or round up the
number of shares of common stock to be issued to the nearest whole number.
Trading Market
There is no established
public trading market for the pre-funded warrants being issued in this offering, and we do not expect a market to develop. We do
not intend to apply for listing of the pre-funded warrants on any securities exchange or other nationally recognized trading system.
Without an active trading market, the liquidity of the pre-funded warrants will be limited.
Rights as a Shareholder
Except as otherwise
provided in the pre-funded warrants or by virtue of such holder’s ownership of our shares of common stock, the holder of
a pre-funded warrant does not have the rights or privileges of a holder of our common shares, including any voting rights, until
the holder exercises the pre-funded warrant.
Fundamental Transaction
In the event of a fundamental
transaction, as described in the pre-funded warrants and generally including any reclassification, reorganization or recapitalization
of our shares of common stock, the sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially
all of our properties or assets, our consolidation or merger with or into another person, the acquisition of 50% or more of the
outstanding shares of common stock or 50% or more of the voting power of the common equity of the Company, or any person or group
becoming the beneficial owner of 50% or more of the voting power represented by our outstanding shares of common stock, the holders
of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities,
cash or other property that the holders would have received had they exercised the pre-funded warrants immediately prior to such
fundamental transaction.
Amendment and Waiver
The pre-funded warrants
may be modified or amended or the provisions thereof waived with the written consent of our company and the respective holder.
PLAN
OF DISTRIBUTION
Pursuant to an engagement
letter agreement dated July 31, 2024, we have engaged H.C. Wainwright & Co., LLC to act as our exclusive placement agent in
connection with this offering. Under the terms of the engagement letter, Wainwright is not purchasing the securities offered by
us in this offering, and is not required to sell any specific number or dollar amount of securities, but will assist us in this
offering on a reasonable best efforts basis. The terms of this offering were subject to market conditions and negotiations between
us, Wainwright and prospective investors. Wainwright will have no authority to bind us by virtue of the engagement letter. Wainwright
may engage sub-agents or selected dealers to assist with this offering. We may not sell the entire amount of our shares of Common
Stock offered pursuant to this prospectus supplement.
The placement agent
proposes to arrange for the sale of the securities we are offering pursuant to this prospectus supplement and accompanying base
prospectus to one or more institutional or accredited investors through securities purchase agreements directly between the purchaser
and us. We will only sell to such investors who have entered into the securities purchase agreement with us.
Delivery of the securities
offered hereby is expected to take place on or about August 1, 2024, subject to satisfaction of customary closing conditions.
Fees and Expenses
We have agreed to pay
the placement agent a cash fee of 7.5% of the aggregate gross proceeds raised in the offering. The following table shows the per
share and total cash fees that we will pay to the placement agent in connection with the sale of our securities offered pursuant
to this prospectus supplement and the accompanying base prospectus, assuming the purchase of all of the securities offered hereby.
|
|
Per Share |
|
|
Per Pre-Funded Warrant |
|
|
Total |
|
Offering price |
|
$ |
0.6200 |
|
|
$ |
0.6190 |
|
|
$ |
1,280,920.00 |
|
Placement agent’s fees (1) |
|
$ |
0.0465 |
|
|
$ |
0.0465 |
|
|
$ |
96,069.00 |
|
Proceeds, before expenses, to us (2) |
|
$ |
0.5735 |
|
|
$ |
0.5725 |
|
|
$ |
1,184,851.00 |
|
In addition, we have
agreed to pay a management fee equal to 1.0% of the gross proceeds raised in the offering to the placement agent, as well as reimburse
the placement agent for its non-accountable expenses in the amount of $10,000, for its fees and expenses of legal counsel in the
amount of up to $35,000, and for its clearing expenses in the amount of $15,950. We estimate the total offering expenses of this
offering that will be payable by us, excluding the placement agent’s fees and expenses, will be approximately $150,000.
In addition, we will
issue to the placement agent, or its designees, the placement agent warrants to purchase up to 154,950 shares of Common Stock.
The placement agent warrants will be exercisable immediately following issuance, expire on July 31, 2029, and will have an exercise
price equal to $0.775 per share.
The securities purchase
agreement that we entered into with the investor prohibits, with certain limited exceptions, us: (i) for thirty (30) days following
the closing date from issuing or entering into an agreement to issue any shares of Common Stock or Common Stock Equivalents (as
defined in the securities purchase agreement) or filing any registration statement (other than a Form S-8), and (ii) for one (1)
year following the closing date from issuing or entering into an agreement to issue any shares of Common Stock or Common Stock
Equivalents in a Variable Rate Transaction (as defined in the securities purchase agreement).
We have also granted
the placement agent a right of first refusal to act as the sole book-running manager, underwriter or placement agent, as applicable,
for each and every future debt financing or refinancing and public or private equity offering or acquisition or disposition by
us or any of our successors or subsidiaries from the date hereof until the 12-month anniversary following consummation of this
offering.
In the event that any
investor whom the placement agent had contacted during the term of its engagement or introduced to the Company during the term
of our engagement of the placement agent provides any capital to us, in a public or private offering or other financing or capital-raising
transaction of any kind, within the twelve (12) months following the expiration of termination of the engagement of the placement
agent, we shall pay the placement agent the cash fee and warrant compensation provided above, calculated in the same manner.
We have agreed to indemnify
the placement agent and specified other persons against certain liabilities relating to or arising out of the placement agent’s
activities under its engagement letter, including liabilities under the Securities Act, and to contribute to payments that the
placement agent may be required to make in respect of such liabilities.
The placement agent
may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by
it and any profit realized on the sale of our securities offered hereby by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the
Securities Act and the Exchange Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules
and regulations may limit the timing of purchases and sales of our securities by the placement agent. Under these rules and regulations,
the placement agent may not (i) engage in any stabilization activity in connection with our securities; and (ii) bid for or purchase
any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange
Act, until they have completed their participation in the distribution.
From time to time,
the placement agent or its affiliates may provide in the future various advisory, investment and commercial banking and other services
to us in the ordinary course of business, for which they have received and may continue to receive customary fees and commissions.
However, except as disclosed in this prospectus supplement, we have no present arrangements with the placement agent for any further
services.
Transfer Agent
The transfer agent and registrar for our
Common Stock is Nevada Agency and Transfer Company.
Listing
Our shares of Common
Stock trade on the Nasdaq Capital Market under the ticker symbol “LIPO.” We do not intend to apply for listing of the
pre-funded warrants on any securities exchange or other nationally recognized trading system.
LEGAL
MATTERS
The validity of the
securities being offered under this prospectus supplement by us will be passed upon for us by Sullivan & Worcester LLP of New
York, New York. Ellenoff Grossman & Schole LLP, New York, New York, is counsel to the placement agent in connection with this
offering.
EXPERTS
The financial statements
of Lipella Pharmaceuticals Inc. as of December 31, 2023 and 2022 and for each of the two years in the period ended December 31,
2023, incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December 31, 2023, have
been so incorporated in reliance on the report of Urish Popeck & Co., LLC, an independent registered public accounting firm,
given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We are subject to the
reporting requirements of the Exchange Act and file annual, quarterly and current reports, proxy statements and other information
with the SEC. You may read and copy these reports, proxy statements and other information at the SEC’s website at www.sec.gov.
This prospectus supplement
and the accompanying base prospectus are only part of a registration statement on Form S-3 that we have filed with the SEC under
the Securities Act and therefore omit certain information contained in the registration statement. We have also filed exhibits
and schedules with the registration statement that are excluded from this prospectus supplement and the accompanying base prospectus,
and you should refer to the applicable exhibit or schedule for a complete description of any statement referring to any contract
or other document. You may inspect a copy of the registration statement, including the exhibits and schedules, without charge,
at the public reference room or obtain a copy from the SEC upon payment of the fees prescribed by the SEC.
We also maintain a
website at https://www.lipella.com, through which you can access our SEC filings. The information set forth on our website
is not part of this prospectus supplement or the accompanying base prospectus.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to
“incorporate by reference” information from other documents that we file with it, which means that we can disclose
important information to you by referring you to those documents. The information incorporated by reference is considered to be
part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the
SEC prior to the date of this prospectus.
We incorporate by reference
into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below
that we have filed with the SEC:
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● |
our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with
the SEC on February 27, 2024; |
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our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, filed
with the SEC on May 9, 2024; |
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our Current Reports on Form 8-K filed with the SEC on March 15, 2024, April 12,
2024 and April 19, 2024 (except in each case for information contained therein which is furnished rather than filed);
and |
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the description of our Common Stock contained in (i) our registration statement on Form
8-A, filed with the SEC on December 19, 2022 pursuant to Section 12(b) of the Exchange Act, including any amendments or
reports filed for the purpose of updating such description and (ii) Exhibit 4.2—Description of Registrant’s Securities
Registered Pursuant to Section 12 of the Exchange Act, to our Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, filed with the SEC on March 31, 2023. |
All documents that
we file with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, except as to any portion of any report
or documents that is not deemed filed under such provisions, on or after the date of this prospectus supplement until the termination
of this offering shall be deemed incorporated by reference in this prospectus supplement and the accompanying base prospectus and
to be a part of this prospectus supplement from the date of filing of those documents.
We will provide to
each person, including any beneficial owner, to whom a copy of this prospectus supplement is delivered, a copy of any or all of
the information that has been incorporated by reference in this prospectus supplement but not delivered with this prospectus supplement
(other than the exhibits to such documents which are not specifically incorporated by reference therein); we will provide this
information upon written or oral request at no cost to the requester. You may request this information by contacting our corporate
headquarters at the following address: at 7800 Susquehanna St., Suite 505, Pittsburgh, PA 15208, Attn: Finance Department, or by
calling (412) 901-0315.
Copies of these filings
are also available through the “Investor Relations” section of our website at https://www.lipella.com. For other ways
to obtain a copy of these filings, please refer to “Where You Can Find More Information” above.
In accordance with
Rule 412 of the Securities Act, any statement contained in a document incorporated by reference herein shall be deemed modified
or superseded to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed
to be incorporated by reference herein modifies or supersedes such statement.
PROSPECTUS

Lipella
Pharmaceuticals Inc.
$50,000,000
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
Convertible Debt Securities
Rights
Units
Lipella Pharmaceuticals Inc. (the “Company”,
“we”, “us” or “our”) may offer and sell, from time to time in one or more offerings, any combination
of our common stock, par value $0.0001 per share (the “Common Stock”), preferred stock, par value $0.0001 per share
(“preferred stock”), debt securities, including debt securities convertible into shares of Common Stock or other Company
securities in any combination thereof, rights to purchase shares of Common Stock or other Company securities in any combination
thereof, warrants to purchase shares of Common Stock or other Company securities in any combination thereof or units consisting
of shares of Common Stock or other Company securities in any combination thereof having an aggregate offering price not exceeding
$50,000,000. Our preferred stock, warrants, convertible debt securities, rights and units may be convertible, exercisable or exchangeable
for shares of Common Stock or other of our securities, and such securities have not been approved for listing on any market or
exchange, and we have not made any application for such listing.
This
prospectus provides you with a general description of the Common Stock that we may offer as well as other securities that we may
offer. A prospectus supplement containing specific information about the terms of the securities being offered and the offering,
including the compensation of any underwriter, agent or dealer, will accompany this prospectus to the extent required. Any prospectus
supplement may also add, update or change information contained in this prospectus. If information in any prospectus supplement
is inconsistent with the information in this prospectus, then the information in that prospectus supplement will apply and will
supersede the information in this prospectus. You should read this prospectus and any such prospectus supplement, as well as the
documents incorporated by reference or deemed to be incorporated by reference into this prospectus, carefully before you invest
in any securities.
These
securities may be sold directly by us, through dealers or agents designated from time to time, to or through underwriters, dealers
or through a combination of these methods, including on a continuous or delayed basis. For additional information on the methods
of sale, see the section entitled “Plan of Distribution” in this prospectus. We will also describe the plan of distribution
for any particular offering of our securities in a prospectus supplement. If any agents, underwriters or dealers are involved
in the sale of any securities in respect of which this prospectus is being delivered, we will disclose their names and the nature
of our arrangements with them in a prospectus supplement, including any applicable fees, commissions, discounts or over-allotment
options. The price to the public of such securities and the net proceeds we expect to receive from any such sale will also be
included in such prospectus supplement.
Our
Common Stock is currently listed on the Nasdaq Capital Market (“Nasdaq”)
under the symbol “LIPO”. On January 31, 2024, the last reported sale price of our Common
Stock on Nasdaq was $1.00. The applicable prospectus supplement will contain information, where applicable, as to any other
listing, if any, on Nasdaq or any other securities market or other securities exchange of the securities covered by such prospectus
supplement.
The aggregate market value of our outstanding
Common Stock held by non-affiliates is $5,141,833, based on 6,053,956 shares of outstanding
Common Stock on January 31, 2024, of which 4,632,282 shares are held by non-affiliates,
and a per share price of $1.11, which is the closing sale price of our Common Stock
on December 5, 2023. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell our Common
Stock in a public primary offering with a value that exceeds more than one-third of our public float in any 12-month period
so long as our public float remains below $75,000,000. During the previous 12 calendar months prior to and including the date of
this prospectus, we have not offered any of our securities pursuant to General Instruction I.B.6 of Form S-3.
We
are an “emerging growth company” as the term is used in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”) and, as such, have elected to comply with certain reduced public company reporting requirements for this and future
filings.
Investing
in our securities involves risks. You should carefully review the risks described under the headings “Risk
Factors” beginning on page 8 of this prospectus and in the documents which are incorporated by reference herein and
contained in the applicable prospectus supplement before you invest in our securities.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is February 8, 2024.
TABLE
OF CONTENTS
You
should rely only on the information contained in this prospectus and any accompanying prospectus supplement or incorporated by
reference in these documents. No dealer, salesperson or other person is authorized to give any information or to represent anything
not contained or incorporated by reference in this prospectus or the accompanying prospectus supplement. If anyone provides you
with different, inconsistent or unauthorized information or representations, you must not rely on them. This prospectus and any
accompanying prospectus supplement are an offer to sell only the securities offered by these documents, but only under circumstances
and in jurisdictions where it is lawful to do so. The information contained in this prospectus or any prospectus supplement is
current only as of the date on the front of those documents.
ABOUT
THIS PROSPECTUS
This prospectus is part of a registration
statement that we filed with the U.S. Securities and Exchange Commission (the “SEC”) using a “shelf” registration
process. By using a shelf registration statement, we may, from time to time, offer shares
of Common Stock; and we may offer shares of our preferred stock, debt securities,
convertible debt securities, warrants for such securities, rights to purchase our securities, and/or units that include any of
these securities, in one or more offerings from time to time, having an aggregate offering price of up to $50,000,000.
This
prospectus provides you with a general description of the securities that we may offer. Each
time we offer securities under this prospectus, we will provide you with a prospectus supplement that
will contain specific information about the terms of that offering. The prospectus supplement also may add, update or change
information contained in this prospectus. You should read carefully both this prospectus, including the section entitled “Risk
Factors,” and any prospectus supplement, together with the additional information described below under the headings “Where
You Can Find More Information” and “Incorporation of Documents by Reference”.
In
addition, this prospectus does not contain all of the information provided in the registration statement that we filed with the
SEC. For further information, we refer you to the registration statement of which this prospectus forms a part, including all
filings and documents incorporated by reference herein and therein, including the applicable exhibits to such registration statement.
Such registration statement, filings and documents can be read on the SEC’s website mentioned below under the heading “Where
You Can Find More Information”. Statements contained in this prospectus and any prospectus supplement about the provisions
or contents of any agreement or other document are not necessarily complete. If the SEC’s rules and regulations require
that an agreement or document be filed as an exhibit to the registration statement, please see that agreement or document for
a complete description of such matters.
You
should rely only on the information contained or incorporated by reference in this prospectus and any prospectus supplement. We
have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent
information, you should not rely on it. This prospectus is not an offer to sell securities, and it is not soliciting an offer
to buy securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing
in this prospectus or any prospectus supplement, as well as information we have previously filed with the SEC and incorporated
by reference, is accurate as of the date on the front of those documents only. Our business, financial condition, results of operations
and prospects may have changed since those dates. This prospectus may not be used to consummate a sale of our securities unless
it is accompanied by a prospectus supplement.
In
such registration statement and this prospectus forming a part thereof, we refer to Lipella Pharmaceuticals Inc. as “we,”
“us,” “our” “LIPO,” and the “Company”, unless we specifically state otherwise
or the context indicates otherwise.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, the applicable prospectus supplement, any amendment and the information incorporated by reference into this prospectus,
including the sections entitled “Risk Factors,” contain “forward-looking statements” within the meaning
of Section 21(E) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”). These forward-looking statements include, without limitation: statements
regarding our business, strategies, products, future results and events and financial performance, and other similar expressions
concerning matters that are not historical facts. Words such as “may,” “will,” “should,” “could,”
“would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”
“future,” “intends,” “plans,” “believes” and “estimates,” and variations
of such terms or similar expressions, are intended to identify such forward-looking statements.
Forward-looking
statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications
of the times at, or by which, that performance or those results will be achieved. Forward-looking statements are based on information
available at the time they are made and/or our management’s good faith belief as of that time with respect to future events.
Our actual results may differ materially from those expressed in, or implied by, the forward-looking statements due to a number
of factors including, but not limited to, those set forth under the heading “Risk Factors” in this prospectus, as
well as other risks discussed in documents that we file with the SEC.
Forward-looking
statements speak only as of the date they are made. You should not put undue reliance on any forward-looking statements. We assume
no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors
affecting forward-looking information, except to the extent required by applicable securities laws. If we do update one or more
forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking
statements. You should review our subsequent reports filed with the SEC described in the sections of this prospectus and the applicable
prospectus supplement, and any amendments thereto, entitled “Where You Can Find More Information” and “Incorporation
of Certain Documents by Reference,” all of which are accessible on the SEC’s website at www.sec.gov.
PROSPECTUS
SUMMARY
This
summary highlights selected information contained elsewhere in this prospectus or incorporated by reference into this prospectus.
This summary does not contain all of the information that you should consider before investing in our Common Stock or in any of
our other securities. You should carefully read the entire registration statement of which this prospectus forms a part, all amendments
and prospectus supplements thereto, and our other filings with the SEC, including the following sections, which are either included
herein and/or incorporated by reference herein, “Risk Factors,” “Special Note Regarding Forward-Looking Statements,”
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements
and the related notes incorporated by reference herein and therein, before making a decision about whether to invest in any of
our securities.
Our
Business
Overview
We
are 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. We believe that this strategy combines many of the cost efficiencies
and risk abatements derived from using existing generic drugs with potential patent protections for our proprietary formulations;
this strategy allows us to expedite, protect, and monetize our product candidates. Additionally, we maintain a therapeutic focus
on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. We believe
that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval.
Consistent
with our strategy, the initial indication that we are currently addressing (via development of our product candidate, which we
have designated as “LP-10”) is hemorrhagic cystitis (“HC”), which is chronic, uncontrolled urinary blood
loss that results from certain chemotherapies (such as alkylating agents) or pelvic radiation therapy (also called “radiation
cystitis”). Many radiation cystitis patients experience severe morbidity (and in some cases, mortality), and currently,
there is no therapy for their condition approved by the U.S. Food and Drug Administration (“FDA”), or, to our knowledge,
any other regulatory body. LP-10 is the development name of our reformulation of tacrolimus (an approved generic active agent)
specifically optimized for topical deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery
platform that we have developed and that we refer to as our metastable liposome drug delivery platform (our “Platform”).
We are developing LP-10 and our Platform to be, to our knowledge, the first drug candidate and drug delivery technology that could
be successful in treating cancer survivors who acquire HC. We have been granted orphan drug”
designation by the FDA for LP-10 in the treatment of moderate to severe HC. LP-10 has been evaluated in a multi-center
Phase 2a dose escalation trial of 13 subjects with moderate to severe refractory HC, obtaining positive top line results demonstrating
safety and efficacy, short duration of systemic uptake of LP-10, and a dose response including decreased hematuria, decreased
cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients. We intend to conduct a Phase-2b trial for
LP-10 involving 36 subjects in a double-blind, placebo-controlled study, focusing on the treatment’s impact on gross hematuria.
In
a second program, we are developing a product candidate, which we have designated “LP-310” and which employs a formulation
similar to LP-10, for the treatment of oral lichen planus (“OLP”). OLP is a chronic, T-cell-mediated, autoimmune oral
mucosal disease, and LP-310 contains tacrolimus which inhibits T-lymphocyte activation. Symptoms of OLP include painful burning
sensations, bleeding and irritation with tooth brushing, painful, thickened patches on the tongue, and discomfort when speaking,
chewing or swallowing. These symptoms frequently cause weight loss, nutritional deficiency, anxiety, depression, and scarring
from erosive lesions. OLP can also be a precursor to cancer, predominately squamous cell carcinoma, with a malignant transformation
rate of approximately one percent. LP-310 is the development name of our oral, liposomal formulation of tacrolimus (the same approved
generic active agent in LP-10) specifically optimized for local delivery to oral mucosa. We believe that our approach of using
metastable liposomal tacrolimus as a treatment for OLP is novel. To date, upon review of relevant FDA public data resources on
approved drugs and biologics, we are not aware of any other liposomal products developed to treat such disease. We recently received
FDA investigational new drug (“IND”) approval for a 12-subject, multicenter, phase-2a clinical trial with a dose escalation
design. We also recently were granted “orphan drug” designation by the
FDA for LP-310 in the treatment of moderate to severe HC.
Our
Platform includes proprietary drug delivery technologies optimized for use with epithelial tissues that coat lumenal surfaces,
such as the colon, the various tissues lining the mouth and esophagus and the tissues lining the bladder and urethra. The Company
has two issued patents in the United States that should exclude competitors from making, selling or using our LP-10 and LP-310
formulations in the United States until July 11, 2035. We also have issued patents in Australia, Canada, and Europe that do not
expire until October 22, 2034. Corresponding patent applications are pending in the United States Patent Offices. We also have
a pending United States patent application on an improvement to the technology.
Since
our inception in 2005, we have focused primarily on business planning and progressing our lead product candidates, including progressing
LP-10 through clinical development, raising capital, organizing and staffing the Company.
Corporate
Information and Where You Can Find Us
We
were incorporated under the laws of the state of Delaware in February 2005. Our principal executive offices are located at 7800
Susquehanna Street, Suite 505, Pittsburgh, PA 15208, and our telephone number is (412) 894-1853. We have approximately 6,000 square
feet of combined laboratory, office and warehouse space at our principal executive offices that we use in our research and development
efforts, including a sterile pharmaceutical pilot plant for manufacturing liposomal and other formulations, as well as relevant
analytical facilities. Our corporate website address is www.lipella.com. The information contained in, or accessible through,
our website is not incorporated by reference into this prospectus or the registration of which it forms a part, or any prospectus
supplements thereto, and is intended for informational purposes only. You should not consider such website information to be a
part of the registration statement of which this prospectus forms a part.
Implications
of Being an Emerging Growth and Smaller Reporting Company
We
qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”). An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that
are otherwise applicable generally to public companies. These provisions include:
● reduced
obligations with respect to financial data;
● an
exception from compliance with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley
Act”);
● reduced
disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements;
and
● exemptions
from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements.
We
may take advantage of these provisions for up to five years following our December 2022 initial public offering (our “IPO”)
or such earlier time that we no longer qualify as an emerging growth company. We would cease to be an emerging growth company
upon the earliest of:
● the
last day of the fiscal year on which we have $1.235 billion or more in annual revenue,
● the
date on which we become a “large accelerated filer” (i.e., as of our fiscal year end, the total market value of our
common equity securities held by non-affiliates is $700 million or more as of June 30),
● the
date on which we issue more than $1.0 billion of non-convertible debt over a three-year period, or
● the
last day of our fiscal year following the fifth anniversary of the date of the completion of our IPO.
We
may choose to take advantage of some but not all of these reduced reporting burdens.
In
addition, under the JOBS Act, emerging growth companies can take advantage of an extended transition period and delay adopting
new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this
extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which
adoption of such standards is required for private companies. If we were to subsequently elect instead to comply with public company
effective dates, such election would be irrevocable pursuant to the JOBS Act.
Also,
we are a “smaller reporting company” (and may continue to qualify as such even after we no longer qualify as an emerging
growth company). For as long as we qualify as a “smaller reporting company,” we may provide reduced disclosure in
the public filings that we make with the SEC than larger public companies, such as the inclusion of only two years of audited
financial statements and only two years of management’s discussion and analysis of financial condition and results of operations
disclosure.
As
a result of qualifying as an emerging growth company and a smaller reporting company, to the extent we take advantage of the allowable
reduced reporting burdens, the information that we provide to our stockholders may be different than what you might receive from
other public reporting companies in which you hold equity interests.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should consider carefully the risks and uncertainties described herein and
in “Risk Factors” in our most recently filed Annual Report on Form 10-K filed with the SEC, in each case as these
risk factors are amended or supplemented by subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K that have
been or will be incorporated by reference in this prospectus and each prospectus supplement thereto. The prospectus supplement
relating to a particular offering of our securities may also discuss certain risks of investing in that offering. The risks incorporated
herein by reference and set forth or incorporated by reference in any prospectus supplement are those which we believe are the
material risks that we face. The occurrence of any of such risks may materially and adversely affect our business, financial condition,
results of operations and future prospects. In such an event, the market price of our Common Stock could decline, the value of
any other securities we may issue could decline, and you could lose part or all of your investment.
USE
OF PROCEEDS
We
cannot assure you that we will receive any proceeds in connection with securities offered by us pursuant to this prospectus. Unless
otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of the securities
offered by this prospectus for general corporate purposes, which may include, among other things, working capital, capital expenditures,
product development, marketing activities, acquisitions of new technologies and investments, repayment of debt and repurchases
and redemptions of securities.
We
will set forth in the applicable prospectus supplement our intended use for the net proceeds received from the sale of any securities
by us. The precise amount and timing of the application of these proceeds will depend on our funding requirements and the availability
and costs of other funds. Accordingly, we will retain broad discretion over the use of such proceeds. Pending the application
of any net proceeds, we intend to invest the net proceeds generally in short-term, investment grade, interest-bearing securities.
THE
SECURITIES THAT WE MAY OFFER
The
descriptions of the securities contained in this prospectus, together with the applicable prospectus supplements, summarize all
of the material terms and provisions of the various types of securities that we may offer. We will describe in the applicable
prospectus supplement relating to any securities the particular terms of the securities offered by that prospectus supplement.
If we indicate in the applicable prospectus supplement, the terms of such securities may differ from the terms that we have summarized
below. We will also include in the prospectus supplement information, where applicable, about material United States federal income
tax considerations relating to the securities, and the securities exchange, if any, on which such securities will be listed.
We
may sell from time to time, in one or more offerings:
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shares of our Common Stock; |
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shares of our preferred stock; |
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warrants to purchase shares of our Common Stock,
preferred stock or debt securities; |
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rights to purchase shares of our Common Stock,
preferred stock or other securities; and/or |
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units consisting of any of the securities listed
above. |
The
terms of any securities that we offer will be determined at the time of sale. We may issue securities that are exchangeable or
exercisable for Common Stock or any of the other securities that may be sold under this prospectus. When particular securities
are offered, a supplement to this prospectus will be filed with the SEC, which will describe the terms of the offering and sale
of such securities.
DESCRIPTION
OF CAPITAL STOCK
General
The following summary description sets
forth some of the general terms and provisions of our capital stock. Because this is a summary description, it does not contain
all of the information that may be important to you. For a more detailed description of our capital stock, you should refer to
the applicable provisions of the General Corporation Law of the State of Delaware (“DGCL”), as well as our second amended
and restated articles of incorporation, as amended (“Charter”), and our second amended and restated bylaws (“Bylaws”),
each as in effect at the time of any offering conducted pursuant to the registration statement of which this prospectus forms a
part. Copies of our Charter and our Bylaws are filed as exhibits to the documents incorporated by reference into the registration
statement of which this prospectus forms a part.
Our
Authorized Capital Stock
Under
our Charter, we are authorized to issue 220,000,000 shares of capital stock consisting of (a) 200,000,000 shares of Common Stock,
par value $0.0001 per share, and (b) 20,000,000 shares of “blank check” preferred stock, par value $0.0001 per share.
As of January 31, 2024, there were 6,053,956 shares of Common Stock issued and outstanding and no shares of such preferred stock
issued and outstanding.
Common
Stock
Voting
Rights. Each share of our Common Stock entitles the owner to one vote. There is no cumulative voting. A simple majority can
elect all of the directors at a given meeting, and the minority would not be able to elect any director at that meeting.
Dividend
Rights. Each share of our Common Stock is entitled to receive an equal dividend, if one is declared. We cannot provide any
assurance that we will declare or pay cash dividends on our Common Stock in the future. Any future determination to declare cash
dividends will be made at the discretion of our Board, subject to applicable laws, and will depend on our financial condition,
results of operations, capital requirements, general business conditions and other factors that our Board may deem relevant. Our
Board may determine it to be necessary to retain future earnings (if any) to finance our growth. See “Risk Factors.”
Liquidation.
If the Company is liquidated, then assets that remain (if any) after the creditors are paid and the owners of any securities with
liquidation preferences senior to the Common Stock are paid will be distributed to the owners of our Common Stock pro rata.
Preemptive
Rights. Owners of our Common Stock have no preemptive rights. We may sell shares of our Common Stock to third parties without
first offering such shares to current stockholders.
Redemption
Rights. We do not have the right to buy back shares of our Common Stock except in extraordinary transactions, such as mergers
and court approved bankruptcy reorganizations. Owners of our Common Stock do not ordinarily have the right to require us to buy
their Common Stock. We do not have a sinking fund to provide assets for any buy back.
Conversion
Rights. Shares of our Common Stock cannot be converted into any other kind of stock except in extraordinary transactions,
such as mergers and court approved bankruptcy reorganizations.
Nonassessability.
All outstanding shares of our Common Stock are fully paid and nonassessable.
Listing.
Our Common Stock trades on Nasdaq under the symbol “LIPO.”
Preferred
Stock
Our
Board is authorized to provide by resolution or resolutions from time to time for the issuance, out of the unissued shares of
preferred stock, of one or more series of preferred stock, without stockholder approval, by filing a certificate pursuant to the
DGCL and any other applicable law of the State of Delaware (the “Preferred Stock Designation”), setting forth such
resolution and, with respect to each such series, establishing the number of shares to be included in such series, and fixing
the voting powers, full or limited, or no voting power of the shares of such series, and the designation, preferences and relative,
participating, optional or other special rights, if any, of the shares of each such series and any qualifications, limitations
or restrictions thereof. The powers, designation, preferences and relative, participating, optional and other special rights of
each series of preferred stock, and the qualifications, limitations and restrictions thereof, if any, may differ from those of
any and all other series at any time outstanding.
It
is not possible to state the actual effects of any future series of preferred stock upon the rights of holders of the Common Stock
because our Board has the power to determine the specific rights of the holders of any future series of preferred stock. Our Board’s
authority to issue preferred stock provides a convenient vehicle in connection with possible acquisitions and other corporate
purposes, but could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting
stock. Accordingly, the issuance of the preferred stock may be used as an “anti-takeover” device without further action
on the part of our stockholders and may adversely affect the holders of the common stock.
Options
and Warrants
As
of January 31, 2024, there were outstanding Common Stock options entitling the holders to purchase 2,453,000 shares of Common
Stock at a weighted average exercise price of $2.73 per share with a weighted average remaining contractual life of 5.13 years,
warrants entitling the holders to purchase up to 1,558,467 shares of Common Stock at a weighted average exercise price of $1.76
per share with a weighted average remaining contractual life of 2.68 years and pre-funded warrants to purchase up to 1,065,790
shares of common stock, which do not have an expiration date.
Anti-Takeover
Provisions
The
provisions of Delaware law and our Charter and our Bylaws could have the effect of delaying, deferring or discouraging another
person from acquiring control of the Company. These provisions, which are summarized below, may have the effect of discouraging
takeover bids. They are also designed, in part, to encourage persons seeking to acquire control of us to negotiate first with
our board of directors. We believe that the benefits of increased protection of our potential ability to negotiate with an unfriendly
or unsolicited acquirer outweigh the disadvantages of discouraging a proposal to acquire us because negotiation of these proposals
could result in an improvement of their terms.
Delaware
Law
We
are subject to the provisions of Section 203 of the DGCL regulating corporate takeovers. In general, Section 203 of the DGCL prohibits
a publicly held Delaware corporation from engaging in a business combination with an interested stockholder for a period of three
years following the date on which the person became an interested stockholder unless:
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prior to the date
of the transaction, the board of directors of the corporation approved either the business combination or the transaction
which resulted in the stockholder becoming an interested stockholder; |
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the interested stockholder
owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for
purposes of determining the voting stock outstanding, but not the outstanding voting stock owned by the interested stockholder:
(i) shares owned by persons who are directors and also officers; and (ii) shares owned by employee stock plans in which employee
participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in
a tender or exchange offer; or |
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at or subsequent
to the date of the transaction, the business combination is approved by the board of directors of the corporation and authorized
at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66.67% of
the outstanding voting stock that is not owned by the interested stockholder. |
Generally,
a business combination includes a merger, asset or stock sale, or other transaction or series of transactions together resulting
in a financial benefit to the interested stockholder. An interested stockholder is a person who, together with affiliates and
associates, owns or, within three years prior to the determination of interested stockholder status, did own 15% or more of a
corporation’s outstanding voting stock. We expect the existence of this provision to have an anti-takeover effect with respect
to transactions our board of directors does not approve in advance. We also anticipate that DGCL Section 203 may also discourage
attempts that might result in a premium over the market price for the shares of Common Stock held by stockholders.
Provisions
of Our Charter and Bylaws
Our
Charter and our Bylaws in effect upon the completion of this offering will include a number of provisions that could deter hostile
takeovers or delay or prevent changes in control of our company, including the following:
|
● |
Board of Directors
Vacancies. Our Charter and our Bylaws will authorize only our board of directors to fill vacant directorships, including
newly created seats, subject to the rights of the holders of any series of preferred stock to elect directors under certain
circumstances. In addition, the number of directors constituting our board of directors will be permitted to be set only by
a resolution adopted by a majority vote of our entire board of directors. These provisions would prevent a stockholder from
increasing the size of our board of directors and then gaining control of our board of directors by filling the resulting
vacancies with its own nominees. This makes it more difficult to change the composition of our board of directors but promotes
continuity of management. |
|
● |
Stockholder Action;
Special Meetings of Stockholders. Our Charter and our Bylaws provide that our stockholders may not take action by
written consent, but may only take action at annual or special meetings of our stockholders. As a result, a holder controlling
a majority of our capital stock would not be able to amend our Bylaws or remove directors without holding a meeting of our
stockholders called in accordance with our Bylaws. Further, our Bylaws and Certificate of Incorporation provide that special
meetings of our stockholders may be called only by a majority of our board of directors, the chairman of our board of directors,
or our Chief Executive Officer, thus prohibiting a stockholder from calling a special meeting. These provisions might delay
the ability of our stockholders to force consideration of a proposal or for stockholders controlling a majority of our capital
stock to take any action, including the removal of directors. |
|
● |
Advance Notice
Requirements for Stockholder Proposals and Director Nominations. Our Bylaws provide advance notice procedures for
stockholders seeking to bring business before our annual meeting of stockholders or to nominate candidates for election as
directors at our annual meeting of stockholders. Our Bylaws also specify certain requirements regarding the form and content
of a stockholder’s notice. These provisions might preclude our stockholders from bringing matters before our annual
meeting of stockholders or from making nominations for directors at our annual meeting of stockholders if the proper procedures
are not followed. We expect that these provisions might also discourage or deter a potential acquirer from conducting a solicitation
of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of the Company. |
|
● |
No Cumulative
Voting. The DGCL provides that stockholders are not entitled to the right to cumulate votes in the election of directors
unless a corporation’s certificate of incorporation provides otherwise. Our Certificate of Incorporation does not provide
for cumulative voting. |
|
● |
Directors Removed
Only for Cause. Our Charter provides that stockholders may remove directors only for cause and only by the affirmative
vote of the holders of a majority of our outstanding Common Stock. |
|
● |
Amendment of
Charter Provisions. Any amendment of the above expected provisions in our Charter requires approval by holders of
at least two-thirds of our outstanding Common Stock. |
|
● |
Issuance of Undesignated
Preferred Stock. Pursuant to our Charter, our board of directors has the authority, without further action by the
stockholders, to issue up to 20,000,000 shares of undesignated preferred stock with rights and preferences, including voting
rights, designated from time to time by our board of directors. The existence of authorized but unissued shares of preferred
stock would enable our board of directors to render more difficult or to discourage an attempt to obtain control of us by
means of a merger, tender offer, proxy contest or other means. |
|
● |
Choice of Forum. Our
Charter and our Bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for: any derivative
action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim
against us arising pursuant to the DGCL, our Charter and our Bylaws; any action to interpret, apply, enforce or determine
the validity of our Charter and our Bylaws; or any action asserting a claim against us that is governed by the internal affairs
doctrine. Notwithstanding the foregoing, the exclusive forum provision does not apply to suits brought to enforce any liability
or duty created by the Securities Act, the Exchange Act or any other claim for which the federal courts have
exclusive jurisdiction. Unless we consent in writing to the selection of an alternative forum, the United States federal district
courts shall, to the fullest extent permitted by applicable law, be the sole and exclusive forum for the resolution of any
complaint asserting a cause of action arising under the Securities Act, Exchange Act or any such other claim
for which the federal courts have exclusive jurisdiction. The enforceability of similar choice of forum provisions in other
companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could
find these types of provisions to be inapplicable or unenforceable. |
Transfer
Agent
Nevada
Agency and Transfer Company is the transfer agent and registrar for our Common Stock. The transfer agent’s address is 50
W Liberty St # 880, Reno, NV 89501, and its telephone number is (775) 322-0626. We intend to issue shares of Common Stock in uncertificated
form only, subject to limited circumstances.
DESCRIPTION
OF WARRANTS
The
following description, together with the additional information that we may include in any applicable prospectus supplements,
summarizes the material terms and provisions of the warrants that we may offer under this prospectus and the related warrant agreements
and warrant certificates. While the terms summarized below will apply generally to any warrants that we may offer, we will describe
the particular terms of any series of warrants in more detail in the applicable prospectus supplement. If we indicate in the prospectus
supplement, the terms of any warrants offered under that prospectus supplement may differ from the terms described below. If there
are differences between that prospectus supplement and this prospectus, the prospectus supplement will control. Thus, the statements
we make in this section may not apply to a particular series of warrants. Specific warrant agreements will contain additional
important terms and provisions and will be incorporated by reference as an exhibit to the registration statement which includes
this prospectus.
General
We
may issue warrants for the purchase of Common Stock and/or other securities described in this prospectus. We may issue warrants
independently or together with Common Stock and/or such other securities, and the warrants may be attached to or separate from
any such offered securities.
We will evidence each series of warrants
by warrant certificates that we may issue under a separate agreement. We may enter into the warrant agreement with a warrant agent.
Each warrant agent may be a bank that we select which has its principal office in the United States and a combined capital and
surplus sufficient under the laws of any jurisdiction under which it is organized or in which it is doing business, and that is
otherwise authorized under such laws to conduct such business and is subject to supervision or examination by federal or state
authorities. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent
in the applicable prospectus supplement relating to a particular series of warrants.
We
will describe in the applicable prospectus supplement the terms of the series of warrants, including:
| ● | the
offering price and aggregate number of warrants offered; |
| ● | the
currency for which the warrants may be purchased; |
| ● | if
applicable, the designation and terms of the securities with which the warrants are issued
and the number of warrants issued with each such security or each principal amount of
such security; |
| ● | if
applicable, the date on and after which the warrants and the related securities will
be separately transferable; |
| ● | the
number of shares of Common Stock or other securities purchasable upon the exercise of
one warrant and the price at which such shares or other securities may be purchased upon
such exercise; |
| ● | the
warrant agreement under which the warrants will be issued; |
| ● | the
effect of any merger, consolidation, sale or other disposition of our business on the
warrant agreement and the warrants; |
| ● | anti-dilution
provisions of the warrants, if any; |
| ● | the
terms of any rights to redeem or call the warrants; |
| ● | any
provisions for changes to or adjustments in the exercise price or number of securities
issuable upon exercising the warrants; |
| ● | the
manner in which the warrant agreement and warrants may be modified; |
| ● | the
identities of the warrant agent and any calculation or other agent for the warrants; |
| ● | federal
income tax consequences of holding or exercising the warrants; |
| ● | the
terms of the securities issuable upon exercise of the warrants; |
| ● | any
securities exchange or quotation system on which the warrants or any securities deliverable
upon exercise of the warrants may be listed; and |
| ● | any
other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
Before
exercising their warrants, holders of warrants will not have any of the rights of holders of Common Stock purchasable upon such
exercise, including the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to
exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to 5:00 p.m. Eastern Time on the expiration date that we set
forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become
void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required amount to the warrant agent in immediately available funds, as provided in
the applicable prospectus supplement. We will set forth on the reverse side of the warrant certificate, and in the applicable
prospectus supplement, the information that the holder of the warrant will be required to deliver to the warrant agent.
Until
the warrant is properly exercised, no holder of any warrant will be entitled to any rights of a holder of the securities purchasable
upon exercise of the warrant.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants. If we so indicate in the applicable prospectus supplement,
holders of the warrants may surrender securities as all or part of the exercise price for warrants.
Enforceability
of Rights By Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance with their
terms.
Calculation
Agent
Calculations
relating to warrants may be made by a calculation agent, an institution that we appoint as our agent for this purpose. The prospectus
supplement for a particular warrant will name the institution that we have appointed to act as the calculation agent for that
warrant as of the original issue date for that warrant. We may appoint a different institution to serve as calculation agent from
time to time after the original issue date without the consent or notification of the holders.
The
calculation agent’s determination of any amount of money payable or securities deliverable with respect to a warrant will
be final and binding in the absence of manifest error.
Governing
Law
Unless
we provide otherwise in the applicable prospectus supplement, the warrants and warrant agreements, and any claim, controversy
or dispute arising under or related to the warrants or warrant agreements, will be governed by and construed in accordance with
the laws of the State of New York.
DESCRIPTION
OF DEBT SECURITIES AND CONVERTIBLE DEBT SECURITIES
The
following description, together with the additional information that we include in any applicable prospectus supplement, summarizes
the material terms and provisions of the debt securities that may be offered from time to time under this prospectus. We may issue
debt securities, in one or more series, as either senior or subordinated debt or as senior or subordinated convertible debt. While
the terms we have summarized below will generally apply to any future debt securities that may be offered under this prospectus,
we will describe the particular terms of any debt securities that may be offered in more detail in the applicable prospectus supplement.
The terms of any debt securities offered under a prospectus supplement may differ from the terms we describe below.
We
may issue secured or unsecured debt securities offered under this prospectus, which may be senior, subordinated or junior subordinated,
and/or convertible and which may be issued in one or more series. We will issue any new senior debt securities under a senior
indenture that we will enter into with a trustee named in such senior indenture. We will issue any subordinated debt securities
under a subordinated indenture that we will enter into with a trustee named in such subordinated indenture. We will have filed
forms of these documents as exhibits to the registration statement, of which this prospectus is a part. The terms of the debt
securities will include those set forth in the applicable indenture, any related supplemental indenture and any related securities
documents that are made a part of the indenture by the Trust Indenture Act of 1939, as amended (the “Trust Indenture
Act”). You should read the summary below, the applicable prospectus supplement and the provisions of the applicable indenture,
any supplemental indenture and any related security documents, if any, in their entirety before investing in our debt securities.
We use the term “indentures” to refer to both the senior indentures and the subordinated indentures.
The
indentures will be qualified under the Trust Indenture Act. We use the term “trustee” to refer to either a trustee
under the senior indenture or a trustee under the subordinated indenture, as applicable.
The
following summaries of material provisions of any senior debt securities, any subordinated debt securities and the related indentures
are subject to, and qualified in their entirety by reference to, all the provisions of the indentures and any supplemental indenture
or related document applicable to a particular series of debt securities. We urge you to read the applicable prospectus supplements
related to the debt securities that are offered under this prospectus, as well as the complete indentures, that contains the terms
of the debt securities. See the information under the heading “Where You Can Find More Information” for information
on how to obtain a copy of the appropriate indenture. Except as we may otherwise indicate, the terms of any senior indenture and
any subordinated indenture will be identical.
In
addition, the material specific financial, legal and other terms as well as any material U.S. federal income tax consequences
particular to securities of each series will be described in the prospectus supplement relating to the securities of that series.
The prospectus supplement may or may not modify the general terms found in this prospectus and will be filed with the SEC. For
a complete description of the terms of a particular series of debt securities, you should read both this prospectus and the prospectus
supplement relating to that particular series.
We
will describe in the applicable prospectus supplement the terms relating to a series of debt securities, including:
| ● | principal
amount being offered, and, if a series, the total amount authorized and the total amount
outstanding; |
| ● | any
limit on the amount that may be issued; |
| ● | whether
or not we will issue the series of debt securities in global form and, if so, the terms
and who the depositary will be; |
| ● | the
principal amount due at maturity, and whether the debt securities will be issued with
any original issue discount; |
| ● | whether
and under what circumstances, if any, we will pay additional amounts on any debt securities
held by a person who is not a United States person for tax purposes, and whether we can
redeem the debt securities if we have to pay such additional amounts; |
| ● | the
annual interest rate, which may be fixed or variable, or the method for determining the
rate, the date interest will begin to accrue, the dates interest will be payable and
the regular record dates for interest payment dates or the method for determining such
dates; |
| ● | whether
or not the debt securities will be secured or unsecured, and the terms of any secured
debt; |
| ● | the
terms of the subordination of any series of subordinated debt; |
| ● | the
place where payments will be payable; |
| ● | restrictions
on transfer, sale or other assignment, if any; |
| ● | our
right, if any, to defer payment of interest and the maximum length of any such deferral
period; |
| ● | the
date, if any, after which, the conditions upon which, and the price at which we may,
at our option, redeem the series of debt securities pursuant to any optional or provisional
redemption provisions, and any other applicable terms of those redemption provisions; |
| ● | provisions
for a sinking fund, purchase or other analogous fund, if any; |
| ● | the
date, if any, on which, and the price at which we are obligated, pursuant to any mandatory
sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s
option to purchase, the series of debt securities; |
| ● | whether
the indenture will restrict our ability and/or the ability of our subsidiaries to: |
| ○ | incur
additional indebtedness; |
| ○ | issue
additional securities; |
| ○ | pay
dividends and make distributions in respect of our capital stock and the capital stock
of our subsidiaries; |
| ○ | place
restrictions on our subsidiaries’ ability to pay dividends, make distributions
or transfer assets; |
| ○ | make
investments or other restricted payments; |
| ○ | sell
or otherwise dispose of assets; |
| ○ | enter
into sale-leaseback transactions; |
| ○ | engage
in transactions with stockholders and affiliates; |
| ○ | issue
or sell stock of or sell assets of our subsidiaries; or |
| ○ | effect
a consolidation or merger; |
| ● | whether
the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based,
asset-based or other financial ratios; |
| ● | a
discussion of any material or special United States federal income tax considerations
applicable to the debt securities; |
| ● | information
describing any book-entry features; |
| ● | the
procedures for any auction and remarketing, if any; |
| ● | the
denominations in which we will issue the series of debt securities, if other than denominations
of $1,000 and any integral multiple thereof; |
| ● | if
other than U.S. dollars, the currency in which the series of debt securities will be
denominated and the currency in which principal, premium, if any, and interest will be
paid; and |
| ● | any
other specific terms, preferences, rights or limitations of, or restrictions on, the
debt securities, including any events of default that are in addition to or different
than those described in this prospectus or any covenants provided with respect to the
debt securities that are in addition to those described above, and any terms which may
be required by us or advisable under applicable laws or regulations or advisable in connection
with the marketing of the debt securities. |
In
addition to the debt securities that may be offered pursuant to this prospectus, we may issue other debt securities in public
or private offerings from time to time. These other debt securities may be issued under other indentures or documentation that
are not described in this prospectus, and those debt securities may contain provisions materially different from the provisions
applicable to one or more issues of debt securities offered pursuant to this prospectus.
Original
Issue Discount
One
or more series of debt securities offered under this prospectus may be sold at a substantial discount below their stated principal
amount, bearing no interest or interest at a rate that at the time of issuance is below market rates. The federal income tax consequences
and special considerations applicable to any series of debt securities generally will be described in the applicable prospectus
supplement.
Senior
Debt Securities
Payment
of the principal or premium, if any, and interest on senior debt securities will rank on a parity with all of our other indebtedness
that is not subordinated.
Subordination
of Subordinated Debt Securities
The
subordinated debt securities will be subordinate and junior in priority of payment to certain of our other indebtedness to the
extent described in a prospectus supplement. The indentures in the forms initially filed as exhibits to the registration statement
of which this prospectus is a part do not limit the amount of indebtedness which we may incur, including senior indebtedness or
subordinated indebtedness, and do not limit us from issuing any other debt, including secured debt or unsecured debt.
Conversion
or Exchange Rights
We
will set forth in the applicable prospectus supplement the terms on which a series of debt securities may be convertible into
or exchangeable for our Common Stock or other securities, including the conversion or exchange rate, as applicable, or how it
will be calculated, and the applicable conversion or exchange period. We will include provisions as to whether conversion or exchange
is mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of securities
that the holders of the series of debt securities receive upon conversion or exchange would, under the circumstance described
in those provisions, be subject to adjustment, or pursuant to which those holders would, under those circumstances, receive other
property upon conversion or exchange, for example in the event of our merger or consolidation with another entity.
Consolidation,
Merger or Sale
The
indentures in the forms initially filed as exhibits to the registration statement of which this prospectus is a part do not contain
any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially
all of our assets. However, any successor of ours or acquirer of such assets must assume all of our obligations under the indentures
and the debt securities.
If
the debt securities are convertible for our other securities, the person with whom we consolidate or merge or to whom we sell
all of our property must make provisions for the conversion of the debt securities into securities which the holders of the debt
securities would have received if they had converted the debt securities before the consolidation, merger or sale.
Events
of Default under the Indentures
Except
as otherwise set forth in an applicable prospectus supplement, the following are events of default under the indentures with respect
to any series of debt securities that we may issue:
| ● | if
we fail to pay interest when due and payable and our failure continues for 30 days and
the time for payment has not been extended or deferred; |
| ● | if
we fail to pay the principal, or premium, if any, when due and payable and the time for
payment has not been extended or delayed; |
| ● | if
we fail to observe or perform any other covenant contained in the debt securities or
the indentures, other than a covenant solely for the benefit of another series of debt
securities, and our failure continues for 90 days after we receive notice from the trustee
or holders of a to-be-determined percentage in aggregate principal amount of the outstanding
debt securities of the applicable series; and |
| ● | if
specified events of bankruptcy, insolvency or reorganization occur. |
If
an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified
in the last bullet point above under “— Events of Default Under the Indentures,” the trustee or the holders
of a to-be-determined percentage in aggregate principal amount of the outstanding debt securities of that series, by notice to
us in writing, and to the trustee if notice is given by such holders, may declare the unpaid principal of, premium, if any, and
accrued interest, if any, due and payable immediately. If an event of default specified in the last bullet point above “—
Events of Default Under the Indentures” occurs with respect to us, the principal amount of and accrued interest, if any,
of each series of debt securities then outstanding shall be due and payable without any notice or other action on the part of
the trustee or any holder.
The
holders of a majority in aggregate principal amount of the outstanding debt securities of an affected series may waive any default
or event of default with respect to the series and its consequences (other than bankruptcy defaults), except there may be no waiver
of defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default
or event of default in accordance with the applicable indenture.
Subject
to the terms of the indentures, if an event of default under an indenture shall occur and be continuing, the trustee will be under
no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of
the applicable series of debt securities, unless such holders have offered the trustee indemnity satisfactory to it. The holders
of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method
and place of conducting any proceeding for any remedy available to the trustee, or exercising any trust or power conferred on
the trustee, with respect to the debt securities of that series, provided that:
| ● | the
direction so given by the holder is not in conflict with any law or the applicable indenture;
and |
| ● | subject
to its duties under the Trust Indenture Act, the trustee need not take any action that
might involve it in personal liability or might be unduly prejudicial to the holders
not involved in the proceeding. |
A
holder of the debt securities of any series will only have the right to institute a proceeding under the indentures or to appoint
a receiver or trustee, or to seek other remedies if:
| ● | the
holder has given written notice to the trustee of a continuing event of default with
respect to that series; |
| ● | the
holders of a to-be-determined percentage in aggregate principal amount of the outstanding
debt securities of that series have made written request to the trustee, and such holders
have offered indemnity satisfactory to the trustee, to institute the proceeding as trustee;
and |
| ● | the
trustee does not institute the proceeding, and does not receive from the holders of a
majority in aggregate principal amount of the outstanding debt securities of that series
other conflicting directions, within 90 days after the notice, request and offer. |
These
limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium,
if any, or interest on, the debt securities.
We
will periodically file statements with the trustee regarding our compliance with the covenants in the indentures.
Modification
of Indenture; Waiver
We
and the trustee may modify an indenture or enter into or modify any supplemental indenture without the consent of any holders
of the debt securities with respect to specific matters, including:
| ● | to
fix any ambiguity, defect or inconsistency in the indenture; |
| ● | to
comply with the provisions described above under “—Consolidation, Merger
or Sale;” |
| ● | to
comply with any requirements of the SEC in connection with the qualification of any indenture
under the Trust Indenture Act; |
| ● | to
evidence and provide for the acceptance of appointment hereunder by a successor trustee; |
| ● | to
provide for uncertificated debt securities and to make any appropriate changes for such
purpose; |
| ● | to
add to, delete from, or revise the conditions, limitations and restrictions on the authorized
amount, terms or purposes of issuance, authorization and delivery of debt securities
of any unissued series; |
| ● | to
add to our covenants such new covenants, restrictions, conditions or provisions for the
protection of the holders, to make the occurrence, or the occurrence and the continuance,
of a default in any such additional covenants, restrictions, conditions or provisions
an event of default, or to surrender any of our rights or powers under the indenture;
or |
| ● | to
change anything that does not materially adversely affect the legal rights of any holder
of debt securities of any series. |
In
addition, under the indentures, the rights of holders of a series of debt securities may be changed by us and the trustee with
the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of
each series that is affected. However, we and the trustee may only make the following changes with the consent of each holder
of any outstanding debt securities affected:
| ● | extending
the fixed maturity of the series of debt securities; |
| ● | reducing
the principal amount, reducing the rate of or extending the time of payment of interest,
or reducing any premium payable upon the redemption of any debt securities; or |
| ● | reducing
the percentage of debt securities, the holders of which are required to consent to any
supplemental indenture. |
Discharge
Each
indenture provides that, subject to the terms of the indenture and any limitation otherwise provided in the prospectus supplement
applicable to a particular series of debt securities, we can elect to be discharged from our obligations with respect to one or
more series of debt securities, except for specified obligations, including obligations to:
| ● | register
the transfer or exchange of debt securities of the series; |
| ● | replace
stolen, lost or mutilated debt securities of the series; |
| ● | maintain
paying agents and agencies for payment, registration of transfer and exchange and service
of notices and demands; |
| ● | recover
excess money held by the trustee; |
| ● | compensate
and indemnify the trustee; and |
| ● | appoint
any successor trustee. |
In
order to exercise our rights to be discharged, we must deposit with the trustee money or government obligations sufficient to
pay all the principal of, any premium and interest on, the debt securities of the series on the date payments are due.
“Street
Name” and Other Indirect Holders
Investors
who hold securities in accounts at banks or brokers generally will not be recognized by us as legal holders of debt securities.
This manner of holding securities is called holding in “street name.” Instead, we would recognize only the bank or
broker, or the financial institution that the bank or broker uses to hold its securities. These intermediary banks, brokers and
other financial institutions pass along principal, interest and other payments on the debt securities, either because they agree
to do so in their customer agreements or because they are legally required to do so. If you hold debt securities in “street
name,” you should check with your own institution to find out, among other things:
| ● | how
it handles payments and notices; |
| ● | whether
it imposes fees or charges; |
| ● | how
it would handle voting if applicable; |
| ● | whether
and how you can instruct it to send you debt securities registered in your own name so
you can be a direct holder as described below; and |
| ● | if
applicable, how it would pursue rights under your debt securities if there were a default
or other event triggering the need for holders to act to protect their interests. |
Our
obligations, as well as the obligations of the trustee under the indentures and those of any third parties employed by us or the
trustee under either of the indentures, run only to persons who are registered as holders of debt securities issued under the
applicable indenture. As noted above, we do not have obligations to you if you hold in “street name” or other indirect
means, either because you choose to hold debt securities in that manner or because the debt securities are issued in the form
of global securities as described below. For example, once we make payment to the registered holder, we have no further responsibility
for the payment even if that holder is legally required to pass the payment along to you as a “street name” customer
but does not do so.
Form,
Exchange and Transfer
We
may issue debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the
applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indentures will provide that
we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited
with, or on behalf of, The Depository Trust Company or another depositary named by us and identified in a prospectus supplement
with respect to that series (the “Depository”). See “Book-Entry” below for a further description of the
terms relating to any book-entry securities.
At
the option of the holder, subject to the terms of the indentures and the limitations applicable to global securities described
below or in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities
for other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject
to the terms of the indentures and the limitations applicable to global securities set forth below in the applicable prospectus
supplement, holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly
endorsed or with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office
of the security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided
in the debt securities that the holder presents for transfer or exchange, we will make no service charge for any registration
of transfer or exchange, but we may require payment of any taxes or other governmental charges.
We
will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar,
that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation
of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required
to maintain a transfer agent in each place of payment for the debt securities of each series.
If
we elect to redeem the debt securities of any series, we will not be required to:
| ● | issue,
register the transfer of, or exchange any debt securities of any series being redeemed
in part during a period beginning at the opening of business 15 days before the day of
mailing of a notice of redemption of any debt securities that may be selected for redemption
and ending at the close of business on the day of the mailing; or |
| ● | register
the transfer of or exchange any debt securities so selected for redemption, in whole
or in part, except the unredeemed portion of any debt securities we are redeeming in
part. |
Book-Entry
Securities
The
following description of book-entry securities will apply to any series of debt securities issued in whole or in part in the form
of one or more global securities, except as otherwise described in a related prospectus supplement.
Book-entry
securities of like tenor and having the same date will be represented by one or more global securities deposited with and registered
in the name of a depositary that is a clearing agent registered under the Exchange Act. Beneficial interests in book-entry
securities will be limited to institutions that have accounts with the depositary, or “participants,” or persons that
may hold interests through participants.
Ownership
of beneficial interests by participants will only be evidenced by, and the transfer of that ownership interest will only be effected
through, records maintained by the depositary. Ownership of beneficial interests by persons that hold through participants will
only be evidenced by, and the transfer of that ownership interest within such participant will only be effected through, records
maintained by the participants. The laws of some jurisdictions require that certain purchasers of securities take physical delivery
of such securities in definitive form. Such laws may impair the ability to transfer beneficial interests in a global security.
Payment
of principal of and any premium and interest on book-entry securities represented by a global security registered in the name
of or held by a depositary will be made to the depositary, as the registered owner of the global security. Neither we, the trustee
nor any agent of ours or the trustee will have any responsibility or liability for any aspect of the depositary’s records
or any participant’s records relating to or payments made on account of beneficial ownership interests in a global security
or for maintaining, supervising or reviewing any of the depositary’s records or any participant’s records relating
to the beneficial ownership interests. Payments by participants to owners of beneficial interests in a global security held through
such participants will be governed by the depositary’s procedures, as is now the case with securities held for the accounts
of customers registered in “street name,” and will be the sole responsibility of such participants.
A
global security representing a book-entry security is exchangeable for definitive debt securities in registered form, of like
tenor and of an equal aggregate principal amount registered in the name of, or is transferable in whole or in part to, a person
other than the depositary for that global security, only if (i) the depositary notifies us that it is unwilling or unable to continue
as depositary for that global security or the depositary ceases to be a clearing agency registered under the Exchange Act,
(ii) there shall have occurred and be continuing an event of default with respect to the debt securities of that series or (iii)
other circumstances exist that have been specified in the terms of the debt securities of that series. Any global security that
is exchangeable pursuant to the preceding sentence shall be registered in the name or names of such person or persons as the depositary
shall instruct the trustee. It is expected that such instructions may be based upon directions received by the depositary from
its participants with respect to ownership of beneficial interests in such global security.
Except
as provided above, owners of beneficial interests in a global security will not be entitled to receive physical delivery of debt
securities in definitive form and will not be considered the holders thereof for any purpose under the indentures, and no global
security shall be exchangeable, except for a security registered in the name of the depositary. This means each person owning
a beneficial interest in such global security must rely on the procedures of the depositary and, if such person is not a participant,
on the procedures of the participant through which such person owns its interest, to exercise any rights of a holder under the
indentures. We understand that under existing industry practices, if we request any action of holders or an owner of a beneficial
interest in such global security desires to give or take any action that a holder is entitled to give or take under the indentures,
the depositary would authorize the participants holding the relevant beneficial interests to give or take such action, and such
participants would authorize beneficial owners owning through such participant to give or take such action or would otherwise
act upon the instructions of beneficial owners owning through them.
Information
Concerning the Trustee
The
trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform only
those duties as are specifically set forth in the applicable indenture and is under no obligation to exercise any of the powers
given it by the indentures at the request of any holder of debt securities unless it is offered reasonable security and indemnity
against the costs, expenses and liabilities that it might incur. However, upon an event of default under an indenture, the trustee
must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.
Payment
and Paying Agents
Unless
we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on
any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered
at the close of business on the regular record date for the interest.
We
will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents
designated by us, except that, unless we otherwise indicate in the applicable prospectus supplement, we may make interest payments
by check which we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in a prospectus
supplement, we will designate an office or agency of the trustee in the City of New York as our paying agent for payments with
respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents that we
initially designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for
the debt securities of a particular series.
All
money we pay to a paying agent or the trustee for the payment of the principal of or any premium or interest on any debt securities
which remains unclaimed at the end of two years after such principal, premium or interest has become due and payable will be repaid
to us, and the holder of the debt security thereafter may look only to us for payment thereof.
Governing
Law
Except
as otherwise specified in the applicable prospectus supplement, the indentures and the debt securities will be governed by and
construed in accordance with the laws of the State of New York, except to the extent that the Trust Indenture Act is
applicable.
DESCRIPTION
OF RIGHTS
General
We
may issue rights to our stockholders to purchase shares of our Common Stock or other securities as described in this prospectus.
We may offer rights separately or together with one or more additional rights, Common Stock, other securities described in this
prospectus or any combination of such securities in the form of units, as described in the applicable prospectus supplement. Each
series of rights will be issued under a separate rights agreement to be entered into between us and a bank or trust company, as
rights agent. The rights agent for any rights we offer will be set forth in the applicable prospectus supplement. The rights agent
will act solely as our agent in connection with the certificates relating to the rights of the series of certificates and will
not assume any obligation or relationship of agency or trust for or with any holders of rights certificates or beneficial owners
of rights. The following description sets forth certain general terms and provisions of the rights to which any prospectus supplement
may relate. The particular terms of the rights to which any prospectus supplement may relate and the extent, if any, to which
the general provisions may apply to the rights so offered will be described in the applicable prospectus supplement. To the extent
that any particular terms of the rights, rights agreement or rights certificates described in a prospectus supplement differ from
any of the terms described below, then the terms described below will be deemed to have been superseded by that prospectus supplement.
We encourage you to read the applicable rights agreement and rights certificate for additional information before you decide whether
to purchase any of our rights.
The
prospectus supplement relating to any rights that we offer will include specific terms relating to the offering, including, among
other matters:
| ● | the
date of determining the stockholders entitled to the rights distribution; |
| ● | the
aggregate number of shares of Common Stock or other securities purchasable upon exercise
of the rights; |
| ● | the
aggregate number of rights issued; |
| ● | whether
the rights are transferrable and the date, if any, on and after which the rights may
be separately transferred; |
| ● | the
date on which the right to exercise the rights will commence, and the date on which the
right to exercise the rights will expire; |
| ● | the
method by which holders of rights will be entitled to exercise; |
| ● | the
conditions to the completion of the offering; |
| ● | the
withdrawal, termination and cancellation rights; |
| ● | whether
there are any backstop or standby purchaser or purchasers and the terms of their commitment; |
| ● | whether
stockholders are entitled to oversubscription rights; |
| ● | any
U.S. federal income tax considerations; and |
| ● | any
other terms of the rights, including terms, procedures and limitations relating to the
distribution, exchange and exercise of the rights. |
If
less than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to
persons other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including
pursuant to standby arrangements, as described in the applicable prospectus supplement. In connection with any rights offering,
we may enter into a standby underwriting or other arrangement with one or more underwriters or other persons pursuant to which
such underwriters or other persons would purchase any offered securities remaining unsubscribed for after such rights offering.
DESCRIPTION
OF UNITS
We
may issue units comprising one or more of the other securities described in this prospectus in any combination. Each unit will
be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit
will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may
provide that the securities included in such unit may not be held or transferred separately, at any time or at any time before
a specified date.
The
applicable prospectus supplement will describe:
| ● | the
designation and terms of the units and of the securities comprising the units, including
whether and under what circumstances those securities may be held or transferred separately; |
| ● | any
unit agreement under which the units will be issued; |
| ● | any
provisions for the issuance, payment, settlement, transfer or exchange of the units or
of the securities comprising the units; and |
| ● | whether
the units will be issued in fully registered or global form. |
The
applicable prospectus supplement will describe the terms of any units. The preceding description and any description of units
in the applicable prospectus supplement does not purport to be complete and is subject to and is qualified in its entirety by
reference to the unit agreement and, if applicable, collateral arrangements and depositary arrangements relating to such units.
PLAN OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus through underwriters or dealers, through agents, or directly
to one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe the terms
of the offering of the securities, including:
| ● | the
name or names of any underwriters, if any, and if required, any dealers or agents; |
| ● | the
purchase price of the securities and the proceeds that we will receive from the sale; |
| ● | any
underwriting discounts and other items constituting underwriters’ compensation; |
| ● | any
discounts or concessions allowed or reallowed or paid to dealers; and |
| ● | any
securities exchange or market on which the securities may be listed. |
We
may distribute the securities from time to time in one or more transactions at:
| ● | a
fixed price or prices, which may be changed; |
| ● | market
prices prevailing at the time of sale; |
| ● | prices
related to such prevailing market prices; or |
Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name
of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation
of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated.
If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may
be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or
at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed
or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations
of the underwriters to purchase the offered securities will be subject to conditions precedent and the underwriters will be obligated
to purchase all of the offered securities if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering
price, with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms
of any over-allotment option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to
be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified
in a prospectus supplement.
We
may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities and we will describe any commissions to be paid to the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, any agent will act on a best-efforts basis for the period of its appointment.
LEGAL
MATTERS
The
validity of the issuance of the securities offered hereby will be passed upon for us by Sullivan & Worcester LLP of New York,
New York. Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that we will name
in the applicable prospectus supplement.
EXPERTS
The
financial statements of Lipella Pharmaceuticals Inc. as of December 31, 2022 and 2021 and for each of the two years in the period
ended December 31, 2022, incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December
31, 2022, have been so incorporated in reliance on the report of Urish Popeck & Co., LLC, an independent registered public
accounting firm, given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus constitutes a part of a registration statement on Form S-3 filed under the Securities Act. As permitted by the SEC’s
rules, this prospectus and any prospectus supplement, which form a part of the registration statement, do not contain all of the
information that is included in the registration statement. You will find additional information about us in the registration
statement and its exhibits. Any statements made in this prospectus or any prospectus supplement concerning legal documents are
not necessarily complete and you should read the documents that are filed as exhibits to the registration statement or otherwise
filed with the SEC for a more complete understanding of the document or matter.
You
can read our electronic SEC filings, including such registration statement, on the internet at the SEC’s website at www.sec.gov.
We are subject to the information reporting requirements of the Exchange Act, and we file reports, proxy statements and other
information with the SEC. These reports, proxy statements and other information will be available at the website of the SEC referred
to above. We also maintain a website at https://www.lipella.com, at which you may access these materials free of charge
as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. However, the information
contained in or accessible through our website is not part of this prospectus or the registration statement of which this prospectus
forms a part, and investors should not rely on such information in making a decision to purchase our securities in this offering.
INCORPORATION
OF DOCUMENTS BY REFERENCE
We
have filed a registration statement on Form S-3 with the SEC under the Securities Act. This prospectus is part of the registration
statement, but the registration statement includes and incorporates by reference additional information and exhibits. The SEC
permits us to “incorporate by reference” the information contained in documents that we file with the SEC, which means
that we can disclose important information to you by referring you to those documents rather than by including them in this prospectus.
Information that is incorporated by reference is considered to be part of this prospectus and you should read it with the same
care that you read this prospectus. Information that we file later with the SEC will automatically update and supersede the information
that is either contained, or incorporated by reference, in this prospectus, and will be considered to be a part of this prospectus
from the date those documents are filed. We have filed with the SEC, and incorporate by reference in this prospectus:
|
● |
our Annual Report on Form 10-K for the
fiscal year ended December 31, 2022, filed with the SEC on March 31, 2023; |
|
● |
our Quarterly Report
on Form 10-Q for the fiscal quarter ended March 31, 2023, filed with the SEC on May 12, 2023, our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 14, 2023; and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 14, 2023; |
|
● |
our Definitive Proxy Statement on Schedule 14A
(other than information furnished rather than filed), filed with the SEC on October 10, 2023, as supplemented by the Definitive
Additional Materials filed on October 11, 2023; |
|
● |
our Current Reports on Forms 8-K filed with
the SEC on March 27, 2023, June 1, 2023, June 23, 2023, August 2, 2023, August 8, 2023, October 26, 2023, November 22, 2023,
November 28, 2023 and December 1, 2023 (except for Item 2.02 and Item 7.01 of any Current Report on Form 8-K which are not
deemed “filed” for purposes of Section 18 of the Exchange Act and are not incorporated by reference in this prospectus);
and |
|
● |
the description
of our Common Stock contained in (i) our registration statement on Form 8-A, filed with the SEC on December 19, 2022 under
Section 12(b) of the Exchange Act, including any amendments or reports filed for the purpose of updating such description
and (ii) Exhibit 4.2—Description of Registrant’s Securities Registered Pursuant to Section 12 of the Exchange
Act, to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 31, 2023. |
We
also incorporate by reference into this prospectus additional documents that we may file with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act (i) on or after the date of the initial filing of the registration statement of which this
prospectus is a part and prior to effectiveness of the registration statement, and (ii) on or after the date of this prospectus
but prior to the completion or termination of the offering of the particular securities covered by the applicable prospectus supplement
has been completed (excluding any information not deemed “filed” with the SEC).
Any
statement contained in a previously filed document is deemed to be modified or superseded for purposes of this prospectus to the
extent that a statement contained in this prospectus or in a subsequently filed document incorporated by reference herein modifies
or supersedes the statement, and any statement contained in this prospectus is deemed to be modified or superseded for purposes
of this prospectus to the extent that a statement contained in a subsequently filed document incorporated by reference herein
modifies or supersedes the statement.
We
will provide this information upon written or oral request at no cost to the requester. You may request this information by contacting
our corporate headquarters at the following address: at 7800 Susquehanna St., Suite 505, Pittsburgh, PA 15208, Attn: Finance Department,
or by calling (412) 901-0315.
Copies
of these filings are also available through the “Investor Relations” section of our website at https://www.lipella.com.
For other ways to obtain a copy of these filings, please refer to “Where You Can Find More Information” above.

Lipella
Pharmaceuticals Inc.
$50,000,000
Common
Stock
Preferred Stock
Warrants
Debt Securities
Convertible
Debt Securities
Rights
Units
PROSPECTUS
The
date of this prospectus is February 8, 2024.
We
have not authorized any dealer, salesperson or other person to give any information or represent anything not contained in this
prospectus. You must not rely on any unauthorized information. If anyone provides you with different or inconsistent information,
you should not rely on it. This prospectus does not offer to sell any securities in any jurisdiction where it is unlawful. Neither
the delivery of this prospectus, nor any sale made hereunder, shall create any implication that the information in this prospectus
is correct after the date hereof.
399,000
Shares of Common Stock
Pre-Funded
Warrants to purchase up to 1,667,000 Shares of Common Stock
Up
to 1,667,000 Shares of Common Stock Underlying the Pre-Funded Warrants

PROSPECTUS
SUPPLEMENT
H.C.
Wainwright & Co.
July
31, 2024
Grafico Azioni Lipella Pharmaceuticals (NASDAQ:LIPO)
Storico
Da Feb 2025 a Mar 2025
Grafico Azioni Lipella Pharmaceuticals (NASDAQ:LIPO)
Storico
Da Mar 2024 a Mar 2025