Filed Pursuant to Rule 424(b)(3)
Registration No. 333-276429
PROSPECTUS
1,762,674 Shares of Common Stock
This prospectus relates
to the resale of up to 1,762,674 shares of First Wave BioPharma, Inc. (the “Company,” “we,” “our”
or “us”) common stock, par value $0.0001 per share (the “Common Stock”), by the selling stockholders listed in
this prospectus or their permitted transferees (the “Selling Stockholders”). The shares of Common Stock registered for resale
pursuant to this prospectus include 1,762,674 shares of Common Stock (the “Warrant Shares”) issuable upon exercise of common
warrants (the “Warrants”) issued to selling stockholders in the private placement offering (the “Private Placement”)
which closed on December 28, 2023.
For additional information
about the Private Placement, see “Private Placement.”
The
Warrants have an exercise price of $5.00 per share and will expire five years from the initial exercise date.
We are registering the shares
on behalf of the Selling Stockholders, to be offered and sold by them from time to time. We are not selling any securities under this
prospectus and will not receive any of the proceeds from the sale of shares by the Selling Stockholders.
The Selling Stockholders
may sell the shares of Common Stock described in this prospectus in a number of different ways and at varying prices. See Plan of
Distribution on page 9 of this prospectus for more information about how the Selling Stockholders may sell the shares of Common
Stock being registered pursuant to this prospectus. The Selling Stockholders may be an “underwriter” within the meaning of
Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”).
We will pay the expenses
incurred in registering the shares, including legal and accounting fees. See Plan of Distribution on page 9 of this prospectus.
Our Common Stock is currently
listed on The Nasdaq Capital Market under the symbol “FWBI”. On January 17, 2024, the last reported sale price of our Common
Stock on The Nasdaq Capital Market was $3.84. Effective as of 12:01 am Eastern Time on December 18, 2023, we filed an amendment to our
Amended and Restated Certificate of Incorporation to effect a one-for-twenty reverse stock split of our issued and outstanding shares
of Common Stock (the “Reverse Stock Split”). Unless otherwise indicated, all share and per share prices in this prospectus
have been adjusted to reflect the Reverse Stock Split. However, common stock share and per share amounts in certain of the documents incorporated
by reference herein have not been adjusted to give effect to the Reverse Stock Split.
Investing in our securities
involves risks. See “Risk Factors” beginning on page 3 of this prospectus for a discussion of the risks that you should
consider in connection with an investment 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 January 18, 2024
TABLE OF CONTENTS
PROSPECTUS SUMMARY
This summary highlights
information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before
deciding to invest in our securities. You should read this entire prospectus carefully, including the “Risk Factors” section
in this prospectus and under similar captions in the documents incorporated by reference into this prospectus. In this prospectus, unless
otherwise stated or the context otherwise requires, references to “First Wave BioPharma”, “Company”, “we”,
“us”, “our” or similar references mean First Wave BioPharma, Inc. and its subsidiaries on a consolidated
basis. References to “First Wave BioPharma” refer to First Wave BioPharma, Inc. on an unconsolidated basis. References
to “First Wave Bio” refer to First Wave Bio, Inc., First Wave BioPharma’s wholly-owned subsidiary.
Overview
We are engaged in the research
and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases.
Non-systemic therapies are drugs that act locally, i.e. in the intestinal lumen, skin or mucosa, without reaching an individual’s
systemic circulation.
We are currently focused on developing our pipeline
of gut-restricted GI clinical drug candidates, including the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed
to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties.
Our adrulipase programs are focused on the development of an oral, non-systemic, biologic capsule for the treatment of exocrine pancreatic
insufficiency (“EPI”) in patients with cystic fibrosis (“CF”) and chronic pancreatitis (“CP”). The
Company’s niclosamide programs leverage proprietary oral and topical formulations to address multiple GI conditions, including
inflammatory bowel disease (“IBD”) indications and viral diseases.
We are developing our drug candidates for a host
of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening
and discomforting consequences for patients.
Corporate Information
We
were incorporated on January 30, 2014 in the State of Delaware. In June 2014, we acquired 100% of the issued and outstanding
capital stock of AzurRx SAS. In September 2021, we acquired First Wave Bio through a merger transaction, and changed our name to
First Wave BioPharma, Inc. Our principal executive offices are located at 777 Yamato Road, Suite 502, Boca Raton, Florida 33431.
Our telephone number is (561) 589-7020. We maintain a website at www.firstwavebio.com. The information contained
on our website is not, and should not be interpreted to be, a part of this prospectus.
The Private Placement
| Shares of common stock offered
by the Selling Stockholders |
1,762,674 shares of Common Stock
consisting of 1,762,674 Warrant Shares. |
| |
|
| Use
of proceeds |
We
are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of the shares of Common
Stock covered hereby by the Selling Stockholders. |
| |
|
| Terms
of this offering |
The
Selling Stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or
otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares
of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market
price or at negotiated prices. |
| |
|
| Nasdaq
symbol |
Our
common stock is listed on The Nasdaq Capital Market under the symbol “FWBI”. |
| |
|
| Risk
Factors |
Investing
in our securities involves significant risks. Before making a decision whether to invest in our securities, please read the information
contained in or incorporated by reference under the heading “Risk Factors” in this prospectus, the documents we have
incorporated by reference herein, and under similar headings in other documents filed after the date hereof and incorporated by reference
into this prospectus. See “Incorporation of Certain Information by Reference” and “Where You Can Find More Information”. |
RISK FACTORS
An investment in our securities
involves a high degree of risk. Before deciding whether to purchase our securities, including the shares of common stock offered by this
prospectus, you should carefully consider the risks and uncertainties described under “Risk Factors” in our Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, our Quarterly Reports on Form 10-Q for the periods ended March 31,
2023,June 30, 2023, and September 30, 2023, and any subsequent Quarterly Report on Form 10-Q and our other filings with
the SEC, all of which are incorporated by reference herein. If any of these risks actually occur, our business, financial condition and
results of operations could be materially and adversely affected and we may not be able to achieve our goals, the value of our securities
could decline and you could lose some or all of your investment. Additional risks not presently known to us or that we currently believe
are immaterial may also significantly impair our business operations. If any of these risks occur, our business, results of operations
or financial condition and prospects could be harmed. In that event, the market price of our common stock and the value of the warrants
could decline, and you could lose all or part of your investment.
Risks Related to This Offering
A substantial
number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common
stock.
Following
this offering, a large number of shares of Common Stock may be sold in the market, which may depress the market price of our Common Stock.
Sales of a substantial number of shares of our Common Stock in the public market following this offering could cause the market price
of our Common Stock to decline. A substantial majority of the outstanding shares of our Common Stock are, and the shares of Common Stock
issuable upon exercise of the Warrants will be, freely tradable without restriction or further registration under the Securities Act,
unless owned or purchased by our “affiliates” as that term is defined in Rule 144 under the Securities Act.
Our failure to maintain compliance
with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.
Our
common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy the continued listing requirements of Nasdaq,
to maintain the listing of our common stock on The Nasdaq Capital Market.
On
August 17, 2023, we received notice from the Listing Qualifications Staff (the “Staff”) of the Nasdaq Stock Market LLC
(“Nasdaq”) indicating that we were not in compliance with the $2.5 million minimum stockholders’ equity requirement
for continued listing of the Common Stock on Nasdaq, as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’
Equity Rule”). In that regard, we reported stockholders’ equity of $881,960 in our Quarterly Report on Form 10-Q for
the period ended June 30, 2023 (we did not then, and do not now, meet the alternative compliance standards relating to the market
value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal
year or in two of the last three most recently completed fiscal years).
On October
2, 2023, we submitted a plan to the Staff to regain compliance with the Minimum Stockholders’ Equity Rule. On November 13, 2023,
we filed our Quarterly Report on Form 10-Q for the period ended September 30, 2023, reporting total stockholders’ equity of $3,278,805
as of September 30, 2023.
Additionally,
as we have previously reported, on August 24, 2023, we received a notice (the “Minimum Bid Price Notice”) from the Staff indicating
that, based upon the closing bid price of our Common Stock for the last 30 consecutive business days, we are not currently in compliance
with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth
in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). We are provided a compliance period of 180 calendar days
from the date of the Notice, or until February 20, 2024, to regain compliance with the Minimum Bid Price Rule, pursuant to Nasdaq Listing
Rule 5810(c)(3)(A). If at any time before February 20, 2024, the closing bid price of the Common Stock closes at or above $1.00 per share
for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period pursuant to Nasdaq Listing Rule
5810(c)(3)(G) to 20 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum
bid price requirement, and the matter would be resolved. On January 4, 2024, we received notice from Nasdaq Listing Qualifications stating
that Nasdaq Listing Qualifications Staff had determined that for the prior eleven consecutive business days, from December 18, 2023 to
January 3, 2024, the closing bid price of our Common Stock had been at $1.00 per share or greater, and accordingly, we had regained compliance
with the Minimum Bid Price Rule.
In addition, on October 26, 2023, we received notice
from the Staff of Nasdaq indicating that, in connection with our July 2023 Offering, we were not in compliance with Nasdaq’s shareholder
approval requirements set forth in Listing Rule 5635(d), which requires prior shareholder approval for transactions, other than public
offerings, involving the issuance of 20% or more of the pre-transaction shares outstanding at less than the Minimum Price, defined as
a price that is the lower of: (i) the Nasdaq Official Closing price (as reflected on Nasdaq.com) immediately preceding the signing of
the binding agreement; or (ii) the average Nasdaq official Closing Price of the common stock (as reflected on Nasdaq.com) for the five
trading days immediately preceding the signing of the binding agreement. On December 12, 2023, during
the Special Meeting, our stockholders’ ratified our entry into the Offering as we received the affirmative vote of the majority
of the votes cast by shares of our common stock present or represented by proxy and entitled to vote at the Special Meeting.
There
can be no assurance that we will be able to ultimately regain and sustain compliance with all applicable requirements for continued listing
on the Nasdaq Stock Market LLC. In 2020, the SEC approved a previously proposed Nasdaq rule change to expedite delisting of securities
with a closing bid price at or below $0.10 for 10 consecutive trading days during any bid price compliance period and that have had one
or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period. In addition, if a company
falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years
that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any bid price compliance periods
under Rule 5810(c)(3)(A), and Nasdaq will instead require the issuance of a Staff delisting determination. We could appeal the determination
to a hearings panel, which could grant us a 180-day exception to remain listed if it believes we would be able to achieve and maintain
compliance with the bid price requirement. Following the exception, the company would be subject to the procedures applicable to a company
with recurring deficiencies (Nasdaq Rule 5815(d)(4)(B)).
In the event that we are
unable to regain and sustain compliance will all the applicable requirements for continued listing, our common stock may be delisted from
Nasdaq.
If
our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established
for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less
convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors
would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading
in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject
to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating
to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions
generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability
of investors to trade in our common stock. In addition, delisting would materially and adversely affect our ability to raise capital on
terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees
and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume
and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial
condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, and any
documents we incorporate by reference, contain certain forward-looking statements that involve substantial risks and uncertainties. All
statements contained in this prospectus and any documents we incorporate by reference, other than statements of historical facts, are
forward-looking statements including statements regarding our strategy, future operations, future financial position, future revenue,
projected costs, prospects, plans, objectives of management and expected market growth. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from
any future results, performance or achievements expressed or implied by the forward-looking statements.
The words “anticipate”,
“believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”,
“project”, “target”, “potential”, “will”, “would”, “could”, “should”,
“continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking statements include, among other things, statements about:
| · |
our ability to maintain
compliance with the continued listing requirements of the Nasdaq Stock Market LLC; |
| · |
our ability to satisfy
our payment obligations in connection with the acquisition of First Wave Bio, Inc. and the settlement payments; |
| · |
statements regarding geopolitical
events, including the wars in Israel and Ukraine and their effects on our operations, access to capital, research and development
and clinical trials and potential disruption in the operations and business of third-party vendors, contract research organizations
(“CROs”), contract development and manufacturing organizations (“CDMOs”), other service providers, and collaborators
with whom we conduct business; |
| · |
the availability of capital
to satisfy our working capital requirements; |
| · |
our
current and future capital requirements and our ability to raise additional funds to satisfy our capital needs; |
| · |
our
ability to consummate our proposed acquisition of ImmunogenX, Inc., our potential sale of niclosamide, and other strategic transactions; |
| · |
the
integration and effects of our acquisitions and other strategic transactions; |
| · |
the accuracy of our estimates
regarding expense, future revenue and capital requirements; |
| · |
ability to continue operating
as a going concern; |
| · |
our
plans to develop and commercialize our product candidates, including adrulipase and niclosamide; |
| · |
our ability to initiate
and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal
clinical trials, and successfully complete such clinical trials; |
| · |
regulatory developments
in the U.S. and foreign countries; |
| · |
the performance of our
third-party vendor(s), CROs, CDMOs and other third-party non-clinical and clinical development collaborators and regulatory service
providers |
| · |
our ability to obtain and
maintain intellectual property protection for our core assets; |
| · |
the size of the potential
markets for our product candidates and our ability to serve those markets; |
| · |
the rate and degree of
market acceptance of our product candidates for any indication once approved; |
| · |
the success of competing
products and product candidates in development by others that are or become available for the indications that we are pursuing; |
| · |
other risks and uncertainties, including those listed
in the “Risk Factors” section of this prospectus and the documents incorporated by reference herein. |
These forward-looking statements
are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements,
so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking statements we make. We have based these forward-looking statements largely
on our current expectations and projections about future events and trends that we believe may affect our business, financial condition
and operating results. We have included important factors in the cautionary statements included in this prospectus that could cause actual
future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
You should read this prospectus
with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation
to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable
law.
PRIVATE PLACEMENT
On December 27, 2023, we entered into a warrant
exercise inducement offer letter (the “Inducement Letter”) with a certain holder (the “Holder”) of warrants to
purchase shares of our common stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their
Existing Warrants to purchase 881,337 shares of our common stock, in the aggregate, at a reduced exercised price of $5.50 per share,
in exchange for our agreement to issue new warrants (the “Warrants”) on substantially the same terms as the Existing Warrants
as described below, to purchase up to 1,762,674 shares of our common stock (the “Warrant Shares”) and a cash payment of $0.125
per Warrant Share which was paid in full upon the exercise of the Existing Warrants. We received aggregate gross proceeds of approximately
$4.8 million from the exercise of the Existing Warrants by the Holder and the sale of the Warrants. We engaged Roth Capital Partners,
LLC (“Roth”) to act as our financial advisor in connection with the transactions summarized above and paid Roth approximately
$290,841 for its services.
SELLING STOCKHOLDERS
This prospectus relates
to the sale from time to time by the Selling Stockholders of up to 1,762,674 shares of our Common Stock. When we refer to the “Selling
Stockholders” in this prospectus, we mean the persons and entities listed in the table below, and their respective pledgees, donees,
permitted transferees, assignees, successors and others who later come to hold any of the Selling Stockholders’ interests in shares
of our common stock other than through a public sale.
The Selling Stockholders may sell some, all or
none of its shares. We do not know how long the Selling Stockholders will hold the shares before selling them, and we currently have
no agreements, arrangements or understandings with the Selling Stockholders regarding the sale of any of the shares.
The following table presents
information regarding the Selling Stockholders and the shares that they may offer and sell from time to time under this prospectus. The
number of shares common stock beneficially owned by the Selling Stockholders is determined under rules promulgated by the SEC. Except
as described above, there are currently no agreements, arrangements or understandings with respect to the resale of any of the securities
covered by this prospectus.
| | |
Shares
Beneficially
Owned
Prior to this | | |
Maximum Number of
Shares Being
Offered Pursuant to
this | | |
Shares
Beneficially
Owned
After this
Offering(3) | |
| Name of Selling Stockholder | |
Offering(1)(2)(3) | | |
Prospectus | | |
Number(3) | | |
Percent(4) | |
| Armistice Capital, LLC (5) | |
| 75,000 | (6) | |
| 1,762,674 | (7) | |
| 77,893 | (8) | |
| 4.99 | % |
| (1) |
Except as noted
below, beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power
with respect to securities. All entries exclude beneficial ownership of shares issuable pursuant to warrants, options or other derivative
securities that have not vested or that are not otherwise exercisable as of the date hereof or which will not become vested or exercisable
within 60 days of January 8, 2024. |
| (2) |
Based upon the internal books and
records of the Company. |
| (3) |
Includes shares of Common Stock
which are not being offered pursuant to this prospectus. |
| (4) |
All percentage
calculations are based on 1,560,998 shares of Common Stock outstanding as of December 28, 2023 and are rounded to the nearest
tenth of a percent. Warrants, options or other derivative securities that are presently exercisable or exercisable within 60 days
are deemed to be beneficially owned by the person holding such securities for the purpose of calculating the percentage ownership
of that person, but are not treated as outstanding for the purpose of calculating the percentage ownership of any other person. |
| |
|
| (5) |
The securities are directly
held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”) and may be deemed to
be indirectly beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager
of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The warrants are subject to a beneficial
ownership limitation of 4.99%, which such limitation restricts the Selling Stockholder from exercising that portion of the warrants
that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess
of the beneficial ownership limitation. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison
Avenue, 7th Floor, New York, NY 10022. |
| |
|
| (6) |
The number of shares of
Common Stock owned by the selling shareholder prior to this offering consists of: (i) 881,337 shares of Common Stock, 806,337
of which are being held in abeyance; and (ii) Warrants issued in the Private Placement to purchase up to an aggregate of 1,762,674
shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such Warrants). |
| (7) |
The maximum
number of shares being offered pursuant to this prospectus consists of Warrants issued in the Private Placement to purchase up to
an aggregate of 1,762,674 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in
such Warrants). |
| |
|
| (8) |
The shares beneficially
owned after this private placement give effect to the 4.99% beneficial ownership limitation contained in the common warrants held
by the selling shareholder. |
Issuances of our Common
Stock to the Selling Stockholders will not affect the rights or privileges of our existing stockholders, except that the economic and
voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares
of Common Stock that our existing stockholders own will not decrease, the shares owned by our existing stockholders will represent a
smaller percentage of our total outstanding shares after any such issuance to the Selling Stockholders identified herein.
USE OF PROCEEDS
The Common Stock to be offered
and sold using this prospectus will be offered and sold by the Selling Stockholders named in this prospectus. Accordingly, we will not
receive any proceeds from any sale of shares of Common Stock in this offering. We will pay all of the fees and expenses incurred by us
in connection with this registration.
PLAN OF DISTRIBUTION
Each Selling Stockholder
of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities
covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the securities are traded
or in private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following
methods when selling securities:
| · |
ordinary brokerage transactions
and transactions in which the broker-dealer solicits purchasers; |
| · |
block trades in which the
broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate
the transaction; |
| · |
purchases by a broker-dealer
as principal and resale by the broker-dealer for its account; |
| · |
an exchange distribution
in accordance with the rules of the applicable exchange; |
| · |
privately negotiated transactions; |
| · |
settlement of short sales; |
| · |
in
transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated
price per security; |
| · |
through the writing or
settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| · |
a combination of any such
methods of sale; or |
| · |
any other method permitted
pursuant to applicable law. |
The Selling Stockholders
may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the
“Securities Act”), if available, rather than under this prospectus.
Broker-dealers engaged by
the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts
from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts
to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of
a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown
in compliance with FINRA Rule 2121.
In connection with the sale
of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling
Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities
to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer
or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution
may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling Stockholders
and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the
meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents
and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the
Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the securities.
The Company is required to
pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify
the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus
effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration
and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to
be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect
or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other
rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under
applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have
been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available
and is complied with.
Under applicable rules and
regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in
market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to
the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange
Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common
stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and
have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
Our Common Stock is quoted
on The Nasdaq Capital Market under the symbol “FWBI”.
DESCRIPTION OF SECURITIES
The
following summary of the rights of our capital stock is not complete and is subject to and qualified in its entirety by reference to
our Charter and Bylaws, copies of which are filed as exhibits to our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 20, 2023, and forms of securities, copies of which are filed as exhibits to
the registration statement of which this prospectus forms a part, which are incorporated by reference herein.
General
Our authorized capital stock consists of:
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100,000,000 shares of common stock, par value $0.0001
per share; and |
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10,000,000 shares of preferred stock, par value $0.0001.
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As of September 30, 2023, there were 50,000,000
shares of Common Stock authorized, and 10,000,000 shares of preferred stock authorized, of which a series of 5,194.81 shares of Series B
Convertible Preferred Stock (the “Series B Preferred Stock”), a series of 75,000 shares of Series C 9.00% Convertible
Junior Preferred Stock (the “Series C Preferred Stock”), a series of 150 shares of Series D Preferred Stock, a
series of 150 shares of Series E Preferred Stock, and a series of 7,000 shares of Series F Preferred Stock have been designated.
On December 12, 2023, shareholders at the
Special Meeting approved a proposal to amend our Charter to increase the authorized shares of common stock from 50,000,000 shares to
100,000,000 shares and to effect a reverse stock split of our issued and outstanding common stock at a ratio of not less than 1-for-10
and not more than 1-for-20, with such ratio to be determined by the Board of Directors. On December 13, 2023, we filed an amendment
to our Charter with the Secretary of State of the State of Delaware increasing our authorized shares of common stock to 100,000,000 shares
and to effect a reverse stock split of our common stock at a ratio of 1-for-20, effective at 12:01 AM on December 18, 2023. Our
Common Stock began trading on a split-adjusted basis when the market opened on Monday, December 18, 2023. There was no corresponding
reduction in the number of authorized shares of common stock and no change in the par value per share.
As of September 30, 2023, there were 673,173
shares of Common Stock issued and outstanding, approximately 521.72 shares of Series B Preferred Stock issued and outstanding, no
shares of Series C Preferred Stock issued and outstanding, no shares of Series D Preferred Stock issued and outstanding, no
shares of Series E Preferred Stock issued and outstanding, and no shares of Series F Preferred Stock issued and outstanding.
The additional shares of our authorized capital
stock available for issuance may be issued at times and under circumstances so as to have a dilutive effect on earnings per share and
on the equity ownership of the holders of our common stock. The ability of our board of directors to issue additional shares of stock
could enhance the board’s ability to negotiate on behalf of the stockholders in a takeover situation but could also be used by
the board to make a change of control more difficult, thereby denying stockholders the potential to sell their shares at a premium and
entrenching current management. The following description is a summary of the material provisions of our capital stock. You should refer
to our certificate of incorporation, as amended and restated (the “Charter”), and our bylaws, as amended and restated (the
“Bylaws”), both of which are on file with the SEC as exhibits to previous SEC filings, for additional information. The summary
below is qualified by provisions of applicable law.
Common Stock
Holders of our common stock are entitled to one
vote for each share held of record on all matters on which the holders are entitled to vote (or consent pursuant to written consent).
Directors are elected by a plurality of the votes present in person or represented by proxy and entitled to vote. Our Charter and Bylaws
do not provide for cumulative voting rights.
Holders of our common stock are entitled to receive,
ratably, dividends only if, when and as declared by our board of directors out of funds legally available therefor and after provision
is made for each class of capital stock having preference over the common stock.
In the event of our liquidation, dissolution
or winding-up, the holders of common stock are entitled to share, ratably, in all assets remaining available for distribution after payment
of all liabilities and after provision is made for each class of capital stock having preference over the common stock.
Holders of our common stock have no preemptive,
conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights,
preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders
of shares of any series of our preferred stock that we may designate and issue in the future.
Transfer Agent
The transfer agent and registrar
for our common stock is Colonial Stock Transfer Co., Inc., 7840 S. 700 E., Sandy, Utah 84070, Tel: (801) 355-5740.
Preferred Stock
We currently have up to 10,000,000 shares of
preferred stock, par value $0.0001 per share, authorized and available for issuance in one or more series. Our board of directors is
authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine
or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The board of may increase
or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding
and duly reserved for issuance. As of September 30, 2023, approximately 5,194.81 shares were designated as Series B Preferred
Stock, of which approximately 521.72 shares were issued and outstanding, 75,000 shares were designated as Series C Preferred Stock,
none of which were issued and outstanding, 150 shares were designated as Series D Preferred Stock, none of which were issued and
outstanding, 150 shares were designated as Series E Preferred Stock, none of which were issued and outstanding, and 7,000 shares
were designated as Series F Preferred Stock, none of which were issued and outstanding.
Anti-Takeover Effects of Certain Provisions
of Delaware Law and of Our Charter and Bylaws
Certain provisions of Delaware
law, our Charter and Bylaws discussed below may have the effect of making more difficult or discouraging a tender offer, proxy contest
or other takeover attempt. These provisions are expected to encourage persons seeking to acquire control of our company to first negotiate
with our Board of Directors. We believe that the benefits of increasing our ability to negotiate with the proponent of an unfriendly
or unsolicited proposal to acquire or restructure our company outweigh the disadvantages of discouraging these proposals because negotiation
of these proposals could result in an improvement of their terms.
Delaware Anti-Takeover Law
We are subject to Section 203
of the Delaware General Corporation Law (the “DGCL”). Section 203 generally prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years after
the date of the transaction in 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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upon consummation of the transaction that resulted
in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding specified shares; or |
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at or subsequent to the date of the transaction, the
business combination is approved by the Board of Directors and authorized at an annual or special meeting of stockholders, and not
by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested
stockholder. |
Section 203 defines a “business combination”
to include:
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any merger or consolidation involving the corporation
and the interested stockholder; |
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any sale, lease, exchange, mortgage, pledge, transfer
or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder; |
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subject to exceptions, any transaction that results
in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; |
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subject to exceptions, any transaction involving the
corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially
owned by the interested stockholder; or |
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the receipt by the interested stockholder of the benefit
of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203 defines an “interested
stockholder” as any person that is:
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the owner of 15% or more of the outstanding voting
stock of the corporation; |
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an affiliate or associate of the corporation who was
the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the
relevant date; or |
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the affiliates and associates of the above. |
Under specific circumstances, Section 203
makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a
three-year period, although the stockholders may, by adopting an amendment to the corporation’s certificate of incorporation or
bylaws, elect not to be governed by this section, effective 12 months after adoption.
Our Charter and Bylaws do
not exclude us from the restrictions of Section 203. We anticipate that the provisions of Section 203 might encourage companies
interested in acquiring us to negotiate in advance with our Board of Directors since the stockholder approval requirement would be avoided
if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder
becoming an interested stockholder.
Charter and Bylaws
Provisions of our Charter
and Bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including
transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise
deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock.
Stockholder Action by Written Consent
Our Bylaws provide that
our stockholders may take action by written consent or electronic transmission, setting forth the action so taken, signed or e-mailed
by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such
action at a meeting for such purpose.
Potential Effects of Authorized but Unissued Stock
We have shares of common
stock and preferred stock available for future issuance without stockholder approval. We may utilize these additional shares for a variety
of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions or payment
as a dividend on the capital stock.
The existence of unissued
and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly to current management
or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us by
means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, the board
of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights,
dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest
extent permissible under the DGCL and subject to any limitations set forth in our Charter. The purpose of authorizing the board of directors
to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated
with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with
possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to
acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.
LEGAL MATTERS
The validity of the securities
offered hereby will be passed upon for us by Ellenoff Grossman & Schole LLP, New York, New York.
EXPERTS
The consolidated audited
financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been incorporated
by reference in reliance upon the report of Mazars USA LLP, independent registered public accounting firm, upon the authority of said
firm as experts in accounting and auditing. The 2022 and 2021 audited annual consolidated financial statements of First Wave BioPharma, Inc.,
as of and for the years ended December 31, 2022 and 2021, have been audited by Mazars USA LLP, independent registered public accounting
firm. The audit report dated March 20, 2023 for the 2022 audited annual consolidated financial statements includes an explanatory
paragraph which states that certain circumstances raise substantial doubt about our ability to continue as a going concern.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational
requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports, proxy statements and other
information with the Commission under the Exchange Act. Such reports, proxy statements and other information, including the Registration
Statement, and exhibits and schedules thereto, are available to the public through the Commission’s website at www.sec.gov.
We make available free of
charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K
and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of
1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Commission.
We have filed with the Commission
a registration statement under the Securities Act of 1933, as amended, relating to the offering of these securities. The registration
statement, including the attached exhibits, contains additional relevant information about us and the securities. This prospectus does
not contain all of the information set forth in the registration statement. You can obtain a copy of the registration statement, at prescribed
rates, from the Commission at the address listed above, or for free at www.sec.gov. The registration statement and the documents referred
to below under “Incorporation of Certain Information by Reference” are also available on our website, www. firstwavebio.com/investors/regulatory-filings.
We have not incorporated
by reference into this prospectus the information on our website, and you should not consider it to be a part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents
filed with the SEC are incorporated by reference into this prospectus:
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our Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 20, 2023; |
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our Quarterly Reports on Form 10-Q for the period ended March 31, 2023, filed on May 12, 2023, for the period ended June 30, 2023, filed with the SEC on August 14, 2023, and for the period ended September 30, 2023, filed with the SEC on November 12, 2023. |
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our Current Reports on
Form 8-K, filed on January 17,
2023, February 7,
2023, March 15,
2023, April 7,
2023, April 21,
2023, June 16,
2023, June 23,
2023, July 13,
2023, July 21,
2023, August 18,
2023, August 25,
2023, September 14,
2023, September 15,
2023, October 10,
2023, October 31,
2023, December 14,
2023, December 18,
2023, December 27,
2023 (two filings), and January 4, 2024 (other than any portions thereof deemed furnished and not filed); |
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our definitive proxy statements on Schedule 14A, filed on May 15, 2023 and November 13, 2023; and |
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the description of our common stock which is registered
under Section 12 of the Exchange Act, in our registration statement on Form 8-A, filed on August 8, 2016, as supplemented
and updated by the description of our capital stock set forth in Exhibit 4.31 of our Annual Report on Form 10-K for the
year ended December 31, 2022, filed on March 20, 2023, including any amendment or reports filed for the purposes of updating
this description. |
We also incorporate by reference
all documents we file pursuant to Section 13(a), 13(c), 14 or 15 of the Exchange Act (other than any portions of filings that are
furnished rather than filed pursuant to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the date of the initial registration
statement of which this prospectus is a part and prior to effectiveness of such registration statement. All documents we file in the
future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to the
termination of the offering are also incorporated by reference and are an important part of this prospectus.
Any statement contained
in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for the purposes
of this registration statement to the extent that a statement contained herein or in any other subsequently filed document which also
is or deemed to be incorporated by reference herein modifies or supersedes such statement. Any statement so modified or superseded shall
not be deemed, except as so modified or superseded, to constitute a part of this registration statement.
We
will provide, without charge, to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, upon written
or oral request of such person, a copy of any or all of the documents incorporated by reference in this prospectus, other than exhibits
to such documents unless such exhibits are specifically incorporated by reference into such documents. Requests may be made in writing
or by telephone at First Wave BioPharma, Inc., 777 Yamato Road, Suite 502, Boca Raton, Florida 33431, phone (561) 589-7020.
You may also find these documents in the “Investors” section of our website, www.firstwavebio.com. The information
on our website is not incorporated into this prospectus.
1,762,674 Shares of Common Stock
PROSPECTUS
We have not authorized any
dealer, salesperson or other person to give any information or to make any representations not contained in this prospectus. You must
not rely on any unauthorized information. This prospectus is not an offer to sell these securities in any jurisdiction where an offer
or sale is not permitted.
The date of this prospectus is January 18, 2024.
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