As filed with the Securities and Exchange Commission
on June 5, 2023
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
FIRST WAVE BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware |
2834 |
46-4993860 |
|
(State or other jurisdiction of
incorporation or organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer
Identification Number) |
777 Yamato Road, Suite 502
Boca Raton, Florida 33431
(561) 589-7020
(Address, including zip code, and telephone number,
including area code, of registrant’s principal
executive offices)
James Sapirstein, President, Chief Executive
Officer and Chairman
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, Florida 33431
(561) 589-7020
(Name, address, including zip code, and telephone
number,
including area code, of agent for service)
Copies to
|
John D. Hogoboom, Esq.
Michael J. Lerner, Esq. |
|
Charles Phillips, Esq. |
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Telephone: (212) 262-6700 |
|
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas
New York, New York 10105
Telephone: (212) 370-1300
|
Approximate
date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check
the following box. x
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act,
please check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. ¨
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box
and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: ¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer |
¨ |
|
Accelerated filer |
¨ |
| Non-accelerated filer |
x |
|
Smaller reporting company |
x |
| |
|
|
Emerging growth company |
¨ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨
The Registrant hereby amends this Registration
Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which
specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission, acting
pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not
complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange
Commission is effective. This preliminary prospectus is not an offer to sell these securities, nor is it a solicitation of offers to buy
these securities, in any state where the offer or sale is not permitted.
| PRELIMINARY PROSPECTUS |
SUBJECT TO COMPLETION |
DATED JUNE 5, 2023 |
Up to Shares of Common Stock
Pre-Funded Warrants to Purchase up to Shares
of Common Stock
Common Warrants to Purchase up to Shares of
Common Stock
Shares of Common Stock underlying the
Pre-Funded Warrants and Common Warrants
We are offering up to shares of common stock,
together with common warrants to purchase up to shares of common stock at an assumed combined public offering price of $ per share and
common warrant, which is equal to the last reported sale price per share of our common stock on The Nasdaq Capital Market, on , 2023 (and
the shares issuable from time to time upon exercise of the common warrants) pursuant to this prospectus. The shares of common stock and
common warrants will be separately issued, but the shares of common stock and common warrants will be issued to purchasers in the ratio
of one-to-one. Each common warrant will have an exercise price of $ per share, will be exercisable upon issuance and will expire five
years from the date of issuance.
We are also offering up to pre-funded warrants
to those purchasers, whose purchase of shares of common stock in this offering would result in the purchaser, together with its affiliates
and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common
stock following the consummation of this offering in lieu of the shares of our common stock that would result in ownership in excess of
4.99% (or, at the election of the purchaser, 9.99%). Each pre-funded warrant will be exercisable for one share of common stock at an exercise
price of $0.0001 per share. Each pre-funded warrant is being issued together with the same common warrant described above being issued
with each share of common stock. The purchase price of each pre-funded warrant will equal the combined public offering price per share
of common stock and common warrant being sold in this offering, less the $0.0001 per share exercise price of each such pre-funded warrant.
Each pre-funded warrant will be exercisable upon issuance and will expire when exercised in full. The pre-funded warrants and common warrants
are immediately separable and will be issued separately in this offering. For each pre-funded warrant that we sell, the number of shares
of common stock that we are selling will be decreased on a one-for-one basis.
There is no established public trading market
for the pre-funded warrants or common warrants, and we do not expect a market to develop. We do not intend to apply for listing of the
pre-funded warrants or common warrants on any securities exchange or other nationally recognized trading system. Without an active trading
market, the liquidity of the pre-funded warrants and common warrants will be limited.
We have engaged Roth Capital Partners, LLC, or
the placement agent, to act as our exclusive placement agent in connection with this offering. The placement agent has agreed to use its
reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The placement agent is not purchasing or
selling any of the securities we are offering and the placement agent is not required to arrange the purchase or sale of any specific
number or dollar amount of securities. We have agreed to pay to the placement agent the placement agent fees set forth in the table below,
which assumes that we sell all of the securities offered by this prospectus. There is no arrangement for funds to be received in escrow,
trust or similar arrangement. There is no minimum number of shares of securities or minimum aggregate amount of proceeds that is a condition
for this offering to close. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of
proceeds received by us, and investors in this offering will not receive a refund if we do not sell all of the securities offered hereby.
Because there is no escrow account and no minimum number of securities or amount of proceeds, investors could be in a position where they
have invested in us, but we have not raised sufficient proceeds in this offering to adequately fund the intended uses of the proceeds
as described in this prospectus. We will bear all costs associated with the offering. See “Plan of Distribution” on
page 17 of this prospectus for more information regarding these arrangements. This offering will end no later than three trading
days from the date of this prospectus.
Our common stock is listed on The Nasdaq Capital
Market under the symbol “FWBI.” On , 2023, the last reported sale price of our common stock on The Nasdaq Capital Market was
$ per share. All share, common warrant and pre-funded warrant numbers are based on an assumed combined public offering price of $ per
share or pre-funded warrant, as applicable, and common warrant. The actual combined public offering price per share and common warrant
and the actual combined public offering price per pre-funded warrant and common warrant will be determined between us and investors based
on market conditions at the time of pricing, and may be at a discount to the current market price of our common stock. Therefore, the
assumed public offering price used throughout this prospectus may not be indicative of the final public offering price.
You should read this prospectus, together with
additional information described under the headings “Incorporation of Certain Information By Reference” and “Where
You Can Find More Information,” carefully before you invest in any of our securities.
Investing in our securities involves a high
degree of risk. See the section entitled “Risk Factors” beginning on page 5 of this prospectus and in the
documents incorporated by reference into this prospectus for a discussion of risks that should be considered in connection with an investment
in our securities.
| |
Per Share and
Accompanying
Common Warrant | |
Per Pre-Funded
Warrant and
Accompanying
Common Warrant | | |
Total | |
| Public offering price(1) | |
$ | |
$ | | |
$ | | |
| Placement agent fees(2) | |
$ | |
$ | | |
$ | | |
| Proceeds to us, before expenses(3) | |
$ | |
$ | | |
$ | | |
(1) The public offering price corresponds
to (x)(i) a public offering price per share of $ and (ii) a public offering price per common warrant of $ , and (y)(i) a
public offering price per pre-funded warrant of $ and (ii) a public offering price per common warrant of $ .
(2) See “Plan of Distribution”
for additional information about the compensation payable to the placement agent.
(3) Because there is no minimum number of
securities or amount of proceeds required as a condition to closing in this offering, the actual public 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 above. We estimate the total expenses of this offering payable by us, excluding the placement agent fee, will be approximately
$ .
The delivery of the shares of common stock and
any pre-funded warrants and common warrants to purchasers is expected to be made on or about , 2023.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus.
Any representation to the contrary is a criminal offense.
Roth Capital Partners
The date of this prospectus is ,
2023.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
We incorporate by reference important information
into this prospectus. You may obtain the information incorporated by reference without charge by following the instructions under “Where
You Can Find More Information.” You should carefully read this prospectus as well as additional information described under
“Incorporation of Certain Information by Reference,” before deciding to invest in our securities.
We have not, and the placement agent has not,
authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free
writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no
assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the securities
offered hereby, and only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus
or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of our securities.
Our business, financial condition, results of operations and prospects may have changed since that date.
The information incorporated by reference or provided
in this prospectus contains statistical data and estimates, including those relating to market size and competitive position of the markets
in which we participate, that we obtained from our own internal estimates and research, as well as from industry and general publications
and research, surveys and studies conducted by third parties. Industry publications, studies and surveys generally state that they have
been obtained from sources believed to be reliable. While we believe our internal company research is reliable and the definitions of
our market and industry are appropriate, neither this research nor these definitions have been verified by any independent source.
For investors outside the United States: We have
not, and the placement agent has not, done anything that would permit this offering or possession or distribution of this prospectus in
any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come
into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities
and the distribution of this prospectus outside the United States.
This prospectus and the information incorporated
by reference into this prospectus contain references to our trademarks and to trademarks belonging to other entities. Solely for convenience,
trademarks and trade names referred to in this prospectus and the information incorporated by reference into this prospectus, including
logos, artwork, and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate,
in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to
these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship
with, or endorsement or sponsorship of us by, any other company.
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:
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our ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market; |
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our ability to satisfy our payment obligations in connection with the acquisition of First Wave Bio, Inc. and the settlement payments; |
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statements regarding geopolitical events, including the war in 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; |
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the availability of capital to satisfy our working capital requirements; |
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our current and future capital requirements and our ability to raise additional funds to satisfy our capital needs; |
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the integration and effects of our acquisitions and other strategic transactions; |
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the accuracy of our estimates regarding expense, future revenue and capital requirements; |
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ability to continue operating as a going concern; |
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our plans to develop and commercialize our product candidates, including adrulipase and niclosamide; |
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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; |
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regulatory developments in the U.S. and foreign countries; |
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the performance of our third-party vendor(s), CROs, CDMOs and other third-party non-clinical and clinical development collaborators and regulatory service providers |
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our ability to obtain and maintain intellectual property protection for our core assets; |
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the size of the potential markets for our product candidates and our ability to serve those markets; |
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the rate and degree of market acceptance of our product candidates for any indication once approved; |
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the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing; |
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the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; and |
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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.
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”, “AzurRx”, “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 “AzurRx SAS” refer to AzurRx SAS, First Wave BioPharma’s wholly-owned subsidiary through which
we conduct our European operations. 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 non-absorbable drugs that act locally, i.e. 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 Offering
| Common Stock to be Offered |
Up to shares of our common stock based on an assumed combined public offering price of $ per share of common stock and accompanying common warrant, which is the last reported sale price of our common stock on , 2023, and no sale of any pre-funded warrants. |
| Pre-funded Warrants to be Offered |
We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, 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 opportunity to purchase, if such purchasers so choose, pre-funded warrants to purchase shares of common stock, in lieu of shares of common stock that would otherwise result in any such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded warrant will be exercisable for one share of our common stock. The purchase price of each pre-funded warrant and accompanying common warrant will equal the price at which the share of common stock and accompanying common warrant are being sold to the public in this offering, minus $0.0001, and the exercise price of each pre-funded warrant will be $0.0001 per share. The pre-funded warrants will be exercisable immediately 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 any pre-funded warrants sold in this offering. For each pre-funded warrant we sell, the number of shares of common stock we are offering will be decreased on a one-for-one basis. Because we will issue a common warrant for each share of our common stock and for each pre-funded warrant to purchase one share of our common stock sold in this offering, the number of common warrants sold in this offering will not change as a result of a change in the mix of the shares of our common stock and pre-funded warrants sold. |
| Common Warrants to be Offered |
Common warrants to purchase up to an aggregate of shares of our common stock, based on the sale of our common stock at an assumed combined public offering price of $ per share of common stock and accompanying common warrant, which is the last reported sale price of our common stock on , 2023. Each share of our common stock and each pre-funded warrant to purchase one share of our common stock is being sold together with a common warrant to purchase one share of our common stock. Each common warrant will have an exercise price of $ per share (representing % of the price at which a share of common stock and accompanying common warrant are sold to the public in this offering), will be immediately exercisable and will expire on the five year anniversary of the original issuance date. The shares of common stock and pre-funded warrants, and the accompanying common warrants, as the case may be, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the common warrants. |
| Common Stock to be Outstanding Immediately After this Offering |
shares, (assuming we sell only shares of common stock and no pre-funded warrants and assuming no exercise of the common warrants). |
| Use of Proceeds |
We estimate that the net proceeds from this offering will be approximately $ million, excluding the proceeds, if any, from the cash exercise of the common warrants in this offering. We currently intend to use the net proceeds from this offering for working capital and general corporate purposes, including the further development of our product candidates. See “Use of Proceeds” for additional information. |
| Risk Factors |
An
investment in our securities involves a high degree of risk. See “Risk Factors” beginning on page 5 of this
prospectus and the other information included and incorporated by reference in this prospectus for a discussion of the risk factors
you should carefully consider before deciding to invest in our securities. |
| Nasdaq symbol |
Our common stock is listed on The Nasdaq Capital Market under the symbol “FWBI.” There is no established public trading market for the pre-funded warrants or common warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list the pre-funded warrants or common warrants on any national securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the pre-funded warrants and common warrants will be limited. |
The above discussion is based on 1,946,663 shares
of our common stock outstanding as of May 25, 2023, assumes no sale of pre-funded warrants and excludes, as of that date, the following:
| ● | 746
shares of common stock issuable upon exercise of stock options, with a weighted average exercise price of $2,325.26 per share, under
our Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”); |
| ● | 292
shares of awarded but unissued restricted stock under our 2014 Plan; |
| ● | 8,224
shares of common stock issuable upon exercise of stock options, with a weighted average exercise price of $232.64 per share, under our
Amended and Restated 2020 Omnibus Equity Incentive Plan (the “2020 Plan”); |
| ● | 120,175
shares of awarded but unissued restricted stock units under our 2020 Plan; |
| ● | 149,017
shares of common stock available for future issuance under our 2020 Plan; |
| ● | 4,334,243
shares of common stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $11.22 per share; |
| ● | 3,137 shares of common stock issuable upon conversion of Series B
Preferred Stock, including in respect of accrued and unpaid dividends of approximately $0.9 million through May 25, 2023; |
| ● | either
(x) if the holders of Series B Preferred Stock elect to exchange into our registered direct and private placement offering
from January 2021, up to 3,227 additional shares of common stock issuable upon conversion of Series C Convertible Preferred
Stock (the “Series C Preferred Stock”) and up to 3,227 shares of common stock issuable upon exercise of warrants or
(y) if the holders of Series B Preferred Stock elect to exchange into our sales made on November 30, 2021, at a price
of $549.297 per share, pursuant to our At The Market Offering Agreement dated May 26, 2021 (the “ATM Agreement”) (such
price being the lowest price per share sold under the ATM Agreement to date and eligible for the holders of the Series B Preferred Stock
to exchange into), up to 9,280 additional shares of common stock, in each case that may be issued pursuant to the exchange right in excess
of amounts currently underlying Series B Preferred Stock; and |
| ● | shares
of common stock issuable upon exercise of the common warrants issued in this offering. |
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, 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
We have broad discretion in the use of the net proceeds from
this offering and may not use them effectively.
Our management will have broad discretion in the
application of the net proceeds, including for any of the purposes described in the section of this prospectus entitled “Use
of Proceeds.” You will be relying on the judgment of our management with regard to the use of these net proceeds, and you will
not have the opportunity, as part of your investment decision, to assess whether the net proceeds are being used appropriately. The failure
by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business,
cause the price of our securities to decline and delay the development of our product candidates. Pending the application of these funds,
we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
You will experience immediate and substantial dilution in the
net tangible book value of the shares you purchase in this offering and may experience additional dilution in the future.
The combined public offering price per share of
common stock and related common warrant, and the combined public offering price of each pre-funded warrant and related common warrant,
will be substantially higher than the pro forma as adjusted net tangible book value per share of our common stock after giving effect
to this offering. Assuming the sale of shares of our common stock and common warrants to purchase up to shares of common stock at an assumed
combined public offering price of $ per share and related common warrant, the closing sale price per share of our common stock on The
Nasdaq Capital Market on , 2023, assuming no sale of any pre-funded warrants in this offering, no exercise of the common warrants being
offered in this offering and after deducting the placement agent fees and commissions and estimated offering expenses payable by us, you
will incur immediate dilution in pro forma as adjusted net tangible book value of approximately $ per share. As a result of the dilution
to investors purchasing securities in this offering, investors may receive significantly less than the purchase price paid in this offering,
if anything, in the event of the liquidation of our company. See the section entitled “Dilution” below for a more detailed
discussion of the dilution you will incur if you participate in this offering. To the extent shares are issued under outstanding options
and warrants at exercise prices lower than the public offering price of our common stock in this offering, you will incur further dilution.
There is no public market for the common warrants or pre-funded
warrants being offered by us in this offering.
There is no established public trading market for
the common warrants or the pre-funded warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list
the common warrants or pre-funded warrants on any national securities exchange or other nationally recognized trading system. Without
an active market, the liquidity of the common warrants and pre-funded warrants will be limited.
The common warrants and pre-funded warrants are speculative in
nature.
The common warrants and pre-funded warrants offered
hereby do not confer any rights of share of common stock ownership on their holders, such as voting rights or the right to receive dividends,
but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing on the date of issuance,
holders of the common warrants may acquire the shares of common stock issuable upon exercise of such warrants at an exercise price of
$ per share of common stock, and holders of the pre-funded warrants may acquire the shares of common stock
issuable upon exercise of such warrants at an exercise price of $0.0001 per share of common stock. Moreover, following this offering,
the market value of the common warrants and pre-funded warrants is uncertain and there can be no assurance that the market value of the
common warrants or pre-funded warrants will equal or exceed their respective public offering prices. There can be no assurance that the
market price of the shares of common stock will ever equal or exceed the exercise price of the common warrants or pre-funded warrants,
and consequently, whether it will ever be profitable for holders of common warrants to exercise the common warrants or for holders of
the pre-funded warrants to exercise the pre-funded warrants.
Holders of the warrants offered hereby will have no rights as
common stockholders with respect to the shares our common stock underlying the warrants until such holders exercise their warrants and
acquire our common stock, except as otherwise provided in the warrants.
Until holders of the common warrants and the pre-funded
warrants acquire shares of our common stock upon exercise thereof, such holders will have no rights with respect to the shares of our
common stock underlying such warrants, except to the extent that holders of such warrants will have certain rights to participate in distributions
or dividends paid on our common stock as set forth in the warrants. Upon exercise of the common warrants and the pre-funded warrants,
the holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after
the exercise date.
This is a best efforts offering, no minimum amount of securities
is required to be sold, and we may not raise the amount of capital we believe is required for our business plans, including our near-term
business plans.
The placement agent has agreed to use its reasonable
best efforts to solicit offers to purchase the securities in this offering. The placement agent has no obligation to buy any of the securities
from us or to arrange for the purchase or sale of any specific number or dollar amount of the 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 the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently
determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities offered
hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund
in the event that we do not sell an amount of securities sufficient to support our continued operations, including our near-term continued
operations. Thus, we may not raise the amount of capital we believe is required for our operations in the short-term and may need to raise
additional funds, which may not be available or available on terms acceptable to us.
Purchasers who purchase our securities in this offering pursuant
to a securities purchase agreement may have rights not available to purchasers that purchase without the benefit of a securities purchase
agreement.
In addition to rights and remedies available to
all purchasers in this offering under federal securities and state law, the purchasers that enter into a securities purchase agreement
will also be able to bring claims of breach of contract against us. The ability to pursue a claim for breach of contract provides those
investors with the means to enforce the covenants uniquely available to them under the securities purchase agreement including, but not
limited to: (i) timely delivery of securities; (ii) agreement to not enter into any financings for days from closing;
and (iii) indemnification for breach of contract.
USE OF PROCEEDS
We estimate that the net proceeds from the offering
will be approximately $ million, after deducting the placement agent fees and estimated offering expenses payable by us, assuming no sale
of any fixed combinations of pre-funded warrants and warrants offered hereunder. If the common warrants are exercised in full for cash,
the estimated net proceeds will increase to $ million. However, because this is a best-efforts offering and there is no minimum offering
amount required as a condition to the closing of this offering, the actual offering amount, the placement agent’s fees and net proceeds
to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus.
We currently intend to use the net proceeds from
this offering for working capital and general corporate purposes, including the further development of our product candidates. This expected
use of proceeds from this offering represents our intentions based upon our current plans and prevailing business conditions, which could
change in the future as our plans and prevailing business conditions evolve. The amounts and timing of our use of proceeds will vary depending
on a number of factors, including the amount of cash generated or used by our operations. As a result, we will retain broad discretion
in the allocation of the net proceeds of this offering.
DILUTION
If you invest in our securities in this offering,
your interest will be diluted immediately to the extent of the difference between the public offering price paid by the purchasers of
the shares of common stock and common warrants sold in this offering and the as-adjusted net tangible book value per shares of common
stock after this offering.
The net tangible book value of our common stock
as of March 31, 2023, was approximately $1.03 million, or approximately $0.6637 per share of common stock. Net tangible book deficit
per share represents the amount of our total tangible assets less total liabilities divided by the total number of our shares of common
stock outstanding as of March 31, 2023.
After giving effect to the sale by us in this offering
of shares of common stock, pre-funded warrants and common warrants at a price per share and related common warrant of $ , and assuming
the exercise in full of pre-funded warrants issued in this offering, our pro forma as adjusted net tangible book value as of March 31,
2023 would have been approximately $ million, or approximately $ per share of common stock. This represents an immediate increase in net
tangible book value of approximately $ per share of common stock to our existing security holders and an immediate dilution in as adjusted
net tangible book value of approximately $ per share of common stock to purchasers of common stock in this offering. The final public
offering price will be determined through negotiation between us, the placement agent, and prospective investors in the offering and may
be at a discount to the current market price. Therefore, the assumed public offering price used throughout this prospectus may not be
indicative of the final public offering price. The following table illustrates this per share dilution:
| Assumed combined public offering price per share and accompanying common warrant |
|
|
|
|
|
$ |
|
|
| Historical net tangible book value per share as of March 31, 2023 |
|
$ |
0.6637 |
|
|
|
|
|
| Increase in as adjusted net tangible book value per share attributable to this offering |
|
$ |
|
|
|
|
|
|
| As adjusted net tangible book value per share after giving effect to this offering |
|
|
|
|
|
$ |
|
|
| Dilution per share to new investors in this offering |
|
|
|
|
|
$ |
|
|
Each $0.10 increase or decrease in the assumed
combined public offering price of $ per share and accompanying common warrant, which was the last reported sale price of our common stock
on The Nasdaq Capital Market on , 2023, would increase or decrease the as adjusted net tangible book value per share by $ per share and
the dilution per share to investors participating in this offering by $ per share, assuming that the number of shares and accompanying
common warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the placement
agent fees and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the cash exercise of
the common warrants issued in this offering.
We may also increase or decrease the number of
shares we are offering. A share increase in the number of shares and accompanying common warrants offered by us, as set forth on the cover
page of this prospectus, would increase the as adjusted net tangible book value per share by approximately $ and decrease the dilution
per share to new investors participating in this offering by approximately $ , based on an assumed combined public offering price of $
per share and accompanying common warrant, which was the last reported sale price of our common stock on The Nasdaq Capital Market on
, 2023, remaining the same and after deducting the placement agent fees and commissions and estimated offering expenses payable by us,
and excluding the proceeds, if any, from the exercise of the common warrants issued in this offering. Similarly, a share decrease
in the number of shares and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, would
decrease the as adjusted net tangible book value per share by approximately $ and increase the dilution per share to new investors participating
in this offering by approximately $ , based on an assumed combined public offering price of $ per share and accompanying common warrant,
which was the last reported sale price of our common stock on The Nasdaq Capital Market on , 2023, remaining the same and after deducting
the placement agent fees and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the cash
exercise of the common warrants issued in this offering.
The table and discussion above are based on 1,549,581
shares of common stock outstanding as of March 31, 2023, and excludes, as of that date, the following:
| ● | 834
shares of common stock issuable upon exercise of stock options, with a weighted average exercise price of $2,540.50 per share, under
our Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”); |
| ● | 292
shares of awarded but unissued restricted stock under our 2014 Plan; |
| ● | 8,231
shares of common stock issuable upon exercise of stock options, with a weighted average exercise price of $232.70 per share, under our
Amended and Restated 2020 Omnibus Equity Incentive Plan (the “2020 Plan”); |
| ● | 160,239
shares of awarded but unissued restricted stock units under our 2020 Plan; |
| ● | 149,010
shares of common stock available for future issuance under our 2020 Plan; |
| ● | 4,691,379
shares of common stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $10.50 per share; |
| ● | 3,102
shares of common stock issuable upon conversion of Series B Preferred Stock, including in respect of accrued and unpaid dividends
of approximately $0.8 million through March 31, 2023; |
| ● | either (x) if the holders of Series B Preferred Stock
elect to exchange into our registered direct and private placement offering from January 2021, up to 3,180 additional shares of
common stock issuable upon conversion of Series C Preferred Stock and up to 3,180 shares of common stock issuable upon exercise
of warrants or (y) if the holders of Series B Preferred Stock elect to exchange into our sales made on November 30, 2021,
at a price of $549.297 per share, pursuant to our ATM Agreement (such price being the lowest price per share sold under the ATM
Agreement to date), up to 9,168 additional shares of common stock, in each case that may be issued pursuant to the exchange right in
excess of amounts currently underlying Series B Preferred Stock; and |
| ● | shares
of common stock issuable upon exercise of the common warrants issued in this offering. |
The information discussed above is illustrative
only and will adjust based on the actual public offering price, the actual number of shares and common warrants that we offer in this
offering, and other terms of this offering determined at pricing. Except as indicated otherwise, the discussion and table above assumes
(i) no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-one
basis, and (ii) no exercise of common warrants accompanying the shares of common stock sold in this offering
DESCRIPTION OF CAPITAL STOCK
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 the Certificate of Designations 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:
| ● | 50,000,000 shares of common stock, par value $0.0001 per share; and |
| ● | 10,000,000 shares of preferred stock, par value $0.0001. |
As of May 25, 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.
As of May 25, 2023, there were 1,946,663
shares of Common Stock issued and outstanding, approximately 545.94 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 (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 May 25, 2023, approximately 5,194.81 shares were designated as Series B Preferred Stock, of which approximately
545.94 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.
Transfer Agent and Registrar for Preferred Stock
The transfer agent and registrar for any series
or class of preferred stock will be set forth in each applicable prospectus supplement.
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:
| ● | 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; |
| ● | 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 |
| ● | 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:
| ● | any merger or consolidation involving the corporation and the interested stockholder; |
| ● | 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; |
| ● | 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; |
| ● | 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 |
| ● | 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:
| ● | the owner of 15% or more of the outstanding voting stock of the corporation; |
| ● | 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 |
| ● | 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.
DESCRIPTION OF SECURITIES WE ARE OFFERING
We are offering up to shares of our common stock
and common warrants to purchase up to shares of common stock. We are also offering pre-funded warrants to those purchasers whose purchase
of shares of common stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially
owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock following the consummation
of this offering in lieu of the shares of common stocks that would result in such excess ownership. Each pre-funded warrant will be exercisable
for one share of common stock. No warrant for fractional shares of common stock will be issued, rather warrants will be issued only for
whole shares of common stock. We are also registering the shares of common stock issuable from time to time upon exercise of the pre-funded
warrants and common warrants offered hereby.
Common Stock
The material terms and provisions of our common
stock are described under the caption “Description of Capital Stock” in this prospectus and are incorporated herein by reference.
Common Warrants
The following is a summary of certain terms and
provisions of the common warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the
provisions of the common warrant, the form of which will be filed as an exhibit to the registration statement of which this prospectus
forms a part. Prospective investors should carefully review the terms and provisions of the form of common warrant for a complete description
of the terms and conditions of the common warrants.
Duration and Exercise Price
Each common warrant offered hereby will have an
exercise price equal to $ . The common warrants will be immediately exercisable and may be exercised until
the fifth anniversary of the issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject
to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock
and the exercise price. The common warrants will be issued separately from the common stock or pre-funded warrants, respectively, and
may be transferred separately immediately thereafter. Pursuant to a warrant agency agreement between us and Colonial Stock Transfer Company, Inc.,
as warrant agent, the common warrants will be issued in book-entry form and shall initially be represented only by one or more global
warrants deposited with the warrant agent, as custodian, on behalf of The Depository Trust Company, or DTC, and registered in the name
of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.
Exercisability
The common warrants will be exercisable, at the
option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the
number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder
(together with its affiliates) may not exercise any portion of such holder’s common warrants to the extent that the holder would
own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice
from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common
warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such
percentage ownership is determined in accordance with the terms of the common warrants.
Cashless Exercise
If, at the time a holder exercises its common warrants,
a registration statement registering the issuance of the shares of common stock underlying the common warrants under the Securities Act
is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to
be made to us upon such exercise 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 common warrant.
Fundamental Transactions
In the event of any fundamental transaction, as
described in the common warrants and generally including any merger with or into another entity, sale of all or substantially all of our
assets, tender offer or exchange offer, or reclassification of our common stock, then upon any subsequent exercise of a common warrant,
the holder will have the right to receive as alternative consideration, for each share of our common stock that would have been issuable
upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor
or acquiring corporation or of our company, if it is the surviving corporation, and any additional consideration receivable upon or as
a result of such transaction by a holder of the number of shares of our common stock for which the common warrant is exercisable immediately
prior to such event. Notwithstanding the foregoing, in the event of a fundamental transaction, the holders of the common warrants have
the right to require us or a successor entity to redeem the common warrants for cash in the amount of the Black-Scholes Value (as defined
in each common warrant) of the unexercised portion of the common warrants concurrently with or within 30 days following the consummation
of a fundamental transaction.
However, in the event of a fundamental transaction
which is not in our control, including a fundamental transaction not approved by our board of directors, the holders of the common warrants
will only be entitled to receive from us or our successor entity, as of the date of consummation of such fundamental transaction the same
type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the common warrant
that is being offered and paid to the holders of our common stock in connection with the fundamental transaction, whether that consideration
is in the form of cash, stock or any combination of cash and stock, or whether the holders of our common stock are given the choice to
receive alternative forms of consideration in connection with the fundamental transaction.
Transferability
Subject to applicable laws, a common warrant may
be transferred at the option of the holder upon surrender of the common warrant to us together with the appropriate instruments of transfer.
Fractional Shares
No fractional shares of common stock will be issued
upon the exercise of the common warrants. Rather, the number of shares of common stock to be issued will, at our election, either be rounded
up to the next whole share or we will pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied
by the exercise price.
Trading Market
There is no established trading market for the
common warrants, and we do not expect an active trading market to develop. We do not intend to apply to list the common warrants on any
securities exchange or other trading market. Without a trading market, the liquidity of the common warrants will be extremely limited.
Right as a Stockholder
Except as otherwise provided in the common warrants
or by virtue of the holder’s ownership of shares of our common stock, such holder of common warrants does not have the rights or
privileges of a holder of our common stock, including any voting rights, until such holder exercises such holder’s common warrants.
The common warrants will provide that the holders of the common warrants have the right to participate in distributions or dividends paid
on our shares of common stock.
Waivers and Amendments
The common warrant may be modified or amended or
the provisions of the common warrant waived with our and the holder’s written consent.
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 the registration statement of which this prospectus forms
a part. 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.
Duration and Exercise Price
Each pre-funded warrant offered hereby will have
an initial exercise price per share of common stock equal to $0.0001. The pre-funded warrants will be immediately exercisable and will
expire when exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate
adjustment in the event of share dividends, share splits, reorganizations or similar events affecting our shares of common stock and the
exercise price. Subject to the rules and regulations of the applicable trading market, we may at any time during the term of the
pre-funded warrant, subject to the prior written consent of the holders, reduce the then current exercise price to any amount and for
any period of time deemed appropriate by our board of directors. The pre-funded warrants will be issued in certificated form only.
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 accompanied by payment in full for
the number of shares of common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder
(together with its affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than
4.99% of the outstanding shares of common stock immediately after exercise, except that upon at least 61 days’ prior notice from
the holder to us, the holder may increase the amount of beneficial ownership of outstanding shares after exercising the holder’s
pre-funded warrants up to 9.99% of the number of our shares of common stock outstanding immediately after giving effect to the exercise,
as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. Purchasers of pre-funded warrants
in this offering may also elect prior to the issuance of the pre-funded warrants to have the initial exercise limitation set at 9.99%
of our outstanding shares of common stock.
Cashless Exercise
In lieu of making the cash payment otherwise contemplated
to be made to us upon such exercise 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 warrants.
Fractional Shares
No fractional shares of common stock will be issued
upon the exercise of the pre-funded warrants. Rather, at the Company’s election, the number of shares of common stock to be issued
will be rounded up to the next whole share or the Company will pay a cash adjustment in an amount equal to such fraction multiplied by
the exercise price.
Transferability
Subject to applicable laws, a pre-funded warrant
may be transferred at the option of the holder upon surrender of the pre-funded warrants to us together with the appropriate instruments
of transfer.
Trading Market
There is no trading market available for the pre-funded
warrants on any securities exchange or nationally recognized trading system, and we do not expect a trading market to develop. We do not
intend to list the pre-funded warrants on any securities exchange or nationally recognized trading market. Without a trading market, the
liquidity of the pre-funded warrants will be extremely limited. The shares of common stock issuable upon exercise of the pre-funded warrants
are currently traded on The Nasdaq Capital Market.
Right as a Shareholder
Except as otherwise provided in the pre-funded
warrants or by virtue of such holder’s ownership of shares of common stock, the holders of the pre-funded warrants do not have the
rights or privileges of holders of our shares of common stock, including any voting rights, until they exercise their pre-funded warrants.
The pre-funded warrants will provide that the holders of the pre-funded warrants have the right to participate in distributions or dividends
paid on our shares of common stock.
Fundamental Transaction
In the event of a fundamental transaction, as described
in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our shares of common stock,
the sale, transfer 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 more than 50% of our outstanding shares of common stock, or any person or group becoming the beneficial
owner of 50% 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 on a net exercise basis
Waivers and Amendments
The pre-funded warrant may be modified or amended
or the provisions of the pre-funded warrant waived with our and the holder’s written consent.
PLAN OF DISTRIBUTION
We engaged Roth Capital Partners, LLC (“Roth”
or the “placement agent”), to act as our exclusive placement agent to solicit offers to purchase the securities offered by
this prospectus on a reasonable best efforts basis. Roth is not purchasing or selling any securities, nor are they required to arrange
for the purchase and sale of any specific number or dollar amount of securities, other than to use their “reasonable best efforts”
to arrange for the sale of the securities by us. Therefore, we may not sell the entire amount of securities being offered. There is no
minimum amount of proceeds that is a condition to closing of this offering. The placement agent does not guarantee that it will be able
to raise new capital in this offering. The terms of this offering were subject to market conditions and negotiations between us and prospective
investors in consultation with the placement agent. The placement agent will have no authority to bind us. This offering will terminate
on , 2023, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. We will have
one closing for all the securities purchased in this offering. The combined public offering price per share (or pre-funded warrant) and
accompanying common warrant will be fixed for the duration of this offering. Roth may engage one or more sub-placement agents or selected
dealers to assist with the offering.
We will enter into a securities purchase agreement
directly with the institutional investors, at the investor’s option, who purchase our securities in this offering. Investors who
do not enter into a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities
in this offering.
Placement Agent Fees and Expenses
The following table shows the per share and accompanying
common warrant, and per pre-funded and accompanying common warrant, and total placement agent fees we will pay in connection with the
sale of the securities in this offering.
| | |
Per Share and
Accompanying
Common Warrant | |
Per Pre-Funded
Warrant and
Accompanying
Common Warrant | |
Total | |
| Public offering price | |
$ | | |
$ | | |
$ | | |
| Placement agent fees | |
$ | | |
$ | | |
$ | | |
| Proceeds to us, before expenses | |
$ | | |
$ | | |
$ | | |
We estimate that the total expenses of the offering,
including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding placement agent fees,
will be approximately $ , all of which are payable by us. This figure includes the placement agent’s accountable expenses, including,
but not limited to, legal fees for placement agent’s legal counsel, that we have agreed to pay at the closing of the offering up
to an aggregate expense reimbursement of $100,000.
Other Relationships
The placement agent acted as the placement agent
in connection with the private placement consummated in March 2023 for which it has received customary fees and expenses. The placement
agent may, from time to time, engage in transactions with or perform services for us in the ordinary course of its business and may continue
to receive compensation from us for such services.
Determination of Offering Price
The combined public offering price per share and
common warrant and the combined public offering price per pre-funded warrant and common warrant we are offering and the exercise prices
and other terms of the warrants were negotiated between us and the investors, in consultation with the placement agent based on the trading
of our common stock prior to this offering, among other things. Other factors considered in determining the public offering prices of
the securities we are offering and the exercise prices and other terms of the warrants include the history and prospects of our company,
the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment
of our management, general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.
Lock-up Agreements
Each of our officers and directors have agreed
to be subject to a lock-up period of days following the date of this prospectus. This means that, during the applicable lock-up period,
they may not offer for sale, contract to sell, or sell any shares of our common stock or any securities convertible into, or exercisable
or exchangeable for, shares of our common stock subject to certain customary exceptions. In addition, we have agreed to not issue any
shares of common stock or securities exercisable or convertible into shares of common stock for a period of days following the closing
date of this offering, subject to certain exceptions, and to not issue any securities that are subject to a price reset based on trading
prices of our common stock or upon a specified or contingent event in the future, or enter into an agreement to issue securities at a
future determined price, for a period of following the closing date of this offering.
Transfer Agent and Registrar
The transfer agent and registrar for our common
stock is Colonial Stock Transfer Company, Inc.
The Nasdaq Capital Market Listing
Our common stock is currently listed on The Nasdaq
Capital Market under the symbol “FWBI.” On , 2023, the reported closing price per share of our common stock was $ . The final
public offering price will be determined between us, the placement agent and the investors in the offering, and may be at a discount to
the current market price of our common stock. Therefore, the assumed public offering price used throughout this prospectus may not be
indicative of the final public offering price. There is no established public trading market for the common warrants or pre-funded warrants,
and we do not expect such markets to develop. In addition, we do not intend to apply for a listing of the common warrants or pre-funded
warrants on any national securities exchange or other nationally recognized trading system.
Indemnification
We have agreed to indemnify the placement agent
against certain liabilities, including certain liabilities arising under the Securities Act, or to contribute to payments that the placement
agent may be required to make for these liabilities.
Regulation M
The placement agent may be deemed to be an underwriter
within the meaning of Section 2(a)(11) of the Securities Act and any fees received by it and any profit realized on the sale of the
securities 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 of 1934, as amended (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.
Electronic Distribution
A prospectus in electronic format may be made available
on a website maintained by the placement agent and the placement agent may distribute prospectuses electronically. Other than the prospectus
in electronic format, the information on these websites is not part of this prospectus or the registration statement of which this prospectus
forms a part, has not been approved and/or endorsed by us or the placement agent and should not be relied upon by investors.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents filed with the SEC are
incorporated by reference into this prospectus:
| |
● |
our Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 20, 2023; |
| |
|
|
| |
● |
our Quarterly Report on Form 10-Q for the period ended March 31, 2023 filed on May 12, 2023; |
| |
|
|
| |
● |
our Current Report on Form 8-K, filed on January 17, 2023, February 7, 2023, March 15, 2023, April 7, 2023, and April 21, 2023 (other than any portions thereof deemed furnished and not filed); |
| |
|
|
| |
● |
our definitive proxy statement on Schedule 14A, filed on May 15, 2023; and |
| |
|
|
| |
● |
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.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement
we filed with the SEC. This prospectus does not contain all of the information set forth in the registration statement and the exhibits
to the registration statement. For further information with respect to us and the securities we are offering under this prospectus, we
refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement. You should rely
only on the information contained in this prospectus or incorporated by reference into this prospectus. We have not authorized anyone
else to provide you with different information. We are not making an offer of these securities in any jurisdiction where the offer is
not permitted. You should assume that the information contained in this prospectus, or any document incorporated by reference in this
prospectus, is accurate only as of the date of those respective documents, regardless of the time of delivery of this prospectus or any
sale of our securities.
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. The registration
statement and the documents referred to 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.
LEGAL MATTERS
The validity of the securities offered hereby
will be passed upon for us by Lowenstein Sandler LLP, New York, New York. The placement agent is being represented by Ellenoff Grossman &
Schole LLP.
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. (formerly known as
AzurRx 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 reports dated March 20, 2023 for the 2022 and March 21, 2022 for the 2021 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.
Up to Shares of Common Stock
Pre-Funded Warrants to Purchase up to Shares
of Common Stock
Common Warrants to Purchase up to Shares of
Common Stock
Shares of Common Stock underlying the Pre-Funded
Warrants and Common Warrants
PRELIMINARY PROSPECTUS
Roth Capital Partners
The date of this prospectus is ,
2023.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
| Item 13. | Other
Expenses of Issuance and Distribution. |
The following table indicates the expenses to
be incurred in connection with the offering described in this registration statement, other than underwriting discounts and commissions,
all of which will be paid by us. All amounts are estimated except the Securities and Exchange Commission registration fee.
| | |
Amount | |
| SEC Registration Fee | |
$ | 551 | |
| FINRA Filing Fee | |
| 1,250 | |
| Legal Fees and Expenses | |
| 150,000 | |
| Accounting Fees and Expenses | |
| 25,000 | |
| Transfer Agent and Registrar fees and expenses | |
| 5,000 | |
| Miscellaneous Expenses | |
| 5,000 | |
| Total expenses | |
$ | 186,801 | |
| Item 14. | Indemnification of Directors and Officers. |
Amended and Restated Bylaws
Pursuant to our bylaws, our directors and officers
will be indemnified to the fullest extent allowed under the laws of the State of Delaware for their actions in their capacity as our directors
and officers.
We must indemnify any person made a party to any
threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative (“Proceeding”)
by reason of the fact that he is or was a director, against judgments, penalties, fines, settlements and reasonable expenses (including
attorney’s fees) (“Expenses”) actually and reasonably incurred by him in connection with such Proceeding if: (a) he
conducted himself in good faith, and: (i) in the case of conduct in his own official capacity with us, he reasonably believed his
conduct to be in our best interests, or (ii) in all other cases, he reasonably believes his conduct to be at least not opposed to
our best interests; and (b) in the case of any criminal Proceeding, he had no reasonable cause to believe his conduct was unlawful.
We must indemnify any person made a party to any
Proceeding by or in the right of us, by reason of the fact that he is or was a director, against reasonable expenses actually incurred
by him in connection with such proceeding if he conducted himself in good faith, and: (a) in the case of conduct in his official
capacity with us, he reasonably believed his conduct to be in our best interests; or (b) in all other cases, he reasonably believed
his conduct to be at least not opposed to our best interests; provided that no such indemnification may be made in respect of any proceeding
in which such person shall have been adjudged to be liable to us.
No indemnification will be made by unless authorized
in the specific case after a determination that indemnification of the director is permissible in the circumstances because he has met
the applicable standard of conduct.
Reasonable expenses incurred by a director who
is party to a proceeding may be paid or reimbursed by us in advance of the final disposition of such Proceeding in certain cases.
We have the power to purchase and maintain insurance
on behalf of any person who is or was our director, officer, employee, or agent or is or was serving at our request as an officer, employee
or agent of another corporation, partnership, joint venture, trust, other enterprise, or employee benefit plan against any liability asserted
against him and incurred by him in any such capacity or arising out of his status as such, whether or not we would have the power to indemnify
him against such liability under the provisions of the amended and restated bylaws.
Delaware Law
We are incorporated under the laws of the State
of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who
are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person
was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person as an officer, director,
employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments,
fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding,
provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s
best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was
illegal. A Delaware corporation may indemnify any persons who are, or are threatened to be made, a party to any threatened, pending or
completed action or suit by or in the right of the corporation by reason of the fact that such person was a director, officer, employee
or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another
corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such
person in connection with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he
or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted
without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful
on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses
which such officer or director has actually and reasonably incurred. Our amended and restated certificate of incorporation and amended
and restated bylaws provide for the indemnification of our directors and officers to the fullest extent permitted under the Delaware General
Corporation Law.
Section 102(b)(7) of the Delaware General
Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally
liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability
for any:
| |
● |
transaction from which the director derives an improper personal benefit; |
| |
|
|
| |
● |
act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
| |
|
|
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● |
unlawful payment of dividends or redemption of shares; or |
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|
|
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● |
breach of a director’s duty of loyalty to the corporation or its stockholders. |
Our amended and restated certificate of incorporation
and amended and restated bylaws include such a provision. Expenses incurred by any officer or director in defending any such action, suit
or proceeding in advance of its final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director
or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be
indemnified by us.
Section 174 of the Delaware General Corporation
Law provides, among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful
stock purchase or redemption may be held liable for such actions. A director who was either absent when the unlawful actions were approved,
or dissented at the time, may avoid liability by causing his or her dissent to such actions to be entered in the books containing minutes
of the meetings of the board of directors at the time such action occurred or immediately after such absent director receives notice of
the unlawful acts.
Indemnification Agreements
As permitted by the Delaware General Corporation
Law, we have entered, and intend to continue to enter, into separate indemnification agreements with each of our directors and executive
officers, that require us to indemnify such persons against any and all expenses (including attorneys’ fees), witness fees, damages,
judgments, fines, settlements and other amounts incurred (including expenses of a derivative action) in connection with any action, suit
or proceeding, whether actual or threatened, to which any such person may be made a party by reason of the fact that such person is or
was a director, an officer or an employee of us or any of our affiliated enterprises, provided that such person acted in good faith and
in a manner such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal proceeding,
had no reasonable cause to believe his or her conduct was unlawful. The indemnification agreements also set forth certain procedures that
will apply in the event of a claim for indemnification thereunder.
At present, there is no pending litigation or
proceeding involving any of our directors or executive officers as to which indemnification is required or permitted, and we are not aware
of any threatened litigation or preceding that may result in a claim for indemnification.
We have an insurance policy covering our officers
and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.
Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to our directors, officers or controlling persons, we have been advised that in the opinion
of the SEC this indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
| Item 15. | Recent
Sales of Unregistered Securities. |
During the three months ended March 31,
2020, the Company issued an aggregate of 48 shares of its Common Stock to consultants with a grant date fair value of $87,105 for services
provided, that was recorded as part of G&A expense. Such issuance was exempt from registration under 4(a)(2) of the Securities
Act.
During the three months ended March 31,
2020, the Company issued its outside Board members an aggregate of 50 shares of Common Stock for the settlement of accounts payable in
the aggregate amount of $131,137. The aggregate effective settlement price was $2,604 per share, and each individual stock issuance was
based on the closing stock price of the Common Stock on the initial date the payable was accrued. Such issuance was exempt from registration
under 4(a)(2) of the Securities Act.
During the three months ended March 31, 2019,
the Company issued 12 shares of its common stock to a consultant as payment of $60,000 of accounts payable. Such issuance was exempt from
registration under 4(a)(2) of the Securities Act.
During the three months ended March 31, 2019,
the Company issued an aggregate of 14 shares of its Common Stock to outside members of its Board as payment of Board fees with an aggregate
grant date fair value of $72,600, that was recorded as part of G&A expense. Such issuance was exempt from registration under 4(a)(2) of
the Securities Act.
On July 16, 2020, we issued an aggregate of
2,912.583005 shares of Series B Convertible Preferred Stock, at a price of $7,700.00 per share, initially convertible into an aggregate
of 13,869 shares of our Common Stock at $1,617.00 per share, together with Series B Warrants to purchase an aggregate of 6,934 shares
of Common Stock at an exercise price of $1,785.00 per share. An aggregate of 1,975.578828 shares of Series B Preferred Stock initially
convertible into 9,407 shares of Common Stock and related 4,703 Series B Warrants were issued for cash consideration, resulting in
aggregate gross proceeds to us of approximately $15.2 million. In addition, the balance of an aggregate of 937.004221 shares of Series B
Preferred Stock initially convertible into 4,461 shares of Common Stock and related Series B Warrants to purchase 2,230 shares of
Common Stock was issued to certain investors in exchange for consideration consisting of approximately $6.9 million aggregate outstanding
principal amount, together with accrued and unpaid interest thereon of approximately $0.3 million, of certain Senior Convertible Promissory
Notes issued between December 20, 2019 and January 9, 2020. As additional consideration to the Exchange Investors, we also issued
certain additional warrants to purchase an aggregate of 844 shares of Common Stock at an exercise price of $1,785.00 per share. We issued
to the placement agent in the offerings warrants to purchase up to 7.0% of the aggregate number of shares of Common Stock underlying the
Series B Preferred Stock sold for cash consideration in the Private Placement, or 655 shares. The issuance of these securities was
made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to accredited investors.
During the period from April 6, 2020 through
May 22, 2020, we sold an aggregate of 640 shares of Common Stock pursuant to an equity line agreement, from which we derived approximately
$869,000 in net proceeds. The sales of these shares under the equity line agreement was exempt from registration under the Securities
Act of 1933, as amended, in reliance upon Section 4(a)(2) (or Regulation D promulgated thereunder).
On January 5, 2021, in a private placement
offering we sold to an investor 5,333.3333 shares of Series C Preferred Stock, which shares are convertible into an aggregate of
2,539 shares of Common Stock, together with warrants to purchase up to an aggregate of 5,079 shares of Common Stock, with an exercise
price of $1,680.00 per share and an expiration term of five and one-half years from the date of issuance. The aggregate gross proceeds
from the offering, excluding the net proceeds, if any, from the exercise of the Private Placement Warrants will be approximately $8.0
million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated
thereunder, to accredited investors.
On January 8, 2021, in connection with entering
into a license agreement with a third party, we entered into a securities purchase agreement where we issued 3,290.1960 shares of Series C
Preferred Stock, initially convertible into an aggregate of 1,566 shares of Common Stock, at an initial stated value of $750.00 per share
and a conversion price of $1,575.00 per share. The Series C Preferred Stock issued, together with any Common Stock issuable upon
conversion, were issued without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of
the Securities Act as transactions not involving a public offering.
On September 13, 2021, in connection with
the merger with First Wave Bio, Inc., we issued the former stockholders of First Wave Bio, Inc. approximately 2,971 shares of
common stock. The common stock was issued without registration under the Securities Act in reliance on exemptions provided by Section 4(a)(2) of
the Securities Act as transactions not involving a public offering.
During the three months ended March 31, 2022,
we issued an aggregate of 429 shares of common stock to consultants with a grant date fair value of approximately $119,000 for investor
relations services provided. Such issuance was exempt from registration under 4(a)(2) of the Securities Act.
On July 15, 2022, in a private placement offering,
we sold to investors 150 shares of Series D Preferred Stock, which is convertible into an aggregate of 4,761 shares of common stock,
150 shares of Series E Preferred Stock, convertible into an aggregate of 4,761 shares of common stock, Series D Warrants to
purchase up to an aggregate of 9,522 shares of common stock, with an exercise price of $31.50 and an expiration term of five years from
its initial exercise date. The aggregate gross proceeds from the offering, excluding the net proceeds, if any from the exercise of the
Series D Warrants was approximately $300,000. The issuance of these securities was made pursuant to Section 4(a)(2) of
the Securities Act, and the rules promulgated thereunder, to accredited investors.
On November 20, 2022, in a private placement
offering, we sold to an investor pre-funded warrants to purchase up to an aggregate of 595,238 shares of common stock and common warrants
to purchase up to an aggregate of 1,190,476 shares of common stock at a purchase price of $4.1993 per pre-funded warrant and accompanying
common warrant. The common warrants had an exercise price of $5.3795 per share and will expire five and one-half years from the initial
exercise date. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the common warrants
was approximately $2.5 million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act,
and the rules promulgated thereunder, to an accredited investor.
On March 12, 2023, in a private placement
offering, we sold to an investor 128,000 shares of common stock, pre-funded warrants to purchase up to an aggregate of 895,018 shares
of common stock and common warrants to purchase up to an aggregate of 2,046,036 shares of common stock at a purchase price of $3.91 per
share and accompanying common warrant. The common warrants had an exercise price of $3.66 per share and will expire five years from the
initial exercise date. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the common
warrants was approximately $4.0 million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities
Act, and the rules promulgated thereunder, to an accredited investor.
During the period from July 16, 2020 to date,
pursuant to the exchange right in the Series B Preferred Stock Certificate of Designations, we issued 11,519 shares of common stock
and warrants to purchase up to 9,966 of common stock to holders of Series B Preferred Stock exercising such right. The issuance of
these securities was made pursuant to exemptions provided by Section 3(a)(9) under the Securities Act.
The list of exhibits following the signature page of
this registration statement is incorporated by reference herein.
(1) The undersigned registrant hereby undertakes:
(a) To file, during any period in which offers
or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of
the Securities Act;
(ii) To reflect in the prospectus
any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof)
which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding
the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed
that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent
no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee”
table in the effective registration statement; and
(iii) To include any material information
with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information
in the registration statement;
provided,
however, that paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Securities and Exchange Commission
by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement.
(b) That, for the purpose of determining any
liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
(c) To remove from registration by means of
a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(d) That, for the purpose of determining liability
under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on
Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a
document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was
made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately
prior to such date of first use.
(e) That, for the purpose of determining liability
of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant
hereby undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means
of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or
sell such securities to such purchaser:
(i) Any preliminary prospectus or
prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424 (§ 230.424 of this
chapter);
(ii) Any free writing prospectus
relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free
writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) Any other communication that
is an offer in the offering made by the undersigned registrant to the purchaser.
(2) The undersigned registrant hereby undertakes that, for purposes
of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or
Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant
to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(3) The undersigned registrant hereby undertakes that:
(a) For purposes of determining any liability
under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance
on Rule 430A and contained in a form of prospectus filed by the undersigned registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective;
and
(b) For the purpose of determining any liability
under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(4) Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized in the City of Boca Raton, State of Florida, on June 5, 2023.
| |
FIRST WAVE BIOPHARMA, INC. |
| |
|
|
| |
By: |
/s/ James Sapirstein |
| |
|
Name: |
James Sapirstein |
| |
|
Title: |
President, Chief Executive Officer and Chairman of the Board
(Principal Executive Officer) |
| |
|
|
|
| |
By: |
/s/ Sarah Romano |
| |
|
Name: |
Sarah Romano |
| |
|
Title: |
Chief Financial Officer
(Principal Financial and Accounting Officer) |
KNOW
ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints James Sapirstein and Sarah
Romano, and each of them, each with full power to act without the other, his or her true and lawful attorneys-in-fact and agents, each
with full power of substitution and resubstitution, for such person and in his or her name, place and stead, in any and all capacities,
to sign any amendments to this registration statement, and to sign any registration statement for the same offering covered by this registration
statement, including post-effective amendments or registration statements filed pursuant to Rule 462(b) under the Securities
Act of 1933, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange
Commission, hereby ratifying and confirming that each of said such attorneys-in-fact and agents or his or her substitute or substitutes,
may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/ James Sapirstein |
|
President, Chief Executive Officer and Chairman of the Board
(Principal Executive Officer) |
|
June 5, 2023 |
| James Sapirstein |
|
| |
|
|
|
|
| /s/ Sarah Romano |
|
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer) |
|
June 5, 2023 |
| Sarah Romano |
|
| |
|
|
|
|
| /s/ Edward J. Borkowski |
|
Director |
|
June 5, 2023 |
| Edward J. Borkowski |
|
| |
|
|
|
|
| /s/ Charles Casamento |
|
Director |
|
June 5, 2023 |
| Charles Casamento |
|
| |
|
|
|
|
| /s/ Terry Coelho |
|
Director |
|
June 5, 2023 |
| Terry Coelho |
|
| |
|
|
|
|
| /s/ David Hoffman |
|
Director |
|
June 5, 2023 |
| David Hoffman |
|
| |
|
|
|
|
| /s/ Alastair Riddell |
|
Director |
|
June 5, 2023 |
| Alastair Riddell |
|
Exhibit
No. |
|
Description |
| 1.1^ |
|
Form of
Placement Agency Agreement. |
| 2.1# |
|
Agreement
and Plan of Merger dated September 13, 2021, by and among the Company, Alpha Merger Sub, Inc., and Fortis Advisors LLC,
as shareholder representative (incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K
filed with the SEC on September 13, 2021). ## |
| 3.1 |
|
Amended and Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 20, 2023). |
| 3.2 |
|
Amended
and Restated Bylaws, as amended to date (incorporated by reference to Exhibit 3.2 of the Company’s Quarterly Report on
Form 10-Q filed with the SEC on August 15, 2022). |
| 4.1 |
|
Form of
Common Stock Certificate (incorporated by reference to Exhibit 4.1 filed with Amendment No 1. to Registration Statement on Form S-1,
filed July 29, 2016). |
| 4.2 |
|
Form of
Investor Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S-1 filed
with the SEC on July 13, 2016). |
| 4.3 |
|
Form of
Underwriter Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1,
filed with the SEC on July 29, 2016). |
| 4.4 |
|
Form of
Series A Warrant, dated April 11, 2017 between the Company and Lincoln Park Capital Fund, LLC (incorporated by reference
to Exhibit 10.3 filed with the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017). |
| 4.5 |
|
Form of
Series A Warrant, dated June 5, 2017 (incorporated by reference to Exhibit 10.3 filed with the Company’s Current
Report on Form 8-K filed with the SEC on June 9, 2017). |
| 4.6 |
|
Form of
Series A-1 Warrant, dated June 5, 2017 (incorporated by reference to Exhibit 10.4 filed with the Company’s Current
Report on Form 8-K filed with the SEC on June 9, 2017). |
| 4.7 |
|
Form of
Underwriter Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on May 4, 2018). |
| 4.8 |
|
Form of
Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed
with the SEC on April 3, 2019). |
| 4.9 |
|
Form of
Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed
with the SEC on May 14, 2019). |
| 4.10 |
|
Form of
Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on July 22, 2019). |
| 4.11 |
|
Form of
Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC
on July 20, 2020). |
| 4.12 |
|
Form of
Warrant for Convertible Notes Offering (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement
on Form S-3 filed with the SEC on July 27, 2020). |
| 4.13 |
|
Form of
Pre-funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 4, 2021). |
| 4.14 |
|
Form of
Private Placement Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed
with the SEC on January 4, 2021). |
| 4.15 |
|
Form of
Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 8, 2021). |
| 4.16 |
|
Form of
Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on March 10, 2021). |
| 4.17 |
|
Form of
Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC
on March 10, 2021). |
| 4.18 |
|
Form of
Wainwright Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with
the SEC on March 10, 2021). |
| 4.19 |
|
Description
of Capital Stock (incorporated by reference to Exhibit 4.31 of the Company’s Annual Report on Form 10-K filed with
the SEC on March 20, 2023). |
| 4.20 |
|
Form of
Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on July 27, 2021). |
| 4.21 |
|
Form of
Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with
the SEC on March 1, 2022). |
| 4.22 |
|
Form of
Series C Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed
with the SEC on March 1, 2022). |
| 4.23 |
|
Form of
Placement Agent Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed
with the SEC on March 1, 2022). |
| 4.24 |
|
Form of
Warrant Amendment Agreement (incorporated by reference to Exhibit 4.4 of the Company’s Current Report on Form 8-K
filed with the SEC on March 1, 2022). |
| 4.25 |
|
Form of
Warrant (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the SEC on July 18,
2022). |
| 4.26 |
|
Form of Placement Agent
Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC
on July 18, 2022). |
| 4.27 |
|
Form of Pre-Funded Warrant
(incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 12,
2022). |
| 4.28 |
|
Form of
Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC
on October 12, 2022). |
| 4.29 |
|
Form of Pre-Funded Warrant
(incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 22,
2022). |
| 4.30 |
|
Form of Warrant (incorporated
by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022). |
| 4.31 |
|
Form of Warrant Amendment
Agreement (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with the SEC
on November 22, 2022). |
| 4.32 |
|
Form of Pre-Funded Warrant
(incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 15,
2023). |
| 4.33 |
|
Form of Warrant (incorporated
by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
|
| 4.34^ |
|
Form of Pre-Funded Warrant. |
| 4.35^ |
|
Form of Common Warrant. |
| 4.36^ |
|
Form of Warrant Agency
Agreement. |
| 5.1^ |
|
Opinion
of Lowenstein Sandler LLP. |
| 10.1 |
|
Stock
Purchase Agreement dated May 21, 2014 between the Registrant, Protea Biosciences Group, Inc. and its wholly-owned subsidiary,
Protea Biosciences, Inc (incorporated by reference to Exhibit 10.1 of the Company’s Registration Statement on Form S-1
filed with the SEC on July 13, 2016). |
| 10.2† |
|
Amended
and Restated AzurRx BioPharma, Inc. 2014 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.3 of the
Company’s Registration Statement on Form S-1 filed with the SEC on July 13, 2016). |
| 10.3 |
|
Securities
Purchase Agreement dated April 11, 2017 between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference
to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017). |
| 10.4 |
|
Registration
Rights Agreement dated April 11, 2017 between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference to
Exhibit 10.4 of the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017). |
| 10.5 |
|
Form of
Securities Purchase Agreement dated June 5, 2017 (incorporated by reference to Exhibit 10.1 of the Company’s Current
Report on Form 8-K filed with the SEC on June 9, 2017). |
| 10.6 |
|
Form of
Registration Rights Agreement dated June 5, 2017 (incorporated by reference to Exhibit 10.2 of the Company’s Current
Report on Form 8-K filed with the SEC on April 12, 2017). |
| 10.7 |
|
Sublicense
Agreement dated August 7, 2017 by and between the Registrant and TransChem, Inc. (incorporated by reference to Exhibit 10.1
of the Company’s Current Report on Form 8-K filed with the SEC on August 11, 2017). |
| 10.8 |
|
Asset
Sale and Purchase Agreement, dated December 7, 2018, by and between Protea Biosciences Group, Inc., Protea Biosciences, Inc.
and AzurRx Biopharma, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
filed with the SEC on December 13, 2018). |
| 10.9 |
|
Registration
Rights Agreement, dated February 14, 2019 (incorporated by reference to Exhibit 10.6 of the Company’s Current Report
on Form 8-K filed with the SEC on February 20, 2019). |
| 10.10 |
|
Asset
Purchase Agreement, by and between AzurRx BioPharma, Inc., AzurRx BioPharma SAS and Laboratoires Mayoly Spindler SAS, dated
March 27, 2019 (incorporated by reference to Exhibit 10.25 of the Company’s Annual Report on Form 10-K filed
with the SEC on April 1, 2019). |
| 10.11 |
|
Patent
License Agreement, by and between AzurRx BioPharma, Inc. and Laboratoires Mayoly Spindler SAS, dated March 27, 2019 (incorporated
by reference to Exhibit 10.26 of the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2019). |
| 10.12† |
|
Employment
Agreement by and between AzurRx BioPharma, Inc. and James Sapirstein, dated October 8, 2019 (incorporated by reference
to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 11, 2019). |
| 10.13 |
|
Securities
Purchase Agreement, dated November 13, 2019 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report
on Form 8-K filed with the SEC on November 14, 2019). |
| 10.14 |
|
Registration
Rights Agreement, dated November 13, 2019 (incorporated by reference to Exhibit 10.2 of the Company’s Current Report
on Form 8-K filed with the SEC on November 14, 2019). |
| 10.15 |
|
Form of
Note Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed
with the SEC on December 30, 2019). |
| 10.16 |
|
Form of
Warrant (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC
on December 30, 2019). |
| 10.17 |
|
Form of
Registration Rights Agreement (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K
filed with the SEC on December 30, 2019). |
| 10.18† |
|
Employment
Agreement by and between AzurRx BioPharma, Inc. and Daniel Schneiderman, dated January 1, 2020 (incorporated by reference
to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 6, 2020). |
| 10.19 |
|
Form of
Purchase Agreement, by and among the Company and the investors set forth on the signature pages thereto, including the form
of Exchange Addendum (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed
with the SEC on July 20, 2020). |
| 10.20 |
|
Form of
Registration Rights Agreement, by and among the Company and the investors set forth on the signature page thereto (incorporated
by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 20, 2020). |
| 10.21† |
|
First
Amendment to 2014 Omnibus Equity Incentive Plan (incorporated by reference as Exhibit 10.3 of the Company’s Current Report
on Form 8-K filed with the SEC on July 20, 2020). |
| 10.22† |
|
2020
Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q
filed with the SEC on November 16, 2020). |
| 10.23 |
|
Form of
Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on January 4, 2021). |
| 10.24 |
|
Form of
Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K
filed with the SEC on January 4, 2021). |
| 10.25 |
|
First
Wave Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed
with the SEC on January 8, 2021). |
| 10.26# |
|
First
Wave License Agreement (incorporated by reference to Exhibit 10.1 filed with the Company’s Current Report on Form 8-K
filed with the SEC on January 13, 2021). |
| 10.27 |
|
Form of
Purchase Agreement (incorporated by reference to Exhibit 10.1 filed with the Company’s Current Report on Form 8-K
filed with the SEC on March 10, 2021). |
| 10.28 |
|
At
The Market Offering Agreement, dated May 26, 2021, by and between AzurRx BioPharma, Inc. and H.C. Wainwright &
Co., LLC (incorporated by reference to Exhibit 1.2 of the Company’s Registration Statement on Form S-3 filed with
the SEC on May 26, 2021). |
| 10.29 |
|
Settlement
Agreement, by and between the Company and Fortis Advisors LLC, dated November 15, 2021 (incorporated by reference to Exhibit 10.1
of the Company’s Current Report on Form 8-K filed with the SEC on November 16, 2021). |
| 10.30 |
|
Form of
Waiver (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC
on February 7, 2022). |
| 10.31† |
|
Employment
Agreement by and between First Wave BioPharma, Inc. and Sarah Romano, dated February 14, 2022 (incorporated by reference
to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 17, 2022). |
| 10.32 |
|
Form of
Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on March 1, 2022). |
| 10.33 |
|
Form of
Indemnification Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
filed with the SEC on May 5, 2022). |
| 10.34 |
|
Form of
Waiver Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on May 12, 2022). |
| 10.35 |
|
Form of
Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on July 18, 2022). |
| 10.36 |
|
Form of
Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K
filed with the SEC on July 18, 2022). |
| 10.37# |
|
Form of
Term Sheet, by and between the Representative and the Company, dated July 29, 2022. (incorporated by reference to Exhibit 10.1
of the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2022). |
| 10.38 |
|
Form of
Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with
the SEC on October 12, 2022). |
| 10.39 |
|
Form of Purchase Agreement
(incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 22,
2022). |
| 10.40 |
|
Form of Registration
Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with
the SEC on November 22, 2022). |
| 10.41 |
|
Form of Settlement Agreement,
by and between the Representative and the Company, dated November 30, 2022) (incorporated by reference to Exhibit 10.1
of the Company’s Current Report on Form 8-K filed with the SEC on December 2, 2022). |
| 10.42 |
|
Form of Purchase Agreement
(incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 15,
2023). |
| 10.43 |
|
Form of Registration
Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with
the SEC on March 15, 2023). |
| 10.44^ |
|
Form of Securities Purchase
Agreement. |
| 16.1 |
|
Letter
from Mazars USA LLP to the U.S. Securities and Exchange Commission, dated May 3, 2022 (incorporated by reference to Exhibit 16.1
of the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2022). |
| 16.2 |
|
Letter
from Marcum LLP to the U.S. Securities and Exchange Commission, dated July 7, 2022 (incorporated by reference to Exhibit 16.1
of the Company’s Current Report on Form 8-K filed with the SEC on July 7, 2022). |
| 21.1 |
|
Subsidiaries
of the Registrant (incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10-K filed with
the SEC on March 20, 2023). |
| 23.1^ |
|
Consent
of Lowenstein Sandler LLP (included in Exhibit 5.1). |
| 23.2*
|
|
Consent
of Independent Registered Public Accounting Firm - Mazars USA LLP. |
| 24.1 |
|
Power
of Attorney (included in signature page). |
| 107* |
|
Filing
Fee Table. |
| ^ |
To be filed by amendment. |
| * |
Filed herewith. |
| # |
Certain portions of this exhibit (indicated by “[*****]”) have been omitted as we have determined (1) it is not material and (2) is the type that the Company treats as private or confidential. |
| ## |
Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted schedules upon request by the SEC. |
| † |
Indicates a management contract or compensation plan, contract or arrangement. |
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