As
filed with the Securities and Exchange Commission on December 20, 2024
Registration
No. 333-__________
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
ZYVERSA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
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86-2685744 |
(State
or other jurisdiction of
incorporation
or organization) |
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(I.R.S.
Employer
Identification
Number) |
2200
N. Commerce Parkway, Suite 208
Weston,
FL 33326
(754)
231-1688
(Address,
including zip code, and telephone number, including
area
code, of registrant’s principal executive offices)
Stephen
C. Glover
Chief
Executive Officer
ZyVersa
Therapeutics, Inc.
2200
N. Commerce Parkway, Suite 208
Weston,
FL 33326
(754)
231-1688
(Name,
address, including zip code, and telephone number, including
area
code, of agent for service)
Copies
to:
Faith
L. Charles
Todd
Mason
Thompson
Hine LLP
300
Madison Avenue, 27th Floor
New
York, New York 10017-6232
Phone:
(212) 344-5680
Fax:
(212) 344-6101
Approximate
date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement.
If
the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check
the following box. ☐
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. ☒
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 registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective
upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If
this form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional
securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 |
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Accelerated
filer |
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Non-accelerated
filer |
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Smaller
reporting company |
☒ |
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Emerging
growth company |
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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 this registration statement shall become effective
on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. The selling stockholders may not resell these securities until the
registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED DECEMBER 20, 2024
PROSPECTUS
1,637,000
Shares of Common Stock
This
prospectus relates to the offer and resale of up to an aggregate of 1,637,000 shares of common stock, par value $0.0001 per share (the
“Common Stock”) of ZyVersa Therapeutics, Inc. (the “Company,” “we,” “our” or “us”),
held by the selling stockholder listed in this prospectus or its permitted transferees (the “Selling Stockholders”). The
shares of Common Stock registered for resale pursuant to this prospectus are comprised of 1,637,000 shares of Common Stock (the “Warrant
Shares”) issuable upon exercise of Series A-2 warrants (the “Warrants”) to purchase up to 1,637,000 shares of Common
Stock that were issued to the Selling Stockholders in a warrant inducement transaction (the “Private Placement”) which closed
on November 6, 2024. For additional information about the Private Placement, see “Prospectus Summary — Private Placement.”
We
are registering the Warrant Shares on behalf of the Selling Stockholders to be offered and sold by them from time to time. We are not
selling any securities under this prospectus and will not receive any proceeds from the sale of our Common Stock by the Selling Stockholders
in the offering described in this prospectus. The Selling Stockholders may sell any, all, or none of the Warrant Shares offered by this
prospectus. In the event the Selling Stockholders exercise all of the Warrants in cash at an exercise price per share of $2.06, we would
receive approximately $3,372,220 of gross proceeds resulting from such exercise. For more information, see “Use of Proceeds.”
The
Selling Stockholders, or their respective transferees, pledgees, donees or other successors-in-interest, may offer or sell the Warrant
Shares from time to time in a number of different ways and at varying prices, including through public or private transactions at prevailing
market prices, at prices related to prevailing market prices, or at privately negotiated prices. See the “Plan of Distribution”
section of this prospectus for more information about how the Selling Stockholders may sell or dispose of the shares of Common Stock
being registered pursuant to this prospectus.
This
prospectus describes the general manner in which the Warrant Shares may be offered and sold. When the Selling Stockholders sell shares
of Common Stock under this prospectus, we may, if necessary and required by law, provide a prospectus supplement that will contain specific
information about the terms of that offering. Any prospectus supplement may also add to, update, modify, or replace information contained
in this prospectus. We urge you to read carefully this prospectus, any accompanying prospectus supplement, any documents we incorporate
by reference into this prospectus, and any accompanying prospectus supplement before you make your investment decision.
On
December 4, 2023 and April 25, 2024, we effected reverse-stock-splits at ratios of 1-for-35
and 1-for-10, respectively. All share and share price information in this prospectus has been adjusted to give effect to the reverse-stock-splits.
Investing
in our securities involves a high degree of risk. You should review carefully the risks and uncertainties referenced under the heading
“Risk Factors” beginning on page 5 of this prospectus, as well as in the other documents that are incorporated
by reference into this prospectus.
Our
common stock is listed on The Nasdaq Stock Market LLC (“Nasdaq”) under the symbol “ZVSA.” On December 19, 2024,
the last reported sale price of our common stock was $1.24 per share.
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.
The
date of this prospectus is __________, 2024
TABLE
OF CONTENTS
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference herein and any prospectus supplement delivered with this prospectus may contain
forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical
facts contained or incorporated by reference in this prospectus, including, but not limited to, statements regarding our future results
of operations and financial position, business strategy, plans and prospects, existing and prospective products, research and development
costs, timing and likelihood of success, and plans and objectives of management for future operations and results, are forward-looking
statements. These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms
“believes,” “can,” “could,” “estimates,” “anticipates,” “expects,”
“seeks,” “projects,” “intends,” “plans,” “may,” “might,” “should,”
“will” or “would” or, in each case, their negative or other variations or comparable terminology, although not
all forward-looking statements contain these identifying words. 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.
Factors
that may impact such forward-looking statements include:
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Our
ability to maintain adequate technology, intellectual property, data privacy, and cybersecurity practices. |
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Our
reliance on third parties. |
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The
risks related to general economic and financial market conditions, including the impact of supply chain disruptions and inflationary
cost pressures. |
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The
possibility of an economic recession. |
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The
impact of the political, legal, and regulatory environment. |
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The
changing landscape of the industries in which we operate. |
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Our
ability to raise capital, which may not be available on acceptable terms or at all, to execute our business plan. |
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The
outbreak of an infectious disease, such as the COVID-19 or a new variant thereof, or emergence of another epidemic or pandemic that
can potentially disrupt our business plans, product development activities, ongoing clinical trials, including the timing and enrollment
of patients, and the health of our employees. |
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The
limited liquidity and trading of our common stock. |
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Volatility
in the price of our common stock due to a variety of factors, including changes in the competitive and highly regulated industries
in which we operate, variations in performance across competitors, and changes in laws and regulations affecting our business. |
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Our
ability to maintain the listing of our common stock on The Nasdaq Capital Market. |
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Geopolitical
changes and changes in applicable laws or regulations. |
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Our
operational risks. |
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Litigation
and regulatory enforcement risks, including the diversion of management time and attention and the additional costs and demands resulting
therefrom. |
Forward-looking
statements contained in this prospectus are based on the Company’s current expectations and beliefs and are based upon information
available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements,
that information may be limited or incomplete. Our forward-looking statements should not be read to indicate that we have conducted an
exhaustive inquiry into, or review of, all relevant information. These forward-looking statements involve a number of risks, uncertainties
(some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially
different from those expressed or implied by these forward-looking statements. Forward-looking statements are inherently uncertain, and
investors are cautioned not to unduly rely upon these statements.
These
risks and uncertainties include, but are not limited to, those factors discussed under the heading “Risk Factors” below and
those described in the section titled “Risk Factors” incorporated by reference into this prospectus from our most recent
Annual Reports on Form 10-K and Form 10-K/A, any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, and all other
information contained in or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act
and in our other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of the assumptions
prove incorrect, actual results may vary in material respects from those projected in our forward-looking statements. Furthermore, we
operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management
to predict all risk factors and uncertainties.
We
qualify all of our forward-looking statements by these cautionary statements. The Company will not and does not undertake any obligation
to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may
be required by law. You should read this prospectus and the documents incorporated by reference herein and filed as exhibits to the registration
statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance,
and achievements may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary
statements.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 (the “Registration Statement”) that we filed with the Securities
and Exchange Commission (the “SEC”). Under this Registration Statement, the Selling Securityholders may sell from time to
time in one or more offerings the Common Stock described in this prospectus. We will not receive any proceeds from the sale of the Warrant
Shares by the Selling Securityholders. In the event the Selling Securityholders exercise all of the Warrants in cash at an exercise price
per share of $2.06, we would receive approximately $3,372,220 of gross proceeds resulting from such exercise. Any proceeds that we receive
from the exercise of such Warrants will be used for working capital and general corporate purposes.
We
have not, and the Selling Securityholders have not authorized anyone to provide you with information different than or inconsistent with
the information contained in or incorporated by reference to this prospectus, any applicable prospectus supplement, or any free writing
prospectus that we have authorized for use in connection with this offering. Neither we nor the Selling Securityholders take responsibility
for, or provide assurance as to the reliability of any other information that others may give you. We are not, and the Selling Securityholders
are not making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted or in which the person
making that offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation. You
should assume that the information contained in or incorporated by reference to this prospectus, any applicable prospectus supplement,
or in any free writing prospectus that we have authorized for use in connection with this offering is accurate only as of the date of
those respective documents, regardless of the time of delivery of those respective documents. Our business, financial condition, results
of operations, and prospects may have changed since those dates. You should read in their entirety this prospectus, any applicable prospectus
supplement, any free writing prospectus that we have authorized for use in connection with this prospectus and the documents incorporated
by reference to this prospectus, any applicable prospectus supplement, and any free writing prospectus that we have authorized for use
in connection with this prospectus, before making an investment decision. You should also read and consider the information in the documents
to which we have referred to you in the sections titled “Where You Can Find More Information” and “Incorporation of
Certain Information by Reference.”
The
Selling Securityholders are offering to sell, and seeking offers to buy the securities offered by the Selling Securityholders described
in this prospectus only in jurisdictions where offers and sales are permitted. The distribution of this prospectus and this offering
of our securities in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this
prospectus must inform themselves about, and observe any restrictions relating to this offering of our securities and the distribution
of this prospectus outside the United States. This prospectus does not constitute, and may not be used in connection with an offer to
sell, or a solicitation of an offer to buy any securities offered by this prospectus by any person in any jurisdiction in which it is
unlawful for such person to make such an offer or solicitation.
In
this prospectus, references to “ZyVersa”, “Company”, “we”, “us”, “our”, or
similar references mean ZyVersa Therapeutics, Inc. unless otherwise stated or the context otherwise requires
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 all documents
incorporated by reference. In particular, attention should be directed to our “Risk Factors” section in this prospectus and
under similar captions in the documents incorporated by reference into this prospectus, including any prospectus supplement incorporated
by reference hereto, and the financial statements and related notes thereto contained herein or otherwise incorporated by reference hereto.
Overview
We
are a clinical stage biopharmaceutical company leveraging proprietary technologies to develop drugs for patients with chronic renal or
inflammatory diseases with high unmet medical needs. Our mission is to develop drugs that optimize health outcomes and improve patients’
quality of life.
We
have two proprietary globally licensed drug development platforms, each of which was discovered by research scientists at the University
of Miami, Miller School of Medicine (the “University of Miami” or “University”). These development platforms
are:
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Cholesterol
Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin or “2HPβCD”) is an injectable drug
in clinical development for treatment of renal diseases. VAR 200 was licensed to us from L&F Research LLC on December 15, 2015.
L&F Research was founded by the University of Miami research scientists who discovered the use of VAR 200 for renal diseases. |
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Inflammasome
ASC Inhibitor IC 100 is a humanized monoclonal antibody in preclinical development for treatment of inflammatory conditions. IC 100
was licensed from InflamaCore, LLC to us on April 18, 2019. InflamaCore, LLC was founded by the University of Miami research scientists
who invented IC 100. |
We
believe that each of our product candidates has the potential to treat numerous indications in their respective therapeutic areas. Our
strategy is to focus on indication expansion to maximize commercial potential.
Our
renal pipeline is initially focused on rare, chronic glomerular diseases. Our lead indication for VAR 200 is focal segmental glomerulosclerosis
(“FSGS”). On January 21, 2020, we filed an Investigational New Drug application (“IND”) for VAR 200, and the
United States Food and Drug Administration (“FDA”) has allowed our development plans to proceed to a Phase 2a trial in patients
with FSGS based on the risk/benefit profile of the active ingredient (2HPβCD). Prior to initiating a Phase 2a trial in patients
with FSGS, we are planning to initiate a small open-label Phase 2a trial in patients with diabetic kidney disease, in which we expect
to obtain patient proof-of-concept data more quickly than in an FSGS trial. This will enable assessment of drug effects as patients proceed
through treatment and will provide insights for developing a lager Phase 2a/b protocol in patients with FSGS. An IND amendment for evaluation
of VAR 200 in a Phase 2a trial in patients with diabetic kidney disease was filed with the FDA on February 16, 2024. VAR 200 has pharmacologic
proof-of-concept data in animal models representative of FSGS, Alport Syndrome, and diabetic kidney disease providing opportunity for
indication expansion.
Our
Inflammasome ASC Inhibitor IC 100 is nearing completion of preclinical development. Our focus is on advancing IC 100 toward an IND submission
followed by initiation of a Phase 1 trial in patients with obesity and certain metabolic complications, our lead indication. IC 100 has
preclinical data in animal models representing six different indications, each demonstrating that IC 100 attenuates pathogenic inflammasome
signaling pathways leading to reduced inflammation and improved histopathological and/or functional outcomes. Those indications are stroke-related
cardiovascular dysfunction, multiple sclerosis (“MS”), retinopathy of prematurity (“ROP”), acute respiratory
distress syndrome (“ARDS”), spinal cord injury, and traumatic brain injury (TBI). Likewise, preclinical studies are underway
in Alzheimer’s and Parkinson’s diseases, and preparations are underway to initiate an IND-enabling preclinical study in obesity
with metabolic complications.
Private
Placement
On
November 5, 2024, we entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with certain holders
(the “Holders”) of (i) outstanding Series Common Stock purchase warrants (the “Series
A Warrants”) exercisable for up to an aggregate of 199,950 shares of Common Stock; (ii) Series B Common Stock purchase warrants
(the “Series B Warrants”) exercisable for up to 139,950 shares of Common Stock; (iii) Series A-1 Common Stock purchase warrants
(the “Series A-1 Warrants”) exercisable for up to an aggregate of 392,000 shares of Common Stock, and (iv) Series B-1 Common
Stock purchase warrants (the “Series B-1 Warrants”) exercisable for up to an aggregate of 86,600 shares of Common Stock (collectively,
the “Existing Warrants”), which Existing Warrants were issued by the Company on December 11, 2023 and August 2, 2024.
Pursuant
to the Inducement Letter, the Holders agreed to exercise the Existing Warrants for cash at a reduced exercise price of $2.06 per share
in consideration of the Company’s agreement to issue Series A-2 Warrants to the Holders, to purchase up to 1,637,000 shares of
Common Stock.
The
issuance of the shares of Common Stock underlying the Warrants is subject to stockholder approval under applicable rules and regulations
of The Nasdaq Stock Market LLC, to the extent required by such rules and regulations (“Stockholder Approval” and the date
on which Stockholder Approval is received and deemed effective, the “Stockholder Approval Date”). The initial exercise date
of the Warrants is the Stockholder Approval Date, and the exercise price thereof is $2.06 per share.
Corporate
Information
On
December 12, 2022 (the “Closing Date”), we consummated a business combination pursuant to the terms of that certain Business
Combination Agreement, dated July 20, 2022, as amended from time to time (the “Business Combination Agreement”), by and among
ZyVersa Therapeutics, Inc., a Florida corporation (“Old ZyVersa”), the representative of Old ZyVersa’s shareholders
named therein (the “Securityholder Representative”), Larkspur Health Acquisition Corp., a Delaware corporation (“Larkspur”)
and Larkspur Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of Larkspur (the “Merger Sub”). Pursuant
to the terms of the Business Combination Agreement (and upon all other conditions of the Business Combination Agreement being satisfied
or waived), on the Closing Date of the Business Combination and transactions contemplated thereby, (i) Larkspur changed its name to “ZyVersa
Therapeutics, Inc.”, a Delaware corporation and (ii) the Merger Sub merged with and into Old ZyVersa (the “Merger”),
with Old ZyVersa as the surviving company in the Merger and, after giving effect to such Merger, Old ZyVersa became a wholly-owned subsidiary
of the Company.
Our
principal executive offices are located at 2200 North Commerce Parkway, Suite 208, Weston, Florida 33326, and our telephone number is
(754) 231-1688. Our website address is http://www.zyversa.com. The information contained on or otherwise accessible through our website
is not part of this prospectus.
The
Offering
Shares
of Common
Stock offered by the
Selling Stockholders |
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1,637,000
shares of Common Stock consisting of 1,637,000 Warrant Shares. |
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Use
of proceeds |
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We
are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of the shares of Common
Stock covered hereby by the Selling Stockholders. To the extent any Warrants are exercised for cash, we intend to use such proceeds
for working capital or general corporate purposes. See “Use of Proceeds.” |
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Terms
of this offering; Determination of offering price |
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The
Selling Stockholders, including their transferees, donees, pledgees, assignees, and successors-in-interest, may sell, transfer or
otherwise dispose of any or all of the shares of Common Stock offered by this prospectus from time to time on The Nasdaq Capital
Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The Selling
Stockholders may offer or sell the shares of Common Stock offered by this prospectus at market prices prevailing at the time of sale,
at prices related to prevailing market price, or at privately negotiated prices.
The
offering price of our Common Stock does not necessarily bear any relationship to our book value, assets, past operating results,
financial condition, or any other established criteria of value. Our Common Stock might not trade at market prices in excess of the
offering price as prices for our Common Stock in any public market will be determined in the marketplace and may be influenced by
many factors, including the depth and liquidity. See “Determination of Offering Price” and “Plan of Distribution”
for more information. |
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Nasdaq
symbol |
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Our
Common Stock is listed on The Nasdaq Capital Market under the symbol “ZVSA”. |
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Risk
Factors |
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Investing
in our securities involves a high degree of risk. See the section titled “Risk Factors” on page 5 of this prospectus
and under similar headings in other documents incorporated by reference herein. |
RISK
FACTORS
Investment
in any securities offered pursuant to this prospectus involves risks. Before deciding whether to invest in our securities, you should
carefully consider the following risk factors and the risk factors discussed under the sections titled “Risk Factors” in
our most recent Annual Reports on Form 10-K and Form 10-K/A, any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form
8-K, and all other information contained in or incorporated by reference into this prospectus, as updated by our subsequent filings under
the Exchange Act. The risks and uncertainties we have described are not the only ones facing our Company. Additional risks and uncertainties
not presently known to us or that we currently believe are not material may also affect our business operations. Past financial performance
may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future
periods. If any of these risks actually occurs, our business, financial condition, results of operations or cash flows could be seriously
harmed. This could cause the trading price of our securities to decline, resulting in a loss of all or part of your investment in the
offered securities. The discussion of risks includes or refers to forward-looking statements. You should read the explanation of the
qualifications and limitations on such forward-looking statements contained in or incorporated by reference into this prospectus and
in any applicable prospectus supplement or free writing prospectus.
Risks
Related to This Offering
The
sale or availability for sale of the Warrant Shares issuable upon exercise of the Warrants may depress the price of our Common Stock
and encourage short sales by third parties, which could further depress the price of our Common Stock.
To
the extent that the Selling Securityholders sell Warrant Shares issued upon exercise of the Warrants, the market price of such shares
may decrease due to the additional selling pressure in the market. In addition, the dilution from issuances of such Warrant Shares may
cause stockholders to sell their shares of our Common Stock, which could further contribute to any decline in the price of our Common
Stock. Any downward pressure on the price of our Common Stock caused by the sale or potential sale of such shares could encourage short
sales by third parties. Such sales could place downward pressure on the price of our Common Stock by increasing the number of shares
of our Common Stock being sold, which could further contribute to any decline in the market price of our Common Stock.
Future
sales and issuances of our Common Stock or other securities might result in significant dilution and could cause the price of our Common
Stock to decline.
To
raise capital, we may sell Common Stock, convertible securities or other equity securities in one or more transactions, at prices and
in a manner we determine from time to time. We may sell shares or other securities in any other offering at a price per share that is
less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could
have rights superior to existing stockholders. The price per share at which we sell additional shares of our Common Stock, or securities
convertible or exchangeable into Common Stock, in future transactions may be higher or lower than the price per share paid by investors
in this offering.
We
cannot predict what effect, if any, sales of shares of our Common Stock in the public market or the availability of shares for sale will
have on the market price of our Common Stock. However, future sales of substantial amounts of our Common Stock in the public market,
including shares issued upon exercise of outstanding options, or the perception that such sales may occur, could adversely affect the
market price of our Common Stock.
Management
will have broad discretion as to the use of the proceeds from the offering, and uses may not improve our financial condition or market
value.
We
will not receive any proceeds from the sale of the Warrant Shares by the Selling Securityholders. In the event the Selling Securityholders
exercise all of the Warrants in cash at an exercise price per share of $2.06, we may receive approximately $3,372,220 of gross proceeds
resulting from such exercise. Any proceeds that we receive from the exercise of such Warrants will be used for working capital and general
corporate purposes.
Because
we have not designated the amount of proceeds from the offering to be used for any particular purpose, our management will have broad
discretion as to the application of such proceeds and could use them for purposes other than those contemplated hereby. Our management
may use the proceeds for corporate purposes that may not improve our financial condition or market value.
Risks
Related to Our Business, Financial Position and Need for Capital
We
may be unable to continue as a going concern.
We
are a development stage pharmaceutical company with no commercial products. Our primary product candidates are in the process of being
developed and will require significant additional preclinical and clinical development and investment before they could potentially be
commercialized. As a result, we have not generated any revenue from operations since inception, and we have incurred substantial net
losses to date. Moreover, our cash position is vastly inadequate to support our business plans and substantial additional funding will
be needed in order to pursue those plans, which include research and development of our primary product candidates, seeking regulatory
approval for those product candidates, and pursuing their commercialization in the United States and other markets. Our independent registered
public accounting firm’s report for the year ended December 31, 2023, contains an explanatory paragraph that expresses doubt about
our ability to continue as a going concern. Those circumstances raise substantial doubt about our ability to continue as a going concern.
In particular, we believe that our current cash on hand will only be sufficient to meet our anticipated cash requirements on a month-to
month basis. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our
assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. In addition,
our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect the value of our
capital stock and our ability to raise new capital or to enter into critical contractual relations with third parties.
We
will need additional capital to develop and commercialize our product candidates. If we are unable to raise sufficient capital, we would
be forced to delay, reduce or eliminate our product development programs.
Developing
pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development
expenses to increase in connection with our ongoing activities, particularly as we start clinical trials for VAR 200 and conduct preclinical
development of IC 100. We have no commitments or arrangements for any additional financing to fund our development and commercialization
efforts for VAR 200, IC 100, or any other product candidate that we may seek to develop. We will need to raise substantial additional
capital to develop and commercialize VAR 200, IC 100, and any other product candidate that we may seek to develop. Because successful
development of VAR 200 or IC 100 is uncertain, we are unable to estimate the actual funds required to complete their development and
commercialization.
Until
we can generate a sufficient amount of revenue from VAR 200, IC 100, or any other product candidate that we may seek to develop, if ever,
we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing
arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds
are not available, we may be required to delay, reduce the scope of, or curtail, our operations. To the extent that we raise additional
funds by issuing equity securities, or securities convertible into equity securities, the ownership of our then existing stockholders
may be diluted, which dilution could be significant depending on the price at which we may be able to sell our securities. Also, if we
raise additional capital through the incurrence of indebtedness, we may become subject to additional covenants restricting our business
activities, the holders of debt instruments may have rights and privileges senior to those of our equity investors, and servicing the
interest and principal repayment obligations under such debt instruments could divert funds that would otherwise be available to support
research and development, clinical or commercialization activities. Corresponding, we may not be able to enter into collaborations that
we seek to establish. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary
to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We
may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need
for additional capital at that time.
Our
future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:
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the
initiation, progress, timing, costs and results of preclinical and clinical trials for our product candidates; |
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whether
the FDA requires that we perform additional studies for our product candidates that we seek to develop beyond those that we anticipate; |
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the
terms and timing of any future collaboration, licensing or other arrangements that we may establish; |
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the
outcome, timing, and cost of regulatory approvals; |
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the
effect of competing technological and market developments; |
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the
cost and timing of establishing commercial-scale outsourced manufacturing capabilities; |
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market
acceptance of our product candidates, if we receive regulatory approval; |
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the
cost of establishing sales, marketing, and distribution capabilities for our product candidates, if we receive regulatory approval;
and |
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the
extent to which we acquire, license, or invest in businesses, products or technologies. |
USE
OF PROCEEDS
The
Common Stock to be offered and sold pursuant to this prospectus will be offered and sold by the Selling Stockholders named in this prospectus.
Accordingly, we will not receive any proceeds from any sale or disposition of shares of Common Stock held by the Selling Stockholders
pursuant to this prospectus. To the extent all of the Warrants are exercised for cash at the exercise price per share of $2.06, we would
receive in aggregate gross proceeds of $3,372,220. There can be no assurance that any of the Warrants will be exercised by the Selling
Stockholders, or that they will exercise any of the Warrants for cash instead of using any applicable cashless exercise feature.
We
intend to use the net proceeds, if any, from the cash exercise of the Warrants for working capital or general corporate purposes.
DETERMINATION
OF OFFERING PRICE
The
Selling Stockholders will offer or sell the shares of Common Stock offered by this prospectus at market prices prevailing at the time
of sale, at prices related to prevailing market price, or at privately negotiated prices. The offering price of our Common Stock does
not necessarily bear any relationship to our book value, assets, past operating results, financial condition, or any other established
criteria of value. Our Common Stock might not trade at market prices in excess of the offering price as prices for our Common Stock in
any public market will be determined in the marketplace and may be influenced by many factors, including the depth and liquidity. See
“Plan of Distribution” for more information.
SELLING
STOCKHOLDERS
This
prospectus covers the resale or other disposition by the Selling Stockholders identified in the table below of up to an aggregate 1,637,000
shares of our Common Stock issuable upon the exercise of the Warrants. The Selling Stockholders acquired their securities in the transactions
described above in the section titled “Prospectus Summary — Private Placement.”
The
Warrants held by the Selling Stockholders contain limitations which prevent the holder from exercising such Warrants if such exercise
would cause the Selling Stockholder, together with certain related parties, to beneficially own a number of shares of Common Stock which
would exceed 4.99% of our then outstanding shares of Common Stock following such exercise, excluding for purposes of such determination,
shares of Common Stock issuable upon exercise of the Warrants which have not been exercised. A Selling Stockholder may increase or decrease
its beneficial ownership limitation upon notice to the Company, provided that in no event such limitation exceeds 9.99%, and that any
increase shall not be effective until the 61st day after such notice.
The
table below sets forth, as of December 19, 2024, the following information regarding the Selling Stockholders:
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the
names of the Selling Stockholders; |
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the
number of shares of Common Stock owned by the Selling Stockholders prior to this offering, without regard to any beneficial ownership
limitations contained in the Warrants; |
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the
number of shares of Common Stock to be offered by the Selling Stockholders in this offering; |
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the
number of shares of Common Stock to be owned by the Selling Stockholders assuming the sale of all of the shares of Common Stock covered
by this prospectus; and |
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the
percentage of our issued and outstanding shares of Common Stock to be owned by Selling Stockholders assuming the sale of all of the
shares of Common Stock covered by this prospectus based on the number of shares of Common Stock issued and outstanding as of December
19, 2024. |
Except
as described above, the number of shares of Common Stock beneficially owned by the Selling Stockholder has been determined in accordance
with Rule 13d-3 under the Exchange Act and includes, for such purpose, shares of Common Stock that the Selling Stockholder has the right
to acquire within 60 days of December 19, 2024.
All
information with respect to the Common Stock ownership of the Selling Stockholders has been furnished by or on behalf of the Selling
Stockholders. We believe, based on information supplied by the Selling Stockholders, that except as may otherwise be indicated in the
footnotes to the table below, the Selling Stockholder has sole voting and dispositive power with respect to the shares of Common Stock
reported as beneficially owned by the Selling Stockholders. Because the Selling Stockholders identified in the table may sell some or
all of the shares of Common Stock beneficially owned by them and covered by this prospectus, and because there are currently no agreements,
arrangements, or understandings with respect to the sale of any of the shares of Common Stock, no estimate can be given as to the number
of shares of Common Stock available for resale hereby that will be held by the Selling Stockholders upon termination of this offering.
In addition, the Selling Stockholders may have sold, transferred, or otherwise disposed of, or may sell, transfer, or otherwise dispose
of, at any time and from time to time, the shares of Common Stock they beneficially own in transactions exempt from the registration
requirements of the Securities Act after the date on which they provided the information set forth in the table below. We have, therefore,
assumed for the purposes of the following table, that the Selling Stockholders will sell all of the shares of Common Stock owned beneficially
by it that are covered by this prospectus, but will not sell any other shares of Common Stock that they presently own. Except as set
forth below, the Selling Stockholders have not held any position or office, or have otherwise had a material relationship, with us or
any of our subsidiaries within the past three years other than as a result of the ownership of our shares of Common Stock or other securities.
Name of Selling Stockholders | |
Shares Owned prior to Offering (1) | | |
Shares Offered by this Prospectus | | |
Shares Owned after Offering | | |
Percentage of Shares Beneficially Owned after Offering (1) | |
Anson Investments Master Fund LP | |
| 664,000 | (2) | |
| 664,000 | | |
| — | | |
| * | |
Armistice Capital, LLC | |
| 957,200 | (3) | |
| 957,200 | | |
| — | | |
| * | |
KBB Asset Management | |
| 2,886 | (4) | |
| 2,600 | | |
| 286 | | |
| * | |
Robert Forster | |
| 5,343 | (5) | |
| 5,200 | | |
| 143 | | |
| * | |
Warberg WF XI LP | |
| 13,938 | (6) | |
| 8,000 | | |
| 5,938 | | |
| * | |
*
Less than 1.0%.
(1) |
Percentages
are based on 2,508,191 shares of Common Stock outstanding as of December 19, 2024, assuming the resale of all of the shares of
Common Stock covered by this prospectus. |
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(2) |
Consists
of 664,000 shares of Common Stock underlying the Warrants held by Anson Investments Master Fund LP (“Anson”). Anson Advisors
Inc. and Anson Funds Management LP, the Co-Investment Advisers of Anson, hold voting and dispositive power over the Common Stock
held by Anson. Bruce Winson is the managing member of Anson Management GP LLC, which is the general partner of Anson Funds Management
LP. Moez Kassam and Amin Nathoo are directors of Anson Advisors Inc. Mr. Winson, Mr. Kassam and Mr. Nathoo each disclaim beneficial
ownership of these Shares. The principal business address of Anson is Walkers Corporate Limited, Cayman Corporate Centre, 27 Hospital
Road, George Town, Grand Cayman KY1-9008, Cayman Islands. |
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(3) |
Consists
of 957,200 shares of Common Stock underlying the Warrants. The securities are directly held by Armistice Capital Master Fund Ltd.,
a Cayman Islands exempted company (the “Master Fund”) and may be deemed to be beneficially owned by: (i) Armistice Capital,
LLC (“Armistice Capital”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member
of Armistice Capital. The Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the
Selling Stockholder from exercising that portion of the Warrants that would result in the Selling Stockholder and its affiliates
owning, after exercise, a number of shares of Common Stock in excess of the beneficial ownership limitation. The address of Armistice
Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. |
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(4) |
Consists
of warrants to purchase up to 286 shares of Common Stock and 2,600 shares of Common Stock underlying the Warrants. The principal
address of KBB Asset Management is 47 Calle Del Sur, Palm Coast, FL 32137. |
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(5) |
Consists
of warrants to purchase up to 143 shares of Common Stock and 5,200 shares of Common Stock underlying the Warrants. The address of
Robert Forster is 54 Deepdale Dr., Great Neck, NY 11021. |
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(6) |
Consists
of 4,010 shares of Common Stock; and (i) warrants to purchase up to 1,928 shares of Common Stock and (ii) 8,000 shares of Common
Stock underlying the Warrants. The address of Warberg WF XI LP is 716 Oak Street, Winnetka, IL 60093. |
PLAN
OF DISTRIBUTION
Each
Selling Stockholder of the securities and any of their pledgees, assignees, and successors-in-interest may, from time to time, sell any
or all of their securities covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which
the securities are traded or in private transactions. These sales may be at fixed or negotiated prices.
A
Selling Stockholder may use any one or more of the following methods when selling securities:
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ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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block
trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block
as principal to facilitate the transaction; |
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purchases
by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an
exchange distribution in accordance with the rules of the applicable exchange; |
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privately
negotiated transactions; |
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settlement
of short sales; |
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in
transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated
price per security; |
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through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
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a
combination of any such methods of sale; or |
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any
other method permitted pursuant to applicable law. |
The
Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available,
rather than under this prospectus.
Broker-dealers
engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions
or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser)
in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in
excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or
markdown in compliance with FINRA Rule 2121.
In
connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they
assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan
or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the
delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The
Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding,
directly or indirectly, with any person to distribute the securities.
The
Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company
has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under
the Securities Act.
We
agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders
without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for
the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar
effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule
of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable
state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered
or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is
complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously
engage in market making activities with respect to the Common Stock for the applicable restricted period, as defined in Regulation M,
prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the
Common Stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders
and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including
by compliance with Rule 172 under the Securities Act).
Our
Common Stock is listed on The Nasdaq Capital Market under the symbol “ZVSA”.
DESCRIPTION
OF SECURITIES
General
The
following description of our capital stock is not complete and may not contain all the information you should consider before investing
in our capital stock. The following description summarizes some of the terms of our Second Amended and Restated Certificate of Incorporation
(the “Certificate of Incorporation”), Second Amended and Restated Bylaws (the “Bylaws”), and of the General Corporation
Law of the State of Delaware (the “DGCL”). This description is summarized from, and qualified in its entirety by reference
to, our Certificate of Incorporation and Bylaws, each of which has been publicly filed with the SEC, as well as the relevant provisions
of the DGCL.
Capital
Stock
Our
authorized capital stock consists of 250,000,000 shares of common stock, par value $0.0001 per share, and 1,000,000 shares of preferred
stock, par value $0.0001 per share.
Common
Stock
Holders
of shares of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of stockholders.
The holders of common stock do not have cumulative voting rights in the election of directors.
In
the event of our liquidation, dissolution or winding up and after payment in full of all amounts required to be paid to creditors and
to any future holders of preferred stock having liquidation preferences, if any, the holders of common stock will be entitled to receive
pro rata our remaining assets available for distribution. Holders of common stock do not have preemptive, subscription, redemption or
conversion rights. There are no redemption or sinking fund provisions applicable to the common stock. The rights, powers, preferences
and privileges of holders of the common stock are subject to those of the holders of any shares of preferred stock that the board of
directors may authorize and issue in the future.
Dividends
Declaration
and payment of any dividend is subject to the discretion of our board of directors. The time and amount of dividends is dependent upon,
among other things, our business prospects, results of operations, financial condition, cash requirements and availability, debt repayment
obligations, capital expenditure needs, contractual restrictions, covenants in the agreements governing current and future indebtedness,
industry trends, the provisions of Delaware law affecting the payment of dividends and distributions to stockholders and any other factors
or considerations our board of directors may regard as relevant.
We
currently intend to retain all available funds and any future earnings to fund the development and growth of our business, and therefore
do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future.
Anti-Takeover
Provisions
The
Certificate of Incorporation and Bylaws contain provisions that may delay, deter or discourage another party from acquiring control of
us. We expect that these provisions, which are summarized below, will discourage coercive takeover practices or inadequate takeover bids.
These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors,
which may result in an improvement of the terms of any such acquisition in favor of our stockholders. However, they also give our board
of directors the power to discourage acquisitions that some stockholders may favor.
Authorized
but Unissued Shares
The
authorized but unissued shares of common stock and preferred stock are available for future issuance without stockholder approval, subject
to any limitations imposed by the listing standards of Nasdaq. These additional shares may be used for a variety of corporate finance
transactions, acquisitions and employee benefit plans. The existence of authorized but unissued and unreserved common stock and preferred
stock could make more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or
otherwise.
Board
Composition, Filling Vacancies, and Staggered Board of Directors
The
Certificate of Incorporation provides that directors may be removed only for cause and only by the affirmative vote of the holders of
at least a majority of the voting power of all of the then outstanding shares of voting stock of the Company entitled to vote at an election
of directors. Any vacancies on the board of directors resulting from death, resignation, disqualification, retirement, removal or other
causes and any newly created directorships resulting from any increase in the number of directors shall be filled exclusively by the
affirmative vote of a majority of the directors then in office, even though less than a quorum, or by a sole remaining director (other
than any directors elected by the separate vote of one or more outstanding series of preferred stock), and shall not be filled by the
stockholders. Any director appointed in accordance with the preceding sentence shall hold office until the expiration of the term of
the class to which such director shall have been appointed or until his or her earlier death, resignation, retirement, disqualification,
or removal. Furthermore, the Certificate of Incorporation divides our board of directors into three classes with staggered three-year
terms. The classification of our board of directors and the limitations on the ability of our stockholders to remove directors and fill
vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of
us.
Special
Meetings of Stockholders
Our
Certificate of Incorporation provides that a special meeting of stockholders may be called by the (a) the Chairperson of the board of
directors, (b) the board of directors or (c) the Chief Executive Officer or President of the Company, provided that such special meeting
may be postponed, rescheduled or canceled by the board of directors or other person calling the meeting. The Bylaws limit the business
that may be conducted at an annual or special meeting of stockholders to those matters properly brought before the meeting.
Action
by Written Consent
Our
Certificate of Incorporation provides that any action required or permitted to be taken by the stockholders must be effected at an annual
or special meeting of the stockholders, and may not be taken by written consent in lieu of a meeting.
Advance
Notice Requirements for Stockholder Proposals and Director Nominations
Our
Bylaws establish advance notice procedures with regard to stockholder proposals relating to the nomination of candidates for election
as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholder proposals
must be timely given in writing and in proper form to our corporate secretary prior to the meeting at which the action is to be taken.
Generally, to be timely, notice must be received at the principal executive offices of the Company not less than 90 days nor more than
120 days prior to the first anniversary date of the annual meeting for the preceding year or, if later, the 10th day following the day
on which public disclosure of the date of such special meeting was first made. The Bylaws specify the requirements as to form and content
of all stockholders’ notices. These requirements may preclude stockholders from bringing matters before the stockholders at an
annual or special meeting.
Amendment
of Bylaws
The
board of directors is expressly authorized to adopt, amend or repeal the Bylaws. Our stockholders also have the power to adopt, amend
or repeal the Bylaws; provided, that in addition to any vote of the holders of any class or series of stock of the Company required
by applicable law or by our Certificate of Incorporation and Bylaws, the adoption, amendment or repeal of the Bylaws by the stockholders
requires the affirmative vote of the holders of at least sixty-six and two-thirds percent (66⅔%) of the voting power of all of
the then outstanding shares of voting stock of the Company entitled to vote generally in an election of directors, voting together as
a single class.
Limitations
on Liability and Indemnification of Officers and Directors
Our
Certificate of Incorporation provides that no director or officer of the Corporation shall have any personal liability to the Corporation
or its stockholders for monetary damages for any breach of fiduciary duty as a director or officer, as applicable, except to the extent
such exemption from liability or limitation thereof is not permitted under the DGCL. Delaware law provides that a director or officer
of the corporation’s personal liability to the corporation or its stockholders for monetary damages for breach of fiduciary duty
as a director or officer may be eliminated or limited, except liability for:
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any
breach of the director’s or officer’s duty of loyalty to us or our stockholders; |
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acts
or omissions not in good faith, or which involve intentional misconduct or a knowing violation of law; |
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unlawful
payments of dividends or unlawful stock repurchases or redemptions; |
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any
transactions from which the director or officer derived an improper personal benefit; and |
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an
officer in any action by or in the right of the corporation. |
These
provisions may be held not to be enforceable for violations of the federal securities laws of the United States.
Our
Certificate of Incorporation also provides that we generally will indemnify our current and former directors and officers to fullest
extent authorized or permitted by applicable law.
Dissenters’
Rights of Appraisal and Payment
Under
the DGCL, with certain exceptions, our stockholders have appraisal rights in connection with a merger or consolidation of our Company.
Pursuant to Section 262 of the DGCL, stockholders who properly demand and perfect appraisal rights in connection with such merger or
consolidation have the right to receive payment of the fair value of their shares as determined by the Delaware Court of Chancery.
Stockholders’
Derivative Actions
Under
the DGCL, any of our stockholders may bring an action in our name to procure a judgment in its favor, also known as a derivative action,
provided that the stockholder bringing the action is a holder of our shares at the time of the transaction to which the action relates.
Transfer
Agent and Registrar
The
transfer agent and registrar for the common stock is Continental Stock Transfer & Trust Company.
Trading
Symbol and Market
Our
common stock is listed on the Nasdaq under the symbol “ZVSA.”
LEGAL
MATTERS
The
validity of the securities offered hereby will be passed upon for us by Thompson Hine LLP, New York, New York.
EXPERTS
The
consolidated financial statements of ZyVersa Therapeutics, Inc. at December 31, 2023 and the year ended December 31, 2023 incorporated
by reference in this Form S-3 from ZyVersa Therapeutics, Inc.’s Post-Effective Amendment No. 1 to Form S-1 (No. 333-275320)
have been audited by Marcum LLP, independent registered public accounting firm, as set forth in their report thereon (which contains
an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going
concern as described in Note 2 to the financial statements) appearing elsewhere therein, and are included in reliance upon such
report given on the authority of such firm as experts in accounting and auditing.
The
consolidated financial statements of ZyVersa Therapeutics, Inc. at December 31, 2022, for the period from December 13, 2022 through December
31, 2022 (Successor), for the period from January 1, 2022 through December 12, 2022 (Predecessor), and the year ended December 31, 2022
incorporated by reference in ZyVersa Therapeutics, Inc. Annual Report for the year ended December 31, 2023, included in the Post-effective
Amendment No. 1 to Form S-1 (No. 333-275320) have been audited by Ernst & Young LLP, independent registered public accounting firm,
as set forth in their report thereon, (which contains an explanatory paragraph describing conditions that raise substantial doubt about
the Company’s ability to continue as a going concern as described in Note 2 to the financial statements) incorporated by reference
therein, and incorporated herein by reference. Such financial statements are incorporated herein in reliance upon the report of Ernst
& Young LLP pertaining to such financial statements (to the extent covered by consents filed with the Securities and Exchange Commission)
given on the authority of such firm as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains a website that contains
reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The
address of that website is www.sec.gov.
Copies
of certain information filed by us with the SEC are also available on our website at www.zyversa.com. The information contained
on, or that may be accessed through, our website is not part of, and is not incorporated into, this prospectus or any prospectus supplement.
Our website address is included in this prospectus as an inactive textual reference only.
This
prospectus and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the
information in the registration statement. The full registration statement may be obtained from the SEC through the SEC’s website
at the address provided above. Forms of the indenture and other documents establishing the terms of any offered securities are or may
be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in
this prospectus or any prospectus supplement about these documents are summaries, and each statement is qualified in all respects by
reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant
matters.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can disclose
important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference
is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede
that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed
to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently
filed document incorporated by reference modifies or replaces that statement.
This
prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been
filed with the SEC:
|
● |
our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 25, 2024, as amended by Amendment No. 1 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on May 15, 2024; |
|
|
|
|
● |
our
Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2024, June 30, 2024, and September 30, 2024, filed with the
SEC on May 15, 2024, August 9, 2024, and November 14, 2024, respectively; |
|
|
|
|
● |
our
Current Reports on Form 8-K filed with the SEC on March 1, 2024, March 8, 2024, April 17, 2024, April 25, 2024, August 1, 2024, September 16, 2024, October 30, 2024, November 6, 2024, and November 14, 2024; |
|
|
|
|
● |
our
Definitive Proxy Statement on Schedule 14A filed with the SEC on September 9, 2024; |
|
|
|
|
● |
our
audited financial statements for the years ended December 31, 2023 and 2022, and the reports of Marcum LLP and Ernst & Young
LLP thereon, contained on pages F-2 through F-28 of the Post-Effective Amendment No. 1 to our Registration Statement on Form S-1
(File No. 333-275320) filed with the SEC on July 12, 2024; and |
|
|
|
|
● |
the
description of our securities set forth in Exhibit 4.8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023,
together with any amendment or report filed with the SEC for the purpose of updating such description. |
Notwithstanding
the foregoing, information furnished under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits under
Item 9.01, is not incorporated by reference in this prospectus or any prospectus supplement.
All
reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination
of this offering, including all such documents we may file with the SEC after the date of the initial registration statement of which
this prospectus forms a part and prior to the effectiveness of the registration statement, but excluding any information furnished to,
rather than filed with, the SEC, will also be incorporated by reference into this prospectus and deemed to be part of this prospectus
from the date of the filing of such reports and documents.
You
may obtain any of the documents incorporated by reference in this prospectus from the SEC through the SEC’s website at www.sec.gov.
You also may request a copy of any document incorporated by reference in this prospectus (excluding any exhibits to those documents,
unless the exhibit is specifically incorporated by reference in this document), at no cost, by writing or telephoning us at the following
address and phone number:
ZyVersa
Therapeutics, Inc.
Attn:
Secretary
2200
N. Commerce Parkway, Suite 208
Weston,
Florida 33326
(754)
231-1688
1,637,000
Shares of Common Stock
PROSPECTUS
We
have not authorized any dealer, salesperson or other person to give any information or to make any representations not contained in this
prospectus. You must not rely on any unauthorized information. This prospectus is not an offer to sell these securities in any jurisdiction
where an offer or sale is not permitted.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. |
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 | |
$ | 256 | |
Legal Fees and
Expenses | |
| 20,000 | |
Accounting Fees and Expenses | |
| 25,000 | |
Transfer Agent and Registrar
fees and expenses | |
| 5,000 | |
Miscellaneous
Expenses | |
| 4,802 | |
Total expenses | |
$ | 55,058 | |
Item
15. |
Indemnification
of Directors and Officers. |
Subsection
(a) of Section 145 of the General Corporation Law of the State of Delaware (the “DGCL”) empowers a corporation to indemnify
any person who was or is a party or who is threatened to be made a party 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 the corporation) by reason of the
fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise,
against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred
by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably
believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had
no reasonable cause to believe the person’s conduct was unlawful.
Subsection
(b) of Section 145 empowers a corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that
the person acted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably
incurred by the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a
manner the person reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification
shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation
unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application
that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled
to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.
Section
145 further provides that to the extent a director or officer of a corporation has been successful on the merits or otherwise in the
defense of any action, suit or proceeding referred to in subsections (a) and (b) of Section 145, or in defense of any claim, issue or
matter therein, such person shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred
by such person in connection therewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights
to which the indemnified party may be entitled; and the indemnification provided for by Section 145 shall, unless otherwise provided
when authorized or ratified, continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the
benefit of such person’s heirs, executors and administrators. Section 145 also empowers the corporation to purchase and maintain
insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other
enterprise against any liability asserted against such person and incurred by such person in any such capacity, or arising out of his
status as such, whether or not the corporation would have the power to indemnify such person against such liabilities under Section 145.
Section
102(b)(7) of the DGCL provides that a corporation’s Certificate of Incorporation may contain a provision eliminating or limiting
the personal liability of a director or officer to the corporation or its stockholders for monetary damages for breach of fiduciary duty
as a director or officer, provided that such provision shall not eliminate or limit the liability of (i) a director or officer for any
breach of the director’s or officer’s duty of loyalty to the corporation or its stockholders, (ii) a director or officer
for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) a director under
Section 174 of the DGCL, (iv) a director or officer for any transaction from which the director derived an improper personal benefit,
or (v) an officer in any action by or in the right of the corporation.
Additionally,
our Certificate of Incorporation limits the liability of our directors and officers to the fullest extent permitted by the DGCL, and
our Bylaws provide that we will indemnify them to the fullest extent permitted by such law. We have entered into and expect to continue
to enter into agreements to indemnify our directors, executive officers and other employees as determined by our board of directors.
Under the terms of such indemnification agreements, we are required to indemnify each of our directors and officers, to the fullest extent
permitted by the laws of the state of Delaware, if the basis of the indemnitee’s involvement was by reason of the fact that the
indemnitee is or was our director or officer or was serving at our request in an official capacity for another entity. We must indemnify
our officers and directors against all reasonable fees, expenses, charges and other costs of any type or nature whatsoever, including
any and all expenses and obligations paid or incurred in connection with investigating, defending, being a witness in, participating
in (including on appeal), or preparing to defend, be a witness or participate in any completed, actual, pending or threatened action,
suit, claim or proceeding, whether civil, criminal, administrative or investigative, or establishing or enforcing a right to indemnification
under the indemnification agreement. The indemnification agreements also require us, if so requested, to advance all fees, expenses and
other costs that such director or officer incurred, provided that such person will return any such advance if it is ultimately determined
that such person is not entitled to indemnification by us. Any claims for indemnification by our directors and officers may reduce our
available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
We
have entered into indemnification agreements with each of our directors and officers. These indemnification agreements may require us,
among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and
settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors
or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.
We
maintain a general liability insurance policy that covers certain liabilities of directors and officers of the Company arising out of
claims based on acts or omissions in their capacities as directors or officers.
Exhibit
Number |
|
Description |
2.1† |
|
Business Combination Agreement, dated as of July 20, 2022, by and among Larkspur Health Acquisition Corp., Larkspur Merger Sub Inc., Stephen Glover and ZyVersa Therapeutics, Inc. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 22, 2022). |
4.1 |
|
Form of Series A-2 Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2024). |
5.1 |
|
Opinion of Thompson Hine LLP. |
10.1 |
|
Inducement Letter, dated November 5, 2024 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2024). |
10.2 |
|
Financial Advisory Agreement, dated November 5, 2024 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2024). |
23.1 |
|
Consent of Marcum LLP. |
23.2 |
|
Consent of Ernst & Young LLP. |
23.3 |
|
Consent of Thompson Hine LLP (included in Exhibit 5.1). |
24.1 |
|
Power of Attorney (included on signature page). |
107 |
|
Filing Fee Table. |
† |
Certain
portions of this Exhibit have been omitted in accordance with Regulation S-K Item 601(b)(10). The Registrant agrees to furnish supplementally
an unredacted copy of this Exhibit to the SEC upon its request. |
The
undersigned registrant hereby undertakes:
(1) |
To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
|
(a) |
To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, |
|
|
|
|
(b) |
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 Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement, |
|
|
|
|
(c) |
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)(a), (1)(b) and (1)(c) above do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed with or furnished to the 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,
or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2) |
That,
for the purpose of determining any liability under the Securities Act of 1933, 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. |
|
|
(3) |
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. |
|
|
(4) |
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
|
(a) |
If
the registrant is relying on Rule 430B: |
|
(i) |
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration statement; and |
|
|
|
|
(ii) |
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale
of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating
to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof. 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 effective date, 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 effective date. |
|
(b) |
If
the registrant is subject to Rule 430C, 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 a 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. |
(5) |
That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution
of the securities: the undersigned registrant undertakes that in a primary offering of securities of the 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 registrant will be a seller to the purchaser
and will be considered to offer or sell such securities to such purchaser: |
|
(a) |
Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
424; |
|
|
|
|
(b) |
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; |
|
|
|
|
(c) |
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 |
|
|
|
|
(d) |
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(6) |
That,
for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant
to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s
annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) 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. |
|
|
(7) |
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the forgoing provisions, or otherwise, the registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification is against public policy as expressed in the 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 Act and
will be governed by the final adjudication of such issue. |
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of Weston, State of Florida, on December 20, 2024.
|
Zyversa
Therapeutics, Inc. |
|
|
|
|
By: |
/s/
Stephen C. Glover |
|
Name: |
Stephen
C. Glover |
|
Title: |
Chief
Executive Officer |
POWER
OF ATTORNEY
We,
the undersigned officers and directors of ZyVersa Therapeutics, Inc. hereby severally constitute and appoint Stephen C. Glover and Peter
Wolfe, and each of them singly (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with
full power of substitution and resubstitution in each of them for him or her and in his or her name, place and stead, and in any and
all capacities, to file and sign any and all amendments (including post-effective amendments) to this registration statement (or any
other registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act
of 1933, as amended), and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform
each and every act and thing requisite or necessary to be done in and about the premises, as fully to all intents and purposes as he
or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their
or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed below by the following persons
in the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Stephen C. Glover |
|
Chief
Executive Officer, President and Chairman |
|
December
20, 2024 |
Stephen
C. Glover |
|
(Principal
Executive Officer) |
|
|
|
|
|
|
|
/s/
Peter Wolfe |
|
Chief
Financial Officer and Secretary |
|
December
20, 2024 |
Peter
Wolfe |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
|
|
|
|
|
|
/s/
Robert G. Finizio |
|
Director |
|
December
20, 2024 |
Robert
G. Finizio |
|
|
|
|
|
|
|
|
|
/s/
Min Chul Park |
|
Director |
|
December
20, 2024 |
Min
Chul Park, Ph.D. |
|
|
|
|
|
|
|
|
|
/s/
James Sapirstein |
|
Director |
|
December
20, 2024 |
James
Sapirstein |
|
|
|
|
|
|
|
|
|
/s/
Gregory Freitag |
|
Director |
|
December
20, 2024 |
Gregory
Freitag |
|
|
|
|
Exhibit
5.1
December
20, 2024
ZyVersa
Therapeutics, Inc.
2200
N. Commerce Parkway, Suite 208
Weston,
FL 33326
Ladies
and Gentlemen:
We
have acted as counsel for ZyVersa Therapeutics, Inc., a Delaware corporation (the “Company”), in connection
with the preparation and filing of a Registration Statement on Form S-3 (the “Registration Statement”), including
a related preliminary prospectus filed with the Registration Statement (the “Prospectus”), with the U.S. Securities
and Exchange Commission (the “Commission”) pursuant to the Securities Act of 1933, as amended (the “Securities
Act”), covering the offer and sale by the selling stockholders identified therein of up to 1,637,000 shares (the “Shares”)
of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) issuable upon the exercise
of Series A-2 warrants (the “Warrants”) to purchase up to 1,637,000 shares of Common Stock.
In
connection with this opinion, we have examined originals or copies (certified or otherwise identified to our satisfaction) of (i) the
Company’s Certificate of Incorporation as amended and/or restated to date and as currently in effect (the “Certificate
of Incorporation”), (ii) the Company’s Bylaws as amended and/or restated to date and as currently in effect, (iii)
the Registration Statement and the Prospectus, (iv) the Warrants, and (v) such corporate records, agreements, documents, and other instruments,
and such certificates or comparable documents of public officials or of officers and representatives of the Company, as we have deemed
relevant and necessary as a basis for the opinion hereinafter set forth.
In
such examination, we have assumed the genuineness of all signatures, the legal capacity of all natural persons, the authenticity of all
documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified, conformed
or photostatic copies, the authenticity of the originals of such latter documents, that all parties (other than the Company) had the
requisite power and authority (corporate or otherwise) to execute, deliver, and perform such agreements or instruments, that all such
agreements or instruments have been duly authorized by all requisite action (corporate or otherwise), executed and delivered by such
parties, and that such agreements or instruments are valid, binding, and enforceable obligations of such parties. As to certain questions
of fact material to this opinion letter, we have relied upon certificates or comparable documents of officers and representatives of
the Company and have not sought to independently verify such facts.
Based
on the foregoing, and subject to the assumptions, limitations and qualifications stated herein, we are of the opinion that the Shares
have been duly authorized and, when issued upon the due exercise of the Warrants, will be validly issued, fully paid, and non-assessable.
In
rendering the foregoing opinion, we have assumed that, (i) before the Shares are issued, the Company will not issue shares of Common
Stock or reduce the total number of shares of Common Stock that the Company is authorized to issue under its then-effective Certificate
of Incorporation such that the number of unissued shares of Common Stock authorized under the Certificate of Incorporation is less than
the aggregate number of Shares, (ii) the Company will comply with all applicable notice requirements regarding uncertificated shares
provided in the DGCL (as defined below), and (iii) upon the issuance of any of the Shares, the total number of shares of Common Stock
issued and outstanding will not exceed the total number of shares of Common Stock that the Company is then authorized to issue under
its Certificate of Incorporation.
The
opinion expressed herein is limited to the General Corporation Law of the State of Delaware (including reported judicial decisions interpreting
the General Corporation Law of the State of Delaware) (the “DGCL”) and we express no opinion as to the effect
on the matters covered by this opinion of the laws of any other jurisdiction.
We
hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the reference to our firm under the caption
“Legal Matters” in the Prospectus. In giving such consents, we do not thereby admit that we are in the category of persons
whose consent is required under Section 7 of the Securities Act.
|
Very
truly yours, |
|
|
|
/s/
Thompson Hine LLP |
|
|
|
Thompson
Hine LLP |
Exhibit
23.1
Independent
Registered Public Accounting Firm’s Consent
We
consent to the incorporation by reference in this Registration Statement of ZyVersa Therapeutics, Inc. on Form S-3 of our report dated
March 25, 2024, (except for the effects of the reverse stock split discussed in Note 11, as to which the date is July 11, 2024), which
includes an explanatory paragraph as to ZyVersa Therapeutics, Inc. ability to continue as a going concern, with respect to our audit
of the consolidated financial statements of ZyVersa Therapeutics, Inc. as of December 31, 2023 and for the year ended December 31, 2023
appearing in the Annual Report included in the Post-effective Amendment No.1 to Form S-1 (No. 333-275320). We also consent to the reference
to our firm under the heading “Experts” in the Prospectus, which is part of this Registration Statement.
/s/
Marcum llp
Marcum
LLP
New
York, NY
December
20, 2024
Exhibit
23.2
Consent
of Independent Registered Public Accounting Firm
We
consent to the reference to our firm under the caption “Experts” in the Registration Statement (Form S-3) and related Prospectus
of ZyVersa Therapeutics, Inc. for the registration of shares of common stock and to the incorporation by reference therein of our report
dated March 31, 2023 (except for the effects of the reverse stock splits discussed in Notes 3 and 11 to the consolidated financial statements,
as to which the date is July 11, 2024), with respect to the consolidated financial statements of ZyVersa Therapeutics, Inc, included
in the Annual Report for the year ended December 31, 2023 included in the Post-effective Amendment No. 1 to Form S-1 (No. 333-275320),
filed with the Securities and Exchange Commission.
/s/
Ernst & Young LLP
Orlando,
Florida
December
20, 2024
Exhibit
107
Calculation
of Filing Fee Tables
Form
S-3
(Form
Type)
ZyVersa
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in its Charter)
| |
Security
Type | |
Security
Class Title | |
Fee
Calculation or Carry Forward Rule | |
Amount
Registered (1) | | |
Proposed
Maximum Offering Price Per Unit (2) | |
Maximum
Aggregate Offering Price (1) | |
Fee
Rate | |
Amount
of Registration Fee |
Fees
to Be Paid | |
Equity | |
Common
Stock, par value $0.0001 per share | |
Other | |
| 1,637,000 | | |
$ |
1.02 | | |
$ |
1,669,740 | | |
| 0.00015310 | |
$ |
256 | |
| |
Total
Offering Amounts | | | |
|
| | |
$ |
1,669,740 | | |
| | |
$ |
256 | |
| |
Total
Fees Previously Paid | | | |
|
| | |
|
| | |
| | |
$ |
0 | |
| |
Total
Fee Offsets | | | |
|
| | |
|
| | |
| | |
$ |
0 | |
| |
Net
Fee Due | | | |
|
| | |
|
| | |
| | |
$ |
256 | |
(1) |
Pursuant
to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”), there is also being registered hereby
such indeterminate number of additional common shares as may be issued or issuable because of stock splits, stock dividends stock
distributions, and similar transactions. |
|
|
(2) |
Estimated
solely for the purpose of calculating the registration fee pursuant to Rule 457(c) under the Securities Act based on a per share
price of $1.02, calculated based on the average of the high and low reported prices of the registrant’s common stock
on The Nasdaq Global Market on December 17, 2024, which date is within five business days prior to the filing of this Registration
Statement. |
ZyVersa Therapeutics (NASDAQ:ZVSA)
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