Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-269442
Prospectus
Supplement No. 2 Dated May 12, 2023
(To
Prospectus Dated April 26, 2023)
11,015,500
Shares of Common Stock
Warrants
to Purchase up to 11,015,500 Shares of Common Stock
11,015,500
Shares of Common Stock underlying the Warrants
This
Prospectus Supplement No. 2 (this “Prospectus Supplement”) supplements the prospectus of ZyVersa Therapeutics, Inc.
(the “Company”, “we”, “us”, or “our”) dated April 26, 2023
(as supplemented to date, the “Prospectus”) with the following attached
document which we filed with the Securities and Exchange Commission:
|
A. |
Our
Current Report on Form 8-K filed with the Securities and Exchange Commission on May 12, 2023. |
This
Prospectus Supplement should be read in conjunction with the Prospectus, which is required to be delivered with this Prospectus Supplement.
This Prospectus Supplement updates, amends and supplements the information included in the Prospectus.
If there is any inconsistency between the information in the Prospectus and this Prospectus Supplement, you should rely on the information
in this Prospectus Supplement.
This
Prospectus Supplement is not complete without, and may not be delivered or utilized except
in connection with, the Prospectus, including any amendments or supplements to it.
Investing
in our securities involves a high degree of risk. See “Risk Factors” beginning on page 7 of the Prospectus.
You
should rely only on the information contained in the Prospectus, as supplemented or amended by this Prospectus Supplement and any other
prospectus supplement or amendment thereto. We have not authorized anyone to provide you with different information.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this Prospectus Supplement No. 2 is May 12, 2023
INDEX
TO FILINGS
ANNEX
A
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 12, 2023
ZYVERSA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41184 |
|
86-2685744 |
(State
or other jurisdiction |
|
(Commission |
|
(I.R.S.
Employer |
of
incorporation) |
|
File
Number) |
|
Identification
No.) |
2200
N. Commerce Parkway, Suite 208
Weston,
Florida, 33326
(Address
of principal executive offices) (Zip Code)
(754)
231-1688
(Registrant’s
telephone number, including area code)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbols |
|
Name
of each exchange on which registered |
Common Stock, par value
$0.0001 per share |
|
ZVSA |
|
The Nasdaq Global Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02. Results of Operations and Financial Condition.
ZyVersa
Therapeutics, Inc. (the “Company”) issued a press release on May 12, 2023, disclosing financial information and operating
metrics for its first fiscal quarter ended March 31, 2023 and discussing its business outlook. A copy of the Company’s press release
is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information in this Current Report on Form 8-K under Item 2.02, including the information contained in Exhibit 99.1, is being
furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18
of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and
shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as shall
be expressly set forth by a specific reference in such filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits:
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date: May 12, 2023 |
|
|
|
By: |
/s/ Stephen
Glover |
|
Name: |
Stephen C. Glover |
|
Title: |
Chief Executive Officer |
Exhibit
99.1
ZyVersa
Therapeutics Reports First Quarter 2023 Corporate and Financial Results
Key
Highlights:
● | Continued
progress has been made in advancing an investigator-initiated clinical trial to gain human
proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal disease |
● | Announced
publication of several peer-reviewed journal articles supporting ASC inhibition as a promising
therapeutic target - data continue to demonstrate that multiple types of inflammasomes are
activated in various conditions (Alzheimer’s disease, traumatic brain injury, and injury
from intracortical implants), and substantiate that extracellular release of ASC specks to
neighboring cells heighten and perpetuate damaging inflammation leading to disease progression
in conditions such as Parkinson’s disease and alcoholic hepatitis |
● | Added
three internationally recognized experts in the field of glomerular disease to Renal Scientific
Advisory Board, and an internationally recognized authority in the field of innate immunity
to our Inflammatory Disease Scientific Advisory Board |
● | Enhanced
our Board of Directors with addition of three biopharmaceutical leaders with impeccable credentials
and a proven track record of success |
Weston,
FL, May 12, 2023 (GLOBE NEWSWIRE) – ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty
biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet
medical needs, provides a corporate update and reports financial results for the first quarter of 2023 ending March 31, 2023.
“This
is a very exciting time in the growth and evolution of ZyVersa as we seek to build shareholder value through development of first-in-class
drugs at the forefront of innovation for renal and inflammatory diseases,” said Stephen C. Glover, Co-founder, Chairman, Chief
Executive Officer, and President of ZyVersa. “We are currently advancing a dynamic pipeline of drug candidates with multiple programs
built around our two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases and
Inflammasome ASC Inhibitor IC 100 for treatment of multiple CNS and other inflammatory diseases. We believe that both technologies have
transformative potential, enabling development of drugs for patients who have limited or no therapeutic options.”
Mr.
Glover continued: “Highlighting our Inflammasome ASC Inhibitor IC 100, ZyVersa expects to complete IC 100’s preclinical program
this year, with an Investigational New Drug (“IND”) submission anticipated in second quarter of 2024. We were pleased to
report publication of data in several peer-reviewed journal articles demonstrating the role of ASC specks in heightening and perpetuating
damaging inflammation in neurological conditions (Alzheimer’s disease, Parkinson’s disease, and traumatic brain injury),
and in alcoholic hepatitis. These data support the therapeutic potential of inhibiting ASC and ASC specks with IC 100 to control inflammation
associated with various inflammatory diseases.”
“Regarding
Cholesterol Efflux MediatorTM VAR 200, ZyVersa continues to leverage relationships with experts in the field of renal disease,”
stated Mr. Glover. “To that end, we welcomed three new members to our Renal Disease Scientific Advisory Board. We look forward
to benefitting from their decades of experience as we advance our investigator-initiated trial to evaluate VAR 200 in patients with renal
disease, expected to begin in the fourth quarter of 2023.”
FIRST
QUARTER AND RECENT PROGRAM UPDATES
Targeting
Renal Disease with Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200
| ● | Continued
progress is being made to launch an investigator-initiated clinical trial in patients with
renal disease to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200,
with trial initiation expected in the fourth quarter of 2023 |
| ● | Added
to ZyVersa’s Renal Scientific Advisory Board (1) Dr. Daniel C. Cattran, Professor of
Medicine, University of Toronto; (2) Dr. Fernando C. Fervenza, Professor of Medicine, Mayo
Graduate School of Medicine and Director of the Nephrology Collaborative Group; and (3) Dr.
Richard J. Glassock, Professor Emeritus, David Geffen School of Medicine, UCLA |
Inflammasome
ASC Inhibitor IC 100: Targeting Inflammation Associated with Multiple CNS and Other Inflammatory Diseases
| ● | On
track to complete IND-enabling preclinical studies by end of year, with the goal of filing
an IND application with the U.S. Food and Drug Administration in the second quarter of 2024 |
| ● | Highlighted
peer-reviewed journal articles supporting the potential of ASC inhibition to control damaging
inflammation associated with numerous diseases, including Alzheimer’s disease, Parkinson’s
disease, traumatic brain injury, and alcohol induced hepatitis |
| ● | Added
to ZyVersa’s Inflammatory Disease Scientific Advisory Board Dr. Douglas Golenbock,
The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology, and Professor
and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School |
FIRST
QUARTER FINANCIAL RESULTS
Since
its inception in 2014 through March 31, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and
negative cash flows from its operations. Based on our current operating plan, we expect our cash of $1.3 million as of March 31, 2023,
will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need
additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity
or debt financings or other sources, which may include government grants and collaborations with third parties.
Research
and development expenses were consistent at approximately $1.1 million for the three months ended March 31, 2023 (“Successor Period”),
with an immaterial decrease of $11 thousand or 1.0% from the three months ended March 31, 2022 (“Predecessor Period”).
General
and administrative expenses were $3.5 million for the three months ended March 31, 2023, an increase of $1.2 million or 53.7% from $2.3
million for the three months ended March 31, 2022. The increase is primarily attributable to an increase of $0.4 million in director
and officer insurance, a $0.4 million increase in marketing costs for investor and public relations, and $0.4 million in payments for
the Effectiveness Failure related to the PIPE shares.
Net
losses were approximately $3.5 million for the three months ended March 31, 2023, with an improvement of $0.2 million or 5.5% compared
to a net loss of approximately $3.7M, for the three months ended March 31, 2022. Net losses for the three months ended March 31, 2023
benefited from a $1.0 Million deferred tax benefit compared to none for the year earlier period.
About
ZyVersa Therapeutics, Inc.
ZyVersa
(Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class
drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing
a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™
VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular
kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory
diseases. For more information, please visit www.zyversa.com.
Cautionary
Statement Regarding Forward-Looking Statements
Certain
statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995.
These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore,
you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,”
“plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,”
“should,” “could,” “estimates,” “predicts,” “potential,” “continue,”
“guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor
provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently,
actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s
plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical
trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational
new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product
candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization,
marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s
estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New
factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of
each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially
from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information
available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements
to reflect events or circumstances after the date of this press release, except as required by applicable law.
This
press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate
and IR Contact
Karen
Cashmere
Chief
Commercial Officer
kcashmere@zyversa.com
786-251-9641
Media
Contacts
Tiberend
Strategic Advisors, Inc.
Casey
McDonald
cmcdonald@tiberend.com
646-577-8520
Dave
Schemelia
Dschemelia@tiberend.com
609-468-9325
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
Successor | |
| |
March 31, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash | |
$ | 1,278,073 | | |
$ | 5,902,199 | |
Prepaid expenses and other current assets | |
| 1,321,551 | | |
| 225,347 | |
Vendor deposits | |
| 235,000 | | |
| 235,000 | |
Total Current Assets | |
| 2,834,624 | | |
| 6,362,546 | |
Equipment, net | |
| 14,733 | | |
| 17,333 | |
In-process research and development | |
| 100,086,329 | | |
| 100,086,329 | |
Goodwill | |
| 11,895,033 | | |
| 11,895,033 | |
Security deposit | |
| 46,659 | | |
| 46,659 | |
Operating lease right-of-use asset | |
| 76,324 | | |
| 98,371 | |
Total Assets | |
$ | 114,953,702 | | |
$ | 118,506,271 | |
| |
| | | |
| | |
Liabilities, Temporary Equity and Stockholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 6,381,086 | | |
$ | 6,025,645 | |
Accrued expenses and other current liabilities | |
| 2,112,812 | | |
| 2,053,559 | |
Operating lease liability | |
| 84,507 | | |
| 108,756 | |
Total Current Liabilities | |
| 8,578,405 | | |
| 8,187,960 | |
Deferred tax liability | |
| 9,276,932 | | |
| 10,323,983 | |
Total Liabilities | |
| 17,855,337 | | |
| 18,511,943 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Successor redeemable common stock, subject to possible redemption, 0 and 65,783 shares outstanding as of March 31, 2023 and
December 31, 2022, respectively | |
| - | | |
| 331,331 | |
Stockholders’ Equity: | |
| | | |
| | |
Successor preferred stock, $0.0001 par value, 1,000,000 shares authorized: | |
| | | |
| | |
Series A preferred stock, 8,635 shares designated, 8,635 shares issued and outstanding as of March 31, 2023 and December 31,
2022, respectively | |
| 1 | | |
| 1 | |
Series B preferred stock, 5,062 shares designated, 5,062 shares issued and outstanding as of March 31, 2023 and December 31,
2022, respectively | |
| 1 | | |
| 1 | |
Successor common stock, $0.0001 par value, 110,000,000 shares authorized; 9,211,922 and 9,016,139 shares issued and outstanding
as of March 31, 2023 and December 31, 2022, respectively | |
| 922 | | |
| 902 | |
Additional paid-in-capital | |
| 105,562,569 | | |
| 104,583,271 | |
Accumulated deficit | |
| (8,465,128 | ) | |
| (4,921,178 | ) |
Total Stockholders’ Equity | |
| 97,098,365 | | |
| 99,662,997 | |
Total Liabilities, Temporary Equity and Stockholders’ Equity | |
$ | 114,953,702 | | |
$ | 118,506,271 | |
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
Successor | | |
Predecessor | |
| |
For the Three | | |
For the Three | |
| |
Months Ended | | |
Months Ended | |
| |
March 31, | | |
March 31, | |
| |
2023 | | |
2022 | |
Operating Expenses: | |
| | | |
| | |
Research and development | |
$ | 1,055,943 | | |
$ | 1,066,962 | |
General and administrative | |
| 3,536,136 | | |
| 2,301,369 | |
Total Operating Expenses | |
| 4,592,079 | | |
| 3,368,331 | |
Loss From Operations | |
| (4,592,079 | ) | |
| (3,368,331 | ) |
| |
| | | |
| | |
Other (Income) Expense: | |
| | | |
| | |
Interest (income) expense | |
| (1,078 | ) | |
| 168,064 | |
Change in fair value of derivative liabilities | |
| - | | |
| 212,100 | |
| |
| | | |
| | |
Pre-Tax Net Loss | |
| (4,591,001 | ) | |
| (3,748,495 | ) |
Income tax benefit | |
| 1,047,051 | | |
| - | |
Net Loss | |
$ | (3,543,950 | ) | |
$ | (3,748,495 | ) |
| |
| | | |
| | |
Net Loss Per Share | |
| | | |
| | |
- Basic and Diluted | |
$ | (0.39 | ) | |
$ | (0.16 | ) |
| |
| | | |
| | |
Weighted Average Number of Common Shares Outstanding | |
| | | |
| | |
- Basic and Diluted | |
| 9,128,488 | | |
| 24,167,257 | |
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