ZyVersa Therapeutics, Inc. (Nasdaq-GM: 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, today provides a corporate
update and reports financial results for the second quarter of 2023
ending June 30, 2023.
“The second quarter of 2023 was a period of continued progress
at ZyVersa as we completed key corporate, developmental, regulatory
and financial initiatives designed to position the company to
achieve value-building milestones involving our Cholesterol Efflux
Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said
Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer,
and President of ZyVersa. “We are pleased to report our VAR 200
program is progressing as planned, and we anticipate initiation of
a Phase 2a clinical trial in diabetic kidney disease (DKD) in the
first quarter of 2024. For our Inflammasome ASC Inhibitor IC 100,
we are completing final preclinical activities to enable submission
of an Investigational New Drug (“IND”) application and initiation
of a first-in-human clinical trial in 2024.”
Mr. Glover concluded: “This is a very exciting time for ZyVersa
as we seek to create shareholder value through the development of
first-in-class drugs at the forefront of renal and inflammatory
diseases. Significant value-building milestones are expected to be
achieved for Cholesterol Efflux MediatorTM VAR 200 and Inflammasome
ASC Inhibitor IC 100 over the remainder of 2023 and early 2024 to
increase shareholder value.”
SECOND QUARTER AND RECENT PROGRAM UPDATES
Phase 2a-Ready Cholesterol Efflux Mediator™ VAR
200
- European patent was granted covering VAR 200 for use in
diabetic nephropathy/diabetic kidney disease
- Planning and key initiatives are underway to initiate a Phase
2a clinical trial in patients with DKD, with initial patient
enrollment expected by first quarter 2024
Inflammasome ASC Inhibitor IC 100
- Continued to provide support for the mechanism of action of
Inflammasome ASC Inhibitor IC 100 with consistent evidence across
peer-reviewed academic literature on the role of inflammasomes in
the pathogenesis of a broad range of diseases including Parkinson’s
disease, Alzheimer’s disease, lupus nephritis, peripheral arterial
disease, juvenile idiopathic arthritis, and alcoholic
hepatitis
- Enhanced Inflammatory Disease Scientific Advisory Board with
the addition of Dr. Douglas Golenbock, a pioneer and
internationally recognized authority in the field of innate
immunity
- Dr. Golenbock is 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
SECOND QUARTER FINANCIAL RESULTS
Since its inception in 2014 through June 30, 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 $0.2 million as of
June 30, 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 $1.2 million for the
three months ended June 30, 2023, an increase of $0.5 million or
69.7% from the three months ended June 30, 2022. The increase is
primarily attributable to an increase of $0.5 million in the costs
of manufacturing of IC 100.
General and administrative expenses were $3.9 million for the
three months ended June 30, 2023, an increase of $2.8 million or
237.5% from the three months ended June 30, 2022. The increase is
primarily attributable to $1.2 million of common stock granted to
certain stockholders in exchange for increasing the duration of
their lockup period for certain common stockholdings, $0.5 million
in professional fees associated with being a public company, a $0.5
million increase in marketing costs for investor and public
relations, $0.4 million in director and officer insurance, and $0.2
million for bonus accruals.
Pre-tax losses were $86.3 million for the three months ended
June 30, 2023, an increase of $84.3 million compared to a pre-tax
loss of approximately $2.0 million, for the three months ended June
30, 2022. The higher net loss reported for the three months ended
June 30, 2023 is primarily due to the impairment of in-process
research and development and impairment of goodwill of $69.3
million and $11.9 million, respectively, compared to none for the
three months ended June 30, 2022. The impairment is a result of the
decline in ZyVersa’s market capitalization as of June 30, 2023.
Net losses were $78.5 million for the three months ended June
30, 2023, an increase of $76.5 million compared to a net loss of
approximately $2.0 million for the three months ended June 30,
2022. A deferred tax benefit of $7.8 million for the three months
ended June 30, 2023, compared to no tax benefit or expense during
the three months ended June 30, 2022, resulted from the impairment
of the in-process research and development.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq-GM: 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 additional financing 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 ContactKaren CashmereChief
Commercial Officerkcashmere@zyversa.com786-251-9641
Media ContactsCasey
McDonaldcmcdonald@tiberend.com646-577-8520
Dave SchemeliaDschemelia@tiberend.com609-468-9325
|
ZYVERSA
THERAPEUTICS, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
Successor |
|
|
|
June 30, |
|
December 31, |
|
|
|
2023 |
|
2022 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
Cash |
$ |
228,693 |
|
|
$ |
5,902,199 |
|
|
Prepaid expenses and other current assets |
|
886,911 |
|
|
|
225,347 |
|
|
Vendor deposits |
|
- |
|
|
|
235,000 |
|
|
|
Total Current Assets |
|
1,115,604 |
|
|
|
6,362,546 |
|
Equipment, net |
|
12,133 |
|
|
|
17,333 |
|
In-process research and development |
|
30,806,158 |
|
|
|
100,086,329 |
|
Goodwill |
|
- |
|
|
|
11,895,033 |
|
Security deposit |
|
- |
|
|
|
46,659 |
|
Operating lease right-of-use asset |
|
53,898 |
|
|
|
98,371 |
|
|
|
|
|
|
|
|
|
Total
Assets |
$ |
31,987,793 |
|
|
$ |
118,506,271 |
|
|
|
|
|
|
|
Liabilities, Temporary Equity and Stockholders'
Equity |
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
$ |
8,144,033 |
|
|
$ |
6,025,645 |
|
|
Accrued expenses and other current liabilities |
|
2,281,026 |
|
|
|
2,053,559 |
|
|
Operating lease liability |
|
59,625 |
|
|
|
108,756 |
|
|
|
Total
Current Liabilities |
|
10,484,684 |
|
|
|
8,187,960 |
|
Deferred tax liability |
|
1,441,467 |
|
|
|
10,323,983 |
|
|
|
Total
Liabilities |
|
11,926,151 |
|
|
|
18,511,943 |
|
|
|
|
|
|
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
|
|
|
|
Successor redeemable common stock, subject to possible
redemption, |
|
|
|
|
0
and 65,783 shares outstanding as of June 30, 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, 200 and 8,635
shares issued |
|
|
|
and outstanding as of June 30, 2023 and December 31, 2022,
respectively |
|
- |
|
|
|
1 |
|
|
Series B preferred stock, 5,062 shares designated, 5,062 shares
issued |
|
|
|
|
and outstanding as of June 30, 2023 and December 31, 2022 |
|
1 |
|
|
|
1 |
|
|
Successor common stock, $0.0001 par value, 110,000,000 shares
authorized; |
|
|
|
23,669,074 and 9,016,139 shares issued at June 30, 2023 and
December 31, 2022, |
|
|
|
respectively, and 23,666,915 and 9,016,139 shares outstanding as
of |
|
|
|
|
June 30, 2023 and December 31, 2022, respectively |
|
2,367 |
|
|
|
902 |
|
|
Additional paid-in-capital |
|
107,044,663 |
|
|
|
104,583,271 |
|
|
Accumulated deficit |
|
(86,978,221 |
) |
|
|
(4,921,178 |
) |
|
Treasury stock, at cost, 2,159 and 0 shares at June 30, 2023 |
|
|
|
|
and December 31, 2022, respectively |
|
(7,168 |
) |
|
|
- |
|
|
|
Total
Stockholders' Equity |
|
20,061,642 |
|
|
|
99,662,997 |
|
|
|
|
|
|
|
|
|
Total
Liabilities, Temporary Equity and Stockholders' Equity |
$ |
31,987,793 |
|
|
$ |
118,506,271 |
|
|
|
|
|
|
|
|
ZYVERSA
THERAPEUTICS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Predecessor |
|
Successor |
|
|
Predecessor |
|
|
|
For the Three |
|
|
For the Three |
|
For the Six |
|
|
For the Six |
|
|
|
Months Ended |
|
|
Months Ended |
|
Months Ended |
|
|
Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
2023 |
|
|
2022 |
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
1,220,576 |
|
|
|
$ |
719,395 |
|
|
$ |
2,276,519 |
|
|
|
$ |
1,786,357 |
|
|
General and administrative |
|
3,929,225 |
|
|
|
|
1,164,013 |
|
|
|
7,465,362 |
|
|
|
|
3,465,382 |
|
|
Impairment of in-process research and development |
|
69,280,171 |
|
|
|
|
- |
|
|
|
69,280,171 |
|
|
|
|
- |
|
|
Impairment of goodwill |
|
11,895,033 |
|
|
|
|
- |
|
|
|
11,895,033 |
|
|
|
|
- |
|
|
|
Total Operating Expenses |
|
86,325,005 |
|
|
|
|
1,883,408 |
|
|
|
90,917,085 |
|
|
|
|
5,251,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From
Operations |
|
(86,325,005 |
) |
|
|
|
(1,883,408 |
) |
|
|
(90,917,085 |
) |
|
|
|
(5,251,739 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other (Income) Expense: |
|
|
|
|
|
|
|
|
|
|
Interest (income) expense |
|
314 |
|
|
|
|
140,404 |
|
|
|
(765 |
) |
|
|
|
308,468 |
|
|
Change in fair value of derivative liabilities |
|
- |
|
|
|
|
(19,600 |
) |
|
|
- |
|
|
|
|
192,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-Tax Net Loss |
|
(86,325,319 |
) |
|
|
|
(2,004,212 |
) |
|
|
(90,916,320 |
) |
|
|
|
(5,752,707 |
) |
|
|
Income tax benefit |
|
7,812,226 |
|
|
|
|
- |
|
|
|
8,859,277 |
|
|
|
|
- |
|
|
|
Net
Loss |
|
(78,513,093 |
) |
|
|
|
(2,004,212 |
) |
|
|
(82,057,043 |
) |
|
|
|
(5,752,707 |
) |
|
|
Deemed dividend to preferred stockholders |
|
(7,915,836 |
) |
|
|
|
(331,200 |
) |
|
|
(7,915,836 |
) |
|
|
|
(331,200 |
) |
|
|
Net
Loss Attributable to Common Stockholders |
$ |
(86,428,929 |
) |
|
|
$ |
(2,335,412 |
) |
|
$ |
(89,972,879 |
) |
|
|
$ |
(6,083,907 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per
Share |
|
|
|
|
|
|
|
|
|
|
|
-
Basic and Diluted |
$ |
(4.84 |
) |
|
|
$ |
(0.10 |
) |
|
$ |
(6.66 |
) |
|
|
$ |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
Average Number of |
|
|
|
|
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
|
|
|
|
|
|
|
|
-
Basic and Diluted |
|
17,855,762 |
|
|
|
|
24,167,257 |
|
|
|
13,517,314 |
|
|
|
|
24,167,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ZyVersa Therapeutics (NASDAQ:ZVSA)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
ZyVersa Therapeutics (NASDAQ:ZVSA)
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De Mai 2023 até Mai 2024