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, today provides a corporate
update, and reports financial results for the third quarter of 2023
ending September 30, 2023.
“The third quarter of 2023 marks substantial progress toward
meeting a key milestone at ZyVersa, initiation of the first
clinical trial with Cholesterol Efflux Mediator™ VAR 200 in
patients with diabetic kidney disease, planned for Q1-2024. We have
identified our clinical research organization (“CRO”) and study
site, manufactured clinical product, and started preparing our IND
amendment for submission in December,” said Stephen C. Glover,
Co-founder, Chairman, Chief Executive Officer, and President of
ZyVersa. “Regarding Inflammasome ASC Inhibitor IC 100, we are
nearing completion of pre-clinical requirements for conduct of our
GLP toxicology studies, the final phase of our preclinical program
before submitting an IND.”
Mr. Glover added: “We remain committed to our goals of
developing first-in-class drugs at the forefront of innovation for
patients with renal and inflammatory diseases. With the development
progress achieved for VAR 200 and IC 100 in 2023, we expect 2024 to
be a year to accomplish significant value-building milestones that
we believe will drive growth for our shareholders as we seek to
improve the lives of patients living with challenging renal and
inflammatory diseases.”
THIRD QUARTER AND RECENT PROGRAM UPDATES
Phase 2a-Ready Cholesterol Efflux Mediator™ VAR
200
- On track to begin a proof-of-concept
clinical trial in patients with DKD planned for Q1-2024.
- Granted European patent for use of VAR 200 in diabetic
nephropathy/diabetic kidney disease.
- Highlighted review article providing
further scientific support for VAR 200’s rationale for mediating
transport of cholesterol and lipids out of kidney cells.
Inflammasome ASC Inhibitor IC 100
- Nearing completion of pre-clinical requirements for conduct of
GLP toxicology studies and subsequent IND submission.
- Substantiated IC 100’s rationale for targeting ASC to inhibit
multiple types of inflammasomes with published data demonstrating
that NLRP3 inhibition alone is insufficient to attenuate
inflammation in diseases associated with activation of multiple
inflammasome pathways.
- Reinforced IC 100’s rationale for targeting ASC with multiple
peer-reviewed papers addressing the critical need to attenuate
inflammation spread to surrounding tissues and organs to minimize
development of co-morbidities.
THIRD QUARTER FINANCIAL RESULTS
Since its inception in 2014 through September 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 have limited our research and
development spending, and we expect our cash of $1.6 million as of
September 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 $0.7 million for the
three months ended September 30, 2023, a decrease of $1.7 million
or 71.1% from the three months ended September 30, 2022. This is
primarily attributable to a decrease of $1.7 million in the costs
of manufacturing materials for IC 100 as compared to the three
months ended September 30, 2022.
General and administrative expenses were $2.2 million for the
three months ended September 30, 2023, an increase of $1.2 million
or 110.1% from the three months ended September 30, 2022. This is
primarily attributable to an increase of $0.4 million in
professional fees associated with being a public company, a $0.3
million increase in director and officer insurance, a $0.2 million
increase for bonus accruals, and $0.1 million increase in marketing
costs for investor and public relations.
Net losses were approximately $2.9 million for the three months
ended September 30, 2023, which were $0.8 million or 21.4% less
than net losses of approximately $3.7 million for the three months
ended September 30, 2022. The net loss improvement was primarily
due to lower costs incurred in connection with our research and
development programs.
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. A
discussion of these and other factors, including risks and
uncertainties with respect to ZyVersa, is set forth in ZyVersa’s
filings with the Securities and Exchange Commission, including
ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q.
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.
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 |
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
Cash |
$ |
1,578,721 |
|
|
$ |
5,902,199 |
|
|
Prepaid expenses and other current assets |
|
426,519 |
|
|
|
225,347 |
|
|
Vendor deposits |
|
- |
|
|
|
235,000 |
|
|
Total Current Assets |
|
2,005,240 |
|
|
|
6,362,546 |
|
Equipment, net |
|
9,533 |
|
|
|
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 |
|
31,078 |
|
|
|
98,371 |
|
|
Total Assets |
$ |
32,852,009 |
|
|
$ |
118,506,271 |
|
|
|
|
|
|
Liabilities, Temporary Equity and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
$ |
8,897,534 |
|
|
$ |
6,025,645 |
|
|
Accrued expenses and other current liabilities |
|
2,775,485 |
|
|
|
2,053,559 |
|
|
Operating lease liability |
|
34,349 |
|
|
|
108,756 |
|
|
Total Current Liabilities |
|
11,707,368 |
|
|
|
8,187,960 |
|
Deferred tax liability |
|
1,440,982 |
|
|
|
10,323,983 |
|
|
Total Liabilities |
|
13,148,350 |
|
|
|
18,511,943 |
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Successor redeemable common stock, subject to possible
redemption, |
|
|
|
|
0 and 65,783 shares outstanding as of September 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, 50 and 8,635
shares issued |
|
|
|
and outstanding as of September 30, 2023 and December 31, 2022,
respectively |
|
- |
|
|
|
1 |
|
|
Series B preferred stock, 5,062 shares designated, 5,062 shares
issued |
|
|
|
|
and outstanding as of September 30, 2023 and December 31, 2022 |
|
1 |
|
|
|
1 |
|
|
Successor common stock, $0.0001 par value, 110,000,000 shares
authorized; |
|
|
|
|
43,517,560 and 9,016,139 shares issued at September 30, 2023 and
December 31, 2022, |
|
|
|
respectively, and 43,515,401 and 9,016,139 shares outstanding as
of |
|
|
|
|
September 30, 2023 and December 31, 2022, respectively |
|
4,353 |
|
|
|
902 |
|
|
Additional paid-in-capital |
|
109,587,097 |
|
|
|
104,583,271 |
|
|
Accumulated deficit |
|
(89,880,624 |
) |
|
|
(4,921,178 |
) |
|
Treasury stock, at cost, 2,159 and 0 shares at September 30,
2023 |
|
|
|
|
and December 31, 2022, respectively |
|
(7,168 |
) |
|
|
- |
|
|
Total Stockholders' Equity |
|
19,703,659 |
|
|
|
99,662,997 |
|
|
|
|
|
|
|
Total Liabilities, Temporary Equity and Stockholders'
Equity |
$ |
32,852,009 |
|
|
$ |
118,506,271 |
|
|
|
|
|
|
ZYVERSA
THERAPEUTICS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Predecessor |
|
Successor |
|
|
Predecessor |
|
|
|
For the
Three |
|
|
For the
Three |
|
For the
Nine |
|
|
For the
Nine |
|
|
|
Months
Ended |
|
|
Months
Ended |
|
Months
Ended |
|
|
Months
Ended |
|
|
|
September
30, |
|
|
September
30, |
|
September
30, |
|
|
September
30, |
|
|
|
|
2023 |
|
|
|
|
2022 |
|
|
|
2023 |
|
|
|
|
2022 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
673,943 |
|
|
|
$ |
2,334,120 |
|
|
$ |
2,950,462 |
|
|
|
$ |
4,120,477 |
|
|
General and administrative |
|
2,228,735 |
|
|
|
|
1,061,046 |
|
|
|
9,694,097 |
|
|
|
|
4,526,428 |
|
|
Impairment of in-process research and development |
|
- |
|
|
|
|
- |
|
|
|
69,280,171 |
|
|
|
|
- |
|
|
Impairment of goodwill |
|
- |
|
|
|
|
- |
|
|
|
11,895,033 |
|
|
|
|
- |
|
|
|
Total Operating Expenses |
|
2,902,678 |
|
|
|
|
3,395,166 |
|
|
|
93,819,763 |
|
|
|
|
8,646,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss From Operations |
|
(2,902,678 |
) |
|
|
|
(3,395,166 |
) |
|
|
(93,819,763 |
) |
|
|
|
(8,646,905 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other (Income) Expense: |
|
|
|
|
|
|
|
|
|
|
Interest (income) expense |
|
210 |
|
|
|
|
69,352 |
|
|
|
(555 |
) |
|
|
|
377,820 |
|
|
Change in fair value of derivative liabilities |
|
- |
|
|
|
|
228,100 |
|
|
|
- |
|
|
|
|
420,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-Tax Net Loss |
|
(2,902,888 |
) |
|
|
|
(3,692,618 |
) |
|
|
(93,819,208 |
) |
|
|
|
(9,445,325 |
) |
|
|
Income tax benefit |
|
485 |
|
|
|
|
- |
|
|
|
8,859,762 |
|
|
|
|
- |
|
|
|
Net Loss |
|
(2,902,403 |
) |
|
|
|
(3,692,618 |
) |
|
|
(84,959,446 |
) |
|
|
|
(9,445,325 |
) |
|
|
Deemed dividend to preferred stockholders |
|
(32,373 |
) |
|
|
|
(9,684,637 |
) |
|
|
(7,948,209 |
) |
|
|
|
(10,015,837 |
) |
|
|
Net Loss Attributable to Common Stockholders |
$ |
(2,934,776 |
) |
|
|
$ |
(13,377,255 |
) |
|
$ |
(92,907,655 |
) |
|
|
$ |
(19,461,162 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share |
|
|
|
|
|
|
|
|
|
|
|
-
Basic and Diluted |
$ |
(0.09 |
) |
|
|
$ |
(0.55 |
) |
|
$ |
(4.79 |
) |
|
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Number of |
|
|
|
|
|
|
|
|
|
|
|
Common Shares Outstanding |
|
|
|
|
|
|
|
|
|
|
|
-
Basic and Diluted |
|
30,978,540 |
|
|
|
|
24,167,257 |
|
|
|
19,403,027 |
|
|
|
|
24,167,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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