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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _______ to _______
Commission
File Number: 001-41184
ZYVERSA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
86-2685744 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(I.R.S.
Employer
Identification No.) |
|
|
|
2200
N. Commerce Parkway, Suite 208
Weston,
FL |
|
33326 |
(Address
of principal executive offices) |
|
(Zip
Code) |
|
|
|
(754)
231-1688 |
(Registrant’s
telephone number, including area code) |
N/A
(Former name, former address and former fiscal year,
if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value per share |
|
ZVSA |
|
The
Nasdaq Capital Market |
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes: ☒ No: ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes: ☒ No: ☐
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 |
☐ |
|
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
|
Smaller
reporting company |
☒ |
|
|
|
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.
Indicate
by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes: ☐ No: ☒
As
of November 11, 2024, the number of shares outstanding of the registrant’s common stock, $0.0001 par value per share, was 2,344,191.
Except
as otherwise indicated, all share and per share information in this Quarterly Report on Form 10-Q gives effect to the reverse stock
split of the registrant’s outstanding common stock at a ratio of one-for-ten shares, which was effected as of 4:01 p.m.
Eastern Time on April 25, 2024.
ZYVERSA
THERAPEUTICS, INC.
INDEX
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
PART
I FINANCIAL INFORMATION
Item
1. Financial Statements
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
September
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash | |
$ | 122,921 | | |
$ | 3,137,674 | |
Prepaid
expenses and other current assets | |
| 267,494 | | |
| 215,459 | |
Total
Current Assets | |
| 390,415 | | |
| 3,353,133 | |
Equipment, net | |
| - | | |
| 6,933 | |
In-process research and development | |
| 18,647,903 | | |
| 18,647,903 | |
Vendor deposit | |
| 178,476 | | |
| 98,476 | |
Deferred offering costs | |
| 207,130 | | |
| - | |
Operating
lease right-of-use asset | |
| - | | |
| 7,839 | |
Total
Assets | |
$ | 19,423,924 | | |
$ | 22,114,284 | |
| |
| | | |
| | |
Liabilities
and Stockholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts
payable | |
$ | 9,284,631 | | |
$ | 8,431,583 | |
Accrued
expenses and other current liabilities | |
| 2,257,372 | | |
| 1,754,533 | |
Operating
lease liability | |
| - | | |
| 8,656 | |
Total
Current Liabilities | |
| 11,542,003 | | |
| 10,194,772 | |
Deferred
tax liability | |
| 854,621 | | |
| 844,914 | |
Total
Liabilities | |
| 12,396,624 | | |
| 11,039,686 | |
| |
| | | |
| | |
Commitments and contingencies
(Note 6) | |
| - | | |
| | |
| |
| | | |
| | |
Stockholders’ Equity: | |
| | | |
| | |
Preferred stock, $0.0001
par value, 1,000,000 shares authorized: | |
| | | |
| | |
Series A preferred stock,
8,635 shares designated, 50 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | |
| - | | |
| - | |
Series B preferred stock,
5,062 shares designated, 5,062 shares issued and outstanding as of September 30, 2024 and December 31, 2023 | |
| 1 | | |
| 1 | |
Preferred stock value | |
| 1 | | |
| 1 | |
Common stock, $0.0001 par
value, 250,000,000 shares authorized; 1,074,203 and 405,212 shares issued at September 30, 2024 and December 31, 2023, respectively,
and 1,074,196 and 402,205 shares outstanding as of September 30, 2024 and December 31, 2023, respectively | |
| 107 | | |
| 40 | |
Common
stock, value | |
| 107 | | |
| 40 | |
Additional
paid-in-capital | |
| 118,245,220 | | |
| 114,300,849 | |
Accumulated
deficit | |
| (111,210,860 | ) | |
| (103,219,124 | ) |
Treasury
stock, at cost, 7 shares at September 30, 2024 and December 31, 2023, respectively | |
| (7,168 | ) | |
| (7,168 | ) |
Total
Stockholders’ Equity | |
| 7,027,300 | | |
| 11,074,598 | |
| |
| | | |
| | |
Total
Liabilities and Stockholders’ Equity | |
$ | 19,423,924 | | |
$ | 22,114,284 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 436,043 | | |
$ | 673,943 | | |
$ | 1,658,030 | | |
$ | 2,950,462 | |
General and administrative | |
| 1,833,578 | | |
| 2,228,735 | | |
| 6,192,205 | | |
| 9,694,097 | |
Impairment of in-process research and development | |
| - | | |
| - | | |
| - | | |
| 69,280,171 | |
Impairment of goodwill | |
| - | | |
| - | | |
| - | | |
| 11,895,033 | |
Total Operating Expenses | |
| 2,269,621 | | |
| 2,902,678 | | |
| 7,850,235 | | |
| 93,819,763 | |
Loss From Operations | |
| (2,269,621 | ) | |
| (2,902,678 | ) | |
| (7,850,235 | ) | |
| (93,819,763 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other (Income) Expense: | |
| | | |
| | | |
| | | |
| | |
Interest (income) expense | |
| 131,635 | | |
| 210 | | |
| 131,794 | | |
| (555 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax (provision) benefit | |
| - | | |
| 485 | | |
| (9,707 | ) | |
| 8,859,762 | |
Net Loss | |
| (2,401,256 | ) | |
| (2,902,403 | ) | |
| (7,991,736 | ) | |
| (84,959,446 | ) |
Deemed dividend to preferred stockholders | |
| - | | |
| (32,373 | ) | |
| - | | |
| (7,948,209 | ) |
Net Loss Attributable to Common Stockholders | |
$ | (2,401,256 | ) | |
$ | (2,934,776 | ) | |
$ | (7,991,736 | ) | |
$ | (92,907,655 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss Per Share | |
| | | |
| | | |
| | | |
| | |
- Basic and Diluted | |
$ | (2.43 | ) | |
$ | (30.18 | ) | |
$ | (9.79 | ) | |
$ | (1,591.46 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Number of Common Shares Outstanding | |
| | | |
| | | |
| | | |
| | |
- Basic and Diluted | |
| 988,378 | | |
| 97,252 | | |
| 816,293 | | |
| 58,379 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
For
The Three and Nine Months Ended September 30, 2024 and 2023
(Unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
For the Three and Nine Months Ended September 30, 2024 | |
| |
Series A | | |
Series B | | |
| | |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Preferred Stock | | |
Preferred Stock | | |
Common Stock | | |
Treasury Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance - December 31, 2023 | |
| 50 | | |
$ | - | | |
| 5,062 | | |
$ | 1 | | |
| 405,212 | | |
$ | 40 | | |
| (7 | ) | |
$ | (7,168 | ) | |
$ | 114,300,849 | | |
$ | (103,219,124 | ) | |
$ | 11,074,598 | |
Exercise of warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 213,800 | | |
| 21 | | |
| - | | |
| - | | |
| 2,672,479 | | |
| - | | |
| 2,672,500 | |
Exercise of pre-funded warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 131,481 | | |
| 13 | | |
| - | | |
| - | | |
| (13 | ) | |
| - | | |
| - | |
Issuance of common stock pursuant to vendor agreements | |
| - | | |
| - | | |
| - | | |
| - | | |
| 9,000 | | |
| 1 | | |
| - | | |
| - | | |
| 79,199 | | |
| - | | |
| 79,200 | |
Round up share adjustment due to reverse split | |
| - | | |
| - | | |
| - | | |
| - | | |
| 75,410 | | |
| 8 | | |
| - | | |
| - | | |
| (8 | ) | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 223,573 | | |
| - | | |
| 223,573 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,826,737 | ) | |
| (2,826,737 | ) |
Balance - March 31, 2024 | |
| 50 | | |
| - | | |
| 5,062 | | |
| 1 | | |
| 834,903 | | |
| 83 | | |
| (7 | ) | |
| (7,168 | ) | |
| 117,276,079 | | |
| (106,045,861 | ) | |
| 11,223,134 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 160,664 | | |
| - | | |
| 160,664 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,763,743 | ) | |
| (2,763,743 | ) |
Balance - June 30, 2024 | |
| 50 | | |
| - | | |
| 5,062 | | |
| 1 | | |
| 834,903 | | |
| 83 | | |
| (7 | ) | |
| (7,168 | ) | |
| 117,436,743 | | |
| (108,809,604 | ) | |
| 8,620,055 | |
Warrant inducement offer - exercise proceeds [1] | |
| - | | |
| - | | |
| - | | |
| - | | |
| 239,300 | | |
| 24 | | |
| - | | |
| - | | |
| 400,900 | | |
| - | | |
| 400,924 | |
Warrant modification | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 246,912 | | |
| | | |
| 246,912 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 160,665 | | |
| - | | |
| 160,665 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,401,256 | ) | |
| (2,401,256 | ) |
Balance - September 30, 2024 | |
| 50 | | |
$ | - | | |
| 5,062 | | |
$ | 1 | | |
| 1,074,203 | | |
$ | 107 | | |
| (7 | ) | |
$ | (7,168 | ) | |
$ | 118,245,220 | | |
$ | (111,210,860 | ) | |
$ | 7,027,300 | |
| |
For the Three and Nine Months Ended September 30, 2023 | |
| |
Series A | | |
Series B | | |
| | |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Preferred Stock | | |
Preferred Stock | | |
Common Stock | | |
Treasury Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance - December 31, 2022 | |
| 8,635 | | |
$ | 1 | | |
| 5,062 | | |
$ | 1 | | |
| 25,760 | | |
$ | 3 | | |
| - | | |
$ | - | | |
$ | 104,584,170 | | |
$ | (4,921,178 | ) | |
$ | 99,662,997 | |
Reclassification of formerly redeemable common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| 188 | | |
| - | | |
| - | | |
| - | | |
| 331,331 | | |
| - | | |
| 331,331 | |
Issuance of common stock pursuant to vendor agreements | |
| - | | |
| - | | |
| - | | |
| - | | |
| 371 | | |
| - | | |
| - | | |
| - | | |
| 395,200 | | |
| - | | |
| 395,200 | |
Registration costs associated with preferred stock issuance | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (34,674 | ) | |
| - | | |
| (34,674 | ) |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 287,461 | | |
| - | | |
| 287,461 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,543,950 | ) | |
| (3,543,950 | ) |
Balance - March 31, 2023 | |
| 8,635 | | |
| 1 | | |
| 5,062 | | |
| 1 | | |
| 26,319 | | |
| 3 | | |
| - | | |
| - | | |
| 105,563,488 | | |
| (8,465,128 | ) | |
| 97,098,365 | |
Registered offering of common stock [2] | |
| - | | |
| - | | |
| - | | |
| - | | |
| 31,473 | | |
| 3 | | |
| - | | |
| - | | |
| 9,831,016 | | |
| - | | |
| 9,831,019 | |
Redemption of Series A Preferred Stock | |
| (8,400 | ) | |
| (1 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,080,000 | ) | |
| - | | |
| (10,080,001 | ) |
Conversion of Series A Preferred Stock into common stock | |
| (35 | ) | |
| - | | |
| - | | |
| - | | |
| 50 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Shares issued as consideration for extension of lock-up period | |
| - | | |
| - | | |
| - | | |
| - | | |
| 8,698 | | |
| 1 | | |
| - | | |
| - | | |
| 1,156,777 | | |
| - | | |
| 1,156,778 | |
Issuance of common stock pursuant to vendor agreements | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,086 | | |
| - | | |
| - | | |
| - | | |
| 210,000 | | |
| - | | |
| 210,000 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 365,742 | | |
| - | | |
| 365,742 | |
Treasury stock acquired, at cost | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7 | ) | |
| (7,168 | ) | |
| - | | |
| - | | |
| (7,168 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (78,513,093 | ) | |
| (78,513,093 | ) |
Balance - June 30, 2023 | |
| 200 | | |
| - | | |
| 5,062 | | |
| 1 | | |
| 67,626 | | |
| 7 | | |
| (7 | ) | |
| (7,168 | ) | |
| 107,047,023 | | |
| (86,978,221 | ) | |
| 20,061,642 | |
Balance | |
| 200 | | |
| - | | |
| 5,062 | | |
| 1 | | |
| 67,626 | | |
| 7 | | |
| (7 | ) | |
| (7,168 | ) | |
| 107,047,023 | | |
| (86,978,221 | ) | |
| 20,061,642 | |
Registered offering of common stock [3] | |
| - | | |
| - | | |
| - | | |
| - | | |
| 9,303 | | |
| 1 | | |
| - | | |
| - | | |
| 1,575,937 | | |
| - | | |
| 1,575,938 | |
Warrant modification | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 181,891 | | |
| - | | |
| 181,891 | |
Redemption of Series A Preferred Stock | |
| (150 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (215,048 | ) | |
| - | | |
| (215,048 | ) |
Exercise of pre-funded warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 27,061 | | |
| 3 | | |
| - | | |
| - | | |
| 944 | | |
| - | | |
| 947 | |
Warrant inducement offer - exercise proceeds[4] | |
| - | | |
| - | | |
| - | | |
| - | | |
| 20,346 | | |
| 2 | | |
| - | | |
| - | | |
| 757,645 | | |
| - | | |
| 757,647 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 243,045 | | |
| - | | |
| 243,045 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,902,403 | ) | |
| (2,902,403 | ) |
Balance - September 30, 2023 | |
| 50 | | |
$ | - | | |
| 5,062 | | |
$ | 1 | | |
| 124,336 | | |
$ | 13 | | |
| (7 | ) | |
$ | (7,168 | ) | |
$ | 109,591,437 | | |
$ | (89,880,624 | ) | |
$ | 19,703,659 | |
Balance | |
| 50 | | |
$ | - | | |
| 5,062 | | |
$ | 1 | | |
| 124,336 | | |
$ | 13 | | |
| (7 | ) | |
$ | (7,168 | ) | |
$ | 109,591,437 | | |
$ | (89,880,624 | ) | |
$ | 19,703,659 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ZYVERSA
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash Flows From Operating Activities: | |
| | | |
| | |
Net loss | |
$ | (7,991,736 | ) | |
$ | (84,959,446 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Impairment of in-process research and development | |
| - | | |
| 69,280,171 | |
Impairment of goodwill | |
| - | | |
| 11,895,033 | |
Stock-based compensation | |
| 544,902 | | |
| 896,248 | |
Issuance of common stock pursuant to vendor agreements | |
| 79,200 | | |
| 605,200 | |
Shares issued as consideration for extension of lock-up period | |
| - | | |
| 1,156,778 | |
Depreciation of fixed assets | |
| 6,933 | | |
| 7,800 | |
Non-cash rent expense | |
| 7,839 | | |
| 67,293 | |
Deferred tax provision (benefit) | |
| 9,707 | | |
| (8,883,001 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (52,035 | ) | |
| (201,172 | ) |
Security deposit | |
| - | | |
| 46,659 | |
Vendor deposits | |
| (80,000 | ) | |
| 235,000 | |
Deferred offering costs | |
| (30,260 | ) | |
| - | |
Accounts payable | |
| 676,178 | | |
| 2,871,889 | |
Operating lease liability | |
| (8,656 | ) | |
| (74,407 | ) |
Accrued expenses and other current liabilities | |
| 502,839 | | |
| 1,122,488 | |
| |
| | | |
| | |
Net Cash Used In Operating Activities | |
| (6,335,089 | ) | |
| (5,933,467 | ) |
| |
| | | |
| | |
| |
| | | |
| | |
Cash Flows From Financing Activities: | |
| | | |
| | |
Proceeds from issuance of common stock in public offering | |
| - | | |
| 13,114,555 | |
Registration and issuance costs associated with common stock issuance | |
| (180,142 | ) | |
| (1,763,584 | ) |
Redemption of Series A Preferred Stock | |
| - | | |
| (10,695,610 | ) |
Purchase of treasury stock | |
| - | | |
| (7,168 | ) |
Exercise of pre-funded warrants | |
| - | | |
| 947 | |
Exercise of warrants | |
| 2,672,500 | | |
| - | |
Warrant inducement offer - exercise proceeds | |
| 827,978 | | |
| 966,349 | |
Registration and issuance costs associated with preferred stock issuance | |
| - | | |
| (5,500 | ) |
| |
| | | |
| | |
Net Cash Provided By Financing Activities | |
| 3,320,336 | | |
| 1,609,989 | |
| |
| | | |
| | |
Net Decrease in Cash | |
| (3,014,753 | ) | |
| (4,323,478 | ) |
| |
| | | |
| | |
Cash - Beginning of Period | |
| 3,137,674 | | |
| 5,902,199 | |
| |
| | | |
| | |
Cash - End of Period | |
$ | 122,921 | | |
$ | 1,578,721 | |
| |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
Reclassification of formerly redeemable common stock | |
$ | - | | |
$ | 331,331 | |
Accounts payable for deferred offering costs | |
$ | 176,870 | | |
$ | 44,892 | |
Warrant modification - incremental value | |
$ | - | | |
$ | 181,891 | |
Warrant inducement offer - incremental value | |
$ | 246,912 | | |
$ | 134,591 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ZYVERSA THERAPEUTICS, INC.
Notes to Condensed Consolidated Financial Statements
Note
1 – Business Organization, Nature of Operations and Basis of Presentation
Organization and Operations
ZyVersa
Therapeutics, Inc. (“ZyVersa” and the “Company”) is a clinical stage biopharmaceutical company leveraging proprietary
technologies to develop first-in-class drugs for patients with chronic renal or inflammatory diseases with high unmet medical needs.
The Company’s mission is to develop drugs that optimize health outcomes and improve patients’ quality of life.
Basis
of Presentation and Principles of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information. Accordingly, they do not
include all of the information and disclosures required by accounting principles generally accepted in the United States of America
for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal
recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements
of the Company as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023. The results of
operations for the nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year.
These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements
and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2023, filed with the
Securities and Exchange Commission (“SEC”) on March 25, 2024 and as amended on May 15, 2024.
On
December 4, 2023, the Company effected a reverse stock split of its common stock at a ratio of 1-for-35 (the “2023 Reverse Split”).
Upon the effectiveness of the 2023 Reverse Split, every 35 issued shares of common stock were reclassified and combined into one share
of common stock. In addition, the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible
securities and warrants was proportionally decreased, and the corresponding conversion price or exercise price was proportionally increased.
No fractional shares were issued as a result of the 2023 Reverse Split.
On
April 25, 2024, the Company effected a reverse stock split of its common stock at a ratio of 1-for-10 (the “2024 Reverse Split”).
Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares of common stock were reclassified and combined into one share
of common stock. In addition, the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible
securities and warrants was proportionally decreased, and the corresponding conversion price or exercise price was proportionally increased.
No fractional shares were issued as a result of the 2024 Reverse Split.
Accordingly,
all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively,
where applicable, to reflect the 2023 Reverse Split and the 2024 Reverse Split and adjustment of the conversion price or exercise price
of each outstanding equity award, convertible security and warrant as if the transaction had occurred as of the beginning of the earliest
period presented. See Note 7 – Stockholders’ Permanent and Temporary Equity – Reverse Stock Split.
Note
2 - Going Concern and Management’s Plans
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not
include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
As
of September 30, 2024, the Company had cash of approximately $0.1 million and a working capital deficit of approximately $11.2 million.
During the nine months ended September 30, 2024, the Company incurred a net loss of approximately $8.0 million and used cash in operations
of approximately $6.3 million. The Company has an accumulated deficit of approximately $111.2 million as of September 30, 2024.
The
Company has not yet achieved profitability and expects to continue to incur cash outflows from operations. It is expected that its research
and development and general and administrative expenses will continue to increase and, as a result, the Company will eventually need
to generate significant product revenues to achieve profitability.
Consequently,
the Company will be required to raise additional funds through equity or debt financing. Subsequent to September 30, 2024, the Company
raised an aggregate of $3.1
million from stock warrant exercises and
its “at-the-market” facility. See Note 8 – Subsequent Events for additional details.
Management believes that the Company has access to capital resources and continues to evaluate additional financing opportunities; however,
there can be no assurance that it will be successful in securing additional capital or that the Company will be able to obtain funds
on commercially acceptable terms, if at all. There is also no assurance that the amount of funds the Company might raise will enable
the Company to complete its development initiatives or attain profitable operations. The aforementioned conditions raise substantial
doubt about the Company’s ability to continue as a going concern for at least one year from the issuance date of these financial
statements.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
Note
3 – Summary of Significant Accounting Policies
Since
the date the Company’s December 31, 2023 financial statements were issued in its 2023 Annual Report on Form 10-K, there have been
no material changes to the Company’s significant accounting policies.
Use
of Estimates
Preparation
of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the
amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company
bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the
circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations
for equity securities, share based compensation and acquired intangible assets, as well as establishment of valuation allowances for
deferred tax assets. Certain of the Company’s estimates could be affected by external conditions, including those unique to the
Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates.
Deferred
Offering Costs
Deferred
offering costs, which primarily consist of direct, incremental professional fees incurred in connection with a debt or equity financing,
are capitalized as deferred offering costs (a non-current asset) on the balance sheet. Once the financing closes, the Company reclassifies
such costs as either discounts to notes payable or as a reduction of proceeds received from equity transactions so that such costs are
recorded as a reduction of additional paid-in capital. If the completion of a contemplated financing was deemed to be no longer probable,
the related deferred offering costs would be charged to general and administrative expense in the consolidated financial statements.
Net
Loss Per Common Share
Basic
net loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during
the period. Diluted net income per common share is computed by dividing net income by the weighted average number of common and dilutive
common-equivalent shares outstanding during each period.
The
following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net
loss per share because to do so would be anti-dilutive:
Schedule
of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Warrants [1] | |
| 928,593 | | |
| 103,929 | |
Options | |
| 9,639 | | |
| 10,170 | |
Series A Convertible Preferred Stock | |
| 72 | | |
| 72 | |
Series B Convertible Preferred Stock | |
| 2,067 | | |
| 2,067 | |
Total potentially dilutive shares | |
| 940,371 | | |
| 116,239 | |
Segment
Reporting
The
Company operates and manages its business as one reportable and operating segment. All assets and operations are in the U.S. The Company’s
Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes
of allocating resources and evaluating financial performance.
Reclassifications
Certain
prior period balances have been reclassified from security deposits to vendor deposits on the condensed consolidated balance sheet in
order to conform to the current year presentation. These reclassifications had no effect on previously reported results of operations
or loss per share.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07,
Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through
enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal
years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects
on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be
required upon adoption of ASU 2023-07.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
Note
4 – Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following as of September 30, 2024 and December 31, 2023:
Schedule of Accrued Expenses and
Other Current Liabilities
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
L&F milestone payment liability | |
$ | - | | |
$ | 500,000 | |
Payroll accrual | |
| 979,030 | | |
| 668,803 | |
Other accrued expenses | |
| 163,269 | | |
| 41,969 | |
Bonus accrual | |
| 1,107,812 | | |
| 536,500 | |
Registration delay liability [1] | |
| 7,261 | | |
| 7,261 | |
Total accrued expenses and other current liabilities | |
$ | 2,257,372 | | |
$ | 1,754,533 | |
Note
5 – Income Taxes
Income
tax expense and the effective tax rate were as follows:
Schedule
of Income Taxes Expense Effective Tax Rate
(in thousands) | |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
(in thousands) | |
2024 | | |
2023 | |
Income tax (expense) benefit | |
$ | (9,707 | ) | |
$ | 8,859,762 | |
| |
| | | |
| | |
Effective tax rate | |
| (0.12 | )% | |
| 9.44 | % |
The
tax provisions for the nine months ended September 30, 2024 and 2023 were computed using the estimated effective tax rates applicable
to the taxable jurisdictions for the full year. The Company’s tax rate is subject to management’s quarterly review and revision,
as necessary. The Company’s effective tax rate was (0.12)% and 9.44% for the nine months ended September 30, 2024 and 2023, respectively. The
decrease in the quarterly rates is primarily the result of the Company recording a full valuation allowance during the nine months ended
September 30, 2024 due to the reversal of a significant deferred tax liability that existed as of September 30, 2023.
Note
6 – Commitments and Contingencies
Litigations,
Claims and Assessments
In
the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course
of business. The Company records contingent liabilities resulting from such claims, if any, when a loss is assessed to be probable and
the amount of the loss is reasonably estimable.
Disputed
Vendor Invoices
On
June 30, 2024 and July 1, 2024, the Company received two invoices from a vendor in the amounts of $992,176 and $162,800, respectively.
The June 30, 2024 invoice represents retroactive interest on invoices going back to September 30, 2022. The July 1, 2024 invoice consisted
of miscellaneous unsupported charges performed over the past several years. On August 1, 2024, ZyVersa management sent the vendor a letter
disputing these invoices and has requested the vendor to rescind each of them. The Company received additional invoices dated July 31,
2024, August 31, 2024, and September 30, 2024 in the amounts of $76,453, $81,826, and $87,481, respectively. Similar to the prior invoices, management
has requested the vendor to rescind each of them. Although the Company has requested the vendor to rescind each of them, the Company
believes that in accordance with the agreement, the vendor can legally charge the Company interest from the point they were notified.
As such, the Company included the calculated interest from July 1, 2024 to September 30, 2024 of $131,300 within accrued expenses and
other current liabilities on the condensed consolidated balance sheet at September 30, 2024.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
License
Agreements
L&F
Research LLC
The
Company entered into a License Agreement with L&F Research LLC (“L&F”) effective December 15, 2015, as amended
(the “L&F License Agreement”) pursuant to which L&F granted the Company an exclusive royalty-bearing, worldwide,
sublicensable license under the patent and intellectual property rights and know-how specific to and for the development and commercialization
of VAR 200, for the treatment, inhibition or prevention of kidney disease in humans and symptoms thereof, including focal segmental glomerulosclerosis.
On
February 28, 2023, the Company and L&F executed an Amendment and Restatement Agreement that waived L&F’s right to terminate
the L&F License Agreement or any other remedies, for non-payment of the First Milestone Payment, until (a) March 31, 2023 as to $1,000,000
of such milestone payments (“Waiver A”) and (b) January 31, 2024 as to $500,000 milestone payments (“Waiver B”).
Waiver A was contingent upon (i) forgiveness by the Company of $351,579 in aggregate principal amount outstanding under a certain convertible
note, and (ii) a cash payment by the Company to L&F in the amount of $648,421, on or before March 31, 2023. Waiver B was contingent
upon a cash payment by the Company to L&F in the amount of $500,000 on or before the earlier of (x) January 31, 2024, and (y) ten
business days from the date that the Company received net proceeds of at least $30,000,000 from the issuance of new equity capital. All
other terms of the L&F License remain in effect.
On
March 29, 2023, the Company paid the $648,421 of cash to L&F, thus meeting the conditions of Waiver A, which also had the effect
of canceling the Note Receivable and the Put Option and resulted in a reclassification of 188 shares of common stock and $331,331 classified
as temporary equity to permanent equity.
On
January 30, 2024, the Company paid $500,000 of cash to L&F, thus meeting the conditions of Waiver B.
Operating
Leases
On
January 18, 2019, the Company entered into a lease agreement for approximately 3,500
square feet of office space in Weston, Florida for a term of five years. Under the lease agreement, the annual base rent, which
excludes the Company’s share of taxes and operating costs, was approximately $89,000
for the first year and has increased approximately 3% every year thereafter for a total base rent lease commitment of approximately
$497,000.
On January 15, 2024, the Company extended the lease for an additional year for a total base rent lease commitment of $112,064.
The Company used the short-term lease practical expedient which permits the Company to not capitalize leases with a term equal to or
less than 12 months.
The
Company recognized right-of-use asset amortization of $0 and $7,839 in connection with its operating lease for the three and nine months
ending September 30, 2024, respectively, and the Company recognized rent expense of $42,696 and $127,439 in connection with its operating lease for
the three and nine months ending September 30, 2024, respectively.
The
Company recognized right-of-use amortization of $38,885 and $116,083 in connection with its operating lease for the three and nine months
ending September 30, 2023, respectively.
A
summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right of
Use Assets and Liabilities
| |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows used in operating activities | |
$ | 8,656 | | |
$ | 74,405 | |
| |
| | | |
| | |
Right-of-use assets obtained in exchange for lease obligations | |
| | | |
| | |
Operating leases | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
Weighted Average Remaining Lease Term | |
| | | |
| | |
Operating leases | |
| - | | |
| 0.34 Years | |
| |
| | | |
| | |
Weighted Average Discount Rate | |
| | | |
| | |
Operating leases | |
| - | | |
| 6.5 | % |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
Note
7 – Stockholders’ Permanent and Temporary Equity
Reverse
Stock Split
On
April 25, 2024, the Company effected the 2024 Reverse Split. Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares
of common stock were reclassified and combined into one share of common stock. In addition, the number of shares of common stock issuable
upon the exercise of the Company’s equity awards, convertible securities and warrants was proportionally decreased, and the corresponding
conversion price or exercise price was proportionally increased. No fractional shares were issued as a result of the 2024 Reverse Split.
See Note 1 – Business Organization, Nature of Operations and Basis of Presentation for additional details.
Common Stock
On
January 2, 2024, the Company entered into a marketing agreement with a vendor in which the Company issued an aggregate of 9,000 shares
of common stock and cash in exchange for marketing services. The $79,200 fair value of the common stock was established as a prepaid
expense and the Company recognized the expense over the six month contract term.
Temporary
Equity
See
Note 6 – Commitments and Contingencies – License Agreements for discussion of the movement of temporary equity to permanent
equity on March 29, 2023.
Stock-Based
Compensation
For
the three months ended September 30, 2024 the Company recorded stock-based compensation expense of $160,665
(of which, $15,447
was included in research and development and $145,218
was included in general and administrative expense) related to options issued to employees and consultants. For the three months
ended September 30, 2023 the Company recorded stock-based compensation expense of $243,045
(of which, ($38,224)
was included in research and development expense and $281,269
was included in general and administrative expense) related to options issued to employees and consultants.
For
the nine months ended September 30, 2024 the Company recorded stock-based compensation expense of $544,902
(of which, $46,342
was included in research and development expense and $498,560
was included in general and administrative expense) related to options issued to employees and consultants. For the nine months
ended September 30, 2023 the Company recorded stock-based compensation expense of $896,249
(of which, $117,320
was included in research and development expense and $778,929
was included in general and administrative expense) related to options issued to employees and consultants. As of September 30, 2024
there was $482,559
of unrecognized stock-based compensation expense, which the Company expects to recognize over a weighted average period of 1.3
years.
Stock
Options
The
grant date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was determined using the Black
Scholes method, with the following assumptions used:
Schedule of Stock
Options Granted
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
| N/A | | |
| N/A | | |
| N/A | | |
| $0.44 - $2.23 | |
Risk free interest rate | |
| N/A | | |
| N/A | | |
| N/A | | |
| 3.53% - 4.27 | % |
Expected term (years) | |
| N/A | | |
| N/A | | |
| N/A | | |
| 6.00 | |
Expected volatility | |
| N/A | | |
| N/A | | |
| N/A | | |
| 120% - 123 | % |
Expected dividends | |
| N/A | | |
| N/A | | |
| N/A | | |
| 0.00 | % |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
A
summary of the option activity for the nine months ended September 30, 2024 is presented below:
Schedule
of Stock Option Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Options | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 | |
| 10,243 | | |
$ | 2,218.51 | | |
| | | |
| | |
Granted | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| (604 | ) | |
| 1,760.50 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 9,639 | | |
$ | 2,247.21 | | |
| 5.5 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 6,797 | | |
$ | 2,986.26 | | |
| 5.7 | | |
$ | - | |
The
following table presents information related to stock options as of September 30, 2024:
Schedule
of Information Related to Stock Options
Options Outstanding | | |
Options Exercisable | |
| | |
| | |
Weighted | | |
| |
| | |
Outstanding | | |
Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Options | | |
In Years | | |
Options | |
$ | 152.50 | | |
| 4,157 | | |
| 8.6 | | |
| 1,674 | |
$ | 738.50 | | |
| 286 | | |
| 8.3 | | |
| 96 | |
$ | 791.00 | | |
| 38 | | |
| 8.4 | | |
| 13 | |
$ | 1,760.50 | | |
| 1,306 | | |
| 2.1 | | |
| 1,306 | |
$ | 3,965.50 | | |
| 37 | | |
| 7.7 | | |
| 37 | |
$ | 4,053.00 | | |
| 2,095 | | |
| 4.5 | | |
| 2,095 | |
$ | 5,726.00 | | |
| 1,720 | | |
| 6.7 | | |
| 1,576 | |
| | | |
| 9,639 | | |
| 5.7 | | |
| 6,797 | |
Stock
Warrants
Between
February 26, 2024 and March 6, 2024, investors in the public offering completed on December 11, 2023 (the “December 2023 Offering”) exercised warrants to
purchase 213,800
shares of common stock at an exercise price of $12.50
per share for total proceeds of $2,672,500.
Between
January 17 and February 23, 2024, a December 2023 Offering investor exercised pre-funded warrants to purchase 131,500 shares of common
stock on a cashless basis to purchase 131,481 shares of common stock at an exercise price of $0.001 per share.
On
August 1, 2024, the Company initiated a limited time program, which was immediately accepted by the warrant holder, that permitted
the holder to exercise its December 2023 Offering warrants at a reduced exercise price of $3.46 per
share and granted new warrants to purchase up to (i) 392,000 shares
of common stock which became exercisable upon stockholder approval with an exercise term of five years and (ii) 86,600 shares
of common stock which became exercisable upon stockholder approval with an exercise term of 18 months.
The Company received stockholder approval for the warrants on October 29, 2024 and the warrants have an exercise price of $3.46 per
share. Under the program, the warrant holder submitted an exercise notice and the related aggregate cash exercise price to purchase 239,300 shares
of common stock on August 1, 2024 for gross proceeds of $827,978 less
issuance costs of $427,054.
Issuance costs included placement agent fees of $50,000,
placement agent legal fees of $50,000,
Company legal fees of $57,267,
other expenses of $22,875 and
warrant modification costs of $246,912.
Because the modification represented a short-term inducement, modification accounting was only performed on the warrants that were
actually exercised under the program. The Company recognized the $246,912 modification
date incremental value of the modified warrants and additional warrants issued as compared to the original warrants, as an issuance
cost of the warrant exercise.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
The
issuance date fair value of stock warrants issued during the three and nine months ended September 30, 2024 and 2023 was determined using
the Black Scholes method, with the following assumptions used:
Schedule
of Issuance Date Fair Value of Stock Warrants
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
$ | 3.46 | | |
| $47.50 - $57.75 | | |
$ | 3.46 | | |
| $47.50 - $350.00 | |
Risk free interest rate | |
| 3.62% - 4.62 | % | |
| 4.09% - 4.42 | % | |
| 3.62% - 4.62 | % | |
| 3.51%
- 4.42 | % |
Expected term (years) | |
| 0.9 - 5.5 years | | |
| 4.9 - 5.5 years | | |
| 0.9 - 5.5 years | | |
| 5 years | |
Expected volatility | |
| 96% - 113 | % | |
| 121% - 123 | % | |
| 96% - 113 | % | |
| 121% - 123 | % |
Expected dividends | |
| n/a | | |
| n/a | | |
| n/a | | |
| n/a | |
A
summary of the warrant activity for the nine months ended September 30, 2024, is presented below:
Summary of Warrant Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 [1] | |
| 903,320 | | |
$ | 123.44 | | |
| | | |
| | |
Issued | |
| 478,600 | | |
| 3.46 | | |
| | | |
| | |
Forfeited | |
| (227 | ) | |
| 4,053 | | |
| | | |
| | |
Exercised [2] | |
| (453,100 | ) | |
| 7.73 | | |
| | | |
| | |
Repriced - Old [3] | |
| (239,300 | ) | |
| 12.50 | | |
| | | |
| | |
Repriced - New [3] | |
| 239,300 | | |
| 3.46 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 928,593 | | |
$ | 114.83 | | |
| 3.73 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 928,393 | | |
$ | 114.48 | | |
| 3.73 | | |
$ | - | |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
The
following table presents information related to stock warrants as of September 30, 2024:
Schedule of Information Related to Stock Warrants
Warrants Outstanding | | |
Warrants Exercisable | |
| | |
Outstanding | | |
Weighted Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Warrants | | |
In Years | | |
Warrants | |
$ | 3.46 | | |
| 478,600 | | |
| 4.45 | | |
| 478,600 | |
$ | 12.50 | | |
| 346,900 | | |
| 2.75 | | |
| 346,900 | |
$ | 47.50 | | |
| 20,347 | | |
| 4.45 | | |
| 20,347 | |
$ | 57.75 | | |
| 19,965 | | |
| 3.77 | | |
| 19,965 | |
$ | 350.00 | | |
| 27,551 | | |
| 3.57 | | |
| 27,551 | |
$ | 700.00 | | |
| 13,944 | | |
| 3.20 | | |
| 13,944 | |
$ | 1,760.50 | | |
| 300 | | |
| 0.10 | | |
| 100 | |
$ | 2,415.00 | | |
| 3,651 | | |
| 3.20 | | |
| 3,651 | |
$ | 4,025.00 | | |
| 17,335 | | |
| 3.20 | | |
| 17,335 | |
| | | |
| 928,593 | | |
| 3.73 | | |
| 928,393 | |
Effectiveness
Failure
In
connection with the business combination with Larkspur Health Acquisition Corp., the Company conducted the Series A Preferred Stock Financing.
On or about February 20, 2023, the Company failed to have the SEC declare a registration statement effective (the “Effectiveness
Failure”) which covered the Series A Preferred Stock registrable securities within the time period prescribed by the Securities
Purchase Agreement (the “SPA”). The SPA entitles the investors to receive registration delay payments (“Registration
Delay Payments”) equal to 1.5% of each investor’s purchase price on the date of the Effectiveness Failure and every thirty
days thereafter that the Effectiveness Failure persists. Failure to make the Registration Delay Payments on a timely basis result in
the accrual of interest at the rate of 2.0% per month. On April 28, 2023, the proceeds from the April 2023 Offering were used to make
most of the Registration Delay Payments and redeem substantially all of the Series A Preferred Stock. As of September 30, 2024, the Company
has accrued additional Registration Delay Payments of approximately $7,261 in the aggregate.
Note
8 – Subsequent Events
At-The-Market
Offering
Subsequent
to September 30, 2024, the Company received approximately $1.39 million in gross proceeds from the sale of 564,495 shares of its common
stock pursuant to its ATM Agreement with A.G.P. for its “at-the-market” facility.
Common
Stock
Subsequent
to September 30, 2024, the Company entered into marketing agreements with two vendors, pursuant to which the Company issued an
aggregate of 51,000
shares of common stock in exchange for marketing services. The fair value of the common stock was established as a prepaid expense
and the Company is recognizing $47,670
of the expense over the six month term of one of the contracts and $69,000
of the expense over the three month term of the other contract.
Stock
Warrants
On
November 5, 2024, the Company initiated a limited time program, which was immediately accepted by warrant holders, that permitted the
holders to exercise 339,900 of its December 2023 and 478,600 of its August 2024 Common Stock Purchase warrants at a reduced exercise
price of $2.06 per share from $12.50 and $3.46 per share, respectively. New warrants were granted to purchase 1,637,000 shares
of common stock at an exercise price of $2.06 per share with an exercise term of 5 years from stockholder approval.
Under
the program, the warrant holders submitted exercise notices and the related aggregate cash exercise price to purchase an aggregate of
818,500 shares of common stock on November 5, 2024 for gross proceeds of $1,686,110. However, due to beneficial ownership
limitations, only 654,500 of the 818,500 shares of common stock have been issued through the filing date. The remaining 164,000
unissued shares of common stock are held in abeyance pending availability under the beneficial ownership limitations. Issuance costs
include financial advisor fees of $110,000 and reimbursement to the financial advisor for non-accountable fees of $10,000.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of the results of operations and financial condition of ZyVersa Therapeutics, Inc. (the “Company,”
“we,” “us” or “our”) as of September 30, 2024 and for the three and nine months ended September 30,
2024 and 2023 should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those financial
statements that are included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis should be read in conjunction
with the Company’s audited financial statements and related disclosures as of December 31, 2023 and for the year then ended, which
are included in the Form 10-K (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”)
on March 25, 2024, as amended on May 15, 2024. This Management’s Discussion and Analysis of Financial Condition and Results of
Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are
subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,”
“will,” “expect,” “believe,” “anticipate,” “intend,” “could,”
“estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because
of the factors discussed in “Risk Factors” in our Annual Report, and other factors that we may not know. Except as otherwise
required by applicable law, we disclaim any duty to update any forward-looking statements, all of which are expressly qualified by the
statements above, to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q.
Business
Overview
We
are a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs
for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome
space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol
Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR
200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential
for numerous indications. The total accessible market is over $100 billion.
Financial
Operations Overview
We
have not generated any revenue to date and have incurred significant operating losses. Our net losses were $8.0 million for the period
from January 1, 2024 through September 30, 2024, compared to $85.0 million for the period from January 1, 2023 through September 30,
2023. As of September 30, 2024, we had an accumulated deficit of approximately $111.2 million and cash of $0.1 million. We expect to
continue to incur significant expenses for the foreseeable future and to incur operating losses. We expect our expenses will increase
in connection with our ongoing activities as we:
|
● |
progress
development of VAR 200 and IC 100; |
|
|
|
|
● |
prepare
and file regulatory submissions; |
|
|
|
|
● |
begin
to manufacture our product candidates for clinical trials; |
|
|
|
|
● |
hire
additional research and development, finance, and general and administrative personnel; |
|
|
|
|
● |
protect
and defend our intellectual property; and |
|
|
|
|
● |
meet
the requirements of being a public company. |
We
will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity
or debt financings or other sources, which may include government grants and collaborations with third parties. Adequate additional financing
may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact
on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve
profitability, and we may never do so.
Components
of Operating Results
Revenue
Since
inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the near future.
If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration
or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from
collaboration or license agreements.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist of costs incurred in the discovery and development of our product candidates, and primarily include:
|
● |
expenses
incurred under third party agreements with contract research organizations (“CROs”), and investigative sites, that conducted
or will conduct our clinical trials and a portion of our pre-clinical activities; |
|
|
|
|
● |
costs
of raw materials, as well as manufacturing cost of our materials used in clinical trials and other development testing; |
|
|
|
|
● |
expenses,
including salaries, stock-based compensation and benefits of employees engaged in research and development activities; |
|
|
|
|
● |
costs
of equipment, depreciation and other allocated expenses; and |
|
|
|
|
● |
fees
paid for contracted regulatory services as well as fees paid to regulatory authorities including the U.S. Food and Drug Administration
(the “FDA”) for review and approval of our product candidates. |
We
expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of
the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based
on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements
as prepaid expenses or accrued expenses.
Research
and development activities are central to our business model. We expect that our research and development expenses will continue to increase
for the foreseeable future as we continue clinical development for our product candidates. As products enter later stages of clinical
development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to
the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related
to the development of VAR 200 and IC 100. As we advance VAR 200 and IC 100, as well as identify any other potential product candidates,
we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development
expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources, including potential
collaborations with other companies or other strategic transactions.
The
successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature,
timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net
cash inflows may commence from our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with
the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:
|
● |
the
number of clinical sites included in the clinical trials; |
|
|
|
|
● |
the
length of time required to enroll suitable patients; |
|
|
|
|
● |
the
size of patient populations participating in the clinical trials; |
|
|
|
|
● |
the
number of doses a patient receives; |
|
|
|
|
● |
the
duration of patient follow-ups; |
|
|
|
|
● |
the
development state of the product candidates; and |
|
|
|
|
● |
the
efficacy and safety profile of the product candidates. |
Our
expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals, and the expense of filing,
prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving regulatory
approval for our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or
modify clinical trials of our product candidates. A change in the outcome of any of these variables with respect to the development of
a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.
For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently
anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant
additional financial resources and time on the completion of clinical development. Product commercialization will take several years
and likely millions of dollars in development costs.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries, stock-based compensation and related costs for our employees in administrative,
executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, audit, tax
and consulting services, insurance, human resource, information technology, office, and travel expenses.
We
expect that our general and administrative expenses will increase in the future as we increase our general and administrative headcount
to support our continued research and development and potential commercialization of our product candidates. We also expect to incur
substantial expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance
services, director and officer insurance, and investor and public relations costs.
Results
of Operations
Comparison
of the three months ended September 30, 2024 and the three months ended September 30, 2023
The
following table summarizes our results of operations for the three months ended September 30, 2024 and for the three months ended September
30, 2023.
| |
For the Three Months Ended | | |
Favorable | |
| |
September 30, | | |
(Unfavorable) | |
(in thousands) | |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 436 | | |
$ | 674 | | |
$ | 238 | | |
| 35.3 | % |
General and administrative | |
| 1,834 | | |
| 2,229 | | |
| 395 | | |
| 17.7 | % |
Total Operating Expenses | |
| 2,270 | | |
| 2,903 | | |
| 633 | | |
| 21.8 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| (2,270 | ) | |
| (2,903 | ) | |
| 633 | | |
| 21.8 | % |
| |
| | | |
| | | |
| | | |
| | |
Other (Income) Expense, Net | |
| 131 | | |
| - | | |
| (131 | ) | |
| (100.0 | )% |
| |
| | | |
| | | |
| | | |
| | |
Pre-tax net loss | |
| (2,401 | ) | |
| (2,903 | ) | |
| 502 | | |
| 17.3 | % |
Income tax benefit | |
| - | | |
| 1 | | |
| (1 | ) | |
| (100.0 | )% |
Net loss | |
$ | (2,401 | ) | |
$ | (2,902 | ) | |
$ | 501 | | |
| 17.3 | % |
Research
and Development Expenses
Research
and development expenses were approximately $0.4 million for the three months ended September 30, 2024, a decrease of approximately $0.2
million or 35.3% from the three months ended September 30, 2023. The decrease is primarily attributable to a decrease of $0.2 million
in the manufacturing and pre-clinical costs of IC 100 and VAR 200.
General
and Administrative Expenses
General
and administrative expenses were approximately $1.8 million for the three months ended September 30, 2024, a decrease of approximately
$0.4 million or 17.7% from the three months ended September 30, 2023. The decrease is attributable to a $0.1 million decrease in professional
fees due to reduced fees of public auditors and legal counsel, a $0.2 million decrease in director and officer insurance due to reduced
costs in the second year of being a public company, and a $0.1 million decrease in stock-based compensation as a result of options becoming
fully amortized in 2024.
Other
(Expense) Income, Net
Interest
expense was approximately $0.1 million for the three months ended September 30, 2024, an increase of approximately $0.1 million or 100%
from the three months ended September 30, 2023. The increase is primarily attributable to an increase in interest charged by a vendor
for outstanding amounts owed.
Comparison
of the nine months ended September 30, 2024 and the nine months ended September 30, 2023
The
following table summarizes our results of operations for the nine months ended September 30, 2024 and for the nine months ended September
30, 2023.
| |
For the Nine Months Ended | | |
Favorable | |
| |
September 30, | | |
(Unfavorable) | |
(in thousands) | |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 1,658 | | |
$ | 2,951 | | |
$ | 1,293 | | |
| 43.8 | % |
General and administrative | |
| 6,192 | | |
| 9,694 | | |
| 3,502 | | |
| 36.1 | % |
Impairment of in-process research and development | |
| - | | |
| 69,280 | | |
| 69,280 | | |
| 100.0 | % |
Impairment of goodwill | |
| - | | |
| 11,895 | | |
| 11,895 | | |
| 100.0 | % |
Total Operating Expenses | |
| 7,850 | | |
| 93,820 | | |
| 85,970 | | |
| 91.6 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| (7,850 | ) | |
| (93,820 | ) | |
| 85,970 | | |
| 91.6 | % |
| |
| | | |
| | | |
| | | |
| | |
Other (Income) Expense, Net | |
| 132 | | |
| (1 | ) | |
| 133 | | |
| 13300.0 | % |
| |
| | | |
| | | |
| | | |
| | |
Pre-tax net loss | |
| (7,982 | ) | |
| (93,819 | ) | |
| 85,837 | | |
| 91.5 | % |
Income tax (provision) benefit | |
| (10 | ) | |
| 8,860 | | |
| (8,870 | ) | |
| (100.0 | )% |
Net loss | |
$ | (7,992 | ) | |
$ | (84,959 | ) | |
$ | 76,967 | | |
| 90.6 | % |
Research
and Development Expenses
Research
and development expenses were approximately $1.7 million for the nine months ended September 30, 2024, a decrease of approximately $1.3
million or 43.8% from the nine months ended September 30, 2023. The decrease is primarily attributable to a decrease of $1.2 million
in the manufacturing and pre-clinical costs of IC 100 and a decrease of approximately $0.5 million in payroll expenses due to employee
attrition. This was slightly offset by an increase of approximately $0.4 million in contract research organization expenses for the production
of VAR 200.
General
and Administrative Expenses
General
and administrative expenses were approximately $6.2 million for the nine months ended September 30, 2024, a decrease of approximately
$3.5 million or 36.1% from the nine months ended September 30, 2023. The decrease is primarily attributable to $1.2 million of common
stock granted to certain members of the Sponsor and recognized in 2023 in exchange for increasing the duration of the period during which
they are not permitted to sell their common stock, a $0.5 million decrease in professional fees due to reduced fees related to public
auditors and legal counsel, a $0.2 million decrease in marketing costs for investor and public relations as a result of a reduction in
marketing vendors in 2024, and a $0.4 million decrease in expense for the Effectiveness Failure related to shares issued to investors
pursuant to a securities purchase agreement in July 2022, a $0.5 million decrease in director and officer insurance due to reduced costs
in the second year of being a public company, a $0.5 million decrease in payroll expenses as a result of a prior period bonus accrual
recognized upon board approval and a $0.2 million for decrease in stock-based compensation as a result of options becoming fully amortized
in 2024
Impairment
of In-Process Research and Development and Goodwill
For
the nine months ended September 30, 2023, impairment of in-process research and development and impairment of goodwill were $69.3 million
and $11.9 million, respectively. The impairment was a result of the decline in stock value and market capitalization of the Company at
June 30, 2023. There was no impairment for the nine months ended September 30, 2024.
Cash
Flows
The
following table summarizes our cash flows from operating and financing activities for the nine months ended September 30, 2024 and for
the nine months ended September 30, 2023:
| |
For the Nine Months Ended September 30, | | |
Increase | |
(in thousands) | |
2024 | | |
2023 | | |
(decrease) | |
Net cash provided by (used in) | |
| | | |
| | | |
| | |
Operating activities | |
$ | (6,335 | ) | |
$ | (5,933 | ) | |
$ | (402 | ) |
Financing activities | |
| 3,320 | | |
| 1,610 | | |
| 1,710 | |
Net Decrease in Cash | |
$ | (3,015 | ) | |
$ | (4,323 | ) | |
$ | 1,308 | |
Cash
Flows from Operating Activities
Net
cash used in operating activities was approximately $6.3 million and approximately $5.9 million for the nine months ended September 30,
2024 and 2023, respectively. For the nine months ended September 30, 2024 and 2023, the net cash used in operating activities was primarily
attributable to the net loss of approximately $8.0 million and $85.0 million, respectively, offset by $0.6 million and $75.0 million,
respectively, of net non-cash expenses, and approximately $1.0 million and $4.0 million, respectively, of cash generated by the levels
of operating assets and liabilities, respectively.
Net
Cash Provided By Financing Activities
Net
cash provided by financing activities was $3.3 million and $1.6 million for the nine months ended September 30, 2024 and 2023, respectively.
Cash provided by financing activities during the nine months ended September 30, 2024 primarily represented proceeds from the exercise
of warrants. Cash provided by financing activities during the nine months ended September 30, 2023 primarily represented $13.1 million
in proceeds from the issuance of common stock in a public offering. This was partially offset by $10.7 million in cash paid for the redemption
of Series A Preferred Stock and $1.8 million in registration and issuance costs associated with common stock issuances.
Liquidity
and Capital Resources
The
following table summarizes our total current assets, liabilities and working capital deficiency at September 30, 2024 and 2023, respectively:
| |
September 30, | | |
December 31, | |
(in thousands) | |
2024 | | |
2023 | |
Current Assets | |
$ | 390 | | |
$ | 3,353 | |
Current Liabilities | |
$ | 11,542 | | |
$ | 10,195 | |
Working Capital Deficiency | |
$ | (11,152 | ) | |
$ | (6,842 | ) |
Since
our inception in 2014 through September 30, 2024, we have not generated any revenue and have incurred significant operating losses and
negative cash flows from our operations. Based on our current operating plan, we expect our cash of $0.1 million as of September 30,
2024 will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. However,
it is difficult to predict our spending for our product candidates prior to obtaining FDA approval. Moreover, changing circumstances
may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected
because of circumstances beyond our control.
Going
Concern
Since
inception we have been engaged in organizational activities, including raising capital and research and development activities. We have
not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations.
There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks
associated with any pre-revenue stage pharmaceutical company that has substantial expenditures for research and development. There can
be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory
approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological
change and are largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the
success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going
concern for 12 months after the issuance date of our financial statements. The accompanying financial statements have been prepared on
a going concern basis. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability
and classification of assets or the amounts and classification of liabilities that may result from the possible inability of us to continue
as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary
course of business. We incurred a net loss of $8.0 million for the nine months ended September 30, 2024 and a net loss of $85.0 million
for the nine months ended September 30, 2023, and we had an accumulated deficit of $111.2 million at September 30, 2024. We anticipate
incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently
in development. Our primary source of capital has been the issuance of debt and equity securities. We believe that current cash is only
sufficient to fund operations and capital requirements on a month-to-month basis. Additional financing will be needed by us to fund our
operations, to complete development of and to commercially develop our product candidates. There is no assurance that such financing
will be available when needed or on acceptable terms.
Subsequent to
September 30, 2024, the Company raised an aggregate of $3.1 million from stock warrant exercises and its “at-the-market”
facility with A.G.P.
Contractual
Obligations
The
following summarizes our contractual obligations as of September 30, 2024 that will affect our future liquidity. Based on our current
operating plan, we plan to satisfy the obligations identified below from our current cash balance and future financing.
Cash
requirements for our current liabilities as of September 30, 2024 include approximately $11.5 million for accounts payable and accrued
expenses.
Capital
Needs
On
September 16, 2024, we entered into a Sales Agreement (the “ATM Agreement”) with A.G.P. pursuant to which we may offer
and sell shares of common stock up to an aggregate offering proceeds of $1,397,396 from time to time. Sales of our common stock
under the ATM Agreement may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4)
promulgated under the Securities Act of 1933, as amended. Subsequent to September 30, 2024, the Company raised $1.39 million in
gross proceeds under the ATM Agreement.
We
intend to raise additional capital in the future to fund continued development of VAR200 and IC100.
We
expect to raise additional capital by issuing equity, equity-linked securities, or debt in subsequent offerings. If we are unable to
raise additional capital on terms favorable to us, we may not have sufficient liquidity to execute on our business strategy. We have
various warrants outstanding that can be exercised for our common stock, many of which must be exercised in exchange for cash paid to
us by the holders of such warrants. If the market price of our common stock is less than the exercise price of a holder’s warrants,
it is unlikely that holders will exercise their warrants. As such, we do not expect to receive significant proceeds in the near term
from the exercise of most of our warrants based on the current market price of our common stock and the exercise prices of such warrants.
Our
policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide
liquidity while producing a modest return on investment. Accordingly, our cash equivalents will be invested primarily in money market
funds.
We
expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our
product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product
candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing
expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including
personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate
governance, internal controls and similar requirements applicable to us as a public company.
Our
future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:
|
● |
the
initiation, progress, timing, costs and results of clinical trials for our product candidates; |
|
● |
the
clinical development plans we establish for each product candidate; |
|
● |
the
number and characteristics of product candidates that we develop or may in-license; |
|
● |
the
terms of any collaboration agreements we may choose to execute; |
|
● |
the
outcome, timing and cost of meeting regulatory requirements established by the FDA or other comparable foreign regulatory authorities; |
|
● |
the
cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
|
● |
the
cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us; |
|
● |
the
cost and timing of the implementation of commercial scale manufacturing activities; and |
|
● |
the
cost of establishing, or outsourcing, sales, marketing and distribution capabilities for any product candidates for which we may
receive regulatory approval in regions where we choose to commercialize our products on our own. |
To
continue to grow our business over the longer term, we plan to commit substantial resources to research and development, clinical trials
of our product candidates, and other operations and potential product acquisitions and in-licensing. We have evaluated and expect to
continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in-license and develop additional products
and product candidates to augment our internal development pipeline. Strategic transaction opportunities that we may pursue could materially
affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. In addition,
we may pursue development, acquisition or in-licensing of approved or development products in new or existing therapeutic areas or continue
the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to
license or acquire additional products, product candidates or companies to expand our operations, or for general corporate purposes.
Strategic transactions may require us to raise additional capital through one or more public or private debt or equity financings or
could be structured as a collaboration or partnering arrangement. We have no arrangements, agreements, or understandings in place at
the present time to enter into any acquisition, in-licensing or similar strategic business transaction. In addition, we continue to evaluate
commercial collaborations and strategic relationships with established pharmaceutical companies, which would provide us with more immediate
access to marketing, sales, market access and distribution infrastructure.
If
we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would
result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to
take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional
equity that we raise may contain terms, such as liquidation and other preferences that are not favorable to us or our existing stockholders.
If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable
rights to our technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us.
JOBS
Act Accounting Election
ZyVersa
is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. The JOBS
Act permits companies with emerging growth company status to take advantage of an extended transition period to comply with new or revised
accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. ZyVersa expects
to use this extended transition period to enable it to comply with new or revised accounting standards that have different effective
dates for public and private companies until the earlier of the date the Company (1) is no longer an emerging growth company or (2) affirmatively
and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be
comparable to companies that comply with the new or revised accounting standards as of public company effective dates.
In
addition, the Company intends to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act.
Off-Balance
Sheet Arrangements
There
are no off-balance sheet arrangements between us and any other entity that have, or are reasonably likely to have, a current or future
effect on financial conditions, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures
or capital resources that is material to stockholders.
Critical
Accounting Estimates
We
prepare our condensed consolidated financial statements in accordance with U.S. generally accepted accounting principles, which require
our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities
at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that
there are material differences between these estimates and actual results, our financial condition or results of operations would be
affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account
of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We
consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were
highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact
on our financial condition or results of operations. There are items within our financial statements that require estimation but are
not deemed critical, as defined above.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed
to ensure that information required to be disclosed in company reports filed or submitted under the Exchange Act is accumulated and communicated
to management, including our Chief Executive Officer and Chief Financial Officer (who serve as our Principal Executive Officer and Principal
Financial and Accounting Officer, respectively), to allow timely decisions regarding required disclosure.
As
required by Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer and Chief Financial Officer carried out an evaluation
of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2024. Based upon their
evaluation and due to the material weakness cited below, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were ineffective.
Specifically,
management’s conclusion was based on the following material weakness which existed as of December 31, 2023 and September 30, 2024:
|
● |
Business
process controls across the entity’s financial reporting processes were not effectively designed and implemented to properly
address the risk of material misstatement, including controls without proper segregation of duties between preparer and reviewer |
Our
management is committed to taking further action and implementing necessary enhancements or improvements, including actions to address
the material weakness identified as of December 31, 2023. Management expects to complete the development and implementation of its remediation
plan during 2024.
Changes
in Internal Control over Financial Reporting
Management
has implemented additional controls to address the material weakness identified as of December 31, 2023. This includes the implementation
of proper segregation of duties controls between preparer and reviewer. However, the material weakness will not be deemed to be remediated
until the controls have been operational for a period of time and have been verified to be operating effectively.
Inherent
Limitations of the Effectiveness of Controls
Management
does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all
error and fraud. A control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable,
not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements
due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
None.
ITEM
1A. RISK FACTORS.
As
a “smaller reporting company”, we are not required to provide information required by this Item. However, investors are encouraged
to review our current risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC
on March 25, 2024, as amended on May 15, 2024.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
Insider
Trading Plans
During
the nine months ended September 30, 2024, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company
adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,”
as each term is defined in Item 408(a) of Regulation S-K.
ITEM
6. EXHIBITS.
Exhibit |
|
Description |
3.1 |
|
Seconded Amended and Restated Certificate of Incorporation of ZyVersa Therapeutics, Inc., as amended. (incorporated by reference to Exhibit 3.1 of the Company’s quarterly report on Form 10-Q filed with the SEC on August 9, 2024). |
4.1 |
|
Form of Series A-1 Warrant (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 8-K filed with the SEC on August 1, 2024). |
4.2 |
|
Form of Series B-1 Warrant (incorporated by reference to Exhibit 4.2 of the Company’s current report on Form 8-K filed with the SEC on August 1, 2024). |
4.3 |
|
Form of Series A-2 Warrant (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 8-K filed with the SEC on November 6, 2024). |
10.1 |
|
Inducement Letter, dated August 1, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed with the SEC on August 1, 2024). |
10.2 |
|
Financial Advisory Agreement, dated August 1, 2024 (incorporated by reference to Exhibit 10.2 of the Company’s current report on Form 8-K filed with the SEC on August 1, 2024). |
10.3 |
|
Sales Agreement dated September 16, 2024, by and between ZyVersa Therapeutics, Inc., and A.G.P./Alliance Global Partners (incorporated by reference to Exhibit 1.1 of the Company’s current report on Form 8-K filed with the SEC on September 16, 2024). |
10.4# |
|
Amended and Restated ZyVersa Therapeutics, Inc. 2022 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K filed with the SEC on October 30, 2024). |
10.5 |
|
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). |
10.6 |
|
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). |
31.1* |
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a). |
31.2* |
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a). |
32.1** |
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
101.INS** |
|
Inline XBRL
Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded
within the Inline XBRL document). |
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document. |
101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB* |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
104* |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101). |
# |
Management contract or compensatory plan or arrangement. |
* |
Filed
herewith. |
** |
Furnished
herewith. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this quarterly report to be signed on its
behalf by the undersigned hereunto duly authorized.
Dated:
November 14, 2024 |
By: |
/s/
Stephen C, Glover |
|
|
Stephen
C. Glover |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Dated:
November 14, 2024 |
By: |
/s/
Peter Wolfe |
|
|
Peter
Wolfe |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit 31.1
Certification of
Principal Executive Officer
of ZyVersa Therapeutics, Inc.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Stephen C. Glover, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of ZyVersa Therapeutics, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f) for the registrant and we have: |
|
|
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
|
|
d) |
Disclosed
in this annual report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected,
or is likely to materially affect, the registrant’s internal control over financial reporting; and |
|
|
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent function): |
|
|
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Dated:
November 14, 2024 |
By: |
/s/
Stephen C. Glover |
|
Name: |
Stephen
C. Glover |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Exhibit 31.2
Certification of
Principal Executive Officer
of ZyVersa Therapeutics, Inc.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Peter Wolfe, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of ZyVersa Therapeutics, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f) for the registrant and we have: |
|
|
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
|
|
d) |
Disclosed
in this annual report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected,
or is likely to materially affect, the registrant’s internal control over financial reporting; and |
|
|
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent function): |
|
|
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting. |
Dated:
November 14, 2024 |
By: |
/s/
Peter Wolfe |
|
Name: |
Peter
Wolfe |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of ZyVersa Therapeutics, Inc. (the “Company”) on Form 10-Q for the quarter ended September
30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned
officers of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that, to such officer’s knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of the dates and for the periods expressed in the Report.
Dated: |
November
14, 2024 |
By: |
/s/
Stephen C. Glover |
|
Name: |
Stephen
C. Glover |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Dated: |
November
14, 2024 |
By: |
/s/
Peter Wolfe |
|
Name: |
Peter
Wolfe |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
v3.24.3
Cover - $ / shares
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Nov. 11, 2024 |
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|
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Current Fiscal Year End Date |
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|
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Entity File Number |
001-41184
|
|
Entity Registrant Name |
ZYVERSA
THERAPEUTICS, INC.
|
|
Entity Central Index Key |
0001859007
|
|
Entity Tax Identification Number |
86-2685744
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DE
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Weston
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FL
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33326
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(754)
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231-1688
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v3.24.3
Condensed Consolidated Balance Sheets - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Current Assets: |
|
|
Cash |
$ 122,921
|
$ 3,137,674
|
Prepaid expenses and other current assets |
267,494
|
215,459
|
Total Current Assets |
390,415
|
3,353,133
|
Equipment, net |
|
6,933
|
In-process research and development |
18,647,903
|
18,647,903
|
Vendor deposit |
178,476
|
98,476
|
Deferred offering costs |
207,130
|
|
Operating lease right-of-use asset |
|
7,839
|
Total Assets |
19,423,924
|
22,114,284
|
Current Liabilities: |
|
|
Accounts payable |
9,284,631
|
8,431,583
|
Accrued expenses and other current liabilities |
2,257,372
|
1,754,533
|
Operating lease liability |
|
8,656
|
Total Current Liabilities |
11,542,003
|
10,194,772
|
Deferred tax liability |
854,621
|
844,914
|
Total Liabilities |
12,396,624
|
11,039,686
|
Commitments and contingencies (Note 6) |
|
|
Stockholders’ Equity: |
|
|
Common stock, value |
107
|
40
|
Additional paid-in-capital |
118,245,220
|
114,300,849
|
Accumulated deficit |
(111,210,860)
|
(103,219,124)
|
Treasury stock, at cost, 7 shares at September 30, 2024 and December 31, 2023, respectively |
(7,168)
|
(7,168)
|
Total Stockholders’ Equity |
7,027,300
|
11,074,598
|
Total Liabilities and Stockholders’ Equity |
19,423,924
|
22,114,284
|
Series A Preferred Stock [Member] |
|
|
Stockholders’ Equity: |
|
|
Preferred stock value |
|
|
Series B Preferred Stock [Member] |
|
|
Stockholders’ Equity: |
|
|
Preferred stock value |
$ 1
|
$ 1
|
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v3.24.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
1,000,000
|
1,000,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
250,000,000
|
250,000,000
|
Common stock, shares issued |
1,074,203
|
405,212
|
Common stock, shares outstanding |
1,074,196
|
402,205
|
Treasury stock shares |
7
|
7
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
8,635
|
8,635
|
Preferred stock, shares issued |
50
|
50
|
Preferred stock, shares outstanding |
50
|
50
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
5,062
|
5,062
|
Preferred stock, shares issued |
5,062
|
5,062
|
Preferred stock, shares outstanding |
5,062
|
5,062
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Operating Expenses: |
|
|
|
|
Research and development |
$ 436,043
|
$ 673,943
|
$ 1,658,030
|
$ 2,950,462
|
General and administrative |
1,833,578
|
2,228,735
|
6,192,205
|
9,694,097
|
Impairment of in-process research and development |
|
|
|
69,280,171
|
Impairment of goodwill |
|
|
|
11,895,033
|
Total Operating Expenses |
2,269,621
|
2,902,678
|
7,850,235
|
93,819,763
|
Loss From Operations |
(2,269,621)
|
(2,902,678)
|
(7,850,235)
|
(93,819,763)
|
Other (Income) Expense: |
|
|
|
|
Interest (income) expense |
131,635
|
210
|
131,794
|
(555)
|
Pre-Tax Net Loss |
(2,401,256)
|
(2,902,888)
|
(7,982,029)
|
(93,819,208)
|
Income tax (provision) benefit |
|
485
|
(9,707)
|
8,859,762
|
Net Loss |
(2,401,256)
|
(2,902,403)
|
(7,991,736)
|
(84,959,446)
|
Deemed dividend to preferred stockholders |
|
(32,373)
|
|
(7,948,209)
|
Net Loss Attributable to Common Stockholders |
$ (2,401,256)
|
$ (2,934,776)
|
$ (7,991,736)
|
$ (92,907,655)
|
Net Loss Per Share |
|
|
|
|
Basic |
$ (2.43)
|
$ (30.18)
|
$ (9.79)
|
$ (1,591.46)
|
Diluted |
$ (2.43)
|
$ (30.18)
|
$ (9.79)
|
$ (1,591.46)
|
Weighted Average Number of Common Shares Outstanding |
|
|
|
|
Basic |
988,378
|
97,252
|
816,293
|
58,379
|
Diluted |
988,378
|
97,252
|
816,293
|
58,379
|
X |
- References
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v3.24.3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member]
Series A Preferred Stock [Member]
|
Preferred Stock [Member]
Series B Preferred Stock [Member]
|
Common Stock [Member] |
Treasury Stock, Common [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
|
$ 1
|
$ 1
|
$ 3
|
|
$ 104,584,170
|
$ (4,921,178)
|
$ 99,662,997
|
Balance, shares at Dec. 31, 2022 |
|
8,635
|
5,062
|
25,760
|
|
|
|
|
Issuance of common stock pursuant to vendor agreements |
|
|
|
|
|
395,200
|
|
395,200
|
Issuance of common stock pursuant to vendor agreements, shares |
|
|
|
371
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
287,461
|
|
287,461
|
Net loss |
|
|
|
|
|
|
(3,543,950)
|
(3,543,950)
|
Reclassification of formerly redeemable common stock |
|
|
|
|
|
331,331
|
|
331,331
|
Reclassification of formerly redeemable common stock, shares |
|
|
|
188
|
|
|
|
|
Registration costs associated with preferred stock issuance |
|
|
|
|
|
(34,674)
|
|
(34,674)
|
Balance at Mar. 31, 2023 |
|
$ 1
|
$ 1
|
$ 3
|
|
105,563,488
|
(8,465,128)
|
97,098,365
|
Balance, shares at Mar. 31, 2023 |
|
8,635
|
5,062
|
26,319
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 1
|
$ 1
|
$ 3
|
|
104,584,170
|
(4,921,178)
|
99,662,997
|
Balance, shares at Dec. 31, 2022 |
|
8,635
|
5,062
|
25,760
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
(84,959,446)
|
Balance at Sep. 30, 2023 |
|
|
$ 1
|
$ 13
|
$ (7,168)
|
109,591,437
|
(89,880,624)
|
19,703,659
|
Balance, shares at Sep. 30, 2023 |
|
50
|
5,062
|
124,336
|
(7)
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 1
|
$ 1
|
$ 3
|
|
105,563,488
|
(8,465,128)
|
97,098,365
|
Balance, shares at Mar. 31, 2023 |
|
8,635
|
5,062
|
26,319
|
|
|
|
|
Issuance of common stock pursuant to vendor agreements |
|
|
|
|
|
210,000
|
|
210,000
|
Issuance of common stock pursuant to vendor agreements, shares |
|
|
|
1,086
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
365,742
|
|
365,742
|
Net loss |
|
|
|
|
|
|
(78,513,093)
|
(78,513,093)
|
Registered offering of common stock |
[1] |
|
|
$ 3
|
|
9,831,016
|
|
9,831,019
|
Registered offering of common stock , shares |
[1] |
|
|
31,473
|
|
|
|
|
Redemption of Series A Preferred Stock |
|
$ (1)
|
|
|
|
(10,080,000)
|
|
(10,080,001)
|
Redemption of Series A Preferred Stock, shares |
|
(8,400)
|
|
|
|
|
|
|
Conversion of Series A Preferred Stock into common stock |
|
|
|
|
|
|
|
|
Conversion of series A preferred stock into common stock , shares |
|
(35)
|
|
50
|
|
|
|
|
Shares issued as consideration for extension of lock-up period |
|
|
|
$ 1
|
|
1,156,777
|
|
1,156,778
|
Shares issued as consideration for extension of lock-up period, shares |
|
|
|
8,698
|
|
|
|
|
Treasury stock acquired, at cost |
|
|
|
|
$ (7,168)
|
|
|
(7,168)
|
Treasury stock acquired, at cost, shares |
|
|
|
|
(7)
|
|
|
|
Balance at Jun. 30, 2023 |
|
|
$ 1
|
$ 7
|
$ (7,168)
|
107,047,023
|
(86,978,221)
|
20,061,642
|
Balance, shares at Jun. 30, 2023 |
|
200
|
5,062
|
67,626
|
(7)
|
|
|
|
Exercise of pre-funded warrants |
|
|
|
$ 3
|
|
944
|
|
947
|
Exercise of pre-funded warrants, shares |
|
|
|
27,061
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
243,045
|
|
243,045
|
Net loss |
|
|
|
|
|
|
(2,902,403)
|
(2,902,403)
|
Warrant inducement offer - exercise proceeds |
[2] |
|
|
$ 2
|
|
757,645
|
|
757,647
|
Warrant inducement offer - exercise proceeds, shares |
[2] |
|
|
20,346
|
|
|
|
|
Warrant modification |
|
|
|
|
|
181,891
|
|
181,891
|
Registered offering of common stock |
[3] |
|
|
$ 1
|
|
1,575,937
|
|
1,575,938
|
Registered offering of common stock , shares |
[3] |
|
|
9,303
|
|
|
|
|
Redemption of Series A Preferred Stock |
|
|
|
|
|
(215,048)
|
|
(215,048)
|
Redemption of Series A Preferred Stock, shares |
|
(150)
|
|
|
|
|
|
|
Balance at Sep. 30, 2023 |
|
|
$ 1
|
$ 13
|
$ (7,168)
|
109,591,437
|
(89,880,624)
|
19,703,659
|
Balance, shares at Sep. 30, 2023 |
|
50
|
5,062
|
124,336
|
(7)
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
$ 1
|
$ 40
|
$ (7,168)
|
114,300,849
|
(103,219,124)
|
11,074,598
|
Balance, shares at Dec. 31, 2023 |
|
50
|
5,062
|
405,212
|
(7)
|
|
|
|
Exercise of warrants |
|
|
|
$ 21
|
|
2,672,479
|
|
2,672,500
|
Exercise of warrants, shares |
|
|
|
213,800
|
|
|
|
|
Exercise of pre-funded warrants |
|
|
|
$ 13
|
|
(13)
|
|
|
Exercise of pre-funded warrants, shares |
|
|
|
131,481
|
|
|
|
|
Issuance of common stock pursuant to vendor agreements |
|
|
|
$ 1
|
|
79,199
|
|
79,200
|
Issuance of common stock pursuant to vendor agreements, shares |
|
|
|
9,000
|
|
|
|
|
Round up share adjustment due to reverse split |
|
|
|
$ 8
|
|
(8)
|
|
|
Round up share adjustment due to reverse split, shares |
|
|
|
75,410
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
223,573
|
|
223,573
|
Net loss |
|
|
|
|
|
|
(2,826,737)
|
(2,826,737)
|
Balance at Mar. 31, 2024 |
|
|
$ 1
|
$ 83
|
$ (7,168)
|
117,276,079
|
(106,045,861)
|
11,223,134
|
Balance, shares at Mar. 31, 2024 |
|
50
|
5,062
|
834,903
|
(7)
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
$ 1
|
$ 40
|
$ (7,168)
|
114,300,849
|
(103,219,124)
|
11,074,598
|
Balance, shares at Dec. 31, 2023 |
|
50
|
5,062
|
405,212
|
(7)
|
|
|
|
Net loss |
|
|
|
|
|
|
|
(7,991,736)
|
Balance at Sep. 30, 2024 |
|
|
$ 1
|
$ 107
|
$ (7,168)
|
118,245,220
|
(111,210,860)
|
7,027,300
|
Balance, shares at Sep. 30, 2024 |
|
50
|
5,062
|
1,074,203
|
(7)
|
|
|
|
Balance at Mar. 31, 2024 |
|
|
$ 1
|
$ 83
|
$ (7,168)
|
117,276,079
|
(106,045,861)
|
11,223,134
|
Balance, shares at Mar. 31, 2024 |
|
50
|
5,062
|
834,903
|
(7)
|
|
|
|
Stock-based compensation |
|
|
|
|
|
160,664
|
|
160,664
|
Net loss |
|
|
|
|
|
|
(2,763,743)
|
(2,763,743)
|
Balance at Jun. 30, 2024 |
|
|
$ 1
|
$ 83
|
$ (7,168)
|
117,436,743
|
(108,809,604)
|
8,620,055
|
Balance, shares at Jun. 30, 2024 |
|
50
|
5,062
|
834,903
|
(7)
|
|
|
|
Stock-based compensation |
|
|
|
|
|
160,665
|
|
160,665
|
Net loss |
|
|
|
|
|
|
(2,401,256)
|
(2,401,256)
|
Warrant inducement offer - exercise proceeds |
[4] |
|
|
$ 24
|
|
400,900
|
|
400,924
|
Warrant inducement offer - exercise proceeds, shares |
[4] |
|
|
239,300
|
|
|
|
|
Warrant modification |
|
|
|
|
|
246,912
|
|
246,912
|
Balance at Sep. 30, 2024 |
|
|
$ 1
|
$ 107
|
$ (7,168)
|
$ 118,245,220
|
$ (111,210,860)
|
$ 7,027,300
|
Balance, shares at Sep. 30, 2024 |
|
50
|
5,062
|
1,074,203
|
(7)
|
|
|
|
|
|
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|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Gross proceeds |
|
$ 2,099,053
|
$ 11,015,500
|
Issuance costs |
|
523,115
|
$ 1,184,481
|
Warrant [Member] |
|
|
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$ 827,978
|
966,349
|
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Issuance costs |
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$ 208,703
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9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash Flows From Operating Activities: |
|
|
Net loss |
$ (7,991,736)
|
$ (84,959,446)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Impairment of in-process research and development |
|
69,280,171
|
Impairment of goodwill |
|
11,895,033
|
Stock-based compensation |
544,902
|
896,248
|
Issuance of common stock pursuant to vendor agreements |
79,200
|
605,200
|
Shares issued as consideration for extension of lock-up period |
|
1,156,778
|
Depreciation of fixed assets |
6,933
|
7,800
|
Non-cash rent expense |
7,839
|
67,293
|
Deferred tax provision (benefit) |
9,707
|
(8,883,001)
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
(52,035)
|
(201,172)
|
Security deposit |
|
46,659
|
Vendor deposits |
(80,000)
|
235,000
|
Deferred offering costs |
(30,260)
|
|
Accounts payable |
676,178
|
2,871,889
|
Operating lease liability |
(8,656)
|
(74,407)
|
Accrued expenses and other current liabilities |
502,839
|
1,122,488
|
Net Cash Used In Operating Activities |
(6,335,089)
|
(5,933,467)
|
Cash Flows From Financing Activities: |
|
|
Proceeds from issuance of common stock in public offering |
|
13,114,555
|
Registration and issuance costs associated with common stock issuance |
(180,142)
|
(1,763,584)
|
Redemption of Series A Preferred Stock |
|
(10,695,610)
|
Purchase of treasury stock |
|
(7,168)
|
Exercise of pre-funded warrants |
|
947
|
Exercise of warrants |
2,672,500
|
|
Warrant inducement offer - exercise proceeds |
827,978
|
966,349
|
Registration and issuance costs associated with preferred stock issuance |
|
(5,500)
|
Net Cash Provided By Financing Activities |
3,320,336
|
1,609,989
|
Net Decrease in Cash |
(3,014,753)
|
(4,323,478)
|
Cash - Beginning of Period |
3,137,674
|
5,902,199
|
Cash - End of Period |
122,921
|
1,578,721
|
Non-cash investing and financing activities: |
|
|
Reclassification of formerly redeemable common stock |
|
331,331
|
Accounts payable for deferred offering costs |
176,870
|
44,892
|
Warrant modification - incremental value |
|
181,891
|
Warrant inducement offer - incremental value |
$ 246,912
|
$ 134,591
|
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v3.24.3
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
|
|
Net Income (Loss) |
$ (2,401,256)
|
$ (2,763,743)
|
$ (2,826,737)
|
$ (2,902,403)
|
$ (78,513,093)
|
$ (3,543,950)
|
$ (7,991,736)
|
$ (84,959,446)
|
X |
- ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-K -Number 229 -Section 402 -Subsection v -Paragraph 1
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v3.24.3
Business Organization, Nature of Operations and Basis of Presentation
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Business Organization, Nature of Operations and Basis of Presentation |
Note
1 – Business Organization, Nature of Operations and Basis of Presentation
Organization and Operations
ZyVersa
Therapeutics, Inc. (“ZyVersa” and the “Company”) is a clinical stage biopharmaceutical company leveraging proprietary
technologies to develop first-in-class drugs for patients with chronic renal or inflammatory diseases with high unmet medical needs.
The Company’s mission is to develop drugs that optimize health outcomes and improve patients’ quality of life.
Basis
of Presentation and Principles of Consolidation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information. Accordingly, they do not
include all of the information and disclosures required by accounting principles generally accepted in the United States of America
for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal
recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements
of the Company as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023. The results of
operations for the nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year.
These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements
and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2023, filed with the
Securities and Exchange Commission (“SEC”) on March 25, 2024 and as amended on May 15, 2024.
On
December 4, 2023, the Company effected a reverse stock split of its common stock at a ratio of 1-for-35 (the “2023 Reverse Split”).
Upon the effectiveness of the 2023 Reverse Split, every 35 issued shares of common stock were reclassified and combined into one share
of common stock. In addition, the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible
securities and warrants was proportionally decreased, and the corresponding conversion price or exercise price was proportionally increased.
No fractional shares were issued as a result of the 2023 Reverse Split.
On
April 25, 2024, the Company effected a reverse stock split of its common stock at a ratio of 1-for-10 (the “2024 Reverse Split”).
Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares of common stock were reclassified and combined into one share
of common stock. In addition, the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible
securities and warrants was proportionally decreased, and the corresponding conversion price or exercise price was proportionally increased.
No fractional shares were issued as a result of the 2024 Reverse Split.
Accordingly,
all share and per share amounts for all periods presented in these financial statements and notes thereto have been adjusted retroactively,
where applicable, to reflect the 2023 Reverse Split and the 2024 Reverse Split and adjustment of the conversion price or exercise price
of each outstanding equity award, convertible security and warrant as if the transaction had occurred as of the beginning of the earliest
period presented. See Note 7 – Stockholders’ Permanent and Temporary Equity – Reverse Stock Split.
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v3.24.3
Going Concern and Management’s Plans
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Going Concern and Management’s Plans |
Note
2 - Going Concern and Management’s Plans
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not
include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
As
of September 30, 2024, the Company had cash of approximately $0.1 million and a working capital deficit of approximately $11.2 million.
During the nine months ended September 30, 2024, the Company incurred a net loss of approximately $8.0 million and used cash in operations
of approximately $6.3 million. The Company has an accumulated deficit of approximately $111.2 million as of September 30, 2024.
The
Company has not yet achieved profitability and expects to continue to incur cash outflows from operations. It is expected that its research
and development and general and administrative expenses will continue to increase and, as a result, the Company will eventually need
to generate significant product revenues to achieve profitability.
Consequently,
the Company will be required to raise additional funds through equity or debt financing. Subsequent to September 30, 2024, the Company
raised an aggregate of $3.1
million from stock warrant exercises and
its “at-the-market” facility. See Note 8 – Subsequent Events for additional details.
Management believes that the Company has access to capital resources and continues to evaluate additional financing opportunities; however,
there can be no assurance that it will be successful in securing additional capital or that the Company will be able to obtain funds
on commercially acceptable terms, if at all. There is also no assurance that the amount of funds the Company might raise will enable
the Company to complete its development initiatives or attain profitable operations. The aforementioned conditions raise substantial
doubt about the Company’s ability to continue as a going concern for at least one year from the issuance date of these financial
statements.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
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v3.24.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
3 – Summary of Significant Accounting Policies
Since
the date the Company’s December 31, 2023 financial statements were issued in its 2023 Annual Report on Form 10-K, there have been
no material changes to the Company’s significant accounting policies.
Use
of Estimates
Preparation
of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the
amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company
bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the
circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations
for equity securities, share based compensation and acquired intangible assets, as well as establishment of valuation allowances for
deferred tax assets. Certain of the Company’s estimates could be affected by external conditions, including those unique to the
Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates.
Deferred
Offering Costs
Deferred
offering costs, which primarily consist of direct, incremental professional fees incurred in connection with a debt or equity financing,
are capitalized as deferred offering costs (a non-current asset) on the balance sheet. Once the financing closes, the Company reclassifies
such costs as either discounts to notes payable or as a reduction of proceeds received from equity transactions so that such costs are
recorded as a reduction of additional paid-in capital. If the completion of a contemplated financing was deemed to be no longer probable,
the related deferred offering costs would be charged to general and administrative expense in the consolidated financial statements.
Net
Loss Per Common Share
Basic
net loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during
the period. Diluted net income per common share is computed by dividing net income by the weighted average number of common and dilutive
common-equivalent shares outstanding during each period.
The
following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net
loss per share because to do so would be anti-dilutive:
Schedule
of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Warrants [1] | |
| 928,593 | | |
| 103,929 | |
Options | |
| 9,639 | | |
| 10,170 | |
Series A Convertible Preferred Stock | |
| 72 | | |
| 72 | |
Series B Convertible Preferred Stock | |
| 2,067 | | |
| 2,067 | |
Total potentially dilutive shares | |
| 940,371 | | |
| 116,239 | |
[1] |
As
part of the InflamaCORE, LLC license agreement, warrants to purchase 342 shares of common stock are to be issued upon the satisfaction
of certain milestones and, accordingly, are not included in the amount currently reported. |
Segment
Reporting
The
Company operates and manages its business as one reportable and operating segment. All assets and operations are in the U.S. The Company’s
Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes
of allocating resources and evaluating financial performance.
Reclassifications
Certain
prior period balances have been reclassified from security deposits to vendor deposits on the condensed consolidated balance sheet in
order to conform to the current year presentation. These reclassifications had no effect on previously reported results of operations
or loss per share.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07,
Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through
enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal
years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects
on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be
required upon adoption of ASU 2023-07.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
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v3.24.3
Accrued Expenses and Other Current Liabilities
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
Note
4 – Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following as of September 30, 2024 and December 31, 2023:
Schedule of Accrued Expenses and
Other Current Liabilities
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
L&F milestone payment liability | |
$ | - | | |
$ | 500,000 | |
Payroll accrual | |
| 979,030 | | |
| 668,803 | |
Other accrued expenses | |
| 163,269 | | |
| 41,969 | |
Bonus accrual | |
| 1,107,812 | | |
| 536,500 | |
Registration delay liability [1] | |
| 7,261 | | |
| 7,261 | |
Total accrued expenses and other current liabilities | |
$ | 2,257,372 | | |
$ | 1,754,533 | |
[1] |
|
See
Note 7 - Stockholders’ Permanent and Temporary Equity for details of the registration delay liability. |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Note
5 – Income Taxes
Income
tax expense and the effective tax rate were as follows:
Schedule
of Income Taxes Expense Effective Tax Rate
(in thousands) | |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
(in thousands) | |
2024 | | |
2023 | |
Income tax (expense) benefit | |
$ | (9,707 | ) | |
$ | 8,859,762 | |
| |
| | | |
| | |
Effective tax rate | |
| (0.12 | )% | |
| 9.44 | % |
The
tax provisions for the nine months ended September 30, 2024 and 2023 were computed using the estimated effective tax rates applicable
to the taxable jurisdictions for the full year. The Company’s tax rate is subject to management’s quarterly review and revision,
as necessary. The Company’s effective tax rate was (0.12)% and 9.44% for the nine months ended September 30, 2024 and 2023, respectively. The
decrease in the quarterly rates is primarily the result of the Company recording a full valuation allowance during the nine months ended
September 30, 2024 due to the reversal of a significant deferred tax liability that existed as of September 30, 2023.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note
6 – Commitments and Contingencies
Litigations,
Claims and Assessments
In
the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course
of business. The Company records contingent liabilities resulting from such claims, if any, when a loss is assessed to be probable and
the amount of the loss is reasonably estimable.
Disputed
Vendor Invoices
On
June 30, 2024 and July 1, 2024, the Company received two invoices from a vendor in the amounts of $992,176 and $162,800, respectively.
The June 30, 2024 invoice represents retroactive interest on invoices going back to September 30, 2022. The July 1, 2024 invoice consisted
of miscellaneous unsupported charges performed over the past several years. On August 1, 2024, ZyVersa management sent the vendor a letter
disputing these invoices and has requested the vendor to rescind each of them. The Company received additional invoices dated July 31,
2024, August 31, 2024, and September 30, 2024 in the amounts of $76,453, $81,826, and $87,481, respectively. Similar to the prior invoices, management
has requested the vendor to rescind each of them. Although the Company has requested the vendor to rescind each of them, the Company
believes that in accordance with the agreement, the vendor can legally charge the Company interest from the point they were notified.
As such, the Company included the calculated interest from July 1, 2024 to September 30, 2024 of $131,300 within accrued expenses and
other current liabilities on the condensed consolidated balance sheet at September 30, 2024.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
License
Agreements
L&F
Research LLC
The
Company entered into a License Agreement with L&F Research LLC (“L&F”) effective December 15, 2015, as amended
(the “L&F License Agreement”) pursuant to which L&F granted the Company an exclusive royalty-bearing, worldwide,
sublicensable license under the patent and intellectual property rights and know-how specific to and for the development and commercialization
of VAR 200, for the treatment, inhibition or prevention of kidney disease in humans and symptoms thereof, including focal segmental glomerulosclerosis.
On
February 28, 2023, the Company and L&F executed an Amendment and Restatement Agreement that waived L&F’s right to terminate
the L&F License Agreement or any other remedies, for non-payment of the First Milestone Payment, until (a) March 31, 2023 as to $1,000,000
of such milestone payments (“Waiver A”) and (b) January 31, 2024 as to $500,000 milestone payments (“Waiver B”).
Waiver A was contingent upon (i) forgiveness by the Company of $351,579 in aggregate principal amount outstanding under a certain convertible
note, and (ii) a cash payment by the Company to L&F in the amount of $648,421, on or before March 31, 2023. Waiver B was contingent
upon a cash payment by the Company to L&F in the amount of $500,000 on or before the earlier of (x) January 31, 2024, and (y) ten
business days from the date that the Company received net proceeds of at least $30,000,000 from the issuance of new equity capital. All
other terms of the L&F License remain in effect.
On
March 29, 2023, the Company paid the $648,421 of cash to L&F, thus meeting the conditions of Waiver A, which also had the effect
of canceling the Note Receivable and the Put Option and resulted in a reclassification of 188 shares of common stock and $331,331 classified
as temporary equity to permanent equity.
On
January 30, 2024, the Company paid $500,000 of cash to L&F, thus meeting the conditions of Waiver B.
Operating
Leases
On
January 18, 2019, the Company entered into a lease agreement for approximately 3,500
square feet of office space in Weston, Florida for a term of five years. Under the lease agreement, the annual base rent, which
excludes the Company’s share of taxes and operating costs, was approximately $89,000
for the first year and has increased approximately 3% every year thereafter for a total base rent lease commitment of approximately
$497,000.
On January 15, 2024, the Company extended the lease for an additional year for a total base rent lease commitment of $112,064.
The Company used the short-term lease practical expedient which permits the Company to not capitalize leases with a term equal to or
less than 12 months.
The
Company recognized right-of-use asset amortization of $0 and $7,839 in connection with its operating lease for the three and nine months
ending September 30, 2024, respectively, and the Company recognized rent expense of $42,696 and $127,439 in connection with its operating lease for
the three and nine months ending September 30, 2024, respectively.
The
Company recognized right-of-use amortization of $38,885 and $116,083 in connection with its operating lease for the three and nine months
ending September 30, 2023, respectively.
A
summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right of
Use Assets and Liabilities
| |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows used in operating activities | |
$ | 8,656 | | |
$ | 74,405 | |
| |
| | | |
| | |
Right-of-use assets obtained in exchange for lease obligations | |
| | | |
| | |
Operating leases | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
Weighted Average Remaining Lease Term | |
| | | |
| | |
Operating leases | |
| - | | |
| 0.34 Years | |
| |
| | | |
| | |
Weighted Average Discount Rate | |
| | | |
| | |
Operating leases | |
| - | | |
| 6.5 | % |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
|
X |
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.3
Stockholders’ Permanent and Temporary Equity
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Permanent and Temporary Equity |
Note
7 – Stockholders’ Permanent and Temporary Equity
Reverse
Stock Split
On
April 25, 2024, the Company effected the 2024 Reverse Split. Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares
of common stock were reclassified and combined into one share of common stock. In addition, the number of shares of common stock issuable
upon the exercise of the Company’s equity awards, convertible securities and warrants was proportionally decreased, and the corresponding
conversion price or exercise price was proportionally increased. No fractional shares were issued as a result of the 2024 Reverse Split.
See Note 1 – Business Organization, Nature of Operations and Basis of Presentation for additional details.
Common Stock
On
January 2, 2024, the Company entered into a marketing agreement with a vendor in which the Company issued an aggregate of 9,000 shares
of common stock and cash in exchange for marketing services. The $79,200 fair value of the common stock was established as a prepaid
expense and the Company recognized the expense over the six month contract term.
Temporary
Equity
See
Note 6 – Commitments and Contingencies – License Agreements for discussion of the movement of temporary equity to permanent
equity on March 29, 2023.
Stock-Based
Compensation
For
the three months ended September 30, 2024 the Company recorded stock-based compensation expense of $160,665
(of which, $15,447
was included in research and development and $145,218
was included in general and administrative expense) related to options issued to employees and consultants. For the three months
ended September 30, 2023 the Company recorded stock-based compensation expense of $243,045
(of which, ($38,224)
was included in research and development expense and $281,269
was included in general and administrative expense) related to options issued to employees and consultants.
For
the nine months ended September 30, 2024 the Company recorded stock-based compensation expense of $544,902
(of which, $46,342
was included in research and development expense and $498,560
was included in general and administrative expense) related to options issued to employees and consultants. For the nine months
ended September 30, 2023 the Company recorded stock-based compensation expense of $896,249
(of which, $117,320
was included in research and development expense and $778,929
was included in general and administrative expense) related to options issued to employees and consultants. As of September 30, 2024
there was $482,559
of unrecognized stock-based compensation expense, which the Company expects to recognize over a weighted average period of 1.3
years.
Stock
Options
The
grant date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was determined using the Black
Scholes method, with the following assumptions used:
Schedule of Stock
Options Granted
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
| N/A | | |
| N/A | | |
| N/A | | |
| $0.44 - $2.23 | |
Risk free interest rate | |
| N/A | | |
| N/A | | |
| N/A | | |
| 3.53% - 4.27 | % |
Expected term (years) | |
| N/A | | |
| N/A | | |
| N/A | | |
| 6.00 | |
Expected volatility | |
| N/A | | |
| N/A | | |
| N/A | | |
| 120% - 123 | % |
Expected dividends | |
| N/A | | |
| N/A | | |
| N/A | | |
| 0.00 | % |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
A
summary of the option activity for the nine months ended September 30, 2024 is presented below:
Schedule
of Stock Option Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Options | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 | |
| 10,243 | | |
$ | 2,218.51 | | |
| | | |
| | |
Granted | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| (604 | ) | |
| 1,760.50 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 9,639 | | |
$ | 2,247.21 | | |
| 5.5 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 6,797 | | |
$ | 2,986.26 | | |
| 5.7 | | |
$ | - | |
The
following table presents information related to stock options as of September 30, 2024:
Schedule
of Information Related to Stock Options
Options Outstanding | | |
Options Exercisable | |
| | |
| | |
Weighted | | |
| |
| | |
Outstanding | | |
Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Options | | |
In Years | | |
Options | |
$ | 152.50 | | |
| 4,157 | | |
| 8.6 | | |
| 1,674 | |
$ | 738.50 | | |
| 286 | | |
| 8.3 | | |
| 96 | |
$ | 791.00 | | |
| 38 | | |
| 8.4 | | |
| 13 | |
$ | 1,760.50 | | |
| 1,306 | | |
| 2.1 | | |
| 1,306 | |
$ | 3,965.50 | | |
| 37 | | |
| 7.7 | | |
| 37 | |
$ | 4,053.00 | | |
| 2,095 | | |
| 4.5 | | |
| 2,095 | |
$ | 5,726.00 | | |
| 1,720 | | |
| 6.7 | | |
| 1,576 | |
| | | |
| 9,639 | | |
| 5.7 | | |
| 6,797 | |
Stock
Warrants
Between
February 26, 2024 and March 6, 2024, investors in the public offering completed on December 11, 2023 (the “December 2023 Offering”) exercised warrants to
purchase 213,800
shares of common stock at an exercise price of $12.50
per share for total proceeds of $2,672,500.
Between
January 17 and February 23, 2024, a December 2023 Offering investor exercised pre-funded warrants to purchase 131,500 shares of common
stock on a cashless basis to purchase 131,481 shares of common stock at an exercise price of $0.001 per share.
On
August 1, 2024, the Company initiated a limited time program, which was immediately accepted by the warrant holder, that permitted
the holder to exercise its December 2023 Offering warrants at a reduced exercise price of $3.46 per
share and granted new warrants to purchase up to (i) 392,000 shares
of common stock which became exercisable upon stockholder approval with an exercise term of five years and (ii) 86,600 shares
of common stock which became exercisable upon stockholder approval with an exercise term of 18 months.
The Company received stockholder approval for the warrants on October 29, 2024 and the warrants have an exercise price of $3.46 per
share. Under the program, the warrant holder submitted an exercise notice and the related aggregate cash exercise price to purchase 239,300 shares
of common stock on August 1, 2024 for gross proceeds of $827,978 less
issuance costs of $427,054.
Issuance costs included placement agent fees of $50,000,
placement agent legal fees of $50,000,
Company legal fees of $57,267,
other expenses of $22,875 and
warrant modification costs of $246,912.
Because the modification represented a short-term inducement, modification accounting was only performed on the warrants that were
actually exercised under the program. The Company recognized the $246,912 modification
date incremental value of the modified warrants and additional warrants issued as compared to the original warrants, as an issuance
cost of the warrant exercise.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
The
issuance date fair value of stock warrants issued during the three and nine months ended September 30, 2024 and 2023 was determined using
the Black Scholes method, with the following assumptions used:
Schedule
of Issuance Date Fair Value of Stock Warrants
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
$ | 3.46 | | |
| $47.50 - $57.75 | | |
$ | 3.46 | | |
| $47.50 - $350.00 | |
Risk free interest rate | |
| 3.62% - 4.62 | % | |
| 4.09% - 4.42 | % | |
| 3.62% - 4.62 | % | |
| 3.51%
- 4.42 | % |
Expected term (years) | |
| 0.9 - 5.5 years | | |
| 4.9 - 5.5 years | | |
| 0.9 - 5.5 years | | |
| 5 years | |
Expected volatility | |
| 96% - 113 | % | |
| 121% - 123 | % | |
| 96% - 113 | % | |
| 121% - 123 | % |
Expected dividends | |
| n/a | | |
| n/a | | |
| n/a | | |
| n/a | |
A
summary of the warrant activity for the nine months ended September 30, 2024, is presented below:
Summary of Warrant Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 [1] | |
| 903,320 | | |
$ | 123.44 | | |
| | | |
| | |
Issued | |
| 478,600 | | |
| 3.46 | | |
| | | |
| | |
Forfeited | |
| (227 | ) | |
| 4,053 | | |
| | | |
| | |
Exercised [2] | |
| (453,100 | ) | |
| 7.73 | | |
| | | |
| | |
Repriced - Old [3] | |
| (239,300 | ) | |
| 12.50 | | |
| | | |
| | |
Repriced - New [3] | |
| 239,300 | | |
| 3.46 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 928,593 | | |
$ | 114.83 | | |
| 3.73 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 928,393 | | |
$ | 114.48 | | |
| 3.73 | | |
$ | - | |
[1] |
|
Warrants
outstanding exclude 131,500
pre-funded warrants, issued in the December 2023 Offering, outstanding with an exercise price of $0.001. |
[2] |
|
Warrants
exercised exclude 131,500
pre-funded warrants, issued in the December 2023 Offering, exercised with an exercise price of $0.001. |
|
|
|
[3] |
|
Warrants
represent the reset of the exercise price of certain December 11, 2023 Series A and Series B warrants to purchase 239,300 shares
of common stock to a price of $3.46 per share. |
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
The
following table presents information related to stock warrants as of September 30, 2024:
Schedule of Information Related to Stock Warrants
Warrants Outstanding | | |
Warrants Exercisable | |
| | |
Outstanding | | |
Weighted Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Warrants | | |
In Years | | |
Warrants | |
$ | 3.46 | | |
| 478,600 | | |
| 4.45 | | |
| 478,600 | |
$ | 12.50 | | |
| 346,900 | | |
| 2.75 | | |
| 346,900 | |
$ | 47.50 | | |
| 20,347 | | |
| 4.45 | | |
| 20,347 | |
$ | 57.75 | | |
| 19,965 | | |
| 3.77 | | |
| 19,965 | |
$ | 350.00 | | |
| 27,551 | | |
| 3.57 | | |
| 27,551 | |
$ | 700.00 | | |
| 13,944 | | |
| 3.20 | | |
| 13,944 | |
$ | 1,760.50 | | |
| 300 | | |
| 0.10 | | |
| 100 | |
$ | 2,415.00 | | |
| 3,651 | | |
| 3.20 | | |
| 3,651 | |
$ | 4,025.00 | | |
| 17,335 | | |
| 3.20 | | |
| 17,335 | |
| | | |
| 928,593 | | |
| 3.73 | | |
| 928,393 | |
Effectiveness
Failure
In
connection with the business combination with Larkspur Health Acquisition Corp., the Company conducted the Series A Preferred Stock Financing.
On or about February 20, 2023, the Company failed to have the SEC declare a registration statement effective (the “Effectiveness
Failure”) which covered the Series A Preferred Stock registrable securities within the time period prescribed by the Securities
Purchase Agreement (the “SPA”). The SPA entitles the investors to receive registration delay payments (“Registration
Delay Payments”) equal to 1.5% of each investor’s purchase price on the date of the Effectiveness Failure and every thirty
days thereafter that the Effectiveness Failure persists. Failure to make the Registration Delay Payments on a timely basis result in
the accrual of interest at the rate of 2.0% per month. On April 28, 2023, the proceeds from the April 2023 Offering were used to make
most of the Registration Delay Payments and redeem substantially all of the Series A Preferred Stock. As of September 30, 2024, the Company
has accrued additional Registration Delay Payments of approximately $7,261 in the aggregate.
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v3.24.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Note
8 – Subsequent Events
At-The-Market
Offering
Subsequent
to September 30, 2024, the Company received approximately $1.39 million in gross proceeds from the sale of 564,495 shares of its common
stock pursuant to its ATM Agreement with A.G.P. for its “at-the-market” facility.
Common
Stock
Subsequent
to September 30, 2024, the Company entered into marketing agreements with two vendors, pursuant to which the Company issued an
aggregate of 51,000
shares of common stock in exchange for marketing services. The fair value of the common stock was established as a prepaid expense
and the Company is recognizing $47,670
of the expense over the six month term of one of the contracts and $69,000
of the expense over the three month term of the other contract.
Stock
Warrants
On
November 5, 2024, the Company initiated a limited time program, which was immediately accepted by warrant holders, that permitted the
holders to exercise 339,900 of its December 2023 and 478,600 of its August 2024 Common Stock Purchase warrants at a reduced exercise
price of $2.06 per share from $12.50 and $3.46 per share, respectively. New warrants were granted to purchase 1,637,000 shares
of common stock at an exercise price of $2.06 per share with an exercise term of 5 years from stockholder approval.
Under
the program, the warrant holders submitted exercise notices and the related aggregate cash exercise price to purchase an aggregate of
818,500 shares of common stock on November 5, 2024 for gross proceeds of $1,686,110. However, due to beneficial ownership
limitations, only 654,500 of the 818,500 shares of common stock have been issued through the filing date. The remaining 164,000
unissued shares of common stock are held in abeyance pending availability under the beneficial ownership limitations. Issuance costs
include financial advisor fees of $110,000 and reimbursement to the financial advisor for non-accountable fees of $10,000.
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v3.24.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Use of Estimates |
Use
of Estimates
Preparation
of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the
amounts reported in the financial statements and the amounts disclosed in the related notes to the financial statements. The Company
bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the
circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, fair value calculations
for equity securities, share based compensation and acquired intangible assets, as well as establishment of valuation allowances for
deferred tax assets. Certain of the Company’s estimates could be affected by external conditions, including those unique to the
Company and general economic conditions. It is reasonably possible that actual results could differ from those estimates.
|
Deferred Offering Costs |
Deferred
Offering Costs
Deferred
offering costs, which primarily consist of direct, incremental professional fees incurred in connection with a debt or equity financing,
are capitalized as deferred offering costs (a non-current asset) on the balance sheet. Once the financing closes, the Company reclassifies
such costs as either discounts to notes payable or as a reduction of proceeds received from equity transactions so that such costs are
recorded as a reduction of additional paid-in capital. If the completion of a contemplated financing was deemed to be no longer probable,
the related deferred offering costs would be charged to general and administrative expense in the consolidated financial statements.
|
Net Loss Per Common Share |
Net
Loss Per Common Share
Basic
net loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during
the period. Diluted net income per common share is computed by dividing net income by the weighted average number of common and dilutive
common-equivalent shares outstanding during each period.
The
following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net
loss per share because to do so would be anti-dilutive:
Schedule
of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Warrants [1] | |
| 928,593 | | |
| 103,929 | |
Options | |
| 9,639 | | |
| 10,170 | |
Series A Convertible Preferred Stock | |
| 72 | | |
| 72 | |
Series B Convertible Preferred Stock | |
| 2,067 | | |
| 2,067 | |
Total potentially dilutive shares | |
| 940,371 | | |
| 116,239 | |
[1] |
As
part of the InflamaCORE, LLC license agreement, warrants to purchase 342 shares of common stock are to be issued upon the satisfaction
of certain milestones and, accordingly, are not included in the amount currently reported. |
|
Segment Reporting |
Segment
Reporting
The
Company operates and manages its business as one reportable and operating segment. All assets and operations are in the U.S. The Company’s
Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes
of allocating resources and evaluating financial performance.
|
Reclassifications |
Reclassifications
Certain
prior period balances have been reclassified from security deposits to vendor deposits on the condensed consolidated balance sheet in
order to conform to the current year presentation. These reclassifications had no effect on previously reported results of operations
or loss per share.
|
Recently Issued Accounting Pronouncements |
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07,
Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through
enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal
years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects
on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be
required upon adoption of ASU 2023-07.
ZYVERSA
THERAPEUTICS, INC.
Notes
to Condensed Consolidated Financial Statements
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v3.24.3
Summary of Significant Accounting Policies (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share |
The
following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net
loss per share because to do so would be anti-dilutive:
Schedule
of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Warrants [1] | |
| 928,593 | | |
| 103,929 | |
Options | |
| 9,639 | | |
| 10,170 | |
Series A Convertible Preferred Stock | |
| 72 | | |
| 72 | |
Series B Convertible Preferred Stock | |
| 2,067 | | |
| 2,067 | |
Total potentially dilutive shares | |
| 940,371 | | |
| 116,239 | |
[1] |
As
part of the InflamaCORE, LLC license agreement, warrants to purchase 342 shares of common stock are to be issued upon the satisfaction
of certain milestones and, accordingly, are not included in the amount currently reported. |
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v3.24.3
Accrued Expenses and Other Current Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following as of September 30, 2024 and December 31, 2023:
Schedule of Accrued Expenses and
Other Current Liabilities
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
L&F milestone payment liability | |
$ | - | | |
$ | 500,000 | |
Payroll accrual | |
| 979,030 | | |
| 668,803 | |
Other accrued expenses | |
| 163,269 | | |
| 41,969 | |
Bonus accrual | |
| 1,107,812 | | |
| 536,500 | |
Registration delay liability [1] | |
| 7,261 | | |
| 7,261 | |
Total accrued expenses and other current liabilities | |
$ | 2,257,372 | | |
$ | 1,754,533 | |
[1] |
|
See
Note 7 - Stockholders’ Permanent and Temporary Equity for details of the registration delay liability. |
|
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v3.24.3
Income Taxes (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Schedule of Income Taxes Expense Effective Tax Rate |
Income
tax expense and the effective tax rate were as follows:
Schedule
of Income Taxes Expense Effective Tax Rate
(in thousands) | |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
(in thousands) | |
2024 | | |
2023 | |
Income tax (expense) benefit | |
$ | (9,707 | ) | |
$ | 8,859,762 | |
| |
| | | |
| | |
Effective tax rate | |
| (0.12 | )% | |
| 9.44 | % |
|
X |
- DefinitionTabular disclosure of the reconciliation using percentage or dollar amounts of the reported amount of income tax expense attributable to continuing operations for the year to the amount of income tax expense that would result from applying domestic federal statutory tax rates to pretax income from continuing operations.
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v3.24.3
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Right of Use Assets and Liabilities |
A
summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right of
Use Assets and Liabilities
| |
2024 | | |
2023 | |
| |
For the Nine Months Ended | |
| |
September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows used in operating activities | |
$ | 8,656 | | |
$ | 74,405 | |
| |
| | | |
| | |
Right-of-use assets obtained in exchange for lease obligations | |
| | | |
| | |
Operating leases | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
Weighted Average Remaining Lease Term | |
| | | |
| | |
Operating leases | |
| - | | |
| 0.34 Years | |
| |
| | | |
| | |
Weighted Average Discount Rate | |
| | | |
| | |
Operating leases | |
| - | | |
| 6.5 | % |
|
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v3.24.3
Stockholders’ Permanent and Temporary Equity (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
Schedule of Stock Options Granted |
The
grant date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was determined using the Black
Scholes method, with the following assumptions used:
Schedule of Stock
Options Granted
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
| N/A | | |
| N/A | | |
| N/A | | |
| $0.44 - $2.23 | |
Risk free interest rate | |
| N/A | | |
| N/A | | |
| N/A | | |
| 3.53% - 4.27 | % |
Expected term (years) | |
| N/A | | |
| N/A | | |
| N/A | | |
| 6.00 | |
Expected volatility | |
| N/A | | |
| N/A | | |
| N/A | | |
| 120% - 123 | % |
Expected dividends | |
| N/A | | |
| N/A | | |
| N/A | | |
| 0.00 | % |
|
Schedule of Stock Option Activity |
A
summary of the option activity for the nine months ended September 30, 2024 is presented below:
Schedule
of Stock Option Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Options | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 | |
| 10,243 | | |
$ | 2,218.51 | | |
| | | |
| | |
Granted | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| (604 | ) | |
| 1,760.50 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 9,639 | | |
$ | 2,247.21 | | |
| 5.5 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 6,797 | | |
$ | 2,986.26 | | |
| 5.7 | | |
$ | - | |
|
Schedule of Information Related to Stock Options |
The
following table presents information related to stock options as of September 30, 2024:
Schedule
of Information Related to Stock Options
Options Outstanding | | |
Options Exercisable | |
| | |
| | |
Weighted | | |
| |
| | |
Outstanding | | |
Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Options | | |
In Years | | |
Options | |
$ | 152.50 | | |
| 4,157 | | |
| 8.6 | | |
| 1,674 | |
$ | 738.50 | | |
| 286 | | |
| 8.3 | | |
| 96 | |
$ | 791.00 | | |
| 38 | | |
| 8.4 | | |
| 13 | |
$ | 1,760.50 | | |
| 1,306 | | |
| 2.1 | | |
| 1,306 | |
$ | 3,965.50 | | |
| 37 | | |
| 7.7 | | |
| 37 | |
$ | 4,053.00 | | |
| 2,095 | | |
| 4.5 | | |
| 2,095 | |
$ | 5,726.00 | | |
| 1,720 | | |
| 6.7 | | |
| 1,576 | |
| | | |
| 9,639 | | |
| 5.7 | | |
| 6,797 | |
|
Summary of Warrant Activity |
A
summary of the warrant activity for the nine months ended September 30, 2024, is presented below:
Summary of Warrant Activity
| |
| | |
| | |
Weighted | | |
| |
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Life | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
In Years | | |
Value | |
| |
| | |
| | |
| | |
| |
Outstanding, January 1, 2024 [1] | |
| 903,320 | | |
$ | 123.44 | | |
| | | |
| | |
Issued | |
| 478,600 | | |
| 3.46 | | |
| | | |
| | |
Forfeited | |
| (227 | ) | |
| 4,053 | | |
| | | |
| | |
Exercised [2] | |
| (453,100 | ) | |
| 7.73 | | |
| | | |
| | |
Repriced - Old [3] | |
| (239,300 | ) | |
| 12.50 | | |
| | | |
| | |
Repriced - New [3] | |
| 239,300 | | |
| 3.46 | | |
| | | |
| | |
Outstanding, September 30, 2024 | |
| 928,593 | | |
$ | 114.83 | | |
| 3.73 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable, September 30, 2024 | |
| 928,393 | | |
$ | 114.48 | | |
| 3.73 | | |
$ | - | |
[1] |
|
Warrants
outstanding exclude 131,500
pre-funded warrants, issued in the December 2023 Offering, outstanding with an exercise price of $0.001. |
[2] |
|
Warrants
exercised exclude 131,500
pre-funded warrants, issued in the December 2023 Offering, exercised with an exercise price of $0.001. |
|
|
|
[3] |
|
Warrants
represent the reset of the exercise price of certain December 11, 2023 Series A and Series B warrants to purchase 239,300 shares
of common stock to a price of $3.46 per share. |
|
Schedule of Information Related to Stock Warrants |
The
following table presents information related to stock warrants as of September 30, 2024:
Schedule of Information Related to Stock Warrants
Warrants Outstanding | | |
Warrants Exercisable | |
| | |
Outstanding | | |
Weighted Average | | |
Exercisable | |
Exercise | | |
Number of | | |
Remaining Life | | |
Number of | |
Price | | |
Warrants | | |
In Years | | |
Warrants | |
$ | 3.46 | | |
| 478,600 | | |
| 4.45 | | |
| 478,600 | |
$ | 12.50 | | |
| 346,900 | | |
| 2.75 | | |
| 346,900 | |
$ | 47.50 | | |
| 20,347 | | |
| 4.45 | | |
| 20,347 | |
$ | 57.75 | | |
| 19,965 | | |
| 3.77 | | |
| 19,965 | |
$ | 350.00 | | |
| 27,551 | | |
| 3.57 | | |
| 27,551 | |
$ | 700.00 | | |
| 13,944 | | |
| 3.20 | | |
| 13,944 | |
$ | 1,760.50 | | |
| 300 | | |
| 0.10 | | |
| 100 | |
$ | 2,415.00 | | |
| 3,651 | | |
| 3.20 | | |
| 3,651 | |
$ | 4,025.00 | | |
| 17,335 | | |
| 3.20 | | |
| 17,335 | |
| | | |
| 928,593 | | |
| 3.73 | | |
| 928,393 | |
|
Warrant [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
Schedule of Issuance Date Fair Value of Stock Warrants |
The
issuance date fair value of stock warrants issued during the three and nine months ended September 30, 2024 and 2023 was determined using
the Black Scholes method, with the following assumptions used:
Schedule
of Issuance Date Fair Value of Stock Warrants
| |
For the Three Months Ended | | |
For the Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Fair value of common stock on date of grant | |
$ | 3.46 | | |
| $47.50 - $57.75 | | |
$ | 3.46 | | |
| $47.50 - $350.00 | |
Risk free interest rate | |
| 3.62% - 4.62 | % | |
| 4.09% - 4.42 | % | |
| 3.62% - 4.62 | % | |
| 3.51%
- 4.42 | % |
Expected term (years) | |
| 0.9 - 5.5 years | | |
| 4.9 - 5.5 years | | |
| 0.9 - 5.5 years | | |
| 5 years | |
Expected volatility | |
| 96% - 113 | % | |
| 121% - 123 | % | |
| 96% - 113 | % | |
| 121% - 123 | % |
Expected dividends | |
| n/a | | |
| n/a | | |
| n/a | | |
| n/a | |
|
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v3.24.3
Business Organization, Nature of Operations and Basis of Presentation (Details Narrative)
|
Apr. 25, 2024 |
Dec. 04, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
Reverse stock split |
the Company effected a reverse stock split of its common stock at a ratio of 1-for-10 (the “2024 Reverse Split”).
Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares of common stock were reclassified and combined into one share
of common stock. In addition,
|
the Company effected a reverse stock split of its common stock at a ratio of 1-for-35 (the “2023 Reverse Split”).
Upon the effectiveness of the 2023 Reverse Split, every 35 issued shares of common stock were reclassified and combined into one share
of common stock.
|
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v3.24.3
Going Concern and Management’s Plans (Details Narrative) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
|
Oct. 01, 2024 |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ 122,921
|
|
|
|
|
|
$ 122,921
|
|
$ 3,137,674
|
Working capital deficit |
|
11,200,000
|
|
|
|
|
|
11,200,000
|
|
|
Net loss |
|
2,401,256
|
$ 2,763,743
|
$ 2,826,737
|
$ 2,902,403
|
$ 78,513,093
|
$ 3,543,950
|
7,991,736
|
$ 84,959,446
|
|
Net cash used In operating activities |
|
|
|
|
|
|
|
(6,335,089)
|
$ (5,933,467)
|
|
Accumulated deficit |
|
$ 111,210,860
|
|
|
|
|
|
$ 111,210,860
|
|
$ 103,219,124
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
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Proceeds from Issuance of Common Stock |
$ 3,100,000
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v3.24.3
Schedule of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Total potentially dilutive shares |
|
940,371
|
116,239
|
Warrant [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Total potentially dilutive shares |
[1] |
928,593
|
103,929
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Total potentially dilutive shares |
|
9,639
|
10,170
|
Series A Convertible Preferred Stock [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Total potentially dilutive shares |
|
72
|
72
|
Series B Convertible Preferred Stock [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Total potentially dilutive shares |
|
2,067
|
2,067
|
|
|
X |
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v3.24.3
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
|
L&F milestone payment liability |
|
|
$ 500,000
|
Payroll accrual |
|
979,030
|
668,803
|
Other accrued expenses |
|
163,269
|
41,969
|
Bonus accrual |
|
1,107,812
|
536,500
|
Registration delay liability |
[1] |
7,261
|
7,261
|
Total accrued expenses and other current liabilities |
|
$ 2,257,372
|
$ 1,754,533
|
|
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v3.24.3
v3.24.3
v3.24.3
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v3.24.3
Commitments and Contingencies (Details Narrative)
|
|
|
|
|
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2024
USD ($)
|
Aug. 31, 2024
USD ($)
|
Jul. 31, 2024
USD ($)
|
Jul. 01, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jan. 30, 2024
USD ($)
|
Jan. 15, 2024
USD ($)
|
Mar. 29, 2023
USD ($)
shares
|
Feb. 28, 2023
USD ($)
|
Jan. 18, 2019
USD ($)
ft²
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Dec. 31, 2023
USD ($)
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Invoices from a vendor |
$ 87,481
|
$ 81,826
|
$ 76,453
|
$ 162,800
|
$ 992,176
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
2,257,372
|
|
|
|
|
|
|
|
|
|
$ 2,257,372
|
|
$ 2,257,372
|
|
$ 1,754,533
|
Number of operating lease square feet | ft² |
|
|
|
|
|
|
|
|
|
3,500
|
|
|
|
|
|
Lease cost |
|
|
|
|
|
|
|
|
|
$ 89,000
|
|
|
|
|
|
Total operating lease rent commitment |
|
|
|
|
|
|
|
|
|
$ 497,000
|
42,696
|
|
127,439
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease asset amortization |
|
|
|
|
|
|
|
|
|
|
0
|
$ 38,885
|
7,839
|
$ 116,083
|
|
Lease Commitment [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating lease rent commitment |
|
|
|
|
|
|
$ 112,064
|
|
|
|
|
|
|
|
|
License Agreement [Member] | L&F Research LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment description |
|
|
|
|
|
|
|
|
the Company and L&F executed an Amendment and Restatement Agreement that waived L&F’s right to terminate
the L&F License Agreement or any other remedies, for non-payment of the First Milestone Payment, until (a) March 31, 2023 as to $1,000,000
of such milestone payments (“Waiver A”) and (b) January 31, 2024 as to $500,000 milestone payments (“Waiver B”).
|
|
|
|
|
|
|
License Agreement [Member] | L&F Research LLC [Member] | Waiver A [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt forgiveness |
|
|
|
|
|
|
|
|
$ 351,579
|
|
|
|
|
|
|
Cash payment |
|
|
|
|
|
|
|
$ 648,421
|
648,421
|
|
|
|
|
|
|
Reclassification shares of common stock | shares |
|
|
|
|
|
|
|
188
|
|
|
|
|
|
|
|
Reclassification shares of common stock value classified as temporary to permanent equity |
|
|
|
|
|
|
|
$ 331,331
|
|
|
|
|
|
|
|
License Agreement [Member] | L&F Research LLC [Member] | Waiver B [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash payment |
|
|
|
|
|
$ 500,000
|
|
|
$ 500,000
|
|
|
|
|
|
|
Maturity date |
|
|
|
|
|
|
|
|
Jan. 31, 2024
|
|
|
|
|
|
|
Net proceeds from issuance of equity capital |
|
|
|
|
|
|
|
|
$ 30,000,000
|
|
|
|
|
|
|
Accrued Expenses and Other Current Liabilities [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
$ 131,300
|
|
|
|
|
|
|
|
|
|
$ 131,300
|
|
$ 131,300
|
|
|
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- DefinitionThe estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term.
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v3.24.3
Schedule of Stock Option Activity (Details)
|
9 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
Number of options, outstanding beginning balance | shares |
10,243
|
Weighted average exercise price, beginning balance | $ / shares |
$ 2,218.51
|
Number of options, granted | shares |
|
Weighted average exercise price, granted | $ / shares |
|
Number of options, exercised | shares |
|
Weighted average exercise price, exercised | $ / shares |
|
Number of options, forfeited | shares |
(604)
|
Weighted average exercise price, forfeited | $ / shares |
$ 1,760.50
|
Number of options, outstanding ending balance | shares |
9,639
|
Weighted average exercise price, ending balance | $ / shares |
$ 2,247.21
|
Weighted average remaining life in years, outstanding |
5 years 6 months
|
Aggregate intrinsic value, ending balance | $ |
|
Number of options, exercisable ending balance | shares |
6,797
|
Weighted average exercise price, Exercisable | $ / shares |
$ 2,986.26
|
Weighted average remaining life in years, exercisable |
5 years 8 months 12 days
|
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|
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v3.24.3
Schedule of Information Related to Stock Options (Details)
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, Number of options |
9,639
|
Options exercisable, weighted average remaining life in years |
5 years 8 months 12 days
|
Options exercisable, Number of options |
6,797
|
Exercise Price One [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 152.50
|
Options outstanding, Number of options |
4,157
|
Options exercisable, weighted average remaining life in years |
8 years 7 months 6 days
|
Options exercisable, Number of options |
1,674
|
Exercise Price Two [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 738.50
|
Options outstanding, Number of options |
286
|
Options exercisable, weighted average remaining life in years |
8 years 3 months 18 days
|
Options exercisable, Number of options |
96
|
Exercise Price Three [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 791.00
|
Options outstanding, Number of options |
38
|
Options exercisable, weighted average remaining life in years |
8 years 4 months 24 days
|
Options exercisable, Number of options |
13
|
Exercise Price Four [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 1,760.50
|
Options outstanding, Number of options |
1,306
|
Options exercisable, weighted average remaining life in years |
2 years 1 month 6 days
|
Options exercisable, Number of options |
1,306
|
Exercise Price Five [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 3,965.50
|
Options outstanding, Number of options |
37
|
Options exercisable, weighted average remaining life in years |
7 years 8 months 12 days
|
Options exercisable, Number of options |
37
|
Exercise Price Six [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 4,053.00
|
Options outstanding, Number of options |
2,095
|
Options exercisable, weighted average remaining life in years |
4 years 6 months
|
Options exercisable, Number of options |
2,095
|
Exercise Price Seven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options outstanding, exercise price | $ / shares |
$ 5,726.00
|
Options outstanding, Number of options |
1,720
|
Options exercisable, weighted average remaining life in years |
6 years 8 months 12 days
|
Options exercisable, Number of options |
1,576
|
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v3.24.3
Summary of Warrant Activity (Details)
|
9 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
|
Number of warrants, outstanding beginning balance | shares |
903,320
|
[1] |
Weighted average exercise price, beginning balance | $ / shares |
$ 123.44
|
[1] |
Number of warrants, granted | shares |
478,600
|
|
Weighted average exercise price, granted | $ / shares |
$ 3.46
|
|
Number of warrants, forfeited | shares |
(227)
|
|
Weighted average exercise price, forfeited | $ / shares |
$ 4,053
|
|
Number of warrants, exercised | shares |
(453,100)
|
[2] |
Weighted average exercise price, exercised | $ / shares |
$ 7.73
|
[2] |
Number of warrants, repriced - old | shares |
(239,300)
|
[3] |
Weighted average exercise price, repriced - old | $ / shares |
$ 12.50
|
[3] |
Number of warrants, repriced - new | shares |
239,300
|
[3] |
Weighted average exercise price, repriced - new | $ / shares |
$ 3.46
|
[3] |
Number of warrants, outstanding ending balance | shares |
928,593
|
|
Weighted average exercise price, ending balance | $ / shares |
$ 114.83
|
|
Weighted average remaining life in years, outstanding |
3 years 8 months 23 days
|
|
Aggregate intrinsic value, ending balance | $ |
|
|
Number of warrants, exercisable ending balance | shares |
928,393
|
|
Weighted average exercise price, Exercisable | $ / shares |
$ 114.48
|
|
Weighted average remaining life in years, exercisable |
3 years 8 months 23 days
|
|
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|
|
|
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v3.24.3
Summary of Warrant Activity (Details) (Parenthetical)
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
|
Number of warrants, outstanding |
9,639
|
|
Number of warrants, exercised |
453,100
|
[1] |
Purchase of warrants shares |
(239,300)
|
[2] |
December 2023 Pre-Funded Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Number of warrants, outstanding |
131,500
|
|
Warrants exercise price | $ / shares |
$ 0.001
|
|
Number of warrants, exercised |
131,500
|
|
Exercise price | $ / shares |
$ 0.001
|
|
December 11, 2023 Series A and Series B Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Purchase of warrants shares |
239,300
|
|
Purchase of warrants per share | $ / shares |
$ 3.46
|
|
|
|
X |
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v3.24.3
Schedule of Information Related to Stock Warrants (Details) - $ / shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Dec. 31, 2023 |
[1] |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Number of warrants, outstanding |
928,593
|
903,320
|
Number of warrants, exercisable |
928,393
|
|
Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Number of warrants, outstanding |
928,593
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 8 months 23 days
|
|
Number of warrants, exercisable |
928,393
|
|
Exercise Price One [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 3.46
|
|
Number of warrants, outstanding |
478,600
|
|
Warrant exercisable, weighted average remaining life in years |
4 years 5 months 12 days
|
|
Number of warrants, exercisable |
478,600
|
|
Exercise Price Two [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 12.50
|
|
Number of warrants, outstanding |
346,900
|
|
Warrant exercisable, weighted average remaining life in years |
2 years 9 months
|
|
Number of warrants, exercisable |
346,900
|
|
Exercise Price Three [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 47.50
|
|
Number of warrants, outstanding |
20,347
|
|
Warrant exercisable, weighted average remaining life in years |
4 years 5 months 12 days
|
|
Number of warrants, exercisable |
20,347
|
|
Exercise Price Four [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 57.75
|
|
Number of warrants, outstanding |
19,965
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 9 months 7 days
|
|
Number of warrants, exercisable |
19,965
|
|
Exercise Price Five [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 350.00
|
|
Number of warrants, outstanding |
27,551
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 6 months 25 days
|
|
Number of warrants, exercisable |
27,551
|
|
Exercise Price Six [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 700.00
|
|
Number of warrants, outstanding |
13,944
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 2 months 12 days
|
|
Number of warrants, exercisable |
13,944
|
|
Exercise Price Seven [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 1,760.50
|
|
Number of warrants, outstanding |
300
|
|
Warrant exercisable, weighted average remaining life in years |
1 month 6 days
|
|
Number of warrants, exercisable |
100
|
|
Exercise Price Eight [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 2,415.00
|
|
Number of warrants, outstanding |
3,651
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 2 months 12 days
|
|
Number of warrants, exercisable |
3,651
|
|
Exercise Price Nine [Member] | Warrant [Member] |
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Weighted average exercise price, outstanding |
$ 4,025.00
|
|
Number of warrants, outstanding |
17,335
|
|
Warrant exercisable, weighted average remaining life in years |
3 years 2 months 12 days
|
|
Number of warrants, exercisable |
17,335
|
|
|
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v3.24.3
Stockholders’ Permanent and Temporary Equity (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
|
Aug. 01, 2024 |
Apr. 25, 2024 |
Mar. 06, 2024 |
Jan. 02, 2024 |
Sep. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Feb. 23, 2024 |
Feb. 20, 2023 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse stock split |
|
the Company effected the 2024 Reverse Split. Upon the effectiveness of the 2024 Reverse Split, every 10 issued shares
of common stock were reclassified and combined into one share of common stock.
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expense |
|
|
|
|
$ 160,665
|
|
$ 243,045
|
|
|
$ 544,902
|
$ 896,249
|
|
|
Unrecognized stock-based compensation expense |
|
|
|
|
482,559
|
|
|
|
|
$ 482,559
|
|
|
|
Weighted average period |
|
|
|
|
|
|
|
|
|
1 year 3 months 18 days
|
|
|
|
Gross proceeds warrants |
|
|
|
|
|
|
|
|
|
$ 2,672,500
|
|
|
|
Exercise term |
|
|
|
|
|
|
|
|
|
5 years 8 months 12 days
|
|
|
|
Payments of Stock Issuance Costs |
|
|
|
|
|
|
|
|
|
$ 180,142
|
1,763,584
|
|
|
Percentage of registration delay payments |
|
|
|
|
|
|
|
|
|
|
|
|
1.50%
|
Effectiveness failure interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
2.00%
|
Accrued registration delay payments |
|
|
|
|
|
|
|
|
|
7,261
|
|
|
|
December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
[custom:ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionsRepricedNewInPeriodWeightedAverageExercisePrice] |
$ 3.46
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre Funded Warrants [Member] | Investor [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
|
|
|
|
|
|
|
|
|
|
131,500
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
|
$ 0.001
|
|
Warrants exercised on cashless basis |
|
|
|
|
|
|
|
|
|
|
|
131,481
|
|
Common Stock One [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Issued During Period, Shares, New Issues |
392,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock Two [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
$ 3.46
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Issued During Period, Shares, New Issues |
86,600
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise term |
18 months
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for services, shares |
|
|
|
|
|
9,000
|
|
1,086
|
371
|
|
|
|
|
Common Stock [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
239,300
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from Issuance of Common Stock |
$ 827,978
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments of Stock Issuance Costs |
427,054
|
|
|
|
|
|
|
|
|
|
|
|
|
[custom:PlacementAgentLegalFees] |
50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Legal Fees |
57,267
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Expenses |
22,875
|
|
|
|
|
|
|
|
|
|
|
|
|
[custom:WarrantModificationCosts] |
$ 246,912
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common shares |
|
|
213,800
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 12.50
|
|
|
|
|
|
|
|
|
|
|
Gross proceeds warrants |
|
|
$ 2,672,500
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expense |
|
|
|
|
15,447
|
|
38,224
|
|
|
46,342
|
117,320
|
|
|
General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expense |
|
|
|
|
$ 145,218
|
|
$ 281,269
|
|
|
$ 498,560
|
$ 778,929
|
|
|
Vendor [Member] | Marketing Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for services, shares |
|
|
|
9,000
|
|
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
|
$ 79,200
|
|
|
|
|
|
|
|
|
|
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v3.24.3
Subsequent Events (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Nov. 05, 2024 |
Oct. 01, 2024 |
Aug. 01, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Nov. 04, 2024 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Common stock purchase warrants |
|
|
|
|
|
|
478,600
|
|
Weighted average remaining life in years, exercisable |
|
|
|
|
|
|
5 years 8 months 12 days
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Number of share issued for services |
|
|
|
9,000
|
1,086
|
371
|
|
|
Common Stock [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Gross proceeds |
|
|
$ 827,978
|
|
|
|
|
|
Warrants exercise |
|
|
239,300
|
|
|
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Gross proceeds |
|
$ 3,100,000
|
|
|
|
|
|
|
Subsequent Event [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Warrants exercise |
339,900
|
|
|
|
|
|
|
|
Common stock purchase warrants |
478,600
|
|
|
|
|
|
|
|
Subsequent Event [Member] | August Two Thousand Twenty Four Offering [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Exercise price |
$ 2.06
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
New issuance of warrants |
1,637,000
|
|
|
|
|
|
|
|
Warrants exercise |
818,500
|
|
|
|
|
|
|
|
Exercise price |
$ 2.06
|
|
|
|
|
|
|
|
Weighted average remaining life in years, exercisable |
5 years
|
|
|
|
|
|
|
|
Warrants exercise |
654,500
|
|
|
|
|
|
|
|
Unissued shares of common stock |
164,000
|
|
|
|
|
|
|
|
Financial advisor fees |
$ 110,000
|
|
|
|
|
|
|
|
Non accountable fees financial advisor fees |
10,000
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] | December 2023 Offering [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Gross proceeds |
$ 1,686,110
|
|
|
|
|
|
|
|
Warrants exercise |
818,500
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Exercise price |
$ 3.46
|
|
|
|
|
|
|
$ 12.50
|
Subsequent Event [Member] | Sales Agreement [Member] | At-The-Market Offering [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Gross proceeds |
|
$ 1,390,000
|
|
|
|
|
|
|
New issuance of warrants |
|
564,495
|
|
|
|
|
|
|
Subsequent Event [Member] | Marketing Agreements [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Number of share issued for services |
|
51,000
|
|
|
|
|
|
|
Subsequent Event [Member] | Marketing Agreements [Member] | Common Stock [Member] | Over Six Month Term of Contract [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Prepaid expense |
|
$ 47,670
|
|
|
|
|
|
|
Subsequent Event [Member] | Marketing Agreements [Member] | Common Stock [Member] | Over Three Month Term of Contract [Member] |
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
Prepaid expense |
|
$ 69,000
|
|
|
|
|
|
|
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