ZyVersa Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 25, 2024.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 25, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31,2023
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
(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 | 33326 |
| (Address of registrant’s principal executive offices) | (Zip Code) |
(754) 231-1688
(Registrant’s telephone number, including area code)
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 if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes: ☐No: ☒
Indicate by check mark if 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 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 whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes: ☐No: ☒
As of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of shares of the registrant’s common stock held by non-affiliates of the registrant (based upon the closing sales price of $8.61 for such shares on the Nasdaq Global Market on June 30, 2023) was approximately $5.6 million. For purposes of calculating the aggregate market value of shares held by non-affiliates, we have assumed that all outstanding shares are held by non-affiliates, except for shares held by each of our executive officers, directors, and 5% or greater stockholders. In the case of 5% or greater stockholders, we have not deemed such stockholders to be affiliates unless there are facts and circumstances which would indicate that such stockholders exercise any control over our company, or unless they hold 10% or more of our outstanding common stock. These assumptions should not be deemed to constitute an admission that all executive officers, directors, and 5% or greater stockholders are, in fact, affiliates of our company, or that there are not other persons who may be deemed to be affiliates of our company. Further information concerning shareholdings of our officers, directors, and principal stockholders is included or incorporated by reference in Part III, Item 12 of this Annual Report on Form 10-K.
As of March 21, 2024, the number of shares outstanding of the registrant’s common stock, $0.0001 par value per share, was 7,594,863.
DOCUMENTS INCORPORATED BY REFERENCE
None.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023
TABLE OF CONTENTS
| Page | |||
|---|---|---|---|
| PART I | 5 | ||
| 1. | Business | 5 | |
| 1A. | Risk Factors | 34 | |
| 1B. | Unresolved Staff Comments | 70 | |
| 1C. | Cybersecurity | 70 | |
| 2. | Properties | 71 | |
| 3. | Legal Proceedings | 71 | |
| 4. | Mine Safety Disclosures | 71 | |
| PART II | 72 | ||
| 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 72 | |
| 6. | Reserved | 72 | |
| 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 73 | |
| 7A. | Quantitative and Qualitative Disclosures About Market Risk | 81 | |
| 8. | Financial Statements and Supplementary Data | 81 | |
| 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 81 | |
| 9A. | Controls and Procedures | 81 | |
| 9B. | Other Information | 81 | |
| 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 81 | |
| PART III | 82 | ||
| 10. | Directors, Executive Officers and Corporate Governance | 82 | |
| 11. | Executive Compensation | 85 | |
| 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 93 | |
| 13. | Certain Relationships and Related Transactions, and Director Independence | 95 | |
| 14. | Principal Accounting Fees and Services | 96 | |
| PART IV | 97 | ||
| 15. | Exhibits, Financial Statement Schedules | 97 | |
| Signatures | 100 | ||
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
| ● | our ability to realize the anticipated benefits of going public through our business combination with Larkspur Health Acquisition Corp., a special purpose acquisition company; |
| ● | our ability to continue as a going concern; |
| ● | the costs associated with our business; |
| ● | our financial and business performance, including financial projections and business metrics; |
| ● | our ability to achieve and maintain profitability in the future |
| ● | our ability to effectively grow and expand operations; |
| ● | the risk of disruption to our current plans and operations; |
| ● | the potential for business or economic disruptions, including those caused by current and future pandemics, such as the COVID-19 pandemic; |
| ● | our ability to maintain the listing of our securities on The Nasdaq Capital Market, and the potential liquidity and trading of our securities; |
| ● | our ability to recognize the anticipated benefits of our business, which may be affected by, among other things, the ability to grow and manage our research and development and clinical activity, and retain key employees; |
| ● | the impact of changes to applicable laws or regulations; |
| ● | our future capital requirements and sources and uses of cash, including the ability to access sources of capital or raise financing in the future; |
| ● | the strength of our network, effectiveness of its technology, and quality of the offerings provided through our platform; |
| ● | the projected financial information, growth rate, strategies, and market opportunities for our business; |
| ● | our ability to maintain our existing license agreements and other collaborative arrangements; |
| ● | our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions and limitations of any approved products in the future; |
| ● | the success, cost and timing of our research and development strategies and activities; |
| ● | our ability to successfully launch our product candidates and be accepted by the market; |
| ● | our ability, assessment of, and strategies to compete with our competitors; |
| ● | our ability to attract and retain talent and the effectiveness of our compensation strategies and leadership; |
| ● | our ability to maintain our licenses and operate in the heavily regulated pharmaceutical industries; |
| ● | our ability to prevent and guard against cybersecurity attacks; |
| ● | our reliance on third-party service providers for processing payments, web and mobile operating systems, software, background checks, and insurance policies; |
| ● | our ability to establish and maintain an effective system of internal controls over financial reporting; |
| ● | the outcome of any known and unknown litigation and regulatory proceedings, including the occurrence of any event, change or other circumstances, including the outcome of any legal proceedings that may be instituted against us that could impact our business; |
| ● | our ability to maintain and protect our brand and intellectual property; and |
| ● | other factors detailed under the section entitled “Risk Factors.” |
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Part I—Item 1A—Risk Factors” for additional risks which could adversely impact our business and financial performance.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.