Chromocell Therapeutics Corp
For the period ended Dec 31, 2023. Filed Apr 16, 2024.
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FY2023 · Filed Apr 16, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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:333-269188
Chromocell Therapeutics Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 86-3335449 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code:(877) 265-8266
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 | CHRO | The NYSE American LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by check mark 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 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 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 whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐No ☒
The registrant completed the initial public offering of its common stock on February 21, 2024. Accordingly, there wasno public market for the registrant’s common stock as of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter.
The registrant had 5,877,835 shares of its common stock outstanding as of April 15, 2024.
References in this Annual Report on Form 10-K to the “Company,” “Chromocell,” “we,” “us,” or “our” mean Chromocell Therapeutics Corporation unless otherwise expressly stated or the context indicates otherwise.
**Documents Incorporated By Reference:**None.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Report”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include information concerning our strategy, future operations, future financial position, future revenue, projected expenses, prospects and plans and objectives of management. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict, “project,” “seek,” “should,” “target,” “will,” “would” or similar expressions and the negatives of those terms.
Forward-looking statements contained in this Report include, but are not limited to, statements about the following:
| ● | the initiation, timing, progress and results of preclinical and clinical trials for CC8464, CT2000 and any other compounds, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; |
| ● | the timing, scope or results of regulatory filings and approvals, including timing of final U.S. Food and Drug Administration (“FDA”) marketing and other regulatory approval of CC8464 and CT2000; |
| ● | our ability to achieve certain accelerated or orphan drug designations from the FDA; |
| ● | our estimates regarding the potential market opportunity for CC8464 and CT2000; |
| ● | our research and development programs for our lead compounds, CC8464 and CT2000; |
| ● | our plans and ability to successfully develop and commercialize future compounds, including CC8464 and CT2000; |
| ● | our ability to identify and develop new compounds; |
| ● | our ability to identify, recruit and retain key personnel; |
| ● | our commercialization, marketing and manufacturing capabilities and strategy; |
| ● | the implementation of our business model, strategic plans for our business, lead compounds and technology; |
| ● | the scalability and commercial viability of our proprietary manufacturing methods and processes; |
| ● | the rate and degree of market acceptance and clinical utility of our lead and any other future compounds; |
| ● | our competitive position; |
| ● | our intellectual property position and our ability to protect our intellectual property and enforce our intellectual property rights; |
| ● | our financial performance; |
| ● | developments and projections relating to our competitors and our industry; |
| ● | our ability to establish and maintain collaborations or obtain additional funding; |
| ● | our expectations related to the use of proceeds from the offering of the shares registered in the Company’s initial public offering (the “IPO”); |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for or ability to obtain additional financing; |
| ● | the impact of laws and regulations; and |
| ● | our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). |
i
Forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” and elsewhere in this Report. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Report. You should read this Report and the documents that we have filed as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
For discussion of factors that we believe could cause our actual results to differ materially from expected and historical results, see “Item 1A - Risk Factors” below. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
ii
TABLE OF CONTENTS
| PART I | 1 | ||
|---|---|---|---|
| Item 1. | Business | 1 | |
| Item 1A. | Risk Factors | 28 | |
| Item 1B. | Unresolved Staff Comments | 68 | |
| Item 1C. | Cybersecurity | 68 | |
| Item 2. | Properties | 69 | |
| Item 3. | Legal Proceedings | 69 | |
| Item 4. | Mine Safety Disclosures | 69 | |
| PART II | 69 | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 69 | |
| Item 6. | Reserved | 71 | |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 71 | |
| Item 7A. | Quantitative and Qualitative Disclosures about Market Risk | 83 | |
| Item 8. | Financial Statements and Supplementary Data | 83 | |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 83 | |
| Item 9A. | Controls and Procedures | 83 | |
| Item 9B. | Other Information | 84 | |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions That Prevent Inspections | 84 | |
| PART III | 84 | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 84 | |
| Item 11. | Executive Compensation | 89 | |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 96 | |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 99 | |
| Item 14. | Principal Accountant Fees and Services | 102 | |
| PART IV | 103 | ||
| Item 15. | Exhibits and Financial Statement Schedules | 103 | |
iii
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