Dermata Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 21, 2024.
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FY2023 · Filed Mar 21, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
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 |
|---|
Commission File Number:001-40739
DERMATA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 86-3218736 |
|---|---|
| (State or Other Jurisdiction of | (I.R.S. Employer |
| Incorporation or Organization) | Identification Number) |
| 3525 Del Mar Heights Rd., #322,San Diego, CA | 92130 |
|---|---|
| (Address of Principal Executive Offices) | (Zip Code) |
858-800-2543** **
(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, par value $0.0001 per share | DRMA | The Nasdaq Capital Market |
| Warrants, exercisable for one share of Common Stock | DRMAW | The Nasdaq Capital Market |
Securities registered pursuant to Section 12(g) of the Act:None
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 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 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 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 Section 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 aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on the Nasdaq Capital Market on June 30, 2023, was approximately $4.8 million.
As of March 18, 2024, the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was 6,660,840.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s proxy statement for the 2024 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year ended December 31, 2023, are incorporated by reference in Part III of this Form 10-K.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023
TABLE OF CONTENTS
| Page | |||
|---|---|---|---|
| Part I | 4 | ||
| Item 1. | Business | 4 | |
| Item 1A. | Risk Factors | 42 | |
| Item 1B. | Unresolved Staff Comments | 90 | |
| Item 1C. | Cybersecurity | 90 | |
| Item 2. | Properties | 91 | |
| Item 3. | Legal Proceedings | 91 | |
| Item 4. | Mine Safety Disclosures | 91 | |
| Part II | |||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 92 | |
| Item 6. | [Reserved] | 92 | |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 102 | |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 102 | |
| Item 8. | Financial Statements and Supplementary Data | 102 | |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 102 | |
| Item 9A. | Controls and Procedures | 102 | |
| Item 9B. | Other Information | 103 | |
| Item 9C. | Disclosure Regarding Foreign Jurisdiction That Prevent Inspections | 103 | |
| Part III | |||
| Item 10. | Directors, Executive Officers and Corporate Governance | 104 | |
| Item 11. | Executive Compensation | 104 | |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 104 | |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 104 | |
| Item 14. | Principal Accountant Fees and Services | 104 | |
| Part IV | |||
| Item 15. | Exhibits and Financial Statement Schedules | 105 | |
| Signatures | 109 | ||
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. 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 lack of operating history; |
| · | the expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital; |
| · | our current and future capital requirements to support our development and commercialization efforts for our product candidates and our ability to satisfy our capital needs; |
| · | our dependence on our product candidates, which are still in preclinical or early stages of clinical development; |
| · | our ability to acquire sufficient quantities of raw material needed to manufacture our drug product; |
| · | our, or that of our third-party manufacturers, ability to manufacture cGMP quantities of our product candidates as required for pre-clinical and clinical trials and, subsequently, our ability to manufacture commercial quantities of our product candidates; |
| · | our ability to complete required clinical trials for our product candidates and obtain approval from the FDA or other regulatory agencies in different jurisdictions; |
| · | our lack of a sales and marketing organization and our ability to commercialize our product candidates if we obtain regulatory approval; |
| · | our dependence on third-parties to manufacture our product candidates; |
| · | our reliance on third-party CROs to conduct our clinical trials; |
| · | our ability to maintain or protect the validity of our intellectual property; |
| · | our ability to internally develop new inventions and intellectual property; |
| · | interpretations of current laws and the passages of future laws; |
| · | acceptance of our business model by investors; |
| · | the accuracy of our estimates regarding expenses and capital requirements; and |
| · | our ability to adequately support organizational and business growth. |
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 disclaim 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.
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