Genprex Inc
For the period ended Dec 31, 2023. Filed Apr 1, 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 Apr 1, 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 FOR THE TRANSITION PERIOD FROM TO |
|---|
Commission File Number 001-38244
Genprex, Inc.
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 90-0772347 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
| 3300 Bee Cave Road #650-227 | |
|---|---|
| Austin, Texas | 78746 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (877)774-4679
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | GNPX | The Nasdaq Capital Market |
Securities registered pursuant to 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 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. ☐
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 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.☐
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 as of June 30, 2023 was approximately $48.5 million, computed by reference to the closing price of the registrant’s common stock on June 30, 2023 (the last business day of the registrant’s most recently completed second fiscal quarter), as reported by The Nasdaq Capital Market.
As of March 25, 2024, there were 1,910,441 shares of the registrant’s common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission, or SEC, subsequent to the date hereof pursuant to Regulation 14A in connection with the registrant’s 2024 annual meeting of stockholders, are incorporated by reference into Part III of this Annual Report on Form 10-K. Such proxy statement will be filed with the SEC not later than 120 days after the conclusion of the registrant’s fiscal year ended December 31, 2023.
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| PART I | 2 | |
| Item 1. | Business | 2 |
| Item 1A. | Risk Factors | 46 |
| Item 1B. | Unresolved Staff Comments | 76 |
| Item 1C. | Cybersecurity | 76 |
| Item 2. | Properties | 76 |
| Item 3. | Legal Proceedings | 76 |
| Item 4. | Mine Safety Disclosures | 76 |
| PART II | 77 | |
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 77 |
| Item 6. | [Reserved] | 77 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 78 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 85 |
| Item 8. | Financial Statements and Supplementary Data | 85 |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 85 |
| Item 9A. | Controls and Procedures | 86 |
| Item 9B. | Other Information | 87 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 87 |
| PART III | 88 | |
| Item 10. | Directors, Executive Officers and Corporate Governance | 88 |
| Item 11. | Executive Compensation | 88 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 88 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 88 |
| Item 14. | Principal Accountant Fees and Services | 88 |
| PART IV | 88 | |
| Item 15. | Exhibit and Financial Statement Schedules | 88 |
| SIGNATURES | 93 | |
| FINANCIAL STATEMENTS | F-1 | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Annual Report on Form 10-K” or this “Annual Report”) contains forward-looking statements that involve substantial risks and uncertainties. Unless the context requires otherwise, references to “Genprex,” the “Company,” “we,” “us” or “our” in this Annual Report refer to Genprex, Inc. Any statements in this Annual Report about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan” and “would.” For example, statements concerning financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement.
Any forward-looking statements are qualified in their entirety by reference to the risk factors discussed throughout this Annual Report. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to:
| • | Market conditions; |
| • | Our capital position; |
| • | Our ability to compete effectively and with larger and/or better-financed biotechnology and pharmaceutical companies; |
| • | Our uncertainty of developing marketable products; |
| • | Our ability to develop and commercialize our products; |
| • | Our ability to obtain regulatory approvals; |
| • | Our ability and third parties’ ability to maintain and protect intellectual property rights; |
| • | Our ability to raise additional future financing and possible lack of financial and other resources, our ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market, our ability to continue as a going concern, and to continue to support and fund our preclinical and clinical development programs and growth of our business; |
| • | The effects and ultimate impact of public health crises such as the coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; |
| • | The success of our clinical trials through all phases of clinical development, including the ability of our third-party suppliers or manufacturers to supply or manufacture our products on a timely, consistent basis in a manner sufficient and appropriate as is commensurate to meet our clinical trial timing, courses of treatment, and other requisite fulfillment considerations necessary to adequately advance our development programs; |
| • | Our ability to conduct and complete our clinical trials in accordance with projected timelines; |
| • | Any delays in regulatory review and approval of our current and future product candidates; |
| • | Our dependence on third-party suppliers or manufacturers to supply or manufacture our key ingredients and/or raw materials, products and/or product components and successfully carry out a sustainable, reproducible and scalable manufacturing process in accordance with specifications or applicable regulations; |
| • | Our ability to control product development costs; |
| • | Our ability to attract and retain key employees; |
| • | Our ability to enter into new strategic collaborations, licensing or other arrangements; |
| • | Changes in government regulation affecting product candidates that could increase our development costs; |
| • | Our involvement in patent, trademark, and other intellectual property litigation that could be expensive and divert management’s attention; |
| • | The possibility that there may be no market acceptance for our products; and |
| • | Changes in third-party reimbursement policies which could adversely affect potential future sales of any of our products that are approved for marketing. |
The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements, which speak only as of the date of this Annual Report. Except as required by law, we assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this Annual Report or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor 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 contained in this Annual Report. All forward-looking statements are expressly qualified in their entirety by the cautionary statements contained in this section.
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