Genprex Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

false 0001595248 0001595248 2025-04-28 2025-04-28

Washington, D.C. 20549 

   

 

 

    

 

 

 

Date of report (Date of earliest event reported)

 

 

Registrant’s telephone number, including area code: (512) 537-7997

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

 

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

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. ☐

 

 

 

On April 28, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release announcing the Company has entered into an exclusive patent license agreement with NYU Langone Health, related to Genprex’s drug candidate Reqorsa® Gene Therapy (quaratusugene ozeplasmid).  The therapy is under investigation as a potential treatment for mesothelioma.  The subject patent is co-owned by Genprex and NYU Langone Health, and the license provides Genprex with patent exclusivity and expands the Company’s portfolio of oncology licenses.  

 

The Company noted in its press release that scientific data indicates that expression of TUSC2 is downregulated in 84% of mesotheliomas. TUSC2 is the tumor suppressor gene used in REQORSA. Research collaborators at NYU presented positive preclinical data from a study of REQORSA for the treatment of mesothelioma at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.  The researchers demonstrated that REQORSA treatment resulted in a significant decrease in cell proliferation, cell invasion, and a significant increase in cell apoptosis in all four Malignant Pleural Mesothelioma (“MPM”) cell lines. Data also demonstrated potent tumor suppressive activity of the TUSC2 gene delivered by REQORSA, and thus, its re-expression could serve as a potential therapeutic strategy for the treatment of MPM. The Company further noted that in 2024, Genprex announced the formation of its Mesothelioma Clinical Advisory Board (“Advisory Board”) to support the Company’s preclinical mesothelioma oncology program. The Advisory Board is comprised of four world-renown researchers from major research institutions specializing in the treatment of mesothelioma.

 

According to the Centers for Disease Control and Prevention, mesothelioma is a cancer that forms in the thin tissue that lines many internal organs, called the mesothelium. The most common kind of mesothelioma forms in the tissue around the lungs, called the pleura. This is called pleural mesothelioma, which accounts for 80-90% of all mesothelioma diagnoses. Approximately 3,000 new cases of mesothelioma are diagnosed each year in the U.S., and there are approximately 2,500 mesothelioma-related deaths each year in the U.S. The life expectancy for pleural mesothelioma is 18 months, and the 3-year survival rate with treatment for pleural mesothelioma is 23%.

 

 

Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2024.

 

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: REQORSA’s potential as a therapeutic treatment for mesothelioma; Genprex’s ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines; the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex’s diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex’s future growth and financial status, including Genprex’s ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex’s commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this filing. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this filing or to reflect the occurrence of unanticipated events, except as required by law.

 

 

(d) Exhibits.

 

 

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.