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

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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 June 23, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release announcing its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company’s diabetes gene therapy drug candidate, at the 2025 American Diabetes Association (“ADA”) 85th Scientific Sessions in Chicago, Illinois.  The studies used an alternative second-generation approach with a non-viral lipid nanoparticle delivery system. The release noted that this exploratory research represents the Company’s forward-thinking work within its diabetes program to determine if the novel diabetes gene therapy can be delivered using a non-viral delivery system which could allow for repeat dosing.

 

The Company noted in its release that it believes the research demonstrates the Company’s ability to use a lipid nanoparticle with a nucleic acid payload to transfect cells within the islets of Langerhans via a direct infusion into the biliary duct/pancreatic duct in place of a viral AAV construct.  The press release further states the Company’s belief that these findings provide the proof of concept needed to move forward with additional studies and opens the door for a next generation approach of our novel gene therapy that would allow repeat dosing of patients, which the Company believes may prove to be very important in the potential treatment of Type 1 diabetes.

 

In the research study, nine lipid nanoparticles (“LNPs”) prepared with patented LipexSil® lipids with a green fluorescent protein (“GFP”) messenger RNA (“mRNA”) payload were evaluated for transfection efficiency in isolated mouse Islets of Langerhans. Two specific LNPs were highly efficient in transfecting α- and β-cells in isolated mouse Islets of Langerhans. LNP made using ALX-184 with a Luciferase mRNA payload injected into the mouse common bile duct efficiently transfected pancreatic cells, and thus efficiently crossed the basement membrane separating the pancreatic duct from pancreatic cells. The same LNP made using ALX-184 with a GFP mRNA payload injected into the mouse common bile duct also efficiently transfected mouse Islet of Langerhans cells.

 

Genprex’s research with its contract development and manufacturing organization partner is in addition to its ongoing preclinical studies using an adeno-associated virus, or AAV, construct. This new research is focused on evaluating potential next generation construct optimization. While AAV delivery is a well understood delivery mechanism, the Company believes there could be many benefits to a non-viral delivery system, including the potential for re-dosing patients to optimize treatment. Additionally, there may be no need for immunosuppression since there is no immune response against LNPs.

 

 

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: 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, including but not limited to, the Company’s beliefs about the anticipated effects of GPX-002 and its potential as a therapeutic approach, whether using AAV delivery or a potential second generation non-viral delivery system; 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.