Genprex, Inc.

false 0001595248 0001595248 2026-05-14 2026-05-14 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 May 14, 2026 Date of report (Date of earliest event reported) GENPREX, INC. (Exact name of registrant as specified in its charter) Delaware 001-38244 90-0772347 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification Number) 3300 Bee Cave Road, #650-227 , Austin , TX 78746 (Address of principal executive offices) (Zip Code) 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: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 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 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. ☐ Item 8.01 Other Events. On May 14, 2026, Genprex, Inc. (“Genprex” or the “Company”) issued a press release announcing that its research collaborators presented positive preclinical data on the Company’s diabetes gene therapy drug candidate at the 2026 American Society of Gene and Cell Therapy (“ASGCT”) Annual Meeting on May 13, 2026 in Boston, Massachusetts. The collaborators presented preclinical data demonstrating that the diabetes gene therapy (Pdx1/MafA gene therapy, “PM” or “GPX-002”) can reverse hyperglycemia in Type 2 diabetic (“T2D”) mouse models. The featured Genprex-supported abstract and poster presented at the 2026 ASGCT Annual Meeting is titled “Pancreatic Delivery of AAV-Pdx1/MafA Reverses Hyperglycemia in a Preclinical Model of Type 2 Diabetes.” In this study, eight-week-old male C57BL/6 mice were maintained on a regular diet (“RD”) or high fat diet (“HFD”) for 24 weeks. HFD mice then either remained unoperated or underwent retrograde infusion into the pancreatic duct of adeno-associated virus (AAV-8) encoding Pdx1 and MafA (PM) cassettes under the CMV promoter (global–islet cell targeting) or the rat insulin promoter (“RIP”) (β-cell–specific targeting) or received a control virus. The diet remained unchanged after surgery. At two and/or four weeks after surgery, researchers performed intraperitoneal glucose tolerance testing, insulin tolerance testing, glucose-stimulated insulin secretion (“GSIS”), calculated HOMA-IR and assessed glucagon secretion. Mice were then euthanized for pancreatic histology, quantification of β- and α-cell mass, electron microscopy (“EM”), and islets were isolated for ex-vivo GSIS and single-cell RNA sequencing. The results at four weeks showed major improvements in the control of diabetes. At four weeks after surgery, ex-vivo GSIS showed that islets isolated from HFD+CMV-PM-GFP treated mice had insulin secretion similar to islets from RD mice, and both groups had increased insulin secretion compared to islets from the control HFD groups, indicating improved β-cell function with PM treatment. Similarly, and importantly, treatment of HFD mice with RIP-PM-GFP, which selectively targets β-cells, reversed hyperglycemia and improved ex-vivo GSIS. In addition, EM imaging showed that PM treatment in HFD mice increased the number of total and mature insulin granules and decreased the number of immature insulin granules compared with HFD controls. Furthermore, transcriptomic pseudotime analysis demonstrated a shift in β-cells from an immature state toward a more mature state after PM treatment. The press release noted that PM gene therapy reverses hyperglycemia, likely in large part by specifically enhancing β-cell function and maturation. This approach is technically translatable to humans using endoscopic retrograde cholangiopancreatography to deliver PM gene therapy to the pancreas. The Company believes this preclinical data is a pivotal step toward a potentially transformative treatment for T2D by directly addressing beta-cell dysfunction. The Company believes that its therapy holds the potential to offer long-term glycemic control, moving beyond symptomatic management to fundamentally address the disease for diabetic patients. Cautionary Language Concerning Forward-Looking Statements 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, 2025. 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; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, including offering a a potentially transformative treatment for T2D by directly addressing beta-cell dysfunction and that its therapy holds the potential to offer long-term glycemic control, moving beyond symptomatic management to fundamentally address the disease for diabetic patients; 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 prop