Genprex Inc.

10/28/2025 | Press release | Distributed by Public on 10/28/2025 06:19

Material Event (Form 8-K)

Item 8.01 Other Events.
On October 28, 2025, Genprex, Inc. ("Genprex" or the "Company") issued a press release announcing that its research collaborators presented positive preclinical data at the 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics which took place October 22-26, 2025 at the Hynes Convention Center in Boston. The collaborators presented positive preclinical data from a study of Genprex's lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), for the treatment of ALK-EML4 positive ("ALK+") non-small cell lung cancer ("NSCLC").
The poster session described that in the study, researchers demonstrated that REQORSA can overexpress the tumor suppressor gene, TUSC2, in EML4-ALK+ NSCLC cell lines and patient derived organoids. The upregulation of TUSC2 by REQORSA therapy induced apoptosis in ALK+ NSCLC cells, including those resistant to alectinib. Researchers also demonstrated in the study that combining REQORSA with alectinib further increases apoptosis. Using in vivo mouse experiments with xenografts of a human ALK+-EML4 NSCLC cell line, treatment with REQORSA and alectinib together improved survival when compared to control. These experiments provide support for a trial of REQORSA in patients with ALK+-EML4 NSCLC. The press release noted that the data also add to the existing preclinical data showing that REQORSA has significant activity on its own as well as when combined with other therapies in a mouse xenograft model with ALK-EML4 rearrangement. The combination of REQORSA and an ALK inhibitor led to longer survival in the mouse model in the study. The Company believes these positive data open a pathway for a potential future clinical trial in ALK-positive lung cancer.
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, 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 REQORSA's potential as a therapeutic treatment alone and/or in combination with ALK-inhibitors for ALK-positive lung cancer; 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.
Genprex Inc. published this content on October 28, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 28, 2025 at 12:19 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]