[8-K] Genprex, Inc. Reports Material Event

Rhea-AI Filing Summary

Genprex, Inc. (GNPX) reported that its research collaborators presented positive preclinical data for Reqorsa Gene Therapy (quaratusugene ozeplasmid) in ALK-EML4 positive non-small cell lung cancer at the 2025 AACR-NCI-EORTC conference in Boston.

The study showed REQORSA can overexpress the tumor suppressor gene TUSC2 in ALK+ NSCLC cell lines and patient-derived organoids, inducing apoptosis, including in cells resistant to alectinib. Combining REQORSA with alectinib further increased apoptosis, and in a mouse xenograft model the combination improved survival versus control. The Company stated these results support a potential future clinical trial in ALK-positive lung cancer.

Insights

Biotech clinical development analyst

Encouraging ALK+ NSCLC preclinical signals; clinical relevance unproven.

Genprex highlighted preclinical results where REQORSA overexpressed TUSC2, triggering apoptosis in ALK-EML4+ NSCLC models, including alectinib-resistant cells. The combination with alectinib increased apoptosis and improved survival in an in vivo mouse xenograft versus control.

These findings align with a mechanistic rationale—restoring a tumor suppressor alongside an ALK inhibitor—but they remain preclinical. Translation risk from cell/organoid and mouse models to patients is substantial, and dosing, safety, and efficacy in humans are not addressed here.

The company notes the data support a potential clinical trial path in ALK+ NSCLC. Subsequent filings may provide protocol details or regulatory interactions before any study initiation.

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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

October 28, 2025

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 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.

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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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.

	GENPREX, INC.
Date: October 28, 2025	By:	/s/ Ryan Confer
		Ryan Confer
		Chief Executive Officer and Chief Financial Officer (Principal Executive Officer and Principal Financial and Accounting Officer)

FAQ

What did Genprex (GNPX) announce in this update?

Genprex reported positive preclinical data for REQORSA in ALK-EML4 positive NSCLC presented at the 2025 AACR-NCI-EORTC conference in Boston.

Which drug candidate is featured and for what indication?

REQORSA Gene Therapy (quaratusugene ozeplasmid) for ALK-EML4 positive non-small cell lung cancer.

What were the key preclinical findings for REQORSA?

REQORSA overexpressed TUSC2, induced apoptosis in ALK+ NSCLC cells including alectinib-resistant cells, and improved survival with alectinib in a mouse xenograft model.

Did the combination with alectinib show benefits?

Yes. Combining REQORSA with alectinib further increased apoptosis and improved survival versus control in a mouse model.

Does this imply a clinical trial is planned for GNPX?

The company stated the data support a pathway for a potential future clinical trial in ALK-positive lung cancer.

Where and when were these results presented?

At the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held October 22–26, 2025, in Boston.