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

Rhea-AI Filing Summary

Genprex, Inc. reported that it has added Gabrail Cancer Center in Canton, Ohio as a new clinical trial site for its Acclaim-1 and Acclaim-3 studies of lead drug candidate REQORSA Gene Therapy in lung cancer. The company also plans to add and open additional Acclaim trial sites over the coming months to reach more patients and speed enrollment.

Acclaim-1 is a Phase 1/2 trial in late-stage non-small cell lung cancer with EGFR mutations combining REQORSA with Tagrisso, with a Phase 2a expansion targeting about 33 patients and an interim analysis after 19 patients, which Genprex currently expects to fully enroll in the first half of 2026; the trial has FDA Fast Track Designation. Acclaim-3 is a Phase 1/2 trial in extensive stage small cell lung cancer combining REQORSA with Tecentriq as maintenance therapy, with Phase 2 expansion for about 50 patients and an interim analysis after the 25th patient reaches 18 weeks of follow-up, also expected to reach that enrollment milestone in the first half of 2026, and benefits from FDA Fast Track and Orphan Drug Designations.

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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

November 19, 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 November 19, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release announcing that the Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in lung cancer. In addition, the Company expects to add and open additional clinical trial sites for its Acclaim clinical trials over the coming months in an effort to expand its reach to additional patients and expedite enrollment.

Acclaim-1 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and AstraZeneca’s Tagrisso® (osimertinib) to treat patients with late-stage non-small cell lung cancer (“NSCLC”) who have activating EGFR mutations and disease progression after treatment with Tagrisso. The Phase 2a expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated with no dose limiting toxicities despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response. The Phase 2a expansion portion of the trial is expected to enroll approximately 33 patients who have previously received Tagrisso treatment and will determine the safety profile and evaluate efficacy, as well as several other exploratory endpoints. Genprex’s team plans to conduct an interim analysis following the treatment of 19 patients, which the Company currently expects to complete enrollment of the first 19 patients in the first half of 2026. The Acclaim-1 clinical trial has received U.S. Food and Drug Administration (“FDA”) Fast Track Designation.

Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1. The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026. The Acclaim-3 clinical trial is supported by FDA Fast Track Designation and Orphan Drug Designation.

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 and specifications, including the adding and opening of additional clinical trial sites for its Acclaim clinical trials; 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.

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: November 19, 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 Form 8-K?

Genprex announced it has added Gabrail Cancer Center in Canton, Ohio as a new clinical trial site for its Acclaim-1 and Acclaim-3 lung cancer trials of REQORSA Gene Therapy, and it plans to add and open additional Acclaim trial sites over the coming months to expand patient reach and expedite enrollment.

What is the focus of Genprexs Acclaim-1 clinical trial for REQORSA?

Acclaim-1 is a Phase 1/2 trial evaluating REQORSA in combination with AstraZenecas Tagrisso in patients with late-stage non-small cell lung cancer who have activating EGFR mutations and disease progression after Tagrisso. The Phase 2a expansion is expected to enroll approximately 33 patients, with an interim analysis planned after 19 patients are treated, and enrollment of those first 19 patients is currently expected to be completed in the first half of 2026. The trial has received FDA Fast Track Designation.

What is Genprexs Acclaim-3 trial and who are the target patients?

Acclaim-3 is a Phase 1/2 trial studying REQORSA in combination with Genentechs Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer who are candidates for maintenance treatment after receiving Tecentriq and chemotherapy as standard initial therapy. The Phase 2 expansion is expected to enroll approximately 50 patients, with an interim analysis after the 25th patient reaches 18 weeks of follow-up, and Genprex currently expects to complete enrollment of those first 25 patients in the first half of 2026.

What prior clinical results has Genprex reported for REQORSA in Acclaim-1 and Acclaim-3?

In both Acclaim-1 and Acclaim-3, the completed Phase 1 dose escalation portions showed that REQORSA was generally well tolerated with no dose limiting toxicities. In Acclaim-1, despite doubling the starting dose, REQORSA remained generally well tolerated and early signs of efficacy were observed, including prolonged progression-free survival in some patients and one partial response. In Acclaim-3, Phase 2 patients are receiving the same REQORSA dose used in the Phase 2 portion of Acclaim-1.

What regulatory designations has REQORSA received in Genprexs lung cancer programs?

The Acclaim-1 clinical trial of REQORSA in combination with Tagrisso has U.S. FDA Fast Track Designation. The Acclaim-3 trial of REQORSA with Tecentriq as maintenance therapy in extensive stage small cell lung cancer is supported by both FDA Fast Track Designation and Orphan Drug Designation.

What are the key endpoints for the Acclaim-3 Phase 2 expansion study?

For Acclaim-3, the primary endpoint of the Phase 2 portion is the 18-week progression-free survival rate from the start of maintenance therapy with REQORSA and Tecentriq in patients with extensive stage small cell lung cancer. Patients will also be followed for overall survival, with an interim analysis planned after the 25th patient enrolled and treated reaches 18 weeks of follow-up.