New cancer patents support Genprex (NASDAQ: GNPX) Acclaim-3 trial

Rhea-AI Filing Summary

Genprex, Inc. reported that the Japanese Patent Office issued a favorable appeal decision to grant a patent covering use of REQORSA Gene Therapy with PD‑L1 antibodies to treat cancer, and the European Patent Office issued a decision to grant a patent for REQORSA in combination with PD‑1 antibodies. Genprex holds an exclusive license to these patents and states they strengthen protection for therapeutic combinations, including its Acclaim‑3 trial in small cell lung cancer.

The company notes it already has granted patents for REQORSA and PD‑L1 combinations in the U.S. and Korea, with a pending grant in Australia, and REQORSA and PD‑1 combinations in multiple regions including the U.S., Japan and the EU. Acclaim‑3 is a Phase 1/2 trial of REQORSA plus Genentech’s Tecentriq as maintenance therapy for extensive‑stage small cell lung cancer. The Phase 2 expansion is expected to enroll about 50 patients, with an interim analysis planned after the 25th patient has 18 weeks of follow‑up. Genprex expects to complete enrollment of the first 25 patients in the first half of 2026 and conduct the interim analysis in the second half of 2026. The trial has U.S. FDA Fast Track and Orphan Drug designations.

Insights

Biotech equity analyst

Genprex expands patent protection for REQORSA while advancing the Acclaim‑3 Phase 2 study on a defined 2026 timeline.

The new Japanese and European patent grants for REQORSA combinations with PD‑L1 and PD‑1 antibodies broaden Genprex’s intellectual property coverage in major oncology markets. The company emphasizes exclusive licensing and an already extensive portfolio across the U.S., Asia, and Europe.

Acclaim‑3 targets extensive‑stage small cell lung cancer, pairing REQORSA with Tecentriq as maintenance therapy. The Phase 2 dose matches that used in Acclaim‑1’s Phase 2, following a Phase 1 portion that was generally well tolerated with no dose‑limiting toxicities reported.

The Phase 2 expansion aims for about 50 patients, with the primary endpoint focused on 18‑week progression‑free survival from the start of maintenance therapy. Genprex plans an interim analysis after the 25th patient reaches 18 weeks of follow‑up, with enrollment of those first 25 patients expected in the first half of 2026 and interim data in the second half of 2026. Fast Track and Orphan Drug designations from the U.S. FDA support the program’s regulatory pathway.

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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

February 23, 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 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 February 23, 2026, Genprex, Inc. (“Genprex” or the “Company”) issued a press release in which it announced that the Japanese Patent Office has issued a favorable Appeal Decision to grant a patent claiming the use of Reqorsa® Gene Therapy in combination with PD-L1 antibodies to treat cancer.  Also, the European Patent Office has issued a Decision to Grant relating to a patent for the combination of REQORSA and PD-1 antibodies to treat cancer. Genprex maintains an exclusive license to these patents. The granting of these patents in key markets will strengthen Genprex’s intellectual property portfolio, providing further protection for various therapeutic combinations, including the Acclaim-3 clinical trial for the treatment of small cell lung cancer using REQORSA in combination with PD-L1 antibodies.

The press release further noted that these patents build upon Genprex’s existing intellectual property framework. The Company already holds granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea, with a pending grant in Australia. Genprex also holds granted patents for the combination of REQORSA and PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and EU.  The Company believes the Japanese and European patents will further solidify the global intellectual property landscape surrounding Genprex’s lead drug candidate in oncology.

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 and expects the interim analysis in the second half of 2026. The Acclaim-3 clinical trial is supported by U.S. Food and Drug Administration 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; 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 regain and/or 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, including the anticipated exclusivity of these patent grants and the potential for future grants of patent applications globally.

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: February 23, 2026	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 about new patents for REQORSA?

Genprex announced that Japan issued a favorable appeal decision to grant a patent for REQORSA with PD‑L1 antibodies, and Europe granted a patent for REQORSA with PD‑1 antibodies. Genprex holds exclusive licenses, expanding protection for its oncology combination therapies globally.

How does this 8-K expand Genprex (GNPX) intellectual property for REQORSA?

The company states the Japanese and European grants strengthen its intellectual property portfolio for REQORSA combination therapies. They build on existing patents for REQORSA with PD‑L1 and PD‑1 antibodies already granted in the U.S., Korea, Japan, Mexico, Australia, China, Singapore, Chile, Russia and the EU.

What is the Acclaim-3 clinical trial described by Genprex (GNPX)?

Acclaim‑3 is a Phase 1/2 trial testing REQORSA with Genentech’s Tecentriq as maintenance therapy for extensive‑stage small cell lung cancer. Patients receive both drugs until disease progression or unacceptable toxicity, following a Phase 1 portion where REQORSA was generally well tolerated without dose‑limiting toxicities.

How many patients will Genprex enroll in the Acclaim-3 Phase 2 portion?

The Phase 2 expansion of Acclaim‑3 is expected to enroll approximately 50 patients. The primary endpoint is the 18‑week progression‑free survival rate from the start of maintenance therapy with REQORSA and Tecentriq in extensive‑stage small cell lung cancer patients.

When does Genprex (GNPX) expect Acclaim-3 interim results?

Genprex plans an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow‑up. The company expects to complete enrollment of these first 25 patients in the first half of 2026 and conduct the interim analysis in the second half of 2026.

What regulatory designations support Genprex’s Acclaim-3 trial?

The Acclaim‑3 clinical trial is supported by U.S. Food and Drug Administration Fast Track Designation and Orphan Drug Designation. These designations are intended to facilitate development and review of treatments for serious conditions and certain rare diseases such as extensive‑stage small cell lung cancer.

In which regions does Genprex hold patents for REQORSA combinations?

Genprex reports granted patents for REQORSA with PD‑L1 antibodies in the U.S. and Korea, with a pending grant in Australia. It also holds granted patents for REQORSA with PD‑1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and the EU.

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