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

Rhea-AI Filing Summary

Genprex, Inc. reported that the U.S. Patent and Trademark Office has granted a patent covering the use of its lead drug candidate, REQORSA Gene Therapy (quaratusugene ozeplasmid), in combination with PD‑L1 antibodies such as Tecentriq, with protection extending through 2037. This patent is intended to secure exclusivity for this cancer treatment combination by preventing competitors from making, using or selling the same drug combination.

The company highlighted that REQORSA is being studied in the Acclaim‑3 Phase 1/2 trial as maintenance therapy with Tecentriq for patients with extensive stage small cell lung cancer. Phase 1 dose escalation showed REQORSA was generally well tolerated with no dose‑limiting toxicities, and the Phase 2 expansion is expected to enroll about 50 patients. The primary goal is to assess 18‑week progression‑free survival, with an interim analysis planned after the 25th patient reaches 18 weeks of follow up in the first half of 2026. Acclaim‑3 is supported by FDA Fast Track and Orphan Drug designations.

Positive

• U.S. patent protection through 2037 for REQORSA in combination with PD‑L1 antibodies such as Tecentriq strengthens Genprex’s intellectual property around its lead oncology program.

Negative

• None.

Insights

Biotech & IP Strategy Analyst

New U.S. patent extends REQORSA–Tecentriq combination protection and supports an ongoing Phase 2 lung cancer study.

Genprex has obtained a U.S. patent covering REQORSA Gene Therapy with PD‑L1 antibodies such as Tecentriq, with coverage through 2037. For a development‑stage biotech, formal protection on its lead asset in a defined drug combination can be strategically important, because it frames how competitors may or may not position similar regimens.

The Acclaim‑3 trial is a Phase 1/2 study in extensive stage small cell lung cancer maintenance, using REQORSA plus Tecentriq after initial Tecentriq and chemotherapy. Phase 1 dose escalation was described as generally well tolerated with no dose limiting toxicities, and Phase 2 uses the same REQORSA dose as in the Phase 2 portion of Acclaim‑1. The Phase 2 expansion aims to enroll approximately 50 patients, with an 18‑week progression‑free survival rate as the primary endpoint.

Operationally, an interim analysis is planned once the 25th patient has 18 weeks of follow up, with completion of enrollment of these first 25 patients expected in the first half of 2026. The study benefits from FDA Fast Track and Orphan Drug designations, which can support interactions with the agency and potential future regulatory pathways, though any ultimate approval or commercial impact will depend on clinical results and subsequent regulatory decisions.

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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 18, 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 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 18, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release in which it announced that the United States Patent and Trademark Office has granted Genprex a patent that covers the use of the Company’s lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in combination with PD-L1 antibodies, such as Tecentriq®, through 2037. The press release noted that in the Acclaim-3 clinical trial, the Company is combining REQORSA with Tecentriq, a PD-L1 antibody, and this patent secures exclusivity for this drug combination for the treatment of cancer, preventing would-be competitors from making, using or selling this drug combination.  PD-L1 antibodies are a type of targeted immunotherapy that block the activity of PD-L1 immune checkpoint proteins present on the surface of cells.

Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would also be applicable to Genprex’s Acclaim-3 clinical trial.

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 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 this patent grant 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: November 18, 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 8-K?

Genprex announced that the U.S. Patent and Trademark Office granted a patent covering REQORSA Gene Therapy in combination with PD‑L1 antibodies, such as Tecentriq, with protection extending through 2037, and provided an update on its Acclaim‑3 clinical trial.

What does the new patent cover for Genprexe28099s REQORSA therapy?

The patent covers the use of REQORSA Gene Therapy (quaratusugene ozeplasmid) in combination with PD‑L1 antibodies, including Tecentriq, and is intended to secure exclusivity for this cancer treatment combination by preventing others from making, using or selling it through 2037.

What is the design of Genprexe28099s Acclaim-3 clinical trial?

Acclaim‑3 is a Phase 1/2 trial evaluating REQORSA plus Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer who have received Tecentriq and chemotherapy as initial treatment, with patients treated until disease progression or unacceptable toxicity.

How many patients will be enrolled in the Phase 2 portion of Acclaim-3 and what is the primary endpoint?

The Phase 2 expansion portion of Acclaim‑3 is expected to enroll approximately 50 patients, and its primary endpoint 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.

When is the interim analysis for the Acclaim-3 Phase 2 study expected?

Genprex plans an interim analysis after the 25th patient in Acclaim‑3 has 18 weeks of follow up, and it expects to complete enrollment of these first 25 patients for interim analysis in the first half of 2026.

What regulatory designations support the Acclaim-3 trial for Genprex (GNPX)?

The Acclaim‑3 clinical trial is supported by U.S. Food and Drug Administration Fast Track Designation and Orphan Drug Designation, reflecting regulatory recognition of the underlying condition and therapy focus.

In which countries besides the U.S. does Genprex pursue patents for REQORSA with PD-L1 antibodies?

Genprex has patents granted in the U.S. and Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel for the use of REQORSA in combination with PD‑L1 antibodies.