Genprex (NASDAQ: GNPX) secures new REQORSA PD-1/PD-L1 patents to 2037

Rhea-AI Filing Summary

Genprex, Inc. reported new patent progress for its lead gene therapy, REQORSA (quaratusugene ozeplasmid), in combination with checkpoint inhibitor drugs. The U.S. Patent and Trademark Office issued a notice of allowance for a patent covering REQORSA with PD-L1 antibodies such as Tecentriq, and the European Patent Office issued a notice of allowance for a patent covering REQORSA with PD-1 antibodies. Both patents will expire in 2037 at the earliest.

The company already holds patents for REQORSA with PD-L1 antibodies in Korea and for REQORSA with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore, and is pursuing additional applications in Europe, Canada, Brazil, China and Israel that could apply to its Acclaim-3 trial. Acclaim-3 is a Phase 1/2 study of REQORSA plus Genentech’s Tecentriq as maintenance therapy for extensive stage small cell lung cancer, and this trial has received FDA Fast Track and Orphan Drug designations.

Insights

Biotech & IP strategy analyst

Genprex expands REQORSA patent coverage for PD-1/PD-L1 combinations through 2037.

The update describes notices of allowance from the U.S. and European patent offices for patents covering REQORSA used with PD-L1 and PD-1 antibodies, respectively, with earliest expiry in 2037. This extends formal protection around combination use with checkpoint inhibitors like Tecentriq, which are central to many lung cancer treatment regimens.

Genprex also highlights granted patents for REQORSA plus PD-L1 antibodies in Korea and REQORSA plus PD-1 antibodies in multiple countries including the U.S., Japan and China, while pursuing further applications in Europe, Canada, Brazil, China and Israel that could relate to the Acclaim-3 trial. The Acclaim-3 Phase 1/2 study, using REQORSA with Tecentriq as maintenance therapy in extensive stage small cell lung cancer, already benefits from FDA Fast Track and Orphan Drug designations, which can support regulatory interactions and potential market exclusivity.

For investors, this filing underscores that Genprex is building an international intellectual property estate focused on REQORSA combinations rather than providing new clinical data or financial metrics. Future disclosures on Acclaim-3 progress and additional patent grants in key markets will shape how valuable this IP position becomes.

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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

August 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 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 August 18, 2025, Genprex, Inc. (“Genprex” or the “Company”) issued a press release in which it announced that the U.S. Patent and Trademark Office has issued a notice of allowance for a patent to Genprex that covers the use of the Company’s lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq®.  Additionally, the European Patent Office has issued a notice of allowance to Genprex for a patent covering the use of REQORSA in combination with PD-1 antibodies.  Both patents will expire in 2037 at the earliest.  

The press release also noted that Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would be applicable to Genprex’s Acclaim-3 clinical trial. Genprex has been granted patents for the use of REQORSA in combination with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore.  PD-L1 and PD-1 antibodies are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-L1 and PD-1 immune checkpoint proteins present on the surface of cells.

The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech’s Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 clinical trial has received U.S. Food and Drug Administration (“FDA”) Fast Track Designation for this patient population, and Acclaim-3 has received FDA 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 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: August 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 regarding new patents for REQORSA?

Genprex announced that the U.S. Patent and Trademark Office issued a notice of allowance for a patent covering the use of REQORSA gene therapy with PD-L1 antibodies such as Tecentriq, and the European Patent Office issued a notice of allowance for a patent covering the use of REQORSA with PD-1 antibodies. Both patents will expire in 2037 at the earliest.

In which countries does Genprex already have REQORSA combination patents?

Genprex has patents for REQORSA in combination with PD-L1 antibodies in Korea. It has patents for REQORSA in combination with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore.

What additional REQORSA patent applications is Genprex (GNPX) pursuing?

Genprex is pursuing additional patent applications for REQORSA combinations in Europe, Canada, Brazil, China and Israel. If granted, these patents would be applicable to the company’s Acclaim-3 clinical trial.

What is Genprex’s Acclaim-3 clinical trial and which designations has it received?

Acclaim-3 is a Phase 1/2 trial evaluating REQORSA combined with Genentech’s Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer who are candidates for maintenance treatment after Tecentriq and chemotherapy. The trial has received FDA Fast Track Designation and FDA Orphan Drug Designation for this patient population.

How do PD-1 and PD-L1 antibodies relate to Genprex’s REQORSA therapy?

PD-1 and PD-L1 antibodies are targeted immunotherapies in a class of checkpoint inhibitor anti-cancer drugs that block PD-1 and PD-L1 immune checkpoint proteins on cell surfaces. Genprex’s patents cover the use of REQORSA in combination with these antibodies, reflecting a strategy to pair its gene therapy with existing immuno-oncology agents.

Does this Genprex 8-K include new financial or earnings information?

No, this 8-K focuses on intellectual property and clinical program updates for REQORSA, including patent notices of allowance and regulatory designations for the Acclaim-3 trial, rather than financial results or earnings data.