gnpx20240803_8k.htm
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0001595248
0001595248
2024-08-13
2024-08-13
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 13, 2024
Date of report (Date of earliest event reported)
GENPREX, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38244
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90-0772347
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer
Identification Number)
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3300 Bee Cave Road, #650-227, Austin, TX
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78746
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(Address of principal executive offices)
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(Zip Code)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001 per share
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GNPX
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The Nasdaq Capital Market
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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 August 13, 2024, Genprex, Inc. (“Genprex” or the “Company”) issued a press release in which it announced that the Singapore Patent Office has granted a patent to Genprex that covers the use of the Company’s lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy, in combination with anti-PD-1 antibodies through 2037. The Company also noted that the patent expands on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile, China and Korea to cover the use of REQORSA in combination with an immune checkpoint inhibitor, i.e., PD-1 antibodies. The granted Korean patent also claims the use of REQORSA in combination with PD-L1 antibodies. Genprex will be pursuing additional patent applications with claims to combinations of REQORSA and PD-L1 antibodies in the U.S., Brazil, Canada, China, Europe and Israel. Should these applications grant, they would be applicable to Genprex’s Acclaim-3 clinical trial, which 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 developed tumor progression 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 also received an 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, 2023.
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 planned pursuit of additional patent applications with claims to combinations of REQORSA and PD-L1 antibodies in certain countries and whether or not they will eventually be granted in those countries; 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; 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.
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Exhibit
Number
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Description
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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.
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GENPREX, INC.
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Date: August 13, 2024
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By:
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/s/ Ryan Confer
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Ryan Confer
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Chief Executive Officer and Chief Financial Officer
(Principal Executive Officer and Principal Financial and Accounting Officer)
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