false
0001595248
0001595248
2025-02-17
2025-02-17
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 17, 2025
Date of report (Date of earliest event reported)
GENPREX, INC.
(Exact name of registrant as specified in its charter)
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:
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 1.01 Entry into a Material Definitive Agreement.
On February 17, 2025 (the “Effective Date”), Genprex, Inc. (“Genprex” or the “Company”) and the University of Pittsburgh – Of the Commonwealth System of Higher Education (“UP”) entered into an amended and restated Exclusive License Agreement (the “New UP License Agreement”), which updates and consolidates into a single agreement the Prior License Agreements (as defined below). Pursuant to the New UP License Agreement, UP grants to Genprex a worldwide, exclusive license for certain patents and related technology, collectively referred to as the “Licensed Technology,” and a worldwide, non-exclusive license to use certain related know-how. The Licensed Technology covered by the New UP License Agreement is based on the same general gene therapy approach as covered under the Prior License Agreements (less the previously-licensed macrophage technology), whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. More specifically, the Licensed Technology covered by the New UP License Agreement is related to a gene therapy for both Type 1 diabetes and Type 2 diabetes using the genes of the Pdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters. As of the Effective Date, the New UP License Agreement effectuates the termination of, and amends, restates, replaces and supersedes in their entirety, the prior license agreements between Genprex and UP which were effective as of February 10, 2020 (as amended August 17, 2022 and November 3, 2022), December 29, 2022 and July 14, 2023 (collectively, the “Prior License Agreements”), provided that Genprex’s prior license from UP dated November 22, 2022 which covered the macrophage technology is being terminated in its entirety and is not incorporated into or covered by the New UP License Agreement.
The New UP License Agreement authorizes Genprex (including any affiliate of Genprex that agrees in writing to be bound by the New UP License Agreement to the same extent as Genprex) to make, have made, use and sell the Licensed Technology and to practice under the patent rights in the field of diabetes therapy. Genprex may enter into sublicensing arrangements for the rights, privileges and licenses granted under the New UP License Agreement upon prior written approval of UP; however, sublicensees shall not have rights to sublicense. Genprex agrees to use its best efforts to bring the Licensed Technology to market as soon as practicable, consistent with sound and reasonable business practice and judgment, to continue active, diligent marketing efforts for the Licensed Technology throughout the term of the New UP License Agreement, and to achieve certain milestones within specified time periods. Genprex agrees to submit annual progress reports to UP and, beginning in the year of the first commercial sale of the Licensed Technology, quarterly reports of manufacturing, sales and sublicense activities to UP, including information as would allow the calculation of amounts owing to UP on account of such activities, as well as Genprex’s calculation of such amounts.
UP has reserved the royalty-free, nonexclusive right to practice the patent rights and know-how and to use the Licensed Technology for non-commercial education and research purposes, and Genprex agreed to sell products and/or services resulting from Licensed Technology to UP and its affiliates upon request at the price and terms as are made available to Genprex’s most favored customer. The licenses granted to Genprex under the New UP License Agreement are subject to the rights of the U.S. government, which may have acquired a nonexclusive, nontransferable, paid up license to practice or have practiced for or on behalf of the United States the inventions described in the patent rights throughout the world.
As consideration for the New UP License Agreement, Genprex agreed to pay UP an initial license fee, annual maintenance fees, running low single digit percentage royalties, minimum annual royalties in a fixed cash amount, a low double digit percentage share of non-royalty sublicense income, and certain milestone payments up to an aggregate of approximately $4,825,000, as well as patent prosecution expenses incurred prior to and after the effective date of the New UP License Agreement.
The New UP License Agreement remains in effect until the later of 20 years after the first commercial sale of the Licensed Technology or the expiration of the last valid claim of the patents licensed under the New UP License Agreement. UP may terminate the agreement in the event of Genprex’s uncured default for thirty (30) days following notice thereof from UP, failure to achieve the specified milestones within the specified time period, or practice of the licensed patent rights or know-how outside the field of diabetes therapy, or if Genprex ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the relief of debtors. Genprex may terminate the New UP License Agreement upon six months prior written notice to UP and payment of all amounts accrued or due to UP through the effective date of termination.
The foregoing description of the material terms of the New UP License Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the New UP License Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 1.02 Termination of a Material Definitive Agreement.
The information set forth in Item 1.01 above is incorporated herein by reference. As disclosed in Item 1.01 above, effective as of the Effective Date, the New UP License Agreement effectuates the termination of, and amends, restates, replaces and supersedes in their entirety, the Prior License Agreements, provided that pursuant to a notice of termination delivered by Genprex to UP on the Effective Date and becoming effective six months thereafter, Genprex’s prior license from UP dated November 22, 2022 which covered the macrophage technology is being terminated in its entirety and is not incorporated into or covered by the New UP License Agreement.
Item 7.01 Regulation FD Disclosure.
Press Release
On February 18, 2025, Genprex issued a press release regarding certain updates on its diabetes gene therapy program, including the New UP License Agreement. The full text of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.
Item 8.01 Other Events.
Formation of Wholly-Owned Subsidiary
In connection with the intended separation of its diabetes clinical development program, on February 18, 2025, Genprex announced that it has formed a wholly-owned subsidiary, Convergen Biotech, Inc., to implement this initial step of the reorganization and facilitate separation of the diabetes program.
Item 9.01: Financial Statements and Exhibits.
(d) Exhibits.
# Certain portions of this exhibit were redacted pursuant to Item 601(b)(10) of Regulation S-K and Genprex, Inc. agrees to furnish supplementally to the U.S. Securities and Exchange Commission a copy of any omitted schedule and/or exhibit upon request. The portions of this exhibit that were omitted by means of marking such portions with asterisks because the identified portions are both (i) not material, and (ii) the type that registrant treats as private or confidential.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, 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: February 18, 2025
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By:
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/s/ Ryan Confer
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Ryan Confer
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President, Chief Executive Officer, and Chief Financial Officer
(Principal Executive Officer and Principal Financial Officer)
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EXHIBIT 10.1
CERTAIN IDENTIFIED INFORMATION MARKED WITH “[***]” HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (“Agreement”) is made and entered into as of as of the date of the last signature to this Agreement (“Effective Date”), by and between the University of Pittsburgh – Of the Commonwealth System of Higher Education, a non-profit corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with an office at 1st Floor Gardner Steel Conference Center, 130 Thackeray Avenue, Pittsburgh, Pennsylvania 15260 (“University”), and Genprex, Inc., a Delaware corporation, with its principal business at 3300 Bee Cave Road, Suite 650-227, Austin, Texas 78746 (“Licensee”).
WHEREAS, University is the owner by assignment from the inventors of certain patent rights, entitled “Virally-mediated endogenous neogenesis of beta cells yields autoimmune-resistant beta cells,” as further defined in Section 1.10 below and more particularly identified in Exhibit A attached hereto (“Patent Rights”) developed by George Gittes, et al, of the University faculty, and of certain know-how as further defined in Section 1.4 below and more particularly identified in number 1 of Exhibit D, attached hereto (“Know-How”);
WHEREAS, University is the owner by assignment from the inventors of certain patent rights, entitled “Insulin promoter for gene therapy for type 2 diabetes mellitus” as further definedin Section 1.10 below and more particularly identified in Exhibit A attached hereto (“Patent Rights”) developed by George Gittes, et al, of the University faculty, and of certain know-how as further defined in Section 1.4 below and more particularly identified in number 2 of Exhibit D attached hereto (“Know-How”);
WHEREAS, University is the owner by assignment from the inventors of certain patent rights, entitled “MafB promoter for gene therapy for diabetes” as further defined in Section 1.10 below and more particularly identified in Exhibit A attached hereto (“Patent Rights”) developed by George Gittes of the University faculty, and of certain know-how as further defined in Section 1.4 below and more particularly identified in number 3 of Exhibit D attached hereto (“Know-How”);
WHEREAS, University desires to have the Patent Rights utilized in the public interest;
WHEREAS, Licensee has represented to University, to induce University to enter into this Agreement, that Licensee is experienced in the development, production, manufacture, marketing and sale of products and/or the use of similar products to the Licensed Technology and that Licensee shall commit itself to a thorough, vigorous and diligent program of exploiting the Patent Rights so that public utilization results therefrom; and
WHEREAS, Licensee desires to obtain a license under the Patent Rights and Know-How upon the terms and conditions hereinafter set forth.
WHEREAS, University and Licensee entered into License Agreements and related Amendments for the above assigned technologies, dated December 29th 2022 (insulin promoter); July 14th 2023 (MafB promoter); Feb 10th 2020, August 17th 2022, November 1st 2022 (glucagon promoter) (together the Prior Agreements), and the Prior Agreements are hereby terminated and replaced in their entirety by this Agreement as of the Effective Date.
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto, intending to be legally bound, agree as follows:
ARTICLE 1 – DEFINITIONS
For purposes of this Agreement, the following words and phrases shall have the following meanings:
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1.1
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“Affiliate” shall mean, with respect to University, any clinical or research entity that is operated or managed as a facility under the UPMC Health System, whether or not owned by University. With respect to Licensee, “Affiliate” means any company or legal entity that directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Licensee but only for as long as such control exists. For this definition, “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the affairs or management of an entity, whether through the ownership of voting securities, by contract or otherwise.
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1.2
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“Field” shall mean diabetes therapy.
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1.3
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“Licensed Technology” shall mean any product or part thereof or service which is:
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a.
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Covered in whole or in part by an issued, unexpired or pending claim contained in the Patent Rights in the country in which any such product or part thereof is made, used or sold or in which any such service is used or sold; or
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b.
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Manufactured by using a process or is employed to practice a process which is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Patent Rights in the country in which any such process that is included in Licensed Technology is used or in which such product or part thereof or service is used or sold.
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c.
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Manufactured by or otherwise makes use of Know-How.
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1.4
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“Licensee” shall mean Genprex, Inc. Licensee may extend the license granted herein to any Affiliate provided that the Affiliate agrees in writing to be bound by this Agreement to the same extent as Licensee. For the sake of clarity, any specific reference to “Licensee” in any provision of this Agreement shall include such Affiliate regardless of whether aspecific reference to an “Affiliate” is made in such provision.
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1.5
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“Know-How” means (a) the University information set forth on Exhibit D and existing on the Effective Date, (b) whether or not covered by a Valid Claim in Patent Rights, and (c) useful or necessary to make, have made, use or sell the Licensed Technology in the Field.
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1.6
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“FDA” means the United States Food & Drug Administration or its successor.
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1.7
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“MafB Patent Claim” shall mean a issued patent claim reciting a composition comprising an adeno-associated virus vector comprising a MafB promoter operably linked to a nucleic acid sequence encoding Pdx1 and a nucleic acid sequence encoding MafA, and [***] or a claim of similar scope.
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1.8
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“Net Sales” shall mean Licensee’s and any sublicensee’s invoice price for products or services included in Licensed Technology and produced hereunder less the sum of the following:
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a.
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Actual cost of freight charges or freight absorption, separately stated in such invoice;
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b.
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Actual trade, quantity or cash discounts allowed, if any; and
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c.
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Sales taxes, tariff duties, use taxes, and other taxes, excluding income taxes, separately stated on each invoice; and
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d.
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Other amounts actually refunded, allowed or credited due to rejection, returns, or reperformance of services, but not exceeding the original invoiced amount.
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Sales, transfers, or other dispositions of any Licensed Technology, at or below cost, for charitable, promotional (including samples), pre-clinical, clinical, or regulatory purposeswill be excluded from Net Sales.
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1.9
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“Non-Commercial Education and Research Purposes” shall mean shall mean use of Patent Rights and/or Know-How (including distribution of biological materials covered by the Patent Rights) in the Field for academic research or other not-for-profit scholarly purposes which are undertaken at a nonprofit or governmental institution that does not use the Patent Rights in the production or manufacture of products for sale or the performance of services for a fee.
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1.10
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“Non-Royalty Sublicense Income” shall mean execution fees, maintenance fees, milestone fees and all other non-royalty payments received by Licensee from its sublicensees pursuant to any sublicense granted pursuant to Section 2.3 hereunder.
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1.11
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“Patent Rights” shall mean University intellectual property described below and assigned to University:
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a.
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The United States (“U.S.”) and foreign patents and/or patent applications listed in Exhibit A;
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b.
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Any non-provisional patent applications that claim priority to any provisional patent application listed in Exhibit A;
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c.
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Any and all foreign patent applications, foreign patents or related foreign patent documents that claim priority to the patents and/or patent applications listed in Exhibit A;
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d.
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Any and all divisionals, continuations, reissues, re-examinations, renewals, substitutions, and extensions of the foregoing; and
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e.
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Any and all patents issuing from the foregoing.
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1.12
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“Territory” shall mean Worldwide.
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1.13
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“Pivotal Trial” means a controlled Phase III clinical trial, as defined by the US FDA, of Licensed Technology that is prospectively designed to demonstrate statistically whether such Licensed Technology is effective and safe for use in a particular indication in a manner sufficient to obtain regulatory approval to market such product in the United States, European Union, or other foreign jurisdiction.
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1.14
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“Valid Claim” shall mean a claim of (i) an issued and unexpired patent which has not been declared invalid or unenforceable in a court of appropriate jurisdiction, withdrawn, abandoned, or revoked, or (ii) a patent application which has not been withdrawn, abandoned, rejected, or revoked and has not been pending for more than six (6) years from the filing date.
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ARTICLE 2 - GRANT
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2.1
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Subject to the terms and conditions of this Agreement, University hereby grants to Licensee, to the extent it may lawfully do so, the right and exclusive license in the Territory to make, have made, use and sell the Licensed Technology in the Field and to practice under the Patent Rights in the Field for the Term set forth in Article 10 below. Licensee shall not practice the Patent Rights outside of the Field. University reserves the royalty-free, nonexclusive right to practice the Patent Rights and the Know-How and to use the Licensed Technology for Non-Commercial Education and Research Purposes. University and any nonprofit or governmental institution also have the right to publish or have published any University information included in the Licensed Technology, Know-How or Patent Rights. This Agreement does not include transfer of any materials.
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2.2
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Subject to the terms and conditions of this Agreement, University hereby grants to Licensee, to the extent it may lawfully do so, the right and nonexclusive license in the Territory to practice the Know-How in the Field for the Term, unless the Agreement is terminated earlier in accordance with Article 10.
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2.3
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The license granted hereby is subject to the rights of the U.S. government, if any, as set forth in 35 U.S.C. § 200 et seq. Pursuant to this law, the U.S. government may have acquired a nonexclusive, nontransferable, paid-up license to practice or have practiced for or on behalf of the U.S. the inventions described in the Patent Rights throughout the world. Pursuant to 35 U.S.C. § 200 et seq. Licensed Technology produced for sale in the U.S. shall be substantially manufactured in the U.S. (unless a waiver under 35 U.S.C. § 204 is granted by the appropriate U.S. government agencies).
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2.4
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Licensee shall have the right to enter into sublicensing arrangements for the rights, privileges and licenses granted hereunder upon prior written approval of each sublicensee by University, except that sublicensees shall not have rights to sublicense. Such sublicense agreements shall include a royalty rate upon sublicense Net Sales in an amount at least equal to the rate set forth in Section 4.l(c). In all such sublicensing agreements, Licensee shall impose on the sublicensee an obligation to not practice the Patent Rights or Know-How outside of the Field. Upon the termination of this Agreement and upon the request of any sublicensee, any sublicenses granted prior to either party’s receipt of any termination notice under this Agreement shall survive termination, provided that such sublicensee: (a) is not at such time in breach of this Agreement; and (b) agrees in writing to assume all of the Licensee’s applicable obligations under this Agreement through an assumption agreement or amended license Agreement, as appropriate.
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2.5
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Licensee agrees that any sublicense granted by it shall provide that the obligations to University of Articles 2, 7, 8, 9, 10, and 13 of this Agreement shall be binding upon the sublicensee as if it were party to this Agreement. Each sublicense granted by Licensee pursuant to this Agreement shall include an audit right by University of sublicensee of the same scope as provided in Section 5.2 with respect to Licensee.
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2.6
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Licensee agrees to forward to University a copy of any and all sublicense agreements promptly upon execution thereof, but in no event later than thirty (30) days after each such sublicense agreement has been executed by both parties thereto; provided however, such sublicense or amendment may be redacted with respect to the sublicensee’s scientific and technical information.
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2.7
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The license granted hereunder shall not be construed to confer any rights upon Licensee by implication, estoppel or otherwise as to any intellectual property not specifically set forth in Exhibit A or Exhibit D hereof..
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ARTICLE 3 – DUE DILIGENCE
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3.1
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Licensee shall use its best efforts to bring the Licensed Technology to market as soon as practicable, consistent with sound and reasonable business practice and judgment, and to continue active, diligent marketing efforts for the Licensed Technology throughout the Term of this Agreement.
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3.2
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In addition, Licensee shall adhere to each of the following milestones:
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3.3
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Licensee shall notify University in writing of the achievement of each milestone within thirty (30) days upon the achievement of the respective milestone.
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3.4
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Licensee’s failure to perform in accordance with Section 3.1 or to fulfill on a timely basis any one of the milestones set forth in Section 3.2 hereof shall be grounds for University to terminate this Agreement and upon termination all rights and interest to the Licensed Technology, Know-How and Patent Rights shall revert to University.
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ARTICLE 4 – LICENSE CONSIDERATION
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4.1
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In consideration of the rights, privileges and license granted by University hereunder, Licensee shall pay royalties and other monetary consideration as follows:
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a.
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Initial license fee, nonrefundable and noncreditable against royalties, of [***] due immediately and payable within thirty (30) days from the Effective Date of this Agreement;
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b.
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Annual maintenance fees, non-refundable, non-creditable, and not to be prorated against any other payment or royalties due, in the following amounts until the first Net Sale of a Licensed Technology occurs:
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c.
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Running royalties in the following amounts shall become due immediately and shall become payable as set forth in Section 4.2:
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i.
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[***] of Net Sales of Licensed Technology covered by a Valid Claim of Patent Rights; and
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ii.
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[***] of Net Sales of Licensed Technology NOT covered by a Valid Claim of Patent Rights, but which uses or was manufactured using Know-How.
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d.
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Beginning with the first Net Sales, a minimum annual royalty in the amount of [***] per calendar year, but only to the extent such minimum royalty is greater than the aggregate annual royalty computed in accordance with Section 4.1(c) above; and
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e.
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A share of Non-Royalty Sublicense Income of [***].
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f.
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Milestone payments as follows:
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4.2
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All payments pursuant to this Agreement shall be made by ACH or by wire transfer in U.S. Dollars without deduction or exchange, collection or other charges and remitted via ACH or wire transfer, to the bank set forth in Article 11. Annual maintenance fees pursuant to Section 4.1(b) hereof shall be paid on the anniversary of the Effective Date of the calendar year in which they are due. Royalty payments pursuant to Section 4.1(c) hereof shall be paid within thirty (30) days after each March 31, June 30, September 30 and December 31. Minimum annual royalties pursuant to Section 4.1(d) shall be due December 31 and paid by January 30 following the calendar year in which they are due. Non-Royalty Sublicense Income payments pursuant to Section 4.1(e) hereof shall be paid within thirty (30) days after receipt of payment by Licensee from sublicense. Milestone payments pursuant to Article 4.1 (f) shall be paid within thirty (30) days of milestone event date.
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4.3
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Taxes imposed by any foreign governmental agency on any payment to be made to University by Licensee shall be paid by Licensee without deduction from any payment due to University hereunder.
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4.4
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The balance of any payments pursuant to this Agreement, including those specified in Section 6.2, which are overdue shall bear interest, compounded monthly, calculated from the due date until payment is received at the rate of [***] per annum. Payment of such interest by Licensee shall not negate or waive the right of University to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment, including, but not limited to, termination of this Agreement as set forth in Article 10. Licensee shall reimburse University for any costs and expenses incurred in connection with collecting any overdue balance of payments with respect to Licensee’s payment and reimbursement obligations under this Agreement, including the costs of engaging counsel or a collection agency for such purpose.
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4.4
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The balance of any payments pursuant to this Agreement, including those specified in Section 6.2, which are overdue shall bear interest, compounded monthly, calculated from the due date until payment is received at the rate of [***] per annum. Payment of such interest by Licensee shall not negate or waive the right of University to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment, including, but not limited to, termination of this Agreement as set forth in Article 10. Licensee shall reimburse University for any costs and expenses incurred in connection with collecting any overdue balance of payments with respect to Licensee’s payment and reimbursement obligations under this Agreement, including the costs of engaging counsel or a collection agency for such purpose.
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4.5
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Licensee shall sell products and/or services resulting from Licensed Technology to University and its Affiliates upon request at such price(s) and on such terms and conditions as such products and/or processes are made available to Licensee’s most favored customer.
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ARTICLE 5 – REPORTS AND AUDIT
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5.1
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Within thirty (30) days after each March 31, June 30, September 30 and December 31 of each year during the term of this Agreement beginning in the year of the first commercial sale of Licensed Technology, Licensee shall deliver to University true, accurate and detailed reports of the following information in a form as illustrated in Exhibit B:
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a.
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Number of Licensed Technology products manufactured and sold by Licensee and all sublicensees;
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b.
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Total billings for all such products;
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c.
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Accounting for all Licensed Technology services used or sold by Licensee and all sublicensees;
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d.
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Deductions set forth in Section 1.5;
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f.
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Name and addresses of sublicensees; and
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g.
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Total Non-Royalty Sublicense Income received during such calendar quarter and total amount of payment due pursuant to Section 4.1(e).
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5.2
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Licensee shall keep full, true and accurate books of account, in accordance with generally accepted accounting principles, containing all information that may be necessary for the purpose of showing the amounts payable to University hereunder. Such books of account shall be kept at Licensee’s principal place of business. Such books of account shall be open at all reasonable times for [***] following the end of the calendar year to which they pertain, and for [***] after the expiration or termination of this Agreement, for inspection by University or its agents for the purpose of verifying Licensee’s royalty statement or compliance in other respects with this Agreement. The fees and expenses of University’s representatives shall be borne by University; however, if an error of more than [***] of the total payments due or owing for any year is discovered, then Licensee shall bear University’s fees and expenses.
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5.3
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No later than sixty (60) days after December 31 of each calendar year during the term of this Agreement, Licensee shall provide to University a written annual progress report, as illustrated in Exhibit C, describing Licensee’s progress on research and development, regulatory approvals, manufacturing, sublicensing, marketing and sales during the preceding twelve-month period ending December 31.
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5.4
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Notwithstanding the above, University shall have the right, on an annual basis during the term of this Agreement and for [***] after the expiration or termination of this Agreement, to inspect technical and other information from Licensee sufficient to evidence whether and to what extent Licensee is: (a) practicing the Patent Rights and/or other University property licensed hereunder; and (b) meeting its diligence obligations under Article 3, above.
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5.5
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Licensee shall report to the University the date of the first commercial sale of a Licensed Technology within sixty (60) days of occurrence in each country.
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ARTICLE 6 – PATENT PROSECUTION
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6.1
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University has or shall apply for, seek prompt issuance of and maintain during the term of this Agreement the Patent Rights in the U.S. and in such foreign countries as may be designated by Licensee in a written notice to University within a reasonable time in advance of the required foreign filing dates. University will confer with Licensee to develop a strategy for the prosecution and maintenance of Patent Rights. Licensee shall have the opportunity to advise and cooperate with University in the prosecution, filing and maintenance of such patents, and to the extent practicable, all documents prepared by University’s counsel for submission to governmental patent offices will be provided to Licensee for review and comment prior to filing.
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6.2
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Licensee shall notify University immediately if, at any time during the term of this Agreement, Licensee or any of its sublicensees does not qualify as a “small entity” as provided by the U.S. Patent and Trademark Office.
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6.3
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All fees and costs, including attorneys’ fees, relating to the filing, prosecution, maintenance, and post grant proceedings relating to the Patent Rights shall be the responsibility of Licensee, whether incurred prior to or after the Effective Date. Fees and costs incurred after the Effective Date, or fees and costs incurred before the Effective Date which are not included in the pre-agreement expenses shall be paid by Licensee within thirty (30) days after receipt of University’s invoice therefor. Additionally, Licensee shall be liable to University for all of University’s out-of-pocket filing, prosecution, and maintenance costs (including all attorneys’ fees and costs), for any and all patent prosecution and maintenance actions that will be taken by patent counsel after the term of this Agreement but in response to any instructions that were sent during the term of this Agreement from University to patent counsel relating to the Patent Rights. Payments pursuant to this Section 6.2 are not creditable against royalties or any other payment due to University under this Agreement.
|
ARTICLE 7 – INFRINGEMENT ACTIONS
|
7.1
|
Licensee shall inform University promptly in writing of any alleged infringement of the Patent Rights by a third party and of any available evidence thereof.
|
|
7.2
|
During the term of this Agreement, Licensee shall have the right, but shall not be obligated, to prosecute at its own expense all infringements of the Patent Rights in the Field and in the Territory if Licensee has notified University in writing of its intent to prosecute; provided, however, that such right to bring such an infringement action shall remain in effect only for so long as the license granted herein remains exclusive. In furtherance of such right, University hereby agrees that Licensee may include University as a party plaintiff in any such suit, without expense to University. The total cost of any such infringement action commenced or defended solely by Licensee shall be borne by Licensee and University shall receive a percentage of any recovery or damages for past infringement derived therefrom which is equal to the percentage royalty due University under Article 4. Licensee shall indemnify University against any order for costs that may be made against University in such proceedings.
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7.3
|
If within six (6) months after having been notified of any alleged infringement, Licensee shall have been unsuccessful in persuading the alleged infringer to desist and shall not have brought and shall not be diligently prosecuting an infringement action, or if Licensee shall notify University at any time prior thereto of its intention not to bring suit against any alleged infringer, then, and in those events only, University shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Patent Rights, and University may, for such purposes, use the name of Licensee as party plaintiff. University shall bear all costs and expenses of any such suit. In any settlement or other conclusion, by litigation or otherwise, University shall keep any recovery or damages for past infringement derived therefrom.
|
|
7.4
|
In the event that a declaratory judgment action alleging invalidity or infringement of any of the Patent Rights shall be brought against University, Licensee, at its option, shall have the right, within thirty (30) days after commencement of such action, to intervene and take over the sole defense of the action at its own expense.
|
|
7.5
|
In any infringement suit either party may institute to enforce the Patent Rights pursuant to this Agreement, the other party shall, at the request and expense of the party initiating such suit, cooperate in all respects and, to the extent possible, have its employees testify when requested and make available relevant records, information, samples, specimens, and other evidence upon request.
|
ARTICLE 8 – INDEMNIFICATION/INSURANCE/LIMITATION OF LIABILITY
|
8.1
|
Licensee shall at all times during the term of this Agreement and thereafter indemnify, defend and hold University, its trustees, officers, faculty members, employees and affiliates (“Indemnified Parties”) harmless against all claims and expenses, including legal expenses and reasonable attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property or the environment, and against any other claim, proceeding, demand, expense and liability of any kind whatsoever resulting from: (i) the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Technology, (ii) the practice by Licensee or sublicensee of the Patent Rights and Know-How; or (iii) arising from or relating to this License Agreement. Licensee shall provide this defense and indemnity whether or not any Indemnified Party, either jointly or severally, is named as a party defendant and whether or not any Indemnified Party is alleged to be negligent or otherwise responsible for any injuries to person or property. The obligation of Licensee to defend and indemnify as set forth herein shall survive termination of this Agreement and shall not be limited by any other limitation of liability elsewhere in this Agreement.
|
|
8.2
|
Licensee shall obtain and carry in full force and effect liability insurance which shall protect Licensee and University in regard to events covered by Section 8.1 above, as provided below:
|
|
a.
|
Commercial General Liability
|
|
i.
|
Coverage: Commercial General Liability, including, but not limited to, Products, Contractual, Fire, Legal and Personal Injury
|
|
ii.
|
Limits: [***] Combined Single Limits for Bodily Injury and Property Damage
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i.
|
Coverage: Products Liability
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ii.
|
Limits: [***] upon first use of Licensed Technology in humans or first commercial sale, whichever is earlier
|
The University of Pittsburgh is to be named as an additional insured with respect to insurance policies identified in Sections 8.2(a) and 8.2(b) above. Certificates of insurance evidencing the coverage required above shall be filed with University’s Innovation Institute, 1st Floor Gardner Steel Conference Center, 130 Thackeray Avenue, Pittsburgh, PA 15260, within thirty (30) days from the Effective Date of this Agreement and on or before July 1 of each subsequent year during the Term of this Agreement. Such certificates shall provide that the insurer will give University not less than thirty (30) days advance written notice of any material changes in or cancellation of coverage.
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8.3
|
UNIVERSITY, AND ITS AGENTS AND/OR EMPLOYEES, MAKE NO REPRESENTATION AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY.  UNIVERSITY ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF UNIVERSITY, ITS AGENTS AND/OR EMPLOYEES FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, INCLUDING THE MANUFACTURE, USE OR SALE OF THE PRODUCT(S) AND SERVICE(S) LICENSED UNDER THIS AGREEMENT. LICENSEE ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT THAT IS MANUFACTURED, USED OR SOLD BY LICENSEE (INCLUDING SUBLICENSEE SALES) WHICH IS LICENSED TECHNOLOGY HEREUNDER. |
ARTICLE 9 – ASSIGNMENT
This Agreement is not assignable without the prior written consent of University and any attempt to do so shall be null and void; except that, Licensee may assign this Agreement without the prior written consent to a third party, who is not a restricted party under US export control laws, in connection with the sale of all or substantially all of the assets to which this Agreement relates or in connection with a merger, acquisition, reorganization, or similar transaction involving the Licensee. For any permitted assignment to be effective, the assignee shall assume all obligations of Licensee set forth in this Agreement in writing, and such assumption agreement is promptly delivered to University upon execution.
ARTICLE 10 – TERM AND TERMINATION
|
10.1
|
The term of this Agreement shall be from the Effective Date until the later of i) 20 years after first commercial sale of the Licensed Technology or ii) expiration of the last Valid Claim of the Patent Rights; unless terminated earlier pursuant to Section 10.2 and 10.3 below.
|
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10.2
|
University shall have the right to terminate this Agreement, upon written notice, if:
|
|
a.
|
Licensee defaults in the performance of any of the obligations herein contained and such default has not been cured within thirty (30) days after receiving written notice thereof from University;
|
|
b.
|
The practice of the Patent Rights or Know-How by Licensee or sublicensee is outside of the Field; or
|
|
c.
|
Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
|
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10.3
|
Licensee may terminate this Agreement upon six (6) months prior written notice to University and upon payment of all amounts accrued or due to the University through the effective date of termination, including patent cost reimbursement pursuant to Section 6.2 hereof.
|
|
10.4
|
Upon termination of this Agreement, neither party shall be released from any obligation that accrued prior to the effective date of such termination. Licensee and any sublicensee may, however, after the effective date of such termination, sell all Licensed Technology which Licensee produced prior to the effective date of such termination, provided that Licensee shall pay to University the royalties thereon as required by Article 4 hereof and submit the reports required by Article 5 hereof.
|
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10.5
|
The provisions of Articles 6-8, Sections 10.4 and 10,5, Article 11, and Sections 13.5 and 13.8 shall survive any expiration or earlier termination of this Agreement.
|
ARTICLE 11 – NOTICES
|
11.1
|
Any notice or communication pursuant to this Agreement shall be sufficiently made or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed to the address below or as either party shall designate by written notice to the other party, or if in accordance with Section 11.3.
|
In the case of University:
Innovation Institute
University of Pittsburgh
1st Floor Gardner Steel Conference Center
130 Thackeray Avenue
Pittsburgh, PA 15260
ATTN: Director
In the case of Licensee, per Exhibit D.
|
11.2
|
Any payments to University by ACH or wire transfer shall be directed as follows:
|
University of Pittsburgh ACH/Wire Instructions – Innovation Institute
BANK ACCOUNT NUMBER: [***]
BANK ACCOUNT NAME: [***]
BANK ADDRESS: [***]
TYPE OF ACCOUNT: [***]
BANK: [***]
SWIFT CODE: [***]
ABA Routing: [***]
REF: Innovation Institute Invoice #
[***]
The Licensee shall be responsible for all applicable fees and costs relating to any ACH or wire transfer, to include translation fees, without any deduction of such fees from amounts due to the University pursuant to this Agreement.
|
11.3
|
All invoices to Licensee generated by University under this Agreement will be sent electronically, via e-mail, in PDF format, unless instructed otherwise by Licensee in writing. |
ARTICLE 12 – AMENDMENT, MODIFICATION
This Agreement may not be amended or modified except by the execution of a written instrument signed by the Director of the University of Pittsburgh Innovation Institute, his successor, or other designated University employee having signatory authority, and Licensee’s Chief Executive Officer. In connection with any agreed upon amendment or modification of this Agreement pursuant to this Article 12, Licensee shall be required to pay an Amendment Fee.
ARTICLE 13 – MISCELLANEOUS
|
13.1
|
This Agreement shall be construed and interpreted in accordance with the laws of the Commonwealth of Pennsylvania. The forum for any action relating to this Agreement, including those brought against individuals such as University employees or agents, shall be the Courts of Allegheny County, Pennsylvania, or, if in a federal proceeding, the U.S. District Court for the Western District of Pennsylvania
|
|
13.2
|
The parties acknowledge that this Agreement sets forth the entire understanding and intentions of the parties hereto as to the subject matter hereof and supersedes all previous representations, negotiations, or understandings between the parties and/or its employees or agents, whether written or oral, regarding the subject matter of this Agreement.
|
|
13.3
|
The parties acknowledge that they consulted, or had the opportunity to investigate and/or consult, with their legal counsel and/or other advisors with respect to the Patent Rights, Licensed Technology, and the terms of this Agreement.
|
|
13.4
|
The parties agree that this Agreement constitutes an arm’s length business transaction and does not create a fiduciary relationship.
|
|
13.5
|
Except as provided herein, nothing contained in this Agreement shall be construed as conferring upon either party any right to use in advertising, publicity or other promotional activities any name, trade name, trademark, or other designation of the other party, including any contraction, abbreviation, or simulation of any of the foregoing. Without the express written approval of the other party, neither party shall use any designation of the other party in any promotional activity associated with this Agreement or the Licensed Technology. Neither party shall issue any press release or make any public statement in regard to this Agreement without the prior written approval of the other party. Licensee may use the name of the University in routine business correspondence, or as needed in appropriate regulatory submissions and disclosures made under state and federal securities laws, and may state the fact that the University is the licensor of the licensed Patent Rights and Know-How without the prior express written consent of the University.
|
|
13.6
|
Licensee agrees that with respect to the performance of this Agreement or the practice of the rights granted by the University hereunder, it shall comply with any and all applicable U.S. export control laws and regulations, as well as any and all embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset Controls.
|
|
13.7
|
Each Party agrees that in connection with this Agreement that it will abide by applicable laws and regulations. No Party will offer, promise or give, directly or indirectly, anything of value to any government official, political party official, political candidate, or employee thereof or to any third party while knowing that such item of value or any portion thereof may be offered, promised, or given to a government official, political party official, political candidate, or employee thereof for the purpose of obtaining or retaining business. Each Party specifically agrees that in connection with this Agreement, it will take no action, or omit to take any action, which would cause another party to be in violation of the applicable laws of the U.S., including the U.S. Foreign Corrupt Practices Act and/or any local laws regarding bribery as well as any U.S. anti-boycott laws. In addition, the Parties represent and certify that neither the Parties nor their officers, board members nor agents involved in the performance of this Agreement have been convicted of crimes involving theft, fraud, bribery, corruption or moral turpitude and that each is not now listed by any government agency as being debarred, suspended or proposed for debarment or suspension.
|
|
13.8
|
If Licensee challenges the validity or enforceability of University’s Patent Rights or University’s ownership of the Patent Rights anywhere in the world, the Licensee shall continue to pay to University all royalties and other financial obligations required under this Agreement, to include patent costs and fees. If any such challenge is unsuccessful by Licensee, the royalty rates and any non-royalty sublicense income rate set forth in Article 4.1 above shall automatically double in value, to include all royalty minimums and floors; and Licensee shall reimburse the University for all fees and costs associated with defending such action, including but not limited to attorney’s fees and expert fees. The effective date of such increase in royalty rates shall be the date of the first court order or date of issuance of a re-examination certificate (or foreign equivalents thereof) declaring any claim of the Patent Rights as valid or enforceable. Within thirty (30) days prior to filing any such challenge, Licensee shall provide the University with written notice of its intent to make such challenge detailing its allegation(s) along with specific and detailed facts supporting those allegations of invalidity or unenforceability of University’s Patent Rights.
|
|
13.9
|
If one or more of the provisions of this Agreement shall be held invalid, illegal or unenforceable, the remaining provisions shall not in any way be affected or impaired thereby. In the event any provision is held illegal or unenforceable, the parties shall use reasonable efforts to substitute a valid, legal and enforceable provision which, insofar as is practical, implements purposes of the provision held invalid, illegal or unenforceable.
|
|
13.10
|
Failure at any time to require performance of any of the provisions herein shall not waive or diminish a party’s right thereafter to demand compliance therewith or with any other provision. Waiver of any default shall not waive any other default. A party shall not be deemed to have waived any rights hereunder unless such waiver is in writing and signed by a duly authorized officer of the party making such waiver.
|
|
13.11
|
Licensee shall mark all Licensed Technology with applicable U.S. and foreign patent numbers in accordance with the applicable laws of the countries in which Licensed Technology is used or sold.
|
[remainder of page intentionally left blank]
IN WITNESS WHEREOF, the parties represent and warrant that each has the authority to bind the party to this Agreement and have set their hands and seals as of the date set forth on the first page hereof.
UNIVERSITY OF PITTSBURGH – OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Evan Facher, Ph.D., MBA
Director, Innovation Institute
Vice Chancellor for Innovation and Entrepreneurship
Date: January 15, 2025
GENPREX, INC.
Name: Ryan M. Confer
Title: President and Chief Executive Officer
Date: February 17, 2025
EXHIBIT A
PATENT RIGHTS FOR EXCLUSIVE LICENSE AGREEMENT BETWEEN
THE UNIVERSITY OF PITTSBURGH AND GENPREX
[***]
EXHIBIT B
SAMPLE ROYALTY REPORT
[***]
EXHIBIT C
SAMPLE PROGRESS REPORT
[***]
EXHIBIT D
KNOW-HOW
[***]
EXHIBIT E
LICENSEE CONTACT INFORMATION
[***]
Exhibit 99.1

Genprex Provides Update on Diabetes Gene Therapy Program
Signs an Amended & Restated License Agreement for Multiple Technologies for Gene Therapy for Type 1 and Type 2 Diabetes
Forms a Wholly-Owned Subsidiary, Convergen Biotech, Inc., to Focus Diabetes Program Development
AUSTIN, Texas — (February 18, 2025) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the advancement of its diabetes gene therapy program, including its relationship and collaboration with the University of Pittsburgh of the Commonwealth System of Higher Education (Pitt).
The parties have updated and consolidated the Company’s existing license agreements for technologies from Pitt into a new exclusive license agreement for multiple technologies relating to the development of a gene therapy product for both T1D and T2D. Additionally, the Company has formed a wholly-owned subsidiary, Convergen Biotech, Inc., which will focus on the Company’s diabetes program development.
“We are excited about the advances we are making with our diabetes gene therapy program, including the updated, consolidated exclusive license agreement with the University of Pittsburgh for several technology combinations,” said Ryan Confer, President and Chief Executive Officer at Genprex. “We are also pleased to have formed our wholly-owned subsidiary. In addition, we’re having ongoing discussions with various patient advocacy groups. We believe GPX-002 is a highly innovative, emerging diabetes gene therapy, and we are working to advance this program toward human clinical trials.”
Exclusive License Agreement with the University of Pittsburgh
The new license agreement consolidates the Company’s licensed technologies from Pitt into a single updated agreement which replaces the existing license agreements with Pitt. The amended and restated agreement grants Genprex a worldwide, exclusive license to patent applications and related technologies and a worldwide, non-exclusive license to use certain related know-how, all related to a gene therapy for both T1D and T2D using the genes of the Pdx1 and MafA transcription factors controlled by insulin, glucagon and MafB promoters. This license creates a comprehensive panel of gene therapies exclusively licensed by Genprex for the Company’s diabetes gene therapy program.
“The latest exclusive license agreement synergizes our pre-existing relationship with the University of Pittsburgh, strengthens our intellectual property portfolio for the diabetes gene therapy program and provides Genprex with valuable rights over multiple diabetes gene therapy combinations that we believe have the potential to disrupt the diabetes market,” said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. “These technologies are currently being evaluated in preclinical studies at the University of Pittsburgh. As we continue to optimize our construct, we are making strides toward clinical trials.”
The licensed technologies are based on the same general gene therapy approach under Genprex’s original licenses, whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. GPX-002 is being developed using the same construct for the treatment of both T1D and T2D. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for T2D, where autoimmunity is not a factor, is believed to rejuvenate and replenish exhausted beta cells.

Each of these technologies may have the potential to provide long-term efficacy, potentially changing the course of this disease for the millions of patients around the world with diabetes. All of the diabetes technologies licensed from Pitt by Genprex were developed in the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine.
The Company has finalized components of the diabetes construct and is continuing with its planned preclinical studies. Genprex plans to request FDA’s guidance for the preclinical studies needed to file an Investigational New Drug (IND) application and initiate first-in-human studies and is poised for FDA Guidance on IND-enabling diabetes studies by the second half of 2025.
Formation of a Wholly-Owned Subsidiary
In addition, as announced in September 2024, Genprex believes separating its diabetes program from its oncology program into a new, wholly-owned subsidiary could expedite clinical development and enable potential direct investment and strategic collaboration into its diabetes program. In connection with the intended separation of its diabetes clinical development program, Genprex has formed a wholly-owned subsidiary, Convergen Biotech, Inc. Genprex believes implementing this initial step and facilitating the separation of its diabetes program into Convergen Biotech will allow both Genprex and Convergen Biotech to enhance each program’s focus on meeting the needs of their respective markets and patients. The decision to implement this initial step of the reorganization demonstrates Genprex’s strong ongoing commitment to the Company's streamlined, focused strategies and prioritization of its ongoing research and development prioritization initiative.
About Diabetes
According to the U.S. Center for Disease Control as of 2024, 38.4 million Americans, or approximately 11.6% of the U.S. population, have diabetes. Approximately 10% of this total has T1D and approximately 90-95% of this total has T2D. It is also believed that more than 97 million Americans aged 18 years or older have prediabetes. In 2021, approximately 537 million adults (20-79 years) worldwide were living with diabetes, and the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million in 2045. Approximately 7.7 million adults over the age of 20 live with T1D worldwide, and approximately 1.6 million children and adolescents under the age of 20 live with T1D worldwide. Also in 2021, diabetes caused more than 6.7 million deaths globally and diabetes resulted in approximately $966 billion dollars in health expenditures, a 316% increase over the preceding fifteen years.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release 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 ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications, such as the Company’s diabetes product candidate, GPX-002; the timing and success of Genprex’s clinical trials and regulatory approvals, including, but not limited to, the Company’s diabetes clinical development program and its ongoing work with UPitt; 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, including successful implementation of the separation of its diabetes clinical development program, including the anticipated benefits of the internal reorganization, the expected timing of the reorganization and/or if it is completed as contemplated or at all; 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 press release. 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 press release or to reflect the occurrence of unanticipated events, except as required by law.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor Relations
investors@genprex.com
GNPX Media Contact
Kalyn Dabbs
media@genprex.com
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