{"url_path":"/sec/gnpx/8-k/2026-07-14/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-07-14","source_url":"https://www.sec.gov/Archives/edgar/data/1595248/0001437749-26-023480-index.html","accession_number":"0001437749-26-023480","cik":"0001595248","ticker":"GNPX","issuer_name":"Genprex, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1595248/0001437749-26-023480-index.html","primary_entity_key":"0001595248","primary_entity_name":"Genprex, Inc."},"word_count":2043,"has_tables":true,"body_markdown":"**Item 8.01. Other Events.**\n\n \n\nThe Company’s investor presentation provides certain business updates, including on its oncology and diabetes gene therapy programs.\n\n \n\n*Acclaim-1 Clinical Trial*\n\n \n\nThe Acclaim-1 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion which has been completed, a Phase 2a expansion portion, and a Phase 2b randomized portion. We are currently enrolling and treating patients in the Phase 2a expansion portion of our Phase 1/2 Acclaim-1 clinical trial.  The Acclaim-1 trial uses a combination of REQORSA and AstraZeneca’s Tagrisso® (*osimertinib*) in patients with late-stage non-small cell lung cancer (“NSCLC”) who have activating epidermal growth factor receptor (“EGFR”) mutations and disease progression on treatment with Tagrisso or Tagrisso-containing regimens. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”), including one patient who achieved a partial response after the second course of REQORSA and Tagrisso and remained on treatment without disease progression for approximately 46 months. The results of the Phase 1 dose escalation portion of the study were published in *Clinical Lung Cancer*, a peer-reviewed journal covering various aspects of clinical and translational research of lung cancer, in January 2026. The Acclaim-1 clinical trial has received U.S. Food and Drug Administration (“FDA”) Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.\n\n \n\nAs previously announced, in April 2026, we entered into a new sponsored research agreement with the University of Texas MD Anderson Cancer Center to study biomarkers that may predict patient response to REQORSA. This preclinical effort led to the identification of two proteins, TROP-2 and PTEN, whose expression appears to predict response to REQORSA. These preclinical data indicated that NSCLC cells with high TROP-2 protein levels or low PTEN protein levels had greater response to REQORSA. In May 2026, an abstract was published by our research collaborators at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting which detailed positive clinical data from studies of predictive biomarkers in patients receiving REQORSA. This clinical validation, derived from patients in our Acclaim clinical trials, underscores the critical role these biomarkers may play in predicting treatment efficacy.  These data advance our understanding of this novel gene therapy and may help to guide patient selection for our clinical trials and optimize clinical outcomes. We plan to further evaluate high (3+) TROP-2 expression as a potential biomarker for REQORSA, which may predict patient response and enable targeted patient selection. We are currently evaluating enrollment criteria based on biomarker identification prior to any potential future interim analysis as we continue to enroll and treat patients in the Phase 2a expansion portion of our Acclaim-1 clinical trial.\n\n \n\n*Acclaim-3 Clinical Trial*\n\n \n\nThe Acclaim-3 study is a Phase 1/2 clinical trial that has two portions - a Phase 1 dose escalation portion which has been completed, and a Phase 2 expansion portion. We are currently enrolling and treating patients in the Phase 2 expansion portion of our Phase 1/2 Acclaim-3 clinical trial. The Acclaim-3 clinical trial uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® (*atezolizumab*) as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. We anticipate that the Phase 2 expansion portion will enroll approximately 50 patients at approximately 10 to 15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow-up. We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study by the end of 2026 and expect the interim analysis in the first half of 2027. The Acclaim-3 clinical trial has received FDA Fast Track Designation for this patient population and Acclaim-3 has also received an FDA Orphan Drug Designation.\n\n \n\n*Risk Factors*\n\n \n\nThe Company is including the below update to its risk factors, for the purpose of supplementing and updating the “Risk Factors” disclosure contained in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026, the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 13, 2026, as further supplemented and updated in the Company’s other periodic and current reports filed from time to time since such Annual Report on Form 10-K.\n\n \n\n**Our Common Stock is currently listed on The Nasdaq Capital Market. If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.**\n\n \n\nOur Common Stock is currently listed for trading on Nasdaq. On June 10, 2026, we received a letter from Nasdaq indicating that, based upon our lack of compliance with the with the requirement under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq (the “Bid Price Requirement”) and our ineligibility for a 180 calendar day compliance period, the Listing Qualifications Staff of Nasdaq (the “Staff”) had determined to delist our securities from Nasdaq unless we timely request a hearing before a Nasdaq Hearings Panel (the “Panel”). Accordingly, Genprex has so requested a hearing before the Panel. Our request for a hearing automatically stayed any suspension or delisting action by the Staff pending the hearing and the expiration of any additional extension period that may be granted by the Panel following the hearing. We intend to continue to take definitive steps in an effort to evidence compliance with the Bid Price Requirement; however, there can be no assurance that the Panel will grant our request for continued listing or that we will be able to evidence compliance with the Bid Price Requirement within any extension period that may be granted by the Panel, or that we will be able to maintain compliance with the Bid Price Requirement or the other Nasdaq continued listing requirements.\n\n \n\nWe intend to continue to monitor the closing bid price of our Common Stock and take definitive steps in an effort to evidence and regain compliance with the Bid Price Requirement, including by implementing effective July 16, 2026 the one-for-twenty-two (1:22) Reverse Stock Split of our Common Stock. To regain compliance with the Bid Price Requirement, the closing bid price of our Common Stock must be at least $1.00 for a minimum of 10 consecutive business days, subject to the Panel’s discretion to extend such 10-day period. The announcement and implementation of the Reverse Stock Split could negatively affect the price of our Common Stock, and there is no guarantee that implementation of the Reverse Stock Split will result in our regaining compliance with the Bid Price Requirement. We cannot assure you that the prices for shares of the Common Stock after the Reverse Stock Split will increase proportionately to prices for shares of our Common Stock immediately before the Reverse Stock Split. Furthermore, even if the market price of our Common Stock does rise following the Reverse Stock Split, we cannot assure you that the market price of our Common Stock immediately after the Reverse Stock Split will be maintained for any period of time. There is also the possibility that liquidity may be adversely affected by the reduced number of shares which would be issued and outstanding when the Reverse Stock Split is effected, particularly if the price per share of our Common Stock begins a declining trend after the Reverse Stock Split is effected. Accordingly, our total market capitalization after the Reverse Stock Split may be lower than the market capitalization before the Reverse Stock Split.\n\n \n\nWe must regain compliance with Nasdaq’s Bid Price Requirement of $1.00 per share (and must continue to maintain compliance with Nasdaq’s other continued listing requirements), or risk delisting, which could have a material adverse effect on our business. If our Common Stock is delisted from Nasdaq, it could result in a corresponding material reduction in the price of our Common Stock as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, contractual counterparties and employees and fewer business development opportunities. If our Common Stock were delisted, it could be more difficult to buy or sell our Common Stock or to obtain accurate quotations, and the price of our Common Stock could suffer a material decline. Delisting could also impair our ability to raise capital on acceptable terms, if at all.\n\n \n\n**Cautionary Language Concerning Forward-Looking Statements**\n\n \n\nThis Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those statements relating to the implementation of the Reverse Stock Split and the anticipated effects, potential benefits and risks thereof; the Company’s estimate of its outstanding shares following the Reverse Stock Split; the Company’s ability to regain and maintain compliance with the Bid Price Requirement, and maintain compliance with the other continued listing requirements of Nasdaq and maintain the listing of the Company’s Common Stock; statements about the future listing of the Company’s Common Stock; statements about the Company’s intentions and plans for addressing the Bid Price Requirement listing deficiency and the related Nasdaq delisting determination and anticipated Panel hearings process, including statements about plans for regaining compliance and intended actions and plans in connection therewith; and statements about the Company’s intentions and plans including anticipated actions and requests in connection with the Nasdaq hearings process, requested relief from Nasdaq or the hearings Panel or the type of relief that may be available, including the Panel hearings process staying any suspension or delisting action and the possibility of whether the Company’s Common Stock is able to maintain its listing or is ultimately delisted; statements regarding plans that the Company may implement or actions that the Company may take in furtherance of regaining compliance; and statements about the Company’s ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines; and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.\n\n \n\nThese statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, the Company’s Quarterly Reports on Form 10-Q filed since such Annual Report on Form 10-K, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law."}