Announcement • Jul 15
Genprex, Inc. Provides Updates On Acclaim-1 And Acclaim-3 Clinical Trials For REQORSA Gene Therapy Genprex, Inc. investor presentation provided certain business updates, including on its oncology and diabetes gene therapy programs. The 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. The Company is currently enrolling and treating patients in the Phase 2a expansion portion of its 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 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. In April 2026, the Company 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 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 the Acclaim clinical trials, underscores the critical role these biomarkers may play in predicting treatment efficacy. These data advance understanding of this novel gene therapy and may help to guide patient selection for clinical trials and optimize clinical outcomes. The Company plans to further evaluate high (3+) TROP-2 expression as a potential biomarker for REQORSA, which may predict patient response and enable targeted patient selection. The Company is currently evaluating enrollment criteria based on biomarker identification prior to any potential future interim analysis as it continues to enroll and treat patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial. The 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. The Company is currently enrolling and treating patients in the Phase 2 expansion portion of its 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. 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. The Company expects 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 expects 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. Announcement • Jun 23
Genprex Receives Notice of Allowance from the Canadian Intellectual Property Office for Patent Covering Reqorsa Gene Therapy Combination with PD-1 or PD-L1 Antibodies to Treat Cancer Genprex, Inc. has announced that The Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance to Genprex for a patent covering the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with either PD-1 or PD-L1 antibodies for the treatment of both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). This patent will expand on the previously granted patents for REQORSA in combination with PD-1 and PD-L1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Chile, China, Singapore Europe, Korea, Australia and Israel. REQORSA is initially being developed in combination with prominent, approved cancer drugs to treat lung cancer. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company believes REQORSA's unique attributes position it to provide potential treatments that improve on these current therapies for patients with lung cancer and possibly other cancers. Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech's Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex's team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Acclaim-3 clinical trial is supported by U.S. Food and Drug Administration (FDA) Fast Track Designation and Orphan Drug Designation. Announcement • Jun 13
Genprex, Inc. Receives Nasdaq Delisting Notice for Common Stock On June 10, 2026, Genprex, Inc. received a letter (the “Letter”) from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, because the Company’s common stock closed at less than $1.00 per share over the previous 30 consecutive business days and as a result is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”), and because the Staff determined that the Company is not eligible for any compliance period, the Staff had accordingly determined to delist the Company’s securities from Nasdaq unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the “Panel”). The Bid Price Requirement of the Nasdaq Listing Rules requires listed securities to maintain a minimum bid price of $1.00 per share. In accordance with Listing Rule 5810(c)(3)(A)(iv), a company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) in certain circumstances including if the company has effected a reverse stock split over the prior one-year period. Genprex effected a reverse stock split on October 21, 2025, and accordingly, the Staff determined that the Company is not eligible for a 180-day compliance period under Rule 5810(c)(3)(A) to demonstrate compliance with the Bid Price Requirement. Accordingly, Genprex fully intends to timely request a hearing before the Panel. The Company’s request for a hearing will automatically stay 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. The Company intends to continue to take definitive steps in an effort to evidence compliance with the Bid Price Requirement, including by effecting a reverse stock split, if necessary. However, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will be able to evidence compliance with the Bid Price Requirement within any extension period that may be granted by the Panel or maintain compliance with the other Nasdaq listing requirements. 
