Genprex(GNPX)
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Genprex(GNPX) - 2025 Q4 - Annual Report
2026-03-30 21:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38244 Genprex, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 90-0772347 (State or other jurisdiction of incorp ...
Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® Gene Therapy for the Treatment of Lung Cancer at the 2026 AACR Annual Meeting
Prnewswire· 2026-03-18 11:00
Core Insights - Genprex, Inc. announced that its research collaborators will present positive preclinical data on Reqorsa® Gene Therapy for lung cancer at the 2026 AACR Annual Meeting, highlighting its potential as a treatment for ALK-EML4 positive translocated non-small cell lung cancer [1][2] Group 1: Preclinical Data and Biomarkers - The presentation will include three distinct abstracts that provide robust preclinical evidence supporting Reqorsa's potential in cancer treatment, particularly focusing on TUSC2's therapeutic mechanisms [2] - TROP2 and PTEN have been identified as potential biomarkers for predicting patient response to TUSC2 gene therapy in non-small cell lung cancer, which could refine patient selection strategies [2] Group 2: Efficacy of Quaratusugene Ozeplasmid - Quaratusugene ozeplasmid (Quar Oze) has shown to induce apoptosis in ALK-positive models, demonstrating a 79% tumor shrinkage when combined with alectinib, compared to a 60% reduction with alectinib alone [4][5] - In resistant models, the combination of Quar Oze and alectinib produced a synergistic effect, achieving significant tumor reduction and improved overall survival [5] Group 3: Immune Response Enhancement - TUSC2 enhances NK cell cytotoxicity, with therapeutic delivery via Quar Oze suppressing tumor progression and driving complete tumor elimination in many cases [7] - In vivo studies showed that Quar Oze significantly increased NK cell degranulation and proliferation, supporting its role as an immunomodulatory tumor suppressor [6][7] Group 4: About Reqorsa - Reqorsa consists of a TUSC2 gene expressing plasmid encapsulated in lipid-based nanoparticles, specifically targeting cancer cells while minimizing uptake by normal tissue [8] - Laboratory studies indicate that TUSC2 uptake in tumor cells after Reqorsa treatment is 10 to 33 times higher than in normal cells [8] Group 5: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene therapy [10] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer and small cell lung cancer, with both programs receiving Fast Track Designation from the FDA [10]
Genprex to Participate at BIO Europe Spring 2026
Prnewswire· 2026-03-10 11:00
Core Insights - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, and will participate in BIO Europe Spring 2026 in Lisbon, Portugal [1] - The company aims to provide an overview of its gene therapies during the conference, with executives available for one-on-one meetings [1] - Genprex's lead product candidate, Reqorsa® Gene Therapy, is under evaluation in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received Fast Track Designation from the FDA [1] Company Overview - Genprex, Inc. specializes in gene therapy, targeting large patient populations with limited treatment options for cancer and diabetes [1] - The company's oncology program utilizes the Oncoprex® Delivery System, which employs lipid-based nanoparticles to deliver gene-expressing plasmids intravenously [1] - The diabetes gene therapy approach involves an AAV vector to deliver Pdx1 and MafA genes to the pancreas, aiming to transform alpha cells into functional beta-like cells [1] Clinical Development - Reqorsa® Gene Therapy is being evaluated in two clinical trials for NSCLC and SCLC, with the SCLC program receiving FDA Orphan Drug Designation [1] - The diabetes therapy GPX-002 is designed to rejuvenate and replenish exhausted beta cells in Type 2 diabetes and transform alpha cells in Type 1 diabetes [1] Event Participation - BIO Europe Spring 2026 is expected to attract over 3,700 executives from biotech, pharma, and finance sectors, facilitating more than 20,000 one-on-one meetings [1] - Genprex executives, including the President and CEO, will be present to engage with industry leaders and investors [1]
Congressman Who Bought Small-Cap Stocks In 2025 Is Back With New 2026 Pick: Here's What He's Buying
Benzinga· 2026-02-25 23:20
Group 1 - Congressman Tim Moore has been actively trading small-cap stocks, including multiple purchases of Genprex stock, a gene therapy company with a market capitalization of $5.2 million [2][3] - Moore's total investments in Genprex in 2025 ranged from $31,000 to $115,000, indicating a significant interest in the company [3] - Another small-cap stock in Moore's portfolio is Simply Good Foods, which has a market capitalization of $1.6 billion and has seen a 53% decline over the past 52 weeks [4] Group 2 - Moore was recognized as the top-performing member of Congress for stock trades in 2025, achieving a 52% gain, significantly outperforming the S&P 500's 16.6% gain [5] - The trading activity of Moore, particularly in small-cap stocks, is noteworthy given the potential for high returns and the relatively low market capitalizations of the stocks involved [5]
Genprex Strengthens Intellectual Property Portfolio with Japanese and EU Patents for Reqorsa® Gene Therapy in Combination with Immunotherapies to Treat Cancer
Prnewswire· 2026-02-23 13:00
Core Insights - Genprex has strengthened its intellectual property portfolio by securing patents in Japan and the EU for Reqorsa® Gene Therapy in combination with immunotherapies to treat cancer [1] Intellectual Property Developments - The Japanese Patent Office has granted a patent for the use of Reqorsa® Gene Therapy in combination with PD-L1 antibodies for cancer treatment [1] - The European Patent Office has also issued a Decision to Grant for a patent related to the combination of Reqorsa and PD-1 antibodies for cancer treatment [1] - Genprex holds exclusive licenses to these patents, enhancing its protection for various therapeutic combinations, including those in the Acclaim-3 clinical trial [1] Clinical Trial Information - Acclaim-3 is a Phase 1/2 clinical trial evaluating Reqorsa in combination with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC) [1] - The trial aims to determine the 18-week progression-free survival rate from the start of maintenance therapy with Reqorsa and Tecentriq [1] - The Phase 2 expansion study is expected to enroll approximately 50 patients, with an interim analysis planned after the 25th patient reaches 18 weeks of follow-up [1] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [1] - The company utilizes a systemic, non-viral Oncoprex® Delivery System to administer disease-fighting genes [1] - Genprex's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [1]
Genprex Announces IP Australia's Intent to Grant Patent for Reqorsa® Gene Therapy in Combination with PD-L1 Antibodies to Treat Cancers
Prnewswire· 2026-02-10 13:00
Core Viewpoint - Genprex has received a Notice of Acceptance from IP Australia for a patent application related to Reqorsa® Gene Therapy in combination with PD-L1 antibodies for cancer treatment, which will enhance its intellectual property portfolio and protect its therapeutic combination currently in the Acclaim-3 clinical trial [1]. Patent Development - The patent application claims the use of Reqorsa® Gene Therapy with PD-L1 antibodies, which has already been granted in other countries [1]. - A granted patent will provide exclusivity in Australia, preventing competitors from manufacturing, using, or selling the drug combination [1]. - Genprex is pursuing additional patent applications in key international markets, including Europe, Canada, Brazil, China, and Israel, to safeguard its innovations [1]. Clinical Trial Updates - Genprex has opened an additional clinical trial site for the Acclaim-3 trial at the University of Kentucky to expand patient reach and expedite enrollment [1]. - The Acclaim-3 trial is a Phase 1/2 study evaluating the combination of REQORSA and Genentech's Tecentriq® in patients with extensive stage small cell lung cancer (ES-SCLC) [1]. - The Phase 2 expansion study aims to enroll approximately 50 patients, with the primary endpoint being the 18-week progression-free survival rate [1]. Company Overview - Genprex is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [1]. - The company's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [1]. - Genprex's diabetes gene therapy approach aims to rejuvenate and replenish exhausted beta cells, with ongoing developments in both Type 1 and Type 2 diabetes treatments [2].
Genprex(GNPX) - Prospectus(update)
2025-11-26 21:31
Table of Contents As filed with the Securities and Exchange Commission on November 26, 2025 Registration No. 333-291722 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 90-0772347 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identifi ...
Data from Genprex's Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer
Prnewswire· 2025-11-24 12:00
Core Viewpoint - Genprex, Inc. announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy in combination with Tagrisso for advanced non-small cell lung cancer, highlighting promising safety and early efficacy results [1][2][3]. Group 1: Clinical Trial Details - The Acclaim-1 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with osimertinib in patients with late-stage NSCLC who have progressed after osimertinib treatment [2][3]. - The trial's dose escalation portion primarily assessed safety, establishing a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg with no Dose Limiting Toxicities (DLTs) reported [3][8]. Group 2: Patient Outcomes - Among the 12 patients treated, three experienced prolonged time to progression, including one with a continuing partial response after 47 cycles over 32 months [4][5]. - Specific patient outcomes included one patient achieving partial remission after extensive prior treatments and continuing treatment for over three years [5][6]. Group 3: Safety Profile - Reqorsa administration was generally well tolerated, with no DLTs and manageable infusion-related reactions similar to those seen with antibody treatments [8][10]. - Symptoms from infusion-related reactions were effectively managed with prophylactic medications [8]. Group 4: Company Overview - Genprex, Inc. focuses on developing gene therapies for cancer and diabetes, utilizing a non-viral Oncoprex Delivery System to administer disease-fighting genes [9][10]. - The company's lead product, Reqorsa, is under evaluation for NSCLC and small cell lung cancer (SCLC), with both programs receiving Fast Track Designation from the FDA [10].
Genprex(GNPX) - Prospectus
2025-11-21 21:56
Table of Contents As filed with the Securities and Exchange Commission on November 21, 2025 Registration No. 333- (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 90-0772347 (I.R.S. Employer Identification Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GENPREX, INC. (Exact name of registrant as specified in its charter) Copies ...
Genprex Adds Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials
Prnewswire· 2025-11-19 12:00
Core Insights - Genprex, Inc. has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for its Acclaim-1 and Acclaim-3 clinical trials studying Reqorsa® Gene Therapy for lung cancer [1][2] - The company aims to expand its reach and expedite patient enrollment in these trials, which have received FDA Fast Track Designation [1][4] Acclaim-1 Clinical Trial - Acclaim-1 is a Phase 1/2 clinical trial evaluating the combination of Reqorsa and AstraZeneca's Tagrisso® for late-stage non-small cell lung cancer (NSCLC) patients with activating EGFR mutations [2][4] - The Phase 1 portion showed that Reqorsa was well tolerated with no dose-limiting toxicities, and early signs of efficacy were observed [3][4] - The trial plans to enroll approximately 33 patients, with an interim analysis expected after treating 19 patients, anticipated to be completed in the first half of 2026 [4] Acclaim-3 Clinical Trial - Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of Reqorsa and Genentech's Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC) [5][7] - The Phase 2 expansion is expected to enroll around 50 patients, with the primary endpoint being the 18-week progression-free survival rate [7] - An interim analysis will be conducted after the 25th patient reaches 18 weeks of follow-up, with completion of enrollment for this analysis also expected in the first half of 2026 [7] Company Overview - Genprex, Inc. is focused on developing gene therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System to administer disease-fighting genes [8][9] - The company's lead product candidate, Reqorsa, is being evaluated in two clinical trials for NSCLC and SCLC, both of which have received FDA Fast Track Designation [9]