Core Points - Genprex, Inc. has announced a registered direct offering of 377,780 shares of common stock at a price of $9.00 per share, with potential additional gross proceeds of up to $6.6 million from short-term warrants [1][2] - The offering is expected to close around October 29, 2025, subject to customary closing conditions [1] - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2] Financial Details - The gross proceeds from the offering are anticipated to be approximately $3.4 million before deducting fees and expenses [2] - The short-term warrants will allow the purchase of up to 755,560 shares at an exercise price of $8.75 per share, which will be immediately exercisable [1][2] Regulatory Information - The shares are being offered under a "shelf" registration statement that was declared effective by the SEC on June 9, 2023 [3] - The unregistered warrants and underlying shares are being offered in a private placement and have not been registered under the Securities Act [4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [6] - 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) [7] - Genprex's diabetes gene therapy approach aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin [7]

Core Points - Genprex, Inc. has announced a registered direct offering of 243,622 shares of common stock at a price of $11.21 per share, with expected gross proceeds of approximately $2.7 million [1][2] - The company will also issue unregistered short-term warrants to purchase up to 487,244 shares at an exercise price of $11.00 per share, potentially adding up to $5.4 million in gross proceeds if fully exercised [1][2] - The offering is expected to close around October 24, 2025, pending customary closing conditions [1] Financial Details - The gross proceeds from the offering are estimated at $2.7 million before deducting fees and expenses [2] - If the short-term warrants are fully exercised, the additional gross proceeds could reach approximately $5.4 million [2] Regulatory Information - The shares are being offered under a "shelf" registration statement declared effective by the SEC on June 9, 2023 [3] - The unregistered warrants and underlying shares are offered in a private placement and have not been registered under the Securities Act [4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [6] - The company's lead product candidate, Reqorsa® Gene Therapy, is in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [7] - Genprex's diabetes gene therapy approach aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin [7]

Core Insights - Genprex, Inc. (NASDAQ: GNPX) has made the Nasdaq top gainers list due to positive preclinical data regarding its lead drug candidate, Reqorsa® Gene Therapy [4][5] - The stock price increased by 204.75%, trading at $0.7695 with a morning high of $1.10 and a trading volume exceeding 643 million shares [4] Company Developments - Genprex's research collaborators are set to present positive preclinical data at the 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics, scheduled for October 22-26, 2025, in Boston [5] - The preclinical data pertains to the treatment of ALK-EML4 positive non-small cell lung cancer (NSCLC) using Reqorsa® Gene Therapy [5][6] Management Commentary - Ryan Confer, President and CEO of Genprex, expressed enthusiasm about the presentation of positive preclinical data, highlighting the potential of Reqorsa to induce apoptosis in ALK positive lung cancer, particularly affecting young, non-smoking individuals [6]

Core Viewpoint - Genprex, Inc. has achieved significant clinical development milestones in 2025, focusing on advancing its gene therapy programs for cancer and diabetes, with ongoing clinical trials for lung cancer treatments [1][2]. Group 1: Company Achievements - The company has issued a stockholder letter summarizing recent achievements and outlining key milestones for 2025 and beyond [1]. - Genprex's lead product candidate, Reqorsa® Gene Therapy, is currently being evaluated in two 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 [3]. - The SCLC program has also received Orphan Drug Designation from the FDA, indicating its potential to address unmet medical needs [3]. Group 2: Technology and Approach - Genprex utilizes a systemic, non-viral Oncoprex® Delivery System that encapsulates gene-expressing plasmids in lipid-based nanoparticles, administered intravenously to target tumor cells [3]. - The diabetes gene therapy approach involves a novel infusion process using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas, aiming to transform alpha cells into functional beta-like cells capable of producing insulin [3]. Group 3: Future Outlook - The company is focused on executing upcoming milestones in the second half of 2025 and beyond, with a commitment to transforming the lives of patients battling cancer and diabetes through innovative gene therapies [2].

Core Viewpoint - Genprex, Inc. has presented promising preclinical research on its diabetes gene therapy candidate GPX-002, demonstrating its potential to improve glucose homeostasis by reprogramming alpha cells into beta-like cells, as showcased at the 2025 American Diabetes Association Scientific Session [1][2]. Group 1: Research Findings - The research indicates that alpha cells in animal models of Type 1 diabetes (T1D) can transdifferentiate into beta-like cells after being treated with GPX-002, maintaining improved glucose control for three months [2][6]. - The gene therapy utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes directly into the pancreatic duct, effectively converting alpha cells into insulin-secreting beta-like cells without the need for immunosuppression in mouse models [3][12]. - In non-human primate studies, the infusion of rAAV resulted in improved glucose tolerance and reduced insulin requirements one month post-infusion, with ongoing evaluations of immune responses to the therapy [5][8]. Group 2: Clinical Development - Genprex is advancing GPX-002 for both Type 1 and Type 2 diabetes, with the same gene therapy approach applied to both conditions, aiming to rejuvenate exhausted beta cells in Type 2 diabetes [9][12]. - The company is currently conducting preclinical studies to gather additional data on the efficacy of GPX-002 after six months of immunosuppression [8][9]. - The therapy is designed to be administered via a routine endoscopy procedure in humans, enhancing its potential for clinical application [9]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, collaborating with leading institutions to advance its drug candidates [10][11]. - The company’s oncology program includes the Oncoprex® Delivery System, which encapsulates gene-expressing plasmids for intravenous administration, targeting tumor cells [11]. - Genprex aims to provide new treatment options for patients with limited alternatives, leveraging its gene therapy technologies [10].

Core Insights - Genprex, Inc. has announced positive preclinical data for its diabetes gene therapy candidate GPX-002, presented at the 2025 American Diabetes Association Scientific Session, utilizing a non-viral lipid nanoparticle delivery system that may allow for repeat dosing [1][2] Group 1: Research and Development - The research indicates that Genprex is pioneering the use of lipid nanoparticles for direct infusion into the pancreatic duct, which could enhance the delivery of gene therapy for diabetes [2] - The study evaluated nine lipid nanoparticles for their efficiency in transfecting isolated mouse Islets of Langerhans, with two specific nanoparticles showing high transfection efficiency [4] - The selected lipid nanoparticle demonstrated 100 times more luciferase activity in the pancreas compared to other organs, indicating a targeted approach to transfection [5] Group 2: Product Information - GPX-002 is being developed for both Type 1 and Type 2 diabetes, aiming to transform alpha cells into functional beta-like cells in Type 1 diabetes and rejuvenate exhausted beta cells in Type 2 diabetes [6][7] - The innovative approach involves administering an adeno-associated virus (AAV) vector containing specific genes directly into the pancreatic duct, which can be performed via routine endoscopy [7] Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing advanced technologies to deliver disease-fighting genes [8] - The company collaborates with leading institutions to advance its pipeline of gene therapies, including its oncology program that employs a systemic, non-viral delivery system [8]

Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [4] - The company utilizes a systemic, non-viral Oncoprex® Delivery System to administer gene therapies [4] - 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) [4] - The company has received Fast Track Designation from the FDA for its lung cancer programs and Orphan Drug Designation for its SCLC program [4] Upcoming Events - Genprex will participate in the BIO 2025 International Convention from June 16-19, 2025, in Boston, Massachusetts [1][3] - Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing, will be available for one-on-one meetings during the conference [2] Technology and Innovation - Genprex's diabetes gene therapy approach involves a novel infusion process using an AAV vector to deliver Pdx1 and MafA genes to the pancreas [4] - In Type 1 diabetes models, GPX-002 transforms alpha cells into functional beta-like cells capable of producing insulin [4] - For Type 2 diabetes, GPX-002 is believed to rejuvenate and replenish exhausted beta cells [4] Industry Context - The BIO International Convention is the largest biotechnology event, attracting 20,000 industry leaders globally [3] - Genprex collaborates with world-class institutions to develop its drug candidates and expand its gene therapy pipeline [4]

Core Viewpoint - Genprex, Inc. is advancing its diabetes gene therapy candidate GPX-002, which shows promise in treating both Type 1 and Type 2 diabetes, as evidenced by positive preclinical data presented at the ASGCT Annual Meeting [1][2]. Group 1: Research and Development - GPX-002 utilizes recombinant adeno-associated virus (rAAV) to deliver Pdx1 and MafA genes, converting alpha cells into beta-like cells that secrete insulin, effectively reversing diabetes in mouse models without the need for immunosuppression [2][3]. - The therapy has been tested in cynomolgus macaques with streptozotocin-induced diabetes, demonstrating improved glucose tolerance and reduced insulin requirements one month post-infusion [4][5]. - Ongoing preclinical studies are evaluating the long-term efficacy of GPX-002 after six months of immunosuppression in non-human primate models for both Type 1 and Type 2 diabetes [6]. Group 2: Presentation Details - The oral presentation at the ASGCT Annual Meeting was titled "Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model," presented by Dr. Hannah Rinehardt [2]. - The presentation highlighted the challenges of managing immune responses to the therapy, indicating that temporary immunosuppression can effectively prevent anti-viral immunity but may need to be extended beyond three months [4][5]. Group 3: Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing innovative therapies for cancer and diabetes, utilizing advanced technologies to deliver disease-fighting genes [8]. - The company’s approach for diabetes involves a novel infusion process using an AAV vector to directly administer therapeutic genes into the pancreas, with the potential for routine endoscopic procedures in humans [7][8].

Core Viewpoint - Genprex, Inc. has announced a new Sponsored Research Agreement (SRA) with the University of Pittsburgh to further study its gene therapy GPX-002 for Type 1 and Type 2 diabetes in animal models, following the completion of a previous two-year agreement [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [5][6]. - The company’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) [5]. Research and Development - The new SRA with the University of Pittsburgh will sponsor preclinical studies of GPX-002, which has shown promising results in reducing insulin requirements and improving glucose tolerance in animal models of diabetes [2][3]. - GPX-002 employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas, aiming to transform alpha cells into functional beta-like cells in Type 1 diabetes and rejuvenate exhausted beta cells in Type 2 diabetes [3][6]. Market Context - As of 2024, approximately 38.4 million Americans have diabetes, with 10% having Type 1 diabetes and 90-95% having Type 2 diabetes. The global diabetes population is projected to rise from 537 million in 2021 to 783 million by 2045 [4]. - Diabetes caused over 6.7 million deaths globally in 2021 and resulted in approximately $966 billion in health expenditures, reflecting a significant increase over the past fifteen years [4].

Core Viewpoint - Genprex, Inc. announced positive preclinical data for Reqorsa® Gene Therapy, demonstrating its robust anti-tumor effects in KRASG12C mutant non-small cell lung cancer (NSCLC), both alone and in combination with LUMAKRAS® [1][2]. Group 1: Preclinical Data Presentation - The positive preclinical data was presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting the therapeutic potential of REQORSA in treating Ras inhibitor resistant lung cancer [1][2]. - The poster titled "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy" showcased that TUSC2 gene therapy effectively overcomes acquired resistance to sotorasib in mouse xenografts [3]. Group 2: Efficacy of Reqorsa - TUSC2 transfection significantly reduced colony formation and increased apoptosis in acquired resistance cell lines, indicating strong anti-tumor efficacy [3]. - REQORSA alone showed a strong anti-tumor effect on TC314AR PDXs, while sotorasib alone exhibited no significant activity [3]. - A synergistic effect was observed when combining REQORSA with sotorasib, enhancing tumor control compared to either treatment alone [3]. Group 3: Technology and Delivery System - Reqorsa consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles, specifically targeting cancer cells while minimizing uptake by normal tissue [5]. - Laboratory studies indicated that the uptake of TUSC2 in tumor cells after REQORSA treatment was 10 to 33 times higher than in normal cells [5]. Group 4: 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 administration [6][7]. - The company is advancing its pipeline of gene therapies and has received Fast Track Designation from the FDA for its lung cancer clinical programs [7].