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. shares experienced a significant increase of 41.39% to $0.36 in after-hours trading following the announcement of a conference presentation [1] Company Developments - Genprex announced that its research collaborators will present preclinical data on its lead drug candidate, "Reqorsa" Gene Therapy, at the 2025 AACR-NCI-EORTC International Conference in Boston from October 22 to October 26 [2] - CEO Ryan Confer emphasized the validation of REQORSA as a potential treatment for various cancer types, including a subset of lung cancer, and expressed anticipation for ongoing studies in combination with ALK inhibitors [3] - In October 2024, Genprex partnered with the University of Michigan Rogel Cancer Center to study TUSC2 alongside ALK-inhibitors, and collaborated with ALK Positive, a patient-led nonprofit, to co-sponsor the research [3] Research Findings - The University of Michigan Rogel Cancer Center will present a poster on October 25, showcasing lab studies that indicate tumor cells absorbed TUSC2 at levels 10 to 33 times higher than normal cells after REQORSA treatment [4] - REQORSA utilizes Genprex's Oncoprex® Delivery System, which employs non-viral lipid-based nanoparticles designed to target negatively charged cancer cells while minimizing uptake by normal tissues [4] Stock Performance - Genprex has faced a decline of 25.7% over the past year and a significant drop of 70.29% year-to-date, although the stock increased by 25.6% over the last five days [5] - The stock price has fluctuated between $0.14 and $3.97 over the past year, with a current market cap of $11.06 million and an average daily trading volume of 14.01 million shares [5] - GNPX closed regular trading on Tuesday at $0.25, reflecting a 30.15% increase [5]

Core Viewpoint - Genprex, Inc. has received patent allowances for its lead drug candidate, Reqorsa® Gene Therapy, in combination with immune checkpoint inhibitors, enhancing its intellectual property portfolio for oncology treatments [1][2][3] Intellectual Property Developments - The U.S. Patent and Trademark Office and the European Patent Office have issued Notices of Allowance for patents covering the use of Reqorsa in combination with PD-L1 and PD-1 antibodies, respectively, with both patents set to expire in 2037 at the earliest [1][3] - Genprex has also secured patents for Reqorsa in combination with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel [3] Clinical Trial Information - The Acclaim-3 study 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) [5] - The Acclaim-3 trial has received FDA Fast Track Designation and Orphan Drug Designation, indicating its potential significance in treating this patient population [5] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a non-viral Oncoprex® Delivery System for its gene therapies [6] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received FDA Fast Track Designation [6]

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].