Core Viewpoint - Genprex, Inc. is advancing its diabetes gene therapy program, GPX-002, which shows promise for treating both Type 1 and Type 2 diabetes, and will present positive preclinical data at the upcoming 2025 American Diabetes Association Scientific Session [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 has established a wholly-owned subsidiary, Convergen Biotech, to concentrate on diabetes program development [2]. Research and Development - GPX-002 is designed to modify the disease process in diabetes, potentially eliminating the need for daily blood glucose monitoring and insulin therapy [2]. - The therapy employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly into the pancreatic duct, with preclinical studies indicating restored normal blood glucose levels in Type 1 diabetes models [4][6]. - For Type 2 diabetes, GPX-002 is believed to rejuvenate and replenish exhausted beta cells [4][6]. Upcoming Presentations - Genprex's collaborators will present several abstracts at the 85th Scientific Sessions, including topics on lipid nanoparticles for transfection of islets and recombinant AAV-mediated gene therapy for diabetes [3][4].

Core Viewpoint - Genprex, Inc. is actively participating in BIO Europe Spring 2025 to showcase its gene therapies for cancer and diabetes, highlighting its commitment to developing innovative treatments for patients with limited options [1][2][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 [4] - 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), both of which have received Fast Track Designation from the FDA [4] - Genprex's diabetes gene therapy, GPX-002, aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin, addressing both Type 1 and Type 2 diabetes [4] Conference Participation - Key executives, including Ryan Confer and Thomas Gallagher, will be attending BIO Europe Spring 2025 in Milan, Italy, to engage with industry groups and provide insights into the company's gene therapies [2][3] - The conference is expected to attract over 3,700 executives from biotech, pharma, and finance sectors, facilitating more than 20,000 one-on-one meetings [3]

Core Insights - Genprex, Inc. is advancing its diabetes program through a strategic collaboration with a CDMO to explore a non-viral lipid nanoparticle delivery system for its diabetes gene therapy drug candidate [1][2] - The collaboration aims to optimize next-generation constructs and positions Genprex as a thought leader in the diabetes market, which currently lacks disease-modifying therapies [2][3] - The company's GPX-002 therapy has shown promising results in preclinical studies, maintaining glucose control for approximately 120 days in Type 1 diabetes models, suggesting potential for multiple treatments with a non-viral delivery system [3] 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 diabetes gene therapy approach involves using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas, transforming alpha cells into functional beta-like cells [6] Industry Context - As of 2024, approximately 38.4 million Americans have diabetes, with 10% having Type 1 diabetes and 90-95% having Type 2 diabetes [4] - The global diabetes prevalence is projected to rise from 537 million in 2021 to 783 million by 2045, highlighting the urgent need for effective treatments [4] - Diabetes caused over 6.7 million deaths globally in 2021 and resulted in approximately $966 billion in health expenditures, indicating a significant economic burden [4]

Core Points - Genprex, Inc. has advanced its diabetes gene therapy program by forming a wholly-owned subsidiary, Convergen Biotech, Inc., and consolidating its license agreements with the University of Pittsburgh for technologies related to Type 1 and Type 2 diabetes [1][2][3] Group 1: License Agreement - The new exclusive license agreement with the University of Pittsburgh consolidates multiple technologies into a single agreement, granting Genprex worldwide exclusive rights to patent applications and related technologies for gene therapy targeting both T1D and T2D [3][4] - The licensed technologies utilize an adeno-associated virus vector to deliver Pdx1 and MafA genes directly into the pancreatic duct, with GPX-002 designed to transform alpha cells into functional beta-like cells for T1D and rejuvenate exhausted beta cells for T2D [4][10] Group 2: Clinical Development - Genprex is finalizing components of the diabetes construct and is continuing preclinical studies, with plans to seek FDA guidance for the preclinical studies necessary to file an Investigational New Drug (IND) application by the second half of 2025 [6][8] - The formation of Convergen Biotech is expected to expedite clinical development and enable direct investment and strategic collaboration for the diabetes program [8] Group 3: Market Context - As of 2024, approximately 38.4 million Americans have diabetes, with projections indicating that the global number of people living with diabetes will rise from 537 million in 2021 to 783 million by 2045 [9] - 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 [9]

Core Insights - Genprex, Inc. announced significant findings regarding NPRL2 gene therapy's effectiveness in treating anti-PD1 resistant non-small cell lung cancer (NSCLC) using a non-viral delivery system [1][2][3] - The study demonstrated that NPRL2 gene therapy alone produced a dramatic antitumor effect, while pembrolizumab (Keytruda®) was ineffective on its own [2][3] - The Oncoprex® Delivery System, which utilizes lipid nanoparticles, allows for the intravenous delivery of tumor suppressor genes, minimizing toxicity risks associated with viral systems [1][4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its non-viral Oncoprex® Delivery System [5][6] - The company's lead product, Reqorsa® Gene Therapy, is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [5][6] - Genprex's oncology programs have received Fast Track Designation from the FDA, and the SCLC program has received Orphan Drug Designation [6] Research Findings - The NPRL2 gene therapy showed greater antitumor effects in humanized mice compared to non-humanized NSG mice, indicating the role of the immune system in its efficacy [3] - The therapy targets KRAS/STK11 mutant tumors, which are known to be resistant to conventional treatments, suggesting potential applicability to approximately 30% of NSCLCs with KRAS mutations [3]

Core Insights - Genprex, Inc. has initiated the Phase 2 expansion of the Acclaim-3 clinical study for Reqorsa® Gene Therapy in combination with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC) patients [1][2] - The study aims to determine the 18-week progression-free survival (PFS) rate, with a median PFS of 5.2 months for ES-SCLC and 2.6 months for those receiving Tecentriq as maintenance therapy [2] - The FDA has granted Fast Track and Orphan Drug Designations for Reqorsa, indicating its potential significance in treating SCLC [3] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a novel cancer treatment platform that re-expresses tumor suppressor genes [4][7] - The lead product candidate, Reqorsa, is being evaluated in clinical trials for both non-small cell lung cancer (NSCLC) and SCLC, with Fast Track Designation from the FDA for both programs [8] Clinical Study Details - The Acclaim-3 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with Tecentriq as maintenance therapy for ES-SCLC patients who did not progress after initial treatment [6] - The Phase 2 expansion will enroll 50 patients across 10 to 15 U.S. sites, with an interim analysis planned after the first 25 patients complete 18 weeks of follow-up [2][5] Research Findings - Data from studies presented at the October 2023 AACR-NCI-EORTC conference indicate that the combination of Reqorsa and Tecentriq shows significantly better tumor control compared to either agent alone [5]

Core Viewpoint - Genprex, Inc. is actively participating in the 43rd Annual J.P. Morgan Healthcare Conference to engage with investors and industry stakeholders regarding its gene therapies for cancer and diabetes [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 [4]. - 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), both of which have received Fast Track Designation from the FDA [4]. - Genprex's diabetes gene therapy, GPX-002, aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin, targeting both Type 1 and Type 2 diabetes [4]. Conference Participation - Key executives from Genprex, including the President, CEO, and Chief Medical Officer, will be available for one-on-one meetings during the conference to discuss the company's gene therapies [2][3].

Core Insights - Genprex has completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial for Reqorsa® Gene Therapy in combination with Tecentriq® for treating extensive stage small cell lung cancer (ES-SCLC) [1][9] - The Safety Review Committee (SRC) has approved the transition to the Phase 2 expansion portion of the trial, which is now open for enrollment [1][3] Company Developments - The combination of Reqorsa and Tecentriq has received FDA Fast Track Designation and Orphan Drug Designation for SCLC treatment [2] - The Recommended Phase 2 Dose (RP2D) of Reqorsa is set at 0.12 mg/kg, the highest dose level from Phase 1, with no dose limiting toxicities reported [3][6] - The Phase 2 expansion will enroll approximately 50 patients across 10 to 15 U.S. sites, focusing on the 18-week progression-free survival rate as the primary endpoint [7] Clinical Trial Insights - The Phase 1 trial demonstrated a partial remission in the first patient treated, with a 30% decrease in tumor size after four cycles of maintenance therapy [4] - Data from humanized mouse models indicate that the combination of Reqorsa and Tecentriq significantly improves tumor control compared to either agent alone [8] - The Acclaim-3 trial is designed to evaluate Reqorsa as maintenance therapy for patients who did not experience tumor progression after initial treatment [9] Future Outlook - The company anticipates promising enrollment rates for the Phase 2 portion of the trial and plans to present Phase 1 results at a clinical meeting in 2025 [4] - Genprex is focused on developing innovative therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene therapy applications [10]

Core Viewpoint - Genprex, Inc. has entered into an exclusive license agreement with the University of Michigan for its lead drug candidate, Reqorsa® Gene Therapy, in combination with ALK-inhibitors for the treatment of ALK-positive lung cancer [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its ONCOPREX® Delivery System to administer disease-fighting genes [6]. - The company is currently evaluating Reqorsa® Gene Therapy 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 [6]. Product Details - Reqorsa® Gene Therapy (quaratusugene ozeplasmid) targets cancer cells by delivering the TUSC2 gene using non-viral nanoparticles, aiming to interrupt cancer cell signaling and promote apoptosis [4]. - The therapy has shown positive preclinical data, indicating its potential effectiveness in treating ALK-positive lung cancer, particularly in patients resistant to alectinib [2][3]. Research and Development - Research at the University of Michigan has demonstrated that Reqorsa can decrease cell growth and proliferation in ALK-positive NSCLC cell lines by activating apoptotic pathways [3]. - The company believes that Reqorsa may be an effective treatment for patients progressing on ALK inhibitors, supporting further clinical studies [3]. Intellectual Property Strategy - Genprex is enhancing its intellectual property portfolio for Reqorsa, which may benefit patients with various types of cancers, thereby widening its exclusivity for drug combinations [2].

Clinical Trials - The company is currently enrolling and treating patients in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial, which combines REQORSA and Tecentriq for extensive stage small cell lung cancer (ES-SCLC) patients [111]. - In the Acclaim-3 trial, the first patient treated experienced a partial remission, defined as at least a 30% decrease in tumor size after two cycles of maintenance therapy [111]. - The FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq in June 2023, and Orphan Drug Designation for REQORSA for SCLC in August 2023 [111]. - The Acclaim-1 trial is currently in the Phase 2a expansion portion, using REQORSA and Tagrisso in late-stage NSCLC patients, with the recommended Phase 2 dose set at 0.12 mg/kg [114]. - The Acclaim-1 trial has shown prolonged progression-free survival in two patients, with one maintaining a partial remission for approximately 30 months [114]. - The Phase 2a expansion portion of the Acclaim-1 study is expected to enroll approximately 33 patients, focusing on those who received only prior Tagrisso treatment [114]. - The company decided to cease enrollment in the Acclaim-2 trial to prioritize resources for the Acclaim-1 and Acclaim-3 trials due to enrollment challenges [112]. - The company plans to conduct clinical trials for its Acclaim-1 and Acclaim-3 programs, with enrollment for the first 19 patients in Acclaim-1 expected in the first half of 2025 [148]. Financial Performance - The company reported a net loss of $4,315,987 for the three months ended September 30, 2024, a decrease of 44% compared to a net loss of $7,748,243 for the same period in 2023 [139]. - For the nine months ended September 30, 2024, the net loss was $16,780,701, representing a decrease of 33% from $24,931,209 in 2023 [140]. - As of September 30, 2024, the company had an accumulated deficit of $150,468,981 and has never generated revenue from product sales [141]. - Net cash used in operating activities decreased to $13,279,658 for the nine months ended September 30, 2024, down 33% from $19,774,740 in 2023 [151]. - The company provided $1,167 in net cash from investing activities for the nine months ended September 30, 2024, compared to a net cash outflow of $61,383 in 2023 [152]. - Net cash provided by financing activities was $8,029,143 for the nine months ended September 30, 2024, a decrease of $2,564,230 from $10,593,373 in 2023 [153]. - The company expects to fund its operations and clinical trials into December 2024 based on current cash levels [149]. Research and Development - The company has entered into a three-year sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes [110]. - The oncology platform utilizes the Oncoprex® Delivery System to deliver tumor suppressor gene-expressing plasmids to cancer cells, administered intravenously [108]. - The company is in early stages of discovery programs to identify other cancer candidates that can be delivered using the ONCOPREX Delivery System [110]. - Research and Development (R&D) expense for Q3 2024 was $2,756,081, a decrease of 40% from $4,616,546 in Q3 2023 [131]. - R&D expense for the nine months ended September 30, 2024 was $7,696,982, down 45% from $13,903,611 in the same period of 2023 [132]. General and Administrative Expenses - General and Administrative (G&A) expense for Q3 2024 was $1,566,085, a decrease of 51% from $3,166,057 in Q3 2023 [133]. - G&A expense for the nine months ended September 30, 2024 was $9,135,225, down 18% from $11,173,643 in the same period of 2023 [134]. Interest and Depreciation - Interest income for Q3 2024 was $8,080, a decrease of $43,311 from $51,391 in Q3 2023 [135]. - Interest income for the nine months ended September 30, 2024 was $58,851, down $116,562 from $175,413 in the same period of 2023 [136]. - Depreciation expense for Q3 2024 was $1,272, a decrease of 66% from $3,724 in Q3 2023 [137]. - Depreciation expense for the nine months ended September 30, 2024 was $6,230, down 46% from $11,578 in the same period of 2023 [138]. Workforce Reduction - The company has reduced its workforce from 31 employees at September 30, 2023, to 19 employees at September 30, 2024, as part of its expense reduction strategies [139]. Future Plans - The company plans to request further regulatory guidance from the FDA in the first half of 2025 regarding nonclinical studies for its diabetes gene therapy product candidates [116]. - The company is considering transferring its diabetes clinical development program and gene therapy assets into a new wholly-owned subsidiary by the end of 2024, subject to financing and approvals [116]. - The company sold 2,318,450 shares of common stock for net proceeds of $2,117,752 during the nine months ended September 30, 2024 [143].