Research Journal Features Genprex Collaborators' Abstract Detailing Positive Preclinical Data on the Use ofReqorsa® Gene Therapy for the Treatment of Lung CancerAUSTIN, Texas, April 22, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators' abstract was published in the online Proceedings supplement of Cancer Rese ...

Clinical Trials and Research - The company is developing REQORSA® gene therapy for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC), with a recommended Phase 2 dose of 0.12 mg/kg established after the Phase 1 trial [486]. - In the Phase 1 portion of the Acclaim-1 trial, one patient achieved a partial remission after 47 courses of treatment, demonstrating prolonged progression-free survival (PFS) of approximately 35 months [486]. - The Acclaim-1 trial is expected to enroll approximately 33 patients who have progressed on Tagrisso or Tagrisso-containing regimens, with an interim analysis planned after treating 19 patients [486]. - The FDA has granted Fast Track Designation for the combination of REQORSA and Tagrisso in NSCLC patients who have progressed on Tagrisso treatment [487]. - The Acclaim-3 trial is currently enrolling patients, with an expected enrollment of approximately 50 patients, focusing on the 18-week progression-free survival rate as a primary endpoint [491]. - The Acclaim-2 trial has been closed due to slow enrollment, with no patients currently receiving study treatment [490]. - The company is collaborating with MD Anderson to identify biomarkers that may enhance patient screening and enrollment for clinical trials [485]. - The company plans to complete interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial by the end of 2025 [523]. - The company may face delays in clinical trials due to various factors, including competition for patients and transitions to new third-party CDMOs [524]. Financial Performance - Research and development (R&D) expenses decreased by $7,081,159, or 40%, to $10,535,446 for the year ended December 31, 2024, compared to $17,616,605 in 2023 [509]. - General and administrative (G&A) expenses decreased by $2,793,257, or 21%, to $10,632,028 for the year ended December 31, 2024, compared to $13,425,285 in 2023 [510]. - Net loss for the fiscal year ended December 31, 2024, was $21,111,163, a decrease of $9,749,298, or 32%, from a net loss of $30,860,461 in 2023 [513]. - As of December 31, 2024, the accumulated deficit was $154,799,443, with no revenue generated from product sales since inception [515]. - Cash balance as of December 31, 2024, was $1,601,660, with subsequent net proceeds of approximately $6.0 million received through the ATM Agreement [522]. - Net cash used in operating activities decreased by $7,589,515, or 31%, from $24,738,603 in 2023 to $17,149,088 in 2024 due to expense reduction strategies [529]. - Net cash provided by investing activities changed from a net cash used of $71,214 in 2023 to a net cash provided of $1,166 in 2024, resulting in a net change of $72,380 [530]. - Net cash provided by financing activities increased by $1,418,576, or 13%, from $10,593,377 in 2023 to $12,011,953 in 2024, attributed to differences in capital raising activities [531]. - The net decrease in cash for the year ended December 31, 2024, was $5,135,969, compared to a decrease of $14,216,440 in 2023 [529]. Future Outlook and Funding - The company expects to fund operations through equity offerings, ATM drawdowns, and potential debt financing, anticipating the need for additional capital to support ongoing clinical trials [523]. - R&D expenses are expected to increase in the future as the company advances product candidates through clinical trials and expands research programs [504]. - The company anticipates needing additional fundraising activities and cash on hand by the second quarter of 2025 to meet fixed cash obligations related to clinical studies [526]. - The company expects insufficient cash to cover ongoing clinical trials and research and development programs through fiscal year 2025 without raising additional working capital [526]. - Future capital requirements will depend on various factors, including development costs, manufacturing expenses, and costs associated with being a public company [528]. - The company may need to use liquidity for acquisitions or additional capital to fund newly acquired operations, which could lead to dilution for existing security holders [527]. - The company has ongoing obligations related to the Acclaim clinical trials, which may require adjustments to its operating plan if cash is insufficient [526]. - The company reduced headcount in R&D from 16 employees at December 31, 2023, to 10 employees at December 31, 2024, as part of expense reduction strategies [509]. - The company has reduced its workforce from 28 employees at December 31, 2023, to 16 employees at December 31, 2024, as part of its expense reduction strategies [529].

Core Viewpoint - Genprex, Inc. announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, targeting KRASG12C mutant non-small cell lung cancer (NSCLC), which may provide a new treatment option for patients resistant to Ras inhibitors [1][2]. Group 1: Research and Development - The upcoming presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting will showcase preclinical data on Reqorsa® Gene Therapy [1]. - The study focuses on overcoming acquired resistance to sotorasib (Lumakras®), the first FDA-approved KRAS inhibitor, in KRASG12C mutant NSCLC [3]. - TUSC2, the active component in Reqorsa, has shown multifunctional activity, including inhibiting cancer cell growth and activating immune responses [3][4]. Group 2: Clinical Efficacy - TUSC2 transfection significantly reduced colony formation and increased apoptosis in acquired resistance (AR) cell lines [4]. - Reqorsa demonstrated a strong antitumor effect in mouse xenografts and patient-derived xenograft (PDX) models, outperforming sotorasib alone [4][5]. - A synergistic effect was observed when combining Reqorsa with sotorasib in treating TC314AR PDX tumors [4]. Group 3: Product Information - Reqorsa (quaratusugene ozeplasmid) is a gene therapy that delivers the TUSC2 gene using a non-viral lipid-based nanoparticle system, specifically targeting cancer cells [6][8]. - Laboratory studies indicate that TUSC2 uptake in tumor cells is significantly higher than in normal cells, ranging from 10 to 33 times [7]. 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 [8]. - The company is advancing its pipeline of gene therapies and has received Fast Track Designation from the FDA for its lung cancer programs [8].

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 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]