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].

Novel Gene Therapy Program is Addressing Type 1 and Type 2 DiabetesAUSTIN, Texas, March 25, 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 have been selected to present at the upcoming 2025 American Diabetes Association (ADA) 85th Scientific Session being held June 20-23, 2025 in Chicago, Illinois. The coll ...

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]

"Prior studies have shown that Non-Obese Diabetic (NOD) mice became hyperglycemic again a median of 17 days after treatment with syngeneic islet cell transplants," said Mark Berger, Chief Medical Officer at Genprex. "Our recent preclinical studies of Type 1 NOD mouse models treated with GPX-002 have shown durability of glucose control to approximately 120 days, or 4 months. This suggests that that the new insulin producing beta- like cells that our therapy produced are poorly recognized by the autoimmune pr ...

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]

New publication indicates that NPRL2 gene therapy has marked single-agent activity in anti-PD1 resistant non-small cell lung cancer xenograftsAUSTIN, Texas, Feb. 13, 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 at a major cancer research center in Houston, Texas have published a new study in eLife titled, ...

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].