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].

Core Insights - Genprex, Inc. announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, which modulates immune responses against cancer [1][2] - The findings will be presented at the 39th Annual Society for Immunotherapy of Cancer Meeting, indicating the growing evidence of Reqorsa's anti-tumor mechanisms [2][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 [7][8] - The company collaborates with academic institutions to advance its drug candidates and has received Fast Track Designation and Orphan Drug Designation from the FDA for its lung cancer programs [8] Research Findings - The study involved TUSC2 Knock Out (KO) and Wild Type (WT) mice, analyzing immune responses through flow cytometry [2][3] - In the Reqorsa supplemented group, tumor growth was significantly reduced, with a notable decrease in T regulatory cells and an increase in Cytotoxic T cells and NK cells [3][4] - The research suggests that Reqorsa can enhance immune responses against tumors, even in individuals with low TUSC levels due to various health conditions [4][5] Product Details - Reqorsa consists of a TUSC2 gene expressing plasmid encapsulated in lipid-based nanoparticles, specifically targeting cancer cells while minimizing normal tissue uptake [5][8] - Laboratory studies indicate that the uptake of TUSC2 in tumor cells post-Reqorsa treatment is 10 to 33 times higher than in normal cells [5] Future Developments - Following the conference, the poster detailing the research will be available for download on Genprex's website [6]

AUSTIN, Texas, Oct. 31, 2024 /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 its participation in the upcoming BIO Europe Conference, taking place Nov. 4-6, 2024 in Stockholm, Sweden and taking place virtually Nov. 12-13, 2024.Attending in-person will be Genprex's Senior Vice President of Intellectual Property and Licensing, Thomas Gallagher, E ...

Preclinical Data Presented at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics AUSTIN, Texas , Oct. 28, 2024 /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 research collaborators delivered poster presentations at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics held October 23-25 ...

Research to Study TUSC2 Combined with ALK-InhibitorsCollaboration with Non-Profit Patient-Focused Research Group Expands Potential Lung Cancer Patient Population for Reqorsa® Gene TherapyAUSTIN, Texas , Oct. 24, 2024 /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 the Company has entered into a Sponsored Research Agreement (SRA) with the Univer ...

Poster Presentation to Focus on Reqorsa's Ability to Modulate In Vivo Immune Responses Against Cancers AUSTIN, Texas, Oct. 7, 2024 /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 Meharry Medical College were selected to present at the upcoming 39th Annual Society for Immunotherapy of Cancer Meeting being held ...

Core Insights - Genprex, Inc. is focused on developing innovative gene therapies for cancer and diabetes, with recent highlights from CEO Ryan Confer in CEO/CFO Magazine [1][2] Group 1: Gene Therapy Programs - The company is advancing its gene therapy approaches in oncology and diabetes, with updates on the Acclaim clinical trials for lung cancer and the introduction of biomarker testing in its oncology program [2][4] - Genprex's lead product candidate, Reqorsa® Gene Therapy, is under evaluation 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 [4] Group 2: Diabetes Program - Genprex plans to spin out its diabetes program into a wholly-owned subsidiary to explore partnerships and funding opportunities, aiming to expedite the development of innovative treatments [3] - The diabetes gene therapy approach utilizes an AAV vector to deliver Pdx1 and MafA genes to the pancreas, showing promise in transforming alpha cells into functional beta-like cells in Type 1 diabetes models [4] Group 3: Market Position and Collaborations - The company is observing the popularity of GLP-1 agonists like Novo Nordisk's Ozempic® and is considering future collaborations in gene therapy for diabetes [2] - Genprex collaborates with world-class institutions to enhance its pipeline of gene therapies, focusing on providing novel treatment options for patients with limited alternatives [4]

Clinical Advisory Board to Provide Strategy for Advancing Preclinical Oncology Program in Mesothelioma AUSTIN, Texas, Sept. 19, 2024 /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 the formation of a Mesothelioma Clinical Advisory Board to support the Company's preclinical mesothelioma oncology program. The Board is comprised of four world-reno ...

Poster Presentations to Focus on Reqorsa as a Potential Treatment for Ras Inhibitor Resistant Lung Cancer, Mesothelioma and Glioblastoma AUSTIN, Texas, Sept. 9, 2024 /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 were selected to present at the upcoming 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Canc ...