Planned Spin-Out to Focus on Gene Therapy for Type 1 and 2 Diabetes in Parallel to Treatments for Late Stage Lung Cancer: Genprex: Stock Symbol: GNPX

AUSTIN, Texas - Amzeal -- Genprex, Inc. (Stock Symbol: GNPX) is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. GNPX technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. GNPX works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The GNPX oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor.

The GNPX lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of GNPX lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and the GNPX SCLC program has received an FDA Orphan Drug Designation. The GNPX diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

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Plans to Launch Separate Company to Focus on the Development of Gene Therapy to Treat Type-1 and Type-2 Diabetes

On September 4^th GNPX announced its intention to transfer the Company's diabetes clinical development program and its diabetes gene therapy assets into a new, wholly-owned subsidiary ("NewCo"). NewCo would focus on developing and commercializing GPX-002, a diabetes gene therapy drug candidate for the treatment of Type 1 (T1D) and Type 2 diabetes (T2D). This decision was made public on September 4, 2024.

The planned spin-out transaction would allow both GNPX and NewCo to enhance each company's focus on meeting the needs of their respective markets, patients and stakeholders. The GNPX spin-out, would result in NewCo focusing on developing GPX-002, while GNPX would retain its oncology clinical development programs and other oncology pipeline assets. The decision to pursue the reorganization demonstrates a strong ongoing commitment to the GNPX streamlined, focused strategies and ongoing research and development prioritization initiative.  The potential formation and transfer of the clinical development program into the wholly-owned subsidiary is currently anticipated to occur by the end of 2024.

The GNPX goal for separating the diabetes clinical development program from its oncology program follows closely behind a recent announcement to re-focus the GNPX oncology clinical development program for streamlined, expeditious regulatory submission of its lead oncology drug candidate, Reqorsa® Gene Therapy.  As previously announced, GNPX continues to evaluate ways to optimize its clinical and research programs and operational strategies.  Additionally, GNPX is considering various strategic alternatives and opportunities to enhance stockholder value.

Presentations to Highlight Gene Therapies for Cancer and Diabetes

GNPX has announced its participation in the following upcoming investor and industry conferences:

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Event: H.C. Wainwright 26th Annual Global Investment Conference
Conference Dates: September 9-13, 2024
Presentation Date: On-demand September 9-11, 2024 in the conference portal (virtual)

Event: Chardan's 8th Annual Genetic Medicines Conference
Dates: September 30 – October 1, 2024
Location: Westin Grand Central in New York, NY

New Video Featuring GNPX Chief Medical Officer Discussing Positive Patient Outcomes in Two Lung Cancer Clinical Trials

On August 15^th GNPX released a new video featuring the Company's Chief Medical Officer, Mark Berger, MD, discussing positive clinical study updates from its Acclaim-1 and Acclaim-3 Phase 1/2 clinical trials in lung cancer and recent updates to the GNPX oncology clinical development program.

To watch the video, visit the GNPX website at: https://www.genprex.com/videos/.

The Acclaim-1 clinical trial is evaluating the combination of the GNPX lead drug candidate, Reqorsa® Gene Therapy, and AstraZeneca's Tagrisso® to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso.

The Acclaim-3 clinical trial is evaluating the combination of REQORSA and GNPX Tecentriq® as a maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

Media Contact:
Company Name: Genprex, Inc.
Contact: Kalyn Dabbs
Email: media@genprex.com
Phone: (877) 774-GNPX (4679)
Country: United States
Website: www.genprex.com

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