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Genprex Inc. (NASDAQ: GNPX)

Genprex Inc. (GNPX) is a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based upon a unique proprietary technology platform, including Genprex's initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex's platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities.

Research and Development

Genprex holds a portfolio of 30 issued and two pending patents covering its technologies and targeted molecular therapies. The company's research and development program is focused on identifying and developing leading-edge gene therapies that can be used alone or in combination with other therapies for treatment of cancer.

Genprex's initial product candidate is Oncoprex™, an immunogene therapy for the treatment of non-small cell lung cancer (NSCLC). Oncoprex works by interrupting cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (or programmed cell death) in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

Preclinical research is being conducted with the goal of developing Oncoprex to be administered with targeted therapies in other solid tumors, and with immunotherapies in NSCLC and other solid tumors. In addition, Genprex has conducted and plans to continue research into other tumor suppressor genes associated with chromosome 3p21.3, as well as other potential applications of the company's immunogene therapy platform.

Clinical Trials

Genprex is currently conducting the second phase of a phase I/II clinical trial at the University of Texas MD Anderson Cancer Center in Houston. The company plans to expand its clinical program by adding a new clinical study evaluating Oncoprex™ in combination with a checkpoint inhibitor for treatment of Stage IV or recurrent NSCLC. In research presented at the 2017 Annual Meeting of the American Association of Cancer Research in Washington, D.C., Genprex's collaborators showed that TUSC2 in combination with PD-1 checkpoint inhibition has a significantly greater anti-tumor effect in lung cancer than either agent alone. The research also shows that TUSC2 in combination with PD-1 blockade has synergistic activity in upregulating natural killer (NK) cells, correlating with prolonged survival in mice.

TUSC2 (Tumor Suppressor Candidate 2) is a tumor suppressor gene that is absent or deficient in cancer cells of many different cancer types.

The Market

Genprex technologies seek to bridge a critical gap by combining with targeted therapies and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them. Genprex technologies are being developed to overcome genomic limitations which are inherent in targeted therapies and immunotherapies in order to provide new treatment solutions to large cancer populations, such as those with lung cancer.

Each year, more people die of lung cancer than of colon, breast and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all lung cancers, according to the American Cancer Society ("ACS"). Despite radical advances in drug development and novel therapeutic standards, survival for late stage lung cancer has not improved significantly in the past 25 years.

Senior Management

Chairman and Chief Executive Officer J. Rodney Varner, JD, is a co-founder of Genprex and has served in these roles since August 2012. He has more than 35 years of legal experience with large and small law firms and as outside general counsel of a Nasdaq-listed company. Varner has served as counsel in company formation, mergers and acquisitions, capital raising, other business transactions, protection of trade secrets and other intellectual property, real estate, and business litigation. He is a member of the State Bar of Texas and has been admitted to practice before the U.S. Court of Appeals for the Fifth Court and the U.S. Tax Court.

Julien L. Pham, M.D., MPH, is president and chief operating officer of Genprex. In March 2013, Dr. Pham co-founded RubiconMD, a healthcare IT company that connects primary care providers to specialists for additional guidance and opinions on medical cases and served as its chief medical officer. He has served on the faculty at Harvard Medical School's Brigham and Women's Hospital and is a board-certified internal medicine doctor and nephrologist.

Ryan M. Confer, MS, has served as Genprex chief financial officer since September 2016. Confer has more than 10 years of executive experience in planning, launching, developing, and growing emerging technology companies and has served in the chief operating and chief financial roles for non-profit and for-profit entities since 2008. Confer has also served as an international business development consultant for the University of Texas at Austin's IC2 Institute, where he focused on evaluating the commercialization potential of nascent technologies in domestic and international markets applicable to technology incubator programs associated with the University. Confer holds a BS in finance and legal studies from Bloomsburg University of Pennsylvania and an MS in technology commercialization from the McCombs School of Business at the University of Texas at Austin.

Jan Stevens, RN, is vice president of Clinical Operations. Stevens has nearly 20 years of comprehensive clinical operations experience in the biopharma industry and a specialization in early-to-late stage oncology companies. Stevens joined the company to help support the various clinical development programs for Oncoprex™.

Investment Considerations

  • Lung cancer is one of the most prevalent and deadly cancers worldwide. Genprex aims to develop cutting-edge gene therapies to improve outcomes, which have not changed significantly in the past 25 years despite radical advances in drug development and novel therapeutic standards.
  • Genprex holds a portfolio of 30 issued and two pending patents covering technologies and targeted molecular therapies, all exclusively licensed from University of Texas MD Anderson Cancer Center. Genprex technologies seek to bridge a critical gap by combining with targeted therapies and immunotherapies to provide treatments to large patient populations who otherwise would not benefit from these important cancer therapies, or who have become resistant to them.
  • Genprex had a cash position of $10.3 million as of September 30, 2018.
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