Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, today announced a clinical and corporate update and the filing of financial results for the year ended December 31, 2018 on Form 10-K with the United States Securities and Exchange Commission.
“Over the past year, we made great progress in advancing the development of our gene therapy platform, including Oncoprex™ immunogene therapy for non-small cell lung cancer,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “I’m pleased with our progress and am excited to continue development of our gene therapies for cancer into 2019 and beyond. I’m confident, given all we’ve accomplished in the past year, that 2019 will be a landmark year for Genprex.”
“As we continue to advance our clinical operations and manufacturing programs, Genprex is well positioned to make 2019 a pivotal year,” Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated. “From our successful IPO launch on NASDAQ, to completing a $10 million private placement, we are gaining momentum to reach the important milestones we set for ourselves.”
Clinical Development and Corporate Update
Genprex’s accomplishments for 2018 and early 2019 include:
- Completing its initial public offering and listing of common stock on NASDAQ Capital Market.
- Completing a $10 million private placement.
- Contracting with Accenture to provide clinical data management services to help accelerate the clinical development of Genprex’s lead drug candidate, Oncoprex™.
- Contracting with WIRB-Copernicus Group (WCG) to provide site selection and feasibility services, including Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) oversight for new clinical trial sites that Genprex anticipates adding to participate in its Phase I/II clinical trial evaluating the combination of Oncoprex™ and erlotinib (Tarceva®) in non-small cell lung cancer (NSCLC).
- Selecting 4Clinics as a CRO to provide clinical and regulatory support for Genprex’s clinical development program in the form of biostatistics, statistical programming and analysis, as well as medical and scientific writing for the Phase I/II clinical trial.
- Entering into an agreement with the University of Texas at Austin Dell Medical School to establish executive offices at the school’s Health Discovery Building, joining the WorkSpaces @ Texas Health CoLab.
- Establishing offices in Cambridge, MA, where Dr. Julien Pham, President and COO will oversee the clinical development of Genprex’s lead drug candidate, Oncoprex™.
- Entering into Amendment No. 2 to Clinical Trial Agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for continued conduct of Phase I/II clinical trial at MD Anderson.
- Entering into a research agreement with MD Anderson for development of a therapeutic approach to treating cancer using TUSC2, the active agent in Genprex’s lead product candidate Oncoprex, in combination with immunotherapies; and for the development and the use of biomarkers to predict patient response to TUSC2 therapy.
- Entering into an agreement with Aldevron, a leading contract manufacturing organization, to supply TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for use in Genprex’s clinical development program evaluating Oncoprex for the treatment of NSCLC.
- Entering into agreements with additional contract manufacturing organizations to assist with manufacturing scale-up and transfer of manufacturing processes from manufacturing facilities of MD Anderson Cancer Center to commercial facilities.
- Appointing Jan Stevens, RN as Vice President of Clinical Operations, Eric Chapdelaine as Senior Director of Pharmaceutical Sciences and Manufacturing, Kalyn Dabbs as Senior Manager of Communications and Marketing, and John N. Bonfiglio, Ph.D. to Board of Directors.
- Launching a state-of-the-art website and overhauled corporate communications capabilities, including the introduction of a new investors email notification system.
2018 Financial Update
Genprex’s research and development expense was $971,427 for the year ended December 31, 2018, compared to $289,934 for the year ended December 31, 2017. This increase of $681,493 was due to the Company’s focus on improving clinical strategies, expanding research activities, refining existing manufacturing processes, and developing new manufacturing and logistics processes to support future research and development activities. Genprex had a cash position of $8.6 million as of December 31, 2018.
About Genprex, Inc.
Genprex, Inc. 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. Oncoprex has a multimodal mechanism of action whereby it interrupts 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. Visit the company’s web site at www.genprex.com or follow Genprex on Twitter at twitter.com/genprex, Facebook at facebook.com/genprexinc, and LinkedIn at linkedin.com/company/genprex.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effects of Oncoprex on cancer, alone or in combination with other drugs, our plans to add additional clinical trial sites, our plans to scale-up and transfer our manufacturing processes to commercial facilities, the effect of methods for predicting patients’ response to therapy, the products and services we expect to receive from companies we contract with and the effect of those products and services on the development of Oncoprex™, and statements about our business plans. Risks that contribute to the uncertain nature of the forward-looking statements include: the presence and level of TUSC2’s effect on cancer; the ability of companies we contract with to provide products and services to us, our ability to utilize those products and services, and the effect of those products and services on the development of Oncoprex™; the effect on cancer of combining TUSC2 with immunotherapies or other drugs; the timing, success and cost of our clinical trials and planned clinical trials of TUSC2 and Oncoprex and other potential product candidates; the timing and success of obtaining FDA approval of Oncoprex and our other potential product candidates; the success, cost and timing of our product candidate development activities; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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