Genprex Provides Clinical, Corporate, and Financial Update for the Year Ending December 31, 2018
April 1, 2019
AUSTIN, Texas & CAMBRIDGE, Mass.— (April 1, 2019) — 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 focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s 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. Genprex 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 Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.
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 effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. 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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