Genprex CEO Rodney Varner says company’s near-term future 'could be transformational'

Genprex Inc (NASDAQ:GNPX) CEO Rodney Varner told shareholders Monday that the clinical-stage gene therapy company’s near-term future “could be transformational.” In a letter, Varner said the company is bullish going forward as it further develops its lead drug candidate Oncoprex to treat non-small cell lung cancer (NSCLC) and secures the necessary capital to carry out its business strategy for at least two years.  READ: Genprex taps Shannon Inman as vice president of global clinical operations Since the start of 2020, Genprex has achieved the following:  Received Fast Track Designation from the US Food and Drug Administration for Oncoprex, in combination with osimertinib for the treatment of patients with NSCLC. Osimertinib is better known as Tagrisso (marketed by AstraZeneca PLC (NYSE:AZ), a first-line treatment for patients with NSCLC and AstraZeneca’s best-selling drug with more than $3 billion in 2019 worldwide sales.  Signed an exclusive license agreement with the University of Pittsburgh for a preclinical diabetes gene therapy candidate that has the potential to cure Type 1 and Type 2 diabetes.  Obtained encouraging preclinical data from our collaborators and independent third parties for the TUSC2 gene, the active agent in Oncoprex, in lung cancer and triple-negative breast cancer.  Raised more than $26 million in gross proceeds from institutional investors, predominantly at market and without attached warrants, providing an operational runway through at least the next 24 months. “We are excited to execute on our business plan to navigate Oncoprex through the clinical and regulatory channels with the goal of bringing it to market for the benefit of lung cancer patients who are desperately in need of new treatment options,” Varner said. “Lung cancer is the world’s leading cause of cancer death. Each year, there are 1.7 million deaths from lung cancer worldwide. Importantly, NSCLC accounts for 84% of all lung cancers. We believe the execution of our clinical strategy will maximize shareholder value and move Genprex closer to commercialization.” Company outlook Looking ahead, Varner said Genprex plans to initiate a Phase I/II clinical trial in late 2020 or early 2021 evaluating Oncoprex in combination with Tagrisso in NSCLC patients with epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso alone. In addition, the company is preparing to file an Investigational New Drug application to initiate a clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck & Co Inc as Keytruda) in NSCLC. Varner also noted that Genprex is moving ahead as planned despite the uncertainty due to the coronavirus (COVID-19) pandemic.  “Despite the challenges this pandemic has presented, we will stick firmly to our corporate mission to develop potentially life-changing gene therapies for patients with both cancer and diabetes, which collectively affect hundreds of millions of people today,” he said. “At Genprex, we believe our therapies offer a strong value proposition to the market to address unmet medical needs and save lives.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham