Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has issued a shareholder letter and corporate update outlining the Company’s developments and initiatives for 2020 and anticipated milestones for 2021 and beyond.
“We achieved many significant milestones in 2020 that have set the stage for a transformational 2021,” said Rodney Varner, President and Chief Executive Officer of Genprex. “The primary focus this past year was on the preparation for our two lead clinical trials in non-small cell lung cancer (NSCLC). Our Acclaim-1 clinical trial will combine REQORSA with Tagrisso® for patients with late stage NSCLC whose disease progressed after treatment with Tagrisso. Our Acclaim-2 clinical trial will combine REQORSA with Keytruda® for NSCLC patients who are low expressors (1% to 49%) of the protein programmed death-ligand 1 (PD-L1). We remain on track to initiate both trials in the first-half of 2021. Additionally, the $40 million-plus in capital infusions in 2020 have provided us with a strong balance sheet as 2021 begins. We are grateful for the confidence and support of our shareholders and look forward to executing on our strategies to achieve a number of potentially value-creating milestones.”
To read the letter in its entirety, a digital copy of the Company’s Shareholder Letter can be found on the Company’s website here.
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, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA 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. REQORSA 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 REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone.
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, 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 REQORSA™ immunogene therapy drug, 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 any FDA approvals of REQORSA and our other potential product candidates including whether we receive necessary approvals to commence clinical trials or benefit from fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. 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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