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Genprex, Inc.

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Market:
NASDAQ
Market Cap:
$6.82 m
Price
0.43 USD
Change
-2.89%
52 weeks high
2.25
52 weeks low
0.42

Our mission is to develop life-changing gene technologies for cancer patients through unique, innovative science.
Genprex is a clinical stage gene therapy company committed to pioneering a new approach to treating cancer. We are developing potentially life-changing gene technologies based upon our novel proprietary technology platform, including our initial product candidate, Oncoprex™ immunogene therapy, or Oncoprex. Our platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles. The nanovesicles are then administered intravenously and are taken up by tumor cells where they express proteins that are missing or found in low quantities.

Our lead product candidate, Oncoprex™, targets non-small cell lung cancer. This initial cancer target represents about 85 percent of all lung cancers and causes more deaths each year than any other type of cancer. Lung cancer is the second most common form of cancer, and the five-year survival rate for late stage lung cancer has not improved substantially in a quarter century. Research indicates that our platform technologies may deliver a number of other cancer fighting genes, alone or in combination with other cancer therapies, to combat additional types of cancer.

The Genprex Approach
We are developing gene therapies for treatment of cancer, including our initial drug candidate Oncoprex immunogene therapy. Our gene therapies 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. Our research indicates that when Oncoprex is combined with targeted therapies (such as Tarceva or Iressa) or immunotherapies (such as Opdivo and Yervoy), Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining Oncoprex with targeted therapies and immunotherapies, we can extend the benefit of these approved lung cancer drugs into the large majority of patients who do not now benefit from them, either because the patients’ tumors do not have the molecular profiles that indicate effectiveness of those drugs, or because the patients have developed resistance to those drugs after receiving them for some period of time.

We hold a portfolio of more than 30 patents covering our technologies and targeted molecular therapies.

We are also conducting pre-clinical research to identify biomarkers that will identify patients most likely to benefit from our gene therapies; and to identify additional cancer drugs that will be synergistic with our gene therapies.

Targeted molecular therapies and immunotherapies offer new options for cancer patients.
As targeted therapies and immunotherapies supplant conventional chemotherapies in lung cancer, many lung cancer patients who do not meet specific genomic profiles are unable to benefit from these new therapies. In fact, a majority of lung cancer patients cannot benefit from targeted therapies or immunotherapies. Genprex seeks to bridge a critical gap by combining its gene therapies with targeted therapies and immunotherapies to provide treatments to large patient populations who would otherwise not be candidates for those important drugs.

In a phase I/II clinical trial, Genprex’s leading drug candidate, Oncoprex, is being combined with the EGFR TKI drug Tarceva® (erlotinib) in Stage IIIb/IV non-small cell lung cancer (NSCLC) patients without an activating EGFR mutation and in patients with an activating EGFR mutation who progressed on erlotinib, whether or not they had prior chemotherapy. Patients without an activating EGFR mutation represent the vast majority of lung cancer patients, however these patients are usually not candidates for EGFR TKI therapies due to the absence of this mutation.

Oncoprex is being developed to overcome this genomic limitation and provide a new treatment solution to this majority of lung cancer patients who do not have the activating EGFR mutation that would allow them to benefit from EGFR TKI therapies such as Tarceva.

In addition, patients who have the EGFR activating mutation and do receive an EGFR TKI inhibitor such as Tarceva usually become resistant to these drugs at some point, and no longer benefit from them. Data indicate that Oncoprex may re-sensititize these patients to EGFR TKI drugs such as Tarceva, allowing the patients to benefit for a longer period time.

ONCOPREX IMMUNOGENE THERAPY

Scientific Rationale

The active ingredient in our lead product candidate, Oncoprex, is the TUSC2 gene, a tumor suppressor gene.

Our lead product candidate, Oncoprex, consists of a TUSC2 gene encapsulated in a positively charged nanovesicle made from lipid molecules with a positive electrical charge. Oncoprex is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once Oncoprex is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. 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 programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

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NANOVESICLE DELIVERY

Platform Delivery

The Genprex gene therapy platform consists of anti-cancer genes encapsulated in nanovesicles that are delivered intravenously. The Oncoprex TUSC2 gene is encapsulated in a positively charged nanovesicle that binds to actively replicating (and, therefore, negatively charged) cancer cells and then enters the cancer cell through selective endocytosis

Nanoscale Technology
The particle size is small enough to allow Oncoprex to cross tight barriers in the lung but large enough to avoid accumulation or clearance in the liver, spleen and kidney. The cationic charge of the nanovesicle targets cancer cells, and direct nanovesicle fusion avoids target cell endocytosis. A Phase I clinical trial showed that intravenous Oncoprex therapy was proven to selectively and preferentially target primary and metastatic tumor cells, resulting in clinically significant anticancer activity. The nanovesicles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

US

Rodney Varner, JD
CEO, Chairman of the Board

Rodney Varner, JD, is a co-founder of Genprex and has served as our President, Chief Executive Officer and Secretary, and as Chairman of our board of directors since August 2012. Mr. Varner served as a partner of the law firm Wilson & Varner, LLP, since 1991. Mr. Varner has more than thirty-five years of legal experience with large and small law firms and as outside general counsel of a Nasdaq-listed company. Mr. Varner has represented for-profit and non-profit companies at the board of directors or senior management levels in a wide variety of contractual, business, tax, and securities matters, including technology transfers, licensing, collaboration and research agreements, clinical trial contracts, pharmaceutical and biologics manufacturing and process development contracts, state and federal grants, including NIH and SBA grants, corporate governance and fiduciary issues, and real estate matters. Mr. Varner 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. Mr. Varner is a member of the State Bar of Texas and has been admitted to practice before the United States Court of Appeals for the Fifth Circuit and the United States Tax Court. He has been a registered securities representative and founder of a company that is a licensed securities broker-dealer. Mr. Varner received his BBA, with high honors, from Texas A&M University and his J.D. from The University of Texas School of Law.

Julien L. Pham, MD, MPH
President & COO

Julien L. Pham, MD, MPH has served as our Chief Operating Officer since October 2016. 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 from March 2013 to September 2016. Prior to co-founding RubiconMD, Dr. Pham served on the faculty at Harvard Medical School’s Brigham and Women’s Hospital (BWH). Dr. Pham joined the combined Harvard Nephrology Fellowship program at Massachusetts General Hospital / Brigham and Women’s Hospital in July 2008 and became an Associate Physician in the BWH Division of Nephrology in August 2011. Dr. Pham has over fifteen years of leadership experience in clinical settings and in emerging medical technology companies. During this time, he has held various research and teaching positions, including Chief Residency in Internal Medicine and Pediatrics at the University of Illinois at Chicago Medical Center, and has received multiple awards, including excellence in teaching awards from AOA and Harvard Medical School. He is a board-certified internal medicine doctor and nephrologist. Dr. Pham has received NIH research funding for translational research while at Harvard Medical School, and he has published in basic science, translational, and health policy fields. He holds a BS in Cell and Molecular Biology from the University of Washington, his MD from the University of Washington School of Medicine, and his MPH from the Harvard School of Public Health.

Ryan M. Confer, MS
Chief Financial Officer

Ryan M. Confer, MS, has served as our Chief Financial Officer since September 2016. From December 2013 through September 2016, he served as our Chief Operating and Financial Officer, and from June 2011 to December 2013 as our business manager. Mr. Confer has served us in a variety of strategic, operations and finance capacities since our inception in 2009 both as a consultant through his own firm, Confer Capital, Inc., and as an employee.

Mr. Confer has more than ten years of entrepreneurial experience in planning, launching, developing and growing emerging technology companies. He has served in c-level and vice president roles for a variety early-stage technology companies since 2008. Most notably, Mr. Confer served as VP of Customer Experience and then later as VP of Strategy for KaiNexus, Inc., an emerging technology company that develops continuous improvement software. Prior to his entrepreneurial experiences, Mr. Confer served as a business development consultant for the University of Texas at Austin’s IC2 Institute, an international thinktank and incubator, where he focused on evaluating the commercialization potential of nascent technologies in emerging growth markets. From 2006 to 2009, Mr. Confer served as a portfolio manager for a $500M early-stage technology investment fund.

Mr. 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
VP of Clinical Operations

Jan Stevens has served as our VP of Clinical Operations since June 2018. Ms. Stevens has over twenty years of clinical operations experience in early to late stage oncology biotech companies. Ms. Stevens has been a member of senior management teams at Ziopharm Oncology and Berg, developing successful clinical strategies to move both small molecules and biologics forward from first in man to global pivotal trials.

Ms. Stevens has expertise in hands on development and management of all Phases of clinical trials from the ground up. Over the past twenty years, Ms. Stevens has led all aspects of clinical operations including clinical trial design and execution; clinical components of regulatory submissions from IND to BLA; and developing, managing, and mentoring high-level clinical operations teams.

Prior to her work in clinical research, Ms. Stevens was a registered nurse in the Neuro Unit at Mass General Hospital. Ms. Stevens obtained a degree in Ethics from Harvard University.

Eric Chapdelaine
Senior Director of Pharmaceutical Sciences and Manufacturing

As the Senior Director of Pharmaceutical Sciences (AD, CMC, Tech Ops, and Supply Chain) and Manufacturing, Eric Chapdelaine is responsible for running all facets of those departments for Genprex, Inc.  Eric has a proven management track record and over 14 years of experience driving growth in the pharmaceutical and biotech industry. Prior to joining Genprex, Eric was Director of Quality Control and Analytical Development at Cognate BioServices, responsible for management and oversight of a large Quality Control and Analytical Development staff (45+ people) and multiple laboratories in a Cell and Gene Therapy CDMO facility.  At Cognate, he led all QC and Analytical functions such as Analytical Development, Qualification, Validation, and Tech Transfer. Previously, he served as Quality Control Manager of Specifications at Alnylam Pharmaceuticals, where he led as Specification Committee Chairperson and authored CMC-related sections of regulatory filings for the first ever approved RNAi therapeutic for commercial use.  He spent the prior 6 years at Sanofi Genzyme holding several corporate management positions.  Eric has recently been awarded as a Global Goodwill Ambassador for his volunteering work with such organizations as Birthday Wishes, Pets of the Homeless, and the ASPCA.  He earned a MS degree in Chemistry from Vanderbilt University and while at UMass Amherst getting his BS degree in Biochemistry and Molecular Biology, he was awarded Time Magazine Student of the Year (Massachusetts).

Kalyn Dabbs
Senior Manager of Communications and Marketing

Kalyn Dabbs joins Genprex as Senior Manager of Communications and Marketing. Kalyn is responsible for developing and implementing internal and external communication and marketing plans, managing the company’s website and social media strategy, drafting and updating communication materials and providing organizational leadership on communication and marketing initiatives. Prior to joining Genprex, Kalyn has worked for corporations within the health industry, specifically with medical devices and health supplements. She has also worked for public relations agencies serving a variety of clients and industries while garnering experience in internal and external communications, investor relations, media relations, social media, content development and crisis communications.

Corporate Headquarters
Dell Medical Center
Health Discovery Building
1601 Trinity Street, Bldg B
Suite 3.322
Austin, TX 78712-1885

Phone:
(877) 774-GNPX (4679)