AUSTIN, Texas & CAMBRIDGE, Mass.–(BUSINESS WIRE)–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.
Forward-Looking Statements
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.
Contacts
Genprex, Inc.
(877) 774-GNPX (4679)
Investor Relations
GNPX Investor Relations
(877)
774-GNPX (4679) ext. #2
investors@genprex.com
Media Contact
Genprex Media Relations
Kalyn Dabbs
(877)
774-GNPX (4679) ext. #3
media@genprex.com