Genprex Provides Clinical, Corporate, and Financial Update for the Year Ending December 31, 2018
April 01 2019 - 8:30AM
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190401005248/en/
Genprex, Inc.(877) 774-GNPX (4679)
Investor RelationsGNPX Investor Relations(877) 774-GNPX
(4679) ext. #2investors@genprex.com
Media ContactGenprex Media RelationsKalyn Dabbs(877)
774-GNPX (4679) ext. #3media@genprex.com
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Sep 2023 to Sep 2024