Intends to Create Two Distinct Businesses,
Re-Focusing Genprex on its Oncology Clinical Development
Program
New Subsidiary to Focus on Developing Novel
Gene Therapy for Diabetes
AUSTIN,
Texas, Sept. 4, 2024 /PRNewswire/ -- 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, today announced its
intention to transfer the Company's diabetes clinical development
program and its diabetes gene therapy assets into a new,
wholly-owned subsidiary ("NewCo"). NewCo would focus on developing
and commercializing GPX-002, a diabetes gene therapy drug candidate
for the treatment of Type 1 (T1D) and Type 2 diabetes (T2D).
"Genprex's diabetes program has received the attention of
several potential investors, partners, collaborators and
pharmaceutical companies, and we believe separating it from our
oncology programs could help increase interest, expedite clinical
development and unlock the value of our novel diabetes program,"
said Ryan Confer, President and
Chief Executive Officer at Genprex. "The new subsidiary would be
positioned to be a pure-play diabetes-focused biopharmaceutical
company, while Genprex would be a pure-play oncology-focused
biopharmaceutical company. This contemplated separation of entities
could enable potential direct investment and strategic
collaboration into the advancement of the diabetes program.
Diabetic patients are in need of advanced therapies, and we believe
GPX-002 holds the potential for disease modification for long-term
effectiveness, which could directly impact the global diabetes
epidemic."
The planned spin-out transaction would allow both Genprex and
NewCo to enhance each company's focus on meeting the needs of their
respective markets, patients and stakeholders. The spin-out, if
completed as presently contemplated, would result in NewCo focusing
on developing GPX-002, while Genprex would retain its oncology
clinical development programs and other oncology pipeline assets.
The decision to pursue the reorganization demonstrates Genprex's
strong ongoing commitment to the Company's streamlined, focused
strategies and ongoing research and development prioritization
initiative. The potential formation and transfer of the
clinical development program into the wholly-owned subsidiary is
currently anticipated to occur by the end of 2024, subject to
adequate financing, the satisfaction of customary conditions and
final approval from the Genprex management and Board of
Directors.
The Company's goal for separating the diabetes clinical
development program from its oncology program follows closely
behind Genprex's recent announcement to re-focus its oncology
clinical development program for streamlined, expeditious
regulatory submission of its lead oncology drug candidate, Reqorsa®
Gene Therapy. As previously announced, the Company continues
to evaluate ways to optimize its clinical and research programs and
operational strategies. Additionally, the Company is
considering various strategic alternatives and opportunities to
enhance stockholder value.
GPX-002, which has been exclusively licensed from the
University of Pittsburgh, is being
developed using the same construct for the treatment of both T1D
and T2D. The same general novel approach is used in each of T1D and
T2D whereby an adeno-associated virus (AAV) vector containing the
Pdx1 and MafA genes is administered directly into the pancreatic
duct. In humans, this can be done with a routine endoscopy
procedure. The diabetes product candidates are currently being
evaluated and optimized in preclinical studies at the University of Pittsburgh.
"With the potential to address the entire diabetes market, we
believe our gene therapy approach would position NewCo as an
innovator in emerging diabetes therapies," continued Confer. "The
most significant advancement in the treatment of diabetes happened
more than 100 years ago when insulin was first introduced to treat
T1D patients. We believe our treatment has the potential to disrupt
the diabetes market by replacing the daily burden of blood glucose
monitoring and insulin replacement therapy, as well as the need for
GLP-1 treatments in T2D."
About GPX-002 and Diabetes
In T1D, GPX-002 is designed to work by transforming alpha cells
in the pancreas into functional beta-like cells, which can produce
insulin but may be distinct enough from beta cells to evade the
body's immune system. In vivo, preclinical studies show that
GPX-002 restored normal blood glucose levels for an extended period
of time.
In February 2023, research
collaborators at the University of
Pittsburgh presented preclinical data in a NHP model of Type
1 diabetes highlighting the therapeutic potential of GPX-002 at the
16th International Conference on Advanced Technologies &
Treatments for Diabetes (ATTD 2023) in Berlin, Germany.
The statistically significant study results showed the treated
animals had:
- Decreased insulin requirements
- Increased c-peptide levels
- Improved glucose tolerance compared to baseline
In April 2023, Genprex hosted a
Key Opinion Leader virtual event entitled "Novel Gene Therapy to
Treat Type 1 Diabetes," which discussed preclinical data reported
at ATTD 2023 supporting gene therapy to treat T1D. Watch the
KOL event here.
In a similar approach for T2D, GPX-002 (formerly known as
GPX-003), where autoimmunity is not at play, is believed to work by
replenishing and rejuvenating exhausted beta cells that make
insulin.
According to the U.S. Center for Disease Control as of 2024,
38.4 million Americans, or approximately 11.6% of the U.S.
population, have diabetes. It is also believed that more than 97
million Americans aged 18 years or older have prediabetes. In 2021,
approximately 537 million adults (20-79 years) worldwide were
living with diabetes, and the total number of people living with
diabetes is projected to rise to 643 million by 2030 and 783
million in 2045. Also in 2021, diabetes caused more than 6.7
million deaths globally and diabetes resulted in approximately
$966 billion dollars in health
expenditures, a 316% increase over the preceding fifteen years.
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. Genprex's oncology program
utilizes its systemic, non-viral Oncoprex® Delivery System which
encapsulates the gene-expressing plasmids using lipid-based
nanoparticles in a lipoplex form. The resultant product is
administered intravenously, where it is taken up by tumor cells
that then express tumor suppressor proteins that were deficient in
the tumor. The Company's lead product candidate, Reqorsa® Gene
Therapy (quaratusugene ozeplasmid), is being evaluated in two
clinical trials as a treatment for NSCLC and SCLC. Each of
Genprex's lung cancer clinical programs has received a Fast Track
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of that patient population, and Genprex's SCLC
program has received an FDA Orphan Drug Designation. Genprex's
diabetes gene therapy approach is comprised of a novel infusion
process that uses an AAV vector to deliver Pdx1 and MafA genes
directly to the pancreas. In models of Type 1 diabetes, GPX-002
transforms alpha cells in the pancreas into functional beta-like
cells, which can produce insulin but may be distinct enough from
beta cells to evade the body's immune system. In a similar
approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at
play, is believed to rejuvenate and replenish exhausted beta
cells.
Interested investors and shareholders are encouraged to sign up
for press releases and industry updates by visiting
the Company Website, registering for Email
Alerts and by following Genprex on Twitter, Facebook and
LinkedIn.
Cautionary Language Concerning 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. These forward-looking
statements are made on the basis of the current beliefs,
expectations and assumptions of management, are not guarantees of
performance and are subject to significant risks and uncertainty.
These forward-looking statements should, therefore, be considered
in light of various important factors, including those set forth in
Genprex's reports that it files from time to time with the
Securities and Exchange Commission and which you should review,
including those statements under "Item 1A – Risk Factors" in
Genprex's Annual Report on Form 10-K for the year ended
December 31, 2023.
Because forward-looking 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 potential separation of its diabetes clinical development
program, including the anticipated benefits of the internal
reorganization, the expected timing of the reorganization and/or if
it is completed as contemplated or at all; Genprex's ability to
advance the clinical development, manufacturing and
commercialization of its product candidates in accordance with
projected timelines and specifications; the timing and success of
Genprex's clinical trials and regulatory approvals; the effect of
Genprex's product candidates, alone and in combination with other
therapies, on cancer and diabetes; the effects of any strategic
research and development prioritization initiatives, and any other
strategic alternatives or other efforts that Genprex takes or may
take in the future that are aimed at optimizing and re-focusing
Genprex's diabetes, oncology and/or other clinical development
programs including prioritization of resources, and the extent to
which Genprex is able to implement such efforts and initiatives
successfully to achieve the desired and intended results thereof;
Genprex's future growth and financial status, including Genprex's
ability to maintain compliance with the continued listing
requirements of The Nasdaq Capital Market and to continue as a
going concern and to obtain capital to meet its short-term and
long-term liquidity needs on acceptable terms, or at all; Genprex's
commercial and strategic partnerships, including those with its
third party vendors, suppliers and manufacturers and their ability
to successfully perform and scale up the manufacture of its product
candidates; and Genprex's intellectual property and licenses.
These forward-looking statements should not be relied upon as
predictions of future events and Genprex cannot assure you that the
events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
prove to be inaccurate, the inaccuracy may be material. You should
not regard these statements as a representation or warranty by
Genprex or any other person that Genprex will achieve its
objectives and plans in any specified timeframe, or at all. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Genprex disclaims any obligation to publicly update or release any
revisions to these forward-looking statements, whether as a result
of new information, future events or otherwise, after the date of
this press release or to reflect the occurrence of unanticipated
events, except as required by law.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor
Relations
investors@genprex.com
GNPX Media Contact
Kalyn
Dabbs
media@genprex.com
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