BioRestorative Therapies, Inc. Releases Year-End Message
December 20 2021 - 6:00AM
BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”)
(NASDAQ:BRTX), a life sciences company focused on adult stem
cell-based therapies, today released the following year-end
message.
As we reach the end of 2021, we are inspired by
the many healthcare workers and biopharmaceutical companies that
have worked to combat the COVID-19 pandemic. This year has been
environmentally difficult, but we have seen incredible advancements
in our sector which have reinforced the importance of our mission
to become a clinical stage company. Since our emergence from
Chapter 11 in 2020, we have sought to take positive steps at
BioRestorative Therapies with the goal of making it a preeminent
cell therapy company. During 2021, we achieved important
transformational milestones, which created meaningful intrinsic
value and advanced us toward our stated strategic goals.
In November of this year, we closed on a $23
million capital raise and concurrently listed our securities on the
Nasdaq Capital Market. This is a very significant development as we
are now fully funded to complete our Phase 2 trial for our lead
clinical candidate, BRTX-100, for the treatment of chronic lumbar
disc disease (CLDD.) During this process, we have attracted many
new institutional fundamental investors as well as some retail
investors. With that accomplished, I would like to briefly discuss
the status of our programs and the opportunities that lie ahead of
us.
BRTX-100 is our lead program for the treatment
of CLDD, one of the leading causes of lower back pain. Our solution
is a one-time injection of 40 million mesenchymal stem cells
derived from a patient’s own bone marrow and expanded ex vivo
before re-injection. Two things make us optimistic about this
program. First, in connection with our IND filing, we referred the
FDA to prior human clinical studies from different institutions
that demonstrated the safety/feasibility of using mesenchymal stem
cells to treat disc orders. This data not only enabled us to
accelerate our clinical program and initiate a Phase 2 trial, but
we believe it substantially reduces risk in offering compelling
guidance on the use of cell-based interventions to treat lower back
pain. Second, our manufacturing of BRTX-100 involves the use of low
oxygen conditions, which ensures that the cells have enhanced
survivability after introduction into the harsh avascular
environment of the injured disc which has little or no blood flow.
The benefits of this process are significant and are illustrated
well in our recent Journal of Translational Medicine publication.
Our approach is akin to transplant medicine in which specific cell
types are used to replace the ones which have been lost to disease.
We believe that transplanting targeted cells can offer a more
attractive safety profile and potentially an improved clinical
outcome. We remain optimistic that we will see significant positive
clinical outcomes as we proceed with our clinical trial.
The most significant milestones we
achieved in 2021 include:
- Raised
$23 million of capital in a public offering, the proceeds of which
will be used to execute the Phase 2 trial for CLDD, for
pre-clinical research and development with respect to our
ThermoStem® Program and for working capital.
-
Uplisted to the Nasdaq Capital Market.
-
Emerged and finalized our Chapter 11 process.
-
Restructured our balance sheet, eliminating all debt and historical
warrant overhang
- Became
a “current” filer of SEC documents (two 10-Ks and six 10-Qs, all in
8 months)
-
Renegotiated all our key vendor agreements, streamlining operations
and reducing historical cash burn rates
- Were
granted 6 new patents protecting novel technology for stem
cell-based therapeutics
- Filed
10 new patent applications to protect novel technology related to
BRTX-100
-
Expanded our manufacturing facility to comply with FDA Good
Manufacturing Practices (GMP) for clinical manufacturing
-
Expanded our management team to provide us with the resources we
need to support our growth and programs
-
Expanded our Board of Directors to include a diverse set of
executives with strong domain expertise and experience
-
Initial research report published by analyst Elemer Piros, Ph.D.,
of Roth Capital Partners
Our 2022 objectives include the initiation of
enrollment for our BRTX-100 clinical trial, the development of our
overall product profiles via manufacturing and delivery system
improvements, and the entering into of technology validation and
enabling partnerships to accelerate our clinical
timelines.
Some of the events and milestones that we hope to
accomplish in 2022 include:
- Sign a
CRO agreement with PRC Clinical related to our Phase 2 clinical
trial targeting CLLD
-
Complete BRTX-100 engineering runs for our Phase 2 clinical study
during the first quarter of 2022
-
Complete the recruitment of approximately 15 US clinical sites in
the first quarter of 2022
-
Complete first patient recruitment for our Phase 2 clinical study
during the second quarter of 2022
- Meet
with the FDA to discuss further development of the off-the-shelf
brown adipose stem cell program during the first half of 2022
-
Evaluate opportunities throughout 2022 for new brown adipose stem
cell product candidates based on pre-clinical animal
data
-
Evaluate throughout 2022 partnership opportunities, the expansion
of existing external collaborations and the identification of new
collaborations for our off-the-shelf brown adipose stem cell
program, ThermoStem®, as well as BRTX-100
-
Participate in key investor and scientific industry conferences to
broaden the exposure of our platforms and our strategic
objectives
This is an exciting time to be part of the
BioRestorative family. As we enter 2022 with a well-capitalized
balance sheet to fully fund our Phase 2 trial, we look to
accelerate our research and development pipeline. We do not take
for granted that our technologies give us an opportunity to make a
profound impact on the everyday lives of many people. We are
grateful for the opportunity to validate such technologies; it is
what we do and what we believe is the center of our core
competencies.
Visit our website
at www.biorestorative.com for more information about
BioRestorative.
Thank you to the BioRestorative family for your
loyalty and ongoing support.
I wish you and all those near and dear to you a
wonderful Holiday Season and the very best for 2022 and beyond.
Very truly yours,
Lance AlstodtPresident, CEO and Chairman of the
Board
About BioRestorative Therapies,
Inc.
BioRestorative Therapies, Inc.
(www.biorestorative.com) develops therapeutic products using cell
and tissue protocols, primarily involving adult stem cells. Our two
core programs, as described below, relate to the treatment of
disc/spine disease and metabolic disorders:
• Disc/Spine Program (brtxDISC™): Our lead cell
therapy candidate, BRTX-100, is a product formulated from
autologous (or a person’s own) cultured mesenchymal stem cells
collected from the patient’s bone marrow. We intend that the
product will be used for the non-surgical treatment of painful
lumbosacral disc disorders or as a complementary therapeutic to a
surgical procedure. The BRTX-100 production process utilizes
proprietary technology and involves collecting a patient’s bone
marrow, isolating and culturing stem cells from the bone marrow and
cryopreserving the cells. In an outpatient procedure, BRTX-100 is
to be injected by a physician into the patient’s damaged disc. The
treatment is intended for patients whose pain has not been
alleviated by non-invasive procedures and who potentially face the
prospect of surgery. We have received authorization from the Food
and Drug Administration to commence a Phase 2 clinical trial using
BRTX-100 to treat chronic lower back pain arising from degenerative
disc disease.
• Metabolic Program (ThermoStem®): We are
developing a cell-based therapy candidate to target obesity and
metabolic disorders using brown adipose (fat) derived stem cells to
generate brown adipose tissue (“BAT”). BAT is intended to mimic
naturally occurring brown adipose depots that regulate metabolic
homeostasis in humans. Initial preclinical research indicates that
increased amounts of brown fat in animals may be responsible for
additional caloric burning as well as reduced glucose and lipid
levels. Researchers have found that people with higher levels of
brown fat may have a reduced risk for obesity and diabetes.
FORWARD-LOOKING STATEMENTS
This letter contains "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, and such forward-looking statements are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. You are cautioned that such
statements are subject to a multitude of risks and uncertainties
that could cause future circumstances, events or results to differ
materially from those projected in the forward-looking statements
as a result of various factors and other risks, including, without
limitation, those set forth in the Company's latest Form 10-K filed
with the Securities and Exchange Commission (SEC) and other filings
made with the SEC. You should consider these factors in evaluating
the forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this
letter are made as of the date hereof and the Company undertakes no
obligation to update such statements.
CONTACT:
Email: ir@biorestorative.com
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