BioRestorative Therapies, Inc. ("BRT" or the "Company")
(OTCBB:BRTX), a life sciences company focused on adult stem
cell-based therapies for various personal medical applications, has
issued a letter to stockholders, the text of which is below.
July 14, 2014
To Our Stockholders:
I am very pleased to present the exciting progress BioRestorative
Therapies, Inc. has made since August 2013, when I last shared an update
letter with our stockholders.
During the past year, we have moved closer to our goal of filing an
Investigational New Drug/ Investigational Device Exemption (IND/IDE)
with the U.S. Food and Drug Administration (FDA) for our brtxDISC™ (Disc
Implanted Stem Cells) Program, to begin a pivotal
study in patients with bulging and protruding lumbar discs who have
failed non-invasive procedures and face the prospect of surgery. The
treatment involves culturing a patient’s own stem cells and then
delivering them via our proprietary medical device to the damaged region
of the disc in an outpatient procedure.
We have also made a great deal of progress in advancing our ThermoStem®
Program, an investigational treatment using brown fat stem cells for
metabolic disorders including diabetes and obesity. Initial preclinical
research indicates that increased amounts of brown fat in the body may
be responsible for additional caloric burning as well as reduced glucose
and lipid levels.
As a recap, below are some of our accomplishments and activities from
the past year.
Business Development/Partnering Activities
During the first half of this year we were thrilled that two
pharmaceutical companies recognized our cellular biology programs, which
culminated in our signing agreements with each of them. We believe that
planned collaborative work will help serve to advance the body of
knowledge of our technology with the ultimate goal of developing
clinical therapies.
In March 2014 we announced a Research and Development Agreement with a
Japanese global pharmaceutical company, Rohto Pharmaceutical Company,
Ltd., under which we will provide stem cell research and development
services. Rohto has approximately $1.3 billion in annual sales and
develops new technology for the medical and cosmetics markets.
Also in March 2014 we entered into a two-year collaborative Research
Agreement with Pfizer Inc. to study human brown adipose (fat) tissue and
cell lines. Under the terms of the agreement, we and Pfizer are jointly
conducting a study titled “Development and Validation of a Human Brown
Adipose Cell Model,” which will seek to further characterize the
identity and metabolic function of these cell lines. We have accumulated
a large collection of human brown adipose tissue samples, preadipocyte
cell lines and immortalized cell lines for use in potentially developing
a cell therapy product.
Clinical Trial Preparation
In the latter half of 2013, we received approval from the Western
Institutional Review Board to complete a retrospective safety study on
selected subjects previously treated by our brtxDISC™ bulging and
protruding disc procedure at the Centeno-Schultz Clinic in Broomfield,
Colorado, near Denver. The study, entitled “Re-consenting and Follow-Up
of Adults from a Retrospective Study Using Autologous Transplantation of
Marrow Derived Mesenchymal Stem Cells to Degenerated Intervertebral
Disc,” is nearing completion and we expect to report results by the end
of the year.
The objective was to determine the safety of subjects who received
autologous stem cell transplants into their disc, using follow-up MRI
results and Quality of Life Questionnaires. We intend to use the safety
results of the study in our FDA filing. To assist us in the preparation
of the medical delivery device requirements for advancing through the
regulatory process, we engaged the consultancy firm Phil Triolo and
Associates, LC during the second half of 2013.
Publications and Scientific Presentations
Our Chief Scientist and Vice President of Research and Development,
Francisco Silva, presented preclinical data from our ThermoStem® brown
fat stem cell Program in November 2013 at the 11th Annual
Meeting of the International Federation for Adipose Therapeutics and
Science (iFATS) in New York City.
In February, our preclinical brown fat study was published in the
peer-reviewed journal Stem Cells. A photograph of our brown fat
cell scaffold appeared prominently on the cover. Our research
demonstrated that functional brown adipose derived stem cells (BADSCs)
produced improvements in mice with diet-induced metabolic disorder. The
results of the study showed for the first time that a multipotent stem
cell population exists in human adult adipose deposits, and that this
population can be differentiated into metabolically functional brown
adipocytes. Brown adipocytes are key cells that are involved in energy
homeostasis and metabolism. In humans, loss of brown adipose related
activity may account for the lower metabolism often associated with
diabetes and obesity. Publication in this journal was an important
validation of the scientific rigor of our work.
Scientific Advisors and Board Members
During the past 12 months we strengthened our management team, Board of
Directors and Scientific Advisory Board.
Gregory Lutz, M.D. was named Chief Medical Advisor for Spine Medicine
for our brtxDISC™ Program. Dr. Lutz is leading the efforts to design our
clinical trial protocol, identify trial sites and assist in the
selection of a contract research organization (CRO) to conduct the
studies. Dr. Lutz also will interact on our behalf with the FDA and the
investment community. Dr. Lutz is Associate Professor of Clinical
Rehabilitation Medicine at Weill Medical College of Cornell University
in New York City, and an attending physician at the Hospital for Special
Surgery.
In April 2014, we were pleased to add Wayne Olan, M.D. to our Scientific
Advisory Board, to assist with the clinical development of our disc
program. Dr. Olan, a board-certified interventional neuroradiologist, is
the director of endovascular and minimally invasive image guided
neurosurgery at the George Washington University Medical Center in
Washington, D.C., and is an associate professor at The George Washington
University School of Medicine & Health Sciences. Dr. Olan also serves as
a consulting physician to the National Institutes of Health.
In recent weeks we made two outstanding additions to our Board of
Directors:
-
The Honorable Paul Jude Tonna, a highly regarded community leader and
an accomplished businessman with an extensive history of public
service, will chair the Compensation Committee and is serving on the
Audit and Nominating Committees of the Board. He was a long-time
Suffolk County Legislator and is currently Executive Director and a
member of the Board of Advisors for The Energeia Partnership at Molloy
College, a leadership academy based in Rockville Centre, N.Y.
dedicated to identifying and addressing the serious, complex and
multi-dimensional issues challenging the Long Island region.
-
Joseph B. Swiader will chair the Nominating Committee and serve on the
Compensation Committee of the Board. He has extensive experience in
both the financial and biotechnology sectors. He is currently managing
partner of Wet Earth Partners LLC, which he founded in 2002. Wet Earth
Partners invests in a range of ventures that include biotechnology,
medical technology and consumer products.
Corporate Activities
We are engaged in negotiations to move our corporate headquarters and
operations to Long Island, N.Y. from Jupiter, Fla. We have identified a
location we expect will enable us to grow over the coming years and have
preliminarily been approved for certain tax abatement benefits from New
York’s Suffolk County Industrial Development Agency.
We have been active in reaching the investment community during the past
12 months, presenting at the LD Micro Conference in Los Angeles in
December 2013 and at the Marcum MicroCap Conference in New York in May
2014. We continue to work to raise our profile among the investment
community. LD Micro is a by-invitation only newsletter firm that focuses
on finding undervalued micro-cap companies. Marcum hosted nearly 100
publicly traded companies with market capitalizations under $500
million, and attracted more than 1,000 people including senior personnel
from the presenting public companies, leading institutional investors,
directors, bankers and service providers to the microcap marketplace.
Looking Ahead
We have a number of exciting initiatives in the coming months:
-
We expect to announce results from our retrospective study of the
brtxDISC™ Program by the end of the year and, shortly thereafter, we
expect to hold our first meeting with the FDA, as we plan our clinical
trial.
-
With regard to our ThermoStem® Program, we are continuing our tissue
procurement efforts, building our library of brown adipose (fat)
tissue and stem cell lines. As a result of our collaboration with
Pfizer, we are well positioned to accelerate our research and advance
the program toward a clinical trial.
-
As we continue to make plans to relocate our laboratory and corporate
headquarters, we expect to hire additional laboratory and scientific
staff to accelerate our research and development efforts, as well as
additional corporate personnel to support our operations.
-
We have been working to shore up our financial position, and since my
last stockholder letter we have raised approximately $3 million
through equity and debt issuances, including a warrant exercise
program. We continue to seek additional funding to advance our
programs.
In summary, we are executing on our plans and are very excited about the
potential of our programs to make a sizable impact on the health of
patients, while working to create value for our stockholders. I am
grateful for the continued support of our employees, strategic partners
and stockholders.
Sincerely,
Mark Weinreb, Chief Executive Officer
BioRestorative Therapies, Inc.
www.biorestorative.com
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
those set forth in the Company's Form 10-K filed with the Securities and
Exchange Commission. 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 we undertake no obligation to update such
statements.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. (www.biorestorative.com)
develops products and medical procedures using cell and tissue
protocols, primarily involving adult stem cells, including:
-
brtxDISC™ (Disc Implanted Stem Cells)
is an investigational non-surgical treatment for bulging and herniated
lumbar discs that is intended for patients who have failed
non-invasive procedures and face the prospect of surgery. The
treatment involves culturing a patient’s own stem cells and then
delivering them via a proprietary medical device to the damaged region
of the disc in an outpatient procedure.
-
ThermoStem® is a treatment using brown fat stem cells that is
under development for metabolic disorders including diabetes and
obesity. Initial preclinical research indicates that increased amounts
of brown fat in the body may be responsible for additional caloric
burning as well as reduced glucose and lipid levels.
-
brtx-C Cosmetic is based on the development of a human cellular
extract that has been demonstrated in in vitro skin studies to
increase the production of collagen and fibronectin, which are
proteins that are essential to combating the aging of skin. Potential
cosmetic uses are being explored with third parties.
The Company also offers plant stem cell-based facial creams and beauty
products under the Stem Pearls® brand at www.stempearls.com.
Copyright Business Wire 2014