BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX
), a clinical stage company
focused on stem cell-based therapies, announced today the filing of
its Form 10-K annual report with the Securities and Exchange
Commission ("SEC") for the year ended December 31, 2023.
The annual report can be accessed on the SEC's
website at www.sec.gov, and on the Company's website at
www.biorestorative.com under "SEC Filing" in the Investors and
Media section.
2023 and Recent Pipeline
Developments
BioRestorative’s two primary platform
technologies include: its lead clinical-stage cell therapy
candidate, BRTX-100, which consists of 40 million autologous bone
marrow-derived, hypoxic-cultured transitional stem cells combined
with an autologous platelet lysate, and is engineered to be
injected into targeted areas of the body that have little blood
flow; and ThermoStem®, a preclinical program that aims to use
allogeneic brown adipose-derived, or brown fat, stem cells to
address major metabolic diseases such as obesity and Type 2
diabetes.
BRTX-100
The safety and efficacy of BRTX-100 in treating
chronic lumbar disc disease (“cLDD”) is being evaluated in a Phase
2, prospective, randomized, double-blinded and controlled study. A
total of up to 99 eligible subjects will be enrolled at up to 16
clinical sites in the United States. Subjects included in the trial
are being randomized 2:1 to receive either BRTX-100 or placebo.
While previous clinical studies have
demonstrated that the harsh microenvironment of the disc could
impact stem cell dose viability and result in a non-efficacious or
the worsening of clinical outcomes, BRTX-100 has been designed to
potentially overcome this challenge by culturing and expanding
these highly potent cells under hypoxic conditions to mimic and
condition them to the unforgiving, low oxygen environment of the
disc in order to maximize cell survivability.
In June 2023, BioRestorative announced that the
independent Data Safety Monitoring Board, which is overseeing the
ongoing Phase 2 clinical trial of BRTX-100 in cLDD, unanimously
recommended the continuation of the study in accordance with the
current version of the protocol with no changes. There were no dose
limiting toxicities (DLTs) observed in the patients within the
initial safety run-in segment of the study.
In early February 2024, a poster describing
positive preliminary 26 and 52 week blinded data from the Phase 2
study was presented for the first time at the Orthopaedic Research
Society (ORS) 2024 Annual Meeting.
“Although the data presented is still blinded
and at an early stage, we were strongly encouraged that the Visual
Analog Scale, Oswestry Disability Index, Roland Morris Disability
Questionnaire, and Functional Rating Index collected at 26 and 52
weeks after injection indicated a positive trend compared to the
baseline,” said Lance Alstodt, Chief Executive Officer of
BioRestorative. “We are looking forward to providing further
updates as the ongoing Phase 2 BRTX-100 program progresses.”
ThermoStem®
BioRestorative received four notices of
allowance (“NOA”s) related to its ThermoStem® program in 2023. The
first three NOAs, issued by the European Patent Office in February,
the United States Patent and Trademark Office (“USPTO”) in March,
and the Japanese Patent and Trademark Office in May, granted claims
covering implantable three-dimensional scaffolds and brown
adipocytes that have been derived from human brown adipose
(fat)-derived stem cells. The fourth NOA, which was issued in
December by the USPTO, covered methods of using differentiated
human brown fat adipocytes as a platform to screen and identify
compounds that can activate and regulate metabolic activity.
“We believe receipt of these four NOAs in rapid
succession serves as a testament to the exciting potential of our
novel ThermoStem® brown fat stem cell technology platform to
deliver a superior efficacy and tolerability profile over current
small molecule receptor agonist treatments for obesity and other
major metabolic diseases. And while all of the NOAs provide us with
further protection in key markets and enhance our ability to engage
with potential collaborators and partners, the most recent NOA from
the USPTO also represents the achievement of an important milestone
as it covers tools that can be used to screen large libraries of
compounds targeting metabolic disorders,” commented Mr.
Alstodt.
Financial Results
For the year ended December 31, 2023, the
Company had a net loss of approximately $14.4 million, or $3.42 per
share, down 22% from a net loss of approximately $18.5 million, or
$5.11 per share, for 2022. This was primarily driven by a 27%
decrease in General and Administrative expenses and higher Interest
Income, offset partially by a 15% increase in Research and
Development expenses and a gain on the U.S. Small Business
Administration’s Paycheck Protection Program loan forgiveness
recognized in 2022. In 2023, net cash used in operating activities
was approximately $6.4 million.
At December 31, 2023, BioRestorative had cash,
cash equivalents and investments in marketable securities of $11.07
million. This did not include the approximate net proceeds of $7.6
million from the Company’s warrant exchange private placement,
which it completed subsequent to year end.
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 commenced 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 press release 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. 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 release 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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