PHOENIX, April 4,
2023 /PRNewswire/ -- Creative Medical Technology
Holdings, Inc. ("Creative Medical Technology" or the "Company" or
"We") (NASDAQ: CELZ), a biotechnology company working to
revolutionize care through the development of potentially
best-in-class regenerative therapeutics, today announced the
filing of its Form 10-K on March 31,
2023 for the year ended December 31,
2022 (FY 2022) and provided a summary of the progress made
in 2022 and thus far in 2023.
"2022 was a year of significant clinical, regulatory, and
partnership milestones, and our efforts in these areas have
continued in earnest during 2023," said Timothy Warbington, Chief Executive Officer of
Creative Medical Technology. "We ended the year in a strong
financial position that provides us with a cash runway to continue
to support the development of best-in-class regenerative
therapeutics to address multiple indications, including immunology,
endocrinology, urology, gynecology, and orthopedics. As we
continue through 2023, we believe that our extensive IP portfolio,
seasoned leadership, strong partnerships, and growing addressable
end markets will support our clinical advancements and serve as the
foundation for further focusing our pipeline development. We
look forward to 2023 with optimism."
Clinical Updates
- Phase 1 / 2 Clinical Trial: we are excited about
our Phase 1/2 randomized, controlled clinical trial (CELZ-201) for
the treatment of early Type 1 Diabetes using AlloStem™ was
cleared by the U.S. Food and Drug Administration (FDA) in Q4 2022
and IRB approved in Q1 2023. This first-in-country clinical
trial delivers allogenic cellular therapy in the dorsal artery of
the pancreas and is designed to leverage what we believe is the
unique approach using AlloStem™ to harness the multi-potent power
of Perinatal Tissue Derived Cells, which will not require any
immunosuppression.
- Orphan Drug Designation: in Q1 2023, we filed an
application with the FDA to receive Orphan Drug Designation for the
treatment of patients with Brittle Type 1 Diabetes using our
ImmCelz® platform with human islet cell transplantation.
This combination has been designated as CELZ-101.
Product Advancements and Partnerships
- Master Collaboration Agreement: in Q1 2022, we entered
into a Master Collaboration Agreement with the world-renowned
University of Miami – Diabetes Research
Institute to optimize and accelerate the development of our
ImmCelz® Supercharged Autologous Immunotherapy Platform.
- iPSC Pipeline: in Q2 2022, we entered into
an agreement with Greenstone Biosciences Inc., a computational
biology and artificial intelligence company whose founding members
are from Stanford, Harvard, and UCLA. The goal of this
collaboration is the development and optimization of our human
induced pluripotent stem cell (iPSC) platform for
ImmCelz®, to be known as iPSCelz™ , and other
immune therapies.
- Product Evolution: in Q1 2023 we announced third
party validation regarding several aspects of our
ImmCelz® (CELZ-100) development program, including
a 400% increase in the clinical grade cell production yield at the
same cost profile as our first generation
ImmCelz® line.
- New Cell Line: in Q4 2022, we announced the production
of an allogenic cell line called AlloStem™ from human perinatal
derived tissue, which includes a Master Cell Bank and a Drug Master
File. The program has received FDA approval and is known as
CELZ-201, and is being utilized in the Early Type 1 Diabetes
clinical trial, and to continue development of therapeutics for
both type 1 and 2 Diabetes.
Clinical Autologous Programs
In addition to our clinical and translational research efforts,
we are also seeking to further develop our programs that use
a patient's own stem cells. These products are, or are
expected to be, exempt from the FDA premarket review and approval
process under Section 361 of the PHS Act, as they involve the
autologous use of a patient's own cells during the same surgical
procedure without any additional processing steps.
- Two-Year Follow Up Data for Autologous OvaStem™: in Q3
2022, we announced positive two-year follow up data for the
OvaStem® pilot study. The OvaStem™ procedure treats
female infertility induced by factors such as chemotherapy and
other non-natural causes, as well as age-associated infertility and
infertility with unexplained causes. There were no safety related
concerns at up to three years and the OvaStem® procedure
resulted in an efficacy of 90% in the treated patients in terms of
improvement in hormonal function and 70% in terms of delivery of
healthy babies using their own eggs.
- Three-Year Follow Up Data for Autologous
StemSpine®: in Q1 2023, we announced the publication
of positive, three-year follow-up results confirming the efficacy
of the StemSpine® procedure for treating
Chronic Lower Back Pain (CLBP). The study demonstrated that
there were no safety related concerns at up to three years, and the
StemSpine® procedure resulted in a continued
efficacy rate of 87% of patients that participated in the pilot
study. No patients required re-dosage or surgical intervention
since the last follow-up at two years.
- CaverStem®: in Q2 2022, we
presented our CaverStem® program at the American
Urological Association Annual Meeting in New Orleans.
CaverStem® is the only patented procedure performed
by a licensed physician that provides a safe, effective solution to
treat erectile dysfunction using the patient's own stem cells to
repair damaged tissue. In January
2020, the results of a three-year clinical trial were
published in the Journal of Translational Medicine that
validated 100% safety and 85% efficacy of the
CaverStem® procedure and marked the largest ever
study of the safety and efficacy of bone marrow stem cells used to
treat erectile dysfunction.
FY 2022 Financial Overview
- At December 31, 2022, the Company
reported cash and certificates of deposit of $18.4 million, working capital of $15.4 million, and $0 long term debt, which it believes should be
sufficient to meet anticipated operating costs and capital
expenditure requirements through at least March 2024. Common
stock outstanding at year end was approximately 14.1
million.
- Gross revenue for FY 2022 was unchanged at $0.1 million from the year ended December 31, 2021 (FY 2021), with higher unit
sales offset by lower revenue per unit.
- Gross profit improved to $0.1
million in FY 2022 from $0.01
million in FY 2021.
- Selling, general and administrative expenses increased to
$3.9 million from $3.0 million in FY 2021, due primarily to higher
salaries and wages, increased director and officer insurance,
and higher marketing and consulting expenses, offset by a decrease
accrued expenses and a reduction in stock-based compensation.
- Research and development expenses increased to $6.3 million from $0.1
million in FY 2021 due to the acquisition of research tools
and development of a Drug Master File, laboratory research in
preparation of our Master Cell Bank submittal to the FDA, the
approval of our FDA application for a Type I Diabetes Phase 1/2
clinical trial, the manufacturing and testing of our ImmCelz™ cell
line, and the development of our iPSC cell line in partnership with
Greenstone Biosciences Inc.
- Operating loss for FY 2022 was $10.2
million compared to an operating loss of $3.2 million in FY 2021.
- Net loss was $10.1 million as
compared to net income of $19.2
million in FY 2021. Net income in FY 2021 included
Other Income of $22.3 million that
reflected a $26.0 million change in
fair value of derivative liabilities, a $0.6
million gain on extinguishment of convertible notes, and
interest expense of $4.3
million. Other Income in FY 2022 was $0.1 million.
A copy of the Company's Form 10-K is available free of charge at
www.sec.gov
About Creative Medical Technology
Holdings
Creative Medical Technology Holdings, Inc. is a biotechnology
company dedicated to the advancement of identifying and translating
novel biological therapeutics in the fields of immunotherapy,
endocrinology, urology, gynecology and orthopedics and is traded on
NASDAQ under the ticker symbol CELZ. For further information about
the Company, please
visit www.creativemedicaltechnology.com.
Forward Looking
Statements
NASDAQ Markets has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release. This
news release may contain forward-looking statements including but
not limited to comments regarding the timing and content of
upcoming clinical trials and laboratory results, marketing efforts,
funding, etc. Forward-looking statements address future events and
conditions and, therefore, involve inherent risks and
uncertainties. Actual results may differ materially from those
currently anticipated in such statements. See the periodic and
other reports filed by Creative Medical Technology Holdings, Inc.
with the Securities and Exchange Commission and available on the
Commission's website at www.sec.gov.
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SOURCE Creative Medical Technology Holdings, Inc.