Continuing to Advance Regenerative Therapies
for Diabetes and Chronic Lower Back Pain
Strong Financial Position with No Long-Term Debt
PHOENIX, Nov. 15,
2023 /PRNewswire/ -- Creative Medical Technology
Holdings, Inc. ("Creative Medical Technology" or the "Company")
(NASDAQ: CELZ), a biotechnology company focused on a
regenerative approach to immunotherapy, endocrinology, urology,
gynecology, and orthopedics, today provided an update on recent
business activities in connection with the filing of its Form 10-Q
with the Securities and Exchange Commission.
"We continue to make progress developing our regenerative
therapeutics, building important assets, and managing a robust
product pipeline, while maintaining a strong financial position,"
said Timothy Warbington, Chief
Executive Officer of Creative Medical Technology.
"We are using our universal and proprietary allogenic (donor)
cell line trademarked as AlloStem™ in separate clinical
trials for Type 1 Diabetes (CELZ-201) and the treatment of chronic
lower back pain with our StemSpine® procedure
(CELZ-201-DDT). Our AlloStem™ cell line, which is
derived from human perinatal tissue, includes a Master Cell Bank
and a Drug Master File that details our products and protects
the Company's IP. We have created and are currently storing
more than 8 billion clinical grade AlloStem™ cells,
which we believe far exceeds what we require to advance our current
clinical trials.
"Our work is supported by a strong intellectual property
portfolio consisting of more than 68 patents and patents pending.
Through partnerships and collaborations with some of the world's
most respected institutions, private companies and consultants with
deep experience in their respective fields, our team continues to
deliver results that belie our modest size. I want to thank them
for their continuing hard work, dedication, and commitment to
excellence."
2023 Development Updates
Chronic Lower Back Pain
In September 2023, the Company
received FDA clearance to initiate a Phase I/II clinical trial of
StemSpine® using AlloStem™ (CELZ-201-DDT) for
the treatment of lower back pain. The first in country study, which
will enroll 30 individuals suffering from chronic lower back pain,
is designed to evaluate the safety, efficacy, and tolerability of
CELZ-201-DDT. The minimally invasive procedure uses ultrasound for
the targeted delivery of the cell product, and thus prevents
radiation exposure to the patient or the injecting physician. This
trial, protected by issued patents, is a huge milestone for the
Company and for patients suffering from this debilitating problem
and their need for opioids for pain.
In October, 2023 the Company filed for and received approval
from an institutional review board (IRB) to proceed with the Phase
I/II clinical trial. The clinical trial is registered on
www.clinicaltrials.gov. We are currently vetting Contract Research
Organizations for a planned trial enrollment commencing in early
2024.
Type 1 Diabetes
We have an FDA cleared and IRB approved Phase I/II clinical
trial for the use of a minimally invasive catheter to deliver
AlloStem™ for patients suffering from early Type 1
Diabetes (CELZ-201). The clinical trial is registered on
www.clinicaltrials.gov, and we continue to recruit patients for
this study.
Type 2 Diabetes
In 2023, the Company presented its one-year follow-up data using
CELZ-001 to treat patients with Type 2 Diabetes which demonstrated
an overall efficacy of 93% in the treated patients demonstrating at
least a 50% reduction in insulin requirement. The Company is
continuing to engage with clinicians and researchers to further
advance this program.
Building Upon ImmCelz® Platform Development
Milestones
The Company continues to advance its ImmCelz®
(CELZ-100) platform, which reprograms/supercharges the patient's
own extracted immune cells by culturing them outside the body with
optimized cell-free factors before re-injecting them back into the
patient from whom they were extracted. We believe this process
endows the patient's own immune cells with "supercharged"
regenerative and immunomodulatory properties, providing them with
the ability to treat multiple indications.
In May, the Company announced that independently conducted
studies validated its advancements with respect to
ImmCelz®, specifically, that the use of fewer donor
cells can reduce production costs while producing a more potent and
efficacious final product. This enables each patient to have
multiple dosing while reducing cost of cell production.
During third quarter of 2023, the Company continued to develop
and manufacture our ImmCelz line for use in multiple programs.
Type 1 Brittle Diabetes
In March 2023, the Company
announced that it filed an application with the FDA to receive
Orphan Drug Designation (ODD) for the treatment of Brittle Type 1
Diabetes using its ImmCelz® (CELZ-100) platform. The FDA
has responded to the ODD filing with additional clarification
requests, to which the Company is responding.
Human iPSC-Line
The Company has announced the successful development,
manufacture, and third-party independent validation of its
Inducible Pluripotent Stem Cell (IPSC) line with Greenstone
Biosciences, a Stanford University
spinout. With the success of the IPSC program, the Company is
proceeding with Greenstone Biosciences to the next stage of its
development programs. Progress will be disclosed as
appropriate.
Our goal is to use such cell lines for our own programs and to
explore licensing and supplying cells to other companies in areas
that do not conflict with our programs.
Financial Position and Share Repurchase
On September 30, 2023 the Company
reported cash and certificates of deposit totaling $12 million, working capital of $11.6 million, and no long-term debt. The Company
believes that it has sufficient funds to meet its
anticipated operating costs and capital expenditure
requirements through the end of 2024.
On June 12, 2023, the Company
announced that its Board of Directors authorized a share repurchase
program for the repurchase of up to $2
million of the Company's common stock (the "Repurchase
Plan). For the three months ended September
30, 2023 the Company repurchased 40,000 shares of its common
stock under the Repurchase Plan. The Company has not proposed an
increase in its authorized shares in its proxy statement for the
December 20, 2023 shareholder
meeting.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a biotechnology
company dedicated to the advancement of identifying and translating
novel immediately deployable FDA registered 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.
Special Note Regarding 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.