Creative Medical Technology Holdings Provides Corporate Update
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 a corporate update in connection with the filing of its Form 10-K on March 22, 2024.
"In the past year our achievements have been some of the most consequential in the history of Creative Medical Technology," said Timothy Warbington, the Company's Chief Executive Officer. "Recent FDA approvals of our novel and potentially life altering regenerative medicine therapies validate the investments we have made into advancing their development, while providing us with an exciting opportunity to blaze a well-defined pathway towards disease treatment and prevention. We believe that our cell-based therapies have the potential to address critical unmet medical needs and are poised to pursue this objective."
He continued, "2023 was a year of significant achievement for Creative Medical, and our progress along multiple fronts has continued into 2024. We continue to be supported in our efforts by a robust product pipeline, a strong IP portfolio, partnerships and collaborations with some of the world's most respected institutions, private companies and consultants, and a strong financial position."
Mr. Warbington noted that the Company has received clearances from the U.S. Food and Drug Administration ("FDA") that advance the use of the Company's proprietary CELZ-101 (ImmCelz®) and CELZ-201 cell lines to treat Type 1 Diabetes (T1D) and chronic lower back pain.
Type 1 Diabetes
- In 2023, the Company received IRB approval from the FDA to proceed with a Phase I/II clinical trial for the treatment of T1D using AlloStem™ (CELZ-201), the Investigational New Drug (IND) application for which was approved by FDA in late 2022. The Company believes that CELZ-201 leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells® to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The clinical trial is registered on www.clinicaltrials.gov. In Q1 2024, the Company announced the receipt of Orphan Drug Designation from the FDA for CELZ-101, or ImmCelz™. This cutting-edge therapy is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation, a significant advancement for individuals dealing with brittle T1D, a condition characterized by extreme fluctuations in blood glucose levels.
- In Q1 2024, the Company announced that it had secured FDA authorization for an expanded access therapy using CELZ-201, its pioneering cell-based program for the use in managing abnormal glucose tolerance and preventing T1D in high-risk individuals. An important advancement in the development of personalized medicine, the Company believes that this is the first time that FDA has authorized the use of proprietary cell biologics for disease prevention.
Chronic Lower Back Pain
- In September 2023, the Company received FDA clearance to initiate a Phase I/II clinical trial of AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain. This first-in-country study will enroll 30 individuals suffering from chronic lower back pain and 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 significant milestone for the Company and for patients suffering from this debilitating condition and their need to use opioids to address the pain. The clinical trial has received IRB approval, and the Company has contracted with a CRO therefore patient screening is expected to begin in Q2 2024.
Financial Position and Share Repurchase
At December 31, 2023, the Company reported cash and investments totaling approximately $10 million, working capital of approximately $9.9 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 at least Q1 2025.
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 twelve months ended December 31, 2023, the Company repurchased 57,500 shares of its common stock under the Repurchase Plan for a total purchase price of $270,952.
About Creative Medical Technology Holdings, Inc.
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
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