Creative Medical Technology Holdings Provides Corporate Update
- FDA approvals for novel regenerative medicine therapies for Type 1 Diabetes and chronic lower back pain.
- Strong financial position with $10 million in cash and investments and no long-term debt.
- Share repurchase program authorized for up to $2 million of the Company's common stock.
- Significant advancements in clinical trials for AlloStem™ (CELZ-201) to treat T1D and lower back pain.
- Orphan Drug Designation received for CELZ-101 (ImmCelz™) for preventing allograft rejection in pancreatic islet cell transplantation.
- FDA authorization for expanded access therapy using CELZ-201 for managing abnormal glucose tolerance and preventing T1D in high-risk individuals.
- First-in-country Phase I/II clinical trial for AlloStemSpine® Chronic Lower Back Pain using CELZ-201-DDT.
- Positive outlook for the Company's product pipeline and partnerships with leading institutions and consultants.
- None.
Insights
The recent FDA approvals for Creative Medical Technology's cell-based therapies, CELZ-101 and CELZ-201, represent a significant milestone for the company and the biotechnology industry. The approval to conduct a Phase I/II clinical trial for the treatment of Type 1 Diabetes using AlloStem™ and the Orphan Drug Designation for ImmCelz™ may lead to a paradigm shift in managing autoimmune diseases and chronic conditions. The market potential for treatments in these areas is substantial, given the current lack of effective long-term therapies for T1D and chronic lower back pain.
Furthermore, the company's financial health, indicated by a strong cash position and no long-term debt, suggests stability and the ability to fund ongoing research and development without the immediate need for additional financing. The share repurchase program also signals confidence in the company's value proposition and may provide support to the stock price.
The use of cell-based therapies, such as CELZ-101 and CELZ-201, reflects a growing trend in personalized medicine, targeting unmet medical needs with innovative approaches. The ability of Perinatal Tissue Derived Cells® to harness self-renewal and low antigenicity could potentially reduce the risk of rejection and toxicity, which are common challenges in transplantation and immunotherapy. The FDA's authorization for expanded access therapy to prevent T1D in high-risk individuals underscores the potential impact of these therapies beyond treatment, extending into preventative measures.
The implications for patient care, particularly for those with brittle T1D and chronic lower back pain, are profound. By potentially reducing dependency on opioids and improving the quality of life, these therapies could also lead to a decrease in long-term healthcare costs.
The strategic positioning of Creative Medical Technology through its robust product pipeline, intellectual property portfolio and partnerships could enhance its competitiveness in the regenerative medicine space. The progress in clinical trials and FDA clearances may attract further collaborations and licensing opportunities, potentially accelerating the path to market for these therapies. The company's emphasis on disease treatment and prevention aligns with broader healthcare trends focused on value-based care and patient outcomes.
In the long term, successful commercialization of these therapies could lead to market share gains and provide a competitive edge. However, it is essential to monitor the outcomes of the ongoing clinical trials, as any setbacks could impact the company's prospects and investor sentiment.
“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
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
On June 12, 2023, the Company announced that its Board of Directors authorized a share repurchase program for the repurchase of up to
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
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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Company Contact
Creative Medical Technology
IR@CreativeMedicalTechnology.com
Investor Relations
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com
Conor Rodriguez, Analyst
crodriguez@equityny.com
Source: Creative Medical Technology Holdings, Inc.
FAQ
What FDA approvals has Creative Medical Technology received?
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What clinical trials has the Company initiated for Type 1 Diabetes?
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