Creative Medical Technology Holdings Issues Corporate Update

Creative Medical Technology Holdings, Inc. (Creative Medical Technology or the Company), a biotechnology company dedicated to regenerative immunotherapy, endocrinology, urology, gynecology, and orthopedics, recently announced significant advancements in its corporate journey. As the company moves into the latter half of 2024, CEO Timothy Warbington shared reflections and updates on their progress.

The company has made considerable strides in developing its cell-based therapies, focusing on addressing critical unmet medical needs such as Type 1 Diabetes (T1D) and Chronic Lower Back Pain. Creative Medical Technology has successfully produced over six billion AlloStem™ clinical-grade cells at a cGMP facility for use in clinical trials. Additionally, they have developed a Drug Master File with the FDA, which streamlines the Investigational New Drug (IND) filing and approval process, minimizing redundant regulatory procedures. The FDA granted clearance for two IND applications and an expanded access therapy within 30 days of filing, and also awarded Orphan Drug Designation for CELZ-101, or ImmCelz™, aimed at treating Brittle T1D.

For T1D, the company received clearance for an IND application to conduct a Phase I/II clinical trial using AlloStem™ (CELZ-201). This innovative treatment utilizes Perinatal Tissue Derived Cells®, which offer benefits such as self-renewal, low antigenicity, reduced toxicity, and scalability. The trial received Institutional Review Board (IRB) approval, initiated at a selected site, and began patient recruitment. The trial is registered and actively enrolling participants. In early 2024, the company secured FDA authorization for an expanded access therapy using CELZ-201, a pioneering initiative to manage abnormal glucose tolerance and prevent T1D in high-risk individuals. This program received IRB approval and commenced patient recruitment in the first half of 2024.

In addressing Chronic Lower Back Pain, Creative Medical Technology obtained IND clearance for a Phase I/II clinical trial of AlloStemSpine™ (CELZ-201 ADAPT) in 2023, which involves minimally invasive outpatient procedures using targeted ultrasound-guided injections. Similar to their T1D initiatives, the company received IRB approval, initiated trial sites, and commenced patient recruitment within the first six months of 2024.

Another notable achievement in Q2 2024 was the successful generation of human induced pluripotent stem cells (iPSC)-derived Islet Cells producing human insulin, under the company's iPSCelz™ program validated by Greenstone Biosciences Inc. This development holds potential for clinical translation of human Islet Cells, as well as standalone human insulin production. The company is currently engaging in strategic discussions for future collaborations to advance these programs.

Financially, Creative Medical Technology expects to report approximately $7.5 million in cash with no long-term debt as of June 30, 2024. They believe they have adequate funds to cover operating costs and capital expenditures through at least Q2 2025. The company's 2024 Annual Meeting of Stockholders is set for July 19, 2024. The Board encourages shareholders to vote FOR all four proposals, particularly Proposal Two, which seeks to increase the authorized shares of common stock from 5,000,000 to 25,000,000. This increase would provide the company with added flexibility for future business and financial strategies, including raising capital, forming strategic partnerships, and acquiring businesses or products.

CEO Timothy Warbington emphasized the company’s commitment to maintaining a strong financial position, prudent resource allocation, and minimizing unnecessary dilution. He expressed gratitude for shareholder support and reiterated the company’s focus on pioneering new disease treatments, while acknowledging the potential necessity of raising additional capital to achieve long-term objectives.

Creative Medical Technology Holdings, Inc. remains committed to advancing novel FDA-registered biological therapeutics and continues to make significant strides in their clinical and financial strategies. The company is publicly traded on NASDAQ under the ticker symbol CELZ.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!