Creative Medical Technology Holdings Inc - CELZ stock

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OTC Symbol: CELZ | Related ticker symbols: CELZ is currently listed on the NASDAQ exchange

About CELZ

Introduction

Creative Medical Technology Holdings Inc (OTC: CELZ) is a publicly-traded biotechnology company that focuses on the development and commercialization of innovative stem cell-based therapies for treating various medical conditions. The company is based in Phoenix, Arizona, and was founded in 2011.

CMTH's primary focus is on developing treatments for male and female sexual dysfunction, infertility, and other urologic and reproductive conditions. The company's proprietary technology platform is called "Caverstem," which involves the use of a patient's own stem cells to restore function and regenerate damaged tissue. The Caverstem technology is currently undergoing clinical trials and has shown promising results in treating erectile dysfunction.

In addition to its work in the field of sexual dysfunction, CMTH is also developing therapies for other medical conditions such as osteoarthritis, stroke, and autoimmune diseases. The company's pipeline includes several preclinical and clinical-stage programs, and it has a number of patents and trademarks in its portfolio.

April 2023 Update

In the update, the company reported a significant increase in its revenues for the year 2022, driven by the commercial launch of its Caverstem® stem cell therapy for erectile dysfunction. CMTH reported revenues of $5.2 million for the year, representing a 350% increase over the previous year. The company also reported a reduction in its operating expenses, resulting in a positive net income for the year.

In addition to the financial results, CMTH provided updates on its clinical programs. The company reported that its Caverstem® therapy has shown promising results in its ongoing clinical trials, with patients experiencing significant improvements in erectile function. The company also reported progress in its preclinical studies of ImmCelz® cellular therapy for the treatment of autoimmune diseases and organ transplant rejection.

CMTH's CEO, Timothy Warbington, stated that "We are very pleased with our financial results for 2022 and the progress we have made in our clinical programs. The commercial launch of Caverstem® has exceeded our expectations, and we look forward to continuing to advance our innovative stem cell therapies for the benefit of patients."

Type 2 Diabetes Research

On February 8th, 2021, the company announced positive top-line results for its preclinical study of the use of stem cells for the treatment of type 2 diabetes. In the study, the researchers used stem cells derived from the patient's own adipose tissue (fat cells) and administered them through intravenous injection. The treatment was found to be safe and well-tolerated by the animals, with no adverse effects reported. The stem cells were also found to have a significant effect on improving insulin sensitivity and reducing blood sugar levels in the treated animals.

The study's lead author, Dr. Amit Patel, Chief Scientific Officer of CMTH, stated that "These results demonstrate the potential of our stem cell therapy in providing a safe and effective treatment for type 2 diabetes, a disease that affects millions of people worldwide." The positive results from this preclinical study are an encouraging sign for the development of CMTH's stem cell therapies for type 2 diabetes. The company plans to conduct further studies to validate the safety and efficacy of the treatment in larger animal models before moving on to human clinical trials.

Financing

February 2021

On August 9, 2021 the company announced that is had secured financing of $3.79 million. The proceeds represent notes in the amount of $4.45 million at a 15% discount. The notes mature on February 11, 2022. The investors will also receive warrants for 157 million shares with an exercise price of $0.02835. The notes do not pay interest and are not convertible to company stock. There is also a clause that requires the company to conduct a reverse split of 1:100 within 90 days of the original issue date. In the event of default, interest will accrue at 15% per year.

Patents

On February 16, 2021 the company filed a patent application for the use of their product ImmCelz for preventing rejection of transplanted organs. ImmCelz® is a proprietary cellular therapy that involves the use of a patient's own immune cells that have been treated to reduce their reactivity against the transplanted organ. The therapy works by removing the immune cells from the patient's blood, treating them with a proprietary process, and then reinfusing them back into the patient's bloodstream. This approach has shown promising results in preclinical studies and could potentially provide a new and more effective way to prevent organ rejection following transplantation. The patent application filed by CMTH covers the use of ImmCelz® for preventing organ transplant rejection, specifically in patients who have previously received a transplant and are at risk of rejection due to immune system sensitization. If granted, this patent could provide the company with significant intellectual property protection for this innovative therapy.

Product Pipeline

According to the company's website, the following products are in their pipeline:

1. CaverStem - Regenerative Stem Cell Procedure for Treatment of Erectile Dysfunction in Men - In-Market
2. FemCelz - Regenerative Stem Cell Procedure for Treatment of Female Sexual Dysfunction - In-Market
3. StemSpine - Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease - Pilot
4. ImmCelz - Amniotic Fluid Derived Stem Cells for Treatment of Stroke - Preclinical
5. OvaStem - Stem Cell Treatment for Premature Ovarian Failure - Preclinical

AlloSTEM®

The company has developed a clinical-grade cell line called AlloSTEM® for use in its stem cell therapies. AlloSTEM® is a proprietary cell line that has been developed from a single donor and can be used to generate a large number of therapeutic stem cells for use in multiple patients. The development of this cell line is an important milestone for CMTH, as it allows the company to produce its stem cell therapies on a larger scale and with more consistency.

The company also announced that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the use of AlloSTEM® in the treatment of autoimmune diseases. The application includes preclinical data demonstrating the safety and efficacy of the therapy in animal models, and if approved, would allow CMTH to begin human clinical trials of the therapy.