Creative Medical Technology Holdings Provides Corporate Update

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) has provided a corporate update, highlighting significant developments in 2024. The company has produced over six billion clinical-grade AlloStem™ cells, filed a Drug Master File with the FDA, and received multiple IND clearances and Orphan Drug Designation for CELZ-101. Key clinical trials for Type 1 Diabetes and Chronic Lower Back Pain are actively recruiting. Additionally, the company announced the successful generation of human insulin-producing cells via its iPSCelz™ program and expects to report $7.5 million in cash with no long-term debt as of June 30, 2024. An annual stockholders meeting is scheduled for July 19, 2024, with a significant proposal to increase the number of authorized shares from 5 million to 25 million.

Positive

• Manufactured over six billion clinical-grade AlloStem™ cells.
• Filed a Drug Master File with the FDA, expediting IND processes.
• Received FDA clearance for two IND applications and expanded access therapy.
• Received Orphan Drug Designation for CELZ-101 for Brittle Type 1 Diabetes.
• On track to complete patient recruitment for clinical trials within 1-2 years.
• Successful generation of insulin-producing cells via iPSCelz™ program.
• Expects $7.5 million in cash and no long-term debt as of June 30, 2024.

Negative

• Proposal to increase authorized shares to 25 million, which may lead to future shareholder dilution.

PHOENIX, July 10, 2024 (GLOBE NEWSWIRE) -- 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 highlighting recent developments of note.

“As we enter the second half of 2024, it is an opportune time to reflect on our recent achievements,” said Timothy Warbington, Chief Executive Officer. “Many of our successes thus far in 2024 were the result of investments we have made in prior years combined with our steadfast adherence to operating a lean corporate structure, and engaging with our global partners and institutions to support the rapid translation of novel therapies into patients.

“Momentum in advancing our proprietary, cell-based therapies towards commercialization is continuing to build. We believe that these novel therapies have the potential to address critical unmet medical needs, including for the treatment of Type 1 Diabetes (“T1D”) and Chronic Lower Back Pain. We have:

• Manufactured over six billion AlloStem^TM clinical-grade cells at a cGMP facility that are being utilized for clinical trials.
• Developed and filed a Drug Master File with the FDA, which accelerates the Investigational New Drug (IND) filing and approval process and eliminates the need for costly and redundant regulatory filings.
• Received FDA clearance of two IND applications and an expanded access therapy within 30 days of filing.
• Received Orphan Drug Designation from the FDA for CELZ-101, or ImmCelz™ for Brittle Type 1 Diabetes.
• On-track to complete patient recruitment for our clinical trials over a 1 to 2-year horizon.
  

With each new accomplishment, I am grateful for the strength of our programs, the dedication of our employees and partners, the opportunities inherent in our addressable markets and most importantly the patients who volunteer for our clinical trials.”

Key Highlights

Type 1 Diabetes

• As previously announced, the Company received clearance of the IND application for a Phase I/II clinical trial for the treatment of T1D using AlloStem™ (CELZ-201). 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. During 2023, the Company received Institutional Review Board (IRB) approval to proceed with the trial, selected and initiated the trial site, and initiated patient recruitment. The clinical trial is registered on www.clinicaltrials.gov and actively enrolling.
• 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. The Company plans to file an IND for a Phase I/II clinical trial in the future.
• 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-based biologics for disease prevention. The program received IRB approval and has initiated patient recruitment during the first six months of 2024.
  

Chronic Lower Back Pain

• During 2023, the Company received IND clearance from the FDA on a Phase I/II clinical trial of AlloStemSpine™ to treat Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT). This is a minimally invasive outpatient procedure with direct injection of the cell-based therapy into the patient using targeted ultrasound guidance. During the first six months of 2024 the Company received IRB approval, selected and initiated the trial site, and initiated patient recruitment.
  

Production of Human Insulin via iPSCelz™ Program

• In Q2 2024, the Company announced that it had successfully generated human induced pluripotent stem cells (“iPSC”)-derived Islet Cells that produce human insulin. The iPSC clinical line that generated these insulin producing Islet Cells is part of the Company’s iPSCelz™ program, which is validated by Greenstone Biosciences Inc. (“Greenstone”). The iPSC cell line has also been utilized to derive validated mesenchymal cells and T-regulatory cells. The Company believes that this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells. The Company is currently in strategic discussions on “next step” collaborations to further these programs.
  

Financial Position

• The Company expects to report cash of approximately $7.5 million and no long-term debt as-of June 30, 2024. The Company believes it has sufficient funds to meet its anticipated operating costs and capital expenditure requirements through at least Q2 2025.
  

Annual Meeting of Stockholders

• The Company’s 2024 Annual Meeting of Stockholders is scheduled to take place on July 19, 2024. The Company’s Board of Directors encourages shareholders of record as of June 3, 2024 to participate and to vote FOR each of the four Proposals to be voted on at the Annual Meeting of Stockholders.

• The Company specifically encourages its stockholders to vote in favor of Proposal Two, which would authorize an increase in the number of authorized shares of our common stock from 5,000,000 to 25,000,000.
• As of June 3, 2024, the record date for the special meeting, the Company had an aggregate of 1,348,126 shares of Common Stock outstanding, outstanding warrants to purchase 2,284,932 shares of Common Stock, and approximately 60,000 shares of Common Stock reserved for issuance under outstanding stock options and the Company’s option plans. Accordingly, at present, the Company has only 1,306,939 authorized shares of its Common Stock available for issuance.
  

• Although at present the Company has no commitments or agreements to issue additional shares of Common Stock, it desires to have additional shares available to provide additional flexibility to use its capital stock for business and financial purposes in the future. These purposes may include, among others: raising capital; establishing strategic relationships with other companies; and the acquisition of other businesses or products.
  

Mr. Warbington concluded, “We have remained focused on maintaining a strong financial position and respecting the investment of our shareholders by allocating our resources prudently, limiting our annual cash burn, and avoiding unnecessary dilution. We will continue to concentrate on pioneering and translating new approaches to treat disease. To that end, should the need arise to raise additional capital in pursuit of this objective, we will do so in a manner that aligns with our commitment to deliver long-term shareholder value. Our current capital structure limits our ability to do this, and we therefore appreciate the support of shareholders in voting FOR Proposal Two.”

Eligible stockholders may vote by contacting the Company's proxy solicitor, Okapi Partners LLC,
at 844-202-7428.

Please refer to the official proxy materials for further details on each proposal, this can be found at https://www.sec.gov/Archives/edgar/data/1187953/000147793224003511/celz_pre14a.htm

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.

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

FAQ

What recent achievements did Creative Medical Technology Holdings announce in their July 10, 2024, update?

Creative Medical Technology Holdings highlighted the manufacturing of over six billion AlloStem™ clinical-grade cells, multiple FDA clearances, and the successful generation of insulin-producing cells via the iPSCelz™ program.

What is the significance of the AlloStem™ cells produced by Creative Medical Technology Holdings?

The AlloStem™ clinical-grade cells are important for the company's ongoing clinical trials, including those for Type 1 Diabetes and Chronic Lower Back Pain.

What FDA designations did CELZ receive in 2024?

CELZ received Orphan Drug Designation for CELZ-101 for Brittle Type 1 Diabetes and FDA clearance for two IND applications and expanded access therapy.

How is Creative Medical Technology Holdings advancing its Type 1 Diabetes treatments?

CELZ is conducting clinical trials for CELZ-201, targeting Type 1 Diabetes, and has received Orphan Drug Designation for CELZ-101 to prevent allograft rejection in pancreatic islet cell transplantation.

What financial position does Creative Medical Technology Holdings expect as of June 30, 2024?

The company expects to report $7.5 million in cash with no long-term debt, sufficient to cover operating costs and capital expenditures through at least Q2 2025.

What is Proposal Two in the upcoming Creative Medical Technology Holdings stockholders meeting?

Proposal Two seeks to authorize an increase in the number of authorized shares from 5 million to 25 million, providing flexibility for future capital raises and strategic initiatives.