Creative Medical Technology Holdings Announces Filing of 2022 Form 10-K and Provides Business Update

PHOENIX, April 4, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company" or "We") (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced the filing of its Form 10-K on March 31, 2023 for the year ended December 31, 2022 (FY 2022) and provided a summary of the progress made in 2022 and thus far in 2023.

"2022 was a year of significant clinical, regulatory, and partnership milestones, and our efforts in these areas have continued in earnest during 2023," said Timothy Warbington, Chief Executive Officer of Creative Medical Technology. "We ended the year in a strong financial position that provides us with a cash runway to continue to support the development of best-in-class regenerative therapeutics to address multiple indications, including immunology, endocrinology, urology, gynecology, and orthopedics.  As we continue through 2023, we believe that our extensive IP portfolio, seasoned leadership, strong partnerships, and growing addressable end markets will support our clinical advancements and serve as the foundation for further focusing our pipeline development. We look forward to 2023 with optimism."

Clinical Updates

• Phase 1 / 2 Clinical Trial:  we are excited about our Phase 1/2 randomized, controlled clinical trial (CELZ-201) for the treatment of early Type 1 Diabetes using AlloStem™  was cleared by the U.S. Food and Drug Administration (FDA) in Q4 2022 and IRB approved in Q1 2023.  This first-in-country clinical trial delivers allogenic cellular therapy in the dorsal artery of the pancreas and is designed to leverage what we believe is the unique approach using AlloStem™ to harness the multi-potent power of Perinatal Tissue Derived Cells, which will not require any immunosuppression.
  
  
• Orphan Drug Designation:  in Q1 2023, we filed an application with the FDA to receive Orphan Drug Designation for the treatment of patients with Brittle Type 1 Diabetes using our ImmCelz^® platform with human islet cell transplantation. This combination has been designated as CELZ-101.

Product Advancements and Partnerships

• Master Collaboration Agreement: in Q1 2022, we entered into a Master Collaboration Agreement with the world-renowned University of Miami – Diabetes Research Institute  to optimize and accelerate the development of our ImmCelz® Supercharged Autologous Immunotherapy Platform.
  
  
• iPSC Pipeline: in Q2 2022, we entered into an agreement with Greenstone Biosciences Inc., a computational biology and artificial intelligence company whose founding members are from Stanford, Harvard, and UCLA.  The goal of this collaboration is the development and optimization of our human induced pluripotent stem cell (iPSC) platform for ImmCelz^®, to be known as iPSCelz™ , and other immune therapies. 
  
  
• Product Evolution: in Q1 2023 we announced third party validation regarding several aspects of our ImmCelz^® (CELZ-100) development program, including a 400% increase in the clinical grade cell production yield at the same cost profile as our first generation ImmCelz^® line.  
  
  
• New Cell Line: in Q4 2022, we announced the production of an allogenic cell line called AlloStem™ from human perinatal derived tissue, which includes a Master Cell Bank and a Drug Master File.  The program has received FDA approval and is known as CELZ-201, and is being utilized in the Early Type 1 Diabetes clinical trial, and to continue development of therapeutics for both type 1 and 2 Diabetes.

Clinical Autologous Programs  

In addition to our clinical and translational research efforts, we are also seeking to  further develop our programs that use a patient's own stem cells.  These products are, or are expected to be, exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as they involve the autologous use of a patient's own cells during the same surgical procedure without any additional processing steps. 

• Two-Year Follow Up Data for Autologous OvaStem™: in Q3 2022, we announced positive two-year follow up data for the OvaStem^® pilot study. The OvaStem™ procedure treats female infertility induced by factors such as chemotherapy and other non-natural causes, as well as age-associated infertility and infertility with unexplained causes. There were no safety related concerns at up to three years and the OvaStem® procedure resulted in an efficacy of 90% in the treated patients in terms of improvement in hormonal function and 70% in terms of delivery of healthy babies using their own eggs.
  
  
• Three-Year Follow Up Data for Autologous StemSpine^®: in Q1 2023, we announced the publication of positive, three-year follow-up results confirming the efficacy of  the StemSpine^® procedure for treating Chronic Lower Back Pain (CLBP).  The study demonstrated that there were no safety related concerns at up to three years, and the StemSpine^® procedure resulted in a continued efficacy rate of 87% of patients that participated in the pilot study. No patients required re-dosage or surgical intervention since the last follow-up at two years.
  
  
• CaverStem^®:  in Q2 2022, we presented our CaverStem^® program at the American Urological Association Annual Meeting in New Orleans.  CaverStem^® is the only patented procedure performed by a licensed physician that provides a safe, effective solution to treat erectile dysfunction using the patient's own stem cells to repair damaged tissue.  In January 2020, the results of a three-year clinical trial were published in the Journal of Translational Medicine that validated 100% safety and 85% efficacy of the CaverStem^® procedure and marked the largest ever study of the safety and efficacy of bone marrow stem cells used to treat erectile dysfunction.

FY 2022 Financial Overview

• At December 31, 2022, the Company reported cash and certificates of deposit of $18.4 million, working capital of $15.4 million, and $0 long term debt, which it believes should be sufficient to meet anticipated operating costs and capital expenditure requirements through at least March 2024.  Common stock outstanding at year end was approximately 14.1 million. 
• Gross revenue for FY 2022 was unchanged at $0.1 million from the year ended December 31, 2021 (FY 2021), with higher unit sales offset by lower revenue per unit.
• Gross profit improved to $0.1 million in FY 2022 from $0.01 million in FY 2021.
• Selling, general and administrative expenses increased to $3.9 million from $3.0 million in FY 2021, due primarily to higher salaries and wages,  increased director and officer insurance, and higher marketing and consulting expenses, offset by a decrease accrued expenses and a reduction in stock-based compensation.
• Research and development expenses increased to $6.3 million from $0.1 million in FY 2021 due to the acquisition of research tools and development of a Drug Master File, laboratory research in preparation of our Master Cell Bank submittal to the FDA, the approval of our FDA application for a Type I Diabetes Phase 1/2 clinical trial, the manufacturing and testing of our ImmCelz™ cell line, and the development of our iPSC cell line in partnership with Greenstone Biosciences Inc.
• Operating loss for FY 2022 was $10.2 million compared to an operating loss of $3.2 million in FY 2021. 
• Net loss was $10.1 million as compared to net income of $19.2 million in FY 2021.  Net income in FY 2021 included Other Income of $22.3 million that reflected a $26.0 million change in fair value of derivative liabilities, a $0.6 million gain on extinguishment of convertible notes, and interest expense of $4.3 million.  Other Income in FY 2022 was $0.1 million.

A copy of the Company's Form 10-K is available free of charge at www.sec.gov 

About Creative Medical Technology Holdings                                                                                            

Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel 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. 

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.

SOURCE Creative Medical Technology Holdings, Inc.