CELZ 10-K & 10-Q changes, risk factors and insider trading
Creative Medical Technology Holdings, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1187953 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
For the year ended December 31,see in full comparison2024,2025, our operations used approximately$5.3$5.9 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in ourDecembersecurities2021offerings,publicincludingoffering,upon exercise of warrants in ourMaywarrant2022exerciseprivate offering and our December 2024 private offering.transactions. At December 31,2024,2025, we had a combined cash, and short-term U.S. treasuries balance of approximately$5.9$7.2 million. Although we generated gross proceeds in excess of$32$40 million from our 2021,20222022, 2024, and20242025 securities offerings, we will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings and other sources. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings could also have a material and adverse effect on the price of our common stock.
Revenues generated from sales of our CaverStem® kits were onlysee in full comparison$11,000$6,000 and$9,000$11,000 for the years ended December 31,2024,2025, andDecember 31, 2023,2024, respectively. To sustain our operating costs and generate profits, we will need to generate revenues from our products or therapies that have not yet been commercialized.
Full comparison: every changed paragraph (5)
Even with the proceeds from our recent securities offerings, we will need additional capital to fund our operations as planned.
For the year ended December 31, 2024,2025, our operations used approximately $5.3$5.9 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our Decembersecurities 2021offerings, publicincluding offering,upon exercise of warrants in our Maywarrant 2022exercise private offering and our December 2024 private offering.transactions. At December 31, 2024,2025, we had a combined cash, and short-term U.S. treasuries balance of approximately $5.9$7.2 million. Although we generated gross proceeds in excess of $32$40 million from our 2021, 20222022, 2024, and 20242025 securities offerings, we will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products. We will seek such additional funds through public or private equity or debt financings and other sources. We cannot be certain that adequate additional funding will be available to us on acceptable terms, if at all. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings could also have a material and adverse effect on the price of our common stock.
Revenues generated from sales of our CaverStem® kits were only $11,000$6,000 and $9,000$11,000 for the years ended December 31, 2024,2025, and December 31, 2023,2024, respectively. To sustain our operating costs and generate profits, we will need to generate revenues from our products or therapies that have not yet been commercialized.
We expect to continue to incur significant financial losses in the future as we seek to proceed with our Type I Diabetes (CELZ-201 CREATE-1) clinical trial, our AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial, and our other planned clinical trials.
We have received the necessary regulatory approval for our Type I Diabetes (CELZ-201 CREATE-1) clinical trial and our AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial.trial, which are in process. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms. We anticipate that our expenses will increase substantially as we:
Management's Discussion & Analysis (MD&A)
Largest changes
“In February, 2025 we announced an expanded agreement with Greenstone Biosciences Inc. to leverage Artificial Intelligence (AI) in further developing our human induced pluripotent stem cell (iPSC) platform for diabetes treatment. The strategic collaboration is expected to extended the progress made on our proprietary hypoimmune iPSC technology, including our iPSC-derived pancreatic islet cells. The innovative cell lines, developed from Good Manufacturing Practice (GMP) grade human perinatal cells, are currently being used in clinical trials. …”see in full comparison
“In August, 2025 we announced the FDA granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT. This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables us to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.”see in full comparison
“In October, 2025 we announced the launch of the BioDefense Inc. Veterans Initiative, believed to be a first-of-its-kind national program to combat the devastating long-term effects of toxic burn pit exposure among U.S. service members. To execute this initiative, we entered into an agreement with Greenstone Biosciences, Inc., as the exclusive AI and iPSC development partner. We are executing a national program which will provide the critical data infrastructure to:”see in full comparison
“On October 29, 2025 we entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 shares of common stock of the Company originally issued in March 2025, at the exercise price of $3.75 per share, in exchange for the issuance of new warrants. The aggregate gross proceeds from the exercise of the existing warrants was approximately $4.2 million, before deducting financial advisory fees. …”see in full comparison
“On October 29, 2025 we entered into warrant exercise inducement agreements with certain holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 shares of common stock of the Company originally issued in March 2025, at the exercise price of $3.75 per share. The aggregate gross proceeds from the exercise of the existing warrants was approximately $4.2 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 2,790,340 shares of common stock, at an exercise price of $2.86 per share. …”see in full comparison
“On March 6, 2025 entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 837,104 shares of common stock of the Company originally issued in October 2024 at the exercise price of $4.42 per share, in exchange for the issuance of new warrants. The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees. …”see in full comparison
Full comparison: every changed paragraph (23)
We are a commercial stage biotechnology company dedicated to the advancement of identifyingregenerative and translating novel biological therapeuticstherapies in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. Our platforms, therapies and products include the following:
In February, 2025 we announced an expanded agreement with Greenstone Biosciences Inc. to leverage Artificial Intelligence (AI) in further developing our human induced pluripotent stem cell (iPSC) platform for diabetes treatment. The strategic collaboration is expected to extended the progress made on our proprietary hypoimmune iPSC technology, including our iPSC-derived pancreatic islet cells. The innovative cell lines, developed from Good Manufacturing Practice (GMP) grade human perinatal cells, are currently being used in clinical trials. By integrating AI-driven drug discovery, the partnership aims to identify small molecules that enhance insulin secretion, further refining the therapeutic potential of our hypoimmunogenic iPSC-derived pancreatic islet cells. Additionally, the program is expected to implement multi-gene editing to develop next generation hypoimmune iPSC lines with enhanced stealth, survival, and differentiation capabilities. These advancements will not only optimize pancreatic islet cell function but also expand the platform’s applications to other regenerative therapies, addressing critical unmet medical needs.
In March, 2025 we announced the FDA had cleared an expanded dose escalation for our ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT). This regulatory milestone followed compelling interim blinded data demonstrating statistically significant pain reduction and improved mobility among trial participants.
In August, 2025 we announced the FDA granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT. This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables us to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.
In October, 2025 we announced the launch of the BioDefense Inc. Veterans Initiative, believed to be a first-of-its-kind national program to combat the devastating long-term effects of toxic burn pit exposure among U.S. service members. To execute this initiative, we entered into an agreement with Greenstone Biosciences, Inc., as the exclusive AI and iPSC development partner. We are executing a national program which will provide the critical data infrastructure to:
Under this partnership, Greenstone will deploy advanced molecular-sequencing, proteomic profiling, and machine-learning algorithms to analyze cellular data from service members exposed to burn pits. These AI-integrated systems will accelerate the creation of predictive exposure models and precision-engineered regenerative therapies—a groundbreaking leap in both biodefense and AI-enabled medicine.
In November, 2025, the Company contributed $43,200 to the capital of Bionance, which, together with Mr. Warbington’s contribution of $10,800, was used to fund Bionance’s $54,000 investment in a convertible promissory note and warrants to purchase common stock issued by Applife Digital Solutions, Inc. To date, the Company has not made any other capital contributions to Bionance, and Bionance has not made any other investments.
In December, 2025 we announced the successful completion of patient enrollment on the ADAPT clinical trial evaluating CELZ-201 (Olastrocel). This enables us to transition the ADAPT program into its next phase focused on follow-up, and data analysis.
On March 6, 2025 entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 837,104 shares of common stock of the Company originally issued in October 2024 at the exercise price of $4.42 per share. The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 1,674,208 shares of common stock, at an exercise price of $3.75 per share, for a period of five years following shareholder approval of the exercise price of the warrants that occurred on May 5, 2025.
On October 29, 2025 we entered into warrant exercise inducement agreements with certain holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 shares of common stock of the Company originally issued in March 2025, at the exercise price of $3.75 per share. The aggregate gross proceeds from the exercise of the existing warrants was approximately $4.2 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 2,790,340 shares of common stock, at an exercise price of $2.86 per share. The new warrants are exercisable for a period of five years following shareholder approval of the exercise of the warrants that occurred on December 26, 2025.
Gross Revenue. We generated $11,000$6,000 in gross revenue for the year ended December 31, 2024,2025, in comparison with $9,000$11,000 for the comparable period a year ago. The increasedecrease of $2,000$5,000 or 22%46% is due to a slight increasedecrease in CaverStem® sales. Management is currently re-evaluating the marketing strategy for the Caverstem® and FemCelz® products. We are exploring options to achieve market penetration and product profitability with a number of potential partners. However, there can be no assurance that the Company will be successful in that regard.
Cost of Goods Sold. We generated $4,400$2,194 in cost of goods sold for the year ended December 31, 2024,2025, in comparison with $3,600$4,400 for the comparable period a year ago. The increasedecrease of $800$2,206 or 22%50% is due to the increasedecrease in revenue as described above.
Gross Profit/(Loss). We generated $6,600$3,806 in gross profit for the year ended December 31, 2024,2025, in comparison with $5,400$6,600 in gross profit for the comparable period a year ago. The increasedecrease of $1,200$2,794 or 22%42% is due to the increasedecrease in revenue.
Selling, General and Administrative Expenses. General and administrative expenses for the year ended December 31, 2024,2025, totaled $3,239,232,$3,763,497, in comparison with $3,560,309$3,239,232 for the comparable period a year ago. The decreaseincrease of $321,077,$524,265, or 9%16% is primarily due to reductionsincreases of $200,553$349,363 in salaries andtied wages,to timing of bonus payments, $229,650 in increased marketing expenses, and $68,559$50,717 in Directortiming andof Officergeneral liability insurance premiums and $118,500 in consulting servicespayments, offset by $87,174an $89,475 decrease in increasedD&O operationsinsurance expenses.premiums.
Research and Development Expenses. Research and development expenses for the year ended December 31, 2024,2025, totaled $2,400,777$2,259,796 in comparison to $1,970,639$2,400,777 for the comparable period a year ago. The increasedecrease of $430,138,$140,981, or 22%6% was primarily due to the ramp-up of the CELZ-201-ADAPT spine trial completing recruitment and dosing, going into follow-up visits and timing in the development of our iPSC cell line in partnership with Greenstone Biosciences Inc.
Other Income. Other income for the year ended December 31, 2024,2025, totaled $250,380$147,806 in comparison with $333,558$250,380 for the comparable period a year ago. The decreased income of $83,178$102,574 or 25%,41%, is due to a $901,385$651,655 reduced average balance and lower interest rates on our short-term U.S. treasuries.
On March 6, 2025 entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 837,104 shares of common stock of the Company originally issued in October 2024 at the exercise price of $4.42 per share, in exchange for the issuance of new warrants. The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees. The new warrants were exercisable for an aggregate of up to 1,674,208 shares of common stock, at an exercise price of $3.75 per share, for a period of five years following shareholder approval of the exercise price of the warrants that occurred on May 5, 2025.
On October 29, 2025 we entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 shares of common stock of the Company originally issued in March 2025, at the exercise price of $3.75 per share, in exchange for the issuance of new warrants. The aggregate gross proceeds from the exercise of the existing warrants was approximately $4.2 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 2,790,340 shares of common stock, at an exercise price of $2.86 per share. The new warrants are exercisable for a period of five years following shareholder approval of the exercise of the warrants that occurred on December 26, 2025. In addition, in connection with this transaction, the Company agreed to (i) reduce the exercise price of certain warrants issued in May 2022 and December 2021 to $4.73 per share, and (ii) issue warrants to purchase up to 279,036 shares of common stock in the same form as the issued warrants, to an investor that consented to the transaction.
Net Cash used in Operating Activities. We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was $5,301,292$5,856,445 for the year-ended ended December 30,31, 2024,2025, in comparison to $8,027,885$5,301,292 for the comparable period a year ago, a decrease of 2,726,593$555,153 or 34%.10%. The decreaseincrease in cash used in operations was primarily related to aincreased one-timeoperating payment of $3,000,000 associated with the acquisition of research assets in 2023.expenses.
Net Cash used in Investing Activities. Cash providedused from investing activities was $50,500 for the year ended December 31, 2025, due to $50,500 in an investment in a convertible note and common stock purchase warrant of a publicly-traded company. In comparison, we received $6,320,191 for the year ended December 31, 2024,2024 primarily due to $6,520,191 in net certificate of deposit redemptions, offset by a $200,000 payment on a patent purchase agreement. In comparison, we used $3,445,185 for the year ended December 31, 2023 related to the deposit redemption in certificates of deposit and U.S. treasuries.
In the year ended December 31, 2025, we received net cash from financing activities of $7,174,666, consisting of proceeds from the exercise of warrants in March and October 2025. During such year, we also used $10,000 on the repurchase of stock, which was offset by $10,800 contributed to the capital of an entity in which we own a controlling interest by the minority member of such entity, which is accounted for as cash of $10,000 received by us in financing activities. In the year ended December 31, 2024, we spent $174,964 on stock repurchases, received $100 from the sale of preferred stock and received $1,629,500 from the sale of common stock and warrants in our October 2024 private offering.
In the year ended December 31, 2024, we spent $174,964 on stock repurchases, received $100 from the sale of preferred stock and received $1,629,500 from the sale of common stock and warrants in our October 2024 private offering. In the year ended December 31, 2023, we spent $270,952 on stock repurchases.
We have continued to realize losses from operations. However, as a result of our Decemberrecent 2021,warrant Mayexercise 2022 and October 2024 offerings,transactions, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements through at least March 2026.2027. We anticipate that we will need to raise additional capital in the future to support our ongoing operations and continue our clinical trials. We expect to continue to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund the development of our proposed products through clinical development, manufacturing, and commercialization. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. There can be no guarantee that we will be successful in our ability to raise capital to fund future operational and development initiatives.
What changed in the latest 10-Q
Risk Factors
We could not find a separate Risk Factors item in the latest 10-Q. Some companies leave it out of quarterly reports; see the annual 10-K risk factors and the original filing. Open the filing on SEC.gov.
Management's Discussion & Analysis (MD&A)
New heading “Olastrocel (CELZ 201) -”
New heading “CELZ Biodefense Platform: Project PHOENIX and Toxic Exposure Atlas™”
Largest changes
“In July 2024, we announced the initiation of a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary iPSC”. This iPSC clinically derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options. …”see in full comparison
“In February, 2025 we announced an expanded agreement with Greenstone Biosciences Inc. to leverage artificial intelligence (AI) in further developing our human induced pluripotent stem cell (iPSC) platform for diabetes treatment. The strategic collaboration is expected to extend the progress made on our proprietary hypoimmune iPSC technology, including our iPSC-derived pancreatic islet cells. The innovative cell lines, developed from Good Manufacturing Practice (GMP) grade human perinatal cells, are currently being used in clinical trials. …”see in full comparison
“The Company’s near term priorities for the biodefense platform include completing initial enrollment and data ingestion for the first 1,000 veterans in the burn pit registry, advancing AI based modeling to identify exposure linked molecular signatures and potential regenerative countermeasures using the Company’s stem cell and induced pluripotent stem cell platforms and pursuing government and strategic collaborations intended to expand the potential utility of the Toxic Exposure Atlas across broader military and civilian populations.”see in full comparison
“CELZ Biodefense Platform: Project PHOENIX and Toxic Exposure Atlas™”see in full comparison
“In November 2022, we announced that the FDA had cleared the Company’s Type I Diabetes (CELZ-201 CREATE-1) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes utilizing our AlloStem™ Clinical Cell Line, which will allow us to begin a Phase I/II clinical trial. The primary objective of the study will be to evaluate CELZ-201 treatment in patients with newly diagnosed Type 1 Diabetes. The trial has also received Institutional Board Review (IRB) approval for the trial to proceed as well as approval of the patient recruitment material. …”see in full comparison
“In August, 2025 we announced the FDA granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT. This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables us to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.”see in full comparison
Full comparison: every changed paragraph (76)
We are clinical-stage biotechnology company focused on developing regenerative medicine therapies derived from adult and perinatal stem cell technologies. We employ scalable, cGMP manufacturing that enables efficient, cost effective production as programs advance. Supported by a clinical, intellectual property and technological foundation, we are advancing from proof of concept into clinical development in pursuit of regenerative stem cell therapies across multiple indications, with a pipeline targeting addressable markets in orthopedics, immunotherapy, endocrinology, urology and gynecology. Out platforms and therapies include the following:
Regenerative medicine refers to approaches that seek to repair, replace or restore damaged cells, tissues and organs rather than solely managing symptoms. These approaches are intended to harness or stimulate the body’s own healing processes. The goal is to regenerate functional tissue, such as rebuilding cartilage in an arthritic joint, improving heart muscle after a heart attack or restoring nerve function after injury, which may allow patients to recover more fully and potentially avoid or delay certain surgical interventions and long term drug therapy.
The Company utilizes three proprietary cell platforms – AlloStem™, ImmCelz™ and iPScelz™ – to pursue multiple therapeutic areas, which we believe broadens our market opportunity while diversifying development risk.
We have two U.S. Food and Drug Administration (FDA) cleared clinical trials in progress:
In addition, we have initiated the CELZ Biodefense Platform, a proprietary, artificial intelligence (AI) driven data and discovery initiative focused on evaluating, modelling and developing potential regenerative countermeasures for conditions associated with toxic environmental exposures, such as military burn pits.
We integrate AI, where applicable, into our drug development activities to analyse biological and clinical datasets, prioritize targets and candidates and support efforts to enhance efficiencies, shorten development timelines and increase the probability of success for our programs.
We operate with a lean, cross functional team and a network of strategic partners to advance our programs, including third-party manufacturers. We seek to allocate capital toward programs that we believe have clearer paths to differentiation, regulatory advancement and commercial or partnering potential.
Our lead clinical asset is CELZ 201 (Olastrocel™), which we are advancing toward Phase 3 development as a potential therapy for chronic lower back pain associated with degenerative disc disease. CELZ 201 also serves as the foundation for additional platform programs that we are currently pursuing.
Our cellular platforms are comprised of the following:
Regenerative Medicine Programs
Based on third party industry analyses, we believe the combined market opportunity for our targeted indications is approximately $10 billion. These analyses indicate potential long term growth driven by new therapies, expanded diagnostic rates and broader patient access. We may refine these estimates by indication as additional data become available.
Olastrocel (CELZ 201) -
Olastrocel, also referred to as CELZ 201, is the Company’s lead allogeneic cell therapy candidate developed on the AlloStem™ platform.
In December 2025, the World Health Organization approved “Olastrocel” as the International Non Proprietary Name for the active cellular substance in CELZ 201. The INN is the globally standardized scientific name used by regulators, clinicians, researchers, and markets to identify a therapeutic substance across development and commercialization. This designation is a key global milestone, typically granted as a program moves into later regulatory stages and requires a unified international identity.
We are currently evaluating Olastrocel™ in our FDA-cleared ADAPT clinical trial for the treatment of chronic lower back associated with degenerative disc disease. This randomized Phase 1/2 study received FDA Fast Track designation in August 2025.
Previously reported interim blinded data showed improvements in disability and pain and did not identify serious adverse events or treatment related safety signals, as confirmed by an independent Data Safety Monitoring Board. In June 2026, the FDA cleared an expansion of the ADAPT trial to enroll an additional cohort of patients receiving less than 90 mg per day in morphine equivalents in order to further characterize safety and efficacy in individuals with ongoing opioid use.
Our near term priorities for Olastrocel™ include completing enrolment of the expanded ADAPT cohort, generating longer term follow up data, continuing regulatory interactions related to Phase 3 planning and evaluating potential strategic and partnering opportunities as the clinical dataset matures.
CELZ-201 is also being used in pre-clinical studies for managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. This personalized medicine approach is believed to be a first in medical history.
Ultrasome™
Ultrasome™ is our proprietary cell free regenerative therapy program for osteoarthritis of the knee along with other indications and is derived from the CELZ 201 platform. We have reported pilot stage clinical data for Ultrasome™ that achieved the primary endpoint and demonstrated improvements in mobility and pain reduction without serious adverse events.
We believe Ultrasome™ may represent a regenerative approach for osteoarthritis in a large market where currently available therapies may provide only temporary relief. The Company’s near term priorities for the program include designing and initiating the next stage of clinical development, generating multi-center controlled data and evaluating regional, indication specific or broader strategic partnership opportunities intended to support development and commercial planning while seeking to limit dilutive capital needs.
CELZ Biodefense Platform: Project PHOENIX and Toxic Exposure Atlas™
Our CELZ Biodefense platform includes Project PHOENIX and the Toxic Exposure Atlas. The platform is designed to integrate exposure histories, clinical outcomes, multi omics datasets, cell response information and disease biology into a unified framework intended to support AI driven discovery and identification of potential regenerative countermeasures.
During 2026, the BioDefense Inc. Burn Pit Initiative received regulatory approval to proceed nationally. The program is being implemented through existing strategic alliances, infrastructure and vendor relationships. and is intended to operate without the need for new capital raises. In June 2026, Project PHOENIX advanced into a nationwide virtual data collection phase that is intended to scale to at least 1,000 veterans through a mobile app registry and field capable logistics.
The Company’s near term priorities for the biodefense platform include completing initial enrollment and data ingestion for the first 1,000 veterans in the burn pit registry, advancing AI based modeling to identify exposure linked molecular signatures and potential regenerative countermeasures using the Company’s stem cell and induced pluripotent stem cell platforms and pursuing government and strategic collaborations intended to expand the potential utility of the Toxic Exposure Atlas across broader military and civilian populations.
We are a commercial stage biotechnology company dedicated to the advancement of regenerative therapeutics in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. Our platforms, therapies and products include the following:
Our subsidiary, Creative Medical Technologies, Inc. (“CMT”), was originally created to monetize U.S. Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired in February 2016. Subsequently, we have expanded our development and acquisition of intellectual property beyond urology to include therapeutic treatments utilizing “re-programmed” stem cells, and the treatment of neurologic disorders, lower back pain, Type-1 diabetes, and heart, liver, kidney, and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC subsidiaries. However, neither ImmCelz Inc., nor AlloCelz LLC have commenced commercial activities.
In 2020, through our ImmCelz Inc. subsidiary, we began developing treatments under our ImmCelz™ platform (CELZ-100), that utilize a patient’s own extracted immune cells that are then “reprogrammed/supercharged” by culturing them outside the patient’s body with optimized cell-free factors. The immune cells are then re-injected into the patient from whom they were extracted. We believe this process endows the immune cells with regenerative properties (or “supercharges” them) providing them with the ability to treat multiple indications. We have validated this ability through the third-party studies described below that were independently conducted on selected human donor patient cells for accuracy and reproducibility. In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration.
In June 2022, we signed an agreement with Greenstone Biosciences Inc. (“Greenstone”) for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz™ platform. This project was identified as iPScelz™. The efforts by Greenstone are expected to complement and expand our current work on novel therapeutic cell lines. In May 2023, we announced that we had received confirmation that Greenstone had successfully developed a human induced pluripotent stem cell (iPSC). We estimate that the development of this cell line will save the Company two to three years in research and development time along with associated expenses. The final iPScelz™ results in a viral-free cell line which has great potential for differentiation into therapeutic biologics both for the cellular and cell-free programs along with targeted drug discovery. Greenstone’s developments were confirmed by an independent, industry-leading research firm.
In October 2022, we announced the development of our AlloStem™ Clinical Cell Line (CELZ-200), a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File. We believe we will able to use this cell line for many of our programs, including our ImmCelz™ immunotherapy platform for multiple diseases, OvaStem™ for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), and IPScelz™ inducible pluripotent stem cell program in ongoing development with Greenstone.
In November 2022, we announced that the FDA had cleared the Company’s Type I Diabetes (CELZ-201 CREATE-1) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes utilizing our AlloStem™ Clinical Cell Line, which will allow us to begin a Phase I/II clinical trial. The primary objective of the study will be to evaluate CELZ-201 treatment in patients with newly diagnosed Type 1 Diabetes. The trial has also received Institutional Board Review (IRB) approval for the trial to proceed as well as approval of the patient recruitment material. Patient recruitment was initiated in September 2023.
In February 2023, we reported positive three-year follow-up data for its StemSpine® pilot study. The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects reported.
In March 2023, we reported the following results of independent studies:
We believe these results show that we will be able to substantially reduce production costs, while allowing for the manufacture of the best clinical product for patients with immune disorders, which will enable us to accelerate our clinical applications and encourage potential collaborations with respect to our ImmCelz™ platform.
In March 2023, we announced that we had filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ (CELZ-100) platform. In March 2024 we received the ODD from the FDA. This designation provides multiple important benefits to support the therapy’s development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.
In April 2023, we reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes. There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial. There were 30 patients in the study, 15 received CELZ-001 and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.
In September 2023, we 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. The first in country study, which will enroll 30 individuals suffering from chronic lower back pain, is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (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 huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.
In October 2023, we filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial for the treatment of chronic lower back pain with its AlloStemSpine® procedure using AlloStem™ (CELZ-201-DDT ADAPT) cell therapy. The clinical trial is registered on www.clinicaltrials.gov. From November 2023 through July 2024, we:
In March 2024, we secured FDA authorization for an expanded access therapy using CELZ-201, in managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. The therapy uses CELZ-201 to potentially prevent Type I Diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focuses on a single high-risk patient. CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level.
In June 2024, we announced that we had successfully generated human induced pluripotent stem cells (iPSCs)-derived islet cells that produce human insulin. We believe 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.
In July 2024, we announced the initiation of a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary iPSC”. This iPSC clinically derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options. The use of AI strengthens the Company’s research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables the Company to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions. Along with Greenstone Biosciences Inc., the Company continues to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs.
In November 2024, we announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) of our CELZ-201 ADAPT clinical trial. The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy. This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients.
In January 2025, we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial. The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned Key Milestones Achieved:
In February, 2025 we announced an expanded agreement with Greenstone Biosciences Inc. to leverage artificial intelligence (AI) in further developing our human induced pluripotent stem cell (iPSC) platform for diabetes treatment. The strategic collaboration is expected to extend the progress made on our proprietary hypoimmune iPSC technology, including our iPSC-derived pancreatic islet cells. The innovative cell lines, developed from Good Manufacturing Practice (GMP) grade human perinatal cells, are currently being used in clinical trials. By integrating AI-driven drug discovery, the partnership aims to identify small molecules that enhance insulin secretion, further refining the therapeutic potential of our hypoimmunogenic iPSC-derived pancreatic islet cells. Additionally, the program is expected to implement multi-gene editing to develop next generation hypoimmune iPSC lines with enhanced stealth, survival, and differentiation capabilities. These advancements will not only optimize pancreatic islet cell function but also expand the platform’s applications to other regenerative therapies, addressing critical unmet medical needs.
In March, 2025 we announced the FDA had cleared an expanded dose escalation for our ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT). This regulatory milestone followed compelling interim blinded data demonstrating statistically significant pain reduction and improved mobility among trial participants.
In August, 2025 we announced the FDA granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT. This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables us to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.
In October, 2025 we launched the BioDefense Veterans Initiative, believed to be a first-of-its-kind national program to combat the devastating long-term effects of toxic burn pit exposure among U.S. service members. To execute this initiative, we entered into an agreement with Greenstone Biosciences, Inc., as the exclusive AI and iPSC development partner. We are executing a national program which will provide the critical data infrastructure to:
Under this partnership, Greenstone will deploy advanced molecular-sequencing, proteomic profiling, and machine-learning algorithms to analyze cellular data from service members exposed to burn pits. These AI-integrated systems will accelerate the creation of predictive exposure models and precision-engineered regenerative therapies—a groundbreaking leap in both biodefense and AI-enabled medicine.
In November, 2025, the Company contributed $43,200 to the capital of Bionance, which, together with Mr. Warbington’s contribution of $10,800, was used to fund Bionance’s $54,000 investment in a convertible promissory note and warrants to purchase common stock issued by Applife Digital Solutions, Inc. To date, the Company has not made any other capital contributions to Bionance, and Bionance has not made any other investments.
In December, 2025 we announced the successful completion of patient enrollment in our ADAPT clinical trial evaluating CELZ-201 (Olastrocel). This enables us to transition the ADAPT program into its next phase focused on follow-up, and data analysis.
On March 6, 2025 we entered into warrant exercise inducement agreements with holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 837,104 shares of common stock of the Company originally issued in October 2024 at the exercise price of $4.42 per share. The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 1,674,208 shares of common stock, at an exercise price of $3.75 per share, for a period of five years following shareholder approval of the exercise price of the warrants that occurred on May 5, 2025.
On October 29, 2025 we entered into warrant exercise inducement agreements with certain holders of existing warrants for the exercise of outstanding warrants to purchase an aggregate of 1,116,136 shares of common stock of the Company originally issued in March 2025, at the exercise price of $3.75 per share. The aggregate gross proceeds from the exercise of the existing warrants was approximately $4.2 million, before deducting financial advisory fees. The new warrants are exercisable for an aggregate of up to 2,790,340 shares of common stock, at an exercise price of $2.86 per share. The new warrants are exercisable for a period of five years following shareholder approval of the exercise of the warrants that occurred on December 26, 2025.
We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc. On May 18, 2016, we completed a reverse merger transaction under which Creative Medical Technologies, Inc. became our wholly owned subsidiary. In connection with this merger, we changed our name to Creative Medical Technologies Holdings, Inc. to reflect our current business.
Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012.
Results of Operations – For the Three-month Periods Ended MarchJune 31,30, 2026, and 2025 Gross Revenue. ThereNo revenues were $0 and $3,000 revenues generated forduring the three-month periods ended MarchJune 31,30, 2026 and 2025 respectively.2025.
Cost of Goods Sold. There were $0 and $1,200 cost of goods sold for the three-month periods ended March 31, 2026 and 2025 respectively.
Gross Profit/(Loss). There were $0 and $1,800 in gross profits for the three-month periods ended March 31, 2026 and 2025.
Selling, General and Administrative Expenses. General and administrative expenses for the three-months ended MarchJune 31,30, 2026, totaled $888,640,$1,080,045, in comparison with $888,397$731,517 for the comparable period a year ago. The increase of $243,$348,528, or 0%48% is primarily due to increases of $76,727$206,642 in compensationmarketing due to a Company-level marketing campaign, $50,513 due to timing of bonusa payouts,general $30,978liability payment, $38,244 increased salaries from an additional hire and $32,642 in publicadditional companytravel related expenses, and $23,016 in legal fees, offset by decreases of $70,617 in marketing, and $50,512 due to timing of liability insurance payments.expenses.
Amortization Expenses. Amortization expenses for the three-months ended MarchJune 31,30, 2026 totaled $28,855$22,918 in comparison with $30,577$30,742 for the comparable period a year ago.
Research and Development Expenses. Research and development expenses for the three-months ended MarchJune 31,30, 2026, totaled $541,658$459,200 in comparison to $743,304$501,261 for the comparable period a year ago. The decrease of $201,646,$42,061, or 27%8% was primarily due to a decrease of $230,328 in general research and development, offset by an increase of $25,682$114,794 associated with the AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) trial.trial as trial proceeds to the follow-up stage, offset by an $66,733 increase in general research and development associated with investments in our other platforms and programs.
CELZ insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-24 | Warbington Timothy |
Grant/award | 1,000,000 | — | — |
Well-known investors holding CELZ (13F)
None of the 59 investors we track reported a position in their latest 13F.