What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+160 added−111 removedSource: 10-K (2026-03-20) vs 10-K (2025-03-14)
Top changes in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2025 10-K
160 paragraphs added · 111 removed · 99 edited across 5 sections
- Item 1. Business+73 / −51 · 45 edited
- Item 7. Management's Discussion & Analysis+59 / −31 · 29 edited
- Item 1A. Risk Factors+21 / −21 · 18 edited
- Item 5. Market for Registrant's Common Equity+6 / −7 · 6 edited
- Item 1C. Cybersecurity+1 / −1 · 1 edited
Item 1. Business
Business — how the company describes what it does
45 edited+28 added−6 removed130 unchanged
Item 1. Business
Business — how the company describes what it does
45 edited+28 added−6 removed130 unchanged
2024 filing
2025 filing
Biggest changeOur patent portfolio is currently composed of four issued patents and fifty pending patent applications filed in the United States with the USPTO as follows: Issued Patents Title Application Number Application Filing Date Patent Number Treatment of Erectile Dysfunction by Stem Cell Therapy 12305589 06/22/2007 8,372,797 Treatment Of Disc Degenerative Disease 12301597 09/30/2009 9,598,673 Methods For Treatment Of Premature Ovarian Failure And Ovarian Aging Using Regenerative Cells 15652213 07/17/2017 10,792,310 Paraspinal Perfusion by Administration of T regulatory Cells Alone or in Combination with Angiogenic Cell Therapies 16009982 06/15/2018 10,842,815 Pending Patent Applications Area Application/Patent # Description Immunology 15/617,813 Adipose Derived Immunomodulatory Cells for Immunotherapy of Recurrent Spontaneous Abortions Immunology 10,792,310 Methods for Treatment of Premature Ovarian Failure and Ovarian Aging Using Regenerative Cells Immunology 15/702,735 Inducing and Accelerating Post-stroke Recovery by Administration of Amniotic Fluid Derived Stem Cells Immunology 15/987,739 Generation of Autologous Immune Modulatory Cells for Treatment of Neurological Conditions Immunology 63/123,380 Induction of Infectious Tolerance by Ex Vivo Reprogrammed Immune Cells Immunology 63/248,324 Suppression of Diabetes Using Exosomes From Stem Cell Programmed Myeloid Cells Immunology 63/270,678 Regenerative T Regulatory Cells Immunology 63/297,876 Chimeric Antigen Receptor Regenerative Gamma Delta T Cells Immunology 63/297,883 Regenerative Car-T Cells Immunology 63/302,228 Regenerative Cell Therapy for Viral Induced Sexual Dysfunction Immunology 63/313,313 Methods for Quantifying Potency of Regenerative Immunotherapies StemSpine 63/331,179 Enhancement of Cartilage Regenerative Activity of Stem Cell Populations Based on Reduction of Intra-articular Cellular Material StemSpine 63/331,183 Enhancement of Stem Cell Therapy for Cartilage Degeneration by Anti-oxidant Pre-conditioning Immunology 63/331,186 Treatment of Cartilage Degeneration Using Treatment of Cartilage Degeneration Using Myeloid Suppressor Cells and Exosomes Derived Thereof Immunology 63/338,416 Cytokine Based Assessment of Recipient Ability to Respond to Stem Cell Therapy for Cartilage Regeneration 11 Table of Contents Endocrinology 63/338,417 Prevention of Menopause Associated Osteoporosis by Intra-ovarian Administration of Regenerative Cells Immunology 63/340,447 Stimulation of Ovarian Function Subsequent to Chemotherapy and/or Radiation Therapy Using Natural Killer Cells Immunology 63/340,450 Protection from Ovarian Failure by Low Dose Interleukin-2 Administration Immunology 63/340,454 Immunological Enhancement of Stem Cell Activity in Treatment of Ovarian Failure Immunology 63/340,828 Exosome Based Assays for Determining Candidates for Osteoarthritis Stem Cell Therapy Immunology 63/343,832 Cytokine Primed Regenerative Cells for Treatment of Ovarian Failure Immunology 63/343,841 Degenerating Ovarian Microenvironment Resistant Mesenchymal Stem Cells Immunology 63/343,846 Repair of Ovarian Damage and Dampening of Inflammatory Microenvironment by Administration of Monisytic-Granulocytic Progenitors with Immunomodulatory Activities Immunology 63/349,297 Gene Therapeutics for Enhancement/Restoration of Endometrial Function Endocrinology 63/349,976 Cellular Regenerative Therapeutics for Enhancement/Restoration of Endometrial Function Immunology 63/351,330 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Endothelian Progenitor Cells Immunology 63/351,332 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Immunology 63/353,011 Inducible Pluripotent Stem Cell Derived Regenerative T Cells Immunology 63/389,091 Overcoming TNF-Alpha Blockade Resistance in Rheumatoid Arthritis by Regenerative T Regulatory Cell Therapy Immunology 63/390,759 Treatment of Limb Ischemia by Bone Marrow Stem Cells and Modification of Diseased Microenvironment Immunology 63/391,865 Potentiation of Bone Marrow Cell Activity by Co-administration with Oxytocin Immunology 63/395,252 Prevention and Treatment of Reproductive Failure by Regenerative Cells and Adjuvants StemSpine 63/395,834 Prevention of Space Travel Associated Bone Density Loss by Regenerative Cell Populations Immunology 63/395,836 Prevention and Treatment of Hair Loss Immunology 63/395,839 Prophylaxis and Treatment of Orthopox Viruses Using Regenerative Cells and Products Thereof Immunology 63/414,823 Treatment of Diabetes by Enhancement of Pancreatic Islet Engraftment Through Regenerative Immune Modulation Immunology 63/455,965 Artificial Intelligence Systems and Processes for In Silico Discovery of Immune Modulators and T Regulatory Cell Screening Methodologies Immunology 63/458,423 Artificial Intelligence Guided Production of Cells and Organs from Pluripotent Stem Cells Immunology 63/460,543 Three-Dimensional Printing of Organs, Organoids, and Chimeric Immuno-Evasive Organs Immunology 63/463,993 Artificial Intelligence Enhanced Real Time Biological Optimization and Health Monitoring for Space Travel 12 Table of Contents Immunology 63/465,616 Induction of Antigen Specific Immunological Tolerance Using Inducible Pluripotent Stem Cell Derived Veto Cells Immunology 63/510,877 Enhanced Mobility of Inducible Pluripotent Stem Cell Derived T Regulatory Cells Immunology 63/514,240 Creation of Inducible Pluripotent Stem Cell Derived T Regulatory Cells by In Vitro Recapitulation of Thymic Development Immunology 63/518,386 Treatment of Spinal Cord Injury with T Regulatory Cells Immunology 63/518,424 Prevention of Immunological Rejection Using Mesenchymal Stem Cells and Derivatives Thereof Endocrinology 63/580,657 In Vitro and In Vivo Generation of Insulin Producing Cells Immunology 63/580,669 Orthopedic Regeneration by Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Endocrinology 63/588,034 Treatment of Lower Back Pain and Disc Degenerative Disease Using Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells and T Regulatory Cells Endocrinology 16/759,671 Augmentation of Fertility by Platelet Rich Plasma Immunology 18/183,900 Therapeutic Regenerative Cells Patent Purchase and License Agreements Lower Back Pain Patent Purchase.
Biggest changeOur patent portfolio is currently composed of seven issued patents and thirty nine pending patent applications filed in the United States with the USPTO as follows: Issued Patents Title Application Number Application Filing Date Patent Number Treatment of Erectile Dysfunction by Stem Cell Therapy 12305589 06/22/2007 8,372,797 Treatment Of Disc Degenerative Disease 12301597 09/30/2009 9,598,673 Methods For Treatment Of Premature Ovarian Failure And Ovarian Aging Using Regenerative Cells 15652213 07/17/2017 10,792,310 Paraspinal Perfusion by Administration of T regulatory Cells Alone or in Combination with Angiogenic Cell Therapies 16009982 06/15/2018 10,842,815 Prevention And/Or Treatment Of Type 1 Diabetes By Augmentation Of Myeloid Suppressor Cell Activity 17/835,818 06/08/2022 12,391,925 Generation of Autologous Immune Mcratiodulatory Cells for Treatment of Neurological Conditions 15/987,739 05/23/2018 11,795,433 Treatment Of Heart Failure And/Or Post Infarct Pathological Remodeling By Ex Vivo Reprogrammed Immune Cells 17/559,970 12/22/2021 12,385,011 12 Table of Contents Pending Patent Applications Area Application/Patent # Description Immunology 18/082,841 Chimeric Antigen Receptor Regenerative Gamma Delta T Cells Immunology 18636179 Three-Dimensional Printing of Organs, Organoids, and Chimeric Immuno-Evasive Organs Immunology 18/646,563 Induction of Antigen Specific Immunological Tolerance Using Inducible Pluripotent Stem Cell Derived Veto Cells Immunology 19/045,363 Prevention Of Autoimmune Diabetes Immunology/ Vascular 18/358,490 Potentiation of Bone Marrow Cell Activity by Coadministration with Oxytocin Immunology 18/775,133 Creation of Inducible Pluripotent Stem Cell Derived T Regulatory Cells by In Vitro Recapitulation of Thymic Development Immunology 18/311,625 Cytokine Primed Regenerative Cells for Treatment of Ovarian Failure Endocrinology 18331029 Cellular Regenerative Therapeutics for Enhancement/Restoration of Endometrial Function Immunology 19015393 Canine Universal Donor Mesenchymal Stem Cells Immunology 18/311,445 Cytokine Based Assessment of Recipient Ability to Respond to Stem Cell Therapy for Cartilage Regeneration Immunology/ Endocrine 18/483,485 Treatment of Diabetes by Enhancement of Pancreatic Islet Engraftment Through Regenerative Immune Modulation Immunology 17/931,868 Suppression of Diabetes Using Exosomes From Stem Cell Programmed Myeloid Cells Immunology/ Endocrine 19/303,763 Prevention And/Or Treatment Of Type 1 Diabetes By Augmentation Of Myeloid Suppressor Cell Activity Immunology 18/311,768 Degenerating Ovarian Microenvironment Resistant Mesenchymal Stem Cells Immunology 18/757,374 Enhanced Mobility of Inducible Pluripotent Stem Cell Derived T Regulatory Cells Immunology 18/315,364 Exosome Based Assays for Determining Candidates for Osteoarthritis Stem Cell Therapy Immunology 18/331,048 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Endothelial Progenitor Cells Immunology 18/331,042 Generation Of Conditioned Media From Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Immunology 18/366,516 Prevention And Treatment Of Hair Loss Immunology/ Endocrine 19462138 Hypoimmune Human Induced Pluripotent Stem Cell Line Derived from Perinatal Cells for Pancreatic Islet Transplantation Immunology/ Endocrine 63/877,634 Hypoimmune Human Induced Pluripotent Stem Cell Line Derived from Perinatal Cells for Pancreatic Islet Transplantation Immunology 18/331,098 Inducible Pluripotent Stem Cell Derived Regenerative T Cells Endocrinology 18785132 In Vitro and In Vivo Generation of Insulin Producing Cells Endocrinology 17585356 Treatment of kidney failure using ex vivo reprogrammed immune cells Endocrinology 18/908,482 Treatment of Lower Back Pain and Disc Degenerative Disease using Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells and T Regulatory Cells Immunology 18/348,292 Treatment of Limb Ischemia by Bone Marrow Stem Cells and Modification of Diseased Microenvironment Immunology 18/173,052 Methods for Quantifying Potency of Regenerative Immunotherapies Immunology 18/785,305 Orthopedic Regeneration by Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Immunology 18/348,288 Overcoming TNF-alpha Blockade Resistance in Rheumatoid Arthritis by Regenerative T regulatory Cell Therapy Immunology 18/785,059 Prevention of Immunological Rejection Using Mesenchymal Stem Cells and Derivatives Thereof Immunology/ Endocrine 19045460 Prevention Of Diabetes By Enhancement Of Immune Modulation Immunology 18/311,464 Protection from Ovarian Failure by Low Dose Interleukin-2 Administration Immunology 18/082,857 Regenerative Car-T Cells Immunology 18/363,642 Prevention And Treatment Of Reproductive Failure By Regenerative Cells And Adjuvants Immunology 18794184 Treatment of Spinal Cord Injury with T regulatory Cells Endocrine 18/311,474 Stimulation of Ovarian Function Subsequent to Chemotherapy and/or Radiation Therapy Using Killer Cells Immunology 17/865,881 Therapeutic Monocytic Lineage Cells Immunology/ Orthopedic 19015315 Treatment of Disc Degeneration using B Regulatory Cells Immunology 18/183,900 Therapeutic Regenerative Cells 13 Table of Contents Patent Purchase and License Agreements Lower Back Pain Patent Purchase.
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: · Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort. · Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease. · DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.
Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned 6 Table of Contents Key Milestones Achieved: · Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort. · Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease. · DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.
Alova The Alova program utilizes the AlloStem™ platform to treat infertility as a result of premature ovarian failure. StemSpine ® - Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease (Clinical Trials) Our StemSpine® procedure uses the patient’s own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain.
Alova The Alova program utilizes the AlloStem™ platform to treat infertility as a result of premature ovarian failure. StemSpine ® - Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease (Clinical Phase) Our StemSpine® procedure uses the patient’s own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain.
Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012. Our Pipeline and Products AlloStem™ (CELZ-201-DDT) - Allogenic Human Perinatal Tissue Derived Cell Program (Clinical Phase) AlloStem™ (CELZ-201-DDT) leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells™ (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion.
Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012. 8 Table of Contents Our Pipeline and Products AlloStem™ (CELZ-201-DDT) - Allogenic Human Perinatal Tissue Derived Cell Program (Clinical Phase) AlloStem™ (CELZ-201-DDT) leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells™ (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion.
Companies failing to comply with HIPAA and the implementing regulations may also be subject to civil money penalties or in the case of knowing violations, potential criminal penalties, including monetary fines, imprisonment, or both. In some cases, the State Attorneys General may seek enforcement and appropriate sanctions in federal court. 20 Table of Contents Other Applicable U.S.
Companies failing to comply with HIPAA and the implementing regulations may also be subject to civil money penalties or in the case of knowing violations, potential criminal penalties, including monetary fines, imprisonment, or both. In some cases, the State Attorneys General may seek enforcement and appropriate sanctions in federal court. Other Applicable U.S.
Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and peripheral blood and skeletal muscle. 14 Table of Contents Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, Longeveron, BioRestorative Therapies, and DiscGenics.
Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and peripheral blood and skeletal muscle. Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, Longeveron, BioRestorative Therapies, and DiscGenics.
Along with Greenstone Biosciences Inc., we continue to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs. 6 Table of Contents In January, 2025 we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial.
Along with Greenstone Biosciences Inc., we continue to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs. In January, 2025 we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial.
No serious adverse effects were noted, with some short-term bruising in two patients at the harvest site. No long-term adverse events were reported related to the procedure. On February 14, 2023, we announced positive three-year follow-up data for the Company’s StemSpine® pilot study.
No serious adverse effects were noted, with some short-term bruising in two patients at the harvest site. No long-term adverse events were reported related to the procedure. 10 Table of Contents On February 14, 2023, we announced positive three-year follow-up data for the Company’s StemSpine® pilot study.
As amended, the Patent Purchase Agreement includes the following terms: · We were required to pay CMH $100,000 within 30 days of demand as an initial payment. · Upon the determination to pursue the technology via use of autologous cells, we were required to pay CMH: o $100,000 upon the signing agreement with a university for the initiation of an IRB clinical trial. o $200,000, upon completion of the IRB clinical trial. o $300,000 in the event we commercialize the technology via use of autologous cells by a physician without a clinical trial. · In the event we determine to pursue the technology via use of allogenic cells, we are required to pay CMH: o $100,000 upon filing an IND with the FDA. o $200,000 upon dosing of the first patient in a Phase 1-2 clinical trial. o $400,000 upon dosing the first patient in a Phase 3 clinical trial. · Each payment may be made in cash or shares of our common at a discount of 30% to the recent trading price. · In the event our shares of common stock trade below $0.01 per share for two or more consecutive trading days, the number of any shares issuable as payment doubles. · For a period of five years from the date of the first sale of any product derived from the patent, we are required to make royalty payments of 5% from gross sales of products, and 50% of sale price or ongoing payments from third parties for licenses granted under the patent to third parties. 13 Table of Contents The Company paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 667 shares of common stock on December 12, 2020.
As amended, the Patent Purchase Agreement includes the following terms: · We were required to pay CMH $100,000 within 30 days of demand as an initial payment. · Upon the determination to pursue the technology via use of autologous cells, we were required to pay CMH: o $100,000 upon the signing agreement with a university for the initiation of an IRB clinical trial. o $200,000, upon completion of the IRB clinical trial. o $300,000 in the event we commercialize the technology via use of autologous cells by a physician without a clinical trial. · In the event we determine to pursue the technology via use of allogenic cells, we are required to pay CMH: o $100,000 upon filing an IND with the FDA. o $200,000 upon dosing of the first patient in a Phase 1-2 clinical trial. o $400,000 upon dosing the first patient in a Phase 3 clinical trial. · Each payment may be made in cash or shares of our common at a discount of 30% to the recent trading price. · In the event our shares of common stock trade below $0.01 per share for two or more consecutive trading days, the number of any shares issuable as payment doubles. · For a period of five years from the date of the first sale of any product derived from the patent, we are required to make royalty payments of 5% from gross sales of products, and 50% of sale price or ongoing payments from third parties for licenses granted under the patent to third parties.
The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: · completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice (or GLP), or other applicable regulations; · submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days; · performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices (or GCP), which are international ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and that the integrity of the data is maintained; · registration of clinical trials of FDA-regulated products and certain clinical trial information; · preparation and submission to the FDA of a new drug application (or NDA), in the case of a drug or biologics license application (or BLA) in the case of a biologic; · review of the product by an FDA advisory committee, where appropriate or if applicable; · satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components thereof, are produced to assess compliance with Good Manufacturing Practice, or cGMP, requirements and of selected clinical trial sites to assess compliance with GCP requirements; and · FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold. 16 Table of Contents Approval of an NDA requires a showing that the drug is safe and effective for its intended use and that the methods, facilities, and controls used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity.
The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: · completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice (or GLP), or other applicable regulations; · submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days; · performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices (or GCP), which are international ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and that the integrity of the data is maintained; · registration of clinical trials of FDA-regulated products and certain clinical trial information; · preparation and submission to the FDA of a new drug application (or NDA), in the case of a drug or biologics license application (or BLA) in the case of a biologic; · review of the product by an FDA advisory committee, where appropriate or if applicable; · satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components thereof, are produced to assess compliance with Good Manufacturing Practice, or cGMP, requirements and of selected clinical trial sites to assess compliance with GCP requirements; and · FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold.
Item 1. Business Overview We are a commercial stage biotechnology company dedicated to the advancement of identifying and translating novel biological 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.
Item 1. Business Overview We are a commercial stage biotechnology company dedicated to the advancement regenerative therapies 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.
Subjects in the Group I (Treatment Group, n=12) will receive standard of care for type 1 diabetes and CELZ-201 within 1 month from enrollment (within 180 days of diagnosis). Subjects in Group II (Control Arm, n=6) and will receive enhanced standard of care for type 1 diabetes.
Subjects in the Group I (Treatment Group, n=12) will receive standard of care for type 1 diabetes and CELZ-201 within 1 month from enrollment (within 180 days of diagnosis).
None of our employees belong to a union. We believe relations with our employees are good. Research and Development Research and development expenses for the year ended December 31, 2024, totaled $2,400,777.
None of our employees belong to a union. We believe relations with our employees are good. Research and Development Research and development expenses for the year ended December 31, 2025, totaled $2,259,796.
If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing, and criminal prosecution. If any of these events were to occur, it could materially adversely affect us.
If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing, and criminal prosecution.
Clinical research of an investigational device is subject to the FDA’s Investigational Device Exemption, or IDE, regulations. Nonsignificant risk devices are subject to abbreviated requirements that do not require a submission to the FDA but must have Institutional Review Board (IRB) approval and comply with other requirements pertaining to informed consent, labeling, recordkeeping, reporting, and monitoring.
Nonsignificant risk devices are subject to abbreviated requirements that do not require a submission to the FDA but must have Institutional Review Board (IRB) approval and comply with other requirements pertaining to informed consent, labeling, recordkeeping, reporting, and monitoring. Significant risk devices require the submission of an IDE application to the FDA and the FDA’s approval of the IDE application.
ImmCelz™ (CELZ-100) - On December 28, 2020, ImmCelz, Inc. (“ImmCelz”), a newly formed Nevada corporation and wholly owned subsidiary of the Company, entered into a Patent License Agreement dated December 28, 2020 (the “Agreement”), with Jadi Cell, LLC. (“Jadi”), a company owned and controlled by Dr. Amit Patel, a former director of the Company.
(“ImmCelz”), a newly formed Nevada corporation and wholly owned subsidiary of the Company, entered into a Patent License Agreement dated December 28, 2020 (the “Agreement”), with Jadi Cell, LLC. (“Jadi”), a company owned and controlled by Dr. Amit Patel, a former director of the Company. The Agreement grants to ImmCelz™ the patent rights under U.S.
We believe AlloStem™ (CELZ-201-DDT) has the following additional benefits and characteristics: · Immediately available, scalable “Universal” recipient product · Immunomodulatory properties to help treat immune and endocrine based disorders · Supports ImmCelz™ (CELZ-100), Alova™, Type I Diabetes (CELZ-201 CREAT-1) and AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) programs and others · Supports FDA cleared clinical trials for rapid translation · Designated and proprietary Master Cell Bank and Drug Master File for US FDA · 8 billion manufactured and validated cells available for clinical trials and further research ImmCelz™ (CELZ-100) - Personalized Supercharged Immune Therapy Platform (Pre-Clinical Trials ) We are developing our ImmCelz™ (CELZ-100) technology for the treatment of multiple indications. 7 Table of Contents ImmCelz™ (CELZ-100) utilizes a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized secreted factors.
We believe AlloStem™ (CELZ-201-DDT) has the following additional benefits and characteristics: · Immediately available, scalable “Universal” recipient product · Immunomodulatory properties to help treat immune and endocrine based disorders · Supports ImmCelz™ (CELZ-100), Alova™, Type I Diabetes (CELZ-201 CREATE-1) and AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) programs and others · Supports FDA cleared clinical trials for rapid translation · Designated and proprietary Master Cell Bank and Drug Master File for US FDA · 8 billion manufactured and validated cells available for clinical trials and further research ImmCelz™ (CELZ-100) - Personalized Supercharged Immune Therapy Platform (Pre-Clinical Trials ) We are developing our ImmCelz™ (CELZ-100) technology for the treatment of multiple indications.
These agencies and other federal, state, and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, post-approval monitoring, advertising, promotion, sampling and import and export of medical products. The following is a general overview of the laws and regulations pertaining to our business.
These agencies and other federal, state, and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, post-approval monitoring, advertising, promotion, sampling and import and export of medical products.
Other Products and Services Additional Indications We are also exploring the use of our technologies and/or have filed patents covering treatments for · Preventing the rejection of transplanted organs · Kidney failure · Liver failure · Heart attack · Parkinson’s Disease 10 Table of Contents Intellectual Property We have developed and acquired a robust intellectual property portfolio related to the utilization of stem cells to improve patient lives in the areas of urology, neurology, and orthopedics.
To date, we have not generated any revenues from this product, and as a result, have paused marketing efforts and are re-evaluating the product strategy. 11 Table of Contents Other Products and Services Additional Indications We are also exploring the use of our technologies and/or have filed patents covering treatments for · Preventing the rejection of transplanted organs · Kidney failure · Liver failure · Heart attack · Parkinson’s Disease Intellectual Property We have developed and acquired a robust intellectual property portfolio related to the utilization of stem cells to improve patient lives in the areas of urology, neurology, and orthopedics.
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.
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.
If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure of our products, total or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions.
Further, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action. 18 Table of Contents If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure of our products, total or partial shutdown of our production, withdrawal of approvals, and criminal prosecutions.
The immune cells are then re-injected into the patient from whom they were extracted. In contrast with 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 contrast with 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.
An NDA or BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA and BLA supplements as it does in reviewing NDAs and BLAs. 17 Table of Contents Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
The contract grants ImmCelz™ access to proprietary process of expanding the master cell bank of Jadi Cell LLC, as currently practiced by Licensor, and as documented in standard operating procedures (SOPs) and other written documentation to augment autologous cells.
Patent# 9,803,176 B2, “Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses”. The contract grants ImmCelz™ access to proprietary process of expanding the master cell bank of Jadi Cell LLC, as currently practiced by Licensor, and as documented in standard operating procedures (SOPs) and other written documentation to augment autologous cells.
Significant risk devices require the submission of an IDE application to the FDA and the FDA’s approval of the IDE application. 19 Table of Contents The FDA premarket clearance and approval process can be lengthy, expensive, and uncertain. It generally takes three to twelve months from submission to obtain 510(k) premarket clearance, although it may take longer.
The FDA premarket clearance and approval process can be lengthy, expensive, and uncertain. It generally takes three to twelve months from submission to obtain 510(k) premarket clearance, although it may take longer.
If one or more of the above factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P. 15 Table of Contents In addition, pursuant to the “Same Surgical Procedure Exception” under Section 1271.15(b) of the HCT/P Regulations, the FDA has provided guidance that exempts HCT/Ps from Section 361 of the PHS Act where autologous cells are removed from an individual and implanted into the same individual during a single surgical procedure without intervening processing steps.
In addition, pursuant to the “Same Surgical Procedure Exception” under Section 1271.15(b) of the HCT/P Regulations, the FDA has provided guidance that exempts HCT/Ps from Section 361 of the PHS Act where autologous cells are removed from an individual and implanted into the same individual during a single surgical procedure without intervening processing steps.
Drug and Biological Product Regulation An HCT/P product that does not meet the criteria for being solely regulated under Section 361 of the PHS Act will be regulated as a drug, device or biological product under the FDCA and/or Section 351 of the PHS Act, and applicable FDA regulations.
If any of these events were to occur, it could materially adversely affect us. 16 Table of Contents Drug and Biological Product Regulation An HCT/P product that does not meet the criteria for being solely regulated under Section 361 of the PHS Act will be regulated as a drug, device or biological product under the FDCA and/or Section 351 of the PHS Act, and applicable FDA regulations.
AlloStemSpine ® Chronic Lower Back Pain (CELZ 201 ADAPT) (Phase I/IIa FDA Study Approved) Our AlloStemSpine® treatment of lower back pain is a minimally invasive procedure that uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician.
Subjects in Group II (Control Arm, n=6) and will receive enhanced standard of care for type 1 diabetes. 9 Table of Contents AlloStemSpine ® Chronic Lower Back Pain (CELZ 201 ADAPT) (Phase I/IIa FDA Study Approved) Our AlloStemSpine® treatment of lower back pain is a minimally invasive procedure that uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician.
These clinical trials are intended to further evaluate dosage, effectiveness, and safety, to establish the overall benefit-risk profile of the investigational product and to provide an adequate basis for product labeling and approval by the FDA. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic.
These clinical trials are intended to further evaluate dosage, effectiveness, and safety, to establish the overall benefit-risk profile of the investigational product and to provide an adequate basis for product labeling and approval by the FDA.
The remaining portion of the $300,000 obligation was paid in cash in 2020. In August 2023, the Company paid CMH $100,000 related to the filing of an IND with the FDA per the terms of the agreement. In August 2024, the Company paid CMH $200,000 as a result of dosing the first patient in a Phase 1-2 clinical trial.
The remaining portion of the $300,000 obligation was paid in cash in 2020. In August 2023, the Company paid CMH $100,000 related to the filing of an IND with the FDA per the terms of the agreement.
Studies have shown that the introduction of stem cells into dysfunctional ovaries induce fertility, reduce ovarian fibrosis, accelerate maturation of immature oocytes, and restore growth factor production damaged by aging and cancer interventions.
Studies have shown that the introduction of stem cells into dysfunctional ovaries induce fertility, reduce ovarian fibrosis, accelerate maturation of immature oocytes, and restore growth factor production damaged by aging and cancer interventions. Accordingly, we believe that our OvaStem™ procedure may be a suitable treatment for these women with damaged ovaries.
This reflects expenses associated with the laboratory research, the execution of our Type I Diabetes Phase I/II and Lower Back Pain Phase I/II clinical trials, the manufacturing and testing of our ImmCelz™ cell line, and the development of our iPSC cell line in partnership with Greenstone Biosciences Inc.
This reflects expenses associated with the laboratory research, the Lower Back Pain Phase I/II 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. Research and development expenses for the year ended December 31, 2024 totaled $2,400,777.
FDA Regulation of Stem Cell Treatment and Products The FDA regulates the manufacture of human stem cell treatments and associated products under the authority of the Public Health Service Act (or PHS Act), and the Federal Food, Drug, and Cosmetic Act (or FDCA).
The following is a general overview of the laws and regulations pertaining to our business. 15 Table of Contents FDA Regulation of Stem Cell Treatment and Products The FDA regulates the manufacture of human stem cell treatments and associated products under the authority of the Public Health Service Act (or PHS Act), and the Federal Food, Drug, and Cosmetic Act (or FDCA).
We expect to enroll the second cohort in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans. On, October 23, 2024 we sold 418,552 shares of common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules.
On, October 23, 2024 we sold 418,552 shares of common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules.
Class II devices are subject to the General Controls as well as certain Special Controls such as 510(k) premarket notification. Class III devices are subject to the highest degree of regulatory scrutiny and typically include life supporting and life sustaining devices and implants.
Class III devices are subject to the highest degree of regulatory scrutiny and typically include life supporting and life sustaining devices and implants. They are subject to the General Controls and Special Controls that include a premarket approval application, or PMA.
A recent study reported that an estimated 2.6 million patients in the U.S. will have suffered from degenerative disc disease in 2021, with the number increasing to close to four million patients in 2028. 8 Table of Contents Management has determined that StemSpine® is exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with his or her own cells during the same surgical procedure without intervening processing steps.
Management has determined that StemSpine® is exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with his or her own cells during the same surgical procedure without intervening processing steps.
Class I devices are subject to the lowest degree of regulatory scrutiny because they are considered low risk devices and need only comply with the FDA’s General Controls. The General Controls include compliance with the registration, listing, adverse event reporting requirements, and applicable portions of the Quality System Regulation as well as the general misbranding and adulteration prohibitions.
Class I devices are subject to the lowest degree of regulatory scrutiny because they are considered low risk devices and need only comply with the FDA’s General Controls.
The FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved. Such trials may be made a condition to be satisfied for continuing drug approval. The results of Phase 4 clinical trials can confirm the effectiveness of a product candidate and can provide important safety information.
Such trials may be made a condition to be satisfied for continuing drug approval. The results of Phase 4 clinical trials can confirm the effectiveness of a product candidate and can provide important safety information. In addition, the FDA has authority to require sponsors to conduct post-marketing trials to specifically address safety issues identified by the agency.
In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track NDA or BLA before the application is complete, a process known as rolling review. 18 Table of Contents Any product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types of FDA programs intended to expedite development and review: · Breakthrough therapy designation .
In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track NDA or BLA before the application is complete, a process known as rolling review.
They are subject to the General Controls and Special Controls that include a premarket approval application, or PMA. “New” devices are automatically regulated as Class III devices unless they are shown to be low risk, in which case they may be subject to de novo review to be moved to Class I or Class II.
“New” devices are automatically regulated as Class III devices unless they are shown to be low risk, in which case they may be subject to de novo review to be moved to Class I or Class II. Clinical research of an investigational device is subject to the FDA’s Investigational Device Exemption, or IDE, regulations.
Delay in obtaining, or failure to obtain, regulatory approval for our products, or obtaining approval but for significantly limited use, would harm our business. Further, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action.
Delay in obtaining, or failure to obtain, regulatory approval for our products, or obtaining approval but for significantly limited use, would harm our business.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. These government regulations may delay or prevent approval of product candidates for a considerable period of time and impose costly procedures upon our business operations.
These government regulations may delay or prevent approval of product candidates for a considerable period of time and impose costly procedures upon our business operations. The FDA may require, or companies may pursue, additional clinical trials, referred to as Phase 4 clinical trials, after a product is approved.
The Department of Health and Human Services, or HHS, through its Office for Civil Rights, investigates breach reports and determines whether administrative or technical modifications are required and whether civil or criminal sanctions should be imposed.
Further, we may need to also comply with additional federal or state privacy laws and regulations that may apply to certain diagnoses, such as HIV/AIDS, to the extent that they apply to us. 20 Table of Contents The Department of Health and Human Services, or HHS, through its Office for Civil Rights, investigates breach reports and determines whether administrative or technical modifications are required and whether civil or criminal sanctions should be imposed.
Accordingly, we believe that our OvaStem™ procedure may be a suitable treatment for these women with damaged ovaries. 9 Table of Contents The OvaStem™ stem cell treatment will consist of a one-hour out-patient visit in a physician’s office. The physician will harvest a patient’s stem cells from bone marrow in the hip using a local anesthetic.
The OvaStem™ stem cell treatment will consist of a one-hour out-patient visit in a physician’s office. The physician will harvest a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device will harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation.
All clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be considered reliable for regulatory purposes. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all.
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The extraction device will harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells would then be administered into the dysfunctional ovaries.
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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.
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To date, we have not generated any revenues from this product, and as a result, have paused marketing efforts and are re-evaluating the product strategy.
Added
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.
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The Agreement grants to ImmCelz™ the patent rights under U.S. Patent# 9,803,176 B2, “Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses”.
Added
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.
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In addition, the FDA has authority to require sponsors to conduct post-marketing trials to specifically address safety issues identified by the agency.
Added
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.
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Further, we may need to also comply with additional federal or state privacy laws and regulations that may apply to certain diagnoses, such as HIV/AIDS, to the extent that they apply to us.
Added
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.
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Research and development expenses for the year ended December 31, 2023 totaled $1,970,639.
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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.
Added
We are executing a national program which will provide the critical data infrastructure to: · Decode the genomic and proteomic architecture of toxic-exposure-related injury. · Engineer iPSC-based regenerative repair models using Creative Medical’s patented cell platform. · Validate next-generation AI/ML biodefense algorithms for exposure classification and precision intervention. · Develop predictive, preemptive disease modeling systems for deployment across military and civilian populations.
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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.
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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. 7 Table of Contents In November, 2025, the Company contributed $43,200 to the capital of Bionance, which, together with Mr.
Added
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.
Added
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.
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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.
Added
The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees.
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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.
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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.
Added
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.
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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.
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ImmCelz™ (CELZ-100) utilizes a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized secreted factors. The immune cells are then re-injected into the patient from whom they were extracted.
Added
A recent study reported that an estimated 2.6 million patients in the U.S. will have suffered from degenerative disc disease in 2021, with the number increasing to close to four million patients in 2028.
Added
The cells would then be administered into the dysfunctional ovaries.
Added
The Company paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 667 shares of common stock on December 12, 2020.
Added
In August 2024, the Company paid CMH $200,000 as a result of dosing the first patient in a Phase 1-2 clinical trial. 14 Table of Contents ImmCelz™ (CELZ-100) - On December 28, 2020, ImmCelz, Inc.
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If one or more of the above factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P.
Added
Approval of an NDA requires a showing that the drug is safe and effective for its intended use and that the methods, facilities, and controls used for the manufacturing, processing, and packaging of the drug are adequate to preserve its identity, strength, quality, and purity.
Added
In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic. 17 Table of Contents All clinical trials must be conducted in accordance with FDA regulations, GCP requirements and their protocols in order for the data to be considered reliable for regulatory purposes.
Added
An NDA or BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA and BLA supplements as it does in reviewing NDAs and BLAs.
Added
Any product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types of FDA programs intended to expedite development and review: · Breakthrough therapy designation .
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The General Controls include compliance with the registration, listing, adverse event reporting requirements, and applicable portions of the Quality System Regulation as well as the general misbranding and adulteration prohibitions. 19 Table of Contents Class II devices are subject to the General Controls as well as certain Special Controls such as 510(k) premarket notification.
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
18 edited+3 added−3 removed109 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
18 edited+3 added−3 removed109 unchanged
2024 filing
2025 filing
Biggest changeIf any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
Biggest changeIf any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. 30 Table of Contents If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations.
We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved. 22 Table of Contents Even with the proceeds from our recent securities offerings, we will need additional capital to fund our operations as planned.
We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved. 22 Table of Contents Even with the proceeds from our securities offerings, we will need additional capital to fund our operations as planned.
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 expect to continue to incur significant financial losses in the future as we 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.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with any third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: · refusals or delays in the approval of applications or supplements to approved applications; · refusal of a regulatory authority to review pending market approval applications or supplements to approved applications; 26 Table of Contents · restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls or seizures; · fines, warning letters, or holds on clinical trials; · injunctions or the imposition of civil or criminal penalties; · restrictions on product administration, requirements for additional clinical trials, or changes to product labeling requirements; or · recommendations by regulatory authorities against entering into governmental contracts with us.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with any third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: · refusals or delays in the approval of applications or supplements to approved applications; · refusal of a regulatory authority to review pending market approval applications or supplements to approved applications; · restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls or seizures; · fines, warning letters, or holds on clinical trials; · injunctions or the imposition of civil or criminal penalties; · restrictions on product administration, requirements for additional clinical trials, or changes to product labeling requirements; or · recommendations by regulatory authorities against entering into governmental contracts with us.
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. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms.
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, which are in process. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms.
To the extent that any disruption or security breach results in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our future product candidates could be delayed. We are subject to risks arising from the global outbreak of the COVID-19 coronavirus.
To the extent that any disruption or security breach results in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our future product candidates could be delayed. 28 Table of Contents We are subject to risks arising from the global outbreak of the COVID-19 coronavirus.
Item 1A. Risk Factors RISK FACTORS Risks Related to our Financial Position and Capital Needs We have incurred recent losses and our future profitability is uncertain. We have incurred an operating loss of approximately $5.7 million for the year ended December 31, 2024, and a loss of approximately $5.6 million for the year ended December 31, 2023, respectively.
Item 1A. Risk Factors RISK FACTORS Risks Related to our Financial Position and Capital Needs We have incurred recent losses and our future profitability is uncertain. We have incurred an operating loss of approximately $6.1 million for the year ended December 31, 2025, and a loss of approximately $5.7 million for the year ended December 31, 2024, respectively.
Although we generated gross proceeds in excess of $32 million from our 2021, 2022 and 2024 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.
Although we generated gross proceeds in excess of $40 million from our 2021, 2022, 2024, and 2025 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.
Revenues generated from sales of our CaverStem ® kits were only $11,000 and $9,000 for the years ended December 31, 2024, and December 31, 2023, 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.
Revenues generated from sales of our CaverStem ® kits were only $6,000 and $11,000 for the years ended December 31, 2025, and 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.
Another significant, outbreak of COVID-19, a communicable disease, could disrupt our clinical trials, supply chain and the manufacture or shipment of our products, and other related activities, which could have a material adverse effect on our business, financial condition and results of operations, and may also have an adverse impact on global economic conditions which could impair our ability to raise capital when needed. 28 Table of Contents We are subject to risks arising from the wars in Ukraine and the Gaza Strip.
Another significant, outbreak of COVID-19, a communicable disease, could disrupt our clinical trials, supply chain and the manufacture or shipment of our products, and other related activities, which could have a material adverse effect on our business, financial condition and results of operations, and may also have an adverse impact on global economic conditions which could impair our ability to raise capital when needed.
Even if we determine to perform sales, marketing, and distribution functions ourselves, we could face a number of additional related risks, including: · we may not be able to attract and build an effective marketing department or sales force; · the cost of establishing a marketing department or sales force may exceed our available financial resources and the revenue generated by our product candidates that we may develop, in-license or acquire; and · our direct sales and marketing efforts may not be successful. 27 Table of Contents We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits and are dependent on their quality and effectiveness.
Even if we determine to perform sales, marketing, and distribution functions ourselves, we could face a number of additional related risks, including: · we may not be able to attract and build an effective marketing department or sales force; 27 Table of Contents · the cost of establishing a marketing department or sales force may exceed our available financial resources and the revenue generated by our product candidates that we may develop, in-license or acquire; and · our direct sales and marketing efforts may not be successful.
Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs. 30 Table of Contents While we believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business.
While we believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business.
We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits.
We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits and are dependent on their quality and effectiveness. We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits.
Globally, governmental, and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue. 25 Table of Contents Our existing and proposed products are and will be subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and the implementation of U.S. health care reform legislation that is increasing these pricing pressures.
Globally, governmental, and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.
Depending on the facts and circumstances, we could be subject to civil or criminal penalties if we knowingly use or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Depending on the facts and circumstances, we could be subject to civil or criminal penalties if we knowingly use or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. 26 Table of Contents Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies and can expose us to product liability claims.
Our success and the extent of our growth will depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as public and private insurers and health systems.
Our success and the extent of our growth will depend in part on the extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as public and private insurers and health systems. 25 Table of Contents The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement, and access to therapies, which could adversely affect our future revenues and profitability.
The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement, and access to therapies, which could adversely affect our future revenues and profitability. Our existing and proposed products may not be considered cost-effective, and third-party or government reimbursement might not be available or sufficient.
Our existing and proposed products may not be considered cost-effective, and third-party or government reimbursement might not be available or sufficient.
At December 31, 2024, we had a combined cash, and short-term U.S. treasuries balance of approximately $5.9 million.
For the year ended December 31, 2025, our operations used approximately $5.9 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our securities offerings, including upon exercise of warrants in our warrant exercise transactions. At December 31, 2025, we had a combined cash, and short-term U.S. treasuries balance of approximately $7.2 million.
Removed
For the year ended December 31, 2024, our operations used approximately $5.3 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our December 2021 public offering, our May 2022 private offering and our December 2024 private offering.
Added
Our existing and proposed products are and will be subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and the implementation of U.S. health care reform legislation that is increasing these pricing pressures.
Removed
Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies and can expose us to product liability claims.
Added
We are subject to risks arising from the wars in Ukraine and the Gaza Strip.
Removed
If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations.
Added
Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
1 edited+0 added−0 removed4 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
1 edited+0 added−0 removed4 unchanged
2024 filing
2025 filing
Biggest changeAccordingly, management has not implemented any formal process for assessing, identifying, and managing risks from cybersecurity threats. Risks from cybersecurity threats have, to date, not materially affected us, our business strategy, results of operations or financial condition.
Biggest changeAccordingly, management has not implemented any formal process for assessing, identifying, and managing risks from cybersecurity threats. 32 Table of Contents Risks from cybersecurity threats have, to date, not materially affected us, our business strategy, results of operations or financial condition.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
6 edited+0 added−1 removed13 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
6 edited+0 added−1 removed13 unchanged
2024 filing
2025 filing
Biggest changeThe following table provides information about our monthly share repurchases for the year ended December 31, 2024, which consisted solely of repurchases on the open market under the Repurchase Plan. 33 Table of Contents ISSUER PURCHASES OF EQUITY SECURITIES Period Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs Maximum Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs January 1, 2023 – December 31, 2023 57,500 $ 4.71 57,500 $ 1,676,510 January 1 - January 31, 2024 6,000 4.30 63,500 1,702,253 February 1 - February 29, 2024 7,500 4.24 71,000 1,671,453 March 1 – March 31, 2024 5,500 4.58 76,500 1,646,253 April 1 – April 30, 2024 6,500 4.74 83,000 1,615,440 May 1 – May 31, 2024 500 4.47 83,500 1,613,206 June 1 – June 30, 2024 9,500 3.54 93,000 1,579,534 July 1 – July 31, 2024 500 2.83 93,500 1,577,262 August 1 – August 31, 2024 5,250 3.16 98,750 1,561,153 September 1 – September 30, 2024 2,500 2.83 101,250 1,554,084 Total January 1 – December 31, 2024 43,750 4.00 Cumulative Purchases 101,250 4.40 Securities Authorized for Issuance under Equity Compensation Plans The following table sets forth as of the most recent fiscal year ended December 31, 2024, certain information with respect to compensation plans (including individual compensation arrangements) under which our common stock is authorized for issuance: Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and Rights (a) Weighted- average exercise price of outstanding options, warrants and rights (b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a) and (b)) (c) Equity compensation plans approved by security holders 11,182 (1) $ 16.90 48,818 (1) Equity compensation plans not approved by security holders 9,813 (2) $ 107.10 3 (3) Total 20,995 $ 56.70 48,821 _________________ (1) Represents 5,858 shares of common stock issuable to Timothy Warbington, the Company’s Chief Executive Officer, under a ten-year option issued on February 9, 2022 with an exercise price of $16.90 per share, and 5,324 shares of common stock issuable to Donald Dickerson, the Company’s Chief Financial Officer, under a ten-year option issued on February 9, 2022 with an exercise price of $16.90 per share, and shares available for issuance under the Company’s 2021 Equity Incentive Plan.
Biggest changeThere were no repurchases of common stock by the Company in the three months ended December 31, 2025. 34 Table of Contents Securities Authorized for Issuance under Equity Compensation Plans The following table sets forth as of the most recent fiscal year ended December 31, 2025, certain information with respect to compensation plans (including individual compensation arrangements) under which our common stock is authorized for issuance: Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and Rights (a) Weighted- average exercise price of outstanding options, warrants and rights (b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a) and (b)) (c) Equity compensation plans approved by security holders 11,182 (1) $ 16.90 48,818 (1) Equity compensation plans not approved by security holders 9,813 (2) $ 107.10 3 (3) Total 20,995 $ 56.70 48,821 _________________ (1) Represents 5,858 shares of common stock issuable to Timothy Warbington, the Company’s Chief Executive Officer, under a ten-year option issued on February 9, 2022 with an exercise price of $16.90 per share, and 5,324 shares of common stock issuable to Donald Dickerson, the Company’s Chief Financial Officer, under a ten-year option issued on February 9, 2022 with an exercise price of $16.90 per share, and shares available for issuance under the Company’s 2021 Equity Incentive Plan.
(3) Represents 3 shares available under the Company’s 2016 Stock Incentive Plan. 34 Table of Contents 2021 Equity Incentive Plan On September 6, 2021, the Company’s Board of Directors, and holders of a majority of the voting power of the Company’s stockholders approved the Company’s 2021 Equity Incentive Plan (the “2021 Plan”).
(3) Represents 3 shares available under the Company’s 2016 Stock Incentive Plan. 35 Table of Contents 2021 Equity Incentive Plan On September 6, 2021, the Company’s Board of Directors, and holders of a majority of the voting power of the Company’s stockholders approved the Company’s 2021 Equity Incentive Plan (the “2021 Plan”).
Unless otherwise approved by the Committee, awards under the 2021 Plan are not assignable or transferable by the person to whom they are granted, either voluntarily or by operation of law, except by will or the laws of descent and distribution, and, during the life of the participant, shall be exercisable only by the participant.
Unless otherwise approved by the Committee, awards under the 2021 Plan are not assignable or transferable by the person to whom they are granted, either voluntarily or by operation of law, except by will or the laws of descent and distribution, and, during the life of the participant, shall be exercisable only by the participant. 36 Table of Contents
Holders As of March 22, 2025, the number of holders of record of shares of common stock, excluding the number of beneficial owners whose securities are held in street name, was approximately 75.
Holders As of March 20, 2026, the number of holders of record of shares of common stock, excluding the number of beneficial owners whose securities are held in street name, was approximately 75.
Subject to the terms of the 2021 Plan, the Committee has the authority to determine the individuals to whom, and the time or times at which, awards are made, the size of each award, and the other terms and conditions of each award (which need not be identical across participants).
The 2021 Plan is administered by the compensation committee of the Board (the “Committee”).Subject to the terms of the 2021 Plan, the Committee has the authority to determine the individuals to whom, and the time or times at which, awards are made, the size of each award, and the other terms and conditions of each award (which need not be identical across participants).
To date, we have repurchased 101,250 shares of common stock under the Repurchase Plan for an aggregate purchase price of $445,916.
To date, we have repurchased 106,250 shares of common stock under the Repurchase Plan for an aggregate purchase price of $455,916.
Removed
The 2021 Plan is administered by the compensation committee of the Board (the “Committee”).
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
29 edited+30 added−2 removed45 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
29 edited+30 added−2 removed45 unchanged
2024 filing
2025 filing
Biggest changeWe expect to enroll the second cohort in this trial in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans. On, October 23, 2024 we sold 418,552 shares of common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules.
Biggest changeOn, Oct. 23, 2024 we sold 418,552 shares of our common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, we issued the same investors warrants to purchase up to 837,104 shares of common stock.
At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement. 37 Table of Contents 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.
At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement. 38 Table of Contents 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.
We acquired a patent (U.S. Patent No. 8,372,797) from CMH on February 2, 2016, in exchange for shares of our restricted common stock valued at $100,000. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis.
Amortization Expense . We acquired a patent (U.S. Patent No. 8,372,797) from CMH on February 2, 2016, in exchange for shares of our restricted common stock valued at $100,000. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis.
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: · Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort. · Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease. · DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.
Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned 39 Table of Contents Key Milestones Achieved: · Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort. · Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease. · DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.
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. 36 Table of Contents In June 2022, we signed an agreement with Greenstone Biosciences Inc.
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. 37 Table of Contents In June 2022, we signed an agreement with Greenstone Biosciences Inc.
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. 38 Table of Contents In January, 2025 we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial.
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 January, 2025 we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial.
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.
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. We have continued to realize losses from operations.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth in the section captioned “ Risk Factors ” in Annual Report. The following should be read in conjunction with our audited financial statements included elsewhere herein.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth in the section captioned “Risk Factors” in Annual Report. The following should be read in conjunction with our audited financial statements included elsewhere herein.
The increase of $2,000 or 22% is due to a slight increase 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.
The decrease of $5,000 or 46% is due to a slight decrease 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.
Overview We are a commercial stage biotechnology company dedicated to the advancement of identifying and translating novel biological 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.
Overview We are a commercial stage biotechnology company dedicated to the advancement of regenerative therapies 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.
Amortization expense of $110,452 was recorded for the year ended December 31, 2024, representing the amortization of the ED, multipotent amniotic fetal stem cell and lower back pain patents and the Jadi Cell patent license agreement based upon the remaining life of the patents and license agreement.
Amortization expense of $123,327 was recorded for the year ended December 31, 2025, representing the amortization of the ED, multipotent amniotic fetal stem cell and lower back pain patents and the Jadi Cell patent license agreement based upon the remaining life of the patents and license agreement.
The share of Series B Preferred Stock were automatically redeemed when the Share Increase Proposal was approved.
The share of Series B Preferred Stock were automatically redeemed when the Share Increase Proposal was approved. The Series B Preferred Stock was not convertible into common stock.
Net Cash used in Investing Activities . Cash provided from investing activities was $6,320,191 for the year ended December 31, 2024, primarily due to $6,520,191 in net certificate of deposit redemptions, offset a $200,000 payment on a patent purchase agreement.
In comparison, we received $6,320,191 for the year ended December 31, 2024 primarily due to $6,520,191 in net certificate of deposit redemptions, offset by a $200,000 payment on a patent purchase agreement. Net Cash from Financing Activities.
General and administrative expenses for the year ended December 31, 2024, totaled $3,239,232, in comparison with $3,560,309 for the comparable period a year ago.
General and administrative expenses for the year ended December 31, 2025, totaled $3,763,497, in comparison with $3,239,232 for the comparable period a year ago.
However, as a result of our December 2021, May 2022 and October 2024 offerings, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements through at least March 2026. We anticipate that we will need to raise additional capital in the future to support our ongoing operations and continue our clinical trials.
However, as a result of our recent warrant exercise transactions, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements through at least March 2027. We anticipate that we will need to raise additional capital in the future to support our ongoing operations and continue our clinical trials.
For the reasons stated above, our operating loss for the year ended December 31, 2024, was $5,743,861 in comparison with $5,620,132 for the comparable period a year ago. Other Income . Other income for the year ended December 31, 2024, totaled $250,380 in comparison with $333,558 for the comparable period a year ago.
For the reasons stated above, our operating loss for the year ended December 31, 2025, was $6,142,814 in comparison with $5,743,861 for the comparable period a year ago. Other Income . Other income for the year ended December 31, 2025, totaled $147,806 in comparison with $250,380 for the comparable period a year ago.
The decreased income of $83,178 or 25%, is due to a $901,385 reduced balance and lower interest rates on our short-term U.S. treasuries. Net Income/Loss . For the reasons stated above, our net loss for the year ended December 31, 2024, was $5,493,481 in comparison with a loss of $5,286,574 for the comparable period a year ago. Amortization Expense .
The decreased income of $102,574 or 41%, is due to a $651,655 reduced average balance and lower interest rates on our short-term U.S. treasuries. Net Income/Loss . For the reasons stated above, our net loss for the year ended December 31, 2025, was $5,995,008 in comparison with a loss of 5,493,481 for the comparable period a year ago.
The Series B Preferred Stock was not convertible into common stock. 40 Table of Contents On, Oct. 23, 2024 we sold 418,552 shares of our common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules.
On, October 23, 2024 we sold 418,552 shares of common stock at a price of $4.42 per share to certain institutional investors in a registered direct offering priced at-the-market under Nasdaq rules.
On December 19, 2024, the stockholders of the Company approved an amendment to the Company’s Articles of Incorporation to increase the number of authorized shares of common stock from 5,000,000 to 25,000,000. Net Cash used in Operating Activities. We used cash in our operating activities due to our losses from operations.
On December 19, 2024, the stockholders of the Company approved an amendment to the Company’s Articles of Incorporation to increase the number of authorized shares of common stock from 5,000,000 to 25,000,000.
In a concurrent private placement, we issued the same investors warrants to purchase up to 837,104 shares of common stock. The warrants have an exercise price of $4.42 per share, are exercisable until December 19, 2029. Net proceeds from these offerings were approximately $1.6 Million. Roth Capital Partners acted as the exclusive placement agent for the offerings.
The warrants have an exercise price of $4.42 per share, are exercisable until December 19, 2029. Net proceeds from these offerings were approximately $1.6 Million. Roth Capital Partners acted as the exclusive placement agent for the offerings.
We generated $6,600 in gross profit for the year ended December 31, 2024, in comparison with $5,400 in gross profit for the comparable period a year ago. The increase of $1,200 or 22% is due to the increase in revenue. Selling, General and Administrative Expenses .
We generated $3,806 in gross profit for the year ended December 31, 2025, in comparison with $6,600 in gross profit for the comparable period a year ago. The decrease of $2,794 or 42% is due to the decrease in revenue. Selling, General and Administrative Expenses .
Cost of Goods Sold . We generated $4,400 in cost of goods sold for the year ended December 31, 2024, in comparison with $3,600 for the comparable period a year ago. The increase of $800 or 22% is due to the increase in revenue as described above. Gross Profit/(Loss) .
Cost of Goods Sold . We generated $2,194 in cost of goods sold for the year ended December 31, 2025, in comparison with $4,400 for the comparable period a year ago. The decrease of $2,206 or 50% is due to the decrease in revenue as described above. 41 Table of Contents Gross Profit/(Loss) .
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.
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.
Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012. Results of Operations – For the Year Ended December 31, 2024, and for the Year Ended December 31, 2023 Gross Revenue . We generated $11,000 in gross revenue for the year ended December 31, 2024, in comparison with $9,000 for the comparable period a year ago.
Results of Operations – For the Year Ended December 31, 2025, and for the Year Ended December 31, 2024 Gross Revenue . We generated $6,000 in gross revenue for the year ended December 31, 2025, in comparison with $11,000 for the comparable period a year ago.
On May 14, 2024, Timothy Warbington, our Chief Executive Officer, purchased one share of our newly designated Series B Preferred Stock for a purchase price of $100.
In comparison, as of December 31, 2024, we had approximately $5,940,402 of available cash and positive working capital of approximately $5,807,659. On May 14, 2024, Timothy Warbington, our Chief Executive Officer, purchased one share of our newly designated Series B Preferred Stock for a purchase price of $100.
There was $94,584 of amortization expense recorded for the period ended December 31, 2023. Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity capital expenditures or capital resources.
Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity capital expenditures or capital resources. 42 Table of Contents Liquidity and Capital Resources As of December 31, 2025, we had $7,208,126 of available cash and certificates of deposit and positive working capital of approximately $7,114,134.
Net cash used in operating activities was $5,301,292 for the year-ended ended December 30, 2024, in comparison to $8,027,885 for the comparable period a year ago, a decrease of 2,726,593 or 34%. The decrease in cash used in operations was primarily related to a one-time payment of $3,000,000 associated with the acquisition of research assets in 2023.
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 $5,856,445 for the year-ended ended December 31, 2025, in comparison to $5,301,292 for the comparable period a year ago, a decrease of $555,153 or 10%.
Research and development expenses for the year ended December 31, 2024, totaled $2,400,777 in comparison to $1,970,639 for the comparable period a year ago. The increase of $430,138, or 22% was primarily due to the ramp-up of the CELZ-201-ADAPT spine trial and the development of our iPSC cell line in partnership with Greenstone Biosciences Inc. Operating Loss .
The decrease of $140,981, or 6% was primarily due to 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. Operating Loss .
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. Net Cash from Financing Activities.
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.
Removed
The decrease of $321,077, or 9% is primarily due to reductions of $200,553 in salaries and wages, and $68,559 in Director and Officer insurance premiums and $118,500 in consulting services offset by $87,174 in increased operations expenses. 39 Table of Contents Research and Development Expenses .
Added
We expect to enroll the second cohort in this trial in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans. 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.
Removed
Liquidity and Capital Resources As of December 31, 2024, we had $5,940,402 of available cash and certificates of deposit and positive working capital of approximately $5,807,659. In comparison, as of December 31, 2023, we had approximately $9,987,058 of available cash and positive working capital of approximately $9,899,504.
Added
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.
Added
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.
Added
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).
Added
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.
Added
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.
Added
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.
Added
We are executing a national program which will provide the critical data infrastructure to: · Decode the genomic and proteomic architecture of toxic-exposure-related injury. · Engineer iPSC-based regenerative repair models using Creative Medical’s patented cell platform. · Validate next-generation AI/ML biodefense algorithms for exposure classification and precision intervention. · Develop predictive, preemptive disease modeling systems for deployment across military and civilian populations.
Added
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.
Added
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. 40 Table of Contents In November, 2025, the Company contributed $43,200 to the capital of Bionance, which, together with Mr.
Added
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.
Added
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.
Added
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.
Added
The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees.
Added
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.
Added
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.
Added
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.
Added
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.
Added
The increase of $524,265, or 16% is primarily due to increases of $349,363 in salaries tied to timing of bonus payments, $229,650 in increased marketing expenses, and $50,717 in timing of general liability insurance payments, offset by an $89,475 decrease in D&O insurance premiums. Research and Development Expenses .
Added
Research and development expenses for the year ended December 31, 2025, totaled $2,259,796 in comparison to $2,400,777 for the comparable period a year ago.
Added
There was $110,452 of amortization expense recorded for the period ended December 31, 2024.
Added
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.
Added
The aggregate gross proceeds from the exercise of the existing warrants was $3.7 million, before deducting financial advisory fees.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
The increase in cash used in operations was primarily related to increased operating expenses. 43 Table of Contents Net Cash used in Investing Activities . Cash used 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.
Added
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.