Did CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. add new Risk Factors in the 2024 10-K?

Yes — Item 1A Risk Factors shows 27 new/edited paragraphs and 29 removed paragraphs versus the 2023 10-K.

What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s MD&A (Item 7) in 2024?

Item 7 Management's Discussion & Analysis shows 56 new/edited paragraphs and 43 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Where does this CELZ 10-K diff come from?

The source filings are CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s official 2023 and 2024 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 10-K — 2023 vs 2024

Q: What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2024 10-K compared to 2023?

Across the narrative sections we track, CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. (CELZ) added 158 paragraphs, removed 155, and edited 102 between the 2023 and 2024 10-K filings. The biggest movers are Item 1. Business (+66/−75), Item 7. Management's Discussion & Analysis (+56/−43), Item 1A. Risk Factors (+27/−29).

Paragraph-level year-over-year comparison of CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2023 and 2024 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 2024 report.

+158 added−155 removedSource: 10-K (2025-03-14) vs 10-K (2024-03-22)

Top changes in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2024 10-K

158 paragraphs added · 155 removed · 102 edited across 5 sections

Item 1. Business+66 / −75 · 44 edited
Item 7. Management's Discussion & Analysis+56 / −43 · 30 edited
Item 1A. Risk Factors+27 / −29 · 23 edited
Item 5. Market for Registrant's Common Equity+8 / −5 · 5 edited
Item 2. Properties+1 / −3

Item 1. Business

Business — how the company describes what it does

44 edited+22 added−31 removed115 unchanged

2023 filing

2024 filing

Biggest changeIn March 2023, we reported the following results of independent studies: · ImmCelz® (CELZ-100) platform required 75% fewer donor patient cells compared to industry standard. · The purity of the final ImmCelz® (CELZ-100) product was greater than 95% compared to the industry standard of greater than 80%. · ImmCelz® (CELZ-100) demonstrated a greater than 200% reduction in functional suppression of effector T cells, which are a critical concern for patients with autoimmune issues, while still possessing a high number of functional T regulatory cells. · The ability to verify repeated potency of the final ImmCelz®(CELZ-100) product. 4 Table of Contents We believe these results show that we will be able to substantially reduce production costs, while allowing for the manufacture of the best clinical product for patients with immune disorders, which will enable us to accelerate our clinical applications and encourage potential collaborations with respect to our ImmCelz® platform.

Biggest changeIn March 2023, we reported the following results of independent studies: · ImmCelz™ (CELZ-100) platform required 75% fewer donor patient cells compared to industry standard. · The purity of the final ImmCelz™ (CELZ-100) product was greater than 95% compared to the industry standard of greater than 80%. · ImmCelz™ (CELZ-100) demonstrated a greater than 200% reduction in functional suppression of effector T cells, which are a critical concern for patients with autoimmune issues, while still possessing a high number of functional T regulatory cells. · The ability to verify repeated potency of the final ImmCelz™(CELZ-100) product.

Our 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 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 12 Table of Contents Patent Purchase and License Agreements Lower Back Pain Patent Purchase.

Our 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.

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.

Drug Master Files do not expire and are utilized by many pharmaceutical and biotechnology giants as well as many other industries for their products, dating back to the 1940s, Additionally, the treatment does not require people to take immunosuppressant drugs, minimizing the risk for various side effects.

Drug Master Files do not expire and are utilized by many pharmaceutical and biotechnology giants as well as many other industries for their products, dating back to the 1940s, Additionally, the treatment does not require the patient to take immunosuppressant drugs, minimizing the risk for various side effects.

In February 2023, the Company reported positive three-year follow-up data for its StemSpine® pilot study. The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects reported.

In February 2023, we reported positive three-year follow-up data for its StemSpine® pilot study. The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects reported.

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 FemCelz® 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 her own cells during the same surgical procedure without intervening processing steps.

The objective is to determine the safety and efficacy of CELZ-201 administration, based on the timing and dose of CELZ-201 treatment. Subjects who meet eligibility criteria will be randomized to treatment or control groups, in a 2:1 ratio.

The objective of the FDA-approved Phase 1/IIa trial is to determine the safety and efficacy of CELZ-201 administration, based on the timing and dose of CELZ-201 treatment. Subjects who meet eligibility criteria will be randomized to treatment or control groups, in a 2:1 ratio.

AlloStemSpine ® Chronic Lower Back Pain (CELZ 201 ADAPT) This study is a double-blinded, randomized, placebo-controlled, dose escalation Phase 1/2a study. The objective is to determine the safety, tolerability, and efficacy of CELZ-201-DDT administered as an intramuscular injection for the treatment of lower back pain in patients with Degenerative Disc Disease.

We have received FDA approval for a double-blinded, randomized, placebo-controlled, dose escalation Phase 1/2a study. The objective is to determine the safety, tolerability, and efficacy of CELZ-201-DDT administered as an intramuscular injection for the treatment of lower back pain in patients with Degenerative Disc Disease.

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 6 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.

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.

In June 2022, we signed an agreement with Greenstone Biosciences Inc. (“Greenstone”) for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz® platform. This project was identified as iPScelz™. The efforts by Greenstone are expected to complement and expand our current work on novel therapeutic cell lines.

(“Greenstone”) for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz™ platform. This project was identified as iPScelz™. The efforts by Greenstone are expected to complement and expand our current work on novel therapeutic cell lines.

(“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.

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.

Government Regulation The health care industry is highly regulated in the United States. The federal government, through various departments and agencies, state and local governments, and private third-party accreditation organizations, regulate and monitor the health care industry, associated products, and operations.

The federal government, through various departments and agencies, state and local governments, and private third-party accreditation organizations, regulate and monitor the health care industry, associated products, and operations.

We continue to have the previously licensed platform from Jadi Cells LLC for the first generation ImmCelz™ (CELZ-100). Type I Diabetes (CELZ-201 CREATE-1) – Type I Diabetes The proposed study is a Phase I/IIa randomized, controlled clinical trial to evaluate CELZ-201 therapy as an intervention for the treatment of recent onset Type 1 Diabetes.

We continue to have the previously licensed platform from Jadi Cells LLC for the first generation ImmCelz™ (CELZ-100). Type I Diabetes (CELZ-201 CREATE-1) – Type I Diabetes (Phase I/IIa FDA Study Approved) Our CELZ-201 CREATE-1 therapy as an intervention for the treatment of recent onset Type 1 Diabetes.

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, 2023, totaled $1,970,639.

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.

We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc. On May 18, 2016, we completed a reverse merger transaction under which Creative Medical Technologies, Inc. became our wholly owned subsidiary. In connection with this merger, we changed our name to Creative Medical Technologies Holdings, Inc. to reflect our current business.

Our 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. 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.

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.

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.

This reflects expenses associated with the development of our drug master file, laboratory research in preparation of our master cell bank submittal to the FDA, the approval of our FDA application for a Type I Diabetes Phase 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 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.

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 Trials) Our StemSpine® procedure uses the patient’s own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain.

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.

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.

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.

In March 2023, the Company announced that it filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz® (CELZ-100) platform. The FDA has responded to the ODD filing with additional clarification requests, which we are in the process of responding.

In March 2023, we announced that we had filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ (CELZ-100) platform . In March 2024 we received the ODD from the FDA.

Patent No. 8,372,797) that utilizes a patient’s own stem cells to treat erectile dysfunction (ED).

CaverStem ® - Erectile Dysfunction Treatment CaverStem® is a clinically proven, patented procedure (U.S. Patent No. 8,372,797) that utilizes a patient’s own stem cells to treat erectile dysfunction (ED).

Like our CaverStem® and FemCelz® procedures, because OvaStem™ will utilize a patient’s own extracted immune cells, management has determined that OvaStem™ will be 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 her own cells during the same surgical procedure without intervening processing steps. 9 Table of Contents On July 28, 2022, we announced positive three-year follow up data for the Company's OvaStem® pilot study.

Because OvaStem™ will utilize a patient’s own extracted immune cells, management has determined that OvaStem™ will be 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 her own cells during the same surgical procedure without intervening processing steps.

The data shows significant efficacy of the OvaStem® procedure for the treatment of medical refractory Primary Ovarian Insufficiency (POI) without any serious adverse effects and the successful birth of healthy babies.

On July 28, 2022, we announced positive three-year follow up data for the Company’s OvaStem™ pilot study. The data shows significant efficacy of the OvaStem™ procedure for the treatment of medical refractory Primary Ovarian Insufficiency (POI) without any serious adverse effects and the successful birth of healthy babies.

Our CaverStem ® and FemCelz ® kits are currently available through physicians at eight locations in the United States. In 2020, through our ImmCelz Inc. subsidiary, we began developing treatments under our ImmCelz® platform (CELZ-100), that utilize a patient’s own extracted immune cells that are then “reprogrammed/supercharged” by culturing them outside the patient’s body with optimized cell-free factors.

However, neither ImmCelz Inc., nor AlloCelz LLC have commenced commercial activities. In 2020, through our ImmCelz Inc. subsidiary, we began developing treatments under our ImmCelz™ platform (CELZ-100), that utilize a patient’s own extracted immune cells that are then “reprogrammed/supercharged” by culturing them outside the patient’s body with optimized cell-free factors.

In April 2023, the Company reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes. There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial.

There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial. There were 30 patients in the study, 15 received CELZ-001 and the rest received optimized medical therapy.

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. ImmCelz™ (CELZ-100) - On December 28, 2020, ImmCelz, Inc.

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.

Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, Longeveron, BioRestorative Therapies, and DiscGenics. Companies working in the area of regenerative medicine to treat back pain inject into the disc, and our treatment is injected around the disc. Government Regulation U.S.

Companies working in the area of regenerative medicine to treat back pain inject into the disc, and our treatment is injected around the disc. Government Regulation U.S. Government Regulation The health care industry is highly regulated in the United States.

Research and development expenses for the year ended December 31, 2022 totaled $6,268,854.

Research and development expenses for the year ended December 31, 2023 totaled $1,970,639.

In September 2023, the Company 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. 5 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 have validated this ability through the third-party studies described below that were independently conducted on selected human donor patient cells for accuracy and reproducibility. In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration.

We have validated this ability through the third-party studies described below that were independently conducted on selected human donor patient cells for accuracy and reproducibility.

This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain. 5 Table of Contents In October, 2023 the Company filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial.

This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.

FemCelz ® - Female Sexual Function Treatment In September 2018, we launched our proprietary FemCelz® procedure for the treatment of the loss of genital sensitivity and dryness experienced by women. The FemCelz® procedure uses the patient’s own stem cells to improve female sexual function, and is similar to the CaverStem® procedure.

The FemCelz® procedure uses the patient’s own stem cells to improve female sexual function, and is similar to the CaverStem® procedure.

Evaluation of patients at 30, 60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score.

In October 2019, we announced the successful completion of a pilot study of 15 patients with over 12 months of data showing safety and efficacy. Evaluation of patients at 30, 60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score.

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.

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.

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.

Companies such as Mesoblast Limited have patient follow-ups as long as three years post injection and show some degree of pain reduction and disc regeneration without adverse effects. A significant number of patients suffering from lower back pain have deficient circulation in the areas surrounding the discs, which is believed by some to be the initial cause of disc degeneration.

A significant number of patients suffering from lower back pain have deficient circulation in the areas surrounding the discs, which is believed by some to be the initial cause of disc degeneration. Our StemSpine® technology utilizes biologicals to stimulate a process termed angiogenesis, which overcomes the deficient circulation causing disc degeneration.

Our StemSpine® technology utilizes biologicals to stimulate a process termed angiogenesis, which overcomes the deficient circulation causing disc degeneration. In May 2017, we formed StemSpine, LLC for the purpose of using stem cells to treat back pain under a patent we acquired from CMH.

In May 2017, we formed StemSpine, LLC for the purpose of using stem cells to treat back pain under a patent we acquired from CMH. In June 2017, we filed an additional patent application covering the synergy between intradiscal stem cell injection subsequent to stimulation of perispinal angiogenesis.

Most efforts involve cell sources, such as bone marrow, adipose tissue, embryonic and fetal tissue, umbilical cord and peripheral blood and skeletal muscle.

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.

The physician harvests a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation.

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.

Unfortunately, in patients whose lower back pain originates from disc degeneration, existing approved treatments do not address the underlying cause, but only symptoms. 8 Table of Contents Recent U.S. clinical trials using stem cells administered directly into the disc have shown promise in regenerating injured discs, and by this means reducing pain in some patients.

Recent U.S. clinical trials using stem cells administered directly into the disc have shown promise in regenerating injured discs, and by this means reducing pain in some patients. Companies such as Mesoblast Limited have patient follow-ups as long as three years post injection and show some degree of pain reduction and disc regeneration without adverse effects.

To date, treatment options have ranged from prescription medication, to physical therapy and even acupuncture.

To date, treatment options have ranged from prescription medication, to physical therapy and even acupuncture. Unfortunately, in patients whose lower back pain originates from disc degeneration, existing approved treatments do not address the underlying cause, but only symptoms.

Going forward, management plans to continue to partner with independent sales representatives. 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.

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.

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However, neither ImmCelz Inc., nor AlloCelz LLC have commenced commercial activities. We currently conduct substantially all of our commercial operations through CMT, which markets and sells our CaverStem ® and FemCelz ® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively.

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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. 4 Table of Contents In June 2022, we signed an agreement with Greenstone Biosciences Inc.

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There were 30 patients in the study, 15 who received CELZ-001 and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.

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We believe these results show that we will be able to substantially reduce production costs, while allowing for the manufacture of the best clinical product for patients with immune disorders, which will enable us to accelerate our clinical applications and encourage potential collaborations with respect to our ImmCelz™ platform.

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The clinical trial is registered on www.clinicaltrials.gov. We are currently vetting Contract Research Organizations for a planned trial enrollment commencing in early 2024. We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc.

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This designation provides multiple important benefits to support the therapy’s development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval. In April 2023, we reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes.

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On May 3, 2022, the Company completed the sale of (i) 299,167 shares of common stock, and pre-funded warrants to purchase 456,389 shares of common stock (the “Pre-Funded Warrants”), and (ii) accompanying warrants to purchase 1,511,112 shares of common stock (the “Common Warrants”), at a combined offering price of $22.50 per share of common stock/Pre-Funded Warrant and related Common Warrant, to a group of institutional investors (the “Purchasers”), pursuant to a Securities Purchase Agreement between the Company and the Purchasers dated as of April 28, 2022 (the “Purchase Agreement”), resulting in gross proceeds to the Company of approximately $17,000,000.

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In October, 2023 we filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial for the treatment of chronic lower back pain with its AlloStemSpine® procedure using AlloStem™ (CELZ-201-DDT ADAPT) cell therapy. The clinical trial is registered on www.clinicaltrials.gov .

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The transaction was effected pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended and Rule 506(b) promulgated thereunder. The Common Warrants have a five-year term, and an exercise price of $20.00 per share. The Pre-Funded Warrants did not have an expiration date and had an exercise price of $0.001 per share.

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From November 2023 through July 2024, we: · Selected a clinical research site. · Vetted and contracted with a Contract Research Organization to assist with trial oversight. · Established a Data Safety Monitoring Board (DSMB) and received authorization to proceed with the trial. · Initiated patient recruitment and started dosing study subjects.

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As of December 31, 2023, all of the Pre-Funded Warrants had been exercised.

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In March 2024, we secured FDA authorization for an expanded access therapy using CELZ-201, in managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. The therapy uses CELZ-201 to potentially prevent Type I Diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focuses on a single high-risk patient.

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The Pre-Funded Warrants were classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, did not embody an obligation for the Company to repurchase its shares, and permitted the holders to receive a fixed number of shares of common stock upon exercise.

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CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level. In June 2024, we announced that we successfully generated human induced pluripotent stem cells (iPSC)-derived islet cells that produce human insulin.

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In addition, the Pre-Funded Warrants did not provide any guarantee of value or return. Roth Capital Partners (“Roth”) acted as sole placement agent for the offering.

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The Company believes this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells.

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The Company paid Roth a placement agent fee in the amount of $1,360,000 and issued Roth a warrant to purchase 113,334 shares of Common Stock with the same terms as the Common Warrants issued to the Purchasers. Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012.

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In November, 2024 we announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy.

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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.

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This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients. In July 2024, we announced that we initiated a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary “iPSC”.

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Subjects who meet all criteria for inclusion will be enrolled and randomized into either low, medium or high dose of CELZ-201-DDT versus Placebo, with a total of 30 subjects enrolled. Each dosing cohort will contain ten subjects (n=10), with eight subjects (n=8) receiving the investigational product and two subjects (n=2) randomized to receive placebo.

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This iPSC clinical derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz®, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options.

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Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance. Alova The Alova program utilizes the AlloStem™ platform to treat infertility as a result of premature ovarian failure. CaverStem ® - Erectile Dysfunction Treatment CaverStem® is a clinically proven, patented procedure (U.S.

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The use of AI strengthens our research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables us to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions.

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Our CaverStem® stem cell treatment consists of a one-hour out-patient visit in a physician’s office. The physician harvests a patient’s stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation.

Added

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.

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The stem cells are then injected into the patient’s corpus cavernosum (erectile tissue) to stimulate muscle and blood vessel regeneration. Clinical research data concludes that our CaverStem® treatment results in a marked increase in duration and frequency of erections and the ability to sustain erections until orgasm, with no known treatment-associated adverse events.

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The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality.

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We generate revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the CaverStem® procedure. We contract with physicians to purchase kits and, in turn, provide exclusivity in their market through our patent protection, marketing support and training. Our CaverStem® technology is protected by U.S.

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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.

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Patent No. 8,372,797, entitled “Treatment of Erectile Dysfunction by Stem Cell Therapy” which was issued to CMH by the United States Patent and Trademark Office (“USPTO”) on February 12, 2013. We acquired this patent and related know-how and technology from CMH in May 2016. CaverStem® is also a U.S. registered trademark (Reg.

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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.

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No. 5716528). 7 Table of Contents In August 2017, we completed recruitment on a clinical trial of the CaverStem® procedure conducted by the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Following completion of recruitment and treatment of the study subjects, an independent Institutional Review Board (IRB) overseeing the study validated the procedure as safe.

Added

In a concurrent private placement, we issued the same investors warrants to purchase up to 837,104 shares of common stock at an exercise price of $4.42 per share, which are exercisable until December 19, 2029. Net proceeds from these offerings were approximately $1.6 million. Roth Capital Partners acted as our placement agent for these transactions.

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In the same time frame, other worldwide, peer-reviewed and published clinical trials using the same procedure validated the efficacy of the ED treatment. As a result of these two developments, management concluded the CaverStem® procedure is both safe and effective and commenced marketing activities in November of 2017.

Added

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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

23 edited+4 added−6 removed103 unchanged

2023 filing

2024 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. 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 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-202 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. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms.

To generate sufficient revenues to support our operations, we will have to seek collaborators, especially for marketing and sales outside of the United States or invest significant amounts of financial and management resources to develop internal sales, distribution, and marketing capabilities.

To generate sufficient revenues to support our operations, we will have to seek collaborators, especially for marketing and sales in and outside of the United States or invest significant amounts of financial and management resources to develop internal sales, distribution, and marketing capabilities.

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.

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.

In the near term, failure to successfully advance the development of our proposed products may have a material adverse effect on us. To date, other than limited sales generated from our CaverStem ® and FemCelz ® products, we have not successfully developed or commercially marketed, distributed, or sold any product candidate.

In the near term, failure to successfully advance the development of our proposed products may have a material adverse effect on us. To date, other than limited sales generated from our CaverStem ® products, we have not successfully developed or commercially marketed, distributed, or sold any product candidate.

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.

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.

During 2023 we effected a 1-for-10 reverse stock split in order to increase the trading price of our common stock and comply with NASDAQA’s $1.00 minimum bid price requirement.

During 2023 we effected a 1-for-10 reverse stock split in order to increase the trading price of our common stock and comply with Nasdaq’s $1.00 minimum bid price requirement.

While we believe that the requirement that patients directly pay the cost for our CaverStem ® and FemCelz ® products and procedures make these procedures more attractive to doctors, these treatments are only available to patients that can afford to pay for them.

While we believe that the requirement that patients directly pay the cost for our autologous products and procedures make these procedures more attractive to doctors, these treatments are only available to patients that can afford to pay for them.

If we raise additional funds through future offerings of shares of our common stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings could also have a material and adverse effect on the price of our common stock. We have generated minimal revenues from our products.

Treasuries balance of approximately $10.0 million. Although we generated gross proceeds in excess of $30 million from our 2021 and 2022 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 $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.

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.

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.

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.

If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products and therapies, we may not be able to generate sufficient revenues to support our operations.

We currently have a very limited marketing and sales organization and may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products and therapies, we may not be able to generate sufficient revenues to support our operations.

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.

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.

We rely upon third parties for the manufacture of our CaverStem ® and FemCelz ® disposable kits.

Our failure, or the failure of third parties on which we rely, to comply with the strict requirements relating to conducting, recording, and reporting the results of clinical trials, or to follow good clinical practices, may delay the regulatory approval process or cause us to fail to obtain regulatory approval for our proposed products and therapies. 27 Table of Contents We currently have a very limited marketing and sales organization and may have to invest significant resources to develop these capabilities.

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.

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.

For the year ended December 31, 2023, our operations used approximately $8.0 million in cash. Cash used in operations consisted primarily of cash on hand and cash raised in our December 2021 public offering and our May 2022 private offering. At December 31, 2023, we had a combined cash, certificates of deposit and short-term U.S.

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.

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.

We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies. Revenues generated from sales of our CaverStem ® and FemCelz ® kits were only $9,000 and $88,600 for the years ended December 31, 2023, and December 31, 2022, respectively.

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.

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.

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.

Our existing and proposed products may not be considered cost-effective, and third-party or government reimbursement might not be available or sufficient.

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.

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We have incurred an operating loss of approximately $5.6 million for the year ended December 31, 2023, and a loss of approximately $10.0 million (which included a $5.0 million investment for the research tools referenced in Note 3) for the year ended December 31, 2022, respectively.

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At December 31, 2024, we had a combined cash, and short-term U.S. treasuries balance of approximately $5.9 million.

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To sustain our operating costs and generate profits, we will need to significantly increase revenues from our CaverStem ® and FemCelz ® products or from our other products or therapies that have not yet been commercialized.

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We have generated minimal revenues from our products and do not expect to generate revenues for the foreseeable future. We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies.

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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.

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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.

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Our current sales, marketing and distribution capabilities consist of independent contractors who promote the sale of our CaverStem ® and FemCelz ® products to medical doctors.

Added

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.

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We are subject to risks arising from the wars in Ukraine and the Gaza Strip.

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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 2. Properties

Properties — owned and leased real estate

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2023 filing

2024 filing

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Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities On June 12, 2023, we announced that our Board of Directors authorized a share repurchase program for the repurchase of up to $2 million of our common stock (the “Repurchase Plan). Purchases under the Repurchase Plan commenced in August 2023.

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Item 2. Properties We do not currently own any real property. Our corporate office is located at 211 East Osborn Road, Phoenix, Arizona, which we lease on a month-to-month basis. Management believes that this space is adequate to meet our current and foreseeable needs.

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The following table provides information about our monthly share repurchases for the year ended December 31, 2023, which consisted solely of repurchases on the open market under the Repurchase Plan.

Removed

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 July 1 - July 31, 2023 - $ - 0 $ 2,000,000 August 1 - August 31, 2023 11,500 4.57 11,500 1,947,462 September 1 - September 30, 2023 28,500 4.89 40,000 1,755,682 October 1 – October 31, 2023 6,500 4.68 46,500 1,725,269 November 1 – November 31, 2023 8,000 4.41 54,500 1,689,959 December 1 – December 31, 2023 3,000 4.48 57,500 1,676,510 Total 57,500 4.71

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+3 added−0 removed12 unchanged

2023 filing

2024 filing

Biggest changeAny future determination to declare dividends will be made at the discretion of our Board and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions, the terms of any future credit agreements and other factors that our Board may deem relevant. 33 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, 2023, 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 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.

The purpose of the 2021 Plan is to secure for the Company and its stockholders the benefits arising from capital stock ownership by eligible participants who are expected to contribute to the Company’s future growth and success. To date, we have not granted any awards under the 2021 Plan. 34 Table of Contents Administration.

Holders As of March 22, 2024, 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 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.

The 2021 Plan provides for the granting to our employees, officers, directors, consultants, and advisors of performance awards payable in shares of common stock, stock options (non-statutory and incentive), restricted stock awards, stock appreciation rights (“SARs”), restricted share units (“RSUs”) and other stock-based awards.

The essential features of the 2021 Plan are outlined below: Purpose. The 2021 Plan provides for the granting to our employees, officers, directors, consultants, and advisors of performance awards payable in shares of common stock, stock options (non-statutory and incentive), restricted stock awards, stock appreciation rights (“SARs”), restricted share units (“RSUs”) and other stock-based awards.

(3) Represents 3 shares available under the Company’s 2016 Stock Incentive Plan. 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”). The essential features of the 2021 Plan are outlined below: Purpose.

(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”).

Added

Any future determination to declare dividends will be made at the discretion of our Board and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions, the terms of any future credit agreements and other factors that our Board may deem relevant.

Added

Issuer Repurchases of Common Stock On June 12, 2023, we announced that our Board of Directors authorized a share repurchase program for the repurchase of up to $2 million of our common stock (the “Repurchase Plan). Purchases under the Repurchase Plan commenced in August 2023.

Added

To date, we have repurchased 101,250 shares of common stock under the Repurchase Plan for an aggregate purchase price of $445,916.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

30 edited+26 added−13 removed20 unchanged

2023 filing

2024 filing

Biggest changeWe believe we will able to use this cell line for many of our programs, including our ImmCelz® immunotherapy platform for multiple diseases, OvaStem® for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), and IPScelz™ inducible pluripotent stem cell program in ongoing development with Greenstone Biosciences. 36 Table of Contents In November 2022, we announced that the FDA had cleared the Company’s Type I Diabetes (CELZ-201 CREATE-1) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes utilizing our AlloStem™ (CELZ-201) Clinical Cell Line, which will allow us to begin a Phase I/II clinical trial.

Biggest changeWe believe we will able to use this cell line for many of our programs, including our ImmCelz ™ immunotherapy platform for multiple diseases, OvaStem ™ for Premature Ovarian Failure, Type I Diabetes (CELZ-201 CREATE-1), AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), and IPScelz™ inducible pluripotent stem cell program in ongoing development with Greenstone.

In May 2023, we announced that that we had received confirmation that Greenstone had successfully developed a human induced pluripotent stem cell (iPSC). We estimate that the development of this cell line will save the Company two to three years in research and development time along with associated expenses.

In May 2023, we announced that we had received confirmation that Greenstone had successfully developed a human induced pluripotent stem cell (iPSC). We estimate that the development of this cell line will save the Company two to three years in research and development time along with associated expenses.

The primary objective of the study will be to evaluate AlloStem™ (CELZ-201) in patients with newly diagnosed Type 1 Diabetes. The trial has also received Institutional Board Review (IRB) approval for the trial to proceed as well as approval of the patient recruitment material. Patient recruitment was initiated in September 2023.

The primary objective of the study will be to evaluate CELZ-201 treatment in patients with newly diagnosed Type 1 Diabetes. The trial has also received Institutional Board Review (IRB) approval for the trial to proceed as well as approval of the patient recruitment material. Patient recruitment was initiated in September 2023.

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: 35 Table of Contents 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 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.

In October 2022, we announced the development of our AlloStem™ Clinical Cell Line (CELZ-201), a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File.

In October 2022, we announced the development of our AlloStem™ Clinical Cell Line (CELZ-200), a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File.

However, as a result of our December 2021 and May 2022 offerings, we believe we will have sufficient cash to meet our anticipated operating costs and capital expenditure requirements through at least March 2025. 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 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.

There was $92,084 of amortization expense recorded for the period ended December 31, 2022. 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.

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.

General and administrative expenses for the year ended December 31, 2023, totaled $3,560,309, in comparison with $3,943,543 for the comparable period a year ago.

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.

Operating Loss . For the reasons stated above, our operating loss for the year ended December 31, 2023, was $5,620,132 in comparison with $10,244,372 for the comparable period a year ago. Other Income . Other income for the year ended December 31, 2023, totaled $333,558 in comparison with $100,328 for the comparable period a year ago.

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.

We generated $3,600 in cost of goods sold for the year ended December 31, 2023, in comparison with $28,491 for the comparable period a year ago. The decrease of $24,891 or 87.4% is due to the reduction in revenue as described above. Gross Profit/(Loss) .

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) .

We generated $5,400 in gross profit for the year ended December 31, 2023, in comparison with $60,109 in gross profit for the comparable period a year ago. The decrease of $54,709 or 91.0% is due to the reduction in revenue. Selling, General and Administrative Expenses .

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 .

The increased income of $233,230 or 234.5%, is due to increased interest rates on our short-term CD’s and treasuries. Net Income/Loss . For the reasons stated above, our net loss for the year ended December 31, 2023, was $5,286,574 in comparison with a loss of $10,144,044 for the comparable period a year ago. Amortization Expense .

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 .

In October, 2023 we filed for and received approval from an institutional review board (IRB) to proceed with this trial. In October, 2023 the Company filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial. The clinical trial is registered on www.clinicaltrials.gov.

Liquidity and Capital Resources As of December 31, 2023, we had $9,899,504 of available cash and certificates of deposit and positive working capital of approximately $9,899,504. In comparison, as of December 31, 2022, we had approximately $18,399,136 of available cash and positive working capital of approximately $15,425,798.

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.

In April 2023, the Company reported positive one-year follow-up data and significant efficacy using AlloStem™ (CELZ-201) to treat patients with Type 2 Diabetes. There were no safety concerns related to AlloStem™ (CELZ-101) at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial.

Net Cash from Financing Activities. In the year ended December 31, 2023, we spent $270,953 on stock repurchases. In the year ended December 31, 2022, we received $15,471,775 from the sale of common stock and warrants in our May 2022 private offering. 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. In the year ended December 31, 2023, we spent $270,952 on stock repurchases. We have continued to realize losses from operations.

We have elected to amortize the patent over a ten-year period on a straight-line basis. 38 Table of Contents Amortization expense of $94,584 was recorded for the year ended December 31, 2023, 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 $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.

We are exploring options to achieve market penetration and product profitability with a number of potential partners. However, there can be no assurance that the Company will be successful in that regard. Cost of Goods Sold .

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.

Cash provided from investing activities was $3,445,185 for the year ended December 31, 2023, due to $3,558,426 in net certificate of deposit redemptions, offset a $100,000 payment on a patent purchase agreement. In comparison, we used $10,078,617 for the year ended December 31, 2022 related to the investment of $10,000,000 in certificates of deposit in 2022.

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.

We have validated this ability through the third-party studies described below that were independently conducted on selected human donor patient cells for accuracy and reproducibility.

Net cash used in operating activities was $8,027,885 for the year-ended ended December 30, 2023, in comparison to $7,796,966 for the comparable period a year ago, an increase of $230,919 or 3.0%.

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.

In September 2023, the Company received FDA clearance to initiate a Phase I/II clinical trial of AlloStemSpine® (CELZ-202 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain. The study is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT). The study will enroll 30 individuals suffering from chronic 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. 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.

The decrease of $383,234, or 9.7% is primarily due to reductions of $259,080 in marketing expenses as we re-evaluate the Caverstem® and FemCelz® marketing strategies, $341,079 in consulting services, $59,885 in Director and Officer insurance, and $53,457 in travel, offset by $308,589 in increased salaries and wages. Research and Development Expenses .

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 .

From June through July 2022, all of the Pre-Funded Warrants were exercised for shares of common stock. 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. Net Cash used in Operating Activities. We used cash in our operating activities due to our losses from operations.

Research and development expenses for the year ended December 31, 2023, totaled $1,970,639 in comparison to $6,268,854 for the comparable period a year ago. The decrease of $4,298,215 , or 68.6% was due to a $5,000,000 one-time expense associated with the acquisition of research tools in 2022.

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 .

We generated $9,000 in gross revenue for the year ended December 31, 2023, in comparison with $88,600 for the comparable period a year ago. The decrease of $79,600 or 89.8% is due to a decrease in Caverstem sales. Management is currently re-evaluating the marketing strategy for the Caverstem® and FemCelz® products.

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.

Removed

However, neither ImmCelz Inc. nor AlloCelz LLC have commenced commercial activities. We currently conduct substantially all of our commercial operations through CMT, which markets and sells our CaverStem ® and FemCelz ® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively.

Added

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.

Removed

There were 30 patients in the study, 15 who received AlloStem™ (CELZ-201) and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.

Added

In November 2022, we announced that the FDA had cleared the Company’s Type I Diabetes (CELZ-201 CREATE-1) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes utilizing our AlloStem™ Clinical Cell Line, which will allow us to begin a Phase I/II clinical trial.

Removed

Using an ultrasound guided, non-surgical procedure, AlloStem™ (CELZ-101-DDT) is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation or any other cell-based procedures.

Added

Removed

We are currently vetting Contract Research Organizations for a planned trial enrollment commencing in early 2024.

Added

The first in country study, which will enroll 30 individuals suffering from chronic lower back pain, is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT). The minimally invasive procedure uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician.

Removed

In addition to our clinical research efforts, we are currently seeking to expand the commercial sale and use of our CaverStem® and FemCelz® products by physicians in the United States. 37 Table of Contents Results of Operations – For the Year Ended December 31, 2023, and for the Year Ended December 31, 2022 Gross Revenue .

Added

This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.

Removed

This was offset by an increase of $661,785 associated with the development of a drug master file, laboratory research in preparation of our master cell bank submittal to the FDA, the approval of our FDA application for a Lower Back Pain (CELZ 202 – ADAPT) 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.

Added

Removed

On May 3, 2022 we received gross proceeds of $17,000,000, before deducting placement agent fees and expenses, upon the closing of an unregistered sale of equity securities of (i) 299,167 shares of our common stock and pre-funded warrants to purchase 456,389 shares of common stock (the “Pre-Funded Warrants”), and (ii) accompanying warrants to purchase 1,511,112 shares of common stock at an exercise price of $20.00 per share (“Warrants”), and, at a combined offering price of $22.50 per share of common stock/Pre-Funded Warrant and related Warrant to a group of institutional investors (the “Purchasers”).

Added

Removed

The Warrants have a five-year term, and an exercise price of $20.00 per share. The Pre-Funded Warrants do not expire and had an exercise price of $0.0001 per share. Roth Capital Partners acted as sole placement agent for the offering.

Added

CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level. In June 2024, we announced that we had successfully generated human induced pluripotent stem cells (iPSC)-derived Islet Cells that produce human insulin.

Removed

We paid Roth a placement agent fee in the amount of $1,360,000 and issued Roth a warrant to purchase 113,334 shares of common stock with the same terms as the common warrants issued to the purchasers.

Added

We believe this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells. In November, 2024 we announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) of our CELZ-201 ADAPT clinical trial.

Removed

Pursuant to the Purchase Agreement, the Company and the Purchasers entered into a Registration Rights Agreement, pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission to register the resale of the shares of Common Stock issued in the offering and the shares of Common Stock underlying the common stock, Warrants and Pre-Funded Warrants.

Added

The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy.

Removed

On May 10, 2022, we filed a Form S-3 registration statement to register the shares, Common Warrants and Pre-Funded Warrants for resale. The registration went effective on May 19, 2022, fulfilling our contractual obligation.

Added

This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients. In July 2024, we announced the initiation of a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary iPSC”.

Removed

In addition, the Company’s directors and officers entered into Lock-Up Agreements under which they agreed not to sell any of their securities of the Company until 90 days following after the earliest of (i) the effective date of the Registration Statement, and (ii) the date all of the securities issued in the offering have been sold under Rule 144, or may be sold under Rule 144 without the Company being in compliance with the current public information requirement under such rule, and without any volume limitation.

Added

This iPSC clinically derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options.

Removed

The increase in cash used in operations was primarily related to an increase of $661,785 in research-related cash outlays associated with personnel and laboratory research in preparation of our master cell bank submittal to the FDA, development, submittal and FDA clearance of our AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) phase I/II clinical trial, continued efforts on our Type I Diabetes (CELZ-201CREATE-1) phase I/II trial, the manufacturing and testing of our ImmCelz™ cell line, and the development of our iPSC cell line in partnership with Greenstone Biosciences Inc. 39 Table of Contents Net Cash used in Investing Activities .

Added

The use of AI strengthens the Company’s research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables the Company to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions.

Added

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.

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. 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.

Added

We have elected to amortize the patent over a ten-year period on a straight-line basis.

Added

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.

Added

The Series B Preferred Stock had no voting rights other than the right to 100,000,000 votes on a proposal to approve an amendment to the Company’s Articles of Incorporation increasing the number of authorized shares of the Company’s common provided, however, that the Series B Preferred Stock will be voted in the same proportion as the votes cast by shares of common stock on the Share Increase Proposal.

Added

The share of Series B Preferred Stock were automatically redeemed when the Share Increase Proposal was approved.

Added

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.

Added

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.

Added

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.

Top changes in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2024 10-K

Item 1. Business

Item 1A. Risk Factors

Item 2. Properties

Item 5. Market for Registrant's Common Equity

Item 7. Management's Discussion & Analysis

Other CELZ 10-K year-over-year comparisons