Did CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. add new Risk Factors in the 2023 10-K?

Yes — Item 1A Risk Factors shows 51 new/edited paragraphs and 57 removed paragraphs versus the 2022 10-K.

What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s MD&A (Item 7) in 2023?

Item 7 Management's Discussion & Analysis shows 48 new/edited paragraphs and 46 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s Legal Proceedings (Item 3) change in 2023?

Item 3 shows 0 added/edited paragraphs and 1 removed paragraphs — usually indicating new litigation disclosed or settled cases removed.

Where does this CELZ 10-K diff come from?

The source filings are CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s official 2022 and 2023 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 — 2022 vs 2023

Q: What changed in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2023 10-K compared to 2022?

Across the narrative sections we track, CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. (CELZ) added 199 paragraphs, removed 192, and edited 140 between the 2022 and 2023 10-K filings. The biggest movers are Item 1. Business (+90/−79), Item 1A. Risk Factors (+51/−57), Item 7. Management's Discussion & Analysis (+48/−46).

Paragraph-level year-over-year comparison of CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2022 and 2023 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 2023 report.

+199 added−192 removedSource: 10-K (2024-03-22) vs 10-K (2023-03-31)

Top changes in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2023 10-K

199 paragraphs added · 192 removed · 140 edited across 6 sections

Item 1. Business+90 / −79 · 61 edited
Item 1A. Risk Factors+51 / −57 · 40 edited
Item 7. Management's Discussion & Analysis+48 / −46 · 32 edited
Item 5. Market for Registrant's Common Equity+7 / −8 · 7 edited
Item 2. Properties+3 / −1

Item 1. Business

Business — how the company describes what it does

61 edited+29 added−18 removed100 unchanged

2022 filing

2023 filing

Biggest changeOur patent portfolio is currently composed of four issued patents and ten 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 9 Table of Contents Pending Patent Applications Area Application/Patent # Description Immunology 63395252 Prevention and Treatment of Reproductive Failure by Regenerative Cells and Adjuvants Immunology 63351330 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Endothelial Progenitor Cells Immunology 63389091 Overcoming TNF-alpha Blockade Resistance in Rheumatoid Arthritis by Regenerative T Regulatory Cell Therapy Immunology 63248324 Suppression of Diabetes Using Exosomes from Stem Cell Programmed Myeloid Cells Immunology 63270678 Regenerative T Regulatory Cells Immunology 63351330 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Immunology 63297883 Regenerative CAR-T Cells Immunology 63123380 Induction of Infectious Tolerance by Ex Vivo Reprogrammed Immune Cells Immunology 63395836 Prevention and Treatment of Hair Loss Endocrinology 63338417 Prevention of Menopause Associated Osteoporosis by Intra-ovarian Administration of Regenerative Cells Endocrinology 63349976 Cellular Regenerative Therapeutics for Enhancement/Restoration of Endometrial Function Immunology 10,792,310 Methods for Treatment of Premature Ovarian Failure and Ovarian Aging Using Regenerative Cells Endocrinology 16759671 Augmentation of Fertility by Platelet Rich Plasma Immunology 63343846 Repair of Ovarian Damage and Dampening of Inflammatory Microenvironment by Administration of Monocytic-Granulocytic Progenitors with Immune Modulatory Activities Immunology 63340454 Immunological Enhancement of Stem Cell Activity in Treatment of Ovarian Failure Immunology 63340450 Protection from Ovarian Failure by Low Dose Interleukin-2 Administration Immunology 63340447 Stimulation of Ovarian Function Subsequent to Chemotherapy Immunology 63343832 Cytokine Primed Regenerative Cells for Treatment of Ovarian Failure Immunology 63343841 Degenerating Ovarian Microenvironment Resistant Mesenchymal Stem Cells Immunology 15617813 Adipose Derived Immunotherapy of Recurrent Spontaneous Abortion Immunology 63349297 Gene Therapeutics for Enhancement/Restoration of Endometrial Function Immunology 15702735 Inducing and Accelerating Post-Stroke Recovery by Administration of Amniotic Fluid Derived Stem Cells Immunology 15987739 Generation of Autologous Immune Modulatory Cells for Treatment of Neurological Conditions Immunology 63313313 Methods for Quantifying Potency of Regenerative Immunotherapies 10 Table of Contents Patent Purchase and License Agreements Lower Back Pain Patent Purchase.

Biggest changeOur patent portfolio is currently composed of four issued patents and fifty pending patent applications filed in the United States with the USPTO as follows: Issued Patents Title Application Number Application Filing Date Patent Number Treatment of Erectile Dysfunction by Stem Cell Therapy 12305589 06/22/2007 8,372,797 Treatment Of Disc Degenerative Disease 12301597 09/30/2009 9,598,673 Methods For Treatment Of Premature Ovarian Failure And Ovarian Aging Using Regenerative Cells 15652213 07/17/2017 10,792,310 Paraspinal Perfusion by Administration of T regulatory Cells Alone or in Combination with Angiogenic Cell Therapies 16009982 06/15/2018 10,842,815 Pending Patent Applications Area Application/Patent # Description Immunology 15/617,813 Adipose Derived Immunomodulatory Cells for Immunotherapy of Recurrent Spontaneous Abortions Immunology 10,792,310 Methods for Treatment of Premature Ovarian Failure and Ovarian Aging Using Regenerative Cells Immunology 15/702,735 Inducing and Accelerating Post-stroke Recovery by Administration of Amniotic Fluid Derived Stem Cells Immunology 15/987,739 Generation of Autologous Immune Modulatory Cells for Treatment of Neurological Conditions Immunology 63/123,380 Induction of Infectious Tolerance by Ex Vivo Reprogrammed Immune Cells Immunology 63/248,324 Suppression of Diabetes Using Exosomes From Stem Cell Programmed Myeloid Cells Immunology 63/270,678 Regenerative T Regulatory Cells Immunology 63/297,876 Chimeric Antigen Receptor Regenerative Gamma Delta T Cells Immunology 63/297,883 Regenerative Car-T Cells Immunology 63/302,228 Regenerative Cell Therapy for Viral Induced Sexual Dysfunction Immunology 63/313,313 Methods for Quantifying Potency of Regenerative Immunotherapies StemSpine 63/331,179 Enhancement of Cartilage Regenerative Activity of Stem Cell Populations Based on Reduction of Intra-articular Cellular Material StemSpine 63/331,183 Enhancement of Stem Cell Therapy for Cartilage Degeneration by Anti-oxidant Pre-conditioning Immunology 63/331,186 Treatment of Cartilage Degeneration Using Treatment of Cartilage Degeneration Using Myeloid Suppressor Cells and Exosomes Derived Thereof Immunology 63/338,416 Cytokine Based Assessment of Recipient Ability to Respond to Stem Cell Therapy for Cartilage Regeneration 11 Table of Contents Endocrinology 63/338,417 Prevention of Menopause Associated Osteoporosis by Intra-ovarian Administration of Regenerative Cells Immunology 63/340,447 Stimulation of Ovarian Function Subsequent to Chemotherapy and/or Radiation Therapy Using Natural Killer Cells Immunology 63/340,450 Protection from Ovarian Failure by Low Dose Interleukin-2 Administration Immunology 63/340,454 Immunological Enhancement of Stem Cell Activity in Treatment of Ovarian Failure Immunology 63/340,828 Exosome Based Assays for Determining Candidates for Osteoarthritis Stem Cell Therapy Immunology 63/343,832 Cytokine Primed Regenerative Cells for Treatment of Ovarian Failure Immunology 63/343,841 Degenerating Ovarian Microenvironment Resistant Mesenchymal Stem Cells Immunology 63/343,846 Repair of Ovarian Damage and Dampening of Inflammatory Microenvironment by Administration of Monisytic-Granulocytic Progenitors with Immunomodulatory Activities Immunology 63/349,297 Gene Therapeutics for Enhancement/Restoration of Endometrial Function Endocrinology 63/349,976 Cellular Regenerative Therapeutics for Enhancement/Restoration of Endometrial Function Immunology 63/351,330 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Endothelian Progenitor Cells Immunology 63/351,332 Generation of Conditioned Media from Inducible Pluripotent Stem Cell Derived Mesenchymal Stem Cells Immunology 63/353,011 Inducible Pluripotent Stem Cell Derived Regenerative T Cells Immunology 63/389,091 Overcoming TNF-Alpha Blockade Resistance in Rheumatoid Arthritis by Regenerative T Regulatory Cell Therapy Immunology 63/390,759 Treatment of Limb Ischemia by Bone Marrow Stem Cells and Modification of Diseased Microenvironment Immunology 63/391,865 Potentiation of Bone Marrow Cell Activity by Co-administration with Oxytocin Immunology 63/395,252 Prevention and Treatment of Reproductive Failure by Regenerative Cells and Adjuvants StemSpine 63/395,834 Prevention of Space Travel Associated Bone Density Loss by Regenerative Cell Populations Immunology 63/395,836 Prevention and Treatment of Hair Loss Immunology 63/395,839 Prophylaxis and Treatment of Orthopox Viruses Using Regenerative Cells and Products Thereof Immunology 63/414,823 Treatment of Diabetes by Enhancement of Pancreatic Islet Engraftment Through Regenerative Immune Modulation Immunology 63/455,965 Artificial Intelligence Systems and Processes for In Silico Discovery of Immune Modulators and T Regulatory Cell Screening Methodologies Immunology 63/458,423 Artificial Intelligence Guided Production of Cells and Organs from Pluripotent Stem Cells Immunology 63/460,543 Three-Dimensional Printing of Organs, Organoids, and Chimeric Immuno-Evasive Organs Immunology 63/463,993 Artificial Intelligence Enhanced Real Time Biological Optimization and Health Monitoring for Space Travel 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.

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.

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. No. 5716528).

Patent Number 9,803,176 and similar patents issued by other countries) and proprietary know how in connection with the enhancement of autologous cells. However, based on our current development of the ImmCelz™ platform, we have engineered the next generation of cell-free secreted factors which are independent of the Jadi Cell LLC license.

Patent Number 9,803,176 and similar patents issued by other countries) and proprietary know how in connection with the enhancement of autologous cells. However, based on our current development of the ImmCelz™ (CELZ-100) platform, we have engineered the next generation of cell-free secreted factors which are independent of the Jadi Cell LLC license.

During Phase 1 clinical trials, sufficient information about the investigational product’s pharmacokinetics and pharmacologic effects may be obtained to permit the design of well-controlled and scientifically valid Phase 2 clinical trials. 14 Table of Contents · Phase 2: These clinical trials are conducted in a limited number of human subjects in the target population to identify possible adverse effects and safety risks, to determine the efficacy of the investigational product for specific targeted diseases and to determine dosage tolerance and dosage levels.

During Phase 1 clinical trials, sufficient information about the investigational product’s pharmacokinetics and pharmacologic effects may be obtained to permit the design of well-controlled and scientifically valid Phase 2 clinical trials. · Phase 2: These clinical trials are conducted in a limited number of human subjects in the target population to identify possible adverse effects and safety risks, to determine the efficacy of the investigational product for specific targeted diseases and to determine dosage tolerance and dosage levels.

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 · Type 1 Diabetes · Heart attack · Parkinson’s Disease 8 Table of Contents Marketing We market our CaverStem ® and FemCelz ® procedures using a multifaceted marketing approach that includes: · A robust web site for each of these products (CaverStem.com and FemCelz.com) designed to attract and educate both physicians and patients · Publishing results of clinical studies demonstrating the efficacy of our products and therapies, and building clinical registries accessible to medical professionals that include the results of such studies · Online advertising · Social Media – Twitter, Facebook · In-office flyers and banners · Patient testimonials · Informative videos The first product we marketed was the CaverStem ® procedure to treat erectile dysfunction, which was initiated in November 2017.

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 Marketing We market our CaverStem ® and FemCelz ® procedures using a multifaceted marketing approach that includes: · A robust web site for each of these products (CaverStem.com and FemCelz.com) designed to attract and educate both physicians and patients · Publishing results of clinical studies demonstrating the efficacy of our products and therapies, and building clinical registries accessible to medical professionals that include the results of such studies · Online advertising · Social Media – Twitter, Facebook · In-office flyers and banners · Patient testimonials · Informative videos The first product we marketed was the CaverStem ® procedure to treat erectile dysfunction, which was initiated in November 2017.

ImmCelz™ 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.

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.

Companies failing to comply with HIPAA and the implementing regulations may also be subject to civil money penalties or in the case of knowing violations, potential criminal penalties, including monetary fines, imprisonment, or both. In some cases, the State Attorneys General may seek enforcement and appropriate sanctions in federal court. Other Applicable U.S.

If any of these events were to occur, it could materially adversely affect us. 17 Table of Contents Current Good Manufacturing Practices and other FDA Regulations of Cellular Therapy Products Products that fall outside of the HCT/P regulations and are regulated as drugs, biological products, or devices must comply with applicable cGMP regulations.

If any of these events were to occur, it could materially adversely affect us. Current Good Manufacturing Practices and other FDA Regulations of Cellular Therapy Products Products that fall outside of the HCT/P regulations and are regulated as drugs, biological products, or devices must comply with applicable cGMP regulations.

The cells are then injected into the pubocervical fascia (peri-G-spot), skene’s glands, and around the peri-clitoral to stimulate muscle and blood vessel regeneration. 6 Table of Contents We generate revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the FemCelz® procedure.

The cells are then injected into the pubocervical fascia (peri-G-spot), skene’s glands, and around the peri-clitoral to stimulate muscle and blood vessel regeneration. We generate revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the FemCelz® procedure.

Significant risk devices require the submission of an IDE application to the FDA and the FDA’s approval of the IDE application. The FDA premarket clearance and approval process can be lengthy, expensive, and uncertain. It generally takes three to twelve months from submission to obtain 510(k) premarket clearance, although it may take longer.

Significant risk devices require the submission of an IDE application to the FDA and the FDA’s approval of the IDE application. 19 Table of Contents The FDA premarket clearance and approval process can be lengthy, expensive, and uncertain. It generally takes three to twelve months from submission to obtain 510(k) premarket clearance, although it may take longer.

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 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.

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.

Laws In addition to the above-described regulation by United States federal and state government, the following are other federal and state laws and regulations that could directly or indirectly affect our ability to operate the business: · state and local licensure, registration, and regulation of the development of pharmaceuticals and biologics; · state and local licensure of medical professionals; · state statutes and regulations related to the corporate practice of medicine; · other laws and regulations administered by the FDA; · other laws and regulations administered by HHS; · state and local laws and regulations governing human subject research and clinical trials; 18 Table of Contents · the federal physician self-referral prohibition, also known as Stark Law, and any state equivalents to Stark Law; · the federal False Claims Act, or FCA; · the federal Anti-Kickback Statute, or AKS, and any state equivalent statutes and regulations; · federal and state coverage and reimbursement laws and regulations; · state and local laws and regulations for the disposal and handling of medical waste and biohazardous material; · Occupational Safety and Health Administration, or OSHA, regulations, and requirements; · the Physician Payments Sunshine Act (in the event that our products are classified as drugs, biologics, devices, or medical supplies and are reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program); · state and other federal laws addressing the privacy of health information; and · state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare professionals and other potential referral sources, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare professionals or marketing expenditures, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Laws In addition to the above-described regulation by United States federal and state government, the following are other federal and state laws and regulations that could directly or indirectly affect our ability to operate the business: · state and local licensure, registration, and regulation of the development of pharmaceuticals and biologics; · state and local licensure of medical professionals; · state statutes and regulations related to the corporate practice of medicine; · other laws and regulations administered by the FDA; · other laws and regulations administered by HHS; · state and local laws and regulations governing human subject research and clinical trials; · the federal physician self-referral prohibition, also known as Stark Law, and any state equivalents to Stark Law; · the federal False Claims Act, or FCA; · the federal Anti-Kickback Statute, or AKS, and any state equivalent statutes and regulations; · federal and state coverage and reimbursement laws and regulations; · state and local laws and regulations for the disposal and handling of medical waste and biohazardous material; · Occupational Safety and Health Administration, or OSHA, regulations, and requirements; · the Physician Payments Sunshine Act (in the event that our products are classified as drugs, biologics, devices, or medical supplies and are reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program); · state and other federal laws addressing the privacy of health information; and · state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare professionals and other potential referral sources, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare professionals or marketing expenditures, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. 21 Table of Contents Violation of any of the laws described above or any other governmental laws and regulations may result in penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of operations, the exclusion from participation in federal and state healthcare programs and imprisonment.

We have also utilized certain cell-free factors pursuant to a license agreement we entered into with Jadi Cell LLC, which is owned and controlled by Dr. Patel. We have been granted the right to exploit Jadi Cell’s patent rights (including U.S.

We have also utilized certain cell-free factors pursuant to a license agreement we entered into with Jadi Cell LLC, which is owned and controlled by Dr. Patel, a former director of the Company. We have been granted the right to exploit Jadi Cell’s patent rights (including U.S.

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.

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.

As amended, the Patent Purchase Agreement includes the following terms: · We were required to pay CMH $100,000 within 30 days of demand as an initial payment. · Upon the determination to pursue the technology via use of autologous cells, we were required to pay CMH: o $100,000 upon the signing agreement with a university for the initiation of an IRB clinical trial. o $200,000, upon completion of the IRB clinical trial. o $300,000 in the event we commercialize the technology via use of autologous cells by a physician without a clinical trial. · In the event we determine to pursue the technology via use of allogenic cells, we are required to pay CMH: o $100,000 upon filing an IND with the FDA. o $200,000 upon dosing of the first patient in a Phase 1-2 clinical trial. o $400,000 upon dosing the first patient in a Phase 3 clinical trial. · Each payment may be made in cash or shares of our common at a discount of 30% to the recent trading price. · In the event our shares of common stock trade below $0.01 per share for two or more consecutive trading days, the number of any shares issuable as payment doubles. · For a period of five years from the date of the first sale of any product derived from the patent, we are required to make royalty payments of 5% from gross sales of products, and 50% of sale price or ongoing payments from third parties for licenses granted under the patent to third parties.

The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following: · completion of non-clinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practice (or GLP), or other applicable regulations; · submission of an IND, which allows clinical trials to begin unless the FDA objects within 30 days; · performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use or uses conducted in accordance with FDA regulations and Good Clinical Practices (or GCP), which are international ethical and scientific quality standards meant to ensure that the rights, safety and well-being of trial participants are protected and that the integrity of the data is maintained; · registration of clinical trials of FDA-regulated products and certain clinical trial information; · preparation and submission to the FDA of a new drug application (or NDA), in the case of a drug or biologics license application (or BLA) in the case of a biologic; · review of the product by an FDA advisory committee, where appropriate or if applicable; · satisfactory completion of pre-approval inspection of manufacturing facilities and clinical trial sites at which the product, or components thereof, are produced to assess compliance with Good Manufacturing Practice, or cGMP, requirements and of selected clinical trial sites to assess compliance with GCP requirements; and · FDA approval of an NDA or BLA which must occur before a drug or biologic can be marketed or sold.

The two procedures are now offered in the following eight markets: · Arkansas – Martinsburg · California o Roseville o San Francisco · Florida – Orlando · Ohio - Dublin · Texas o Austin o San Antonio · West Virginia - Fayetteville To-date, we have recruited physicians by partnering with independent sales representatives who represent the Company to physicians across the United States and Europe.

The two procedures are now offered in the following eight markets: · Arkansas – Martinsburg · California o Roseville o San Francisco · Florida – Orlando · Ohio - Dublin · Texas o Austin o San Antonio · West Virginia - Fayetteville 10 Table of Contents To-date, we have recruited physicians by partnering with independent sales representatives who represent the Company to physicians across the United States.

Unlike our CaverStem ® , FemCelz ® and StemSpine® procedures, because the patient’s cells are reprogrammed/supercharged prior to reinjection, we will require FDA approval before we can market or sell ImmCelz™. We developed ImmCelz™ initially using co-culture techniques which have now been advanced to a cell-free culture system.

Unlike our CaverStem ® , FemCelz ® and StemSpine® procedures, because the patient’s cells are reprogrammed/supercharged prior to reinjection, we will require FDA approval before we can market or sell products that use our ImmCelz™ (CELZ-100) technology. We developed ImmCelz™ (CELZ-100) initially using co-culture techniques which have now been advanced to a cell-free culture system.

This reflects expenses associated with the acquisition of research tools 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 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.

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.

On December 31, 2020, following our announcement with respect to the clinical commercialization of the StemSpine technology, we paid CMH $50,000 of the $300,000 obligation due under this agreement through the issuance of 133 shares of common stock.

On December 31, 2020, following the Company’s announcement with respect to the clinical commercialization of the StemSpine technology, the Company paid CMH $50,000 of the $300,000 obligation due under this agreement through the issuance of 14 shares of common stock.

The process can take many years, depending on the product and the FDA’s requirements. 15 Table of Contents In addition, even if a product candidate receives regulatory approval, the approval may be limited to specific disease states, patient populations and dosages, or might contain significant limitations on use in the form of warnings, precautions or contraindications, or in the form of onerous risk management plans, restrictions on distribution or use, or post-marketing trial requirements.

In addition, even if a product candidate receives regulatory approval, the approval may be limited to specific disease states, patient populations and dosages, or might contain significant limitations on use in the form of warnings, precautions or contraindications, or in the form of onerous risk management plans, restrictions on distribution or use, or post-marketing trial requirements.

If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions including public warning letters, fines, consent decrees, orders of retention, recall or destruction of product, orders to cease manufacturing, and criminal prosecution.

We contract with physicians to purchase kits and, in turn, provide exclusivity in their market through our patent protection, marketing support and training. FemCelz® is a U.S. registered trademark (Reg. No. 6107881).

We contract with physicians to purchase kits and, in turn, provide exclusivity in their market through our patent protection, marketing support and training. However, to date, we have generated no revenues from this treatment. FemCelz® is a U.S. registered trademark (Reg. No. 6107881).

To date, we have not made any payments to Jadi Cell under this agreement, other than the $250,000 initial license fee, which we paid by the issuance of 180,180 shares of common stock to Jadi Cell in February 2022.

To date, the Company has not made any payments to Jadi Cell under this agreement, other than the $250,000 initial license fee, which was paid by the issuance of 18,018 shares of common stock to Jadi Cell in February 2022.

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.

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.

As a condition of approval, the FDA may require that a sponsor of a drug or biologic product candidate receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials.

On September 30, 2021, we paid CMH an additional $40,000 of the $300,000 obligation due under this agreement through the issuance of 84,656 shares of common stock, and in January 2021 we paid CMH an additional $50,000 of the $300,000 obligation due under this agreement through the issuance of 89,286 shares of common stock.

On September 30, 2021, the Company paid CMH an additional $40,000 of the $300,000 obligation due under this agreement through the issuance of 8,466 shares of common stock, and in January 2021 the Company paid CMH an additional $50,000 of the $300,000 obligation due under this agreement through the issuance of 8,929 shares of common stock.

In November 2022, we announced that the FDA had cleared the Company’s AlloStem™ (CELZ-201) Investigational New Drug (IND) application for the treatment of Type 1 Diabetes, which will allow us to begin a Phase I/II clinical trial. The primary objective of the study (CELZ-201) will be to evaluate AlloStem™ in patients with newly diagnosed Type 1 Diabetes.

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.

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.

Food and Drug Administration (the “FDA”) for registration. We believe we will able to use this cell line for many of our programs, including our ImmCelz® immunotherapy platform for multiple diseases, OvaStem® for Premature Ovarian Failure, CELZ-201 for Type 1 diabetes, StemSpine® for lower back pain, and IPScelz ™ perinatal stem cell program in ongoing development with Greenstone Biosciences.

Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.

An NDA or BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA and BLA supplements as it does in reviewing NDAs and BLAs. 17 Table of Contents Drug and biological products must also comply with applicable requirements, including monitoring and recordkeeping activities, manufacturing requirements, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling, or off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.

None of our employees belong to a union. We believe relations with our employees are good. 19 Table of Contents Research and Development Research and development expenses for the year ended December 31, 2022, totaled $6,268,854.

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.

In addition, pursuant to the “Same Surgical Procedure Exception” under Section 1271.15(b) of the HCT/P Regulations, the FDA has provided guidance that exempts HCT/Ps from Section 361 of the PHS Act where autologous cells are removed from an individual and implanted into the same individual during a single surgical procedure without intervening processing steps.

If one or more of the above factors has been exceeded, the product would be regulated as a drug, biological product, or medical device rather than an HCT/P. 15 Table of Contents In addition, pursuant to the “Same Surgical Procedure Exception” under Section 1271.15(b) of the HCT/P Regulations, the FDA has provided guidance that exempts HCT/Ps from Section 361 of the PHS Act where autologous cells are removed from an individual and implanted into the same individual during a single surgical procedure without intervening processing steps.

If any of these events were to occur, it could materially adversely affect us. 13 Table of Contents Drug and Biological Product Regulation An HCT/P product that does not meet the criteria for being solely regulated under Section 361 of the PHS Act will be regulated as a drug, device or biological product under the FDCA and/or Section 351 of the PHS Act, and applicable FDA regulations.

Drug and Biological Product Regulation An HCT/P product that does not meet the criteria for being solely regulated under Section 361 of the PHS Act will be regulated as a drug, device or biological product under the FDCA and/or Section 351 of the PHS Act, and applicable FDA regulations.

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.

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.

Similarly, while there are many treatments available for female sexual dysfunction, we are not aware of any competitor for our FemCelz® procedure that uses or proposes to use autological stem cells to treat female sexual dysfunction, nor are we aware of any potential competitor for OvaStem™ that uses or proposes to use autologous stem cells to treat women with damaged ovaries who do not respond to available medications.

None of these firms is believed to have filed for patent protection or conducted clinical trials using bone marrow to validate safety and efficacy as we have. 14 Table of Contents Similarly, while there are many treatments available for female sexual dysfunction, we are not aware of any competitor for our FemCelz® procedure that uses or proposes to use autological stem cells to treat female sexual dysfunction, nor are we aware of any potential competitor for OvaStem™ that uses or proposes to use autologous stem cells to treat women with damaged ovaries who do not respond to available medications.

Results, products and all intellectual property related to this work is owned by the Company. In June 2022, we signed an agreement with Greenstone Biosciences Inc. for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz® platform. This project was identified as iPScelz™.

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.

The immune cells are then re-injected into the patient from whom they were extracted. We believe this process endows the immune cells with regenerative properties that may be suitable for the treatment of multiple indications.

The immune cells are then re-injected into the patient from whom they were extracted. We believe this process endows the immune cells with regenerative properties (or “supercharges” them) providing them with the ability to treat multiple indications.

Further, with the passage of the 21st Century Cures Act, or the Cures Act, in December 2016, Congress authorized the FDA to accelerate review and approval of products designated as regenerative advanced therapies.

Fast Track designation, breakthrough therapy designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Further, with the passage of the 21st Century Cures Act, or the Cures Act, in December 2016, Congress authorized the FDA to accelerate review and approval of products designated as regenerative advanced therapies.

Research and development expenses for the year ended December 31, 2021 totaled $109,180.

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

We paid Roth a placement agent fee in the amount of $1,360,000 and issued Roth a warrant to purchase 1,133,333 shares of common stock with the same terms as the Warrants issued to the Purchasers.

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.

In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track NDA or BLA before the application is complete, a process known as rolling review. 18 Table of Contents Any product submitted to the FDA for marketing, including under a Fast Track program, may also be eligible for the following other types of FDA programs intended to expedite development and review: · Breakthrough therapy designation .

No patients required re-dosage or surgical intervention since the last follow-up at two years. StemSpine® is a U.S. registered trademark (Reg. No. 5997521). 7 Table of Contents ImmCelz™ - Personalized Supercharged Immune Therapy (Pre-Clinical Trials ) We are developing our ImmCelz™ technology for the treatment of multiple indications.

No patients required re-dosage or surgical intervention since the last follow-up at two years. StemSpine® is a U.S. registered trademark (Reg. No. 5997521). We have filed an application with the USPTO to trademark ImmCelz TM (Ser. No. 88829362). OvaStem™ - Stem Cell Therapy for Premature Ovarian Failure We are developing our OvaStem™ technology for the treatment of female infertility.

Patent No. 9,803,176 “Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses” and the proprietary process of expanding the master cell bank of Jadi Cell LLC, in the field of enhancing autologous cells.

Patent# 9,803,176 B2, “Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses”. The contract grants ImmCelz™ access to proprietary process of expanding the master cell bank of Jadi Cell LLC, as currently practiced by Licensor, and as documented in standard operating procedures (SOPs) and other written documentation to augment autologous cells.

Companies working in the area of regenerative medicine with regard to the disc and spine include, among others, Mesoblast, SpinalCyte, BioRestorative Therapies, DiscGenics and Isto Biologics.

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.

All data, products and intellectual property related to this work is owned by the Company. 4 Table of Contents In October 2022, we announced the development of our AlloStem™ Clinical Cell Line, a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File which we intend to submit to the U.S.

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.

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.

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

Trademarks We have obtained trademark registration for CaverStem®, StemSpine® and FemCelz®, and have trademark applications pending for ImmCelz™, OvaStem™ , iPScelz™, AlloStem™ and Alova™. Competition We compete with many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies involved in the development and commercialization of cell-based medical technologies and therapies.

Competition We compete with many pharmaceutical, biotechnology and medical device companies, as well as other private and public stem cell companies involved in the development and commercialization of cell-based medical technologies and therapies. Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do.

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.

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.

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.

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.

Regenerative medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from human tissues. 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.

The remaining portion of the $300,000 obligation has been paid in cash. 11 Table of Contents ImmCelz™ License. On December 28, 2020, we entered into a patent license agreement with Jadi Cell, LLC, a company owned and controlled by Dr. Amit Patel, a former director of ours. The agreement provides us with an exclusive, worldwide license to U.S.

(“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.

Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing and personnel resources than we do. We cannot forecast when or if these companies are likely to bring their products and therapies to market in competition with our products and therapies or those that we are pursuing.

We cannot forecast when or if these companies are likely to bring their products and therapies to market in competition with our products and therapies or those that we are pursuing. Regenerative medicine is rapidly progressing, in large part through the development of cell-based therapies or devices designed to isolate cells from human tissues.

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) 2,991,669 shares of our common stock and pre-funded warrants to purchase 4,563,887 shares of common stock (the “Pre-Funded Warrants”), and (ii) accompanying warrants to purchase 15,111,112 shares of common stock at an exercise price of $2.00 per share (“Warrants”), at a combined offering price of $2.25 per share of common stock/Pre-Funded Warrant and related Warrant, to a group of institutional investors (the “Purchasers”).

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.

In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration. In March 2022 we contracted with The University of Miami and the Diabetes Research Institute to further develop, test and manufacture our ImmCelz technology.

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.

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.

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.

The Warrants have a five-year term, and an exercise price of $2.00 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.

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.

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.

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

The agreement includes the following terms: · We were required to pay an initial license fee of $250,000 either in cash or shares of our common stock at a discount of 25% of the closing price of our common stock on the date of the agreement. · Within thirty (30) days of the end of each calendar quarter, we are required to pay Jadi Cell five percent (5%) of the net income we generate from ImmCelz™ during such calendar quarter. · If we sell or dispose of the ImmCelz™ business, we will be required to pay Jadi Cell ten percent of the proceeds of the sale. · The agreement may only be terminated by Jadi Cell if we are in material breach of the agreement, in the event of our bankruptcy, if we cease to engage in the ImmCelz™ business or if we challenge the validity of the patent rights granted to us under the agreement.

The terms of the agreement are as follows: · Licensee shall pay Licensor a license fee of $250,000 (the “Upfront Royalty”), which can also be paid in CELZ stock at a discount of 25% of the closing price of $0.0037, which is based on the date of this agreement · Within thirty (30) days of the end of each calendar quarter during the term of this Agreement, Licensee will pay Licensor five percent (5%) of the Net Income of ImmCelz™. during such calendar quarter (the “Continuing Royalty”) · in one or a series of related transactions, of all or substantially all of the business or assets of Licensee ImmCelz, Inc.

Patient recruitment is expected to begin in 2023. 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. We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc.

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.

Removed

The efforts by Greenstone Biosciences Inc. are expected to complement and expand our current work on novel therapeutic cell lines.

Added

In 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.

Removed

On December 7, 2021, we received gross proceeds of $16,003,750, before deducting underwriting discounts and commissions of seven percent (7%) and offering expenses, upon the closing of a public offering of 3,875,000 shares of our common stock, and accompanying warrants to purchase 3,875,000 shares of common stock at an exercise price of $4.13 per share (“Warrants”), at a combined public offering price to the public of $4.13 per share of common stock and related Warrant.

Added

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.

Removed

We used a portion of the net proceeds of the offering to (i) redeem 15% Original Issue Discount Senior Notes in the aggregate outstanding amount of $5,146,176, and (ii) repurchase Series A Preferred Stock from our Chief Executive Officer for an aggregate purchase price of approximately $195,000.

Added

The final iPScelz™ results in a viral-free cell line which has great potential for differentiation into therapeutic biologics both for the cellular and cell-free programs along with targeted drug discovery. Greenstone’s developments were confirmed by an independent, industry-leading research firm.

Removed

We intend to use the remaining proceeds from the offering to (i) hire marketing and sales personnel to support sales of our CaverStem® and FemCelz® products, (ii) proceed with a clinical study of 100 patients intended to support the safety and efficacy of our StemSpine® Regenerative Stem Cell Procedure for Treatment of Degenerative Disc Disease, (iii) conduct a Phase I clinical trial for the treatment of stroke utilizing our ImmCelz TM technology, (iv) continue to develop other products and therapies, and (v) fund working capital and general corporate purposes using any remaining amounts.

Added

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.

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 Warrants and Pre-Funded Warrants.

Added

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.

Removed

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

Added

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.

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

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.

Removed

From June through July 2022, all of the Pre-Funded Warrants were exercised for shares of common stock. Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012. 5 Table of Contents Our Products CaverStem ® - Erectile Dysfunction Treatment CaverStem® is a clinically proven, patented procedure (U.S.

Added

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.

Removed

We continue to have the previously licensed platform from Jadi Cells LLC for the first generation ImmCelz™. We have filed an application with the USPTO to trademark ImmCelz TM (Ser. No. 88829362). OvaStem™ - Stem Cell Therapy for Premature Ovarian Failure We are developing our OvaStem™ technology for the treatment of female infertility.

Added

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.

Removed

We paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 6,667 shares of common stock on December 12, 2020.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

40 edited+11 added−17 removed81 unchanged

2022 filing

2023 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.

Failure can occur at any stage of the testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to: · delays in securing clinical investigators or trial sites for the clinical trials; · delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial; · slower than anticipated patient recruitment and enrollment; · negative or inconclusive results from clinical trials; 22 Table of Contents · unforeseen safety issues; · uncertain dosing issues; · an inability to monitor patients adequately during or after treatment; and · problems with investigator or patient compliance with the trial protocols A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials.

Failure can occur at any stage of the testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to: · delays in securing clinical investigators or trial sites for the clinical trials; · delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial; · slower than anticipated patient recruitment and enrollment; · negative or inconclusive results from clinical trials; · unforeseen safety issues; · uncertain dosing issues; · an inability to monitor patients adequately during or after treatment; and · problems with investigator or patient compliance with the trial protocols A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials.

We do not know whether any clinical trials we conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market ImmCelz TM . Our autologous products are currently not eligible for reimbursement from public or private insurers.

We do not know whether any clinical trials we conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market ImmCelz TM (CELZ-100). Our autologous products are currently not eligible for reimbursement from public or private insurers.

These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares. Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our securities.

These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares. 31 Table of Contents Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our securities.

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.

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.

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 $88,600 and $87,754 for the years ended December 31, 2022, and December 31, 2021, respectively.

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.

The degree of market acceptance of our products and therapies will depend on a number of factors, including: · their efficacy; · limitations or warnings or any restrictions on use, and the prevalence and severity of any side effects; · the availability and efficacy of alternative treatments; · the effectiveness of sales and marketing efforts and the strength of marketing and distribution support; · their cost-effectiveness compared to alternative therapies; and · availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors. 21 Table of Contents The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects.

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.

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.

If we are unable to obtain and maintain required approval from one or more foreign jurisdictions where we would like to sell our products or therapies, we will be unable to market products as intended, our international market opportunity will be limited, and our results of operations will be harmed. 24 Table of Contents We rely in part on third parties for research and clinical trials for our products and therapies.

These and other requirements could require us or our collaborators to incur additional costs to achieve compliance, limit our competitiveness, necessitate the acceptance of more onerous obligations in our contracts, restrict our ability to use, store, transfer, and process data, impact our or our collaborators’ ability to process or use data in order to support the provision of our products, affect our or our collaborators’ ability to offer our products in certain locations, or cause regulators to reject, limit or disrupt our clinical trial activities. 23 Table of Contents We and our collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security).

We cannot predict whether we will encounter problems with any of our completed, ongoing, or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials or delay the analysis of data from completed or ongoing clinical trials.

Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we will encounter problems with any of our completed, ongoing, or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials or delay the analysis of data from completed or ongoing clinical trials.

Accordingly, investors seeking cash dividends should not purchase our shares. 29 Table of Contents

Accordingly, investors seeking cash dividends should not purchase our shares.

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.

We are exposed to the risk of fraud or other misconduct by our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners.

Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards. We are exposed to the risk of fraud or other misconduct by our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners.

We estimate that clinical trials of CELZ-201 for the treatment of Type I diabetes will continue for several years, but they may take significantly longer to complete.

We estimate that clinical trials of Type I Diabetes (CELZ-201 CREATE-1) and AlloStemSpine ® Chronic Lower Back Pain (CELZ-201 ADAPT) will continue for several years, but they may take significantly longer to complete.

We expect our operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund our operations. We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.

We expect our operating losses to continue until such time, if ever, that product sales, licensing fees, royalties and other sources generate sufficient revenue to fund our operations.

Our stock price could be subject to wide fluctuations in response to a variety of factors, which include: · whether we achieve our anticipated corporate objectives; · termination of lock-up agreements or other restrictions on the ability of our stockholders and other security holders to sell shares; and · general economic or political conditions in the United States or elsewhere. 28 Table of Contents In addition, the stock market in general, and the stock of clinical stage biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

Accordingly, we may have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own.

We rely or will rely heavily on these parties for the execution of our clinical studies and control only certain aspects of their activities. Accordingly, we may have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own.

Our CaverStem ® and FemCelz ® products are exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells. However, we will require FDA approval of CELZ-201 for the treatment of Type I diabetes and other indications.

Our CaverStem ® and FemCelz ® products are exempt from the FDA premarket review and approval process as these autologous therapies involve treating the patient with his or her own cells.

We rely on contract research organizations (“CROs”), academic institutions, corporate partners, and other third parties to assist us in managing, monitoring, and otherwise carrying out clinical trials and research activities. We rely or will rely heavily on these parties for the execution of our clinical studies and control only certain aspects of their activities.

We rely in part on third parties for research and clinical trials for our products and therapies. We rely on contract research organizations (“CROs”), academic institutions, corporate partners, and other third parties to assist us in managing, monitoring, and otherwise carrying out clinical trials and research activities.

If third parties we rely on fail to perform satisfactorily, or do not adequately fulfill their obligations under the terms of our agreements with them, our efforts to secure regulatory approval of our product candidates may be delayed or prove unsuccessful. 24 Table of Contents Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

We are subject to risks arising from the recent global outbreak of the COVID-19 coronavirus. The recent outbreak of the COVID-19 coronavirus has spread across the globe and is impacting worldwide economic activity.

The outbreak of the COVID-19 coronavirus has spread across the globe and is impacting worldwide economic activity.

Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize any products that are safer, more effective, have fewer side effects or are less expensive than our products and therapies. These potential competitors may also compete with us in establishing clinical trial sites, and patient enrollment for clinical trials.

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. Our internal controls were inadequate in our most recent year.

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.

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.

We may need to initiate lawsuits to protect or enforce our intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market.

We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect the Company from prior infringement. 29 Table of Contents We may need to initiate lawsuits to protect or enforce our intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market.

We have received the necessary regulatory approval for our CELZ-201 Type I diabetes clinical trial. In addition, we are investing significant resources to submit our drug master file to the FDA, further develop 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-202 ADAPT) clinical trial. In addition, we are further developing our cell platforms, and file INDs for additional indications that utilize our cell platforms.

These potential competitors may also compete with us in establishing clinical trial sites, and patient enrollment for clinical trials. 25 Table of Contents Our business and operations would suffer in the event of computer system failures or security breaches. In the ordinary course of our business, we collect, store and transmit confidential information, including intellectual property, and proprietary business information.

Our business and operations would suffer in the event of computer system failures or security breaches. In the ordinary course of our business, we collect, store and transmit confidential information, including intellectual property, and proprietary business information.

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.

In addition, the continued spread of COVID-19 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.

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.

United States and foreign patent applications are not immediately made public, so we might be surprised by the grant to someone else of a patent on a technology we are actively using. 26 Table of Contents In addition to patents, we rely on unpatented trade secrets and proprietary technological expertise, and confidentiality agreements with our partners, employees, advisors, vendors, and consultants to protect our trade secrets and proprietary technological expertise.

United States and foreign patent applications are not immediately made public, so we might be surprised by the grant to someone else of a patent on a technology we are actively using.

COVID-19 has also had an adverse impact on global economic conditions which could impair our ability to raise capital when needed. Risks Related to Our Intellectual Property We may not be able to protect our proprietary rights. Our commercial success will depend in large part upon our ability to protect our proprietary rights.

Risks Related to Our Intellectual Property We may not be able to protect our proprietary rights. Our commercial success will depend in large part upon our ability to protect our proprietary rights.

We cannot assure you that the results of our ongoing preclinical studies or clinical trials will support or justify the continued development of our product candidates, or that we will receive the necessary approvals from the FDA, or similar regulatory authorities in other countries, to advance the development of our product candidates. 23 Table of Contents We may not be successful in our commercialization efforts for our proposed products and therapies, which may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

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 $10.2 million for the year ended December 31, 2022, and a loss of approximately $3.1 million for the year ended December 31, 2021, respectively.

Item 1A. Risk Factors RISK FACTORS Risks Related to our Financial Position and Capital Needs We have incurred recent losses and our future profitability is uncertain.

Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. If our shares of common stock are delisted from The Nasdaq Capital Market and become subject to the penny stock rules, it will be more difficult to trade our shares.

If our shares of common stock are delisted from The Nasdaq Capital Market and become subject to the penny stock rules, it will be more difficult to trade our shares. The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks.

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. 20 Table of Contents We expect to continue to incur significant financial losses in the future as we seek to proceed with our CELZ-201 Type I Diabetes clinical trial and other planned clinical trials.

Even with the proceeds from our recent securities offerings, we will need additional capital to fund our operations as planned. For the year ended December 31, 2022, our operations used approximately $7.8 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.

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.

Our success to date has largely depended on the efforts and abilities of Timothy Warbington, our Chief Executive Officer and Don Dickerson, our Chief Financial Officer.

Our success to date has largely depended on the efforts and abilities of Timothy Warbington, our Chief Executive Officer and Don Dickerson, our Chief Financial Officer. Our ability to manage our operations and meet our business objectives could be adversely affected if, for any reason, such officers do not remain with us.

The Company intends to actively monitor the bid price for its common stock and is considering available options to regain compliance with the Nasdaq minimum bid price requirement. If we fail to satisfy the minimum bid rule when required, or any other continued listing requirements of Nasdaq, Nasdaq may take steps to delist our securities.

Although we are currently in compliance with Nasdaq’s minimum bid price requirement, if we again fail to satisfy this or any other continued listing requirement, Nasdaq may take steps to delist our securities.

The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement, and access to therapies, which could adversely affect our future revenues and profitability. Our existing and proposed products may not be considered cost-effective, and third-party or government reimbursement might not be available or sufficient.

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

Removed

At December 31, 2022, we had a combined cash and certificates of deposit balance of approximately $18.4 million.

Added

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.

Removed

We may not be successful in our commercialization efforts for our proposed products and therapies, which may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

Added

We cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved. 22 Table of Contents Even with the proceeds from our recent securities offerings, we will need additional capital to fund our operations as planned.

Removed

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Clinical trials are expensive and complex, can take many years and have uncertain outcomes.

Added

We expect to continue to incur significant financial losses in the future as we seek to proceed with our Type I Diabetes (CELZ-201 CREATE-1) clinical trial, our AlloStemSpine ® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial, and our other planned clinical trials.

Removed

Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies and can expose us to product liability claims.

Added

The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects.

Removed

As a public company, our management is responsible for establishing and maintaining adequate internal control over financial reporting. In addition, we are required to include in our Annual Reports on Form 10-K, a report by management on, among other things, the effectiveness of our internal control over financial reporting.

Added

However, we will require FDA approval of CELZ-201 CREATE-1 for the treatment of Type I diabetes, AlloStemSpine (CELZ 201 – ADAPT) treatment for chronic lower back pain, and other indications.

Removed

This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

Added

We and our collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security).

Removed

As defined in Exchange Act Rule 13a-15(f), internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

Added

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

Removed

As disclosed in Item 9A of this Annual Report on Form 10-K, management has concluded that our internal control over financial reporting was not effective for our year ended December 31, 2022, and has identified material weaknesses in our internal controls.

Added

Although we believe we do not have any exposure to the wars in Ukraine and the Gaza Strip, we cannot predict how global supply chain activities, or the economy at large may be impacted by prolonged wars in those or other regions, or whether global conflicts, if any, may in the future adversely affect our results of operations.

Removed

Faulty judgments, simple errors or mistakes, or the failure of our personnel to adhere to established controls and procedures, may make it difficult for us to ensure that the objectives of the control system are met. A failure of our controls and procedures to detect material errors or fraud could seriously harm our business and results of operations.

Added

In addition to patents, we rely on unpatented trade secrets and proprietary technological expertise, and confidentiality agreements with our partners, employees, advisors, vendors, and consultants to protect our trade secrets and proprietary technological expertise.

Removed

During 2021 and 2022, COVID-19 has resulted in significantly reduced revenues from our CaverStem ® and FemCelz ® products, as elective procedures in general have been greatly reduced throughout the United States during the pandemic.

Added

In addition, the stock market in general, and the stock of clinical stage biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

Removed

We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect the Company from prior infringement.

Added

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.

Removed

Our ability to manage our operations and meet our business objectives could be adversely affected if, for any reason, such officers do not remain with us. 27 Table of Contents Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards.

Removed

If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations.

Removed

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks.

Removed

On July 8, 2022, we received a letter from The Nasdaq Stock Market stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the closing bid price of our common stock was below $1.00 per share for 30 consecutive business days.

Removed

Pursuant to Nasdaq’s Listing Rules, the Company had an initial 180-day grace period, until January 4, 2023, during which the Company could have regained compliance if the bid price of its common stock closed at $1.00 per share or more for a minimum of ten consecutive business days.

Removed

The Company was eligible for an additional 180-day grace period if the Company met Nasdaq’s initial listing standards (other than with respect to minimum bid price) for The Nasdaq Capital Market. The Company applied for and received the additional 180-day grace period and now has until July 4, 2023, to meet the Nasdaq minimum bid price listing rule.

Item 2. Properties

Properties — owned and leased real estate

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2023 filing

Removed

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.

Added

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.

Added

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.

Added

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 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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2023 filing

Removed

In October 2022, we terminated an employee for cause. Subsequent to the termination, in December 2022, the employee brought claims against us for breach of contract, wrongful termination and related claims in the Superior Court of the State California (Orange County). The parties have submitted the action for arbitration before JAMS, where it is now pending.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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2023 filing

Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans The following table sets forth as of the most recent fiscal year ended December 31, 2022, 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 111,817 (1) $ 1.69 488,183 (1) Equity compensation plans not approved by security holders 100,102 (2) $ 10.71 27 (3) Total 211,919 $ 5.67 376,393 _________________ (1) Represents 58,580 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 $1.69 per share, and (x) 53,237 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 $1.69 per share, and shares available for issuance under the Company’s 2021 Equity Incentive Plan.

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.

Stock Subject to 2021 Plan. Subject to certain adjustment provisions described below, the number of shares of common stock which are set aside and reserved for issuance under the 2021 Plan is 600,000 shares. Eligible Participants.

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. Administration.

(2) Represents (i) 20,000 shares of common stock issuable to Donald Dickerson, the Company’s Chief Financial Officer, under a ten-year warrant issued on December 28, 2020 with an exercise price of $2.00 per share, (ii) 10,000 shares of common stock issuable to Donald Dickerson under a ten-year warrant issued on July 15, 2021 with an exercise price of $15.00 per share, (iii) 20,000 shares of common stock issuable to Amit Patel, a former director of the Company, under a ten-year warrant issued on December 28, 2020 with an exercise price of $2.00 per share, (iv) 10,000 shares of common stock issuable to Amit Patel under a ten-year warrant issued on July 15, 2021 with an exercise price of $15.00 per share, (v) 10,000 shares of common stock issuable to Thomas Ichim, a former director of the Company, under a ten-year warrant issued on July 15, 2021 with an exercise price of $15.00 per share, (vi) 28,020 shares of common stock issuable to various consultants of the Company under three-year warrant issued in April and May 2021 with an exercise price of $15.00 per share; (vii) 95 shares of common stock issuable to a consultant of the Company under three-year warrant issued September 2020 with an exercise price of $1.45 per share, and (viii) 7 shares of common stock issuable under options granted under the Company’s 2016 Stock Incentive Plan.

(2) Represents (i) 2,000 shares of common stock issuable to Donald Dickerson, the Company’s Chief Financial Officer, under a ten-year warrant issued on December 28, 2020 with an exercise price of $20.00 per share, (ii) 1,000 shares of common stock issuable to Donald Dickerson under a ten-year warrant issued on July 15, 2021 with an exercise price of $150.00 per share, (iii) 2,000 shares of common stock issuable to Amit Patel, a former director of the Company, under a ten-year warrant issued on December 28, 2020 with an exercise price of $20.00 per share, (iv) 1,000 shares of common stock issuable to Amit Patel under a ten-year warrant issued on July 15, 2021 with an exercise price of $150.00 per share, (v) 1,000 shares of common stock issuable to Thomas Ichim, a former director of the Company, under a ten-year warrant issued on July 15, 2021 with an exercise price of $150.00 per share, (vi) 2,802 shares of common stock issuable to various consultants of the Company under three-year warrant issued in April and May 2021 with an exercise price of $150.00 per share; (vii) 10 shares of common stock issuable to a consultant of the Company under three-year warrant issued September 2020 with an exercise price of $14.50 per share, and (viii) 1 share of common stock issuable under options granted under the Company’s 2016 Stock Incentive Plan.

Holders As of March 31, 2023, 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, 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.

(3) Represents 27 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”).

(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.

The essential features of the 2021 Plan are outlined below: 31 Table of Contents 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.

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.

Removed

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.

Item 7. Management's Discussion & Analysis

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

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2023 filing

Biggest changeThe primary objective of the study will be to evaluate CELZ-201 in patients with newly diagnosed Type 1 Diabetes. Patient recruitment is expected to begin in 2023. 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.

Biggest changeIn 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 .

There was $92,084 of amortization expense recorded for the period ended December 31, 2021. 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 $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.

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 2024. 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 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.

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.

Patent No. 8,372,797) from CMH on February 2, 2016, in exchange for shares of our restricted common stock valued at $100,000. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis.

We acquired a patent (U.S. Patent No. 8,372,797) from CMH on February 2, 2016, in exchange for shares of our restricted common stock valued at $100,000. The patent expires in 2026 and we have elected to amortize the patent over a ten-year period on a straight-line basis.

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.

There can be no guarantee that we will be successful in our ability to raise capital to fund future operational and development initiatives. 36 Table of Contents Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles accepted in the United States.

There can be no guarantee that we will be successful in our ability to raise capital to fund future operational and development initiatives. Critical Accounting Policies and Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles accepted in the United States.

We believe we will able to use this cell line for many of our programs, including our ImmCelz® immunotherapy platform for multiple diseases, OvaStem® for Premature Ovarian Failure, CELZ-201 for Type 1 diabetes, StemSpine® for lower back pain, and IPScelz ™ inducible pluripotent stem cell program in ongoing development with Greenstone Biosciences. 33 Table of Contents In November 2022, we announced that the FDA had cleared the Company’s CELZ-201 Investigational New Drug (IND) application for the treatment of Type 1 Diabetes, which will allow us to begin a Phase I/II clinical trial.

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

We paid Roth a placement agent fee in the amount of $1,360,000 and issued Roth a warrant to purchase 1,133,333 shares of common stock with the same terms as the common warrants issued to the purchasers.

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.

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

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.

Our actual results could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth in the section captioned “ Risk Factors ” in Annual Report. The following should be read in conjunction with our audited financial statements included elsewhere herein.

Selling, General and Administrative Expenses . General and administrative expenses for the year ended December 31, 2022, totaled $3,943,543, in comparison with $2,964,490 for the comparable period a year ago.

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.

Execution of the contract triggered a milestone payment due from the Company to Jadi Cells, Inc. in the amount of $250,000, which was paid with shares of our common stock in February 2022.

Execution of the contract triggered a milestone payment due from the Company to Jadi Cells, Inc. in the amount of $250,000, which was paid with shares of our common stock in February 2022. 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.

Operating Loss . For the reasons stated above, our operating loss for the year ended December 31, 2022, was $10,244,372 in comparison with $3,125,949 for the comparable period a year ago. Other Income . Other income for the year ended December 31, 2022, totaled $100,328 in comparison with $22,337,717 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.

The increase in cash used in operations was primarily related to an increase of $3,159,674 in research-related cash outlays associated with the acquisition of research assets, personnel and laboratory research in preparation of our master cell bank submittal to the FDA, development, submittal and FDA clearance of our CELZ-201 Type I Diabetes 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.

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 .

The increase of $6,159,674 , or 5,641.8% was due to expenses associated with the acquisition of research tools and development of a drug master file, laboratory research in preparation of our master cell bank submittal to the FDA, the approval of our FDA application for a Type I Diabetes Phase 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.

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.

In the year ended December 31, 2022, we received $15,471,775 in net proceeds from the sale of common stock and warrants in our May 2022 private offering.

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 comparison, as of December 31, 2021, we had approximately $10,723,870 of available cash and positive working capital of approximately $9,686,780. 35 Table of Contents 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) 2,991,669 shares of our common stock and pre-funded warrants to purchase 4,563,887 shares of common stock (the “Pre-Funded Warrants”), and (ii) accompanying warrants to purchase 15,111,112 shares of common stock at an exercise price of $2.00 per share (“Warrants”), and, at a combined offering price of $2.25 per share of common stock/Pre-Funded Warrant and related Warrant to a group of institutional investors (the “Purchasers”).

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”).

From June through July 2022, all of the Pre-Funded Warrants were exercised for shares of common stock.

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.

Amortization expense of $92,084 was recorded for the year ended December 31, 2022, 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 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.

We generated $28,491 in cost of goods sold for the year ended December 31, 2022, in comparison with $47,949 for the comparable period a year ago. The decrease of $19,458 or 40.6% is due to the effects of the business model change in the fourth quarter of 2021 as described above. Gross Profit/(Loss) .

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) .

Net Cash used in Operating Activities. We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was $7,796,966 for the year-ended ended December 30, 2022, in comparison to $2,215,782 for the comparable period a year ago, an increase of $5,581,184 or 252%.

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 Investing Activities . Cash used in investing activities was $10,078,617 for the year ended December 31, 2022, related to the investment of $10,000,000 in certificates of deposit in comparison to $0 for the year ended December 31, 2021. Net Cash from Financing Activities.

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.

This project was identified as iPScelz™. The efforts by Greenstone Biosciences Inc. are expected to complement and expand our current work on novel therapeutic cell lines. In October 2022, we announced the development of our AlloStem™ Clinical Cell Line, a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File.

Our platforms, therapies and products include the following: Our subsidiary, Creative Medical Technologies, Inc. (“CMT”), was originally created to monetize U.S. Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired in May 2016.

Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired in February 2016.

The following should be read in conjunction with our audited financial statements included elsewhere herein. 32 Table of Contents 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.

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.

Research and Development Expenses . Research and development expenses for the years ended December 31, 2022, totaled $6,268,854 in comparison to $109,180 for the comparable period a year ago.

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.

In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration. In June 2022, we signed an agreement with Greenstone Biosciences Inc. for the development of a human induced pluripotent stem cell (iPSC) pipeline for our ImmCelz® platform.

Results of Operations – For the Year Ended December 31, 2022, and for the Year Ended December 31, 2021 Gross Revenue . We generated $88,600 in gross revenue for the year ended December 31, 2022, in comparison with $87,754 for the comparable period a year ago.

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.

We generated $60,109 in gross profit for the year ended December 31, 2022, in comparison with $39,805 in gross profit for the comparable period a year ago. The increase of $20,304 or 51.0% is due to the increased per-unit profit from moving off the temporary shift to a direct-to-patient model in the fourth quarter of 2021.

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 .

The derivative liabilities were re-measured as of each reporting date. 34 Table of Contents Net Income/Loss . For the reasons stated above, our net loss for the year ended December 31, 2022, was $10,144,044 in comparison with income of $19,211,768 for the comparable period a year ago. Amortization Expense . We acquired a patent (U.S.

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 .

Removed

The increase of $846 or 1.0% is the result of lower revenue per unit offset by an increased number of unit sales. In the fourth quarter of 2021 we field tested an alternative sales and marketing program for CaverStem® whereby we marketed directly to the patient, collected the procedure fees from the patient and paid the physicians for their services.

Added

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.

Removed

While this effort resulted in an increase in the number of procedures and gross revenues per procedure, gross margins were greatly reduced. As a result, in the first quarter of 2022, we reverted to our model of contracting with physicians, who resell our kits and bill their patients directly. Cost of Goods Sold .

Added

Removed

The increase of 979,053, or 33% is primarily due to a net increase of $810,513 in salaries and wages from both new hires and the transition of our CEO and CFO from being reimbursed via management fees for most of 2021 to full-time employees throughout 2022, an increase of $423,209 associated with director and officer insurance, an increase of $355,984 in marketing expenses, an increase of $264,623 in consulting services, offset by a decrease of $688,146 relating to an expense associated with an accrual related to a vendor dispute in 2021, and a reduction of $526,634 in stock-based compensation.

Added

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.

Removed

The decreased income of $22,237,389 or 99.6%, is primarily due to a decrease of $26,030,549 in the in the fair value of derivative liabilities, a $585,601 decrease in the gain upon the extinguishment of convertible notes, offset by a $4,278,433 decrease in interest expense for the comparable period a year ago. In 2022, we had no outstanding promissory notes.

Added

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.

Removed

In 2021 we incurred interest expense calculated on our promissory notes and we recorded the amortization of various debt discounts associated with our promissory notes. The discounts were the result of a combination of on-issuance discounts and fees, warrants issued with promissory notes, and derivative liabilities which are recorded due to the variability of the notes conversion price.

Added

Removed

On December 7, 2021, we sold an aggregate of 3,875,000 shares of our common stock and accompanying warrants to purchase 3,875,000 shares of common stock at an exercise price of $4.13 per share, at a combined public offering price to the public of $4.13 per share of common stock and related Warrant, pursuant to an Underwriting Agreement we entered into Roth Capital Partners, LLC.

Added

Removed

We received gross proceeds of $16,003,750, before deducting underwriting discounts and commissions of seven percent (7%) of the gross proceeds and offering expenses.

Added

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.

Removed

We used a portion of the proceeds from the offering to (i) redeem our Bridge Notes described below, in the aggregate outstanding amount of $5,146,176, and (ii) repurchase the Company’s Series A Preferred Stock from the Company’s Chief Executive Officer for an aggregate purchase price of approximately $195,000.

Added

Removed

In addition to our 2021 public offering and smaller private convertible note and preferred stock financing transactions we completed in the last two years, in August 2021, we completed the sale of 15% Original Issue Discount Senior Notes (“Bridge Notes”) in the aggregate principal amount of $4,456,176.

Added

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.

Removed

In connection with the sale of the Bridge Notes, holders of shares of our preferred stock issued earlier in 2021 exchanged such preferred stock for additional Bridge Notes in the aggregate principal amount of $690,000.

Added

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.

Removed

We also issued to the purchasers of our Bridge Notes five-year warrants to purchase an aggregate of 363,046 shares of our common stock at an initial exercise price of $14.175 per share, subject to anti-dilution adjustment in the event of future sales of equity by us below the then exercise price, stock dividends, stock splits and other specified events.

Added

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.

Removed

In addition, there was a net increase of $810,513 in salaries and wages from both new hires and the transition of our CEO and CFO from being reimbursed via management fees for most of 2021 to full-time employees throughout 2022, an increase of $761,327 associated with cash outlays for director and officer insurance, an increase of $355,984 in marketing expenses, an increase of $283,642 in consulting services, and payments associated with a vendor dispute in 2021.

Added

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.

Removed

In the year ended December 31, 2021, we received $14,758,488 in net proceeds from the sale of common stock and warrants in our December 2021 public offering, along with $4,784,790 from the issuance of convertible debt, preferred stock, and short-term, non-convertible notes, and we spent $6,925,032 on re-payment of notes, redemption of preferred stock, and payment of debt issuance and offering costs.

Added

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.

Removed

The $2,630,592 or 20% increase in cash flows from financing activities was primarily related to a $713,287 increase in net proceeds between our December 2021 and May 2022 offerings and a net reduction of $1,916,848 associated with retirement of convertible debt and other financing related expenses incurred in 2021. We have continued to realize losses from operations.

Added

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

Added

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 .

Added

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 .

Top changes in CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.'s 2023 10-K

Item 1. Business

Item 1A. Risk Factors

Item 2. Properties

Item 3. Legal Proceedings

Item 5. Market for Registrant's Common Equity

Item 7. Management's Discussion & Analysis

Other CELZ 10-K year-over-year comparisons