Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 22, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Entity Registrant Name | CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. | ||
Entity Central Index Key | 0001187953 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Current Reporting Status | Yes | ||
Document Period End Date | Dec. 31, 2023 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Entity Common Stock Shares Outstanding | 1,356,626 | ||
Entity Public Float | $ 6,633,274 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Fin Stmt Error Correction Flag | false | ||
Entity File Number | 000-53500 | ||
Entity Incorporation State Country Code | NV | ||
Entity Tax Identification Number | 87-0622284 | ||
Entity Address Address Line 1 | 211 E Osborn Road | ||
Entity Address City Or Town | Phoenix | ||
Entity Address State Or Province | AZ | ||
Entity Address Postal Zip Code | 85012 | ||
City Area Code | 480 | ||
Icfr Auditor Attestation Flag | false | ||
Auditor Name | Haynie & Company | ||
Auditor Location | Salt Lake City, Utah | ||
Auditor Firm Id | 457 | ||
Local Phone Number | 399-2822 | ||
Security 12b Title | Common Stock, par value $0.001 per share | ||
Trading Symbol | CELZ | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash | $ 3,466,867 | $ 8,320,519 |
Investments | 6,520,191 | 10,078,617 |
Inventory | 6,594 | 10,194 |
Prepaids and other current assets | 277,246 | 338,120 |
Total Current Assets | 10,270,898 | 18,747,450 |
OTHER ASSETS | ||
Other assets | 3,281 | 3,281 |
Licenses, net of amortization | 441,011 | 435,595 |
TOTAL ASSETS | 10,715,190 | 19,186,326 |
CURRENT LIABILITIES | ||
Accounts payable | 317,280 | 3,267,538 |
Accrued expenses | 39,920 | 39,920 |
Advances from related party | 14,194 | 14,194 |
Total Current Liabilities | 371,394 | 3,321,652 |
TOTAL LIABILITIES | 371,394 | 3,321,652 |
STOCKHOLDERS' EQUITY | ||
Common stock, $0.001 par value, 5,000,000 and 50,000,000 shares authorized; 1,431,126 and 1,407,625 issued and 1,373,626 and 1,407,624 outstanding at December 31, 2023 and 2022, respectively | 1,431 | 1,407 |
Additional paid-in capital | 69,711,749 | 69,675,125 |
Accumulated deficit | (59,098,432) | (53,811,858) |
Treasury stock, at cost, 57,500 shares as of December 31, 2023 | (270,952) | 0 |
TOTAL STOCKHOLDERS' EQUITY | 10,343,796 | 15,864,674 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 10,715,190 | $ 19,186,326 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
CONSOLIDATED BALANCE SHEETS | ||
Common Stock, Shares Par Value | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 5,000,000 | 50,000,000 |
Common Stock, Shares Issued | 1,431,126 | 1,407,625 |
Common Stock, Shares Outstanding | 1,373,626 | 1,407,624 |
Treasury stock | 57,500 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CONSOLIDATED STATEMENTS OF OPERATIONS | ||
Revenues | $ 9,000 | $ 88,600 |
Cost of revenues | 3,600 | 28,491 |
Gross profit | 5,400 | 60,109 |
OPERATING EXPENSES | ||
Research and development | 1,970,639 | 6,268,854 |
Selling, general and administrative | 3,560,309 | 3,943,543 |
Amortization of patent costs | 94,584 | 92,084 |
TOTAL EXPENSES | 5,625,532 | 10,304,481 |
Operating loss | (5,620,132) | (10,244,372) |
OTHER INCOME/(EXPENSE) | ||
Interest income | 333,558 | 100,328 |
Total other income (expense) | 333,558 | 100,328 |
LOSS BEFORE PROVISION FOR INCOME TAXES | (5,286,574) | (10,144,044) |
Provision for income taxes | 0 | 0 |
NET LOSS | $ (5,286,574) | $ (10,144,044) |
NET LOSS PER SHARE - BASIC AND DILUTED | $ (3.76) | $ (9.28) |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - BASIC AND DILUTED | 1,407,632 | 1,093,204 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Common Stock | Additional Paid In Capital | Retained Earnings (Accumulated Deficit) | Treasury Stocks [Member] |
Balance, shares at Dec. 31, 2021 | 633,886 | ||||
Balance, amount at Dec. 31, 2021 | $ 10,217,740 | $ 634 | $ 53,884,920 | $ (43,667,814) | $ 0 |
Issuance of common stock and accompanying warrants, net of issuance costs, shares | 299,167 | ||||
Issuance of common stock and accompanying warrants, net of issuance costs, amount | 15,471,775 | $ 299 | 15,471,476 | 0 | 0 |
Common stock issued for related party management and patent liabilities, shares | 18,182 | ||||
Common stock issued for related party management and patent liabilities, amount | 250,000 | $ 18 | 249,982 | 0 | 0 |
Common Stock issued for warrant exercise, shares | 456,389 | ||||
Common Stock issued for warrant exercise, amount | 457 | $ 456 | 1 | 0 | 0 |
Stock-based compensation | 68,746 | 0 | 68,746 | 0 | 0 |
Net loss | (10,144,044) | $ 0 | 0 | (10,144,044) | 0 |
Balance, shares at Dec. 31, 2022 | 1,407,624 | ||||
Balance, amount at Dec. 31, 2022 | 15,864,674 | $ 1,407 | 69,675,125 | (53,811,858) | 0 |
Stock-based compensation | 36,648 | 0 | 36,648 | 0 | 0 |
Net loss | (5,286,574) | $ 0 | 0 | (5,286,574) | 0 |
Round-up shares issued in reverse stock split, shares | 23,502 | ||||
Round-up shares issued in reverse stock split, amount | 0 | $ 24 | (24) | 0 | 0 |
Purchase of common stock | (270,952) | $ 0 | 0 | 0 | (270,952) |
Balance, shares at Dec. 31, 2023 | 1,431,126 | ||||
Balance, amount at Dec. 31, 2023 | $ 10,343,796 | $ 1,431 | $ 69,711,749 | $ (59,098,432) | $ (270,952) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (5,286,574) | $ (10,144,044) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 36,648 | 68,746 |
Amortization | 94,584 | 92,084 |
Unrealized gain on investments | (34,087) | |
Changes in assets and liabilities: | ||
Accounts receivable | 0 | 2,485 |
Inventory | 3,600 | 672 |
Prepaids and other current assets | 108,202 | (338,120) |
Accounts payable | (2,950,258) | 2,505,676 |
Accrued expenses | 0 | 15,535 |
Net cash used in operating activities | (8,027,885) | (7,796,966) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of investments | (22,854,815) | (10,078,617) |
Redemptions of investments | 26,400,000 | 0 |
Purchase of patents | (100,000) | 0 |
Net cash provided by (used in) investing activities | 3,445,185 | (10,078,617) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock and warrants, net of issuance costs | 0 | 15,471,775 |
Proceeds from exercise of warrants | 0 | 457 |
Purchase of common stock | (270,952) | 0 |
Net cash provided by financing activities | (270,952) | 15,472,232 |
NET (DECREASE) IN CASH | (4,853,652) | (2,403,351) |
BEGINNING CASH BALANCE | 8,320,519 | 10,723,870 |
ENDING CASH BALANCE | 3,466,867 | 8,320,519 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash payments for interest | 0 | 0 |
Cash payments for income taxes | 0 | 0 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Conversion of management fees and patent liability into common stock | $ 0 | $ 250,000 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization CMT was originally created on December 30, 2015 (“Inception”), as the urological arm of CMH to monetize a patent and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired from CMH in February 2016. Subsequently, the Company has expanded its development and acquisition of intellectual property beyond urology to include therapeutic treatments utilizing “re-programmed” stem cells, and the treatment of neurologic disorders, lower back pain, type I diabetes, and heart, liver, kidney, and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AlloCelz LLC have commenced commercial activities. The Company currently conducts substantially all of its commercial operations through CMT, which markets and sells the Company’s CaverStem ® ® In 2020, through the Company’s ImmCelz Inc. subsidiary, the Company began developing treatments that utilize a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized stem cells. The immune cells are then re-injected into the patient from whom they were extracted. The Company believes this process endows the immune cells with regenerative properties that may be suitable for the treatment of multiple indications. 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. Risks and Uncertainties The outbreak of the COVID-19 coronavirus has spread across the globe and is impacting worldwide economic activity. A pandemic, including COVID-19 or other public health epidemic, poses the risk that we or our employees, CROs, suppliers, manufacturers and other partners may be prevented from conducting business activities for an indefinite period of time, including due to the spread of the disease or shutdowns that may be requested or mandated by governmental authorities. 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. The Company’s business and operations are sensitive to general business and economic conditions in the U.S. and worldwide. These conditions include short-term and long-term interest rates, inflation, fluctuations in debt and equity capital markets and the general condition of the U.S. and world economy. A host of factors beyond the Company’s control could cause fluctuations in these conditions, including the political environment and acts or threats of war or terrorism. Adverse developments in these general business and economic conditions, including through recession, downturn or otherwise, could have a material adverse effect on the Company’s financial condition and the results of its operations. The Company has generated minimal sales and has limited marketing and/or distribution capabilities. The Company has limited experience in developing, training, or managing a sales force and will incur substantial additional expenses if it decides to market any of its current and future products and services with an internal sales organization. Developing a marketing and sales force is also time-consuming and could delay the launch of its future products and services. In addition, the Company will compete with many companies that currently have extensive and well-funded marketing and sales operations. The Company’s marketing and sales efforts may be unable to compete successfully against these companies. In addition, the Company has limited capital to devote to sales and marketing. The Company’s industry is characterized by rapid changes in technology and customer demands. As a result, the Company’s products and services may quickly become obsolete and unmarketable. The Company’s future success will depend on its ability to adapt to technological advances, anticipate customer demands, develop new products and services, and enhance the Company’s current products and services on a timely and cost-effective basis. Further, the Company’s products and services must remain competitive with those of other companies with substantially greater resources. The Company may experience technical or other difficulties that could delay or prevent the development, introduction or marketing of new products and services or enhanced versions of existing products and services. Also, the Company may not be able to adapt new or enhanced products and services to emerging industry standards, and the Company’s new products and services may not be favorably received. In addition, the Company may not have the capital resources to further the development of existing and/or new ones. We cannot predict how global supply chain activities, or the economy at large may be impacted by prolonged global conflicts or sanctions imposed in response to the wars, or whether future conflicts, if any, may adversely affect our results of operations. Use of Estimates – Basis of Presentation U.S. GAAP Concentration Risks Cash Equivalents Inventories Fair Value of Financial Instrument Fair value is an exit price, representing the amount that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are required to be disclosed by level within the following fair value hierarchy: Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 – Inputs lack observable market data to corroborate management’s estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. When determining fair value, whenever possible the Company uses observable market data, and relies on unobservable inputs only when observable market data is not available. As of December 31, 2023, and 2022, the Company had no outstanding derivative liabilities. Intangible Assets Impairment Derivative Liabilities As a matter of policy, the Company does not invest in separable financial derivatives or engage in hedging transactions. Revenue The Company generates revenue from the sale of disposable stem cell concentration kits. Revenues are recognized when control of the promised goods or services are transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services, which is generally on delivery to the customer. Payments received for which the earnings process is not yet complete are deferred. As of December 31, 2023, and 2022, the Company had $40,000 in deferred revenue. Research and Development TM TM Stock-Based Compensation Income Taxes The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such positions are then measured based on the largest benefit that has a greater than 50% likelihood of being realized upon settlement. The Company will recognize interest and penalties related to unrecognized tax benefits in the income tax provision in the accompanying statement of operations. The Company calculates the current and deferred income tax provision based on estimates and assumptions that could differ from the actual results reflected in income tax returns filed in subsequent years. Adjustments based on filed income tax returns are recorded when identified. The amount of income taxes paid is subject to examination by U.S. federal and state tax authorities. The estimate of the potential outcome of any uncertain tax issue is subject to management’s assessment of relevant risks, facts and circumstances existing at that time. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. Basic and Diluted Income (Loss) Per Share On June 12, 2023, we effected a 1-for-10 reverse split of our authorized and issued and outstanding shares of common stock. All share references have been restated for this reverse split to the earliest period presented. As a result of the split, the authorized shares of the Company’s common stock decreased to 5,000,000 shares. Recent Accounting Pronouncements |
LICENSING AGREEMENTS
LICENSING AGREEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
LICENSING AGREEMENTS | |
LICENSING AGREEMENTS | NOTE 2 – LICENSING AGREEMENTS ED Patent Multipotent Amniotic Fetal Stem Cells License Agreement The Company estimates that the patent expires in February 2026 and has elected to amortize the patent through the period of expiration on a straight-line basis. Amortization expense of $1,172 was recorded for the years ended December 31, 2023, and 2022. As of December 31, 2023, the carrying value of the patent was $2,033. The Company expects to amortize approximately $1,172 annually through 2025 related to the patent costs. Lower Back Patent · The Company is required to pay CMH $100,000 within 30 days of demand as an initial payment. · In the event the Company determines to pursue the technology via use of autologous cells, the Company will 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 the Company determines to pursue the technology via use of allogenic cells, the Company will 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. · Payment may be made in cash or shares of our common at a discount of 30% to the lowest closing price within 20 business days prior to the conversion date. · In the event the Company’s 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, the Company is 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 Company paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 667 shares of common stock on December 12, 2020. 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. 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. The remaining portion of the $300,000 obligation was paid in cash in 2020. In August 2023, the Company paid CMH $100,000 related to the filing of an IND with the FDA per the terms of the agreement. The patent expires on May 19, 2027, and the Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expense of $10,000 was recorded for the years ended December 31, 2023, and 2022. As of December 31, 2023, the carrying value of the initial patent license was $35,000. The Company expects to amortize approximately $10,000 annually through 2027 related to the patent costs. The Company has elected to amortize the additional $400,000 associated with the patent over a ten-year period on a straight-line basis. Amortization expense of $48,440 was recorded for the years ended December 31, 2023, and 2022. As of December 31, 2023, the carrying value of the patent was $207,936. The Company expects to amortize approximately $56,000 annually through 2026 related to the patent costs. ImmCelz™ · 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. (“Sale of Assets”) will result in a one-time ten-percent allocation to the licensor, the Continuing Royalty will be calculated at five percent (5%) of the Net Income of Licensee in any calendar quarter in which the Net Income in such calendar quarter reflects the receipt of any consideration from such Sale of Assets. 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 Company has elected to amortize the patent over a ten-year period on a straight-line basis. Amortization expenses of $25,000 and $25,000 were recorded for the years ended December 31, 2023, and 2022. As of December 31, 2023, the carrying value of the patent was $175,000. The Company expects to amortize approximately $25,000 annually through 2030 related to the patent costs. As of December 31, 2023, future expected amortization of these assets is as follows: For the year ended December 31, 2024 $ 102,085 2025 101,774 2026 64,650 2027 40,000 2028 35,000 Thereafter 97,502 Total $ 441,011 The following is a rollforward of the Company’s licensing agreements for the year end December 31, 2023. Assets Accumulated Amortization Balances at December 31, 2022 $ 760,000 $ (324,405 ) Addition of new assets 100,000 - Amortization - (94,584 ) Balances at December 31, 2023 $ 860,000 $ (418,989 ) |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 3 – RELATED PARTY TRANSACTIONS Narkeshyo Research Tools Purchase On December 15, 2022, the Company purchased a set of components referred to as “research tools” for $5,000,000 from Narkeshyo LLC, an entity a former director and current consultant of the Company is affiliated with, pursuant to the terms of an Asset Purchase Agreement between the Company and Narkeshyo. Some of the acquired research tools were originally developed by the former director and current consultant. Under the terms of the agreement, the Company made an initial payment to Narkeshyo in the amount of $2,000,000 upon execution of the agreement, with the remaining amounts to be paid at various times through March 15, 2023, which were made as scheduled. Upon execution of the agreement, the Company recorded $5,000,000 as research and development expenses. The vision and pipeline of the Company is based on robust and thorough development of its biological platforms, therapies and products. This acquisition of the research tools aligned with the Company’s priority of advancing and augmenting its suite of cGMP (Current Good Manufacturing Practices) cellular therapy products. The Company believes that the acquired research tools will allow it to protect its intellectual property while complying with regulatory requirements, and accelerate product development. The information contained in the research tools will not only be used to support and fast-track the Company’s regulatory filings (such as IND, NDA, ANDA and export applications), but also, provide clinical and regulatory support to potential partners and collaborators without having to divulge trade secrets and know-how. A third-party analysis of this acquisition concluded it would accelerate development time by 3-5 years and result in a substantial reduction in the Company’s research and development expenses over the long term. The purchased tools included (but were not limited to): · Toxicology · Screening · Preclinical Testing · Assays · Authorization · Tools of Biological Transaction · Tools of Intellectual Property Jadi Cell License Agreement On December 28, 2020, the Company entered into a patent license agreement with Jadi Cell, LLC, a company owned and controlled by Dr. Amit Patel, a former director of the Company. The agreement provides Company with an exclusive, worldwide license to U.S. 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. The agreement is described in detail in Note 2 above. 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. StemSpine Patent Purchase The Company acquired U.S. Patent No. 9,598,673 covering the use of various stem cells for the treatment of lower back pain from its affiliate CMH pursuant to a Patent Purchase Agreement dated May 17, 2017, which was amended in November 2017. The inventors of the patent were Thomas Ichim, PhD and Amit Patel, MD, former directors of the Company, and Annette Marleau, PhD. The Patent Purchase Agreement is described in detail in Note 2 above. Pursuant to the Patent Purchase Agreement, the Company paid CMH the $100,000 obligation of the initial payment due under this agreement, by a $50,000 cash payment and the issuance of 667 shares of common stock on December 12, 2020. 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. 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. The remaining portion of the $300,000 obligation has been paid in cash. |
STOCKBASED COMPENSATION
STOCKBASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
STOCKBASED COMPENSATION | |
STOCK-BASED COMPENSATION | NOTE 6 – STOCK-BASED COMPENSATION 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”) and reserved 60,000 shares of common stock for the issuance of awards thereunder. 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 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. As of December 31, 2023, stock options to purchase 16,984 The Company has also reserved stock options to purchase 3 common shares under its 2016 Stock Incentive Plan (the “Prior Plan”). In July 2016, the Company granted 10-year options to one party under the Prior Plan for accepting appointment to the Company’s scientific advisory board. The award consisted of options to purchase 1 During 2023 and 2022, the fair market value of the options was insignificant to the financial statements. Since the expected life of the options was greater than the Company’s historical stock information available, the Company determined the expected volatility based on price fluctuations of comparable public companies. There were no options issued during the year-ended December 31, 2023 and 11,182 options issued during the year-ended 2022. Option activity for the years ended December 31, 2023, and 2022 consists of the following: Stock Options Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 1 $ 75,000 4.64 Issued 11,182 16.90 - Exercised - - - Expired - - - Outstanding, December 31, 2022 11,183 $ 83.96 9.11 Issued - - - Exercised - - - Expired - - - Outstanding, December 31, 2023 11,183 $ 83.96 8.11 Vested, December 31, 2023 7,735 $ 210.83 8.11 See Note 2 for discussion related to the issuance of common stock in connection with licensing agreements. See Note 7 for warrants issued in connection with our May 2022 private offering. In February 2022, we granted a total of 11,182 options to Timothy Warbington and Donald Dickerson at an exercise price of $16.90. The value of the options was determined to be $145,525 based upon the Black-Scholes method, see variables used below. As of December 31, 2023, future estimated stock-based compensation expected to be recorded was estimated to be $40,132. Inputs Used Annual dividend yield $ - Expected life (years) 6.5 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 16.90 See Note 2 for discussion related to the issuance of common stock in connection with licensing agreements. See Note 7 for warrant rollforward |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
STOCKHOLDERS EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 7 – STOCKHOLDERS’ EQUITY May 2022 Private Offering 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. 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 $0.0001 per share. As of December 31, 2023, all of the Pre-Funded Warrants had been exercised. The Pre-Funded Warrants were classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, did not embody an obligation for the Company to repurchase its shares, and permitted the holders to receive a fixed number of shares of common stock upon exercise. In addition, the Pre-Funded Warrants did not provide any guarantee of value or return. Roth Capital Partners (“Roth”) acted as sole placement agent for the offering. 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. Share Repurchase Program On June 12, 2023 the Company announced that its Board of Directors has approved a share repurchase program. The program authorizes the Company to repurchase up to $2 million of its shares of common stock, in the open market or through privately negotiated transactions, in accordance with applicable securities laws and other restrictions. The manner, timing and amount of any purchase will be based on an evaluation of market conditions, the Company's stock price and other factors. The program has no termination date, may be suspended or discontinued at any time, and does not obligate the Company to acquire any particular number of shares of common stock. As-of December 31, 2023, 57,500 shares had been repurchased under this program for a total purchase price of $270,952. Warrants In connection with our May 2022 private offering, we issued pre-funded warrants to purchase 456,389 shares of common stock and accompanying warrants to purchase 1,624,446 shares of common stock at a price of $20.00 per share. Assumptions used in calculating the fair value of the warrants issued in 2022 were as follows: Range of Inputs Used Annual dividend yield $ - Expected life (years) 5.0 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 18.30 As of December 31, 2023, and 2022, warrants to purchase 2,284,932 shares of common stock were outstanding. Warrant activity for the years ended December 31, 2023 and 2022 consists of the following: Warrants Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 660,486 $ 42.70 4.85 Issued 2,080,835 Exercises (456,389 ) Anti-Dilution Modifications - Forfeiture/Cancellations - Outstanding, December 31, 2022 2,284,932 $ 26.59 4.22 Issued - Exercises - Anti-Dilution Modifications - Forfeiture/Cancellations - Outstanding, December 31, 2023 2,284,932 $ 26.59 3.22 See Note 2 for discussion related to the issuance of common stock in connection with licensing agreements. |
SIGNIFICANT RESEARCH AND DEVELO
SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES | 12 Months Ended |
Dec. 31, 2023 | |
SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES | |
SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES | NOTE 8 – SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES On December 15, 2022, the Company purchased a set of components referred to as “research tools” for $5,000,000 from Narkeshyo LLC, an entity a former director and current consultant of the Company is affiliated with, pursuant to the terms of an Asset Purchase Agreement between the Company and Narkeshyo. Some of the acquired research tools were originally developed by the former director and current consultant. Under the terms of the agreement, the Company made an initial payment to Narkeshyo in the amount of $2,000,000 upon execution of the agreement, with the remaining amounts to be paid at various times through March 15, 2023, which were made as scheduled. Upon execution of the agreement, the Company recorded $5,000,000 as research and development expenses. The vision and pipeline of the Company is based on robust and thorough development of its biological platforms, therapies and products. This acquisition of the research tools aligned with the Company’s priority of advancing and augmenting its suite of cGMP (Current Good Manufacturing Practices) cellular therapy products. The Company believes that the acquired research tools will allow it to protect its intellectual property while complying with regulatory requirements, and accelerate product development. The information contained in the research tools will not only be used to support and fast-track the Company’s regulatory filings (such as IND, NDA, ANDA and export applications), but also, provide clinical and regulatory support to potential partners and collaborators without having to divulge trade secrets and know-how. A third-party analysis of this acquisition concluded it would accelerate development time by 3-5 years and result in a substantial reduction in the Company’s research and development expenses over the long term. The purchased tools included (but were not limited to): · Toxicology · Screening · Preclinical Testing · Assays · Authorization · Tools of Biological Transaction · Tools of Intellectual Property |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
INCOME TAXES | NOTE 9 – INCOME TAXES The provision for income tax expense consists for the years ended December 31, 2023, and 2022: 2023 2022 Income tax provision attributable to: Federal $ (1,082,622 ) $ (2,096,475 ) State and local (300,783 ) (582,461 ) Valuation allowance 1,383,405 2,678,936 Net provision for income tax $ - $ - Deferred tax assets consist of the following at December 31, 2023, and 2022: 2023 2022 Deferred tax asset attributable to: Net operating loss carryover $ 6,266,742 $ 4,843,337 Accrued management fees, related party - - Valuation allowance (6,266,742 ) (4,843,337 ) Net deferred tax asset $ - $ - The primary difference between the statutory federal rate and the Company’s effective tax rate for the years ended December 31, 2023 and 2022 was due to the 100% valuation allowance. The following is a reconciliation of the statutory federal rate and the Company’s effective tax rate for the year ended December 31, 2023, and 2022: 2023 2022 Tax at federal statutory rate 21.0 % 21.0 % State, net of federal benefit 5.7 % 5.7 % Change in temporary differences (0.0 )% (0.0 )% Permanent differences (0.4 )% (0.2 )% Valuation allowance (26.2 )% (26.4 )% Provision for taxes - - As of December 31, 2023 the Company had federal and state gross net operating loss carryforwards of approximately $23.5 million. The federal and state net operating losses and tax credits expire in years beginning in 2036. Under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income may be limited. In general, an “ownership change” will occur if there is a cumulative change in our ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. To date, the Company hasn’t experienced “ownership changes” under section 382 of the Code and comparable state tax laws. As of December 31, 2023, the Company estimates that none of the federal and state net operating losses will be limited under Section 382 of the Code. As of December 31, 2023, and 2022, the Company maintained a full valuation allowance on its net deferred tax assets. The valuation allowance was determined in accordance with the provisions of ASC 740, Accounting for Income Taxes, which requires an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. Such assessment is required on a jurisdiction-by-jurisdiction basis. The Company’s history of cumulative losses, along with expected future U.S. losses required that a full valuation allowance be recorded against all net deferred tax assets. The Company intends to maintain a full valuation allowance on net deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance. The applicable federal and state rates used in calculating the deferred tax provision were 21.0% and 8.9%, respectively. The Company files income tax returns in the U.S. and Arizona. All years presented remain subject to examination for U.S. federal and state purposes. The Company is not currently under examination in federal or state jurisdictions. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 11 – SUBSEQUENT EVENTS Management has reviewed subsequent events through the date of the filing noting none. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Organization | Organization CMT was originally created on December 30, 2015 (“Inception”), as the urological arm of CMH to monetize a patent and related intellectual property related to the treatment of erectile dysfunction (“ED”), which it acquired from CMH in February 2016. Subsequently, the Company has expanded its development and acquisition of intellectual property beyond urology to include therapeutic treatments utilizing “re-programmed” stem cells, and the treatment of neurologic disorders, lower back pain, type I diabetes, and heart, liver, kidney, and other diseases using various types of stem cells through our ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AlloCelz LLC have commenced commercial activities. The Company currently conducts substantially all of its commercial operations through CMT, which markets and sells the Company’s CaverStem ® ® In 2020, through the Company’s ImmCelz Inc. subsidiary, the Company began developing treatments that utilize a patient’s own extracted immune cells that are then “reprogrammed” by culturing them outside the patient’s body with optimized stem cells. The immune cells are then re-injected into the patient from whom they were extracted. The Company believes this process endows the immune cells with regenerative properties that may be suitable for the treatment of multiple indications. 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. |
Risks and Uncertainties | Risks and Uncertainties The outbreak of the COVID-19 coronavirus has spread across the globe and is impacting worldwide economic activity. A pandemic, including COVID-19 or other public health epidemic, poses the risk that we or our employees, CROs, suppliers, manufacturers and other partners may be prevented from conducting business activities for an indefinite period of time, including due to the spread of the disease or shutdowns that may be requested or mandated by governmental authorities. 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. The Company’s business and operations are sensitive to general business and economic conditions in the U.S. and worldwide. These conditions include short-term and long-term interest rates, inflation, fluctuations in debt and equity capital markets and the general condition of the U.S. and world economy. A host of factors beyond the Company’s control could cause fluctuations in these conditions, including the political environment and acts or threats of war or terrorism. Adverse developments in these general business and economic conditions, including through recession, downturn or otherwise, could have a material adverse effect on the Company’s financial condition and the results of its operations. The Company has generated minimal sales and has limited marketing and/or distribution capabilities. The Company has limited experience in developing, training, or managing a sales force and will incur substantial additional expenses if it decides to market any of its current and future products and services with an internal sales organization. Developing a marketing and sales force is also time-consuming and could delay the launch of its future products and services. In addition, the Company will compete with many companies that currently have extensive and well-funded marketing and sales operations. The Company’s marketing and sales efforts may be unable to compete successfully against these companies. In addition, the Company has limited capital to devote to sales and marketing. The Company’s industry is characterized by rapid changes in technology and customer demands. As a result, the Company’s products and services may quickly become obsolete and unmarketable. The Company’s future success will depend on its ability to adapt to technological advances, anticipate customer demands, develop new products and services, and enhance the Company’s current products and services on a timely and cost-effective basis. Further, the Company’s products and services must remain competitive with those of other companies with substantially greater resources. The Company may experience technical or other difficulties that could delay or prevent the development, introduction or marketing of new products and services or enhanced versions of existing products and services. Also, the Company may not be able to adapt new or enhanced products and services to emerging industry standards, and the Company’s new products and services may not be favorably received. In addition, the Company may not have the capital resources to further the development of existing and/or new ones. We cannot predict how global supply chain activities, or the economy at large may be impacted by prolonged global conflicts or sanctions imposed in response to the wars, or whether future conflicts, if any, may adversely affect our results of operations. |
Use of Estimates | Use of Estimates – |
Basis of Presentation | Basis of Presentation U.S. GAAP |
Concentration Risks | Concentration Risks |
Cash Equivalents | Cash Equivalents |
Inventories | Inventories |
Fair Value of Financial Instruments | Fair Value of Financial Instrument Fair value is an exit price, representing the amount that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are required to be disclosed by level within the following fair value hierarchy: Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2 – Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 – Inputs lack observable market data to corroborate management’s estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. When determining fair value, whenever possible the Company uses observable market data, and relies on unobservable inputs only when observable market data is not available. As of December 31, 2023, and 2022, the Company had no outstanding derivative liabilities. |
Intangible Assets | Intangible Assets |
Impairment | Impairment |
Derivative Liabilities | Derivative Liabilities As a matter of policy, the Company does not invest in separable financial derivatives or engage in hedging transactions. |
Revenue | Revenue The Company generates revenue from the sale of disposable stem cell concentration kits. Revenues are recognized when control of the promised goods or services are transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services, which is generally on delivery to the customer. Payments received for which the earnings process is not yet complete are deferred. As of December 31, 2023, and 2022, the Company had $40,000 in deferred revenue. |
Research and Development | Research and Development TM TM |
Stock-Based Compensation | Stock-Based Compensation |
Income Taxes | Income Taxes The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such positions are then measured based on the largest benefit that has a greater than 50% likelihood of being realized upon settlement. The Company will recognize interest and penalties related to unrecognized tax benefits in the income tax provision in the accompanying statement of operations. The Company calculates the current and deferred income tax provision based on estimates and assumptions that could differ from the actual results reflected in income tax returns filed in subsequent years. Adjustments based on filed income tax returns are recorded when identified. The amount of income taxes paid is subject to examination by U.S. federal and state tax authorities. The estimate of the potential outcome of any uncertain tax issue is subject to management’s assessment of relevant risks, facts and circumstances existing at that time. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. |
Basic and Diluted Income (Loss) Per Share | Basic and Diluted Income (Loss) Per Share On June 12, 2023, we effected a 1-for-10 reverse split of our authorized and issued and outstanding shares of common stock. All share references have been restated for this reverse split to the earliest period presented. As a result of the split, the authorized shares of the Company’s common stock decreased to 5,000,000 shares. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements |
LICENSING AGREEMENTS (Tables)
LICENSING AGREEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
LICENSING AGREEMENTS | |
Schedule of future expected amortization | 2024 $ 102,085 2025 101,774 2026 64,650 2027 40,000 2028 35,000 Thereafter 97,502 Total $ 441,011 |
Schedule of licensing agreements | Assets Accumulated Amortization Balances at December 31, 2022 $ 760,000 $ (324,405 ) Addition of new assets 100,000 - Amortization - (94,584 ) Balances at December 31, 2023 $ 860,000 $ (418,989 ) |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
STOCKBASED COMPENSATION | |
Schedule of fair value of warrants | Stock Options Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 1 $ 75,000 4.64 Issued 11,182 16.90 - Exercised - - - Expired - - - Outstanding, December 31, 2022 11,183 $ 83.96 9.11 Issued - - - Exercised - - - Expired - - - Outstanding, December 31, 2023 11,183 $ 83.96 8.11 Vested, December 31, 2023 7,735 $ 210.83 8.11 |
Schedule of Warrants | Inputs Used Annual dividend yield $ - Expected life (years) 6.5 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 16.90 |
STOCKHOLDERS DEFICIT (Tables)
STOCKHOLDERS DEFICIT (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
STOCKHOLDERS DEFICIT (Tables) | |
Schedule of Stockholders Deficit | Range of Inputs Used Annual dividend yield $ - Expected life (years) 5.0 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 18.30 |
Schedule of warrant activity | Warrants Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 660,486 $ 42.70 4.85 Issued 2,080,835 Exercises (456,389 ) Anti-Dilution Modifications - Forfeiture/Cancellations - Outstanding, December 31, 2022 2,284,932 $ 26.59 4.22 Issued - Exercises - Anti-Dilution Modifications - Forfeiture/Cancellations - Outstanding, December 31, 2023 2,284,932 $ 26.59 3.22 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
Schedule of deferred tax assets | 2023 2022 Deferred tax asset attributable to: Net operating loss carryover $ 6,266,742 $ 4,843,337 Accrued management fees, related party - - Valuation allowance (6,266,742 ) (4,843,337 ) Net deferred tax asset $ - $ - |
Schedule of income taxes | 2023 2022 Income tax provision attributable to: Federal $ (1,082,622 ) $ (2,096,475 ) State and local (300,783 ) (582,461 ) Valuation allowance 1,383,405 2,678,936 Net provision for income tax $ - $ - |
Schedule of effective tax rate | 2023 2022 Tax at federal statutory rate 21.0 % 21.0 % State, net of federal benefit 5.7 % 5.7 % Change in temporary differences (0.0 )% (0.0 )% Permanent differences (0.4 )% (0.2 )% Valuation allowance (26.2 )% (26.4 )% Provision for taxes - - |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | |||
Jun. 12, 2023 | Mar. 15, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
FDIC insured amount | $ 250,000 | |||
Reverse split description | we effected a 1-for-10 reverse split of our authorized and issued and outstanding shares of common stock | |||
Deferred revenue | 40,000 | $ 40,000 | ||
Interest income | 34,000 | |||
Research and development | $ 5,000,000 | $ 1,970,639 | $ 6,268,854 | |
Common Stock, Shares Authorized | 5,000,000 | 5,000,000 | 50,000,000 | |
Option [Member] | ||||
Anti-dilutive Securities Excluded From Computation Of Earning Per Share | 11,183 | 11,183 | ||
Warrants [Member] | ||||
Anti-dilutive Securities Excluded From Computation Of Earning Per Share | 2,284,932 | 2,284,932 |
LICENSING AGREEMENTS (Details)
LICENSING AGREEMENTS (Details) | Dec. 31, 2023 USD ($) |
LICENSING AGREEMENTS | |
2024 | $ 102,085 |
2025 | 101,774 |
2026 | 64,650 |
2027 | 40,000 |
2028 | 35,000 |
Thereafter | 97,502 |
Total | $ 441,011 |
LICENSING AGREEMENTS (Details 1
LICENSING AGREEMENTS (Details 1) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Assets | |
Beginning Balance | $ 760,000 |
Amortization | 0 |
Addition of new Assets | 100,000 |
Ending balance | 860,000 |
Accumulated Amortization | |
Accumulated Amortization, Beginning Balance | (324,405) |
Addition of new assets | 0 |
Amortization | (94,584) |
Accumulated Amortization, Ending Balance | $ (418,989) |
LICENSING AGREEMENTS (Details N
LICENSING AGREEMENTS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Dec. 12, 2020 | Feb. 28, 2022 | Dec. 28, 2020 | May 17, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2021 | Jan. 31, 2021 | Dec. 31, 2020 | Feb. 02, 2016 | |
Pyment For License fees | $ 250,000 | |||||||||
Number of shares | 43,112 | |||||||||
Common Stock Value | $ 1,431 | $ 1,407 | $ 100,000 | |||||||
Initial payment | 300,000 | $ 300,000 | $ 300,000 | $ 300,000 | ||||||
Payment | 50,000 | 40,000 | 50,000 | 50,000 | ||||||
Amortization expenses | 94,584 | 92,084 | ||||||||
Amortization expenses | 48,440 | 48,440 | ||||||||
Carrying value of patent | 207,936 | |||||||||
Amortization | 0 | |||||||||
Amortization | 56,000 | |||||||||
Payments upon completion of the IRB clinical trial | $ 200,000 | |||||||||
Payments in the event of commercialization of technology | 400,000 | |||||||||
Jadi Cell [Member] | ||||||||||
Discount Rate | 5% | |||||||||
Common Stock Shares | 18,018 | |||||||||
Carrying value of patent | 175,000 | |||||||||
Amortization | 25,000 | |||||||||
StemSpine LLC [Member] | ||||||||||
Amortization expenses | 10,000 | 10,000 | ||||||||
Carrying value of patent | $ 35,000 | |||||||||
Expiration period of finite-lived intangible assets | May 19, 2027 | |||||||||
Amortization | $ 10,000 | |||||||||
License Agreement [Member] | ||||||||||
Amortization expenses | 1,172 | 1,172 | ||||||||
Carrying value of patent | 2,033 | |||||||||
Expected amount of amortization | $ 1,172 | |||||||||
ImmCelz Patent [Member] | ||||||||||
Common Stock Value | $ 667 | $ 8,466 | $ 8,929 | $ 14 | ||||||
Discount Rate | 25% | |||||||||
Amortization expenses | $ 25,000 | 25,000 | ||||||||
Interest rate | 5% | |||||||||
Carrying value of patent | $ 250,000 | |||||||||
Exercise Price | $ 0.0037 | |||||||||
EDI Patent [Member] | ||||||||||
Amortization expenses | $ 9,972 | $ 9,972 | ||||||||
Carrying value of patent | 21,042 | |||||||||
Amortization | 9,972 | |||||||||
Option [Member] | ||||||||||
Discount Rate | 30% | |||||||||
Initial payment | $ 100,000 | $ 100,000 | ||||||||
Payments upon signing agreement with university for the initiation of an IRB clinical trial | 100,000 | |||||||||
Payments upon filing an IND with the FDA | 100,000 | |||||||||
Payments upon dosing of the first patient in a Phase 1-2 clinical trial | 200,000 | |||||||||
Payments upon dosing of the first patient in Phase 3 clinical trial | $ 300,000 | |||||||||
Share price for two or more consecutive trading days | 0.01 | |||||||||
Option Warrant [Member] | ||||||||||
Discount Rate | 50% | |||||||||
Interest rate | 5% | |||||||||
Carrying value of patent | $ 0 | |||||||||
Initial payment | $ 100,000 | |||||||||
Payments upon dosing of the first patient in Phase 3 clinical trial | $ 400,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Mar. 15, 2023 | Dec. 15, 2022 | Dec. 28, 2020 | May 17, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2021 | Jan. 31, 2021 | Dec. 31, 2020 | Dec. 12, 2020 | |
Research tool purchased | $ 5,000,000 | |||||||||
Initial payment | $ 2,000,000 | |||||||||
Research and development expenses | $ 5,000,000 | $ 1,970,639 | $ 6,268,854 | |||||||
Paid amount to related parties | $ 50,000 | $ 40,000 | $ 50,000 | $ 50,000 | ||||||
Common Stock Issued | 1,431,126 | 1,407,625 | ||||||||
StemSpine Patent Purchase [Member] | ||||||||||
Paid amount to related parties | $ 50,000 | 40,000 | 50,000 | 50,000 | ||||||
Obligation Of The Initial Payment | $ 300,000 | $ 300,000 | $ 300,000 | |||||||
Common Stock Issued | 8,466 | 8,929 | 14 | 667 | ||||||
Long-term Purchase Commitment, Amount | $ 100,000 | |||||||||
Remaining portion of obligation paid in cash | $ 300,000 | |||||||||
Jadi Cell License Agreement [Member] | ||||||||||
License Fee | $ 250,000 | |||||||||
Agreement Description | Company entered into a patent license agreement with Jadi Cell, LLC, a company owned and controlled by Dr. Amit Patel, a former director of the Company | |||||||||
Common Stock Issued | 18,018 |
STOCKBASED COMPENSATION (Detail
STOCKBASED COMPENSATION (Details) - Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock option, Outstanding at the begining | 11,183 | 1 |
Stock option, Issued | 0 | 11,182 |
Stock option, Outstanding at the ending | 11,183 | 11,183 |
Stock option, Vested | 7,735 | |
Weighted Average Exercise Price, Outstanding beginning | $ 83.96 | $ 75,000 |
Weighted Average Exercise Price, Issued | 0 | 16.90 |
Weighted Average Exercise Price, Outstanding ending | 83.96 | $ 83.96 |
Weighted Average Exercise Price, Vested | $ 210.83 | |
Weighted Average Life Remaining, Outstanding beginning | 8 years 1 month 9 days | 4 years 7 months 20 days |
Weighted Average Life Remaining, Outstanding ending | 8 years 1 month 10 days | 9 years 1 month 9 days |
Weighted Average Life Remaining, Vested | 8 years 1 month 9 days |
STOCKBASED COMPENSATION (Deta_2
STOCKBASED COMPENSATION (Details 1) | 12 Months Ended |
Dec. 31, 2023 $ / shares | |
Annual dividend yield | 0% |
Expected life (years) | 5 years |
Common stock price | $ 18.30 |
Option Warrant [Member] | |
Annual dividend yield | 0% |
Expected volatility | 92.95% |
Risk-free interest rate | 0.81% |
Expected life (years) | 6 years 6 months |
Common stock price | $ 16.90 |
STOCKBASED COMPENSATION (Deta_3
STOCKBASED COMPENSATION (Details Narrative) - USD ($) | 2 Months Ended | 12 Months Ended | |
Feb. 28, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Board of Directors [Member] | |||
Fair value of warrants | $ 145,525 | ||
Stock option, Issued | 11,182 | ||
Allocated Share-based Compensation Expense | $ 40,132 | ||
Weighted Average Exercise Price, Issued | $ 16.90 | ||
Employee Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 10 years | ||
Stock option, Issued | 0 | 11,182 | |
Under the 2021 Plan [Member] | |||
Option to purchase common shares | 16,984 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 60,000 | ||
2016 Stock Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options Issued Grants in Period, Gross | 1 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options Issued pershare | $ 75,000 | ||
Option to purchase common shares | 3 |
STOCKHOLDERS EQUITY (Details)
STOCKHOLDERS EQUITY (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares | |
STOCKHOLDERS EQUITY | |
Annual dividend yield | 0% |
Expected life (years) | 5 years |
Risk-free interest rate | 0.81% |
Expected volatility | 92.95% |
Common stock price | $ 18.30 |
STOCKHOLDERS EQUITY (Details 1)
STOCKHOLDERS EQUITY (Details 1) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Warrants, Outstanding Beginning Balance | 2,284,932 | 660,486 |
Warrants, Issued | 0 | 2,080,835 |
Warrants, Exercised | 0 | (456,389) |
Anti-Dilution Modifications | 0 | 0 |
Forfeiture/Cancellations | 0 | 0 |
Warrants, Outstanding Ending Balance | 2,284,932 | 2,284,932 |
Weighted Average Exercise Price, Outstanding beginning | $ 26.59 | $ 42.70 |
Weighted Average Exercise Price, Outstanding ending | $ 26.59 | $ 26.59 |
Weighted Average Life Remaining, Outstanding Beginning | 4 years 10 months 6 days | |
Weighted Average Life Remaining, Outstanding Ending | 3 years 2 months 19 days | 4 years 2 months 19 days |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
May 03, 2022 | May 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Amendment description | 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. The transaction was effected pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended and Rule 506(b) promulgated thereunder | |||
Sale of shares of common stock | 299,167 | |||
Pre-Funded Warrants Exercise price | $ 0.0001 | |||
Purchase of warrants shares | 456,389 | |||
Purchase of Pre-Funded Warrant and related Common Warrant | 1,511,112 | |||
Common warrants exercise price | $ 20 | |||
Private Offering [Member] | ||||
Securities | $ 2,000,000 | |||
Purchase price | $ 270,952 | |||
Common stock shares repurchased | 57,500 | |||
Warrants to purchase shares of common stock | 456,389 | |||
Roth Capital Partners [Member] | ||||
Paid placement agent fee | $ 1,360,000 | |||
Issued warrant to purchase shares of common stock | 113,334 | |||
Warrants [Member] | ||||
Common stock shares repurchased | 1,624,446 | |||
Offering price | $ 22.50 | |||
Warrant exercise price | $ 20 | |||
Class of Warrant or Right, Outstanding | 2,284,932 | 2,284,932 |
SIGNIFICANT RESEARCH AND DEVE_2
SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 15, 2022 | Dec. 31, 2023 | |
SIGNIFICANT RESEARCH AND DEVELOPMENT PURCHASES | ||
Research and development expenses | $ 5,000,000 | $ 5,000,000 |
Initial payment amount | $ 2,000,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Federal | $ (1,082,622) | $ (2,096,475) |
State and local | (300,783) | (582,461) |
Valuation allowance | 1,383,405 | 2,678,936 |
Net provision for income taxes | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
INCOME TAXES | ||
Net operating loss carryover | $ 6,266,742 | $ 4,843,337 |
Accrued management fees, related party | 0 | 0 |
Valuation allowance | (6,266,742) | (4,843,337) |
Net deferred tax asset | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Tax at federal statutory rate | 21% | 21% |
State, net of federal benefit | 5.70% | 5.70% |
Change in temporary differences | (0.00%) | 0% |
Permanent differences | (0.40%) | (0.20%) |
Valuation allowance | (26.20%) | (26.40%) |
Provision for taxes | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Effective tax rate due to valuation allowance | (26.20%) | (26.40%) |
Statutory Federal Rate [Member] | ||
Deferred income tax provision, percentage | 21% | 8.90% |
Federal and state net operating carry forward loss | $ 23.5 | |
Effective tax rate due to valuation allowance | 100% | 100% |