Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. | |
Entity Central Index Key | 0001187953 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Document Period End Date | Sep. 30, 2022 | |
Entity Filer Category | Non-accelerated Filer | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Entity Common Stock Shares Outstanding | 14,076,246 | |
Document Quarterly Report | true | |
Document Transition Report | 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 | |
Local Phone Number | 399-2822 | |
Security 12b Title | Common Stock, par value $0.001 per share | |
Trading Symbol | CELZ | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS | ||
Cash | $ 16,969,063 | $ 10,723,870 |
Certificates of deposit | 5,021,307 | 0 |
Accounts receivable | 0 | 2,485 |
Inventory | 15,894 | 10,866 |
Total Current Assets | 22,006,264 | 10,737,221 |
OTHER ASSETS | ||
Other assets | 3,281 | 3,281 |
Licenses, net of amortization | 458,616 | 527,679 |
TOTAL ASSETS | 22,468,161 | 11,268,181 |
CURRENT LIABILITIES | ||
Accounts payable | 327,843 | 761,862 |
Accrued expenses | 54,920 | 24,385 |
Management fee and patent liabilities - related parties | 0 | 250,000 |
Advances from related party | 14,194 | 14,194 |
Total Current Liabilities | 396,957 | 1,050,441 |
STOCKHOLDERS' EQUITY | ||
Common stock, $0.001 par value, 25,000,000,000 and 6,000,000,000 shares authorized; 14,076,246 and 6,338,872 issued and 14,076,238 and 6,338,864 outstanding at September 30, 2022 and December 31, 2021, respectively | 14,077 | 6,339 |
Additional paid-in capital | 69,653,293 | 53,879,215 |
Accumulated deficit | (47,596,166) | (43,667,814) |
TOTAL STOCKHOLDERS' EQUITY | 22,071,204 | 10,217,740 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 22,468,161 | $ 11,268,181 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Common Stock, Shares Par Value | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 25,000,000,000 | 6,000,000,000 |
Common Stock, Shares Issued | 14,076,246 | 6,338,872 |
Common Stock, Shares Outstanding | 14,076,238 | 6,338,864 |
UNAUDITED CONDENSED CONSOLIDATE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Revenues | $ 55,000 | $ 10,000 | $ 70,000 | $ 20,000 |
Cost of revenues | 16,000 | 4,000 | 22,791 | 8,500 |
Gross profit | 39,000 | 6,000 | 47,209 | 11,500 |
OPERATING EXPENSES | ||||
Research and development | 230,940 | 59,180 | 900,635 | 59,180 |
Selling, general and administrative | 805,461 | 757,235 | 3,043,946 | 1,536,479 |
Amortization of patent costs | 23,021 | 23,021 | 69,063 | 69,063 |
TOTAL EXPENSES | 1,059,422 | 839,436 | 4,013,644 | 1,664,722 |
Operating loss | (1,020,422) | (833,436) | (3,966,435) | (1,653,222) |
OTHER INCOME/(EXPENSE) | ||||
Interest expense | 0 | (1,305,273) | 0 | (1,875,687) |
Gain on extinguishment of convertible notes | 0 | 489,157 | 0 | 585,601 |
Change in fair value of derivatives liabilities | 0 | (194,044) | 0 | 26,030,549 |
Other income | 38,083 | 0 | 38,083 | 0 |
Total other income (expense) | 38,083 | (1,010,160) | 38,083 | 24,740,463 |
INCOME (LOSS) BEFORE PROVISION FOR INCOME TAXES | (982,339) | (1,843,596) | (3,928,352) | 23,087,241 |
Provision for income taxes | 0 | 0 | 0 | 0 |
NET INCOME (LOSS) | $ (982,339) | $ (1,843,596) | $ (3,928,352) | $ 23,087,241 |
BASIC NET INCOME (LOSS) PER SHARE | $ (0.07) | $ (0.75) | $ (0.40) | $ 9.98 |
DILUTED NET INCOME (LOSS) PER SHARE | $ (0.07) | $ (0.75) | $ (0.40) | $ 9.77 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - BASIC | 14,068,412 | 2,452,076 | 9,872,450 | 2,313,005 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - DILUTED | 14,068,412 | 2,452,076 | 9,872,450 | 2,363,145 |
UNAUDITED CONDENSED CONSOLIDA_2
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ (3,928,352) | $ 23,087,241 |
Adjustments to reconcile net income (loss) to net cash from operating activities: | ||
Stock-based compensation | 59,584 | 595,380 |
Amortization | 69,063 | 69,063 |
Amortization of debt discounts | 0 | 1,755,104 |
Change in fair value of derivatives liabilities | 0 | (26,030,549) |
Increase in principal and accrued interest balances due to penalty provision | 0 | 93,821 |
Gain on extinguishment of convertible notes | 0 | (585,601) |
Changes in assets and liabilities: | ||
Accounts receivable | 2,485 | 0 |
Inventory | (5,028) | 0 |
Accounts payable | (434,019) | 103,626 |
Accrued expenses | 30,535 | 26,169 |
Management fee payable | 0 | (168,700) |
Net cash used in operating activities | (4,205,732) | (1,054,446) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of certificates of deposit | (5,021,307) | 0 |
Advance to related party | 0 | (200,000) |
Net cash used in investing activities | (5,021,307) | (200,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock and warrants, net of issuance costs | 15,471,775 | 0 |
Proceeds from exercise of warrants | 457 | 0 |
Proceeds from note payable | 0 | 3,887,750 |
Payments on notes payable | 0 | (105,000) |
Payment of debt issuance costs | 0 | (443,239) |
Payment of deferred offering costs | 0 | (3,282) |
Proceeds from convertible notes payable | 0 | 435,040 |
Proceeds from sale of preferred stock | 0 | 462,000 |
Related party advances | 0 | 226,500 |
Repayment of related party advances | 0 | (220,000) |
Payments to settle convertible notes payable and warrants | 0 | (705,405) |
Net cash provided by financing activities | 15,472,232 | 3,534,364 |
NET INCREASE IN CASH | 6,245,193 | 2,279,918 |
BEGINNING CASH BALANCE | 10,723,870 | 98,012 |
ENDING CASH BALANCE | 16,969,063 | 2,377,930 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash payments for interest | 0 | 9,186 |
Cash payments for income taxes | 0 | 0 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Accrued dividends on preferred stock | 0 | 27,725 |
Warrants issued with notes payable as a service fee | 0 | 2,097,629 |
Conversion of notes payable, accrued interest and derivative liabilities into common stock | 0 | 13,747,415 |
Conversion of management fees and patent liability into common stock | 250,000 | 50,000 |
Discounts on convertible notes payable due to derivative liabilities | 0 | 134,640 |
Exchange of preferred stock for notes payable | $ 0 | $ 572,275 |
UNAUDITED CONDENSED CONSOLIDA_3
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Retained Earnings (Accumulated Deficit) | Series A, Preferred Stock | Series B, Preferred Stock | Series C, Preferred Stock |
Balance, shares at Dec. 31, 2020 | 1,537,073 | 3,000,000 | |||||
Balance, amount at Dec. 31, 2020 | $ (39,803,010) | $ 1,537 | $ 22,082,689 | $ (61,890,236) | $ 3,000 | $ 0 | $ 0 |
Proceeds from sales of preferred stock, shares | 4,286 | 350 | 150 | ||||
Proceeds from sales of preferred stock, amount | 462,000 | $ 4 | (4) | 0 | 0 | $ 321,000 | $ 141,000 |
Common stock issued for related party management liabilities, shares | 89,286 | ||||||
Common stock issued for related party management liabilities, amount | 50,000 | $ 89 | 49,911 | 0 | 0 | 0 | 0 |
Common stock issued for conversion of convertible notes, accrued interest and derivative liabilities, shares | 789,727 | ||||||
Common stock issued for conversion of convertible notes, accrued interest and derivative liabilities, amount | 1,383,331 | $ 790 | 1,382,541 | 0 | 0 | 0 | 0 |
Relief of derivative liabilities | 12,364,084 | 0 | 12,364,084 | 0 | 0 | 0 | 0 |
Dividends on preferred stock | (27,725) | $ 0 | (27,725) | 0 | 0 | 0 | 0 |
Cashless exercise of warrants, shares | 37,870 | ||||||
Cashless exercise of warrants, amount | 0 | $ 38 | (38) | 0 | 0 | 0 | 0 |
Warrants issued with notes payable | 2,097,629 | 0 | 2,097,629 | 0 | 0 | $ 0 | $ 0 |
Preferred stock redemption, shares | 350 | 150 | |||||
Preferred stock redemption, amount | (572,275) | 0 | (110,275) | 0 | 0 | $ (321,000) | $ (141,000) |
Stock-based compensation | 595,380 | 0 | 595,380 | 0 | 0 | 0 | 0 |
Net income | 23,087,241 | $ 0 | 0 | 23,087,241 | $ 0 | 0 | 0 |
Balance, shares at Sep. 30, 2021 | 2,458,242 | 3,000,000 | |||||
Balance, amount at Sep. 30, 2021 | (363,345) | $ 2,458 | 38,434,192 | (38,802,995) | $ 3,000 | $ 0 | $ 0 |
Balance, shares at Jun. 30, 2021 | 2,440,614 | 3,000,000 | 350 | 150 | |||
Balance, amount at Jun. 30, 2021 | (714,453) | $ 2,440 | 35,777,506 | (36,959,399) | $ 3,000 | $ 321,000 | $ 141,000 |
Common stock issued for conversion of convertible notes, accrued interest and derivative liabilities, shares | 17,628 | ||||||
Common stock issued for conversion of convertible notes, accrued interest and derivative liabilities, amount | 153,980 | $ 18 | 153,962 | 0 | 0 | 0 | 0 |
Relief of derivative liabilities | 138,731 | 0 | 138,731 | 0 | 0 | 0 | 0 |
Dividends on preferred stock | (6,973) | 0 | (6,973) | 0 | 0 | 0 | 0 |
Warrants issued with notes payable | 2,097,629 | 0 | 2,097,629 | 0 | 0 | $ 0 | $ 0 |
Preferred stock redemption, shares | 350 | 150 | |||||
Preferred stock redemption, amount | (572,275) | 0 | (110,275) | 0 | 0 | $ (321,000) | $ (141,000) |
Stock-based compensation | 383,612 | 0 | 383,612 | 0 | 0 | 0 | 0 |
Net income | (1,843,596) | $ 0 | 0 | (1,843,596) | $ 0 | 0 | 0 |
Balance, shares at Sep. 30, 2021 | 2,458,242 | 3,000,000 | |||||
Balance, amount at Sep. 30, 2021 | (363,345) | $ 2,458 | 38,434,192 | (38,802,995) | $ 3,000 | 0 | 0 |
Balance, shares at Dec. 31, 2021 | 6,338,864 | ||||||
Balance, amount at Dec. 31, 2021 | 10,217,740 | $ 6,339 | 53,879,215 | (43,667,814) | 0 | 0 | 0 |
Stock-based compensation | 59,584 | 0 | 59,584 | 0 | 0 | 0 | 0 |
Net income | (3,928,352) | $ 0 | 0 | (3,928,352) | 0 | 0 | 0 |
Issuance of common stock and accompanying warrants, net of issuance costs, shares | 2,991,669 | ||||||
Issuance of common stock and accompanying warrants, net of issuance costs, amount | 15,471,775 | $ 2,992 | 15,468,783 | 0 | 0 | 0 | 0 |
Common stock issued for related party patent liabilities, shares | 181,818 | ||||||
Common stock issued for related party patent liabilities, amount | 250,000 | $ 182 | 249,818 | 0 | 0 | 0 | 0 |
Common stock issued for warrant exercise, shares | 4,563,887 | ||||||
Common stock issued for warrant exercise, amount | 457 | $ 4,564 | (4,107) | 0 | 0 | 0 | 0 |
Balance, shares at Sep. 30, 2022 | 14,076,238 | ||||||
Balance, amount at Sep. 30, 2022 | 22,071,204 | $ 14,077 | 69,653,293 | (47,596,166) | 0 | 0 | 0 |
Balance, shares at Jun. 30, 2022 | 13,956,238 | ||||||
Balance, amount at Jun. 30, 2022 | 23,044,369 | $ 13,957 | 69,644,239 | (46,613,827) | 0 | 0 | 0 |
Stock-based compensation | 9,162 | 0 | 9,162 | 0 | 0 | 0 | 0 |
Net income | (982,339) | $ 0 | 0 | (982,339) | 0 | 0 | 0 |
Common stock issued for warrant exercise, shares | 120,000 | ||||||
Common stock issued for warrant exercise, amount | 12 | $ 120 | (108) | 0 | 0 | 0 | 0 |
Balance, shares at Sep. 30, 2022 | 14,076,238 | ||||||
Balance, amount at Sep. 30, 2022 | $ 22,071,204 | $ 14,077 | $ 69,653,293 | $ (47,596,166) | $ 0 | $ 0 | $ 0 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2022 | |
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 AmnioStem LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AmnioStem 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® and FemCelz® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. On October 20, 2022 the Company announced it has produced an allogenic Cell Line called AlloStem™, which includes a Master Cell Bank and a Drug Master File which shall be submitted for FDA registration. The importance of the company creating and developing such assets, as opposed to licensing agreements with third parties, provides further de-risking of an important component to many of our programs, including, but not limited to, the ImmCelz ® ® ® In 2020, through the Company’s ImmCelz Inc. subsidiary, the Company began exploring the development of an immunotherapy platform that “supercharges” the patients own immune cells. Secreted factors from AlloStem™ cells are used to “reprogram” the patient’s own immune cells. They are then harvested and injected back into the patient in less than 72 hours. 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. On June 15, 2022, the Company signed an agreement with Greenstone Biosciences Inc. in Palo Alto, CA for the development of a human induced pluripotent stem cell (iPSC) pipeline for the Company's ImmCelz® platform. This project is identified as iPScelz TM TM Use of Estimates Basis of Presentation U.S. GAAP Risks and Uncertainties On January 30, 2020, the World Health Organization declared the COVID-19 outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic. Actions taken around the world to help mitigate the spread of the COVID-19 include restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and businesses. The COVID-19 and actions taken to mitigate it have had and are expected to continue to have an adverse impact on the economies and financial markets of many countries, including the geographical area in which the Company operates. While it is unknown how long these conditions will last and what the complete financial effect will be to the company, to-date, the Company has experienced a reduction in revenues due to the COVID-19 outbreak. 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 only recently started to generate sales and we have 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 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. On July 8, 2022, the Company received a letter from The Nasdaq Stock Market LLC advising us that we were 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. Pursuant to Nasdaq’s Listing Rules, the Company has a 180 day grace period, until January 4, 2023, during which the Company may regain compliance if the bid price of our common stock closes at $1.00 per share or more for a minimum of ten consecutive business days. In addition, the Company may be eligible for an additional 180-day grace period if we meet Nasdaq’s initial listing standards (other than with respect to minimum bid price) for The Nasdaq Capital Market. The Company intends to actively monitor the bid price for our common stock between now and January 4, 2023, and will consider available options to regain compliance with Nasdaq’s minimum bid price requirements. However, there can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rules and maintain our Nasdaq listing. The delisting of our shares of common stock from Nasdaq may have a material negative impact on the liquidity of our securities, as well as a material negative impact on our ability to raise capital in the future. 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 September 30, 2022, the Company had no deferred revenue. Concentration Risks 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 September 30, 2022, the Company has no derivative liabilities. Basic and Diluted Loss Per Share – The following is a summary of outstanding securities which have been included in the calculation of diluted net income per share and reconciliation of net income to net income available to common stockholders for the Nine-Months ended September 30, 2021. For the Nine- Months Ended September 30, 2021 Weighted average common shares outstanding used in calculating basic earnings per share 2,313,005 Effect of Series B and C preferred stock - Effect of warrants 50,140 Effect of convertible notes payable - Effect of convertible related party management fee and patent liabilities - Weighted average common shares outstanding used in calculating diluted earnings per share 2,363,145 Net income as reported $ 23,087,241 Add - Interest on convertible notes payable - Net income available to common stockholders $ 23,087,241 The Company excluded 7 options and 18 warrants from the computation of diluted net income per share for the Nine-Months ended September 30, 2021 as their exercise prices were in excess of the average closing market price of the Company’s common stock during that period. During the Nine-Months ended September 30, 2022, the Company had 111,824 options and 22,849,272 warrants to purchase shares of common stock which have been excluded from the dilutive net loss per share calculation as their effects are anti-dilutive. On November 10, 2021, we effected a 1-for-500 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 50,000,000 shares. Recent Accounting Pronouncements – |
LICENSING AGREEMENTS
LICENSING AGREEMENTS | 9 Months Ended |
Sep. 30, 2022 | |
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 $879 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 6,667 shares of common stock on December 12, 2019. On January 8, 2021, 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 133 shares of common stock. On September 30, 2020, the Company 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 the Company 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. The remaining portion of the $300,000 obligation was paid in cash in 2021. 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 $7,500 was recorded for the nine-month periods ended September 30, 2022 and 2021. As of September 30, 2022, the carrying value of the initial patent license was $47,500. The Company expects to amortize approximately $10000 annually through 2027 related to the patent costs. The Company has elected to amortize the increased obligation from the election to commercialize the StemSpine technology over a ten-year period on a straight-line basis. Amortization expense of $34,455 was recorded for the nine-month periods ended September 30, 2022 and 2021. As of September 30, 2022, the carrying value of the patent was $167,859. The Company expects to amortize approximately $46,000 annually through 2027 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 180,180 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 expense of $18,750 were recorded for the nine-month periods ended September 30, 2022 and 2021. As of September 30, 2022, the carrying value of the patent was $206,250. The Company expects to amortize approximately $25,000 annually through 2030 related to the patent costs. The following is a roll-forward of the Company’s licensing agreements for the Nine-Months ended September 30, 2022. Assets Accumulated Amortization Balances at December 31, 2021 $ 760,000 $ (232,321 ) Addition of new assets - Amortization - (69,063 ) Balances at September 30, 2022 $ 760,000 $ (301,384 ) |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 2022 | |
RELATED PARTY TRANSACTIONS | |
Related Party Transactions | NOTE 3 – RELATED PARTY TRANSACTIONS Management Reimbursement Agreement On November 17, 2017, the Company entered into a Management Reimbursement Agreement with CMH, a related party whose directors and executive officers include the Company’s officers and directors. Pursuant to this agreement, during 2019 and 2020, and until September 16, 2021, the Company reimbursed CMH an aggregate of $45,000 per month for the services of management and consultants employed by CMH (including the Company’s Chief Executive Officer and Chief Financial Officer, and the Company’s former directors Dr. Patel and Dr. Ichim). The agreement provided that at the option of CMH, the reimbursable amounts may be paid from time to time in shares of common stock of the Company at a price equal to a 30% discount to the lowest closing price during the 20 trading days prior to time the notice is given. This agreement was terminated effective September 15, 2021. At September 30, 2021 and 2022, no amounts were owed CMH under this agreement. Debt Settlement Agreement On January 12, 2018, the Company entered into a Debt Settlement Agreement with Timothy Warbington, the Company’s Chief Executive Officer, under which the Company issued 3,000,000 shares of super-voting Series A Preferred Stock to Mr. Warbington in exchange for the cancellation of $150,000 of debt owed by the Company to CMH, which CMH in turn was obligated to pay Mr. Warbington. The Series A Preferred Stock previously provided Mr. Warbington with substantial control over all matters subject to a vote of the Company’s shareholders. Mr. Warbington surrendered the Series A Preferred Stock to the Company in December 2021 immediately prior to the closing of the Company’s public offering in exchange for $150,000 plus 8% interest on such amount from January 2018 until the date of surrender. 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 181,818 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 6,667 shares of common stock on December 12, 2020. On January 8, 2021, 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 133 shares of common stock. On September 30, 2020, the Company 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 the Company 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. The remaining portion of the $300,000 obligation has been paid in cash. Insider Loans On May 28, 2021, Timothy Warbington, who is our CEO and Chairman; and Dr. Amit Patel, who was formerly a director of ours, advanced the Company $50,000 and $150,000 respectively. The two notes were repaid during the quarter ended September 30, 2021, did not have any conversion features, and bore interest at the rate of 5% per annum. |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2022 | |
DEBT | |
Debt | NOTE 4 – DEBT As-of September 30, 2022, the Company had no outstanding loans and there was no loan activity during the Nine-Months ended September 30, 2022. On August 11, 2021, we completed the sale of 15% Original Issue Discount Senior Notes (“Bridge Notes”) in the aggregate principal amount of $4,456,176 to a group of institutional investors (the “Purchasers”). In connection with the sale of the Bridge Notes, holders of our shares of Series B Preferred Stock and Series C Preferred Stock exchanged such preferred stock for additional Bridge Notes in the aggregate principal amount of $690,000. The Bridge Notes were scheduled to mature on February 11, 2022, subject to the requirement that we redeem the Bridge Notes prior to such date with the net proceeds of any future offering of our securities. The notes were redeemed in full as a result of the securities offering on December 7, 2021. The Notes did not bear interest other than upon an event of default, and were not convertible into the Company’s common stock. In addition, the Notes were subject to covenants, events of defaults and other terms and conditions customary in transactions of this nature. The Company amortized the on-issuance discount and financing fees totaling $758,426 to interest expense with respect to these notes. The Company also issued to the purchasers of the 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 our equity below the then exercise price, stock dividends, stock splits and other specified events. Roth Capital Partners (“Roth”), acted as sole placement agent for the offering. Pursuant to terms of an engagement letter with Roth, the Company paid Roth a placement agent fee in the amount $312,750. The Company also issued Roth a warrant to purchase 20,189 shares of common stock with the same terms as the warrants issued to the Purchasers. During the nine-months ended September 30, 2021, we also issued $498,800 in convertible notes to accredited investors with net proceeds of $435,040, which have since been repaid in full. The notes were to mature during February and July of 2022 and bore interest at a rate of 8%. The notes were convertible into shares of the Company’s common stock at conversion prices ranging from 60% to 71% of the average of the two lowest traded prices or the lowest trade price of the Company’s common stock during the previous 15 trading days preceding the conversion date. The Company amortized the discount due to derivative liabilities and on-issuance discount totaling $443,905 to interest expense with respect to these notes. On May 28, 2021, Mr. Timothy Warbington, who is our CEO and Chairman; and Dr. Amit Patel, who is a director of ours, advanced the company $50,000 and $150,000 respectively. The two notes were repaid during the quarter ended September 30, 2021, did not have any conversion features, and bore interest at the rate of 5% per annum. On June 21, 2021, we issued a $105,000, non-convertible note to an accredited investor with net proceeds of $100,000. The note was repaid during the quarter ended September 30, 2021, did not have any conversion features, and bore interest at the rate of 10% per annum. During the nine-months ended September 30, 2022 there was no amortization to interest expense. During the nine-months ended September 30, 2021, the Company amortized $1,755,104 to interest expense. As of September 30, 2022, total discounts were $0. During the nine-months ended September 30, 2021, the Company issued an aggregate of 789,727 shares upon the conversion of $1,383,331 of outstanding principal, interest and fees on outstanding notes, and 37,870 shares upon the cashless exercise of 43,167 warrants. |
DERIVATIVE LIABILITIES
DERIVATIVE LIABILITIES | 9 Months Ended |
Sep. 30, 2022 | |
DERIVATIVE LIABILITIES | |
Derivative Liabilities | NOTE 5 – DERIVATIVE LIABILITIES Derivative Liabilities As-of September 30, 2022, the Company had no outstanding derivative liabilities and there was no derivative activity during the Nine-Months ended September 30, 2022. In connection with convertible notes payable, the Company records derivative liabilities for the conversion feature. The derivative liabilities are valued on the date the convertible note payable become convertible and revalued at each reporting period. During the nine-months ended September 30, 2021, the Company recorded initial derivative liabilities of $1,077,757 based upon the following Black-Scholes option pricing model average assumptions: an exercise price of $0.0106 to $0.0248 our stock price on the date of grant of $0.0340 to $0.0806, expected dividend yield of 0%, expected volatility of 75.03% to 98.14%, risk free interest rate of 0.10% and expected terms of 1.0 year. Upon initial valuation, the derivative liabilities exceeded the face values certain of the convertible notes payable by approximately $697,602, which was recorded as a day one loss in derivative liability. 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 to a group of institutional investors (the “Purchasers”). A portion of the proceeds were used to repay the principal, accrued interest, pre-payment fees and other premiums of all the outstanding convertible notes as well as all previously outstanding warrants with re-pricing and anti-dilutive features. The result was $0 in derivative liabilities as-of the period ended September 30, 2021. |
STOCKBASED COMPENSATION
STOCKBASED COMPENSATION | 9 Months Ended |
Sep. 30, 2022 | |
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 600,000 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. During the Nine-Months ended September 30, 2022, Messrs. Warbington and Dickerson received 10-year options to purchase an aggregate of 111,187 shares of common stock with an exercise price of $1.69. The options vested immediately as to 25% of the shares subject to the option, and will vest in three equal installments of 25% of the shares subject to the option on each of the next three annual anniversary dates of the grant date. The value of the options was determined to be $145,525 based upon the Black-Scholes method, see variables used below. Inputs Used Annual dividend yield $ - Expected life (years) 10.0 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 1.69 During the Nine-Months ended September 30, 2021, 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 Nine-Months ended September 30, 2021. Option activity for the Nine-Months ended September 30, 2022 consists of the following: Stock Options Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 7 $ 7,500 4.64 Issued 111,817 - Exercised - - - Expired - - - Outstanding, September 30, 2022 111,824 $ 2.16 9.32 Vested, September, 30, 2022 27,961 $ 3.57 9.32 |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 9 Months Ended |
Sep. 30, 2022 | |
STOCKHOLDERS EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 7 – STOCKHOLDERS’ EQUITY On May 3, 2022, the “Company” completed the sale of (i) 2,991,669 shares of 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 (the “Common Warrants”), at a combined offering price of $2.25 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 $2.00 per share. The Pre-Funded Warrants do not expire, and have an exercise price of $0.0001 per share. The Pre-Funded Warrants are 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, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the Pre-Funded Warrants do 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 $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. The issuances and exercises during the Nine-Months ended September 30, 2022, are as follows: Outstanding at December 31, 2021 6,604,820 Issuances 20,808,332 Exercises (4,563,887 ) Outstanding at September 30, 2022 22,849,272 Weighted Average Price at September 30, 2022 $ 2.66 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
SUBSEQUENT EVENTS | |
Subsequent Events | NOTE 8 – SUBSEQUENT EVENTS In accordance with ASC 855, management reviewed all material events through November 15, 2022, for these financial statements. The material subsequent events are as follows: On October 20, 2022 the Company announced it has produced an allogenic Cell Line called AlloStem™, which includes a Master Cell Bank and a Drug Master File which shall be submitted for FDA registration. The importance of the company creating and developing such assets, as opposed to licensing agreements with third parties, provides further de-risking of an important component to many of our programs, including, but not limited to, the ImmCelz ® ® ® On November 3, 2022 the Company announced he U.S. Food and Drug Administration has cleared the Company's Investigational New Drug (IND) application, enabling the Company to proceed with initiating a clinical trial for Type 1 Diabetes using AlloStem™ AlloStem™ leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells® (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The primary objective of the study (CELZ-201) is to evaluate AlloStem™ in patients with newly diagnosed Type 1 Diabetes. Patient recruitment is expected to begin in Q1 2023 with trial commencement updates to follow. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
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 AmnioStem LLC subsidiaries. However, neither ImmCelz Inc., StemSpine Inc. nor AmnioStem 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® and FemCelz® disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. On October 20, 2022 the Company announced it has produced an allogenic Cell Line called AlloStem™, which includes a Master Cell Bank and a Drug Master File which shall be submitted for FDA registration. The importance of the company creating and developing such assets, as opposed to licensing agreements with third parties, provides further de-risking of an important component to many of our programs, including, but not limited to, the ImmCelz ® ® ® In 2020, through the Company’s ImmCelz Inc. subsidiary, the Company began exploring the development of an immunotherapy platform that “supercharges” the patients own immune cells. Secreted factors from AlloStem™ cells are used to “reprogram” the patient’s own immune cells. They are then harvested and injected back into the patient in less than 72 hours. 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. On June 15, 2022, the Company signed an agreement with Greenstone Biosciences Inc. in Palo Alto, CA for the development of a human induced pluripotent stem cell (iPSC) pipeline for the Company's ImmCelz® platform. This project is identified as iPScelz TM TM |
Use Of Estimates | Use of Estimates |
Basis Of Presentation | Basis of Presentation U.S. GAAP |
Risks And Uncertainties | Risks and Uncertainties On January 30, 2020, the World Health Organization declared the COVID-19 outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic. Actions taken around the world to help mitigate the spread of the COVID-19 include restrictions on travel, and quarantines in certain areas, and forced closures for certain types of public places and businesses. The COVID-19 and actions taken to mitigate it have had and are expected to continue to have an adverse impact on the economies and financial markets of many countries, including the geographical area in which the Company operates. While it is unknown how long these conditions will last and what the complete financial effect will be to the company, to-date, the Company has experienced a reduction in revenues due to the COVID-19 outbreak. 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 only recently started to generate sales and we have 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 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. On July 8, 2022, the Company received a letter from The Nasdaq Stock Market LLC advising us that we were 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. Pursuant to Nasdaq’s Listing Rules, the Company has a 180 day grace period, until January 4, 2023, during which the Company may regain compliance if the bid price of our common stock closes at $1.00 per share or more for a minimum of ten consecutive business days. In addition, the Company may be eligible for an additional 180-day grace period if we meet Nasdaq’s initial listing standards (other than with respect to minimum bid price) for The Nasdaq Capital Market. The Company intends to actively monitor the bid price for our common stock between now and January 4, 2023, and will consider available options to regain compliance with Nasdaq’s minimum bid price requirements. However, there can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rules and maintain our Nasdaq listing. The delisting of our shares of common stock from Nasdaq may have a material negative impact on the liquidity of our securities, as well as a material negative impact on our ability to raise capital in the future. |
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 September 30, 2022, the Company had no deferred revenue. |
Concentration Risks | Concentration Risks |
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 September 30, 2022, the Company has no derivative liabilities. |
Basic and Diluted Loss Per Share | Basic and Diluted Loss Per Share – The following is a summary of outstanding securities which have been included in the calculation of diluted net income per share and reconciliation of net income to net income available to common stockholders for the Nine-Months ended September 30, 2021. For the Nine- Months Ended September 30, 2021 Weighted average common shares outstanding used in calculating basic earnings per share 2,313,005 Effect of Series B and C preferred stock - Effect of warrants 50,140 Effect of convertible notes payable - Effect of convertible related party management fee and patent liabilities - Weighted average common shares outstanding used in calculating diluted earnings per share 2,363,145 Net income as reported $ 23,087,241 Add - Interest on convertible notes payable - Net income available to common stockholders $ 23,087,241 The Company excluded 7 options and 18 warrants from the computation of diluted net income per share for the Nine-Months ended September 30, 2021 as their exercise prices were in excess of the average closing market price of the Company’s common stock during that period. During the Nine-Months ended September 30, 2022, the Company had 111,824 options and 22,849,272 warrants to purchase shares of common stock which have been excluded from the dilutive net loss per share calculation as their effects are anti-dilutive. On November 10, 2021, we effected a 1-for-500 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 50,000,000 shares. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements – |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule Of Basic And Diluted Loss Per Share | For the Nine- Months Ended September 30, 2021 Weighted average common shares outstanding used in calculating basic earnings per share 2,313,005 Effect of Series B and C preferred stock - Effect of warrants 50,140 Effect of convertible notes payable - Effect of convertible related party management fee and patent liabilities - Weighted average common shares outstanding used in calculating diluted earnings per share 2,363,145 Net income as reported $ 23,087,241 Add - Interest on convertible notes payable - Net income available to common stockholders $ 23,087,241 |
LICENSING AGREEMENTS (Tables)
LICENSING AGREEMENTS (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
LICENSING AGREEMENTS | |
Schedule Of Licensing Agreements | Assets Accumulated Amortization Balances at December 31, 2021 $ 760,000 $ (232,321 ) Addition of new assets - Amortization - (69,063 ) Balances at September 30, 2022 $ 760,000 $ (301,384 ) |
STOCKBASED COMPENSATION (Tables
STOCKBASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
STOCKBASED COMPENSATION | |
Schedule Of Warrants | Inputs Used Annual dividend yield $ - Expected life (years) 10.0 Risk-free interest rate 0.81 % Expected volatility 92.95 % Common stock price $ 1.69 |
Schedule Of Stock Option Activity | Stock Options Weighted Average Exercise Price Weighted Average Life Remaining Outstanding, December 31, 2021 7 $ 7,500 4.64 Issued 111,817 - Exercised - - - Expired - - - Outstanding, September 30, 2022 111,824 $ 2.16 9.32 Vested, September, 30, 2022 27,961 $ 3.57 9.32 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
STOCKHOLDERS EQUITY | |
Schedule Of issuances and exercises | Outstanding at December 31, 2021 6,604,820 Issuances 20,808,332 Exercises (4,563,887 ) Outstanding at September 30, 2022 22,849,272 Weighted Average Price at September 30, 2022 $ 2.66 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||
Weighted Average Common Shares Outstanding Used In Calculating Basic Earnings Per Share | 2,313,005 | |||
Effect Of Warrants | 50,140 | |||
Weighted Average Common Shares Outstanding Used In Calculating Diluted Earnings Per Share | 14,068,412 | 2,452,076 | 9,872,450 | 2,363,145 |
Net Income As Reported | $ 23,087,241 | |||
Add - Interest On Convertible Notes Payable | 0 | |||
Net Income Available To Common Stockholders | $ 23,087,241 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 9 Months Ended | |||
Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Nov. 10, 2021 | |
Fdic Insured Amount | $ 250,000 | |||
Reverse stock split | On November 10, 2021, we effected a 1-for-500 reverse split of our authorized and issued and outstanding shares of common stock | |||
Common shares auhorized | 25,000,000,000 | 6,000,000,000 | 50,000,000 | |
Options [Member] | ||||
Anti-dilutive Securities Excluded From Computation Of Earning Per Share | 111,824 | |||
Warrants [Member] | ||||
Anti-dilutive Securities Excluded From Computation Of Earning Per Share | 22,849,272 |
LICENSING AGREEMENTS (Details)
LICENSING AGREEMENTS (Details) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Assets | |
Beginning Balance | $ 760,000 |
Amortization | 0 |
Ending Balance | 760,000 |
Accumulated Amortization | |
Accumulated Amortization, Beginning Balance | (232,321) |
Addition Of New Assets | 0 |
Amortization Accumulated | (69,063) |
Accumulated Amortization, Ending Balance | $ (301,384) |
LICENSING AGREEMENTS (Details N
LICENSING AGREEMENTS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Dec. 28, 2020 | May 17, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Jan. 31, 2021 | Jan. 08, 2021 | Sep. 30, 2020 | Dec. 12, 2019 | Feb. 02, 2016 | |
Company Paid Cmh | $ 50,000 | $ 50,000 | $ 40,000 | |||||||||
Common Stock Issue | 89,286 | 133 | 84,656 | 6,667 | ||||||||
Common stock value | $ 14,077 | $ 14,077 | $ 6,339 | $ 100,000 | ||||||||
Obligation Of The Initial Payment | $ 300,000 | $ 300,000 | $ 300,000 | |||||||||
License Fees | $ 250,000 | |||||||||||
Cash Payment In Intial Payment | $ 50,000 | |||||||||||
License Agreement Description | 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 | |||||||||||
License Agreement Description final | 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 | |||||||||||
Restricted Common Stock | $ 431,111 | |||||||||||
Amortization Expenses | 7,479 | |||||||||||
Carrying Value Of Patent | 33,507 | $ 33,507 | ||||||||||
Expiration Period Of Finite-lived Intangible Assets | 2025 | |||||||||||
Expected Amount Of Amortization | $ 9,972 | |||||||||||
Amortization Expenses | 23,021 | $ 23,021 | 69,063 | $ 69,063 | ||||||||
Option [Member] | ||||||||||||
Initial Payment | $ 100,000 | |||||||||||
Creative Medical Health Inc [Member] | Patents [Member] | ||||||||||||
Amortization Expenses | 7,500 | |||||||||||
Carrying Value Of Patent | 47,500 | $ 47,500 | ||||||||||
Expiration Period Of Finite-lived Intangible Assets | May 19, 2027 | |||||||||||
Expected Amount Of Amortization | $ 10,000 | |||||||||||
Initial Payment | $ 100,000 | |||||||||||
Percentage Of Discount On The Basis Of Recent Trading Price | 30 | |||||||||||
Share Price For Two Or More Consecutive Trading Days | 0.01 | |||||||||||
Creative Medical Health Inc [Member] | Patents [Member] | Scenario One [Member] | ||||||||||||
Payments Upon Signing Agreement With University For The Initiation Of An Irb Clinical Trial | $ 100,000 | |||||||||||
Payments Upon Completion Of The Irb Clinical Trial | 200,000 | |||||||||||
Payments In The Event Of Commercialization Of Technology | 300,000 | |||||||||||
Creative Medical Health Inc [Member] | Patents [Member] | Scenario Two [Member] | ||||||||||||
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 | $ 400,000 | |||||||||||
Stemspine LLC [Member] | ||||||||||||
Royalty Payment Percentage | 5% | |||||||||||
Non-royalty Sublease Income Percentage. | 50% | |||||||||||
Stemspine LLC [Member] | Patents [Member] | ||||||||||||
Amortization Expenses | 34,455 | |||||||||||
Carrying Value Of Patent | 167,859 | 167,859 | ||||||||||
Expected Amount Of Amortization | 46,000 | |||||||||||
Patent License Agreement [Member] | ||||||||||||
License Fees | 250,000 | |||||||||||
Amortization Expenses | 12,500 | |||||||||||
Carrying Value Of Patent | 212,500 | $ 212,500 | ||||||||||
Expiration Period Of Finite-lived Intangible Assets | 2030 | |||||||||||
Expected Amount Of Amortization | $ 25,000 | |||||||||||
Multipotent Amniotic Fetal Stem Cells License Agreement [Member] | Patents [Member] | ||||||||||||
Carrying Value Of Patent | $ 3,498 | $ 3,498 | ||||||||||
Expiration Period Of Finite-lived Intangible Assets | 2026 | |||||||||||
Expected Amount Of Amortization | $ 1,172 | |||||||||||
Amortization Expenses | 879 | |||||||||||
Number of share issuance cf common stock to jadi cell | $ 180,180 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 1 Months Ended | ||||||||||||
Jan. 12, 2018 | May 28, 2021 | Dec. 28, 2020 | Nov. 17, 2017 | May 17, 2017 | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Jan. 31, 2021 | Jan. 08, 2021 | Dec. 12, 2020 | Sep. 30, 2020 | Dec. 12, 2019 | |
Proceeds From Director | $ 150,000 | ||||||||||||
Debt Interest Rate | 5% | ||||||||||||
Company Paid Cmh | $ 50,000 | $ 50,000 | $ 40,000 | ||||||||||
Obligation Of The Initial Payment | $ 300,000 | 300,000 | $ 300,000 | ||||||||||
Cash Payment In Intial Payment | $ 50,000 | ||||||||||||
Common Stock Issued | 14,076,246 | 6,338,872 | |||||||||||
Management Reimbursement agreement CMH [Member] | |||||||||||||
Reimbursement of management fees monthly | $ 45,000 | ||||||||||||
StemSpine Patent Purchase [Member] | |||||||||||||
Company Paid Cmh | $ 50,000 | $ 50,000 | |||||||||||
Obligation Of The Initial Payment | $ 300,000 | ||||||||||||
Common Stock Issued | 89,286 | 133 | 6,667 | 84,656 | |||||||||
Long-term Purchase Commitment, Amount | $ 100,000 | ||||||||||||
Remaining portion of obligation paid in cash | $ 300,000 | ||||||||||||
Debt Settlement Agreement Timothy Warbington [Member] | |||||||||||||
Series A Preferred Stock Issued | 3,000,000 | ||||||||||||
Cancellation Of Debt | $ 150,000 | ||||||||||||
Preferred Stock Surrender And Exchange Description | Mr. Warbington surrendered the Series A Preferred Stock to the Company in December 2021 immediately prior to the closing of the Company’s public offering in exchange for $150,000 plus 8% interest on such amount from January 2018 until the date of surrender | ||||||||||||
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 | 181,818 |
DEBT (Details Narrative)
DEBT (Details Narrative) | 1 Months Ended | 9 Months Ended | |||
Jun. 21, 2021 USD ($) | May 28, 2021 USD ($) | Sep. 30, 2022 USD ($) integer $ / shares shares | Sep. 30, 2021 USD ($) | Aug. 11, 2021 USD ($) | |
Debt Conversion, Shares Issued | shares | 789,727 | ||||
Aggregate principal amount | $ 4,456,176 | ||||
Aggregate principal amount for Bridge notes | 690,000 | ||||
Financing Fees | $ 758,426 | ||||
Debt Conversion, Converrted Instrument, Shares Issued | shares | 37,870 | ||||
Aggregate of outstanding principal, interest and fees | $ 1,383,331 | ||||
Common Stock Issued For Cashless Warrant Exercise, Shares | shares | 43,167 | ||||
Unamortized Debt Discount | $ 0 | ||||
Amortization Of Debt Discount | $ 1,755,104 | ||||
Initial exercise price | $ / shares | $ 14.175 | ||||
Stock issued to common stock | shares | 363,046 | ||||
Placement agent fee to ROATH | $ 312,750 | ||||
Proceeds from convertible notes payable | 0 | $ 435,040 | |||
Accredited Investors [Member] | Convertible Debt [Member] | |||||
Amortization Of Debt Discount | $ 443,905 | ||||
Interest Rate | 10% | 5% | 8% | ||
Debt Instrument, Convertible, Threshold Trading Day | integer | 15 | ||||
Proceeds from convertible notes payable | $ 100,000 | $ 435,040 | |||
Convertible notes issued | $ 105,000 | $ 498,800 | |||
Accredited Investors [Member] | Convertible Debt [Member] | Minimum [Member] | |||||
Conversion Price, Percentage | 60% | ||||
Accredited Investors [Member] | Convertible Debt [Member] | Maximum [Member] | |||||
Conversion Price, Percentage | 71% | ||||
CEO [Member] | |||||
Advanced received | $ 50,000 | ||||
Board Member [Member] | |||||
Advanced received | $ 150,000 |
DERIVATIVE LIABILITIES (Details
DERIVATIVE LIABILITIES (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Aug. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Aggregate principal amount | $ 4,456,176 | |||
Initial derivative liabilities | $ 1,077,757 | |||
Dividend yield | 0% | |||
Risk free interest | 0.10% | |||
Convertible notes payable | $ 697,602 | |||
Fair Value Assumptions, Expected Term | 10 years | 1 year | ||
Maximum [Member] | ||||
Exercise price | $ 0.0248 | |||
Stock price granted | $ 0.0806 | |||
Expected volatility | 98.14% | |||
Minimum [Member] | ||||
Exercise price | $ 0.0106 | |||
Stock price granted | $ 0.0340 | |||
Expected volatility | 75.03% |
STOCKBASED COMPENSATION (Detail
STOCKBASED COMPENSATION (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
STOCKBASED COMPENSATION (Details) | ||
Annual dividend yield | $ 0 | |
Expected life (years) | 10 years | 1 year |
Risk-free interest rate | 0.81% | |
Expected volatility | 92.95% | |
Common stock price | $ 1.69 |
STOCKBASED COMPENSATION (Deta_2
STOCKBASED COMPENSATION (Details 1) - Option [Member] | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Outstanding at the begining | 7 |
Issued | 111,817 |
Exercised | 0 |
Expired | 0 |
Outstanding at the end | 111,824 |
Vested | 27,961 |
Weighted Average Exercise Price, Outstanding beginning | $ / shares | $ 7,500 |
Weighted Average Exercise Price, Exercised | $ / shares | 0 |
Weighted Average Exercise Price, Expired | $ / shares | 0 |
Weighted Average Exercise Price, Outstanding ending | $ / shares | 2.16 |
Weighted Average Exercise Price, Vested | $ / shares | $ 3.57 |
Weighted Average Life Remaining, Outstanding beginning | 4 years 7 months 20 days |
Weighted Average Life Remaining, Outstanding ending | 9 years 3 months 25 days |
Weighted Average Life Remaining, Vested | 9 years 3 months 25 days |
STOCKBASED COMPENSATION (Deta_3
STOCKBASED COMPENSATION (Details Narrative) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 06, 2021 | |
Common stock price | $ 1.69 | |
Employee Stock Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 10 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 111,187 | |
Common stock price | $ 1.69 | |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights | The options vested immediately as to 25% of the shares subject to the option, and will vest in three equal installments of 25% of the shares subject to the option on each of the next three annual anniversary dates of the grant date | |
Employee Stock Options [Member] | Black Scholes Method [Member] | ||
Options vested, value | $ 145,525 | |
Board of Directors [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 600,000 |
STOCKHOLDERS EQUITY (Details)
STOCKHOLDERS EQUITY (Details) - Warrants [Member] | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Outstanding at the begining | 6,604,820 |
Issuances | 20,808,332 |
Exercises | 4,563,887 |
Outstanding at the end | 22,849,272 |
Weighted Average Exercise Price, Outstanding ending | $ / shares | $ 2.66 |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 9 Months Ended | |
May 03, 2022 | Sep. 30, 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 | 2,991,669 | |
Pre-Funded Warrants Exercise price | $ 0.0001 | |
Purchase of warrants shares | 4,563,887 | |
Purchase of Pre-Funded Warrant and related Common Warrant | 15,111,112 | |
Common warrants exercise price | $ 2 | |
Combined offering price of Pre-Funded Warrant and related Common Warrant | $ 2.25 | |
Roth Capital Partners [Member] | ||
Paid placement agent fee | $ 1,360,000 | |
Issued warrant to purchase shares of common stock | 1,133,333 |