Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-32404 | ||
Entity Registrant Name | POLARITYTE, INC. | ||
Entity Central Index Key | 0001076682 | ||
Entity Tax Identification Number | 06-1529524 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 1960 S. 4250 West | ||
Entity Address, City or Town | Salt Lake City | ||
Entity Address, State or Province | UT | ||
Entity Address, Postal Zip Code | 84104 | ||
City Area Code | (800) | ||
Local Phone Number | 560-3983 | ||
Title of 12(b) Security | Common Stock, par value $0.001 | ||
Trading Symbol | PTE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 80,190,567 | ||
Entity Common Stock, Shares Outstanding | 89,498,691 | ||
Documents Incorporated by Reference [Text Block] | Portions of the registrant’s definitive proxy statement for the Special Meeting of Stockholders called for May 12, 2022 (2022 Proxy Statement) are incorporated into Part III hereof. The 2022 Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the registrant’s fiscal year ended December 31, 2021. | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | EisnerAmper LLP | ||
Auditor Location | Iselin, New Jersey | ||
Auditor Firm ID | 274 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 19,375 | $ 25,522 |
Accounts receivable, net | 978 | 3,819 |
Inventory | 883 | |
Assets held for sale | 441 | |
Prepaid expenses and other current assets | 1,595 | 992 |
Total current assets | 22,389 | 31,216 |
Property and equipment, net | 6,923 | 10,550 |
Operating lease right-of-use assets | 1,146 | 2,452 |
Intangible assets, net | 542 | |
Goodwill | 278 | |
Other assets | 720 | 472 |
TOTAL ASSETS | 31,178 | 45,510 |
Current liabilities | ||
Accounts payable and accrued expenses | 3,115 | 4,148 |
Other current liabilities | 1,520 | 2,106 |
Current portion of long-term note payable | 2,059 | |
Deferred revenue | 74 | 168 |
Total current liabilities | 4,709 | 8,481 |
Common stock warrant liability | 6,844 | 5,975 |
Operating lease liabilities | 43 | 1,476 |
Other long-term liabilities | 338 | 723 |
Long-term notes payable | 1,517 | |
Total liabilities | 11,934 | 18,172 |
Commitments and Contingencies (Note 16) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock – 25,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2021 and 2020 | ||
Common stock - $.001 par value; 250,000,000 shares authorized; 82,484,462 and 54,857,099 shares issued and outstanding at December 31, 2021 and 2020, respectively | 82 | 55 |
Additional paid-in capital | 527,560 | 505,494 |
Accumulated deficit | (508,398) | (478,211) |
Total stockholders’ equity | 19,244 | 27,338 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 31,178 | $ 45,510 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 82,484,462 | 54,857,099 |
Common stock, shares outstanding | 82,484,462 | 54,857,099 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Net revenues | |||
Total net revenues | $ 9,404 | $ 10,126 | |
Cost of revenues | |||
Total costs of revenues | 4,316 | 4,424 | |
Gross profit | 5,088 | 5,702 | |
Operating costs and expenses | |||
Research and development | 14,182 | 11,532 | |
General and administrative | 20,476 | 27,557 | |
Sales and marketing | 2,808 | 8,719 | |
Restructuring and other charges | 678 | 3,834 | |
Impairment of goodwill and intangible assets | 630 | ||
Total operating costs and expenses | 38,774 | 51,642 | |
Operating loss | (33,686) | (45,940) | |
Other income (expense), net | |||
Gain on extinguishment of debt | 3,612 | ||
Change in fair value of common stock warrant liability | 4,995 | 2,914 | |
Inducement loss on sale of liability classified warrants | (5,197) | ||
Interest (expense) income, net | (127) | (182) | |
Other income, net | 216 | 354 | |
Net loss | $ (30,187) | $ (42,854) | |
Net loss per share attributable to common stockholders | |||
Basic | $ (0.38) | $ (1.11) | |
Diluted | $ (0.38) | $ (1.16) | |
Weighted average shares outstanding | |||
Basic | [1] | 80,014,014 | 38,779,316 |
Diluted | 80,014,014 | 39,367,390 | |
Product [Member] | |||
Net revenues | |||
Total net revenues | $ 3,076 | $ 3,730 | |
Cost of revenues | |||
Total costs of revenues | 448 | 1,068 | |
Service [Member] | |||
Net revenues | |||
Total net revenues | 6,328 | 6,396 | |
Cost of revenues | |||
Total costs of revenues | $ 3,868 | $ 3,356 | |
[1] | In December 2020 and January 2021, the Company sold pre-funded warrants to purchase up to 5,238,043 2,420,910 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Net loss | $ (30,187) | $ (42,854) |
Other comprehensive income (loss): | ||
Unrealized gain on available-for-sale securities | 11 | |
Reclassification of realized gains included in net loss | (83) | |
Comprehensive loss | $ (30,187) | $ (42,926) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 27 | $ 474,174 | $ 72 | $ (435,357) | $ 38,916 |
Beginning balance, shares at Dec. 31, 2019 | 27,374,653 | ||||
Issuance of common stock, net of issuance costs | $ 11 | 12,589 | 12,600 | ||
Issuance of common stock, net of issuance costs, shares | 10,854,710 | ||||
Issuance of common stock and pre-funded warrants through underwritten offering, net of issuance costs | $ 5 | 2,261 | 2,266 | ||
Issuance of common stock and pre-funded warrants through underwritten offering, net of issuance costs, shares | 5,450,000 | ||||
Issuance of common stock upon exercise of warrants | $ 10 | 9,263 | 9,273 | ||
Issuance of common stock upon exercise of warrants, shares | 10,073,298 | ||||
Stock option exercises | 31 | 31 | |||
Stock option exercises, shares | 10,208 | ||||
Stock-based compensation expense | 7,258 | 7,258 | |||
Purchase of ESPP shares | 75 | 75 | |||
Purchase of ESPP shares, shares | 97,445 | ||||
Vesting of restricted stock units | $ 2 | (2) | |||
Vesting of restricted stock units, shares | 1,161,658 | ||||
Shares withheld for tax withholding | (155) | (155) | |||
Shares withheld for tax withholding, shares | (117,987) | ||||
Forfeiture of restricted stock awards | |||||
Forfeiture of restricted stock awards, shares | (46,886) | ||||
Other comprehensive income | (72) | (72) | |||
Net loss | (42,854) | (42,854) | |||
Ending balance, value at Dec. 31, 2020 | $ 55 | 505,494 | (478,211) | 27,338 | |
Ending balance, shares at Dec. 31, 2020 | 54,857,099 | ||||
Issuance of common stock and pre-funded warrants through underwritten offering, net of issuance costs | $ 7 | 1,248 | 1,255 | ||
Issuance of common stock and pre-funded warrants through underwritten offering, net of issuance costs, shares | 6,670,000 | ||||
Issuance of common stock upon exercise of warrants | $ 10 | 6,661 | 6,671 | ||
Issuance of common stock upon exercise of warrants, shares | 10,713,543 | ||||
Stock option exercises | 3 | 3 | |||
Stock option exercises, shares | 2,500 | ||||
Stock-based compensation expense | 5,600 | 5,600 | |||
Purchase of ESPP shares | 55 | 55 | |||
Purchase of ESPP shares, shares | 101,900 | ||||
Vesting of restricted stock units | $ 2 | (2) | |||
Vesting of restricted stock units, shares | 3,126,564 | ||||
Shares withheld for tax withholding | (463) | (463) | |||
Shares withheld for tax withholding, shares | (608,144) | ||||
Forfeiture of restricted stock awards | |||||
Forfeiture of restricted stock awards, shares | (37,953) | ||||
Net loss | (30,187) | (30,187) | |||
Reclassification of warrant liability upon exercise | 8,964 | 8,964 | |||
Issuance of common stock upon exercise of pre-funded warrants | $ 8 | 8 | |||
Issuance of common stock upon exercise of pre-funded warrants, shares | 7,658,953 | ||||
Ending balance, value at Dec. 31, 2021 | $ 82 | $ 527,560 | $ (508,398) | $ 19,244 | |
Ending balance, shares at Dec. 31, 2021 | 82,484,462 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Subsidiary, Sale of Stock [Line Items] | ||
Debt issuance costs, net | $ 1,319 | |
Underwritten Offering [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Debt issuance costs, net | $ 114 | $ 251 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (30,187) | $ (42,854) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,381 | 7,258 |
Depreciation and amortization | 2,652 | 3,074 |
Impairment of goodwill and intangible assets | 630 | |
Amortization of intangible assets | 190 | 189 |
Amortization of debt discount | 19 | |
Bad debt expense | 75 | 148 |
Inventory write-off | 747 | |
Gain on extinguishment of debt – PPP loan | (3,612) | |
Change in fair value of common stock warrant liability | (4,995) | (2,914) |
Inducement loss on sale of liability classified warrants | 5,197 | |
Loss on restructuring and other charges | 321 | |
Loss on sale of property and equipment and ROU assets | 12 | 2,806 |
Loss on abandonment of property and equipment | 209 | |
Other non-cash adjustments | (45) | (21) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 2,766 | (2,236) |
Inventory | 136 | (631) |
Prepaid expenses and other current assets | (603) | 272 |
Operating lease right-of-use assets | 1,318 | 1,700 |
Other assets/liabilities, net | (248) | (200) |
Accounts payable and accrued expenses | (1,047) | (2,761) |
Other current liabilities | (29) | 35 |
Deferred revenue | (94) | 70 |
Operating lease liabilities | (1,404) | (1,708) |
Net cash used in operating activities | (22,630) | (37,754) |
CASH FLOWS FROM (USED IN) INVESTING ACTIVITIES | ||
Purchase of property and equipment | (123) | (1,339) |
Proceeds from sale of property and equipment | 27 | |
Purchase of available-for-sale securities | (14,144) | |
Proceeds from maturities of available-for-sale securities | 16,945 | |
Proceeds from sale of available-for-sale securities | 16,171 | |
Net cash provided by/(used in) investing activities | (96) | 17,633 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from term note payable and financing arrangements | 1,028 | 4,629 |
Principal payments on term note payable and financing arrangements | (1,054) | (1,675) |
Principal payments on financing leases | (555) | (508) |
Net proceeds from the sale of common stock, warrants and pre-funded warrants | 9,884 | 32,020 |
Proceeds from the sale of new warrants | 1,002 | |
Proceeds from warrants exercised | 6,671 | 1,008 |
Proceeds from pre-funded warrants exercised | 8 | |
Cash paid for tax withholdings related to net share settlement | (463) | (155) |
Proceeds from stock options exercised | 3 | 31 |
Proceeds from ESPP purchase | 55 | 75 |
Net cash provided by financing activities | 16,579 | 35,425 |
Net increase (decrease) in cash and cash equivalents | (6,147) | 15,304 |
Cash and cash equivalents - beginning of period | 25,522 | 10,218 |
Cash and cash equivalents - end of period | 19,375 | 25,522 |
Supplemental cash flow information: | ||
Cash paid for interest | 118 | 187 |
Supplemental schedule of non-cash investing and financing activities: | ||
Fair value of placement agent warrants issued in connection with offering | 838 | |
Reclassification of warrant liability to stockholders’ equity upon exercise of warrant | 8,964 | 8,265 |
Allocation of proceeds from sale of common stock and warrants to warrant liability | 8,629 | 17,154 |
Unpaid liability for acquisition of property and equipment | 21 | 87 |
Right-of-use asset obtained in exchange for new lease liability | 42 | 82 |
Accrued offering costs | 400 | |
Reclassification of equipment to assets held for sale | $ 441 |
PRINCIPAL BUSINESS ACTIVITY AND
PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION | 1. PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION PolarityTE, Inc. (together with its subsidiaries, the “Company”) is a clinical stage biotechnology company developing regenerative tissue products and biomaterials. The Company also operates a laboratory testing and clinical research business. The Company’s first regenerative tissue product is SkinTE. In July 2021, the Company submitted an investigational new drug application (“IND”) for SkinTE to the United States Food and Drug Administration (the “FDA”) through its subsidiary, PolarityTE MD, Inc. Prior to June 1, 2021, the Company sold SkinTE under Section 361 of the Public Health Service Act in 2020 and into 2021 and, after the Company’s decision to file an IND under Section 351 of that Act, under an enforcement discretion position stated by the FDA in a regenerative medicine policy framework to help facilitate regenerative medicine therapies. The FDA’s stated period of enforcement discretion ended May 31, 2021. Consequently, the Company terminated commercial sales of SkinTE on May 31, 2021, and ceased its SkinTE commercial operations, and has transitioned to a clinical stage company pursuing an IND for SkinTE. As a result, there are no product sales from commercial SkinTE after June 2021. The only revenues recognized subsequent to June 2021 for SkinTE were nominal amounts collected on accounts for product shipped prior to the end of May 2021 that were not previously recognized because of concerns with collectability. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation Principles of Consolidation Use of estimates Segments two Cash and cash equivalents Accounts Receivable 202,000 174,000 Inventory 0.7 0.3 0.4 No Assets Held for Sale In November 2021, the Company committed to a plan to sell a variety of lab equipment within the regenerative medicine products reporting segment. The lab equipment has been designated as held for sale and is presented as such within the consolidated balance sheet as of December 31, 2021. Property and Equipment Leases The Company has lease agreements with lease and non-lease components. As allowed under ASC 842, the Company has elected not to separate lease and non-lease components for any leases involving real estate and office equipment classes of assets and, as a result, accounts for the lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement of ASC 842 to leases with a term of 12 months or less for all classes of assets. Goodwill and Intangible Assets Goodwill is tested for impairment at a reporting unit level by performing either a qualitative or quantitative analysis. The qualitative analysis is an assessment of factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then no further testing is necessary. If the Company concludes otherwise, a quantitative analysis is performed by comparing the fair value of a reporting unit to its carrying amount. If the fair value exceeds the carrying value, there is no impairment. If the fair value is less than the carrying value, an impairment charge is recorded for the difference between the fair value and the carrying value. For the year ended December 31, 2021, the Company performed a qualitative assessment and concluded that it is more likely than not that the fair value of the IBEX reporting unit was less than its carrying value which resulted in the Company also performing a quantitative analysis. The results of the quantitative analysis showed the carrying value of the reporting unit exceeding its fair value. Intangible assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, which generally range from one to eleven years. The useful life is the period over which the asset is expected to contribute directly, or indirectly, to its future cash flows. Intangible assets are reviewed for impairment when certain events or circumstances exist. For amortizable intangible assets, impairment exists when the undiscounted cash flows exceed its carrying value and an impairment charge would be recorded for the excess of the carrying value over its fair value. At least annually, the remaining useful life is evaluated. For the year ended December 31, 2021, the Company identified indicators of impairment which led the Company to perform an assessment that resulted in carrying values of the intangible assets exceeding the undiscounted cash flows. As a result of the goodwill and intangible assets impairment analyses, the Company determined that goodwill and intangible assets of the IBEX reporting unit were fully impaired and recorded impairment charges of $ 0.6 million for the year ended December 31, 2021 within the Company’s contract services business segment and are included in impairment of goodwill and intangible assets Impairment of Long-Lived Assets Offering Costs Capitalized Software Revenue Recognition The Company recorded product revenues primarily from the sale of SkinTE, its regenerative tissue products. When the Company marketed its SkinTE product, it was sold to healthcare providers (customers), primarily through direct sales representatives. Product revenues consisted of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognized product revenue upon delivery to the customer. In the contract services segment, the Company records service revenues from the sale of its preclinical research services, which includes delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date relative to the total costs expected to be required to satisfy the performance obligation. The Company believes that this method provides an appropriate measure of the transfer of services over the term of the performance obligation based on the remaining services needed to satisfy the obligation. This requires the Company to make reasonable estimates of the extent of progress toward completion of the contract. As a result, unbilled receivables and deferred revenue are recognized based on payment timing and work completed. Generally, a portion of the payment is due upfront and the remainder upon completion of the contract, with most contracts completing in less than a year. Contract services also includes research and laboratory testing services to unrelated third parties on a contract basis. Due to the short-term nature of the services, these customer contracts generally consist of a single performance obligation that the Company satisfies at a point in time. The Company satisfies the single performance obligation and recognizes revenue upon delivery of testing results to the customer. As of December 31, 2021 and 2020, the Company had unbilled receivables of $ 0.5 0.2 0.1 0.2 0.2 Any costs incurred to obtain a contract would be recognized as product is shipped. The Company considers a significant customer to be one that comprises more than 10% of net revenues or accounts receivable. Customers that accounted for 10% or more of net revenues were as follows: SCHEDULE OF CONCENTRATION RISK For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Segment % of Revenue % of Revenue Customer A Contract Services 20 % – % Customer B Regenerative Medicine Products 13 % 13 % Customer C Contract Services 18 % 41 % Customers that accounted for 10% or more of accounts receivable were as follows: December 31, 2021 December 31, 2020 Segment % of Accounts Receivable % of Accounts Receivable Customer A Contract Services 31 % – % Customer B Regenerative Medicine Products – % 14 % Customer C Contract Services – % 46 % Customer F Contract Services 17 % – % Customer G Contract Services 12 % – % The following table contains revenues as presented in the Consolidated Statements of Operations disaggregated by services and products. SCHEDULE OF REVENUE DISAGGREGATED BY SERVICES AND PRODUCTS For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Regenerative Medicine Products SkinTE Products $ 3,076 $ 3,730 Contract Services Lab Testing Services 1,877 4,454 Preclinical Research Services 4,451 1,942 6,328 6,396 Total Net Revenues $ 9,404 $ 10,126 Research and Development Expenses Accruals for Clinical Trials Common Stock Warrant Liability Stock-Based Compensation The fair value for options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate is derived from the U.S. Treasury yield curve in effect at the time of the grant commensurate with the expected term of the option. The volatility factor is determined based on the Company’s historical stock prices. Forfeitures are recognized as they occur. The fair value of restricted stock grants is measured based on the fair market value of the Company’s common stock on the date of grant and recognized as compensation expense over the vesting period of, generally, six months to three years. Income Taxes Net Loss Per Share 0.001 Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326) Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40) Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes |
LIQUIDITY AND GOING CONCERN
LIQUIDITY AND GOING CONCERN | 12 Months Ended |
Dec. 31, 2021 | |
Liquidity And Going Concern | |
LIQUIDITY AND GOING CONCERN | 3. LIQUIDITY AND GOING CONCERN The Company has experienced recurring losses and cash outflows from operating activities. As of December 31, 2021, the Company had an accumulated deficit of $ 508.4 million. As of December 31, 2021, the Company had cash and cash equivalents of $ 19.4 million. The Company has been funded historically through sales of equity and debt. These financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and settle its liabilities in the normal course of business. The Company’s significant operating losses raise substantial doubt regarding the Company’s ability to continue as a going concern for at least one year from the date of issuance of these consolidated financial statements. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might result from the outcome of this uncertainty. The Company is a clinical stage biotechnology company that has historically incurred losses and negative cash flows. Consequently, the future success of the Company depends on its ability to attract additional capital and, ultimately, on its ability to successfully complete the regulatory approval process for its product, SkinTE, and develop future profitable operations. The Company will seek additional capital through equity offerings or debt financing. However, such financing may not be available in the future on favorable terms, if at all. |
FAIR VALUE
FAIR VALUE | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE | 4. FAIR VALUE In accordance with ASC 820, Fair Value Measurements and Disclosures ● Level 1: Observable inputs such as quoted prices in active markets for identical instruments. ● Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the market. ● Level 3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires significant judgment or estimation. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. There were no transfers within the hierarchy for any of the periods presented. The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands): SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS Level 1 Level 2 Level 3 Total December 31, 2021 Level 1 Level 2 Level 3 Total Liabilities Common stock warrant liability $ – $ – $ 6,844 $ 6,844 Total $ – $ – $ 6,844 $ 6,844 Level 1 Level 2 Level 3 Total December 31, 2020 Level 1 Level 2 Level 3 Total Liabilities Common stock warrant liability $ – $ – $ 5,975 $ 5,975 Total $ – $ – $ 5,975 $ 5,975 The Company assesses its long-lived assets, including property, plant, and equipment, ROU assets, intangible assets, and goodwill, at fair value on a non-recurring basis. The Company reviews the carrying amounts of such assets when events indicate that their carrying amounts may not be recoverable. Any resulting impairment would require that the asset be recorded at its fair value. During the year ended December 31, 2021, the Company recognized an impairment charge of $ 0.6 0.4 The following table presents the change in fair value of the liability classified common stock warrants for the year ended December 31, 2021 (in thousands): SCHEDULE OF FAIR VALUE OF LIABILITY CLASSIFIED COMMON STOCK WARRANTS Fair Value at December 31, 2020 Initial Fair Value at Issuance (Gain) Loss Upon Change in Fair Value Liability Reduction Due to Exercises Fair Value at December 31, 2021 Warrant liabilities February 14, 2020 issuance $ 328 $ – $ (37 ) $ – $ 291 December 23, 2020 issuance 5,647 – 3,556 (8,964 ) 239 January 14, 2021 issuance – 8,629 (5,284 ) – 3,345 January 25, 2021 issuance (1) (1) – 6,199 (3,230 ) – 2,969 Total $ 5,975 $ 14,828 $ (4,995 ) $ (8,964 ) $ 6,844 (1) Concurrent with the issuance of the January 25, 2021 warrants, upon the exercise of the December 23, 2020 warrants, an inducement loss of $ 5.2 6.2 1.0 million The following table presents the change in fair value of the liability classified common stock warrants for the year ended December 31, 2020 (in thousands): Initial Fair Value at Issuance Liability Reduction Due to Exercises (Gain) Loss Upon Change in Fair Value Fair Value at December 31, 2020 Warrant liabilities February 14, 2020 issuance $ 11,677 $ (8,265 ) $ (3,084 ) $ 328 December 23, 2020 issuance 5,477 – 170 5,647 Total $ 17,154 $ (8,265 ) $ (2,914 ) $ 5,975 The Company uses the Monte Carlo valuation model to determine the fair value of the liability classified warrants issued during 2021 and 2020. Input assumptions for these freestanding instruments are as follows: SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY For the Year Ended December 31, 2021 Stock price $ 0.59 1.21 Exercise price $ 0.10 1.38 Risk-free rate 0.42 1.27 Volatility 99.0 103.9 Remaining term (years) 4.0 5.9 For the Year Ended December 31, 2020 Stock price $ 0.65 1.69 Exercise price $ 0.10 2.80 Risk-free rate 0.36 1.51 Volatility 93.4 99.7 Remaining term (years) 5.0 7.0 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 5. PREPAID EXPENSES AND OTHER CURRENT ASSETS The following table presents the major components of prepaid expenses and other current assets (in thousands): SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS December 31, 2021 December 31, 2020 Other current receivable $ 67 $ 306 Short term deposit 150 – Prepaid insurance 239 201 Prepaid expenses 445 485 Deferred offering costs 694 – Total prepaid expenses and other current assets $ 1,595 $ 992 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 6. PROPERTY AND EQUIPMENT, NET The following table presents the components of property and equipment, net (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT, NET December 31, 2021 December 31, 2020 Machinery and equipment $ 8,502 $ 12,232 Land and buildings 2,000 2,000 Computers and software 1,129 1,240 Leasehold improvements 2,107 2,107 Construction in progress 133 87 Furniture and equipment 123 148 Total property and equipment, gross 13,994 17,814 Accumulated depreciation (7,071 ) (7,264 ) Total property and equipment, net $ 6,923 $ 10,550 The Company sold SkinTE under Section 361 of the Public Health Service Act in 2020 and into 2021 and, after the Company’s decision to file an IND under Section 351 of that Act, under an enforcement discretion position stated by the FDA in a regenerative medicine policy framework to help facilitate regenerative medicine therapies. The FDA’s stated period of enforcement discretion ended May 31, 2021. Consequently, the Company terminated commercial sales of SkinTE on May 31, 2021, and ceased its SkinTE commercial operations. As a result, there are no product sales from commercial SkinTE after June 2021 and the Company has eliminated or reduced costs associated with commercial sale of SkinTE. The Company evaluated the future use of its commercial property and equipment and recorded an impairment charge of approximately $ 0.4 no Depreciation and amortization expense for property and equipment, including assets acquired under financing leases was as follows (in thousands): SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE 2021 2020 For the Year Ended December 31, 2021 2020 General and administrative expense $ 739 $ 1,533 Research and development expense 1,913 1,541 Total depreciation and amortization expense $ 2,652 $ 3,074 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
LEASES | 7. LEASES The Company leases facilities and certain equipment under noncancelable leases that expire at various dates through November 2024. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases may include options to extend or terminate the lease at the election of the Company. These optional periods have not been considered in the determination of the right-of-use-assets or lease liabilities associated with these leases as the Company did not consider it reasonably certain it would exercise the options. Operating Leases On December 27, 2017, the Company entered into a commercial lease agreement with Adcomp LLC, a Utah limited liability company, pursuant to which the Company leased approximately 178,528 five years November 30, 2022 The Company has a one-time option to renew for an additional five years The initial base rent under this lease is $ 98,190 3.0 10 Effective July 15, 2018, the Company entered into a commercial lease agreement with Salt Lake City Corporation, pursuant to which the Company leased approximately 44,695 two years the option to extend the term for an additional five years by agreement of the parties 39,108 3.0 9 In April 2019, the Company entered into an operating lease to obtain 6,307 The lease provided for monthly lease payments subject to annual increases and had an expiration date in April 2024 1.2 0 0.3 In November 2021, the Company entered into an operating lease to obtain office equipment with Pacific Office Automation, Inc. The initial term of the lease is three years November 2024 The initial base rent under this lease is $ 3,983 0.1 7.42 Financing Leases In November 2018 and April 2019, the Company entered into financing leases primarily for laboratory equipment used in research and development activities. The financing leases have remaining terms that range from 3 28 10 In the fourth quarter of 2021, management recorded $ 0.2 As of December 31, 2021, the maturities of operating and finance lease liabilities were as follows (in thousands): SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES Year ending December 31: Operating leases Finance leases 2022 $ 1,185 $ 377 2023 48 316 2024 42 42 Total lease payments 1,275 735 Less: Imputed interest (63 ) (68 ) Total $ 1,212 $ 667 Supplemental balance sheet information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES Finance leases December 31, 2021 December 31, 2020 Finance lease right-of-use assets included within property and equipment, net $ 461 $ 1,301 Current finance lease liabilities included within other current liabilities $ 329 $ 556 Non-current finance lease liabilities included within other long-term liabilities 338 711 Total $ 667 $ 1,267 Total finance lease liabilities $ 667 $ 1,267 Operating leases December 31, 2021 December 31, 2020 Current operating lease liabilities included within other current liabilities $ 1,169 $ 1,485 Operating lease liabilities – non-current 43 1,476 Total $ 1,212 $ 2,961 Total operating lease liabilities $ 1,212 $ 2,961 The components of lease expense were as follows (in thousands): SUMMARY OF COMPONENTS OF LEASE EXPENSE 2021 2020 For the Year Ended December 31, 2021 2020 Operating lease costs included within operating costs and expenses $ 1,511 $ 2,428 Finance lease costs: Amortization of right of use assets $ 617 $ 698 Interest on lease liabilities 99 151 Total $ 716 $ 849 Supplemental cash flow information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES 2021 2020 For the Year Ended December 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash out flows from operating leases $ 1,596 $ 2,070 Operating cash out flows from finance leases $ 99 $ 151 Financing cash out flows from finance leases $ 555 $ 508 Lease liabilities arising from obtaining right-of-use assets: Operating leases $ 42 $ – Remeasurement of operating lease liability due to lease modification/termination $ 386 $ 154 As of December 31, 2021, the weighted average remaining operating lease term is 1.0 9.96 2.0 9.63 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS AND GOODWILL | 8. INTANGIBLE ASSETS AND GOODWILL In March 2022, the Company reached a non-binding understanding with an unrelated third party that contemplates the sale of IBEX and the real property used in the operation of IBEX. The potential sale is subject to a number of contingencies. Even though the proposed sale may not materialize, the Company is exploring its options with respect to IBEX, which is likely to result in curtailed operation of the business or some other disposition in 2022. For the year ended December 31, 2021, the Company performed an impairment review and concluded that goodwill and intangible assets were impaired. This resulted in the Company writing off the goodwill and intangible assets. Intangible assets, net, consist of the following (in thousands): SCHEDULE OF INTANGIBLE ASSETS December 31, 2021 December 31, 2020 Non-compete agreement $ – $ 410 Customer contracts and relationships – 534 Trade names and trademarks – 101 Backlog – 12 Total intangible assets, gross – 1,057 Accumulated amortization – (515 ) Total intangible assets, net $ – $ 542 Amortization expense for the years ended December 31, 2021 and December 31, 2020 was approximately $ 0.2 million for each period. Changes to goodwill during the year ended December 31, 2021 were as follows: SCHEDULE OF CHANGES GOODWILL Total Balance – December 31, 2020 $ 278 Impairment charge to goodwill (278 ) Balance – December 31, 2021 $ – |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES The following table presents the major components of accounts payable and accrued expenses (in thousands): SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES December 31, 2021 December 31, 2020 Accounts payable $ 173 $ 1,193 Salaries and other compensation 722 1,129 Legal and accounting 1,082 241 Accrued severance 111 330 Benefit plan accrual 102 659 Clinical trials 161 – Accrued offering costs 400 – Other 364 596 Total accounts payable and accrued expenses $ 3,115 $ 4,148 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 10. OTHER CURRENT LIABILITIES The following table presents the major components of other current liabilities (in thousands): SCHEDULE OF OTHER CURRENT LIABILITIES December 31, 2021 December 31, 2020 Current finance lease liabilities $ 329 $ 556 Current operating lease liabilities 1,169 1,485 Other 22 65 Total other current liabilities $ 1,520 $ 2,106 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | 11. STOCK-BASED COMPENSATION 2020, 2019 and 2017 Equity Incentive Plans 2020 Plan On October 25, 2019, the Company’s Board of Directors (the “Board”) approved the Company’s 2020 Stock Option and Incentive Plan (the “2020 Plan”). The 2020 Plan became effective on December 19, 2019, the date approved by the stockholders. The 2020 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, unrestricted stock awards, dividend equivalent rights, and cash-based awards to the Company’s employees, officers, directors, and consultants. The Board designated the Compensation Committee of the Board the administrator of the 2020 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 7,191,917 December 19, 2029 153,927 2019 Plan On October 5, 2018, the Company’s Board approved the Company’s 2019 Equity Incentive Plan (the “2019 Plan”). The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors, and consultants. The Board designated the Compensation Committee of the Board the administrator of the 2019 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 3,000,000 October 5, 2028 1,361 2017 Plan On December 1, 2016, the Company’s Board approved the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). The purpose of the 2017 Plan is to promote the success of the Company and to increase stockholder value by providing an additional means through the grant of awards to attract, motivate, retain and reward selected employees, consultants and other eligible persons. The 2017 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors, and consultants. The Board designated the Compensation Committee of the Board the administrator of the 2017 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 7,300,000 December 1, 2026 38,814 A summary of the Company’s employee and non-employee stock option activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY Number of Shares Weighted- Average Exercise Price Outstanding – December 31, 2020 4,794,567 $ 10.03 Granted 1,476,731 $ 1.25 Exercised (1) (2,500 ) $ 1.10 Forfeited (495,996 ) $ 8.63 Outstanding – December 31, 2021 5,772,802 $ 7.91 Options exercisable, December 31, 2021 4,734,311 $ 9.32 (1) The number of exercised options includes shares withheld on behalf of employees to satisfy minimum statutory tax withholding requirements. During the years ended December 31, 2021 and 2020, the estimated weighted-average grant-date fair value of options granted was $ 0.91 0 2.6 8.4 The aggregate intrinsic value of options outstanding and exercisable at December 31, 2021 was $ 0 6.15 0.3 1.5 Employee Stock Purchase Plan (ESPP) In May 2018, the Company adopted the Employee Stock Purchase Plan (“ESPP”). The Company has initially reserved 500,000 85 264,478 Stock-based compensation related to the ESPP for the years ended December 31, 2021 and 2020 was $ 40,000 64,000 101,900 0.54 0.1 97,445 0.76 0.1 Stock Options and ESPP Valuation The fair value of each option grant and ESPP purchase right is estimated on the date of grant using the Black-Scholes option-pricing model with the following range of assumptions: SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS For the Year Ended December 31, 2021 2020 Option grants Risk free annual interest rate 0.3 1.2 0.2 1.7 Expected volatility 97.9 104.7 94.3 100.9 Expected term of options (years) 4.6 4.7 4.4 4.6 Assumed dividends – – ESPP Risk free annual interest rate 0.1 0.2 0.2 1.6 Expected volatility 98.4 125.2 100.5 143.2 Expected term of options (years) 0.5 0.5 Assumed dividends – – Restricted Stock A summary of the Company’s employee and non-employee restricted stock activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY Number of shares Unvested - December 31, 2020 3,468,969 Granted 5,769,593 Vested (1) (3,480,366 ) Forfeited (594,511 ) Unvested – December 31, 2021 5,163,685 (1) The number of vested restricted stock units and awards includes shares that were withheld on behalf of employees to satisfy the minimum statutory tax withholding requirements. The weighted-average per share grant-date fair value of restricted stock granted during the years ended December 31, 2021 and 2020 was $ 0.73 1.18 4.7 9.0 As of December 31, 2021, there was approximately $ 1.3 2.3 Stock-Based Compensation Expense Total stock-based compensation expense related to stock options, restricted stock awards, and ESPP was as follows (in thousands): SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS For the Year Ended December 31, 2021 2020 General and administrative expense $ 4,097 $ 5,879 Research and development expense 1,146 943 Sales and marketing expense 357 436 Total stock-based compensation expense $ 5,600 $ 7,258 |
SALE OF COMMON STOCK, WARRANTS
SALE OF COMMON STOCK, WARRANTS AND PRE- FUNDED WARRANTS | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
SALE OF COMMON STOCK, WARRANTS AND PRE- FUNDED WARRANTS | 12. SALE OF COMMON STOCK, WARRANTS AND PRE- FUNDED WARRANTS On February 14, 2020, the Company completed an underwritten offering of 10,638,298 10,638,298 2.35 2.80 February 12, 2027 2.80 0.10 10,073,298 1.0 11.7 12.0 1.3 SCHEDULE FOR MEASUREMENT OF FAIR VALUE OF WARRANTS February 14, 2020 November 20, 2020 December 31, 2020 Stock price $ 1.69 $ 0.92 $ 0.68 Exercise price $ 2.80 $ 0.10 $ 0.10 Risk-free rate 1.51 % 0.53 % 0.52 % Volatility 93.4 % 99.4 % 98.9 % Remaining term (years) 7.0 6.2 6.1 On December 23, 2020, the Company completed a registered direct offering of 5,450,000 0.001 5,238,043 10,688,043 0.7485 0.7475 0.001 0.624 five years 641,283 125 0.9356 7.2 As the common stock warrants and placement agent common stock warrants could each require cash settlement in certain scenarios, the common stock warrants and placement agent common stock warrants were classified as liabilities upon issuance and were initially recorded at estimated fair values of $ 5.2 0.3 2.5 0.3 0.5 Accompanying common warrants: December 23, 2020 December 31, 2020 Stock price $ 0.65 $ 0.68 Exercise price $ 0.62 $ 0.62 Risk-free rate 0.38 % 0.36 % Volatility 99.7 % 96.2 % Remaining term (years) 5.0 5.0 Placement agent warrants: December 23, 2020 December 31, 2020 Stock price $ 0.65 $ 0.68 Exercise price $ 0.94 $ 0.94 Risk-free rate 0.38 % 0.36 % Volatility 99.7 % 96.2 % Remaining term (years) 5.0 5.0 The following table summarizes warrant activity for the year ended December 31, 2020. SUMMARY OF WARRANT ACTIVITY Transaction Outstanding December 31, 2019 Warrants Issued Warrants Exercised Outstanding December 31, 2020 February 14, 2020 common warrants - 10,638,298 10,073,298 565,000 December 23, 2020 common warrants - 10,688,043 – 10,688,043 December 23, 2020 placement agent warrants - 641,283 – 641,283 Total - 21,967,624 10,073,298 11,894,326 The Company measured the fair value of the liability-classified warrants issued during 2020 as of December 31, 2021 using the Monte Carlo simulation model using the following inputs: February 14, 2020 Warrants December 31, 2021 Stock price $ 0.59 Exercise price $ 0.10 Risk-free rate 1.27 % Volatility 102.0 % Remaining term (years) 5.1 December 23, 2020 Warrants December 31, 2021 Stock price $ 0.59 Exercise price $ 0.94 Risk-free rate 1.11 % Volatility 103.9 % Remaining term (years) 4.0 On January 14, 2021, the Company completed a registered direct offering of 6,670,000 0.001 2,420,910 9,090,910 1.10 1.099 0.001 1.20 five years 545,455 125 1.375 9.2 0.8 As the January 14 Warrants and placement agent common stock warrants could each require cash settlement in certain scenarios, the January 14 Warrants and placement agent common stock warrants were classified as liabilities upon issuance and were initially recorded at estimated fair values of $ 8.1 0.5 1.4 0.1 0.7 Accompanying common warrants: January 14, 2021 December 31, 2021 Stock price $ 1.21 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.49 % 1.12 % Volatility 100.1 % 103.0 % Remaining term (years) 5.0 4.0 Placement agent warrants: January 14, 2021 December 31, 2021 Stock price $ 1.21 $ 0.59 Exercise price $ 1.38 $ 1.38 Risk-free rate 0.49 % 1.12 % Volatility 99.3 % 103.0 % Remaining term (years) 5.0 4.0 On January 22, 2021, the Company entered into a letter agreement with the holder of warrants to exercise the warrants and purchase 10,688,043 shares of common stock at an exercise price of $ 0.624 per share that were issued to the holder in the registered direct offering that closed on December 23, 2020. Under the letter agreement the holder agreed to exercise the 10,688,043 warrants in full and the Company agreed to issue and sell to the holder common warrants to purchase up to 8,016,033 shares of the Company’s common stock, par value $ 0.001 per share, at a price of $ 0.125 (the “January 25 Warrants”). Each January 25 Warrant is exercisable for one share of Common Stock at an exercise price of $1.20 per share. The January 25 Warrants are immediately exercisable and will expire five years from the date of issuance . A holder may not exercise any portion of the January 25 Warrants to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election to a lower percentage at any time or to a higher percentage not to exceed 9.99% upon 61 days’ notice to the Company. The Company also issued to designees of the placement agent, warrants to purchase 6.0% of the aggregate number of common stock shares and pre-funded warrants sold in the offering (or warrants to purchase up to 480,962 shares of common stock). The placement agent warrants have substantially the same terms as the new warrants. The 10,688,043 warrants issued on December 23, 2020, were exercised on January 22, 2021, and closing of the offering occurred on January 25, 2021. The Company received gross proceeds of approximately $ 6.7 million from the exercise of the existing warrants and gross proceeds of approximately $ 1.0 million from the sale of the new warrants. Immediately prior to the exercise of the existing 10,688,043 3.6 January 22, 2021 Stock price $ 1.05 Exercise price $ 0.62 Risk-free rate 0.43 % Volatility 99.4 % Remaining term (years) 4.9 As the new January 25 Warrants and placement agent common stock warrants could each require cash settlement in certain scenarios, the new January 25 Warrants and placement agent common stock warrants were classified as liabilities upon issuance and were initially recorded at estimated fair values of $ 5.8 0.4 0.1 Accompanying new common stock warrants: January 25, 2021 December 31, 2021 Stock price $ 1.02 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.42 % 1.13 % Volatility 99.0 % 103.0 % Remaining term (years) 5.0 4.1 Placement agent warrants: January 22, 2021 December 31, 2021 Stock price $ 1.05 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.44 % 1.12 % Volatility 99.6 % 103.0 % Remaining term (years) 5.0 4.1 The following table summarizes warrant activity for the year ended December 31, 2021. Outstanding December 31, 2020 Warrants Issued Warrants Exercised Outstanding December 31, 2021 Transaction February 14, 2020 common warrants 565,000 – (25,500 ) 539,500 December 23, 2020 common warrants 10,688,043 – (10,688,043 ) – December 23, 2020 placement agent warrants 641,283 – – 641,283 December 23, 2020 pre-funded warrants 5,238,043 – (5,238,043 ) – January 14, 2021 common warrants – 9,090,910 – 9,090,910 January 14, 2021 placement agent warrants – 545,455 – 545,455 January 14, 2021 pre-funded warrants – 2,420,910 (2,420,910 ) – January 25, 2021 common warrants – 8,016,033 – 8,016,033 January 22, 2021 placement agent warrants – 480,962 – 480,962 Total 17,132,369 20,554,270 (18,372,496 ) 19,314,143 Pursuant to an Equity Purchase Agreement dated as of December 5, 2019 (the “Purchase Agreement”) that the Company entered into with Keystone Capital Partners, LLC (“Keystone”), Keystone agreed to purchase up to $ 25.0 On March 30, 2021, the Company entered into a sales agreement (“Sales Agreement”) with an investment banking firm to sell shares of common stock having aggregate sales proceeds of up to $ 50.0 million, from time to time, through an “at the market” equity offering program under which the investment banking firm would act as sales agent for a fee equal to 4% of gross proceeds sold in the offering with a minimum payment of $400,000 if the Sales Agreement was terminated within one year. As of December 31, 2021, no common stock had been sold. The Sales Agreement continues until the earlier of the date shares having aggregate sales proceeds of $ 50.0 million are sold or the date either party terminates the Sales Agreement by giving three days’ prior notice to the other party. On February 28, 2022, the Company exercised its right to terminate the Sales Agreement and was obligated to make a one-time payment to the investment banking firm of $400,000. See Note 21 for additional details. |
NET LOSS PER SHARE ATTRIBUTABLE
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS | 13. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS The following tables present reconciliations for the numerators and denominators of basic and diluted net loss per share: SCHEDULE OF EARNINGS PER SHARE, BASIC AND DILUTED Numerator: 2021 2020 For the Year Ended December 31, Numerator: 2021 2020 Net loss, primary $ (30,187 ) $ (42,854 ) Gain from change in fair value of warrant liabilities – 2,914 Net loss, diluted $ (30,187 ) $ (45,768 ) Numerator: 2021 2020 For the Year Ended December 31, Denominator: 2021 2020 Basic weighted average number of common shares (1) 80,014,014 38,779,316 Potentially dilutive effect of warrants – 588,074 Diluted weighted average number of common shares 80,014,014 39,367,390 (1) In December 2020 and January 2021, the Company sold pre-funded warrants to purchase up to 5,238,043 2,420,910 The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY For the Year Ended December 31, 2021 2020 Stock options 5,772,802 4,794,567 Restricted stock 5,163,685 3,468,969 Common stock warrants 19,314,143 – |
DEBT
DEBT | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
DEBT | 14. DEBT PPP Loan On April 12, 2020, our subsidiary PolarityTE MD, Inc. (the “Borrower”) entered into a promissory note evidencing an unsecured loan in the amount of $ 3,576,145 1.00 24 150,563 3.6 On September 17, 2021, the Company received notice from the Lender that the SBA is continuing to review the PPP Loan. As part of this review, the SBA requested documents that the Company is required to maintain but may not have been required to submit with its application for the PPP Loan. These documents included an affiliation worksheet showing the relationship between the Company and Borrower and affiliated subsidiaries, documents showing the use of the PPP Loan proceeds, documents showing the calculation of the loan amount requested in the Company’s loan application, federal tax returns, and documents showing employee compensation information. The Company submitted the documents to the SBA through the Lender on September 28, 2021. There has been no additional communication from the SBA as of December 31, 2021. |
RESTRUCTURING
RESTRUCTURING | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
RESTRUCTURING | 15. RESTRUCTURING In the second quarter of 2020, management approved several actions as part of a restructuring plan designed to improve operational efficiency and financial results. Management approved a reduction in force, which affected 40 of the 126 employees in the regenerative medicine business segment, or approximately 31.7% of that workforce. The Company did not make any change in the workforce of its contract services segment 1.0 1.5 In the fourth quarter of 2020, management recorded $ 0.9 0.4 As discussed in Note 6, the Company decided to file an IND in the second half of 2021, cease commercial sales of SkinTE by May 31, 2021, and wind down its SkinTE commercial operations. As a result, management approved several actions as part of a restructuring plan. Costs associated with the restructuring plan were included in restructuring and other charges on the consolidated statement of operations. The following table presents the components of incremental restructuring costs and gains associated with the cessation of commercial operations and wind down on SkinTE commercial operation (in thousands): SCHEDULE OF RESTRUCTURING COSTS AND GAINS Year Ended Year Ended December 31, 2021 December 31, 2020 Property and equipment impairment and disposal $ 425 $ 2,443 Employee severance and benefit arrangements 390 1,025 Modification of employee stock options 187 – Net gain on lease termination (1) (324 ) – Abandonment of ROU assets – 366 Net restructuring costs $ 678 $ 3,834 (1) During the second quarter of 2021 and effective June 30, 2021, the Company terminated a lease which included manufacturing, laboratory, and office space. The Company recorded a net gain on termination of $ 0.3 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 16. COMMITMENTS AND CONTINGENCIES Contingencies Securities Class Action and Derivative Lawsuits On September 24, 2021, a class action complaint alleging violations of the Federal securities laws was filed in the United States District Court, District of Utah, by Marc Richfield against the Company and certain officers of the Company, Case No. 2:21-cv-00561-BSJ. The Court subsequently appointed a Lead Plaintiff and ordered the Lead Plaintiff to file an amended Complaint by February 7, 2022, which was extended to February 21, 2022. The Lead Plaintiff filed an amended complaint on February 21, 2022, against the Company, two current officers of the Company, and three former officers of the Company (the “Complaint”). The Complaint alleges that during the period from January 30, 2018, through November 9, 2021, the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10(b) and 20(a) of the Securities and Exchange Act of 1934, as amended, and Rule 10b-5 adopted thereunder. Specifically, the Complaint alleges that the defendants misrepresented or failed to disclose that: (i) the Company’s product, SkinTE, was improperly registered as a 361 HCT/P under Section 361 of the Public Health Service Act and that, as a result, the Company’s ability to commercialize SkinTE as a 361 HCT/P was not sustainable because it was inevitable SkinTE would need to be registered under Section 351 of the Public Health Service Act; (ii) the Company characterized itself as a commercial stage company when it knew sales of SkinTE as a 361 HCT/P were unsustainable and that, as a result, it would need to file an IND and become a development stage company; (iii) issues arising from an FDA inspection of the Company’s facility in July 2018, were not resolved even though the Company stated they were resolved; and (iv) the IND for SkinTE was deficient with respect to certain chemistry, manufacturing, and control items, including items identified by the FDA in July 2018, and as a result it was unlikely that the FDA would approve the IND in the form it was originally filed. The Company believes the allegations in the Complaint are without merit, and intends to defend the litigation, vigorously. At this early stage of the proceedings, we are unable to make any prediction regarding the outcome of the litigation. On October 25, 2021, a stockholder derivative complaint alleging violations of the Federal securities laws was filed in the United States District Court, District of Utah, by Steven Battams against the Company, each member of the Board of directors, and two officers of the Company, Case No. 2:21-cv-00632-DBB (the “Stockholder Derivative Complaint”). The Stockholder Derivative Complaint alleges that the defendants made, or were responsible for, disseminating information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10(b) and 20(a) of the Securities and Exchange Act of 1934, as amended, and Rule 10b-5 adopted thereunder. Specifically, the Stockholder Derivative Complaint alleges that the defendants misrepresented or failed to disclose that: (i) the IND for the Company’s product, SkinTE, filed with the FDA was deficient with respect to certain chemistry, manufacturing, and control items; (ii) as a result, it was unlikely that the FDA would approve the IND in its current form; (iii) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) as a result, the public statements regarding the IND were materially false and misleading. The parties have stipulated to stay the Stockholder Derivative Complaint until (1) the dismissal of the Complaint described above, (2) denial of a motion to dismiss the Complaint, or (3) notice is given that any party is withdrawing its consent to the stipulated stay of the Stockholder Derivative Complaint proceeding. At this early stage of the proceedings the Company is unable to make any prediction regarding the outcome of the litigation. Other Matters In the ordinary course of business, the Company may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements, employment, regulatory compliance, and other matters. Except as noted above, at December 31, 2021, the Company was not party to any legal or arbitration proceedings that may have significant effects on its financial position or results of operations. No governmental proceedings are pending or, to the Company’s knowledge, contemplated against the Company. The Company is not a party to any material proceedings in which any director, member of senior management or affiliate of the Company’s is either a party adverse to the Company or its subsidiaries or has a material interest adverse to the Company or its subsidiaries. Commitments The Company has entered into employment agreements with key executives that contain severance terms and change of control provisions. On September 2, 2020, Arches Research, Inc., a subsidiary of PolarityTE, Inc. (“Arches”) entered into two agreements with Co-Diagnostics, Inc. (“Co-Diagnostics”). The COVID-19 Laboratory Services Agreement between the parties provided that Arches would perform specimen testing services for customers referred by Co-Diagnostics to Arches. Co-Diagnostics would arrange all logistics for delivering specimens to Arches for COVID-19 testing for those customers of Co-Diagnostics electing to use the service. Arches would bill Co-Diagnostics for the testing services and Co-Diagnostics would manage all customer billing. The Rental Agreement for LGC Genomics Oktopure Extraction Machine between Arches and Co-Diagnostics provided that Co-Diagnostics would make available to Arches the Oktopure high throughput extraction machine that Arches will use to perform COVID-19 testing. The term of the rental agreement was 12 3,300 On June 25, 2021, the Company entered into a statement of work with a contract research organization to provide services for a proposed clinical trial described as a multi-center, prospective, randomized controlled trial evaluating the effects of SkinTE in the treatment of full-thickness diabetic foot ulcers at a cost of approximately $ 6.5 3.1 3.4 1.4 5.1 0.5 0.4 |
CERTAIN RELATIONSHIPS AND RELAT
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 17. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS On August 21, 2019, the Company and Dr. Denver Lough, a principal shareholder and former officer and director, signed a settlement terms agreement that provides, in part, that the Company pay to Dr. Lough $ 1,500,000 1,500,000 200,000 0.8 In October 2018, the Company entered into an office lease covering approximately 7,250 The lease is for a term of three years 60 Initially the Company would occupy and pay for only 3,275 square feet of space, and the Company was not obligated under the lease to pay for the remaining 3,975 square feet covered by the lease unless it elected to occupy that additional space. The Company believes the terms of the lease were very favorable to it, and the Company obtained the favorable terms through the assistance of Peter A. Cohen, a director, which he provided so that the company he owns, Peter A. Cohen, LLC (“Cohen LLC”), could sublease a portion of the office space. The lease expired on October 31, 2021. 182,000 250,000 no |
SEGMENT REPORTING
SEGMENT REPORTING | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
SEGMENT REPORTING | 18. SEGMENT REPORTING Reportable segments are presented in a manner consistent with the internal reporting provided to the chief operating decision maker (CODM), the Chief Executive Officer of the Company. The CODM allocates resources to and assesses the performance of each segment using information about its revenue and operating income (loss). The Company’s operations involve products and services which are managed separately. Accordingly, it operates in two Certain information concerning the Company’s segments is presented in the following tables (in thousands): SCHEDULE OF SEGMENT INFORMATION 2021 2020 For the Year Ended December 31, 2021 2020 Net revenues: Reportable segments: Regenerative medicine products $ 3,076 $ 3,730 Contract services 6,328 6,396 Total net revenues $ 9,404 $ 10,126 Net income/(loss): Reportable segments: Regenerative medicine products $ (29,568 ) $ (42,815 ) Contract services (619 ) (39 ) Total net loss $ (30,187 ) $ (42,854 ) December 31, 2021 December 31, 2020 Identifiable assets employed: Reportable segments: Regenerative medicine products $ 25,344 $ 36,858 Contract services 5,834 8,652 Total assets $ 31,178 $ 45,510 |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLAN | 19. EMPLOYEE BENEFIT PLAN The Company’s 401(k) Plan is a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) Plan, participating employees (full-time employees with the Company for one year) may defer a portion of their pre-tax earnings, up to the IRS annual contribution limit ($ 19,500 3 0.3 0.2 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 20. INCOME TAXES The Company calculates its provision for federal and state income taxes based on current tax law. The provision (benefit) for income taxes consisted of the following (in thousands): SCHEDULE OF COMPONENTS OF INCOME TAX EXPENSE (BENEFIT) For the Year Ended December 31, 2021 2020 Current: Federal $ – $ – State – – Deferred: Federal (5,484 ) (593 ) State 605 (79 ) Change in valuation allowance 4,879 672 Total provision (benefit) for income taxes $ – $ – The difference between income taxes computed at the statutory federal rate and the provision for income taxes related to the following (in thousands, except percentages): SCHEDULE OF STATUTORY FEDERAL RATE AND PROVISION FOR INCOME TAX For the Year Ended December 31, 2021 2020 Amount Percent of Pretax Loss Amount Percent of Pretax Loss Tax (benefit) at federal statutory rate $ (6,340 ) 21 % $ (8,999 ) 21 % State income taxes, net of federal income taxes 605 (2 )% (79 ) – % Effect of warrant liability 215 (1 )% (209 ) 1 % Effect of other permanent items 16 – % 65 – % Effect of stock compensation 238 (1 )% 9,032 (21 )% Change in valuation allowance 4,879 (16 )% 672 (2 )% Other 387 (1 )% (482 ) 1 % $ – – % $ – – % The components of deferred income tax assets (liabilities) were as follows (in thousands): SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2021 2020 December 31, 2021 2020 Leases $ 17 $ 132 Depreciation and amortization (38 ) (784 ) Compensation expense not deductible until options are exercised 8,343 9,494 All other temporary differences 430 488 Net operating loss carry forwards 47,223 41,766 Less valuation allowance (55,975 ) (51,096 ) Deferred tax asset (liability) $ – $ – Realization of deferred tax assets, including those related to net operating loss carryforwards, are dependent upon future earnings, if any, of which the timing and amount are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. Based upon the Company’s current operating results management cannot conclude that it is more likely than not that such assets will be realized. Utilization of the net operating loss carryforwards may be subject to a substantial annual limitation due to the “change in ownership” provisions of the Internal Revenue Code. The annual limitation may result in the expiration of net operating loss carryforwards before utilization. The net operating loss carryforwards available for income tax purposes at December 31, 2021 amounts to approximately $ 185.8 38.4 expire between 2038 and 2039 147.4 195.7 expire starting in 2034 The Company files income tax returns in the U.S. and various states. As of December 31, 2021, the Company had no no |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 21. SUBSEQUENT EVENTS On March 30, 2021, the Company entered into a sales agreement (“Sales Agreement”) with an investment banking firm to sell shares of common stock having aggregate sales proceeds of up to $ 50.0 400,000 On March 16, 2022, the Company completed a registered direct offering of (i) 3,000.000435 shares of Series A Convertible Preferred Stock, par value $ 0.001 per share (“Series A”); (ii) 2,000.00029 shares of Series B Convertible Preferred Stock, par value $ 0.001 per share (“Series B,” and together with the Series A, the “Preferred Stock”); and (iii) warrants to purchase up to 16,393,445 shares of common stock (“Common Warrants”). The shares of Preferred Stock have a stated value of $ 1,000 per share and are convertible, following the date of the issuance thereof, into an aggregate of 9,836,067 shares of common stock of the Company upon the conversion of Series A and into an aggregate of 6,557,378 shares of common stock of the Company upon the conversion of Series B, at a conversion price of $ 0.305 per share each. Each Common Warrant has an exercise price of $ 0.35 per share and will become exercisable six months after the original issuance date and will expire two years following the original issuance. The Company issued to designees of the placement agent for the registered direct offering as part of the placement agent’s compensation warrants to purchase up to 819,672 shares of common stock at an exercise price of $ 0.38125 per share. The Company expects to realize net proceeds of approximately $ 4,485,000 from the offering after deducting offering expenses. On March 17, 2022, the holder of the Series B converted the shares to 6,557,378 shares of common stock of the Company. On March 29, 2022, the holder of the Series A converted the shares to 9,836,067 The investor in the forgoing offering is a holder of the January 14 Warrants and January 25 Warrants described in Note 12, above. Concurrent with the offering, the Company entered into a Warrant Amendment Agreement with the investor pursuant to which, in consideration for the investor’s purchase of $ 5 0.35 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Principles of Consolidation | Principles of Consolidation |
Use of estimates | Use of estimates |
Segments | Segments two |
Cash and cash equivalents | Cash and cash equivalents |
Accounts Receivable | Accounts Receivable 202,000 174,000 |
Inventory | Inventory 0.7 0.3 0.4 No |
Assets Held for Sale | Assets Held for Sale In November 2021, the Company committed to a plan to sell a variety of lab equipment within the regenerative medicine products reporting segment. The lab equipment has been designated as held for sale and is presented as such within the consolidated balance sheet as of December 31, 2021. |
Property and Equipment | Property and Equipment |
Leases | Leases The Company has lease agreements with lease and non-lease components. As allowed under ASC 842, the Company has elected not to separate lease and non-lease components for any leases involving real estate and office equipment classes of assets and, as a result, accounts for the lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement of ASC 842 to leases with a term of 12 months or less for all classes of assets. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill is tested for impairment at a reporting unit level by performing either a qualitative or quantitative analysis. The qualitative analysis is an assessment of factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then no further testing is necessary. If the Company concludes otherwise, a quantitative analysis is performed by comparing the fair value of a reporting unit to its carrying amount. If the fair value exceeds the carrying value, there is no impairment. If the fair value is less than the carrying value, an impairment charge is recorded for the difference between the fair value and the carrying value. For the year ended December 31, 2021, the Company performed a qualitative assessment and concluded that it is more likely than not that the fair value of the IBEX reporting unit was less than its carrying value which resulted in the Company also performing a quantitative analysis. The results of the quantitative analysis showed the carrying value of the reporting unit exceeding its fair value. Intangible assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, which generally range from one to eleven years. The useful life is the period over which the asset is expected to contribute directly, or indirectly, to its future cash flows. Intangible assets are reviewed for impairment when certain events or circumstances exist. For amortizable intangible assets, impairment exists when the undiscounted cash flows exceed its carrying value and an impairment charge would be recorded for the excess of the carrying value over its fair value. At least annually, the remaining useful life is evaluated. For the year ended December 31, 2021, the Company identified indicators of impairment which led the Company to perform an assessment that resulted in carrying values of the intangible assets exceeding the undiscounted cash flows. As a result of the goodwill and intangible assets impairment analyses, the Company determined that goodwill and intangible assets of the IBEX reporting unit were fully impaired and recorded impairment charges of $ 0.6 million for the year ended December 31, 2021 within the Company’s contract services business segment and are included in impairment of goodwill and intangible assets |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Offering Costs | Offering Costs |
Capitalized Software | Capitalized Software |
Revenue Recognition | Revenue Recognition The Company recorded product revenues primarily from the sale of SkinTE, its regenerative tissue products. When the Company marketed its SkinTE product, it was sold to healthcare providers (customers), primarily through direct sales representatives. Product revenues consisted of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognized product revenue upon delivery to the customer. In the contract services segment, the Company records service revenues from the sale of its preclinical research services, which includes delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date relative to the total costs expected to be required to satisfy the performance obligation. The Company believes that this method provides an appropriate measure of the transfer of services over the term of the performance obligation based on the remaining services needed to satisfy the obligation. This requires the Company to make reasonable estimates of the extent of progress toward completion of the contract. As a result, unbilled receivables and deferred revenue are recognized based on payment timing and work completed. Generally, a portion of the payment is due upfront and the remainder upon completion of the contract, with most contracts completing in less than a year. Contract services also includes research and laboratory testing services to unrelated third parties on a contract basis. Due to the short-term nature of the services, these customer contracts generally consist of a single performance obligation that the Company satisfies at a point in time. The Company satisfies the single performance obligation and recognizes revenue upon delivery of testing results to the customer. As of December 31, 2021 and 2020, the Company had unbilled receivables of $ 0.5 0.2 0.1 0.2 0.2 Any costs incurred to obtain a contract would be recognized as product is shipped. The Company considers a significant customer to be one that comprises more than 10% of net revenues or accounts receivable. Customers that accounted for 10% or more of net revenues were as follows: SCHEDULE OF CONCENTRATION RISK For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Segment % of Revenue % of Revenue Customer A Contract Services 20 % – % Customer B Regenerative Medicine Products 13 % 13 % Customer C Contract Services 18 % 41 % Customers that accounted for 10% or more of accounts receivable were as follows: December 31, 2021 December 31, 2020 Segment % of Accounts Receivable % of Accounts Receivable Customer A Contract Services 31 % – % Customer B Regenerative Medicine Products – % 14 % Customer C Contract Services – % 46 % Customer F Contract Services 17 % – % Customer G Contract Services 12 % – % The following table contains revenues as presented in the Consolidated Statements of Operations disaggregated by services and products. SCHEDULE OF REVENUE DISAGGREGATED BY SERVICES AND PRODUCTS For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Regenerative Medicine Products SkinTE Products $ 3,076 $ 3,730 Contract Services Lab Testing Services 1,877 4,454 Preclinical Research Services 4,451 1,942 6,328 6,396 Total Net Revenues $ 9,404 $ 10,126 |
Research and Development Expenses | Research and Development Expenses |
Accruals for Clinical Trials | Accruals for Clinical Trials |
Common Stock Warrant Liability | Common Stock Warrant Liability |
Stock-Based Compensation | Stock-Based Compensation The fair value for options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate is derived from the U.S. Treasury yield curve in effect at the time of the grant commensurate with the expected term of the option. The volatility factor is determined based on the Company’s historical stock prices. Forfeitures are recognized as they occur. The fair value of restricted stock grants is measured based on the fair market value of the Company’s common stock on the date of grant and recognized as compensation expense over the vesting period of, generally, six months to three years. |
Income Taxes | Income Taxes |
Net Loss Per Share | Net Loss Per Share 0.001 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326) Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40) |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SCHEDULE OF CONCENTRATION RISK | The Company considers a significant customer to be one that comprises more than 10% of net revenues or accounts receivable. Customers that accounted for 10% or more of net revenues were as follows: SCHEDULE OF CONCENTRATION RISK For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Segment % of Revenue % of Revenue Customer A Contract Services 20 % – % Customer B Regenerative Medicine Products 13 % 13 % Customer C Contract Services 18 % 41 % Customers that accounted for 10% or more of accounts receivable were as follows: December 31, 2021 December 31, 2020 Segment % of Accounts Receivable % of Accounts Receivable Customer A Contract Services 31 % – % Customer B Regenerative Medicine Products – % 14 % Customer C Contract Services – % 46 % Customer F Contract Services 17 % – % Customer G Contract Services 12 % – % |
SCHEDULE OF REVENUE DISAGGREGATED BY SERVICES AND PRODUCTS | The following table contains revenues as presented in the Consolidated Statements of Operations disaggregated by services and products. SCHEDULE OF REVENUE DISAGGREGATED BY SERVICES AND PRODUCTS For the Year Ended December 31, 2021 For the Year Ended December 31, 2020 Regenerative Medicine Products SkinTE Products $ 3,076 $ 3,730 Contract Services Lab Testing Services 1,877 4,454 Preclinical Research Services 4,451 1,942 6,328 6,396 Total Net Revenues $ 9,404 $ 10,126 |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS | The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands): SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS Level 1 Level 2 Level 3 Total December 31, 2021 Level 1 Level 2 Level 3 Total Liabilities Common stock warrant liability $ – $ – $ 6,844 $ 6,844 Total $ – $ – $ 6,844 $ 6,844 Level 1 Level 2 Level 3 Total December 31, 2020 Level 1 Level 2 Level 3 Total Liabilities Common stock warrant liability $ – $ – $ 5,975 $ 5,975 Total $ – $ – $ 5,975 $ 5,975 |
SCHEDULE OF FAIR VALUE OF LIABILITY CLASSIFIED COMMON STOCK WARRANTS | The following table presents the change in fair value of the liability classified common stock warrants for the year ended December 31, 2021 (in thousands): SCHEDULE OF FAIR VALUE OF LIABILITY CLASSIFIED COMMON STOCK WARRANTS Fair Value at December 31, 2020 Initial Fair Value at Issuance (Gain) Loss Upon Change in Fair Value Liability Reduction Due to Exercises Fair Value at December 31, 2021 Warrant liabilities February 14, 2020 issuance $ 328 $ – $ (37 ) $ – $ 291 December 23, 2020 issuance 5,647 – 3,556 (8,964 ) 239 January 14, 2021 issuance – 8,629 (5,284 ) – 3,345 January 25, 2021 issuance (1) (1) – 6,199 (3,230 ) – 2,969 Total $ 5,975 $ 14,828 $ (4,995 ) $ (8,964 ) $ 6,844 (1) Concurrent with the issuance of the January 25, 2021 warrants, upon the exercise of the December 23, 2020 warrants, an inducement loss of $ 5.2 6.2 1.0 million The following table presents the change in fair value of the liability classified common stock warrants for the year ended December 31, 2020 (in thousands): Initial Fair Value at Issuance Liability Reduction Due to Exercises (Gain) Loss Upon Change in Fair Value Fair Value at December 31, 2020 Warrant liabilities February 14, 2020 issuance $ 11,677 $ (8,265 ) $ (3,084 ) $ 328 December 23, 2020 issuance 5,477 – 170 5,647 Total $ 17,154 $ (8,265 ) $ (2,914 ) $ 5,975 |
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY | The Company uses the Monte Carlo valuation model to determine the fair value of the liability classified warrants issued during 2021 and 2020. Input assumptions for these freestanding instruments are as follows: SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY For the Year Ended December 31, 2021 Stock price $ 0.59 1.21 Exercise price $ 0.10 1.38 Risk-free rate 0.42 1.27 Volatility 99.0 103.9 Remaining term (years) 4.0 5.9 For the Year Ended December 31, 2020 Stock price $ 0.65 1.69 Exercise price $ 0.10 2.80 Risk-free rate 0.36 1.51 Volatility 93.4 99.7 Remaining term (years) 5.0 7.0 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses And Other Current Assets | |
SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS | The following table presents the major components of prepaid expenses and other current assets (in thousands): SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS December 31, 2021 December 31, 2020 Other current receivable $ 67 $ 306 Short term deposit 150 – Prepaid insurance 239 201 Prepaid expenses 445 485 Deferred offering costs 694 – Total prepaid expenses and other current assets $ 1,595 $ 992 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT, NET | The following table presents the components of property and equipment, net (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT, NET December 31, 2021 December 31, 2020 Machinery and equipment $ 8,502 $ 12,232 Land and buildings 2,000 2,000 Computers and software 1,129 1,240 Leasehold improvements 2,107 2,107 Construction in progress 133 87 Furniture and equipment 123 148 Total property and equipment, gross 13,994 17,814 Accumulated depreciation (7,071 ) (7,264 ) Total property and equipment, net $ 6,923 $ 10,550 |
SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE | Depreciation and amortization expense for property and equipment, including assets acquired under financing leases was as follows (in thousands): SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE 2021 2020 For the Year Ended December 31, 2021 2020 General and administrative expense $ 739 $ 1,533 Research and development expense 1,913 1,541 Total depreciation and amortization expense $ 2,652 $ 3,074 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES | As of December 31, 2021, the maturities of operating and finance lease liabilities were as follows (in thousands): SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES Year ending December 31: Operating leases Finance leases 2022 $ 1,185 $ 377 2023 48 316 2024 42 42 Total lease payments 1,275 735 Less: Imputed interest (63 ) (68 ) Total $ 1,212 $ 667 |
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES | Supplemental balance sheet information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES Finance leases December 31, 2021 December 31, 2020 Finance lease right-of-use assets included within property and equipment, net $ 461 $ 1,301 Current finance lease liabilities included within other current liabilities $ 329 $ 556 Non-current finance lease liabilities included within other long-term liabilities 338 711 Total $ 667 $ 1,267 Total finance lease liabilities $ 667 $ 1,267 Operating leases December 31, 2021 December 31, 2020 Current operating lease liabilities included within other current liabilities $ 1,169 $ 1,485 Operating lease liabilities – non-current 43 1,476 Total $ 1,212 $ 2,961 Total operating lease liabilities $ 1,212 $ 2,961 |
SUMMARY OF COMPONENTS OF LEASE EXPENSE | The components of lease expense were as follows (in thousands): SUMMARY OF COMPONENTS OF LEASE EXPENSE 2021 2020 For the Year Ended December 31, 2021 2020 Operating lease costs included within operating costs and expenses $ 1,511 $ 2,428 Finance lease costs: Amortization of right of use assets $ 617 $ 698 Interest on lease liabilities 99 151 Total $ 716 $ 849 |
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES | Supplemental cash flow information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES 2021 2020 For the Year Ended December 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash out flows from operating leases $ 1,596 $ 2,070 Operating cash out flows from finance leases $ 99 $ 151 Financing cash out flows from finance leases $ 555 $ 508 Lease liabilities arising from obtaining right-of-use assets: Operating leases $ 42 $ – Remeasurement of operating lease liability due to lease modification/termination $ 386 $ 154 |
INTANGIBLE ASSETS AND GOODWILL
INTANGIBLE ASSETS AND GOODWILL (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF INTANGIBLE ASSETS | Intangible assets, net, consist of the following (in thousands): SCHEDULE OF INTANGIBLE ASSETS December 31, 2021 December 31, 2020 Non-compete agreement $ – $ 410 Customer contracts and relationships – 534 Trade names and trademarks – 101 Backlog – 12 Total intangible assets, gross – 1,057 Accumulated amortization – (515 ) Total intangible assets, net $ – $ 542 |
SCHEDULE OF CHANGES GOODWILL | Changes to goodwill during the year ended December 31, 2021 were as follows: SCHEDULE OF CHANGES GOODWILL Total Balance – December 31, 2020 $ 278 Impairment charge to goodwill (278 ) Balance – December 31, 2021 $ – |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES | The following table presents the major components of accounts payable and accrued expenses (in thousands): SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES December 31, 2021 December 31, 2020 Accounts payable $ 173 $ 1,193 Salaries and other compensation 722 1,129 Legal and accounting 1,082 241 Accrued severance 111 330 Benefit plan accrual 102 659 Clinical trials 161 – Accrued offering costs 400 – Other 364 596 Total accounts payable and accrued expenses $ 3,115 $ 4,148 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Other Liabilities Disclosure [Abstract] | |
SCHEDULE OF OTHER CURRENT LIABILITIES | The following table presents the major components of other current liabilities (in thousands): SCHEDULE OF OTHER CURRENT LIABILITIES December 31, 2021 December 31, 2020 Current finance lease liabilities $ 329 $ 556 Current operating lease liabilities 1,169 1,485 Other 22 65 Total other current liabilities $ 1,520 $ 2,106 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY | A summary of the Company’s employee and non-employee stock option activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY Number of Shares Weighted- Average Exercise Price Outstanding – December 31, 2020 4,794,567 $ 10.03 Granted 1,476,731 $ 1.25 Exercised (1) (2,500 ) $ 1.10 Forfeited (495,996 ) $ 8.63 Outstanding – December 31, 2021 5,772,802 $ 7.91 Options exercisable, December 31, 2021 4,734,311 $ 9.32 (1) The number of exercised options includes shares withheld on behalf of employees to satisfy minimum statutory tax withholding requirements. |
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS | The fair value of each option grant and ESPP purchase right is estimated on the date of grant using the Black-Scholes option-pricing model with the following range of assumptions: SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS For the Year Ended December 31, 2021 2020 Option grants Risk free annual interest rate 0.3 1.2 0.2 1.7 Expected volatility 97.9 104.7 94.3 100.9 Expected term of options (years) 4.6 4.7 4.4 4.6 Assumed dividends – – ESPP Risk free annual interest rate 0.1 0.2 0.2 1.6 Expected volatility 98.4 125.2 100.5 143.2 Expected term of options (years) 0.5 0.5 Assumed dividends – – |
SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY | A summary of the Company’s employee and non-employee restricted stock activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY Number of shares Unvested - December 31, 2020 3,468,969 Granted 5,769,593 Vested (1) (3,480,366 ) Forfeited (594,511 ) Unvested – December 31, 2021 5,163,685 (1) The number of vested restricted stock units and awards includes shares that were withheld on behalf of employees to satisfy the minimum statutory tax withholding requirements. |
SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS | Total stock-based compensation expense related to stock options, restricted stock awards, and ESPP was as follows (in thousands): SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS For the Year Ended December 31, 2021 2020 General and administrative expense $ 4,097 $ 5,879 Research and development expense 1,146 943 Sales and marketing expense 357 436 Total stock-based compensation expense $ 5,600 $ 7,258 |
SALE OF COMMON STOCK, WARRANT_2
SALE OF COMMON STOCK, WARRANTS AND PRE- FUNDED WARRANTS (Tables) - Monte Carlo Simulation Model [Member] | 12 Months Ended |
Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
SCHEDULE FOR MEASUREMENT OF FAIR VALUE OF WARRANTS | SCHEDULE FOR MEASUREMENT OF FAIR VALUE OF WARRANTS February 14, 2020 November 20, 2020 December 31, 2020 Stock price $ 1.69 $ 0.92 $ 0.68 Exercise price $ 2.80 $ 0.10 $ 0.10 Risk-free rate 1.51 % 0.53 % 0.52 % Volatility 93.4 % 99.4 % 98.9 % Remaining term (years) 7.0 6.2 6.1 Accompanying common warrants: December 23, 2020 December 31, 2020 Stock price $ 0.65 $ 0.68 Exercise price $ 0.62 $ 0.62 Risk-free rate 0.38 % 0.36 % Volatility 99.7 % 96.2 % Remaining term (years) 5.0 5.0 Placement agent warrants: December 23, 2020 December 31, 2020 Stock price $ 0.65 $ 0.68 Exercise price $ 0.94 $ 0.94 Risk-free rate 0.38 % 0.36 % Volatility 99.7 % 96.2 % Remaining term (years) 5.0 5.0 The Company measured the fair value of the liability-classified warrants issued during 2020 as of December 31, 2021 using the Monte Carlo simulation model using the following inputs: February 14, 2020 Warrants December 31, 2021 Stock price $ 0.59 Exercise price $ 0.10 Risk-free rate 1.27 % Volatility 102.0 % Remaining term (years) 5.1 December 23, 2020 Warrants December 31, 2021 Stock price $ 0.59 Exercise price $ 0.94 Risk-free rate 1.11 % Volatility 103.9 % Remaining term (years) 4.0 Accompanying common warrants: January 14, 2021 December 31, 2021 Stock price $ 1.21 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.49 % 1.12 % Volatility 100.1 % 103.0 % Remaining term (years) 5.0 4.0 Placement agent warrants: January 14, 2021 December 31, 2021 Stock price $ 1.21 $ 0.59 Exercise price $ 1.38 $ 1.38 Risk-free rate 0.49 % 1.12 % Volatility 99.3 % 103.0 % Remaining term (years) 5.0 4.0 January 22, 2021 Stock price $ 1.05 Exercise price $ 0.62 Risk-free rate 0.43 % Volatility 99.4 % Remaining term (years) 4.9 Accompanying new common stock warrants: January 25, 2021 December 31, 2021 Stock price $ 1.02 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.42 % 1.13 % Volatility 99.0 % 103.0 % Remaining term (years) 5.0 4.1 Placement agent warrants: January 22, 2021 December 31, 2021 Stock price $ 1.05 $ 0.59 Exercise price $ 1.20 $ 1.20 Risk-free rate 0.44 % 1.12 % Volatility 99.6 % 103.0 % Remaining term (years) 5.0 4.1 |
SUMMARY OF WARRANT ACTIVITY | The following table summarizes warrant activity for the year ended December 31, 2020. SUMMARY OF WARRANT ACTIVITY Transaction Outstanding December 31, 2019 Warrants Issued Warrants Exercised Outstanding December 31, 2020 February 14, 2020 common warrants - 10,638,298 10,073,298 565,000 December 23, 2020 common warrants - 10,688,043 – 10,688,043 December 23, 2020 placement agent warrants - 641,283 – 641,283 Total - 21,967,624 10,073,298 11,894,326 The following table summarizes warrant activity for the year ended December 31, 2021. Outstanding December 31, 2020 Warrants Issued Warrants Exercised Outstanding December 31, 2021 Transaction February 14, 2020 common warrants 565,000 – (25,500 ) 539,500 December 23, 2020 common warrants 10,688,043 – (10,688,043 ) – December 23, 2020 placement agent warrants 641,283 – – 641,283 December 23, 2020 pre-funded warrants 5,238,043 – (5,238,043 ) – January 14, 2021 common warrants – 9,090,910 – 9,090,910 January 14, 2021 placement agent warrants – 545,455 – 545,455 January 14, 2021 pre-funded warrants – 2,420,910 (2,420,910 ) – January 25, 2021 common warrants – 8,016,033 – 8,016,033 January 22, 2021 placement agent warrants – 480,962 – 480,962 Total 17,132,369 20,554,270 (18,372,496 ) 19,314,143 |
NET LOSS PER SHARE ATTRIBUTAB_2
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF EARNINGS PER SHARE, BASIC AND DILUTED | The following tables present reconciliations for the numerators and denominators of basic and diluted net loss per share: SCHEDULE OF EARNINGS PER SHARE, BASIC AND DILUTED Numerator: 2021 2020 For the Year Ended December 31, Numerator: 2021 2020 Net loss, primary $ (30,187 ) $ (42,854 ) Gain from change in fair value of warrant liabilities – 2,914 Net loss, diluted $ (30,187 ) $ (45,768 ) Numerator: 2021 2020 For the Year Ended December 31, Denominator: 2021 2020 Basic weighted average number of common shares (1) 80,014,014 38,779,316 Potentially dilutive effect of warrants – 588,074 Diluted weighted average number of common shares 80,014,014 39,367,390 (1) In December 2020 and January 2021, the Company sold pre-funded warrants to purchase up to 5,238,043 2,420,910 |
SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY | The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY For the Year Ended December 31, 2021 2020 Stock options 5,772,802 4,794,567 Restricted stock 5,163,685 3,468,969 Common stock warrants 19,314,143 – |
RESTRUCTURING (Tables)
RESTRUCTURING (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
SCHEDULE OF RESTRUCTURING COSTS AND GAINS | The following table presents the components of incremental restructuring costs and gains associated with the cessation of commercial operations and wind down on SkinTE commercial operation (in thousands): SCHEDULE OF RESTRUCTURING COSTS AND GAINS Year Ended Year Ended December 31, 2021 December 31, 2020 Property and equipment impairment and disposal $ 425 $ 2,443 Employee severance and benefit arrangements 390 1,025 Modification of employee stock options 187 – Net gain on lease termination (1) (324 ) – Abandonment of ROU assets – 366 Net restructuring costs $ 678 $ 3,834 (1) During the second quarter of 2021 and effective June 30, 2021, the Company terminated a lease which included manufacturing, laboratory, and office space. The Company recorded a net gain on termination of $ 0.3 |
SEGMENT REPORTING (Tables)
SEGMENT REPORTING (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
SCHEDULE OF SEGMENT INFORMATION | Certain information concerning the Company’s segments is presented in the following tables (in thousands): SCHEDULE OF SEGMENT INFORMATION 2021 2020 For the Year Ended December 31, 2021 2020 Net revenues: Reportable segments: Regenerative medicine products $ 3,076 $ 3,730 Contract services 6,328 6,396 Total net revenues $ 9,404 $ 10,126 Net income/(loss): Reportable segments: Regenerative medicine products $ (29,568 ) $ (42,815 ) Contract services (619 ) (39 ) Total net loss $ (30,187 ) $ (42,854 ) December 31, 2021 December 31, 2020 Identifiable assets employed: Reportable segments: Regenerative medicine products $ 25,344 $ 36,858 Contract services 5,834 8,652 Total assets $ 31,178 $ 45,510 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF COMPONENTS OF INCOME TAX EXPENSE (BENEFIT) | The Company calculates its provision for federal and state income taxes based on current tax law. The provision (benefit) for income taxes consisted of the following (in thousands): SCHEDULE OF COMPONENTS OF INCOME TAX EXPENSE (BENEFIT) For the Year Ended December 31, 2021 2020 Current: Federal $ – $ – State – – Deferred: Federal (5,484 ) (593 ) State 605 (79 ) Change in valuation allowance 4,879 672 Total provision (benefit) for income taxes $ – $ – |
SCHEDULE OF STATUTORY FEDERAL RATE AND PROVISION FOR INCOME TAX | The difference between income taxes computed at the statutory federal rate and the provision for income taxes related to the following (in thousands, except percentages): SCHEDULE OF STATUTORY FEDERAL RATE AND PROVISION FOR INCOME TAX For the Year Ended December 31, 2021 2020 Amount Percent of Pretax Loss Amount Percent of Pretax Loss Tax (benefit) at federal statutory rate $ (6,340 ) 21 % $ (8,999 ) 21 % State income taxes, net of federal income taxes 605 (2 )% (79 ) – % Effect of warrant liability 215 (1 )% (209 ) 1 % Effect of other permanent items 16 – % 65 – % Effect of stock compensation 238 (1 )% 9,032 (21 )% Change in valuation allowance 4,879 (16 )% 672 (2 )% Other 387 (1 )% (482 ) 1 % $ – – % $ – – % |
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES | The components of deferred income tax assets (liabilities) were as follows (in thousands): SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES 2021 2020 December 31, 2021 2020 Leases $ 17 $ 132 Depreciation and amortization (38 ) (784 ) Compensation expense not deductible until options are exercised 8,343 9,494 All other temporary differences 430 488 Net operating loss carry forwards 47,223 41,766 Less valuation allowance (55,975 ) (51,096 ) Deferred tax asset (liability) $ – $ – |
SCHEDULE OF CONCENTRATION RISK
SCHEDULE OF CONCENTRATION RISK (Details) - Customer Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Customer A [Member] | Revenue Benchmark [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 20.00% | |
Customer A [Member] | Accounts Receivable [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 31.00% | |
Customer B [Member] | Revenue Benchmark [Member] | Regenerative Medicine [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 13.00% | 13.00% |
Customer B [Member] | Accounts Receivable [Member] | Regenerative Medicine [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 14.00% | |
Customer C [Member] | Revenue Benchmark [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 18.00% | 41.00% |
Customer C [Member] | Accounts Receivable [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 46.00% | |
Customer F [Member] | Accounts Receivable [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 17.00% | |
Customer G [Member] | Accounts Receivable [Member] | Contract Services [Member] | ||
Product Information [Line Items] | ||
Concentration risk percentage | 12.00% |
SCHEDULE OF REVENUE DISAGGREGAT
SCHEDULE OF REVENUE DISAGGREGATED BY SERVICES AND PRODUCTS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Product Information [Line Items] | ||
Total Net Revenues | $ 9,404 | $ 10,126 |
Product [Member] | ||
Product Information [Line Items] | ||
Total Net Revenues | 3,076 | 3,730 |
Lab Testing Services [Member] | ||
Product Information [Line Items] | ||
Total Net Revenues | 1,877 | 4,454 |
Preclinical Research Services [Member] | ||
Product Information [Line Items] | ||
Total Net Revenues | 4,451 | 1,942 |
Service [Member] | ||
Product Information [Line Items] | ||
Total Net Revenues | $ 6,328 | $ 6,396 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 12 Months Ended | |||||
Dec. 31, 2021USD ($)Segments$ / shares | Dec. 31, 2020USD ($) | Jan. 14, 2021$ / shares | Nov. 20, 2020$ / shares | Nov. 19, 2020$ / shares | Feb. 14, 2020$ / shares | |
Number of operating segment | Segments | 2 | |||||
Allowance doubtful debts | $ 202,000 | $ 174,000 | ||||
Inventory write-offs | 747,000 | |||||
Research and development and cost of sales | 300,000 | |||||
Inventory valuation reserves | 0 | 0 | ||||
Asset Impairment Charges | 425,000 | 2,443,000 | ||||
Unbilled receivables | 500,000 | 200,000 | ||||
Deferred revenue | 100,000 | $ 200,000 | ||||
Deferred revenue, revenue recognized | $ 200,000 | |||||
Class of warrant right exercise price | $ / shares | $ 0.10 | $ 2.80 | $ 2.80 | |||
Pre-funded Warrants [Member] | ||||||
Class of warrant right exercise price | $ / shares | $ 0.001 | $ 1.375 | ||||
Cost of Sales [Member] | ||||||
Research and development and cost of sales | $ 400,000 | |||||
General and Administrative Expense [Member] | ||||||
Asset Impairment Charges | $ 600,000 |
LIQUIDITY AND GOING CONCERN (De
LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Liquidity And Going Concern | ||
Retained Earnings (Accumulated Deficit) | $ 508,398 | $ 478,211 |
Cash and Cash Equivalents, at Carrying Value | $ 19,375 | $ 25,522 |
SCHEDULE OF FAIR VALUE OF FINAN
SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 6,844 | $ 5,975 |
Common Stock Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 6,844 | 5,975 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | ||
Fair Value, Inputs, Level 1 [Member] | Common Stock Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | ||
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | ||
Fair Value, Inputs, Level 2 [Member] | Common Stock Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | ||
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 6,844 | 5,975 |
Fair Value, Inputs, Level 3 [Member] | Common Stock Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 6,844 | $ 5,975 |
SCHEDULE OF FAIR VALUE OF LIABI
SCHEDULE OF FAIR VALUE OF LIABILITY CLASSIFIED COMMON STOCK WARRANTS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair Value, beginning | $ 5,975 | ||
Initial Fair Value at Issuance | 14,828 | $ 17,154 | |
(Gain) Loss Upon Change in Fair Value | (4,995) | (2,914) | |
Liability Reduction Due to Exercises | (8,964) | (8,265) | |
Fair Value, ending | 6,844 | 5,975 | |
February 14, 2020 Issuance [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair Value, beginning | 328 | ||
Initial Fair Value at Issuance | 11,677 | ||
(Gain) Loss Upon Change in Fair Value | (37) | (3,084) | |
Liability Reduction Due to Exercises | (8,265) | ||
Fair Value, ending | 291 | 328 | |
December 23, 2020 Issuance [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair Value, beginning | 5,647 | ||
Initial Fair Value at Issuance | 5,477 | ||
(Gain) Loss Upon Change in Fair Value | 3,556 | 170 | |
Liability Reduction Due to Exercises | (8,964) | ||
Fair Value, ending | 239 | 5,647 | |
January 14, 2021 Issuance [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair Value, beginning | |||
Initial Fair Value at Issuance | 8,629 | ||
(Gain) Loss Upon Change in Fair Value | (5,284) | ||
Liability Reduction Due to Exercises | |||
Fair Value, ending | 3,345 | ||
January 25, 2021 Issuance [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair Value, beginning | [1] | ||
Initial Fair Value at Issuance | [1] | 6,199 | |
(Gain) Loss Upon Change in Fair Value | [1] | (3,230) | |
Liability Reduction Due to Exercises | [1] | ||
Fair Value, ending | [1] | $ 2,969 | |
[1] | Concurrent with the issuance of the January 25, 2021 warrants, upon the exercise of the December 23, 2020 warrants, an inducement loss of $ 5.2 6.2 |
SCHEDULE OF FAIR VALUE OF LIA_2
SCHEDULE OF FAIR VALUE OF LIABILITY CLASSIFIED COMMON STOCK WARRANTS (Details) (Parenthetical) $ in Millions | Jan. 25, 2021USD ($) |
Fair Value Disclosures [Abstract] | |
Issuance of Stock and Warrants for Services or Claims | $ 5.2 |
Fair value of warrants liability | 6.2 |
Proceeds from Issuance of Warrants | $ 1 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Share price | $ 0.59 | $ 0.65 |
Exercise price | $ 0.10 | $ 0.10 |
Risk-free rate | 0.42% | 0.36% |
Volatility rate | 99.00% | 93.40% |
Remaining term (years) | 4 years | 5 years |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Share price | $ 1.21 | $ 1.69 |
Exercise price | $ 1.38 | $ 2.80 |
Risk-free rate | 1.27% | 1.51% |
Volatility rate | 103.90% | 99.70% |
Remaining term (years) | 5 years 10 months 24 days | 7 years |
FAIR VALUE (Details Narrative)
FAIR VALUE (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | ||
Definite-lived intangible assets | $ 630 | |
Impairment charges, property plant and equipment | $ 400 |
SCHEDULE OF PREPAID EXPENSE AND
SCHEDULE OF PREPAID EXPENSE AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expenses And Other Current Assets | ||
Other current receivable | $ 67 | $ 306 |
Short term deposit | 150 | |
Prepaid insurance | 239 | 201 |
Prepaid expenses | 445 | 485 |
Deferred offering costs | 694 | |
Total prepaid expenses and other current assets | $ 1,595 | $ 992 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT, NET (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Abstract] | ||
Machinery and equipment | $ 8,502 | $ 12,232 |
Land and buildings | 2,000 | 2,000 |
Computers and software | 1,129 | 1,240 |
Leasehold improvements | 2,107 | 2,107 |
Construction in progress | 133 | 87 |
Furniture and equipment | 123 | 148 |
Total property and equipment, gross | 13,994 | 17,814 |
Accumulated depreciation | (7,071) | (7,264) |
Total property and equipment, net | $ 6,923 | $ 10,550 |
SCHEDULE OF DEPRECIATION AND AM
SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||
Total depreciation and amortization expense | $ 2,652 | $ 3,074 |
General and Administrative Expense [Member] | ||
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||
Total depreciation and amortization expense | 739 | 1,533 |
Research and Development Expense [Member] | ||
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||
Total depreciation and amortization expense | $ 1,913 | $ 1,541 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Asset impairment charges | $ 425,000 | $ 2,443,000 |
Other asset impairment charges | 0 | |
Commercial Property and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Asset impairment charges | $ 400,000 |
SCHEDULE OF OPERATING AND FINAN
SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases | ||
Operating leases 2022 | $ 1,185 | |
Finance leases 2022 | 377 | |
Operating leases 2023 | 48 | |
Finance leases 2023 | 316 | |
Operating leases 2024 | 42 | |
Finance leases 2024 | 42 | |
Total Operating lease payments | 1,275 | |
Total Finance lease payments | 735 | |
Less: Operating leases Imputed interest | (63) | |
Less: Finance leases Imputed interest | (68) | |
Total Operating leases | 1,212 | $ 2,961 |
Total Finance leases | $ 667 | $ 1,267 |
SCHEDULE OF SUPPLEMENTAL BALANC
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases | ||
Finance lease right-of-use assets included within property and equipment, net | $ 461 | $ 1,301 |
Current finance lease liabilities included within other current liabilities | 329 | 556 |
Non-current finance lease liabilities included within other long-term liabilities | 338 | 711 |
Total finance lease liabilities | 667 | 1,267 |
Current operating lease liabilities included within other current liabilities | 1,169 | 1,485 |
Operating lease liabilities – non-current | 43 | 1,476 |
Total operating lease liabilities | $ 1,212 | $ 2,961 |
SUMMARY OF COMPONENTS OF LEASE
SUMMARY OF COMPONENTS OF LEASE EXPENSE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases | ||
Operating lease costs included within operating costs and expenses | $ 1,511 | $ 2,428 |
Amortization of right of use assets | 617 | 698 |
Interest on lease liabilities | 99 | 151 |
Total | $ 716 | $ 849 |
SCHEDULE OF SUPPLEMENTAL CASH F
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases | ||
Operating cash out flows from operating leases | $ 1,596 | $ 2,070 |
Operating cash out flows from finance leases | 99 | 151 |
Financing cash out flows from finance leases | 555 | 508 |
Operating leases | 42 | |
Remeasurement of operating lease liability due to lease modification/termination | $ 386 | $ 154 |
LEASES (Details Narrative)
LEASES (Details Narrative) | Jul. 15, 2018USD ($)ft² | Dec. 27, 2017USD ($)ft² | Nov. 30, 2021USD ($) | Apr. 30, 2019USD ($)ft² | Dec. 31, 2021USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | ||
Area of land | ft² | 6,307 | |||||||||
Lease renewal description | The lease provided for monthly lease payments subject to annual increases and had an expiration date in April 2024 | |||||||||
Carry value of assets to be disposed | $ 1,200,000 | $ 0 | ||||||||
Net gain on lease termination | $ 300,000 | $ 324,000 | [1] | [1] | ||||||
Financing lease, incremental borrowing rate | 10.00% | 10.00% | ||||||||
Operating lease, weighted average remaining lease term | 1 year | 1 year | ||||||||
Operating lease, weighted average discount rate, percent | 9.96% | 9.96% | ||||||||
Finance lease, weighted average remaining lease term | 2 years | 2 years | ||||||||
Finance lease, weighted average discount rate, percent | 9.63% | 9.63% | ||||||||
Regenerative Medicine [Member] | General and Administrative Expense [Member] | ||||||||||
Charges on abandonment of finance lease right of use assets | $ 200,000 | |||||||||
Minimum [Member] | ||||||||||
Lessee, operating lease, remaining lease term | 3 months | 3 months | ||||||||
Maximum [Member] | ||||||||||
Lessee, operating lease, remaining lease term | 28 months | 28 months | ||||||||
Pacific Office Automation Inc [Member] | ||||||||||
Lease term | 3 years | |||||||||
Rent description | The initial base rent under this lease is $3,983 per month for the entire lease term and includes a cash incentive of $0.1 million | |||||||||
Base rental | $ 3,983 | |||||||||
Incremental borrowing rate | 7.42% | |||||||||
Lease expiration date | 2024-11 | |||||||||
Incentive fee | $ 100,000 | |||||||||
Commercial Lease Agreement [Member] | Adcomp LLC [Member] | ||||||||||
Area of land | ft² | 178,528 | |||||||||
Lease term | 5 years | |||||||||
Lease expiration date | Nov. 30, 2022 | |||||||||
Lease renewal description | The Company has a one-time option to renew for an additional five years | |||||||||
Rent description | The initial base rent under this lease is $98,190 per month ($0.55 per sq. ft.) for the first year of the initial lease term and increases 3.0% per annum thereafter | |||||||||
Base rental | $ 98,190 | |||||||||
Increase in rental rate | 3.00% | |||||||||
Incremental borrowing rate | 10.00% | |||||||||
Commercial Lease Agreement [Member] | Salt Lake City Corporation [Member] | ||||||||||
Area of land | ft² | 44,695 | |||||||||
Lease term | 2 years | |||||||||
Lease renewal description | the option to extend the term for an additional five years by agreement of the parties | |||||||||
Base rental | $ 39,108 | |||||||||
Increase in rental rate | 3.00% | |||||||||
Incremental borrowing rate | 9.00% | |||||||||
[1] | During the second quarter of 2021 and effective June 30, 2021, the Company terminated a lease which included manufacturing, laboratory, and office space. The Company recorded a net gain on termination of $ 0.3 |
SCHEDULE OF INTANGIBLE ASSETS (
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets [Line Items] | ||
Total intangible assets, gross | $ 1,057 | |
Accumulated amortization | (515) | |
Total intangible assets, net | 542 | |
Noncompete Agreements [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total intangible assets, gross | 410 | |
Customer Contracts and Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total intangible assets, gross | 534 | |
Trademarks and Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total intangible assets, gross | 101 | |
Backlog [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total intangible assets, gross | $ 12 |
SCHEDULE OF CHANGES GOODWILL (D
SCHEDULE OF CHANGES GOODWILL (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Balance – December 31, 2020 | $ 278 |
Impairment charge to goodwill | (278) |
Balance – December 31, 2021 |
INTANGIBLE ASSETS AND GOODWIL_2
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of Intangible Assets | $ 190 | $ 189 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 173 | $ 1,193 |
Salaries and other compensation | 722 | 1,129 |
Legal and accounting | 1,082 | 241 |
Accrued severance | 111 | 330 |
Benefit plan accrual | 102 | 659 |
Clinical trials | 161 | |
Accrued offering costs | 400 | |
Other | 364 | 596 |
Total accounts payable and accrued expenses | $ 3,115 | $ 4,148 |
SCHEDULE OF OTHER CURRENT LIABI
SCHEDULE OF OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Current finance lease liabilities | $ 329 | $ 556 |
Current operating lease liabilities | 1,169 | 1,485 |
Other | 22 | 65 |
Total other current liabilities | $ 1,520 | $ 2,106 |
SCHEDULE OF SHARE-BASED COMPENS
SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Option Indexed to Issuer's Equity [Line Items] | |||
Weighted Average Exercise Price, Granted | $ 0.91 | $ 0.91 | |
Employee and Non Employee Stock Option [Member] | |||
Option Indexed to Issuer's Equity [Line Items] | |||
Number of Shares, Outstanding at beginning of period | 4,794,567 | ||
Weighted Average Exercise Price, Outstanding at beginning of period | $ 10.03 | ||
Number of Shares, Granted | 1,476,731 | ||
Weighted Average Exercise Price, Granted | $ 1.25 | ||
Number of Shares, Exercised | [1] | (2,500) | |
Weighted Average Exercise Price, Exercised | [1] | $ 1.10 | |
Number of Shares, Forfeited | (495,996) | ||
Weighted Average Exercise Price, Forfeited | $ 8.63 | ||
Number of Shares, Outstanding at end of period | 5,772,802 | 4,794,567 | |
Weighted Average Exercise Price, Outstanding at end of period | $ 7.91 | $ 10.03 | |
Number of Shares, Options exercisable | 4,734,311 | ||
Weighted Average Exercise Price, Options exercisable | $ 9.32 | ||
[1] | The number of exercised options includes shares withheld on behalf of employees to satisfy minimum statutory tax withholding requirements. |
SCHEDULE OF SHARE-BASED PAYMENT
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (years) | 4 years | 5 years |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (years) | 5 years 10 months 24 days | 7 years |
Option Grants [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free annual interest rate, minimum | 0.30% | 0.20% |
Risk free annual interest rate, maximum | 1.20% | 1.70% |
Expected volatility, minimum | 97.90% | 94.30% |
Expected volatility, maximum | 104.70% | 100.90% |
Assumed dividends | ||
Option Grants [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (years) | 4 years 7 months 6 days | 4 years 4 months 24 days |
Option Grants [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term of options (years) | 4 years 8 months 12 days | 4 years 7 months 6 days |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free annual interest rate, minimum | 0.10% | 0.20% |
Risk free annual interest rate, maximum | 0.20% | 1.60% |
Expected volatility, minimum | 98.40% | 100.50% |
Expected volatility, maximum | 125.20% | 143.20% |
Expected term of options (years) | 6 months | 6 months |
Assumed dividends |
SCHEDULE OF SHARE-BASED COMPE_2
SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY (Details) - Restricted Stock [Member] | 12 Months Ended | |
Dec. 31, 2021shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Shares, Unvested at beginning of period | 3,468,969 | |
Number of Shares, Granted | 5,769,593 | |
Number of Shares, Vested | (3,480,366) | [1] |
Number of Shares, Forfeited | (594,511) | |
Number of Shares, Unvested at end of period | 5,163,685 | |
[1] | The number of vested restricted stock units and awards includes shares that were withheld on behalf of employees to satisfy the minimum statutory tax withholding requirements. |
SCHEDULE OF SHARE-BASED COMPE_3
SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 5,600 | $ 7,258 |
General and Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 4,097 | 5,879 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,146 | 943 |
Selling and Marketing Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 357 | $ 436 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | Oct. 25, 2019 | Oct. 05, 2018 | Dec. 01, 2016 | May 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Fair value of stock options shares granted price per share | $ 0.91 | $ 0.91 | ||||
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value | $ 0 | $ 0 | ||||
Fair value of options vested | 2,600,000 | 8,400,000 | ||||
Aggregate intrinsic value of options outstanding and exercisable | $ 0 | |||||
Weighted average remaining contractual term | 6 years 1 month 24 days | |||||
Available for future issuances ESPP | 264,478 | |||||
Stock based compensation | $ 5,600,000 | 7,258,000 | ||||
Number of stock issued under ESPP, value | 55,000 | $ 75,000 | ||||
Restricted Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation cost | $ 1,300,000 | |||||
Unrecognized compensation cost, period for recognition | 2 years 3 months 18 days | |||||
Weighted-average per share grant-date fair value of restricted stock granted | $ 0.73 | $ 1.18 | ||||
Total fair value of restricted stock vested | $ 4,700,000 | $ 9,000,000 | ||||
2017 Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation cost | $ 300,000 | |||||
Unrecognized compensation cost, period for recognition | 1 year 6 months | |||||
2020 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock based compensation terminate date | Dec. 19, 2029 | |||||
Number of share available for future issuance | 153,927 | |||||
2020 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of stock issuable | 7,191,917 | |||||
2019 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock based compensation terminate date | Oct. 5, 2028 | |||||
Number of share available for future issuance | 1,361 | |||||
2019 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of stock issuable | 3,000,000 | |||||
2017 Equity Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock based compensation terminate date | Dec. 1, 2026 | |||||
Number of share available for future issuance | 38,814 | |||||
2017 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of stock issuable | 7,300,000 | |||||
Employee Stock Purchase Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Fair value of stock options shares granted price per share | $ 0.54 | $ 0.76 | ||||
Number of shares reserved | 500,000 | |||||
Common stock purchase price percentage | 85.00% | |||||
Stock based compensation | $ 40,000 | $ 64,000 | ||||
Number of stock issued under ESPP | 101,900 | 97,445 | ||||
Number of stock issued under ESPP, value | $ 100,000 | $ 100,000 |
SCHEDULE FOR MEASUREMENT OF FAI
SCHEDULE FOR MEASUREMENT OF FAIR VALUE OF WARRANTS (Details) - $ / shares | Jan. 25, 2021 | Jan. 22, 2021 | Jan. 14, 2021 | Dec. 23, 2020 | Nov. 20, 2020 | Feb. 14, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Warrant [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 0.92 | $ 1.69 | $ 0.68 | |||||
Exercise price | $ 0.10 | $ 2.80 | $ 0.10 | |||||
Risk-free rate | 0.53% | 1.51% | 0.52% | |||||
Volatility rate | 99.40% | 93.40% | 98.90% | |||||
Remaining term (years) | 6 years 2 months 12 days | 7 years | 6 years 1 month 6 days | |||||
Common Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 1.21 | $ 0.65 | $ 0.59 | $ 0.68 | ||||
Exercise price | $ 1.20 | $ 0.62 | $ 1.20 | $ 0.62 | ||||
Risk-free rate | 0.49% | 0.38% | 1.12% | 0.36% | ||||
Volatility rate | 100.10% | 99.70% | 103.00% | 96.20% | ||||
Remaining term (years) | 5 years | 5 years | 4 years | 5 years | ||||
Placement Agent Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 1.05 | $ 0.59 | ||||||
Exercise price | $ 1.20 | $ 1.20 | ||||||
Risk-free rate | 0.44% | 1.12% | ||||||
Volatility rate | 99.60% | 103.00% | ||||||
Remaining term (years) | 5 years | 4 years 1 month 6 days | ||||||
Placement Agent Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 1.21 | $ 0.65 | $ 0.59 | $ 0.68 | ||||
Exercise price | $ 1.38 | $ 0.94 | $ 1.38 | $ 0.94 | ||||
Risk-free rate | 0.49% | 0.38% | 1.12% | 0.36% | ||||
Volatility rate | 99.30% | 99.70% | 103.00% | 96.20% | ||||
Remaining term (years) | 5 years | 5 years | 4 years | 5 years | ||||
February 14, 2020 Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 0.59 | |||||||
Exercise price | $ 0.10 | |||||||
Risk-free rate | 1.27% | |||||||
Volatility rate | 102.00% | |||||||
Remaining term (years) | 5 years 1 month 6 days | |||||||
December 23, 2020 Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 0.59 | |||||||
Exercise price | $ 0.94 | |||||||
Risk-free rate | 1.11% | |||||||
Volatility rate | 103.90% | |||||||
Remaining term (years) | 4 years | |||||||
Common Stock Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 1.05 | |||||||
Exercise price | $ 0.62 | |||||||
Risk-free rate | 0.43% | |||||||
Volatility rate | 99.40% | |||||||
Remaining term (years) | 4 years 10 months 24 days | |||||||
New Common Stock Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stock price | $ 1.02 | $ 0.59 | ||||||
Exercise price | $ 1.20 | $ 1.20 | ||||||
Risk-free rate | 0.42% | 1.13% | ||||||
Volatility rate | 99.00% | 103.00% | ||||||
Remaining term (years) | 5 years | 4 years 1 month 6 days |
SUMMARY OF WARRANT ACTIVITY (De
SUMMARY OF WARRANT ACTIVITY (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 17,132,369 | |
Warrants Issued | 20,554,270 | |
Warrants Exercised | (18,372,496) | |
Warrant Outstanding, Ending Balance | 19,314,143 | 17,132,369 |
February 14, 2020 Common Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 565,000 | |
Warrants Issued | 10,638,298 | |
Warrants Exercised | (25,500) | 10,073,298 |
Warrant Outstanding, Ending Balance | 539,500 | 565,000 |
December 23, 2020 Common Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 10,688,043 | |
Warrants Issued | 10,688,043 | |
Warrants Exercised | (10,688,043) | |
Warrant Outstanding, Ending Balance | 10,688,043 | |
December 23, 2020 Placement Agent Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 641,283 | |
Warrants Issued | 641,283 | |
Warrants Exercised | ||
Warrant Outstanding, Ending Balance | 641,283 | 641,283 |
Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 11,894,326 | |
Warrants Issued | 21,967,624 | |
Warrants Exercised | 10,073,298 | |
Warrant Outstanding, Ending Balance | 11,894,326 | |
December 23, 2020 Pre-funded Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | 5,238,043 | |
Warrants Issued | ||
Warrants Exercised | (5,238,043) | |
Warrant Outstanding, Ending Balance | 5,238,043 | |
January 14, 2021 Common Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | ||
Warrants Issued | 9,090,910 | |
Warrants Exercised | ||
Warrant Outstanding, Ending Balance | 9,090,910 | |
January 14, 2021 Placement Agent Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | ||
Warrants Issued | 545,455 | |
Warrants Exercised | ||
Warrant Outstanding, Ending Balance | 545,455 | |
January 14, 2021 Pre-funded Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | ||
Warrants Issued | 2,420,910 | |
Warrants Exercised | (2,420,910) | |
Warrant Outstanding, Ending Balance | ||
January 25, 2021 Common Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | ||
Warrants Issued | 8,016,033 | |
Warrants Exercised | ||
Warrant Outstanding, Ending Balance | 8,016,033 | |
January 22, 2021 Placement Agent Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant Outstanding, Beginning Balance | ||
Warrants Issued | 480,962 | |
Warrants Exercised | ||
Warrant Outstanding, Ending Balance | 480,962 |
SALE OF COMMON STOCK, WARRANT_3
SALE OF COMMON STOCK, WARRANTS AND PRE- FUNDED WARRANTS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Mar. 30, 2021 | Jan. 25, 2021 | Jan. 22, 2021 | Jan. 22, 2021 | Jan. 14, 2021 | Dec. 23, 2020 | Feb. 14, 2020 | Dec. 05, 2019 | Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 31, 2021 | Nov. 20, 2020 | Nov. 19, 2020 |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 10,638,298 | 10,073,298 | ||||||||||||
Public offering price per share | $ 2.35 | |||||||||||||
Class of warrant right exercise price | $ 2.80 | $ 0.10 | $ 2.80 | |||||||||||
Warrants expiration date | Feb. 12, 2027 | |||||||||||||
Proceeds from warrant exercises | $ 1,000 | $ 6,671 | $ 1,008 | |||||||||||
Residual value of warrants and stock offering | $ 2,500 | $ 12,000 | 12,000 | |||||||||||
Reclassification as a reduction in additional paid-in capital | 300 | $ 1,300 | ||||||||||||
Warrant liability, issuance costs | 500 | |||||||||||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||
Fair value adjustment of warrants | $ 6,200 | |||||||||||||
Proceeds from Issuance of Warrants | $ 1,000 | |||||||||||||
Stock issued during period, value, new issues | $ 25,000 | $ 12,600 | ||||||||||||
Cantor Fitzerald and Co [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 50,000 | $ 50,000 | ||||||||||||
Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of warrant right exercise price | $ 0.624 | $ 0.624 | ||||||||||||
Maximum [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Common stock and warrants purchase shares | 10,688,043 | 10,688,043 | ||||||||||||
Warrant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Estimated fair value, liability | 5,200 | $ 11,700 | $ 11,700 | |||||||||||
Exisitng Warrant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Proceeds from warrant exercises | $ 9,200 | $ 7,200 | ||||||||||||
Noninterest expense offering cost | $ 800 | |||||||||||||
Exisitng Warrant [Member] | Monte Carlo Simulation Model [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Noninterest expense offering cost | $ 100 | |||||||||||||
Pre-funded Warrants [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of warrant right exercise price | $ 1.375 | $ 0.001 | $ 0.001 | |||||||||||
Common Stock Warrants [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | $ 8,100 | |||||||||||||
Common Stock Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | 5,800 | |||||||||||||
Placement Agent Common Stock Warrants [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | 500 | |||||||||||||
Placement Agent Common Stock Warrants [Member] | Monte Carlo Simulation Model [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | $ 400 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 5,238,043 | 2,420,910 | ||||||||||||
Stock issued during period, shares, new issues | 10,854,710 | |||||||||||||
Fair value adjustment of warrants | 1,400 | |||||||||||||
Stock issued during period, value, new issues | $ 11 | |||||||||||||
Common Stock [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Public offering price per share | $ 0.125 | $ 0.125 | ||||||||||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | ||||||||||||
Common Stock [Member] | Maximum [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Stock issued during period, shares, new issues | 8,016,033 | |||||||||||||
Additional Paid-in Capital [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | 100 | |||||||||||||
Stock issued during period, value, new issues | 12,589 | |||||||||||||
Classified Warrants [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Fair value adjustment of warrants | $ 700 | |||||||||||||
Warrants [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 480,962 | 480,962 | ||||||||||||
Proceeds from warrant exercises | $ 6,700 | |||||||||||||
Proceeds from Issuance of Warrants | $ 1,000 | |||||||||||||
Warrants [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Warrant exercisable description | Each January 25 Warrant is exercisable for one share of Common Stock at an exercise price of $1.20 per share. The January 25 Warrants are immediately exercisable and will expire five years from the date of issuance | |||||||||||||
Warrant or Right, Reason for Issuance, Description | A holder may not exercise any portion of the January 25 Warrants to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election to a lower percentage at any time or to a higher percentage not to exceed 9.99% upon 61 days’ notice to the Company. The Company also issued to designees of the placement agent, warrants to purchase 6.0% of the aggregate number of common stock shares and pre-funded warrants sold in the offering | |||||||||||||
Warrants [Member] | Maximum [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 10,688,043 | 10,688,043 | ||||||||||||
Warrant One [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Remeasurement loss | $ 3,600 | |||||||||||||
Warrant One [Member] | Maximum [Member] | Letter Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 10,688,043 | |||||||||||||
Underwritten Offering [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 10,638,298 | |||||||||||||
IPO [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of warrant right exercise price | $ 0.001 | |||||||||||||
Stock issued during period, shares, new issues | 6,670,000 | 5,450,000 | ||||||||||||
Warrants and rights outstanding, term | 5 years | 5 years | ||||||||||||
Common stock, par or stated value per share | $ 0.001 | |||||||||||||
IPO [Member] | Maximum [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Common stock and warrants purchase shares | 9,090,910 | 10,688,043 | ||||||||||||
IPO [Member] | Warrant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of warrant right exercise price | $ 1.20 | $ 0.624 | ||||||||||||
Shares issued, price per share | 1.10 | |||||||||||||
IPO [Member] | Pre-Funded Warrant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Class of warrant right exercise price | $ 0.001 | $ 0.001 | ||||||||||||
Common stock and warrants purchase shares | 2,420,910 | 5,238,043 | ||||||||||||
Shares issued, price per share | $ 1.099 | $ 0.7475 | ||||||||||||
IPO [Member] | Common Stock and Warrant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Shares issued, price per share | 0.7485 | |||||||||||||
Private Placement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Estimated fair value, liability | $ 300 | |||||||||||||
Warrant exercise price | $ 0.9356 | |||||||||||||
Private Placement [Member] | Maximum [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Common stock and warrants purchase shares | 545,455 | 641,283 | ||||||||||||
Percentage of exercise of warrants | 125.00% | |||||||||||||
Percentage of warrant exercise price | 125.00% |
SCHEDULE OF EARNINGS PER SHARE,
SCHEDULE OF EARNINGS PER SHARE, BASIC AND DILUTED (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Earnings Per Share [Abstract] | |||
Net loss, primary | $ (30,187) | $ (42,854) | |
Gain from change in fair value of warrant liabilities | 2,914 | ||
Net loss, diluted | $ (30,187) | $ (45,768) | |
Basic weighted average number of common shares | [1] | 80,014,014 | 38,779,316 |
Potentially dilutive effect of warrants | 588,074 | ||
Diluted weighted average number of common shares | 80,014,014 | 39,367,390 | |
[1] | In December 2020 and January 2021, the Company sold pre-funded warrants to purchase up to 5,238,043 2,420,910 |
SCHEDULE OF EARNINGS PER SHAR_2
SCHEDULE OF EARNINGS PER SHARE, BASIC AND DILUTED (Details) (Parenthetical) - shares | Jan. 31, 2021 | Dec. 31, 2020 | Feb. 14, 2020 |
Number of warrant to purchase shares of common stock | 10,073,298 | 10,638,298 | |
Common Stock [Member] | |||
Number of warrant to purchase shares of common stock | 2,420,910 | 5,238,043 |
SCHEDULE OF ANTI-DILUTIVE POTEN
SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding potentially dilutive securities | 5,772,802 | 4,794,567 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding potentially dilutive securities | 5,163,685 | 3,468,969 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding potentially dilutive securities | 19,314,143 |
DEBT (Details Narrative)
DEBT (Details Narrative) - USD ($) | Apr. 12, 2020 | Dec. 31, 2021 |
Short-term Debt [Line Items] | ||
Debt instrument decrease forgiveness | $ 3,600,000 | |
Paycheck Protection Program [Member] | ||
Short-term Debt [Line Items] | ||
Unsecured debt | $ 3,576,145 | |
Debt instrument, interest rate, stated percentage | 1.00% | |
Debt instrument term | 24 months | |
Debt instrument, periodic payment | $ 150,563 |
SCHEDULE OF RESTRUCTURING COSTS
SCHEDULE OF RESTRUCTURING COSTS AND GAINS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |||
Restructuring and Related Activities [Abstract] | |||||
Property and equipment impairment and disposal | $ 425,000 | $ 2,443,000 | |||
Employee severance and benefit arrangements | 390,000 | 1,025,000 | |||
Modification of employee stock options | 187,000 | ||||
Net gain on lease termination | $ (300,000) | (324,000) | [1] | [1] | |
Abandonment of ROU assets | 366,000 | ||||
Net restructuring costs | $ 678,000 | $ 3,834,000 | |||
[1] | During the second quarter of 2021 and effective June 30, 2021, the Company terminated a lease which included manufacturing, laboratory, and office space. The Company recorded a net gain on termination of $ 0.3 |
SCHEDULE OF RESTRUCTURING COS_2
SCHEDULE OF RESTRUCTURING COSTS AND GAINS (Details) (Parenthetical) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |||
Restructuring and Related Activities [Abstract] | |||||
Net gain on lease termination | $ 300,000 | $ 324,000 | [1] | [1] | |
[1] | During the second quarter of 2021 and effective June 30, 2021, the Company terminated a lease which included manufacturing, laboratory, and office space. The Company recorded a net gain on termination of $ 0.3 |
RESTRUCTURING (Details Narrativ
RESTRUCTURING (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Restructuring and related activities, description | Management approved a reduction in force, which affected 40 of the 126 employees in the regenerative medicine business segment, or approximately 31.7% of that workforce. The Company did not make any change in the workforce of its contract services segment | ||
Severance expense | $ 390,000 | $ 1,025,000 | |
Asset abandonments | $ 1,500,000 | ||
Abandonment Of Certain Production Assets And Leasehold Improvements [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Abandonment of product | $ 900,000 | ||
Abandonment Of Right Of Use Assets [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Abandonment of product | $ 400,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | Sep. 29, 2021 | Jun. 25, 2021 | Jun. 25, 2021 | Sep. 02, 2020 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | |||||
Agreement term | 12 months | ||||
Rental agreement fee | $ 3,300 | ||||
Debt instrument face amount | $ 6,500,000 | $ 6,500,000 | |||
Service fees | 3,100,000 | ||||
Estimated cost | $ 1,400,000 | $ 5,100,000 | 3,400,000 | ||
Recited costs | $ 500,000 | ||||
Costs and expenses | $ 400,000 |
CERTAIN RELATIONSHIPS AND REL_2
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS (Details Narrative) | Oct. 01, 2019USD ($)shares | Oct. 31, 2018USD ($)ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublease income | $ 182,000 | $ 250,000 | ||
Due from related parties | 0 | $ 0 | ||
Office Lease [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Net rentable area | ft² | 7,250 | |||
Lessee, operating lease, description | The lease is for a term of three years | |||
Payments for rent | $ 60 | |||
Description of Lessee Leasing Arrangements, Operating Leases | Initially the Company would occupy and pay for only 3,275 square feet of space, and the Company was not obligated under the lease to pay for the remaining 3,975 square feet covered by the lease unless it elected to occupy that additional space. The Company believes the terms of the lease were very favorable to it, and the Company obtained the favorable terms through the assistance of Peter A. Cohen, a director, which he provided so that the company he owns, Peter A. Cohen, LLC (“Cohen LLC”), could sublease a portion of the office space. The lease expired on October 31, 2021. | |||
Dr. Denver Lough [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Stock issued during period, shares, restricted stock award, gross | shares | 200,000 | |||
Stock issued during period, value, restricted stock award, gross | $ 800,000 | |||
Settlement Terms Agreement [Member] | Dr. Denver Lough [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Due to related parties | $ 1,500,000 | |||
Settlement Terms Agreement [Member] | Dr. Denver Lough [Member] | Equal Monthly Installments Beginning November1, 2019 and Ending April 1, 2021 [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Due to related parties | $ 1,500,000 |
SCHEDULE OF SEGMENT INFORMATION
SCHEDULE OF SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Segment Reporting Information [Line Items] | ||
Total net revenues | $ 9,404 | $ 10,126 |
Total net loss | (30,187) | (42,854) |
Total assets | 31,178 | 45,510 |
Regenerative Medicine [Member] | ||
Segment Reporting Information [Line Items] | ||
Total net revenues | 3,076 | 3,730 |
Total net loss | (29,568) | (42,815) |
Total assets | 25,344 | 36,858 |
Contract Services [Member] | ||
Segment Reporting Information [Line Items] | ||
Total net revenues | 6,328 | 6,396 |
Total net loss | (619) | (39) |
Total assets | $ 5,834 | $ 8,652 |
SEGMENT REPORTING (Details Narr
SEGMENT REPORTING (Details Narrative) | 12 Months Ended |
Dec. 31, 2021Segments | |
Segment Reporting [Abstract] | |
Number of operating segment | 2 |
EMPLOYEE BENEFIT PLAN (Details
EMPLOYEE BENEFIT PLAN (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | ||
Pre-tax earnings of contribution | $ 19,500 | |
Percentage of contribution | 3.00% | |
Contribution expense | $ 300,000 | $ 200,000 |
SCHEDULE OF COMPONENTS OF INCOM
SCHEDULE OF COMPONENTS OF INCOME TAX EXPENSE (BENEFIT) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Current: Federal | ||
Current: State | ||
Deferred: Federal | (5,484) | (593) |
Deferred: State | 605 | (79) |
Change in valuation allowance | 4,879 | 672 |
Total provision (benefit) for income taxes | $ 0 | $ 0 |
SCHEDULE OF STATUTORY FEDERAL R
SCHEDULE OF STATUTORY FEDERAL RATE AND PROVISION FOR INCOME TAX (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Tax (benefit) at federal statutory rate, amount | $ (6,340) | $ (8,999) |
Tax (benefit) at federal statutory rate, percentage of pretax loss | 21.00% | 21.00% |
State income taxes, net of federal income taxes, amount | $ 605 | $ (79) |
State income taxes, net of federal income taxes, percentage of pretax loss | (2.00%) | |
Effect of warrant liability, amount | $ 215 | $ (209) |
Effect of warrant liability, percentage of pretax loss | (1.00%) | 1.00% |
Effect of other permanent items, amount | $ 16 | $ 65 |
Effect of other permanent items, percentage of pretax loss | ||
Effect of stock compensation, amount | $ 238 | $ 9,032 |
Effect of stock compensation, percentage of pretax loss | (1.00%) | (21.00%) |
Change in valuation allowance, amount | $ 4,879 | $ 672 |
Change in valuation allowance, percentage of pretax loss | (16.00%) | (2.00%) |
Other, amount | $ 387 | $ (482) |
Other, percent of pretax loss | (1.00%) | 1.00% |
Income taxes, amount | $ 0 | $ 0 |
Income taxes, percentage of pretax loss |
SCHEDULE OF DEFERRED TAX ASSETS
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
Leases | $ 17 | $ 132 |
Depreciation and amortization | (38) | (784) |
Compensation expense not deductible until options are exercised | 8,343 | 9,494 |
All other temporary differences | 430 | 488 |
Net operating loss carry forwards | 47,223 | 41,766 |
Less valuation allowance | (55,975) | (51,096) |
Deferred tax asset (liability) |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 185,800,000 |
Net operating loss carryforwards with expiration | $ 38,400,000 |
Operating loss carryforwards, description | expire between 2038 and 2039 |
Net operating loss carryforwards with expiration indefinite life | $ 147,400,000 |
Unrecognized tax benefits, which would impact its tax rate | 0 |
Payment for penalties accrual | 0 |
State [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards with expiration | $ 195,700,000 |
Operating loss carryforwards, description | expire starting in 2034 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | Mar. 16, 2022 | Feb. 28, 2022 | Mar. 30, 2021 | Mar. 29, 2022 | Mar. 17, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 20, 2020 | Nov. 19, 2020 | Feb. 14, 2020 |
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Shares Issued | 0 | 0 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.10 | $ 2.80 | $ 2.80 | |||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 10,073,298 | 10,638,298 | ||||||||
Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 1,000 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 16,393,445 | |||||||||
Preferred Stock, Convertible, Conversion Price | $ 0.305 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.35 | |||||||||
Debt Instrument, Term | 2 years | |||||||||
Subsequent Event [Member] | Placement Agent Warrants [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.38125 | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 819,672 | |||||||||
Proceeds from Issuance of Private Placement | $ 4,485,000 | |||||||||
Subsequent Event [Member] | Series A Convertible Preferred Stock [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Shares Issued | 3,000.000435 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 9,836,067 | 9,836,067 | ||||||||
Subsequent Event [Member] | Series B Convertible Preferred Stock [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Shares Issued | 2,000.00029 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 6,557,378 | 6,557,378 | ||||||||
Sales Agreement [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Proceeds from issuance of common stock | $ 50,000,000 | |||||||||
Sales Agreement [Member] | Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Payment to the investment | $ 400,000 | |||||||||
Warrant Amendment Agreement [Member] | Subsequent Event [Member] | January 14 Warrants [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.35 | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 5,000,000 | |||||||||
Warrant Amendment Agreement [Member] | Subsequent Event [Member] | January 25 Warrants [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.35 | |||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 5,000,000 |