Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 21, 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 | 001-15771 | ||
Entity Registrant Name | ABEONA THERAPEUTICS INC. | ||
Entity Central Index Key | 0000318306 | ||
Entity Tax Identification Number | 83-0221517 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 1330 Avenue of the Americas | ||
Entity Address, Address Line Two | 33rd Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10019 | ||
City Area Code | (646) | ||
Local Phone Number | 813-4701 | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Trading Symbol | ABEO | ||
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 | $ 137,200,000 | ||
Entity Common Stock, Shares Outstanding | 147,378,022 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 726 | ||
Auditor Name | WHITLEY PENN LLP | ||
Auditor Location | Plano, Texas |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 32,938,000 | $ 12,596,000 |
Short-term investments | 12,086,000 | 82,438,000 |
Accounts receivable | 3,000,000 | |
Prepaid expenses, other current assets and restricted cash | 7,377,000 | 2,708,000 |
Total current assets | 55,401,000 | 97,742,000 |
Property and equipment, net | 12,339,000 | 11,322,000 |
Right-of-use lease assets | 9,403,000 | 7,032,000 |
Licensed technology, net | 1,384,000 | 1,500,000 |
Goodwill | 32,466,000 | |
Other assets and restricted cash | 1,059,000 | 1,136,000 |
Total assets | 79,586,000 | 151,198,000 |
Current liabilities: | ||
Accounts payable | 4,325,000 | 4,695,000 |
Accrued expenses | 5,585,000 | 3,410,000 |
Current portion of lease liability | 1,818,000 | 1,713,000 |
Current portion of PPP loan payable | 330,000 | |
Current portion of payable to licensor | 4,599,000 | 31,515,000 |
Deferred revenue | 296,000 | 296,000 |
Total current liabilities | 16,623,000 | 41,959,000 |
PPP loan payable | 1,428,000 | |
Payable to licensor | 3,828,000 | |
Other long-term liabilities | 200,000 | |
Long-term lease liabilities | 7,560,000 | 5,260,000 |
Total liabilities | 28,211,000 | 48,647,000 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock - $0.01 par value; authorized 2,000,000 shares; no issued and outstanding shares at December 31, 2021 and 2020 | ||
Common stock - $0.01 par value; authorized 200,000,000 shares; issued and outstanding 147,205,422 at December 31, 2021; issued and outstanding 96,131,678 at December 31, 2020 | 1,472,000 | 961,000 |
Additional paid-in capital | 705,570,000 | 672,304,000 |
Accumulated deficit | (655,640,000) | (570,704,000) |
Accumulated other comprehensive loss | (27,000) | (10,000) |
Total stockholders’ equity | 51,375,000 | 102,551,000 |
Total liabilities and stockholders’ equity | $ 79,586,000 | $ 151,198,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 147,205,422 | 96,131,678 |
Common stock, shares outstanding | 147,205,422 | 96,131,678 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | ||
Total revenues | $ 3,000,000 | $ 10,000,000 |
Expenses: | ||
Research and development | 34,325,000 | 30,139,000 |
General and administrative | 22,795,000 | 23,779,000 |
Depreciation and amortization | 3,250,000 | 4,586,000 |
Goodwill impairment charge | 32,466,000 | |
Licensed technology impairment charge | 32,916,000 | |
Total expenses | 92,836,000 | 91,420,000 |
Loss from operations | (89,836,000) | (81,420,000) |
Gain on settlement with licensor | 6,743,000 | |
PPP loan payable forgiveness income | 1,758,000 | |
Interest and miscellaneous income | 69,000 | 1,301,000 |
Interest and other expense | (3,670,000) | (4,115,000) |
Net loss | $ (84,936,000) | $ (84,234,000) |
Basic and diluted loss per common share | $ (0.86) | $ (0.91) |
Weighted average number of common shares outstanding – basic and diluted | 98,441,911 | 92,663,574 |
Other comprehensive income/(loss): | ||
Change in unrealized gains/(losses) related to available-for-sale debt securities | $ 9,000 | $ (10,000) |
Foreign currency translation adjustments | (26,000) | |
Comprehensive loss | (84,953,000) | (84,244,000) |
License and Other Revenues [Member] | ||
Revenues: | ||
Total revenues | $ 3,000,000 | $ 10,000,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 836,000 | $ 664,064,000 | $ (486,470,000) | $ 178,430,000 | |
Beginning balance, shares at Dec. 31, 2019 | 83,622,135 | ||||
Stock option-based compensation expense | 5,853,000 | 5,853,000 | |||
Restricted stock-based compensation expense | 2,334,000 | 2,334,000 | |||
Issuance of common stock in connection with the exercise of stock options | $ 1,000 | 176,000 | 177,000 | ||
Issuance of common stock in connection with the exercise of stock options, shares | 77,560 | ||||
Issuance of common stock in connection with restricted share awards, net of cancellations | $ 34,000 | (34,000) | |||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | 3,414,928 | ||||
Issuance of common stock in connection with the exercise of pre-funded warrants | $ 90,000 | (89,000) | 1,000 | ||
Issuance of common stock in connection with the exercise of pre-funded warrants, shares | 9,017,055 | ||||
Net loss | (84,234,000) | (84,234,000) | |||
Other comprehensive loss | (10,000) | (10,000) | |||
Ending balance, value at Dec. 31, 2020 | $ 961,000 | 672,304,000 | (570,704,000) | (10,000) | 102,551,000 |
Ending balance, shares at Dec. 31, 2020 | 96,131,678 | ||||
Stock option-based compensation expense | 5,250,000 | 5,250,000 | |||
Restricted stock-based compensation expense | 3,666,000 | 3,666,000 | |||
Issuance of common stock in connection with the exercise of stock options | $ 6,000 | 825,000 | 831,000 | ||
Issuance of common stock in connection with the exercise of stock options, shares | 630,675 | ||||
Issuance of common stock in connection with restricted share awards, net of cancellations | $ 21,000 | (21,000) | |||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | 2,071,275 | ||||
Issuance of common stock for cash under open market sale agreement | $ 37,000 | 8,014,000 | 8,051,000 | ||
Issuance of common stock for cash under open market sale agreement, shares | 3,671,794 | ||||
Issuance of common stock and stock purchase warrants in connection with public offering, net of offering costs | $ 447,000 | 15,532,000 | 15,979,000 | ||
Issuance of common stock and stock purchase warrants in connection with public offering, net of offering costs, shares | 44,700,000 | ||||
Net loss | (84,936,000) | (84,936,000) | |||
Other comprehensive loss | (17,000) | (17,000) | |||
Ending balance, value at Dec. 31, 2021 | $ 1,472,000 | $ 705,570,000 | $ (655,640,000) | $ (27,000) | $ 51,375,000 |
Ending balance, shares at Dec. 31, 2021 | 147,205,422 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (84,936,000) | $ (84,234,000) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Non-cash goodwill impairment charge | 32,466,000 | |
Non-cash licensed technology impairment charge | 32,916,000 | |
Non-cash gain on settlement with licensor | (6,743,000) | |
Depreciation and amortization | 3,250,000 | 4,586,000 |
Stock option-based compensation expense | 5,250,000 | 5,853,000 |
Restricted stock-based compensation expense | 3,666,000 | 2,334,000 |
Non-cash PPP loan payable forgiveness income | (1,758,000) | |
Non-cash interest expense | 67,000 | 600,000 |
Accretion and interest on short-term investments | 122,000 | (70,000) |
Amortization of right-of-use lease assets | 1,214,000 | 1,015,000 |
Other | 347,000 | |
Change in operating assets and liabilities: | ||
Accounts receivable | (3,000,000) | |
Prepaid expenses, other current assets and restricted cash | 331,000 | 424,000 |
Other assets and restricted cash | (7,000) | (127,000) |
Accounts payable, accrued expenses, lease liabilities and other liabilities | 825,000 | (2,178,000) |
Payable to licensor | (16,412,000) | 3,515,000 |
Net cash used in operating activities | (65,665,000) | (35,019,000) |
Cash flows from investing activities: | ||
Capital expenditures | (4,151,000) | (1,336,000) |
Purchases of short-term investments | (20,163,000) | (170,472,000) |
Proceeds from maturities of short-term investments | 90,376,000 | 88,094,000 |
Net cash provided by/(used in) investing activities | 66,062,000 | (83,714,000) |
Cash flows from financing activities: | ||
Proceeds from loan payable | 1,758,000 | |
Proceeds from issuance of common stock and warrants in public offering | 17,433,000 | 1,000 |
Payment of offering costs in public offering | (1,454,000) | |
Proceeds from open market sales of common stock | 8,051,000 | |
Proceeds from exercise of stock options | 831,000 | 177,000 |
Net cash provided by financing activities | 24,861,000 | 1,936,000 |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 25,258,000 | (116,797,000) |
Cash, cash equivalents and restricted cash at beginning of year | 13,571,000 | 130,368,000 |
Cash, cash equivalents and restricted cash at end of year | 38,829,000 | 13,571,000 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 32,938,000 | 12,596,000 |
Restricted cash | 5,891,000 | 975,000 |
Total cash, cash equivalents and restricted cash | 38,829,000 | 13,571,000 |
Cash paid for interest | ||
Cash paid for taxes | ||
Additions to right-of-use lease assets obtained from new operating lease liabilities resulting from modification of original lease arrangement | $ 3,585,000 |
NATURE OF OPERATIONS AND SUMMAR
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 - NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Operations Abeona Therapeutics Inc. (together with our subsidiaries, “we,” “our,” “Abeona” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company developing gene and cell therapies for life-threatening rare genetic diseases. Our lead clinical program is EB-101, an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (“RDEB”), which is currently in the pivotal Phase 3 VIITAL™ clinical trial. Following a comprehensive portfolio review in early 2022, we have decided to focus our research and development resources on the VIITAL™ readout while actively pursuing a potential commercialization partner for EB-101 with the objective of reducing operating expenses and extending our cash runway. As part of this portfolio prioritization, we have intensified our pursuit of a strategic partnership to take over development activities for our adeno-associated virus (“AAV”)-based gene therapy ABO-102 for Sanfilippo syndrome type A (“MPS IIIA”) and we have discontinued development of our AAV-based gene therapy ABO-101 for Sanfilippo syndrome type B (“MPS IIIB”). We plan to continue development of AAV-based gene therapies designed to treat ophthalmic and other diseases and next-generation AAV-based gene therapies using the novel AIM™ capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill (“UNC”), and internal AAV vector research programs. A summary of the significant accounting policies applied in the preparation of the accompanying consolidated financial statements follows: Principles of Consolidation The consolidated financial statements include the financial statements of Abeona Therapeutics Inc. and our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Uses and Sources of Liquidity The financial statements have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report was issued. As of December 31, 2021, we had cash, cash equivalents, restricted cash and short-term investments of $ 50.9 million and net assets of $ 51.4 million. For the year ended December 31, 2021, we had cash outflows from operations of $ 65.7 million. We have not generated significant product revenues and have not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and nonclinical testing, and commercialization of our products will require significant additional financing. We are subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of product candidates, obtaining the necessary regulatory approval to market our product candidates, raising additional capital to continue to fund our operations, development of competing drugs and therapies, protection of proprietary technology and market acceptance of our products. As a result of these and other risks and the related uncertainties, there can be no assurance of our future success. Following a comprehensive portfolio review in early 2022, we have decided to focus our research and development resources on the EB-101 program with the objective of reducing operating expenses and extending our cash runway. As part of this portfolio prioritization, we have intensified our pursuit of a strategic partnership to take over development activities for our AAV-based gene therapy ABO-102 for MPS IIIA and we have discontinued development of our AAV-based gene therapy ABO-101 for MPS IIIB. Based upon these current operating plans, our ability to access additional financial resources and/or our financial flexibility to further reduce operating expenses if required, we believe that we have sufficient resources to fund operations through at least the next 12 months from the date of this report on Form 10-K. We will need to secure additional funding beyond the next 12 months to carry out all of our planned research and development activities. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material adverse effect on our future prospects. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reported period. Actual results could differ from these estimates and assumptions. Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. We maintain deposits primarily in financial institutions, which may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation (“FDIC”). We have not experienced any losses related to amounts in excess of FDIC limits. Short-term Investments Short-term investments consist of investments in U.S. government, U.S. agency and U.S. treasury securities. We determine the appropriate classification of the securities at the time they are acquired and evaluate the appropriateness of such classifications at each balance sheet date. We classify our short-term investments as available-for-sale pursuant to Accounting Standards Codification (“ASC”) 320, Investments – Debt and Equity Securities Property and Equipment Property and equipment are recorded at cost. Depreciation is provided using the straight-line method over estimated useful lives ranging from three to seven years for equipment and five to ten years for leasehold improvements. Expenditures for major renewals and betterments that extend the useful lives are capitalized. Expenditures for normal maintenance and repairs are expensed as incurred. The cost of assets sold or abandoned, and the related accumulated depreciation are eliminated from the accounts and any gains or losses are recognized in the accompanying consolidated statements of operations of the respective period. Leases We account for leases in accordance with ASC 842, Leases Our leases do not have significant rent escalation, holidays, concessions, material residual value guarantees, material restrictive covenants or contingent rent provisions. Our leases include both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases. Most leases include one or more options to renew. The exercise of lease renewal options is typically at our sole discretion; therefore, the majority of renewals to extend the lease terms are not included in our right-of-use assets and lease liabilities as they are not reasonably certain of exercise. We regularly evaluate the renewal options and when they are reasonably certain of exercise, we include the renewal period in our lease term. Additional information and disclosures required under ASC 842 are included in Note 14. Licensed Technology We have entered into agreements to license the rights to certain technologies. We recorded the purchase price paid for the license, which represents fair value, on our consolidated balance sheet. We maintain licensed technology on our consolidated balance sheet until either the licensed technology agreement underlying it is completed or the asset becomes impaired. When we determine that an asset has become impaired or we abandon a project, we write down the carrying value of the related intangible asset to its fair value and take an impairment charge in the period in which the impairment occurs. Licensed technology is amortized over the life of the patent or the agreement and periodically reviewed for impairment. We test our intangible assets for impairment on an annual basis, or more frequently if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding our drug candidate or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate or new information regarding potential sales for the drug. In connection with each annual impairment assessment and any interim impairment assessment, we compare the fair value of the asset as of the date of the assessment with the carrying value of the asset on our consolidated balance sheet. We considered the status of our discussions with REGENXBIO in March 2020 as a potential indicator of impairment in accordance with ASC 360-10-35-21. Our impairment test indicated that the carrying value of the license agreement exceeded its fair value and we recorded a $ 32.9 Goodwill In accordance with ASC 350, Intangibles — Goodwill and Other, Restricted Cash As of December 31, 2021 and 2020, restricted cash of $ 5.0 nil 0.9 1.0 Segments The Company operates in a single segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. Revenue Recognition We account for contracts with customers in accordance with ASC 606, Revenue from Contracts with Customers Additional information and disclosures required under ASC 606 are included in Note 10. Research and Development Expenses Research and development costs are expensed as incurred. Research and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical and development cost, clinical trial expense, manufacturing, regulatory, and consulting. The cost of materials and equipment or facilities that are acquired for research and development activities and that have alternative future uses are capitalized when acquired. General and Administrative Expenses General and administrative expenses primarily consist of personnel, contract personnel, personnel-related expenses to support our administrative and operating activities, facility costs and professional expenses (i.e., legal expenses) and investor relations fees. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided for deferred tax assets to the extent their realization is in doubt. We account for uncertain income tax positions in accordance with ASC 740, Income Taxes Loss Per Common Share We have presented basic and diluted loss per common share on the statement of operations and comprehensive loss. Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock. We do not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock purchase warrants. We did not include the following potentially dilutive securities in the computation of diluted net loss per common share during the periods presented: SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE For the years ended December 31, 2021 2020 Restricted stock 2,431,515 2,952,499 Stock options 7,934,851 5,685,539 Stock purchase warrants 44,700,000 - Total 55,066,366 8,638,038 Stock-Based Compensation We account for stock-based compensation expense in accordance with ASC 718, Stock Based Compensation The fair value of modifications to share-based awards are determined using Hull White I lattice model which includes assumptions for expected volatility, risk-free interest rate, dividend yield and performance period. If a share-based compensation award is modified after the grant date, incremental compensation expense, if any, is recognized in an amount equal to the excess of the fair value of the modified award over the fair value of the original award immediately before the modification. Incremental compensation expense for vested awards is recognized immediately. For unvested awards, the sum of the incremental compensation expense and the remaining unrecognized compensation expense for the original award on the modification date is recognized over the modified service period. The following table summarizes stock option-based option compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,915,000 $ 3,126,000 General and administrative 3,335,000 2,727,000 Stock option-based compensation expense included in operating expense 5,250,000 5,853,000 Total stock option-based compensation expense 5,250,000 5,853,000 Tax benefit - - Stock option-based compensation expense, net of tax $ 5,250,000 $ 5,853,000 The following table summarizes restricted stock-based compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,384,000 $ 957,000 General and administrative 2,282,000 1,377,000 Restricted stock-based compensation expense included in operating expense 3,666,000 2,334,000 Total restricted stock-based compensation expense 3,666,000 2,334,000 Tax benefit - - Restricted stock-based compensation expense, net of tax $ 3,666,000 $ 2,334,000 Additional information and disclosures required under ASC 718 are included in Note 11. |
SHORT-TERM INVESTMENTS
SHORT-TERM INVESTMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
SHORT-TERM INVESTMENTS | NOTE 2 – SHORT-TERM INVESTMENTS The following table summarizes the available-for-sale investments held as of December 31, 2021 and 2020. SCHEDULE OF AVAILABLE-FOR-SALE INVESTMENTS HELD Description December 31, December 31, 2020 U.S. government and agency securities and treasuries $ 12,086,000 $ 82,438,000 The amortized cost of the available-for-sale investments, which is adjusted for amortization of premiums and accretion of discounts to maturity, was $ 12,087,000 82,448,000 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 3 - PROPERTY AND EQUIPMENT Property and equipment consist of the following: SCHEDULE OF PROPERTY AND EQUIPMENT December 31, December 31, Laboratory equipment $ 9,081,000 $ 8,160,000 Furniture and office equipment 1,896,000 1,818,000 Leasehold improvements 8,603,000 8,602,000 Construction work-in-progress 3,219,000 71,000 22,799,000 18,651,000 Less: accumulated depreciation and amortization 10,460,000 7,329,000 Property and equipment, net $ 12,339,000 $ 11,322,000 Depreciation and amortization on property and equipment was $ 3.1 3.2 |
LICENSED TECHNOLOGY
LICENSED TECHNOLOGY | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
LICENSED TECHNOLOGY | NOTE 4 – LICENSED TECHNOLOGY On November 4, 2018, we entered into a license agreement with REGENXBIO Inc. (“REGENXBIO”) to obtain rights to an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with rights to sublicense, to REGENXBIO’s NAV AAV9 vector for gene therapies for treating MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease. Consideration for the rights granted under the original agreement included fees totaling $ 180 20 10 10 100 20 60 eight years 10 3 8 1 8 20 November 4, 2020 8 20 Prior to the April 1, 2020 deadline, we engaged REGENXBIO in discussions in an attempt to renegotiate the financial terms of the agreement, but we were unable to reach an agreement, and we did not make the $ 8 million payment due by April 1, 2020. On April 17, 2020, REGENXBIO sent us a written demand for the $ 8 million fee, payable within a 15-day cure period after receipt of the demand letter. The license terminated on May 2, 2020 , when the 15-day period expired. We considered the status of our discussions with REGENXBIO in March 2020 as a potential indicator of impairment in accordance with ASC 360-10-35-21. Our impairment test indicated that the carrying value of the license agreement exceeded its fair value and we recorded a $ 32.9 million non-cash impairment charge during the three months ended March 31, 2020. On May 25, 2020, we filed an arbitration claim with the American Arbitration Association (“AAA”) alleging that REGENXBIO materially breached the license agreement prior to termination and seeking, among other things, a declaration that as a result of REGENXBIO’s material breach, we were not responsible for payments totaling $ 28 28 28.0 On August 9, 2021, we filed a second arbitration claim with the AAA asserting that a settlement had been reached before the tribunal’s award in the first arbitration was issued. On September 14, 2021, REGENXBIO filed its answer, a counterclaim seeking attorney fees and costs, and a request for permission to file a case dispositive motion. A preliminary hearing was held on November 1, 2021, during which the AAA tribunal set timetables for discovery and for REGENXBIO’s filing of its case dispositive motion. Those timetables were formalized in a procedural order issued by the tribunal on November 8, 2021. Under the schedule set by the tribunal, REGENXBIO’s opening brief in support of its case dispositive motion was filed on November 8, 2021, briefing was scheduled to be completed on December 29, 2021, and oral argument was scheduled for January 14, 2022. REGENXBIO had also filed suit in the New York State Supreme Court Commercial Division seeking enforcement of the original arbitration award, and we had requested that the Court stay that proceeding until the second arbitration was complete. Oral argument on our request for a stay was set for March 10, 2022. On November 12, 2021, we entered into a settlement agreement (“Settlement Agreement”) with REGENXBIO to resolve all current disputes between the parties including the aforementioned AAA arbitration and New York State Supreme Court action. In accordance with the Settlement Agreement, we agreed to pay REGENXBIO a total of $ 30 million, payable as follows: (1) $20 million that was paid in November 2021 after execution of the Settlement Agreement, (2) $5 million on the first anniversary of the effective date of the Settlement Agreement, and (3) $5 million upon the earlier of: (i) the third anniversary of the effective date of the Settlement Agreement or (ii) the closing of a Strategic Transaction, as defined in the Settlement Agreement. Under the Settlement Agreement’s terms, the prior license agreement between the parties is not reinstituted, and any future license agreement would need to be negotiated separately and require consideration in addition to the consideration set forth in the Settlement Agreement. As of December 31, 2021, we have recorded the payable to licensor in the balance sheet based on the present value of the remaining payments due to REGENXBIO under the Settlement Agreement. As of December 31, 2021, we have also recorded $ 5 6.7 million gain on settlement with licensor in the statement of operations and comprehensive loss during the year ended December 31, 2021 and a $ 6.7 million non-cash gain on settlement with licensor in the statement of cash flows during the year ended December 31, 2021. On May 15, 2015, we acquired Abeona Therapeutics LLC, which had an exclusive license through Nationwide Children’s Hospital to the AB-101 and AB-102 patent portfolios for developing treatments for patients with Sanfilippo Syndrome Type A and Type B. The license is amortized over the life of the license of 20 Licensed technology consists of the following: SCHEDULE OF LICENSED TECHNOLOGY December 31, December 31, Licensed technology $ 2,156,000 $ 2,156,000 Less accumulated amortization 772,000 656,000 Licensed technology, net $ 1,384,000 $ 1,500,000 The aggregate estimated amortization expense for intangible assets remaining as of December 31, 2021 is as follows: SCHEDULE OF AMORTIZATION EXPENSE FOR INTANGIBLE ASSETS 2022 $ 116,000 2023 116,000 2024 117,000 2025 117,000 2026 117,000 Thereafter 801,000 Total $ 1,384,000 Amortization on licensed technology was $ 116,000 1.4 |
GOODWILL
GOODWILL | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
GOODWILL | NOTE 5 – GOODWILL As of December 31, 2021 and 2020, goodwill of nil and $ 32.5 SCHEDULE OF GOODWILL For the years ended December 31, 2021 2020 Goodwill at the beginning of the year $ 32,466,000 $ 32,466,000 Goodwill impairment charge (32,466,000 ) - Goodwill at the end of the year $ - $ 32,466,000 We completed our annual goodwill impairment test as of year-end 2021 and determined that the carrying value of our net assets exceeded fair value using our market capitalization as a proxy for fair value. In accordance with ASC 350, we recognized an impairment loss for the excess of the carrying value over the fair value but limited to the total amount of goodwill recorded on our consolidated balance sheet. As a result, we recorded a goodwill impairment charge of $ 32.5 million for the year ended December 31, 2021. We completed our annual goodwill impairment test as of year-end 2020 and determined that the fair value of our net assets exceeded the carrying value. As a result, the Company did not recognize any impairment charges related to goodwill for the year ended December 31, 2020. |
LOAN PAYABLE
LOAN PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
LOAN PAYABLE | NOTE 6 – LOAN PAYABLE On May 2, 2020, we received loan proceeds in the amount of approximately $ 1.8 million (the “PPP Loan”) under the Paycheck Protection Program (“PPP”). The PPP was established under the Coronavirus Aid, Relief and Economic Security Act, as amended (“CARES Act”) and is administered by the U.S. Small Business Administration (“SBA”). Under the terms of the CARES Act, PPP loan recipients can apply for loan forgiveness. The loan forgiveness for all or a portion of PPP loans was determined, subject to limitations, based on the use of loan proceeds over the 24 weeks after the loan proceeds are disbursed. In July 2021, we received notice from the SBA that our PPP loan was forgiven. The extinguishment of the PPP loan payable was recorded as PPP loan payable forgiveness income in the statement of operations and comprehensive loss and as non-cash PPP loan payable forgiveness income in the statement of cash flows during the year ended December 31, 2021. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
ACCRUED EXPENSES | NOTE 7 – ACCRUED EXPENSES Accrued expenses as of December 31, 2021 and 2020 consisted of the following: Schedule of Accrued expenses December 31, December 31, Accrued employee compensation $ 1,794,000 $ 1,982,000 Accrued contracted services and other 3,091,000 1,428,000 Accrued sublicense fee owed to licensor 700,000 - Accrued expenses $ 5,585,000 $ 3,410,000 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 8 - FAIR VALUE MEASUREMENTS We calculate the fair value of our assets and liabilities that qualify as financial instruments and include additional information in the notes to the consolidated financial statements when the fair value is different than the carrying value of these financial instruments. The estimated fair value of prepaid expenses and other current assets, other assets, accounts payable, accrued expenses, loan payable and deferred revenue approximate their carrying amounts due to the relatively short maturity of these instruments. U.S. GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. This guidance establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: ● Level 1 – Quoted prices in active markets for identical assets or liabilities. ● Level 2 – Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. ● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. The guidance requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. We have segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually) into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below. Financial assets and liabilities measured at fair value on a recurring and non-recurring basis as of December 31, 2021 and 2020 are summarized below: SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description December 31, Level 1 Level 2 Level 3 Total Recurring Assets: Short-term investments $ 12,086,000 $ - $ 12,086,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 1,384,000 $ - $ - $ 1,384,000 $ - Goodwill - - - - (32,466,000 ) Description December 31, Level 1 Level 2 Level 3 Total Recurring Assets: Short-term investments $ 82,438,000 $ - $ 82,438,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 1,500,000 $ - $ - $ 1,500,000 $ (32,916,000 ) Goodwill 32,466,000 - - 32,466,000 - |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 9 – STOCKHOLDERS’ EQUITY 2021 Public Offering of Common Stock and Stock Purchase Warrants On December 21, 2021, we closed an underwritten public offering of 44,700,000 shares of common stock at a public offering price of $ 0.39 per share and stock purchase warrants to purchase 44,700,000 shares of common stock at an exercise price of $ 0.39 . The net proceeds to the Company were approximately $ 16.0 million, after deducting $ 1.5 As of December 31, 2021, there were 44,700,000 2019 Public Offering of Common Stock and “Pre-Funded” Warrants On December 24, 2019, we closed an underwritten public offering of 32,382,945 2.50 9,017,055 2.4999 0.0001 103.5 In October 2020, all of the 9,017,055 9,017,055 |
REVENUE FROM CONTRACTS WITH CUS
REVENUE FROM CONTRACTS WITH CUSTOMERS | 12 Months Ended |
Dec. 31, 2021 | |
Revenues: | |
REVENUE FROM CONTRACTS WITH CUSTOMERS | NOTE 10 – REVENUE FROM CONTRACTS WITH CUSTOMERS Sublicense and Inventory Purchase Agreements Relating to CLN1 Disease: The transaction price of the contract includes (i) $ 7.0 26.0 30.0 26.0 Under this arrangement, we recognized $ 7.0 million of revenue during the year ended December 31, 2020, which amount related solely to fixed consideration. During the year ended December 31, 2021, Taysha achieved an event-based milestone payment and, accordingly, we recognized $ 3.0 million of revenue. As of December 31, 2021, we have a contract asset for $ 3.0 million consisting of our accounts receivable balance of $ 3.0 no t have any contract liabilities as a result of this transaction. We collected the $ 3.0 million of cash in January 2022 in full satisfaction of the contract asset. Sublicense Agreement Relating to Rett Syndrome: We assessed the nature of the promised license to determine whether the license has significant stand-alone functionality and evaluated whether such functionality can be retained without ongoing activities by us and determined that the license has significant stand-alone functionality. Furthermore, we have no ongoing activities associated with the license to support or maintain the license’s utility. Based on this, we determined that the pattern of transfer of control of the license to Taysha was at a point in time. The transaction price of the contract includes (i) $ 3.0 26.5 30.0 3.0 Under this arrangement, we recognized $ 3.0 no |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 11 – STOCK-BASED COMPENSATION We have two stock-based compensation plans as follows: (1) Abeona Therapeutics Inc. 2015 Equity Incentive Plan, which was approved by stockholders on May 7, 2015 and last amended on May 20, 2020 and (2) Abeona Therapeutics Inc. 2005 Equity Incentive Plan, which no further grants can be made under this plan. Stock Option Repricing: 1.16 17.30 1.15 79 0.6 On November 17, 2020, the Compensation Committee unanimously approved the repricing of all stock options outstanding under the Abeona Therapeutics Inc. 2015 Equity Incentive Plan and the Abeona Therapeutics Inc. 2005 Equity Incentive Plan held by the four current members of the Board that had an exercise price per share between $ 1.29 18.50 1.28 four 0.5 2015 Equity Incentive Plan Under our 2015 Equity Incentive Plan, as amended, up to 18,000,000 shares of our authorized but unissued common stock are reserved for issuance to employees, consultants, or to non-employee members of the Board or to any member of the board of directors (or similar governing authority) of any affiliate of the Company. As of December 31, 2021, we had 1,388,108 10 years. Stock Options: ● Expected volatility – we estimate the volatility of our share price at the date of grant using a “look-back” period which coincides with the expected term, defined below. We believe using a “look-back” period which coincides with the expected term is the most appropriate measure for determining expected volatility. ● Expected term – we estimate the expected term using the “simplified” method, as outlined in Staff Accounting Bulletin No. 107, “Share-Based Payment.” ● Risk-free interest rate – we estimate the risk-free interest rate using the U.S. Treasury yield curve for periods equal to the expected term of the options in effect at the time of grant. ● Dividends – we use an expected dividend yield of zero because we have not declared or paid a cash dividend, nor do we have any plans to declare a dividend. We used the following weighted-average assumptions to estimate the grant date fair value of the stock options granted for the years indicated: SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED For the years ended December 31, 2021 2020 Expected volatility 96 % 110 % Expected term 6.0 6.2 Risk-free interest rate 1.01 % 0.30 % Expected dividend yield 0.00 % 0.00 % We account for forfeitures as they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. Summarized stock option information for the 2015 Equity Incentive Plan is as follows: SCHEDULE OF OPTIONS ACTIVITY Options Weighted- Outstanding options at January 1, 2020 5,795,395 $ 7.96 Granted, fair value of $ 1.88 2,645,146 $ 2.26 Exercised (77,560 ) 2.28 Expired/forfeited (2,802,242 ) 6.52 Outstanding options at December 31, 2020 5,560,739 $ 2.21 Granted, fair value of $ 1.36 4,877,308 $ 1.75 Exercised (630,675 ) 1.32 Expired/forfeited (1,952,521 ) 4.07 Outstanding options at December 31, 2021 7,854,851 $ 1.54 Non-vested options at December 31, 2020 2,507,203 $ 1.29 Non-vested options at December 31, 2021 4,720,304 $ 1.64 The intrinsic value related to the outstanding options under this plan was $ 0 1.7 0 0.7 The total intrinsic value of the options exercised was $ 0.6 0 Further information regarding options outstanding under the 2015 Equity Incentive Plan as of December 31, 2021 is summarized below: SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE Weighted-average Weighted-average Range of exercise Number of Remaining Exercise Number of Remaining Exercise $ 0.34 $ 0.91 494,000 9.8 $ 0.84 - - $ - 1.02 1.88 5,576,851 7.0 1.30 3,069,547 5.2 1.27 2.18 2.34 1,719,000 9.2 2.29 - - - 6.59 7.34 65,000 3.7 7.28 65,000 3.7 7.28 7,854,851 3,134,547 As of December 31, 2021, the total compensation cost related to non-vested options not recognized is $ 6.6 2.8 Restricted Common Stock SCHEDULE OF RESTRICTED COMMON STOCK ACTIVITY Restricted Weighted- Outstanding awards at January 1, 2020 354,625 $ 3.14 Granted 5,290,312 $ 1.75 Vested (817,054 ) 2.26 Forfeited (1,875,384 ) 1.75 Outstanding awards at December 31, 2020 2,952,499 $ 1.78 Granted 2,890,668 $ 1.72 Vested (2,592,259 ) 1.55 Forfeited (819,393 ) 2.02 Outstanding awards at December 31, 2021 2,431,515 $ 1.86 The fair market value of the restricted common stock awards vested was $ 3.6 1.3 As of December 31, 2021, the total compensation cost related to restricted common stock not recognized is $ 3.6 3.0 2005 Equity Incentive Plan Under the 2005 Equity Incentive Plan, as amended, shares of our authorized but unissued common stock were reserved for issuance to employees, consultants, or to non-employee members of the Board or to any member of the board of directors (or similar governing authority) of any affiliate of the Company. As of January 20, 2015, no additional shares were available for grant under the 2005 Equity Incentive Plan. A total of 80,000 Summarized information for the 2005 Equity Incentive Plan is as follows: SCHEDULE OF OPTIONS ACTIVITY Options Weighted- Outstanding options at January 1, 2020 260,000 $ 12.94 Expired/forfeited (135,200 ) 6.80 Outstanding options at December 31, 2020 124,800 $ 8.55 Expired/forfeited (44,800 ) 21.53 Outstanding options at December 31, 2021 80,000 $ 1.28 The intrinsic value related to the outstanding or exercisable options under this plan was $ 0 Further information regarding options outstanding under the 2005 Equity Incentive Plan as of December 31, 2021 is summarized below: SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE Weighted-average Weighted-average Range of exercise Number of Remaining Exercise Number of Remaining Exercise $ 1.28 $ 1.28 80,000 1.8 $ 1.28 80,000 1.8 $ 1.28 80,000 80,000 |
401(k) PLAN
401(k) PLAN | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
401(k) PLAN | NOTE 12 – 401(k) PLAN We have a tax-qualified employee savings and retirement plan (the “401(k) Plan”) covering all our employees in the United States. Pursuant to the 401(k) Plan, employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit ($ 19,500 26,000 50 0.4 0.3 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 13 - INCOME TAXES Income tax expense differs from the statutory amounts for each of the following years: SCHEDULE OF INCOME TAX EXPENSE 2021 2020 For the years ended December 31, 2021 2020 Income taxes at U.S. statutory rate $ (17,836,000 ) $ (17,689,000 ) Current year reserve 12,539,000 12,020,000 Expenses not deductible 5,297,000 5,669,000 Total tax expense $ - $ - Deferred taxes are provided for the temporary differences between the financial reporting bases and the tax bases of our assets and liabilities. The temporary differences that give rise to deferred tax assets and liabilities were as follows: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES December 31, December 31, Deferred tax assets (liabilities): Net operating loss carryforwards $ 71,001,000 $ 61,062,000 General business credit carryforwards 4,741,000 4,398,000 State credits 2,780,000 2,857,000 Property, equipment and goodwill 200,000 8,000 Stock options 10,537,000 9,551,000 Deferred revenue 62,000 62,000 Intangible assets 367,000 312,000 Other 16,000 70,000 Gross deferred tax assets 89,704,000 78,320,000 Valuation allowance (89,704,000 ) (78,320,000 ) Net deferred taxes $ - $ - As of December 31, 2021, we had approximately $ 338.1 million of net operating loss carryforwards and approximately $ 4.7 million of general business credit carryforwards. These carryforwards expire as follows: SUMMARY OF NET OPERATING LOSS AND GENERAL BUSINESS CREDIT CARRYFORWARDS Net operating General business 2022 $ 8,230,000 $ 431,000 2023 5,434,000 362,000 2024 8,711,000 287,000 2025 2,370,000 182,000 2026 7,160,000 72,000 Thereafter 90,416,000 3,407,000 $ 122,321,000 $ 4,741,000 As of December 31, 2021, we had approximately $ 215.8 million of net operating loss carryforwards that do not expire and can be carried forward indefinitely. Such net operating loss carryforwards can only be used to offset 80 We acquired MacroChem Corporation on March 25, 2009 and Somanta Pharmaceuticals, Inc. on January 4, 2008. Both of these corporations were loss-making entities at the time of acquisition. As a result, the net operating losses related to those acquisitions may be subject to annual limitations. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 14 – COMMITMENTS AND CONTINGENCIES Operating Leases We lease space under operating leases for manufacturing and laboratory facilities and administrative offices in Cleveland, Ohio, as well as administrative offices in New York, New York. We also lease certain office equipment under operating leases, which have a non-cancelable lease term of less than one year Components of lease cost under ASC 842 for the years ended December 31, 2021 and 2020 are as follows: SCHEDULE OF COMPONENTS OF LEASE COST 2021 2020 For the years ended December 31, 2021 2020 Operating lease cost $ 1,761,000 $ 1,736,000 Variable lease cost $ 445,000 $ 337,000 Short-term lease cost $ 183,000 $ 61,000 The following table presents information about the amount and timing of cash flows arising from operating leases under ASC 842 as of December 31, 2021: SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES Maturity of lease liabilities: 2022 $ 1,818,000 2023 1,834,000 2024 1,879,000 2025 1,896,000 2026 871,000 Thereafter 3,663,000 Total undiscounted operating lease payments 11,961,000 Less: imputed interest 2,583,000 Present value of operating lease liabilities $ 9,378,000 Balance sheet classification: Current portion of lease liability $ 1,818,000 Long-term lease liability 7,560,000 Total operating lease liabilities $ 9,378,000 Other information: Weighted-average remaining lease term for operating leases 86 Weighted-average discount rate for operating leases 7.4 % |
NATURE OF OPERATIONS AND SUMM_2
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | Nature of Operations Abeona Therapeutics Inc. (together with our subsidiaries, “we,” “our,” “Abeona” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company developing gene and cell therapies for life-threatening rare genetic diseases. Our lead clinical program is EB-101, an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (“RDEB”), which is currently in the pivotal Phase 3 VIITAL™ clinical trial. Following a comprehensive portfolio review in early 2022, we have decided to focus our research and development resources on the VIITAL™ readout while actively pursuing a potential commercialization partner for EB-101 with the objective of reducing operating expenses and extending our cash runway. As part of this portfolio prioritization, we have intensified our pursuit of a strategic partnership to take over development activities for our adeno-associated virus (“AAV”)-based gene therapy ABO-102 for Sanfilippo syndrome type A (“MPS IIIA”) and we have discontinued development of our AAV-based gene therapy ABO-101 for Sanfilippo syndrome type B (“MPS IIIB”). We plan to continue development of AAV-based gene therapies designed to treat ophthalmic and other diseases and next-generation AAV-based gene therapies using the novel AIM™ capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill (“UNC”), and internal AAV vector research programs. A summary of the significant accounting policies applied in the preparation of the accompanying consolidated financial statements follows: |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the financial statements of Abeona Therapeutics Inc. and our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Uses and Sources of Liquidity | Uses and Sources of Liquidity The financial statements have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report was issued. As of December 31, 2021, we had cash, cash equivalents, restricted cash and short-term investments of $ 50.9 million and net assets of $ 51.4 million. For the year ended December 31, 2021, we had cash outflows from operations of $ 65.7 million. We have not generated significant product revenues and have not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and nonclinical testing, and commercialization of our products will require significant additional financing. We are subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of product candidates, obtaining the necessary regulatory approval to market our product candidates, raising additional capital to continue to fund our operations, development of competing drugs and therapies, protection of proprietary technology and market acceptance of our products. As a result of these and other risks and the related uncertainties, there can be no assurance of our future success. Following a comprehensive portfolio review in early 2022, we have decided to focus our research and development resources on the EB-101 program with the objective of reducing operating expenses and extending our cash runway. As part of this portfolio prioritization, we have intensified our pursuit of a strategic partnership to take over development activities for our AAV-based gene therapy ABO-102 for MPS IIIA and we have discontinued development of our AAV-based gene therapy ABO-101 for MPS IIIB. Based upon these current operating plans, our ability to access additional financial resources and/or our financial flexibility to further reduce operating expenses if required, we believe that we have sufficient resources to fund operations through at least the next 12 months from the date of this report on Form 10-K. We will need to secure additional funding beyond the next 12 months to carry out all of our planned research and development activities. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material adverse effect on our future prospects. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reported period. Actual results could differ from these estimates and assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. We maintain deposits primarily in financial institutions, which may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation (“FDIC”). We have not experienced any losses related to amounts in excess of FDIC limits. |
Short-term Investments | Short-term Investments Short-term investments consist of investments in U.S. government, U.S. agency and U.S. treasury securities. We determine the appropriate classification of the securities at the time they are acquired and evaluate the appropriateness of such classifications at each balance sheet date. We classify our short-term investments as available-for-sale pursuant to Accounting Standards Codification (“ASC”) 320, Investments – Debt and Equity Securities |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Depreciation is provided using the straight-line method over estimated useful lives ranging from three to seven years for equipment and five to ten years for leasehold improvements. Expenditures for major renewals and betterments that extend the useful lives are capitalized. Expenditures for normal maintenance and repairs are expensed as incurred. The cost of assets sold or abandoned, and the related accumulated depreciation are eliminated from the accounts and any gains or losses are recognized in the accompanying consolidated statements of operations of the respective period. |
Leases | Leases We account for leases in accordance with ASC 842, Leases Our leases do not have significant rent escalation, holidays, concessions, material residual value guarantees, material restrictive covenants or contingent rent provisions. Our leases include both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases. Most leases include one or more options to renew. The exercise of lease renewal options is typically at our sole discretion; therefore, the majority of renewals to extend the lease terms are not included in our right-of-use assets and lease liabilities as they are not reasonably certain of exercise. We regularly evaluate the renewal options and when they are reasonably certain of exercise, we include the renewal period in our lease term. Additional information and disclosures required under ASC 842 are included in Note 14. |
Licensed Technology | Licensed Technology We have entered into agreements to license the rights to certain technologies. We recorded the purchase price paid for the license, which represents fair value, on our consolidated balance sheet. We maintain licensed technology on our consolidated balance sheet until either the licensed technology agreement underlying it is completed or the asset becomes impaired. When we determine that an asset has become impaired or we abandon a project, we write down the carrying value of the related intangible asset to its fair value and take an impairment charge in the period in which the impairment occurs. Licensed technology is amortized over the life of the patent or the agreement and periodically reviewed for impairment. We test our intangible assets for impairment on an annual basis, or more frequently if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding our drug candidate or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate or new information regarding potential sales for the drug. In connection with each annual impairment assessment and any interim impairment assessment, we compare the fair value of the asset as of the date of the assessment with the carrying value of the asset on our consolidated balance sheet. We considered the status of our discussions with REGENXBIO in March 2020 as a potential indicator of impairment in accordance with ASC 360-10-35-21. Our impairment test indicated that the carrying value of the license agreement exceeded its fair value and we recorded a $ 32.9 |
Goodwill | Goodwill In accordance with ASC 350, Intangibles — Goodwill and Other, |
Restricted Cash | Restricted Cash As of December 31, 2021 and 2020, restricted cash of $ 5.0 nil 0.9 1.0 |
Segments | Segments The Company operates in a single segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. |
Revenue Recognition | Revenue Recognition We account for contracts with customers in accordance with ASC 606, Revenue from Contracts with Customers Additional information and disclosures required under ASC 606 are included in Note 10. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred. Research and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical and development cost, clinical trial expense, manufacturing, regulatory, and consulting. The cost of materials and equipment or facilities that are acquired for research and development activities and that have alternative future uses are capitalized when acquired. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses primarily consist of personnel, contract personnel, personnel-related expenses to support our administrative and operating activities, facility costs and professional expenses (i.e., legal expenses) and investor relations fees. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided for deferred tax assets to the extent their realization is in doubt. We account for uncertain income tax positions in accordance with ASC 740, Income Taxes |
Loss Per Common Share | Loss Per Common Share We have presented basic and diluted loss per common share on the statement of operations and comprehensive loss. Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock. We do not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock purchase warrants. We did not include the following potentially dilutive securities in the computation of diluted net loss per common share during the periods presented: SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE For the years ended December 31, 2021 2020 Restricted stock 2,431,515 2,952,499 Stock options 7,934,851 5,685,539 Stock purchase warrants 44,700,000 - Total 55,066,366 8,638,038 |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation expense in accordance with ASC 718, Stock Based Compensation The fair value of modifications to share-based awards are determined using Hull White I lattice model which includes assumptions for expected volatility, risk-free interest rate, dividend yield and performance period. If a share-based compensation award is modified after the grant date, incremental compensation expense, if any, is recognized in an amount equal to the excess of the fair value of the modified award over the fair value of the original award immediately before the modification. Incremental compensation expense for vested awards is recognized immediately. For unvested awards, the sum of the incremental compensation expense and the remaining unrecognized compensation expense for the original award on the modification date is recognized over the modified service period. The following table summarizes stock option-based option compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,915,000 $ 3,126,000 General and administrative 3,335,000 2,727,000 Stock option-based compensation expense included in operating expense 5,250,000 5,853,000 Total stock option-based compensation expense 5,250,000 5,853,000 Tax benefit - - Stock option-based compensation expense, net of tax $ 5,250,000 $ 5,853,000 The following table summarizes restricted stock-based compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,384,000 $ 957,000 General and administrative 2,282,000 1,377,000 Restricted stock-based compensation expense included in operating expense 3,666,000 2,334,000 Total restricted stock-based compensation expense 3,666,000 2,334,000 Tax benefit - - Restricted stock-based compensation expense, net of tax $ 3,666,000 $ 2,334,000 Additional information and disclosures required under ASC 718 are included in Note 11. |
NATURE OF OPERATIONS AND SUMM_3
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE | SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE For the years ended December 31, 2021 2020 Restricted stock 2,431,515 2,952,499 Stock options 7,934,851 5,685,539 Stock purchase warrants 44,700,000 - Total 55,066,366 8,638,038 |
SCHEDULE OF STOCK BASED COMPENSATION | The following table summarizes stock option-based option compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,915,000 $ 3,126,000 General and administrative 3,335,000 2,727,000 Stock option-based compensation expense included in operating expense 5,250,000 5,853,000 Total stock option-based compensation expense 5,250,000 5,853,000 Tax benefit - - Stock option-based compensation expense, net of tax $ 5,250,000 $ 5,853,000 |
Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
SCHEDULE OF STOCK BASED COMPENSATION | The following table summarizes restricted stock-based compensation for 2021 and 2020, which was allocated as follows: SCHEDULE OF STOCK BASED COMPENSATION For the years ended December 31, 2021 2020 Research and development $ 1,384,000 $ 957,000 General and administrative 2,282,000 1,377,000 Restricted stock-based compensation expense included in operating expense 3,666,000 2,334,000 Total restricted stock-based compensation expense 3,666,000 2,334,000 Tax benefit - - Restricted stock-based compensation expense, net of tax $ 3,666,000 $ 2,334,000 |
SHORT-TERM INVESTMENTS (Tables)
SHORT-TERM INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
SCHEDULE OF AVAILABLE-FOR-SALE INVESTMENTS HELD | The following table summarizes the available-for-sale investments held as of December 31, 2021 and 2020. SCHEDULE OF AVAILABLE-FOR-SALE INVESTMENTS HELD Description December 31, December 31, 2020 U.S. government and agency securities and treasuries $ 12,086,000 $ 82,438,000 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment consist of the following: SCHEDULE OF PROPERTY AND EQUIPMENT December 31, December 31, Laboratory equipment $ 9,081,000 $ 8,160,000 Furniture and office equipment 1,896,000 1,818,000 Leasehold improvements 8,603,000 8,602,000 Construction work-in-progress 3,219,000 71,000 22,799,000 18,651,000 Less: accumulated depreciation and amortization 10,460,000 7,329,000 Property and equipment, net $ 12,339,000 $ 11,322,000 |
LICENSED TECHNOLOGY (Tables)
LICENSED TECHNOLOGY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF LICENSED TECHNOLOGY | Licensed technology consists of the following: SCHEDULE OF LICENSED TECHNOLOGY December 31, December 31, Licensed technology $ 2,156,000 $ 2,156,000 Less accumulated amortization 772,000 656,000 Licensed technology, net $ 1,384,000 $ 1,500,000 |
SCHEDULE OF AMORTIZATION EXPENSE FOR INTANGIBLE ASSETS | The aggregate estimated amortization expense for intangible assets remaining as of December 31, 2021 is as follows: SCHEDULE OF AMORTIZATION EXPENSE FOR INTANGIBLE ASSETS 2022 $ 116,000 2023 116,000 2024 117,000 2025 117,000 2026 117,000 Thereafter 801,000 Total $ 1,384,000 |
GOODWILL (Tables)
GOODWILL (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF GOODWILL | SCHEDULE OF GOODWILL For the years ended December 31, 2021 2020 Goodwill at the beginning of the year $ 32,466,000 $ 32,466,000 Goodwill impairment charge (32,466,000 ) - Goodwill at the end of the year $ - $ 32,466,000 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Schedule of Accrued expenses | Accrued expenses as of December 31, 2021 and 2020 consisted of the following: Schedule of Accrued expenses December 31, December 31, Accrued employee compensation $ 1,794,000 $ 1,982,000 Accrued contracted services and other 3,091,000 1,428,000 Accrued sublicense fee owed to licensor 700,000 - Accrued expenses $ 5,585,000 $ 3,410,000 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS | Financial assets and liabilities measured at fair value on a recurring and non-recurring basis as of December 31, 2021 and 2020 are summarized below: SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description December 31, Level 1 Level 2 Level 3 Total Recurring Assets: Short-term investments $ 12,086,000 $ - $ 12,086,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 1,384,000 $ - $ - $ 1,384,000 $ - Goodwill - - - - (32,466,000 ) Description December 31, Level 1 Level 2 Level 3 Total Recurring Assets: Short-term investments $ 82,438,000 $ - $ 82,438,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 1,500,000 $ - $ - $ 1,500,000 $ (32,916,000 ) Goodwill 32,466,000 - - 32,466,000 - |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED | We used the following weighted-average assumptions to estimate the grant date fair value of the stock options granted for the years indicated: SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED For the years ended December 31, 2021 2020 Expected volatility 96 % 110 % Expected term 6.0 6.2 Risk-free interest rate 1.01 % 0.30 % Expected dividend yield 0.00 % 0.00 % |
2015 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
SCHEDULE OF OPTIONS ACTIVITY | Summarized stock option information for the 2015 Equity Incentive Plan is as follows: SCHEDULE OF OPTIONS ACTIVITY Options Weighted- Outstanding options at January 1, 2020 5,795,395 $ 7.96 Granted, fair value of $ 1.88 2,645,146 $ 2.26 Exercised (77,560 ) 2.28 Expired/forfeited (2,802,242 ) 6.52 Outstanding options at December 31, 2020 5,560,739 $ 2.21 Granted, fair value of $ 1.36 4,877,308 $ 1.75 Exercised (630,675 ) 1.32 Expired/forfeited (1,952,521 ) 4.07 Outstanding options at December 31, 2021 7,854,851 $ 1.54 Non-vested options at December 31, 2020 2,507,203 $ 1.29 Non-vested options at December 31, 2021 4,720,304 $ 1.64 |
SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE | Further information regarding options outstanding under the 2015 Equity Incentive Plan as of December 31, 2021 is summarized below: SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE Weighted-average Weighted-average Range of exercise Number of Remaining Exercise Number of Remaining Exercise $ 0.34 $ 0.91 494,000 9.8 $ 0.84 - - $ - 1.02 1.88 5,576,851 7.0 1.30 3,069,547 5.2 1.27 2.18 2.34 1,719,000 9.2 2.29 - - - 6.59 7.34 65,000 3.7 7.28 65,000 3.7 7.28 7,854,851 3,134,547 |
SCHEDULE OF RESTRICTED COMMON STOCK ACTIVITY | Restricted Common Stock SCHEDULE OF RESTRICTED COMMON STOCK ACTIVITY Restricted Weighted- Outstanding awards at January 1, 2020 354,625 $ 3.14 Granted 5,290,312 $ 1.75 Vested (817,054 ) 2.26 Forfeited (1,875,384 ) 1.75 Outstanding awards at December 31, 2020 2,952,499 $ 1.78 Granted 2,890,668 $ 1.72 Vested (2,592,259 ) 1.55 Forfeited (819,393 ) 2.02 Outstanding awards at December 31, 2021 2,431,515 $ 1.86 |
2005 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
SCHEDULE OF OPTIONS ACTIVITY | Summarized information for the 2005 Equity Incentive Plan is as follows: SCHEDULE OF OPTIONS ACTIVITY Options Weighted- Outstanding options at January 1, 2020 260,000 $ 12.94 Expired/forfeited (135,200 ) 6.80 Outstanding options at December 31, 2020 124,800 $ 8.55 Expired/forfeited (44,800 ) 21.53 Outstanding options at December 31, 2021 80,000 $ 1.28 |
SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE | Further information regarding options outstanding under the 2005 Equity Incentive Plan as of December 31, 2021 is summarized below: SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE Weighted-average Weighted-average Range of exercise Number of Remaining Exercise Number of Remaining Exercise $ 1.28 $ 1.28 80,000 1.8 $ 1.28 80,000 1.8 $ 1.28 80,000 80,000 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF INCOME TAX EXPENSE | Income tax expense differs from the statutory amounts for each of the following years: SCHEDULE OF INCOME TAX EXPENSE 2021 2020 For the years ended December 31, 2021 2020 Income taxes at U.S. statutory rate $ (17,836,000 ) $ (17,689,000 ) Current year reserve 12,539,000 12,020,000 Expenses not deductible 5,297,000 5,669,000 Total tax expense $ - $ - |
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES | Deferred taxes are provided for the temporary differences between the financial reporting bases and the tax bases of our assets and liabilities. The temporary differences that give rise to deferred tax assets and liabilities were as follows: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES December 31, December 31, Deferred tax assets (liabilities): Net operating loss carryforwards $ 71,001,000 $ 61,062,000 General business credit carryforwards 4,741,000 4,398,000 State credits 2,780,000 2,857,000 Property, equipment and goodwill 200,000 8,000 Stock options 10,537,000 9,551,000 Deferred revenue 62,000 62,000 Intangible assets 367,000 312,000 Other 16,000 70,000 Gross deferred tax assets 89,704,000 78,320,000 Valuation allowance (89,704,000 ) (78,320,000 ) Net deferred taxes $ - $ - |
SUMMARY OF NET OPERATING LOSS AND GENERAL BUSINESS CREDIT CARRYFORWARDS | SUMMARY OF NET OPERATING LOSS AND GENERAL BUSINESS CREDIT CARRYFORWARDS Net operating General business 2022 $ 8,230,000 $ 431,000 2023 5,434,000 362,000 2024 8,711,000 287,000 2025 2,370,000 182,000 2026 7,160,000 72,000 Thereafter 90,416,000 3,407,000 $ 122,321,000 $ 4,741,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF COMPONENTS OF LEASE COST | Components of lease cost under ASC 842 for the years ended December 31, 2021 and 2020 are as follows: SCHEDULE OF COMPONENTS OF LEASE COST 2021 2020 For the years ended December 31, 2021 2020 Operating lease cost $ 1,761,000 $ 1,736,000 Variable lease cost $ 445,000 $ 337,000 Short-term lease cost $ 183,000 $ 61,000 |
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES | The following table presents information about the amount and timing of cash flows arising from operating leases under ASC 842 as of December 31, 2021: SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES Maturity of lease liabilities: 2022 $ 1,818,000 2023 1,834,000 2024 1,879,000 2025 1,896,000 2026 871,000 Thereafter 3,663,000 Total undiscounted operating lease payments 11,961,000 Less: imputed interest 2,583,000 Present value of operating lease liabilities $ 9,378,000 Balance sheet classification: Current portion of lease liability $ 1,818,000 Long-term lease liability 7,560,000 Total operating lease liabilities $ 9,378,000 Other information: Weighted-average remaining lease term for operating leases 86 Weighted-average discount rate for operating leases 7.4 % |
SCHEDULE OF ANTIDILUTIVE SECURI
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 55,066,366 | 8,638,038 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,431,515 | 2,952,499 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 7,934,851 | 5,685,539 |
Stock Purchase Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 44,700,000 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | $ 5,250,000 | $ 5,853,000 |
Tax benefit | ||
Stock based compensation expense, net of tax | 5,250,000 | 5,853,000 |
Share-based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | 5,250,000 | 5,853,000 |
Share-based Payment Arrangement, Option [Member] | Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | 1,915,000 | 3,126,000 |
Share-based Payment Arrangement, Option [Member] | Selling, General and Administrative Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | 3,335,000 | 2,727,000 |
Restricted Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | 3,666,000 | 2,334,000 |
Tax benefit | ||
Stock based compensation expense, net of tax | 3,666,000 | 2,334,000 |
Restricted stock-based compensation expense included in operating expense | 3,666,000 | 2,334,000 |
Restricted Stock [Member] | Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | 1,384,000 | 957,000 |
Restricted Stock [Member] | Selling, General and Administrative Expenses [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock based compensation expense | $ 2,282,000 | $ 1,377,000 |
NATURE OF OPERATIONS AND SUMM_4
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash, Cash Equivalents, and Short-term Investments | $ 50,900,000 | |
Net Assets | 51,400,000 | |
Net Cash Provided by (Used in) Operating Activities | 65,665,000 | $ 35,019,000 |
Non-cash licensed technology impairment charge | 32,900,000 | |
Prepaid Expenses and Other Current Assets [Member] | ||
Restricted cash | 5,000,000 | |
Other Assets and Restricted Cash [Member] | ||
Restricted cash | $ 900,000 | $ 1,000,000 |
SCHEDULE OF AVAILABLE-FOR-SALE
SCHEDULE OF AVAILABLE-FOR-SALE INVESTMENTS HELD (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
U.S. government and agency securities and treasuries | $ 12,086,000 | $ 82,438,000 |
SHORT-TERM INVESTMENTS (Details
SHORT-TERM INVESTMENTS (Details Narrative) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized cost of available-for-sale debt securities | $ 12,087,000 | $ 82,448,000 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 22,799,000 | $ 18,651,000 |
Property and equipment, gross | 10,460,000 | 7,329,000 |
Property and equipment, gross | 12,339,000 | 11,322,000 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,081,000 | 8,160,000 |
Furniture and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,896,000 | 1,818,000 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 8,603,000 | 8,602,000 |
Construction Work in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,219,000 | $ 71,000 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation, Depletion and Amortization, Nonproduction | $ 3.1 | $ 3.2 |
SCHEDULE OF LICENSED TECHNOLOGY
SCHEDULE OF LICENSED TECHNOLOGY (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Licensed technology | $ 2,156,000 | $ 2,156,000 |
Less accumulated amortization | 772,000 | 656,000 |
Licensed technology, net | $ 1,384,000 | $ 1,500,000 |
SCHEDULE OF AMORTIZATION EXPENS
SCHEDULE OF AMORTIZATION EXPENSE FOR INTANGIBLE ASSETS (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2022 | $ 116,000 | |
2023 | 116,000 | |
2024 | 117,000 | |
2025 | 117,000 | |
2026 | 117,000 | |
Thereafter | 801,000 | |
Licensed technology, net | $ 1,384,000 | $ 1,500,000 |
LICENSED TECHNOLOGY (Details Na
LICENSED TECHNOLOGY (Details Narrative) - USD ($) | Nov. 12, 2021 | Jul. 13, 2021 | Nov. 04, 2020 | May 25, 2020 | Apr. 17, 2020 | Apr. 02, 2020 | Nov. 04, 2018 | May 15, 2015 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 04, 2019 |
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Royalties payments | $ 20,000,000 | $ 8,000,000 | |||||||||
Current portion of payable to licensor | $ 4,599,000 | $ 31,515,000 | |||||||||
License to be paid | $ 8,000,000 | ||||||||||
Interest payable | $ 1,000,000 | ||||||||||
Debt instrument, maturity date | Nov. 4, 2020 | ||||||||||
License termination date | May 2, 2020 | ||||||||||
Other Cost and Expense, Operating | 32,916,000 | ||||||||||
Settlement Liabilities, Current | $ 30,000,000 | ||||||||||
Loss Contingency, Settlement Agreement, Court | (1) $20 million that was paid in November 2021 after execution of the Settlement Agreement, (2) $5 million on the first anniversary of the effective date of the Settlement Agreement, and (3) $5 million upon the earlier of: (i) the third anniversary of the effective date of the Settlement Agreement or (ii) the closing of a Strategic Transaction, as defined in the Settlement Agreement. | ||||||||||
Other assets and restricted cash | 1,059,000 | 1,136,000 | |||||||||
[custom:GainOnSettlementOfRelatedParty] | 6,743,000 | ||||||||||
Amortization of licensed technology | 116,000 | $ 1,400,000 | |||||||||
Abeona Therapeutics LLC [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Finite-lived intangible asset, useful life | 20 years | ||||||||||
Other Current Assets [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Other assets and restricted cash | 5,000,000 | ||||||||||
RDEB Product [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Gain loss on payments for settlement | $ 28,000,000 | ||||||||||
Original License Agreement [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
License to be paid | 10,000,000 | ||||||||||
Amended Agreements [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
License to be paid | 3,000,000 | ||||||||||
Amended Agreements [Member] | April 1, 2020 [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
License to be paid | $ 8,000,000 | ||||||||||
REGENXBIO [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
[custom:GainOnSettlementOfRelatedParty] | 6,700,000 | ||||||||||
REGENXBIO [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Gain loss on payments for settlement | $ 28,000,000 | $ 28,000,000 | |||||||||
Licensing Agreements [Member] | REGENXBIO [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Royalty fees | $ 180,000,000 | ||||||||||
Royalties payments | $ 20,000,000 | 60,000,000 | |||||||||
Payment for execution of contracts | 10,000,000 | ||||||||||
Current portion of payable to licensor | $ 10,000,000 | ||||||||||
Finite-lived intangible asset, useful life | 8 years | ||||||||||
Loss contingency accrual | 8,000,000 | ||||||||||
Payments for legal settlements | $ 20,000,000 | ||||||||||
Licensing Agreements [Member] | REGENXBIO [Member] | Maximum [Member] | |||||||||||
Indefinite-lived Intangible Assets [Line Items] | |||||||||||
Annual fees | $ 100,000,000 |
SCHEDULE OF GOODWILL (Details)
SCHEDULE OF GOODWILL (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill at the beginning of the year | $ 32,466,000 | $ 32,466,000 |
Goodwill impairment charge | (32,466,000) | |
Goodwill at the end of the year | $ 32,466,000 |
GOODWILL (Details Narrative)
GOODWILL (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Goodwill | $ 32,466,000 | $ 32,466,000 | |
Goodwill, Impairment Loss | $ 32,466,000 |
LOAN PAYABLE (Details Narrative
LOAN PAYABLE (Details Narrative) $ in Millions | May 02, 2020USD ($) |
Paycheck Protection Program [Member] | |
Short-term Debt [Line Items] | |
Proceeds from Notes Payable | $ 1.8 |
Schedule of Accrued expenses (D
Schedule of Accrued expenses (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses | ||
Accrued employee compensation | $ 1,794,000 | $ 1,982,000 |
Accrued contracted services and other | 3,091,000 | 1,428,000 |
Accrued sublicense fee owed to licensor | 700,000 | |
Accrued expenses | $ 5,585,000 | $ 3,410,000 |
SCHEDULE OF FAIR VALUE, ASSETS
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Short Term Investment [Member] | Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | $ 12,086,000 | $ 82,438,000 |
Fair value disclosure of gain loss | ||
Short Term Investment [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Short Term Investment [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | 12,086,000 | 82,438,000 |
Short Term Investment [Member] | Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Licensed Technology Net [Member] | Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | 1,384,000 | 1,500,000 |
Fair value disclosure of gain loss | (32,916,000) | |
Licensed Technology Net [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Licensed Technology Net [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Licensed Technology Net [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | 1,384,000 | 1,500,000 |
Goodwill [Member] | Fair Value, Nonrecurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | 32,466,000 | |
Fair value disclosure of gain loss | (32,466,000) | |
Goodwill [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Goodwill [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | ||
Goodwill [Member] | Fair Value, Nonrecurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value disclosure of assets | $ 32,466,000 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | Dec. 21, 2021 | Dec. 24, 2019 | Oct. 31, 2020 | Dec. 31, 2021 |
Class of Warrant or Right [Line Items] | ||||
Underwriter discounts and offering expenses | $ 1.5 | |||
2021 Public Offering [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Issuance of common shares | 44,700,000 | |||
Shares issued, price per share | $ 0.39 | |||
Issuance of warrant to purchase common stock | 44,700,000 | |||
Warrants exercise price | $ 0.39 | |||
Issuance of common shares, value | $ 16 | |||
Warrants outstanding | 44,700,000 | |||
2019 Public Offering [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Issuance of common shares | 32,382,945 | |||
Shares issued, price per share | $ 2.50 | |||
Warrants exercise price | $ 0.0001 | |||
Issuance of common shares, value | $ 103.5 | |||
2019 Public Offering [Member] | Pre - Funded Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Issuance of warrant to purchase common stock | 9,017,055 | |||
Warrants exercise price | $ 2.4999 | |||
Warrants exercised | 9,017,055 | |||
2019 Public Offering [Member] | Maximum [Member] | Pre - Funded Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Issuance of warrant to purchase common stock | 9,017,055 |
REVENUE FROM CONTRACTS WITH C_2
REVENUE FROM CONTRACTS WITH CUSTOMERS (Details Narrative) - USD ($) | Aug. 14, 2020 | Jan. 31, 2022 | Oct. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 3,000,000 | $ 10,000,000 | |||
Accounts receivable | 3,000,000 | ||||
Sublicense and Inventory Purchase Agreements [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Fixed consideration | $ 7,000,000 | ||||
Contract assets | 3,000,000 | ||||
Accounts receivable | 3,000,000 | ||||
Contract liability | 0 | ||||
Sublicense and Inventory Purchase Agreements [Member] | Subsequent Event [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
[custom:ProceedsFromContractWithCustomerAssets] | $ 3,000,000 | ||||
Sublicense and Inventory Purchase Agreements [Member] | Event Based Milestone Payments [Member] | Maximum [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Milestone payments | 26,000,000 | ||||
Sublicense and Inventory Purchase Agreements [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Milestone payments | $ 30,000,000 | ||||
Sublicense and Inventory Purchase Agreements [Member] | License [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 3,000,000 | 7,000,000 | |||
Sublicense Agreement [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Fixed consideration | $ 3,000,000 | 3,000,000 | |||
Contract assets | 0 | ||||
Contract liability | $ 0 | ||||
Sublicense Agreement [Member] | Event Based Milestone Payments [Member] | Maximum [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Milestone payments | 26,500,000 | ||||
Sublicense Agreement [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Milestone payments | $ 30,000,000 | ||||
Sublicense Agreement [Member] | License [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 3,000,000 |
SCHEDULE OF WEIGHTED-AVERAGE AS
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Expected volatility | 96.00% | 110.00% |
Expected term | 6 years | 6 years 2 months 12 days |
Risk-free interest rate | 1.01% | 0.30% |
Expected dividend yield | 0.00% | 0.00% |
SCHEDULE OF OPTIONS ACTIVITY (D
SCHEDULE OF OPTIONS ACTIVITY (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
2015 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning balance, Options, Outstanding options | 5,560,739 | 5,795,395 |
Beginning balance, Weighted- average exercise price, Outstanding options | $ 2.21 | $ 7.96 |
Options, Granted | 4,877,308 | 2,645,146 |
Weighted- average exercise price, Granted | $ 1.75 | $ 2.26 |
Options, Exercised | (630,675) | (77,560) |
Weighted- average exercise price, Exercised | $ 1.32 | $ 2.28 |
Options, Expired/forfeited | (1,952,521) | (2,802,242) |
Weighted- average exercise price, Expired/forfeited | $ 4.07 | $ 6.52 |
Ending balance, Options, Outstanding options | 7,854,851 | 5,560,739 |
Ending balance, Options, Outstanding options | $ 1.54 | $ 2.21 |
Options, Non-vested options | 4,720,304 | 2,507,203 |
Weighted- average exercise price, Non-vested options | $ 1.64 | $ 1.29 |
2005 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning balance, Options, Outstanding options | 124,800 | 260,000 |
Beginning balance, Weighted- average exercise price, Outstanding options | $ 8.55 | $ 12.94 |
Options, Expired/forfeited | (44,800) | (135,200) |
Weighted- average exercise price, Expired/forfeited | $ 21.53 | $ 6.80 |
Ending balance, Options, Outstanding options | 80,000 | 124,800 |
Ending balance, Options, Outstanding options | $ 1.28 | $ 8.55 |
SCHEDULE OF OPTIONS ACTIVITY _2
SCHEDULE OF OPTIONS ACTIVITY (Details) (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
2015 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of granted | $ 1.36 | $ 1.88 |
SCHEDULE OF OPTIONS OUTSTANDING
SCHEDULE OF OPTIONS OUTSTANDING AND EXERCISABLE (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
2015 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options outstanding | 7,854,851 | 5,560,739 | 5,795,395 |
Weighted-average Remaining life in years | 10 years | ||
Weighted-average Exercise price | $ 1.54 | $ 2.21 | $ 7.96 |
Number of options exercisable | 3,134,547 | ||
2015 Equity Incentive Plan [Member] | Range One [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise price, lower limit | $ 0.34 | ||
Range of exercise price, upper limit | $ 0.91 | ||
Number of options outstanding | 494,000 | ||
Weighted-average Remaining life in years | 9 years 9 months 18 days | ||
Weighted-average Exercise price | $ 0.84 | ||
Number of options exercisable | |||
Weighted-average Remaining life in years, exercisable | |||
Weighted-average Exercise price, exercisable | |||
2015 Equity Incentive Plan [Member] | Range Two [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise price, lower limit | 1.02 | ||
Range of exercise price, upper limit | $ 1.88 | ||
Number of options outstanding | 5,576,851 | ||
Weighted-average Remaining life in years | 7 years | ||
Weighted-average Exercise price | $ 1.30 | ||
Number of options exercisable | 3,069,547 | ||
Weighted-average Remaining life in years, exercisable | 5 years 2 months 12 days | ||
Weighted-average Exercise price, exercisable | $ 1.27 | ||
2015 Equity Incentive Plan [Member] | Range Three [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise price, lower limit | 2.18 | ||
Range of exercise price, upper limit | $ 2.34 | ||
Number of options outstanding | 1,719,000 | ||
Weighted-average Remaining life in years | 9 years 2 months 12 days | ||
Weighted-average Exercise price | $ 2.29 | ||
Number of options exercisable | |||
Weighted-average Remaining life in years, exercisable | |||
Weighted-average Exercise price, exercisable | |||
2015 Equity Incentive Plan [Member] | Range Four [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise price, lower limit | 6.59 | ||
Range of exercise price, upper limit | $ 7.34 | ||
Number of options outstanding | 65,000 | ||
Weighted-average Remaining life in years | 3 years 8 months 12 days | ||
Weighted-average Exercise price | $ 7.28 | ||
Number of options exercisable | 65,000 | ||
Weighted-average Remaining life in years, exercisable | 3 years 8 months 12 days | ||
Weighted-average Exercise price, exercisable | $ 7.28 | ||
2005 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options outstanding | 80,000 | 124,800 | 260,000 |
Weighted-average Exercise price | $ 1.28 | $ 8.55 | $ 12.94 |
Number of options exercisable | 80,000 | ||
2005 Equity Incentive Plan [Member] | Range One [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise price, lower limit | $ 1.28 | ||
Range of exercise price, upper limit | $ 1.28 | ||
Number of options outstanding | 80,000 | ||
Weighted-average Remaining life in years | 1 year 9 months 18 days | ||
Weighted-average Exercise price | $ 1.28 | ||
Number of options exercisable | 80,000 | ||
Weighted-average Remaining life in years, exercisable | 1 year 9 months 18 days | ||
Weighted-average Exercise price, exercisable | $ 1.28 |
SCHEDULE OF RESTRICTED COMMON S
SCHEDULE OF RESTRICTED COMMON STOCK ACTIVITY (Details) - 2015 Equity Incentive Plan [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted common stock awards, Vested | (3,600,000) | (1,300,000) |
Restricted Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Beginning balance, Restricted common stock awards, Outstanding awards | 2,952,499 | 354,625 |
Beginning balance, Weighted-average grant date fair value, Outstanding awards | $ 1.78 | $ 3.14 |
Restricted common stock awards, Granted | 2,890,668 | 5,290,312 |
Weighted-average grant date fair value, Granted | $ 1.72 | $ 1.75 |
Restricted common stock awards, Vested | (2,592,259) | (817,054) |
Weighted-average grant date fair value, Vested | $ 1.55 | $ 2.26 |
Restricted common stock awards | (819,393) | (1,875,384) |
Weighted-average grant date fair value, Forfeited | $ 2.02 | $ 1.75 |
Ending balance, Restricted common stock awards, Outstanding awards | 2,431,515 | 2,952,499 |
Ending balance, Weighted-average grant date fair value, Outstanding awards | $ 1.86 | $ 1.78 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) | Nov. 17, 2020USD ($)Grantees$ / shares | Nov. 10, 2020USD ($)Grantees$ / shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019$ / sharesshares |
2015 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.54 | $ 2.21 | $ 7.96 | ||
Common Stock, Shares Subscribed but Unissued | shares | 18,000,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 10 years | ||||
Intrinsic value outstanding options | $ | $ 0 | $ 1,700,000 | |||
Intrinsic value exercisable options | $ | 0 | 700,000 | |||
Intrinsic value of the options exercised | $ | 600,000 | $ 0 | |||
Compensation cost related to non-vested options not recognized | $ | $ 6,600,000 | ||||
Weighted average period total compensation costs related to non-vested options | 2 years 9 months 18 days | ||||
Shares of restricted common stock vested | shares | 3,600,000 | 1,300,000 | |||
Compensation cost related to restricted common stock not recognized | $ | $ 3,600,000 | ||||
Weighted average compensation costs related to restricted common stock | 3 years | ||||
Options outstanding | shares | 7,854,851 | 5,560,739 | 5,795,395 | ||
Options exercisable | shares | 3,134,547 | ||||
2015 Equity Incentive Plan [Member] | Eligible Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.15 | ||||
Number of grantees affected | Grantees | 79 | ||||
Incremental compensation cost | $ | $ 600,000 | ||||
2015 Equity Incentive Plan [Member] | Eligible Stock Options [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.16 | ||||
2015 Equity Incentive Plan [Member] | Eligible Stock Options [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 17.30 | ||||
2015 Equity Incentive Plan [Member] | Eligible Director Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.28 | ||||
Number of grantees affected | Grantees | 4 | ||||
Incremental compensation cost | $ | $ 500,000 | ||||
2015 Equity Incentive Plan [Member] | Eligible Director Stock Options [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.29 | ||||
2015 Equity Incentive Plan [Member] | Eligible Director Stock Options [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 18.50 | ||||
Two Thousand And Fifteen Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock for future issuance | shares | 1,388,108 | ||||
2005 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price per share | $ / shares | $ 1.28 | $ 8.55 | $ 12.94 | ||
Intrinsic value outstanding options | $ | $ 0 | $ 0 | |||
Options outstanding | shares | 80,000 | 124,800 | 260,000 | ||
Options exercisable | shares | 80,000 |
401(k) PLAN (Details Narrative)
401(k) PLAN (Details Narrative) | 12 Months Ended | |
Dec. 31, 2021USD ($)Integer | Dec. 31, 2020USD ($) | |
Defined Benefit Plan Disclosure [Line Items] | ||
Maximum annual contribution per employee under 401(k) plan | $ 19,500 | $ 19,500 |
Number of investment options | Integer | 50 | |
Company contributions under 401 (k) Plan | $ 400,000 | 300,000 |
Under Age Fiffty [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Maximum annual contribution per employee under 401(k) plan | $ 26,000 | $ 26,000 |
SCHEDULE OF INCOME TAX EXPENSE
SCHEDULE OF INCOME TAX EXPENSE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income taxes at U.S. statutory rate | $ (17,836,000) | $ (17,689,000) |
Current year reserve | 12,539,000 | 12,020,000 |
Expenses not deductible | 5,297,000 | 5,669,000 |
Total tax expense |
SCHEDULE OF DEFERRED TAX ASSETS
SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 71,001,000 | $ 61,062,000 |
General business credit carryforwards | 4,741,000 | 4,398,000 |
State credits | 2,780,000 | 2,857,000 |
Property, equipment and goodwill | 200,000 | 8,000 |
Stock options | 10,537,000 | 9,551,000 |
Deferred revenue | 62,000 | 62,000 |
Intangible assets | 367,000 | 312,000 |
Other | 16,000 | 70,000 |
Gross deferred tax assets | 89,704,000 | 78,320,000 |
Valuation allowance | (89,704,000) | (78,320,000) |
Net deferred taxes |
SUMMARY OF NET OPERATING LOSS A
SUMMARY OF NET OPERATING LOSS AND GENERAL BUSINESS CREDIT CARRYFORWARDS (Details) | Dec. 31, 2021USD ($) |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | $ 122,321,000 |
General business credit carryforwards | 4,741,000 |
Tax Year 2022 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 8,230,000 |
General business credit carryforwards | 431,000 |
Tax Year 2023 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 5,434,000 |
General business credit carryforwards | 362,000 |
Tax Year 2024 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 8,711,000 |
General business credit carryforwards | 287,000 |
Tax Year 2025 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 2,370,000 |
General business credit carryforwards | 182,000 |
Tax Year 2026 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 7,160,000 |
General business credit carryforwards | 72,000 |
Thereafter [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 90,416,000 |
General business credit carryforwards | $ 3,407,000 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Income Tax Disclosure [Abstract] | |
[custom:OperatingLossCarryforward-0] | $ 338,100,000 |
Tax Credit Carryforward, Amount | 4,741,000 |
Net operating loss carryforwards not expired and carried forward indefinitely, amount | $ 215,800,000 |
Operating loss taxable percentage | 80.00% |
SCHEDULE OF COMPONENTS OF LEASE
SCHEDULE OF COMPONENTS OF LEASE COST (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,761,000 | $ 1,736,000 |
Variable lease cost | 445,000 | 337,000 |
Short-term lease cost | $ 183,000 | $ 61,000 |
SCHEDULE OF SUPPLEMENTAL CASH F
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 | $ 1,818,000 | |
2023 | 1,834,000 | |
2024 | 1,879,000 | |
2025 | 1,896,000 | |
2026 | 871,000 | |
Thereafter | 3,663,000 | |
Total undiscounted operating lease payments | 11,961,000 | |
Less: imputed interest | 2,583,000 | |
Total operating lease liabilities | 9,378,000 | |
Current portion of lease liability | 1,818,000 | $ 1,713,000 |
Long-term lease liability | $ 7,560,000 | $ 5,260,000 |
Weighted-average remaining lease term for operating leases | 86 months | |
Weighted-average discount rate for operating leases | 7.40% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 12 Months Ended |
Dec. 31, 2021 | |
RDEB Product [Member] | |
Product Liability Contingency [Line Items] | |
Operating lease, term of contract | non-cancelable lease term of less than one year |