Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 07, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | ABEONA THERAPEUTICS INC. | |
Entity Central Index Key | 0000318306 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 51,154,395 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 47,923,000 | $ 18,750,000 |
Short-term investments | 66,218,000 | |
Receivables | 15,000 | 81,000 |
Prepaid expenses and other current assets | 1,654,000 | 3,802,000 |
Total current assets | 49,592,000 | 88,851,000 |
Property and equipment, net | 13,814,000 | 9,443,000 |
Right-of-use lease assets | 8,286,000 | |
Licensed technology, net | 37,471,000 | 43,042,000 |
Goodwill | 32,466,000 | 32,466,000 |
Other assets and restricted cash | 1,143,000 | 597,000 |
Total assets | 142,772,000 | 174,399,000 |
Current liabilities: | ||
Accounts payable | 2,714,000 | 6,122,000 |
Accrued expenses | 5,532,000 | 3,936,000 |
Current portion of lease liability | 1,696,000 | |
Current portion of payable to licensor | 10,000,000 | 10,000,000 |
Deferred revenue | 296,000 | 296,000 |
Total current liabilities | 20,238,000 | 20,354,000 |
Long-term lease liabilities | 6,482,000 | |
Payable to licensor, net of current portion | 20,000,000 | 20,000,000 |
Total liabilities | 46,720,000 | 40,354,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock - $0.01 par value; authorized 200,000,000 shares; issued and outstanding 51,054,395 at September 30, 2019; issued and outstanding 47,944,486 at December 31, 2018 | 511,000 | 479,000 |
Additional paid-in capital | 565,580,000 | 543,754,000 |
Accumulated deficit | (470,039,000) | (410,188,000) |
Total stockholders' equity | 96,052,000 | 134,045,000 |
Total liabilities and stockholders' equity | $ 142,772,000 | $ 174,399,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common Stock, par value | $ 0.01 | $ 0.01 |
Common Stock, shares authorized | 200,000,000 | 200,000,000 |
Common Stock, shares issued | 51,054,395 | 47,944,486 |
Common Stock, shares outstanding | 51,054,395 | 47,944,486 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 1,709,000 | $ 2,516,000 | ||
Expenses: | ||||
Research and development | 10,917,000 | 13,150,000 | 38,961,000 | 29,228,000 |
General and administrative | 4,700,000 | 4,970,000 | 15,971,000 | 12,475,000 |
Depreciation and amortization | 2,032,000 | 505,000 | 5,747,000 | 969,000 |
Total expenses | 17,649,000 | 18,625,000 | 60,679,000 | 42,672,000 |
Loss from operations | (17,649,000) | (16,916,000) | (60,679,000) | (40,156,000) |
Interest and miscellaneous income | 277,000 | 500,000 | 828,000 | 973,000 |
Interest and other expense | (3,000) | (9,000) | ||
Net loss | $ (17,372,000) | $ (16,419,000) | $ (59,851,000) | $ (39,192,000) |
Basic and diluted loss per common share | $ (0.35) | $ (0.34) | $ (1.22) | $ (0.83) |
Weighted average number of common shares outstanding - basic and diluted | 49,721,753 | 47,794,394 | 48,883,883 | 47,388,833 |
Foundation Revenues [Member] | ||||
Revenues: | ||||
Total revenues | $ 1,687,000 | $ 2,427,000 | ||
Royalties [Member] | ||||
Revenues: | ||||
Total revenues | $ 22,000 | $ 89,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Deficit [Member] | Total |
Beginning balance at Dec. 31, 2017 | $ 469,000 | $ 529,421,000 | $ (359,792,000) | $ 170,098,000 |
Beginning balance, shares at Dec. 31, 2017 | 46,888,108 | |||
Cumulative effect adjustment of ASC 606 on January 1, 2018 | 6,275,000 | 6,275,000 | ||
Stock-based compensation expense | 1,900,000 | 1,900,000 | ||
Restricted stock-based compensation expense | 172,000 | 172,000 | ||
Common stock issued for cash exercise of options | $ 3,000 | 1,682,000 | 1,685,000 | |
Common stock issued for cash exercise of options, shares | 267,196 | |||
Common stock issued for exercise of $5.00 warrants | 144,000 | 144,000 | ||
Common stock issued for exercise of $5.00 warrants, shares | 28,874 | |||
Common stock issued for cashless warrant exercises | ||||
Common stock issued for cashless warrant exercises, shares | 48,762 | |||
Net loss | (10,530,000) | (10,530,000) | ||
Ending balance at Mar. 31, 2018 | $ 472,000 | 533,319,000 | (364,047,000) | 169,744,000 |
Ending balance, shares at Mar. 31, 2018 | 47,232,940 | |||
Beginning balance at Dec. 31, 2017 | $ 469,000 | 529,421,000 | (359,792,000) | 170,098,000 |
Beginning balance, shares at Dec. 31, 2017 | 46,888,108 | |||
Net loss | (39,192,000) | |||
Ending balance at Sep. 30, 2018 | $ 480,000 | 542,476,000 | (392,709,000) | 150,247,000 |
Ending balance, shares at Sep. 30, 2018 | 47,944,486 | |||
Beginning balance at Mar. 31, 2018 | $ 472,000 | 533,319,000 | (364,047,000) | 169,744,000 |
Beginning balance, shares at Mar. 31, 2018 | 47,232,940 | |||
Stock-based compensation expense | 2,673,000 | 2,673,000 | ||
Restricted stock-based compensation expense | 172,000 | 172,000 | ||
Common stock issued for cash exercise of options | $ 1,000 | 480,000 | 481,000 | |
Common stock issued for cash exercise of options, shares | 76,956 | |||
Common stock issued for exercise of $5.00 warrants | 89,000 | 89,000 | ||
Common stock issued for exercise of $5.00 warrants, shares | 17,889 | |||
Net loss | (12,243,000) | (12,243,000) | ||
Ending balance at Jun. 30, 2018 | $ 473,000 | 536,733,000 | (376,290,000) | 160,916,000 |
Ending balance, shares at Jun. 30, 2018 | 47,327,785 | |||
Stock-based compensation expense | 2,499,000 | 2,499,000 | ||
Restricted stock-based compensation expense | 172,000 | 172,000 | ||
Common stock issued for cash exercise of options | $ 1,000 | 78,000 | 79,000 | |
Common stock issued for cash exercise of options, shares | 16,701 | |||
Common stock issued for exercise of $5.00 warrants | $ 6,000 | 2,994,000 | 3,000,000 | |
Common stock issued for exercise of $5.00 warrants, shares | 600,000 | |||
Net loss | (16,419,000) | (16,419,000) | ||
Ending balance at Sep. 30, 2018 | $ 480,000 | 542,476,000 | (392,709,000) | 150,247,000 |
Ending balance, shares at Sep. 30, 2018 | 47,944,486 | |||
Beginning balance at Dec. 31, 2018 | $ 479,000 | 543,754,000 | (410,188,000) | 134,045,000 |
Beginning balance, shares at Dec. 31, 2018 | 47,944,486 | |||
Stock-based compensation expense | 2,103,000 | 2,103,000 | ||
Restricted stock-based compensation expense | 172,000 | 172,000 | ||
Common stock issued for cash exercise of options | 28,000 | 28,000 | ||
Common stock issued for cash exercise of options, shares | 5,208 | |||
Net loss | (18,555,000) | (18,555,000) | ||
Ending balance at Mar. 31, 2019 | $ 479,000 | 546,057,000 | (428,743,000) | 117,793,000 |
Ending balance, shares at Mar. 31, 2019 | 47,949,694 | |||
Beginning balance at Dec. 31, 2018 | $ 479,000 | 543,754,000 | (410,188,000) | 134,045,000 |
Beginning balance, shares at Dec. 31, 2018 | 47,944,486 | |||
Net loss | (59,851,000) | |||
Ending balance at Sep. 30, 2019 | $ 511,000 | 565,580,000 | (470,039,000) | 96,052,000 |
Ending balance, shares at Sep. 30, 2019 | 51,054,395 | |||
Beginning balance at Mar. 31, 2019 | $ 479,000 | 546,057,000 | (428,743,000) | 117,793,000 |
Beginning balance, shares at Mar. 31, 2019 | 47,949,694 | |||
Stock-based compensation expense | 1,678,000 | 1,678,000 | ||
Restricted stock-based compensation expense | 78,000 | 78,000 | ||
Common stock issued for cash exercise of options | $ 1,000 | 384,000 | 385,000 | |
Common stock issued for cash exercise of options, shares | 91,126 | |||
Common stock issued for cash under open market sale agreement | $ 17,000 | 12,605,000 | 12,622,000 | |
Common stock issued for cash under open market sale agreement, shares | 1,658,677 | |||
Shares returned in connection with arbitration ruling on licensing agreement | $ (5,000) | (1,467,000) | (1,472,000) | |
Shares returned in connection with arbitration ruling on licensing agreement, shares | (450,000) | |||
Net loss | (23,924,000) | (23,924,000) | ||
Ending balance at Jun. 30, 2019 | $ 492,000 | 559,335,000 | (452,667,000) | 107,160,000 |
Ending balance, shares at Jun. 30, 2019 | 49,249,497 | |||
Stock-based compensation expense | 1,826,000 | 1,826,000 | ||
Restricted stock-based compensation expense | 98,000 | 98,000 | ||
Common stock issued for restricted share awards | $ 4,000 | (4,000) | ||
Common stock issued for restricted share awards, shares | 376,625 | |||
Net loss | (17,372,000) | (17,372,000) | ||
Ending balance at Sep. 30, 2019 | $ 511,000 | $ 565,580,000 | $ (470,039,000) | $ 96,052,000 |
Ending balance, shares at Sep. 30, 2019 | 51,054,395 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 |
Statement of Stockholders' Equity [Abstract] | ||||
Class of warrant or right, exercise price of warrants or rights | $ 5 | $ 5 | $ 5 | $ 5 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||||
Net loss | $ (17,372,000) | $ (16,419,000) | $ (59,851,000) | $ (39,192,000) |
Adjustments to reconcile net loss to cash used in operating activities: | ||||
Depreciation and amortization | 2,032,000 | 505,000 | 5,747,000 | 969,000 |
Stock option-based compensation expense | 1,826,000 | 2,499,000 | 5,607,000 | 7,072,000 |
Restricted stock-based compensation expense | 348,000 | 516,000 | ||
Accretion and interest on short-term investments | (1,090,000) | |||
Non-cash loss on arbitration ruling on licensing agreement | 367,000 | |||
Change in operating assets and liabilities: | ||||
Receivables | 66,000 | (245,000) | ||
Prepaid expenses and other current assets | 2,148,000 | 760,000 | ||
Right-of-use lease assets and other assets | 623,000 | 40,000 | ||
Accounts payable, accrued expenses and lease liabilities | (2,539,000) | 7,936,000 | ||
Net cash used in operating activities | (48,574,000) | (22,144,000) | ||
Cash flows from investing activities: | ||||
Capital expenditures | (6,187,000) | (8,580,000) | ||
Acquisition of licensed technology | (199,000) | |||
Purchases of short-term investments | (94,991,000) | |||
Proceeds from maturities of short-term investments | 67,308,000 | 16,366,000 | ||
Net cash provided by (used in) investing activities | 60,922,000 | (87,205,000) | ||
Cash flows from financing activities: | ||||
Proceeds from open market sales of common stock | 16,962,000 | |||
Proceeds from exercise of $5.00 warrants | 3,233,000 | |||
Proceeds from exercise of stock options | 413,000 | 2,245,000 | ||
Net cash provided by financing activities | 17,375,000 | 5,478,000 | ||
Net increase (decrease) in cash, cash equivalents and restricted cash | 29,723,000 | (103,871,000) | ||
Cash, cash equivalents and restricted cash at beginning of period | 19,310,000 | 138,030,000 | ||
Cash, cash equivalents and restricted cash at end of period | 49,033,000 | 34,159,000 | 49,033,000 | 34,159,000 |
Supplemental cash flow information: | ||||
Cash and cash equivalents | 47,923,000 | 33,599,000 | 47,923,000 | 33,599,000 |
Restricted cash | 1,110,000 | 560,000 | 1,110,000 | 560,000 |
Total cash, cash equivalents and restricted cash | $ 49,033,000 | $ 34,159,000 | 49,033,000 | 34,159,000 |
Shares returned in connection with arbitration ruling on licensing agreement | 1,472,000 | |||
Cash paid for interest | $ 9,000 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 |
Statement of Cash Flows [Abstract] | ||||
Class of warrant or right, exercise price of warrants or rights | $ 5 | $ 5 | $ 5 | $ 5 |
Nature of Operations and Signif
Nature of Operations and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations and Significant Accounting Policies | NOTE 1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES Background Abeona Therapeutics Inc., a Delaware corporation (together with our subsidiaries, “we,” “our,” “Abeona” or the “Company”), is a clinical-stage biopharmaceutical company developing gene and cell therapies for life-threatening rare genetic diseases. Our lead programs include EB-101, an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (“RDEB”); ABO-102, an adeno-associated virus (“AAV”)-based gene therapy for Sanfilippo syndrome type A (“MPS IIIA”); and ABO-101, an AAV-based gene therapy for Sanfilippo syndrome type B (“MPS IIIB”). We also are developing ABO-202 and ABO-201, which are AAV-based gene therapies for the CLN1 and CLN3 forms of Batten Disease, respectively, ABO-401 for the treatment of cystic fibrosis, and ABO-5OX for the treatment of retinal diseases. In addition, we are developing next-generation AAV-based gene therapy though our novel AIM™ capsid platform and internal AAV vector research programs. Our efforts since inception have been principally devoted to research and development, resulting in significant losses. Basis of Presentation The condensed consolidated balance sheet as of September 30, 2019, the condensed consolidated statements of operations and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018, were prepared by management without audit. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for such periods, have been made. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2018. The results of operations for the periods ended September 30, 2019 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2018 contains financial information taken from the audited Abeona consolidated financial statements as of that date. As of September 30, 2019, we had 6,697,980 options and 1,820,686 warrants that were not included in the EPS calculation as their effect would be antidilutive. As of September 30, 2018, we had 5,999,544 options and 2,220,687 warrants that were not included in the earnings per share calculation as their effect would be antidilutive. Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers Uses and Sources of Liquidity The financial statements have been prepared on a 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. Therefore, we believe it is appropriate to prepare the financial statements on a going concern basis. As of September 30, 2019, we had cash, cash equivalents and short-term investments of $47.9 million and net assets of $96.1 million. For the nine months ended September 30, 2019, we had cash outflows from operations of $48.6 million. In early 2019, the Company implemented a multi-faceted program to seek sufficient liquidity through at least the end of 2020. This program considered the possibility of accessing additional equity funding from current or new stockholders, out-licensing technology and/or other assets, deferring and/or eliminating planned expenditures, restructuring operations and/or reducing headcount and sales of assets. In September 2019, the Company announced that it has retained Jefferies LLC as its financial advisor to assist with the review of strategic options focused on advancing the Company’s mission and maximizing stockholder value. In an effort to unlock potential additional value, the Company initiated this more formal process to explore a broad range of strategic alternatives including but not limited to the partnering of its various clinical and pre-clinical programs, or a sale or merger of the Company. |
New Accounting Standard Impleme
New Accounting Standard Implemented | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
New Accounting Standard Implemented | NOTE 2 – NEW ACCOUNTING STANDARD IMPLEMENTED In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-02, Leases Additional information and disclosures required by this new standard are contained in Note 8. |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-Term Investments | NOTE 3 – SHORT-TERM INVESTMENTS The following table summarizes the available-for-sale investments held: Description September 30, 2019 December 31, 2018 U.S. government and agency securities and treasuries $ - $ 66,218,000 The amortized cost of the available-for-sale investments is adjusted for amortization of premiums and accretion of discounts to maturity. There were no material realized gains or losses recognized on the sale or maturity of available-for-sale investments during the three and nine months ended September 30, 2019 and 2018. |
Licensed Technology
Licensed Technology | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Licensed Technology | NOTE 4 – LICENSED TECHNOLOGY On November 4, 2018, we entered into a license agreement with 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 the development and commercialization of gene therapies for the treatment of MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease. In return for these rights, REGENXBIO received a guaranteed $20 million upfront payment, $10 million of which was paid on signing of the agreement on November 4, 2018 and $10 million of which was originally required under the agreement to be paid by November 4, 2019. In addition, REGENXBIO will receive a total of $100 million in annual fees, payable upon the second through sixth anniversaries of the agreement, $20 million of which is guaranteed and payable on November 4, 2020. REGENXBIO is also eligible to receive potential commercial milestone payments of up to $60 million as well as royalties payable in the low double digits to low teens on net sales of products incorporating the licensed intellectual property. The license is amortized over the life of the patent of eight years. On November 1, 2019, we entered into an amendment of the original license agreement. The amended agreement replaced the $10 million payment due on November 4, 2019 with a $3 million payment due on November 4, 2019 and an additional $8 million payment due on April 1, 2020. On August 3, 2016, we announced that we entered into an agreement (the “EB Agreement”) with EB Research Partnership (“EBRP”) and Epidermolysis Bullosa Medical Research Foundation (“EBMRF”) to collaborate on gene therapy treatments for EB. The EB Agreement became effective August 3, 2016 on the execution of two licensing agreements with The Board of Trustees of Leland Stanford Junior University (“Stanford”). On August 3, 2016, we recorded the issuance of 375,000 of our common shares to each of EBRP and EBMRF and recorded licensed technology of $2.45 million, which was being amortized over 20 years. In connection with an arbitration proceeding relating to the EB Agreement, on May 15, 2019, the arbitrator issued a decision in favor of the Company requiring the Company to cancel any and all shares of its common stock issued to EBRP and EBMRF that were still in their possession. As a result, we have recorded the return of 450,000 shares of our common stock and the reversal of the licensed technology from our financial statements. The net of these transactions resulted in a non-cash charge to expense of $367,000 recorded during the nine months ended September 30, 2019. 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 years. Licensed technology consists of the following: September 30, 2019 December 31, 2018 Licensed technology $ 42,606,000 $ 44,859,000 Less accumulated amortization 5,135,000 1,817,000 Licensed technology, net $ 37,471,000 $ 43,042,000 The aggregate estimated amortization expense for intangible assets remaining as of September 30, 2019 is as follows: 2019, remainder $ 1,293,000 2020 5,167,000 2021 5,167,000 2022 5,167,000 2023 5,167,000 Thereafter 15,510,000 Total $ 37,471,000 |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2019 | |
Restricted Cash [Abstract] | |
Restricted Cash | NOTE 5 – RESTRICTED CASH Restricted cash, which is reported within other assets and restricted cash on the condensed consolidated balance sheets, consists of cash and cash equivalents held as collateral for a corporate credit card and office space in New York. As such, the cash and cash equivalents are restricted in use. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | NOTE 6 – 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 receivables, prepaid expenses, other assets, accounts payable, accrued expenses, payable to licensor 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 September 30, 2019 and December 31, 2018 are summarized below: Description September 30, 2019 Level 1 Level 2 Level 3 Total Gains/(Losses) Non-recurring Assets: Licensed technology, net $ 37,471,000 $ - $ - $ 37,471,000 $ (367,000 ) Goodwill 32,466,000 - - 32,466,000 - Description December 31, 2018 Level 1 Level 2 Level 3 Total Gains/(Losses) Recurring Assets: Short-term investments $ 66,218,000 $ - $ 66,218,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 43,042,000 $ - $ - $ 43,042,000 $ - Goodwill 32,466,000 - - 32,466,000 - |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | NOTE 7 – STOCK-BASED COMPENSATION The following table summarizes option-based compensation expense for the three and nine months ended September 30, 2019 and 2018: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Research and development $ 972,000 $ 1,012,000 $ 3,013,000 $ 2,756,000 General and administrative 854,000 1,487,000 2,594,000 4,316,000 Stock-based compensation expense included in operating expense 1,826,000 2,499,000 5,607,000 7,072,000 Total stock-based compensation expense 1,826,000 2,499,000 5,607,000 7,072,000 Tax benefit - - - - Stock-based compensation expense, net of tax $ 1,826,000 $ 2,499,000 $ 5,607,000 $ 7,072,000 We estimate the fair value of each option award on the date of grant using the Black-Scholes option valuation model. We then recognize the grant date fair value of each option as compensation expense ratably using the straight-line attribution method over the service period (generally the vesting period). The Black-Scholes model incorporates the following assumptions: ● 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 fair value of the options granted for the periods indicated: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Expected volatility 103 % 109 % 108 % 109 % Expected term 6.25 years 5.00 years 5.09 years 5.00 years Risk-free interest rate 1.83 % 2.78 % 2.21 % 2.54 % Expected dividend yield 0 % 0 % 0 % 0 % The following table summarizes the options granted for the periods indicated: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Options granted 105,600 157,000 1,490,490 1,026,800 Weighted-average: Exercise price $ 2.58 $ 14.45 $ 6.53 $ 14.38 Grant date fair value $ 2.09 $ 11.44 $ 5.14 $ 11.36 The following table summarizes restricted common stock-based compensation expense for the three and nine months ended September 30, 2019 and 2018: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Research and development $ 66,000 $ - $ 66,000 $ - General and administrative 32,000 172,000 282,000 516,000 Stock-based compensation expense included in operating expense 98,000 172,000 348,000 516,000 Total stock-based compensation expense 98,000 172,000 348,000 516,000 Tax benefit - - - - Stock-based compensation expense, net of tax $ 98,000 $ 172,000 $ 348,000 $ 516,000 We granted 376,625 shares of restricted common stock to employees during the three and nine months ended September 30, 2019. We did not grant any restricted common stock to employees during the three and nine months ended September 30, 2018. |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Operating Leases | NOTE 8 – OPERATING LEASES We lease space under non-cancelable operating leases for manufacturing and laboratory facilities and administrative offices in Cleveland as well as administrative offices in New York. The 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. We also lease office space in Madrid, Spain as well as certain office equipment under operating leases, which have a non-cancelable lease term of less than one year and therefore, we have elected the practical expedient to exclude these short-term leases from our right-of-use assets and lease liabilities. 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. As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. Components of lease cost are as follows: Three months ended September 30, 2019 Nine months ended September 30, 2019 Operating lease cost $ 434,000 $ 1,157,000 Variable lease cost $ 82,000 $ 241,000 Short-term lease cost $ 32,000 $ 113,000 The following table presents information about the amount and timing of cash flows arising from operating leases as of September 30, 2019: Maturity of lease liabilities: 2019, remainder $ 422,000 2020 1,699,000 2021 1,713,000 2022 1,727,000 2023 1,741,000 Thereafter 3,667,000 Total undiscounted operating lease payments 10,969,000 Less: imputed interest 2,791,000 Present value of operating lease liabilities $ 8,178,000 Balance sheet classification: Current portion of lease liability $ 1,696,000 Long-term lease liability 6,482,000 Total operating lease liabilities $ 8,178,000 Other information: Weighted-average remaining lease term for operating leases 76 months Weighted-average discount rate for operating leases 9.6 % |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 9 – COMMITMENTS AND CONTINGENCIES On January 18, 2018, William Mahon, a Company stockholder, served a demand upon the Company’s board of directors (the “Board”) pursuant to Section 220 of the Delaware General Corporation Law (the “Demand”) seeking to inspect certain of the Company’s books and records. Generally, the Demand’s stated purpose was to investigate allegedly excessive compensation awarded to non-employee Board members for the fiscal years 2015–2017. The Board denied the allegations in the Demand, and agreed to provide limited books and records to Mahon. On September 17, 2018, another Company stockholder, Francisco Dos Ramos, filed a stockholder derivative complaint in the Delaware Chancery Court (the “Dos Ramos Action”) against Steven Rouhandeh, Frank Carsten Thiel, Mark Alvino, Stefano Buono, Stephen Howell, Richard Van Duyne, and Todd Wider as defendants, and the Company as nominal defendant (the “Dos Ramos Defendants”). Dos Ramos generally alleged that the Board breached its fiduciary duties, were unjustly enriched, and committed corporate waste by approving allegedly excessive compensation to non-employee Board members for the fiscal years 2015–2017. Dos Ramos generally sought disgorgement of the allegedly improper payments to the Board, money damages, an order requiring corporate governance reforms, costs and attorneys’ fees. On November 28, 2018, Mahon filed a stockholder derivative complaint (the “Mahon Action”) in the United States District Court for the District of Delaware (the “District Court”) against Mark Ahn, Mark Alvino, Jeffrey Davis, Stephen Howell, Todd Wider, and Steven Rouhandeh, as defendants, and the Company as a nominal defendant (“Mahon Defendants”). The allegations in the Mahon Action were substantially similar to those set forth in his Demand, as well as those in the Dos Ramos Action. Mahon generally sought the disgorgement of the allegedly improper payments to the Board, a constructive trust, money damages, costs and attorneys’ fees. On December 6, 2018, Mahon and the Mahon Defendants filed a joint motion for preliminary approval of settlement, along with a stipulation of settlement (the “Stipulation”) intending to settle all claims asserted in the Mahon Action. On January 8, 2019, the District Court approved the parties’ notice of settlement, enjoining all Company stockholders from commencing or further prosecuting any claims asserted in the Mahon Action, and scheduled a settlement approval hearing for May 1, 2019. On January 25, 2019, the Chancery Court entered an order staying the Dos Ramos Action until May 8, 2019—one week after the May 1, 2019 settlement hearing in the Mahon Action. On May 2, 2019 the District Court entered an Order and Final Judgment approving the Stipulation. On August 6, 2019, the plaintiff in the Dos Ramos Action filed a voluntary notice of dismissal. On August 7, 2019, the Chancery Court entered an order of dismissal. On October 22, 2018, EB Research Partnership, Inc. (“EBRP”) served upon the Company a Request for Arbitration (the “Request”), alleging that the Company was in breach of an Agreement executed in July 2016 (the “Agreement”) between and among the Company, EBRP, and Epidermolysis Bullosa Medical Research Foundation (“EBMRF” and together with EBRP, “Claimants”). EBRP alleged that Abeona had refused to lift trading restrictions on certain shares of Abeona common stock issued to EBRP, purportedly in breach of the Agreement. On November 21, 2018, the Company filed an action in the United States District Court for the Southern District of New York seeking a declaration that it was not required to arbitrate its dispute with EBRP on the basis that the Agreement was void for lack of consideration. On February 4, 2019, the court granted Claimants’ motion to compel arbitration. EBMRF was subsequently joined as a party to the arbitration. The parties submitted briefs to the arbitrator on March 18 and April 18, 2019. On May 15, 2019, the arbitrator issued a decision in favor of the Company (the “Final Award”). Specifically, the Final Award provides that the Agreement is void for lack of consideration; that Claimants fraudulently induced Abeona to enter into the Agreement; that Claimants cannot enforce the Agreement; that Claimants are not entitled to any relief under the Agreement; that, in view of their status as charitable organizations, Claimants would not be required to repay to Abeona the value of Abeona common stock they already sold; that the Company shall cancel any and all shares of Abeona common stock issued to Claimants that were still in Claimants’ possession; and that, as the losing parties, Claimants must bear the costs and expenses of the arbitration and Abeona’s costs and expenses. |
Nature of Operations and Sign_2
Nature of Operations and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background | Background Abeona Therapeutics Inc., a Delaware corporation (together with our subsidiaries, “we,” “our,” “Abeona” or the “Company”), is a clinical-stage biopharmaceutical company developing gene and cell therapies for life-threatening rare genetic diseases. Our lead programs include EB-101, an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (“RDEB”); ABO-102, an adeno-associated virus (“AAV”)-based gene therapy for Sanfilippo syndrome type A (“MPS IIIA”); and ABO-101, an AAV-based gene therapy for Sanfilippo syndrome type B (“MPS IIIB”). We also are developing ABO-202 and ABO-201, which are AAV-based gene therapies for the CLN1 and CLN3 forms of Batten Disease, respectively, ABO-401 for the treatment of cystic fibrosis, and ABO-5OX for the treatment of retinal diseases. In addition, we are developing next-generation AAV-based gene therapy though our novel AIM™ capsid platform and internal AAV vector research programs. Our efforts since inception have been principally devoted to research and development, resulting in significant losses. |
Basis of Presentation | Basis of Presentation The condensed consolidated balance sheet as of September 30, 2019, the condensed consolidated statements of operations and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018, were prepared by management without audit. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for such periods, have been made. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Form 10-K for the year ended December 31, 2018. The results of operations for the periods ended September 30, 2019 are not necessarily indicative of the operating results that may be expected for a full year. The condensed consolidated balance sheet as of December 31, 2018 contains financial information taken from the audited Abeona consolidated financial statements as of that date. As of September 30, 2019, we had 6,697,980 options and 1,820,686 warrants that were not included in the EPS calculation as their effect would be antidilutive. As of September 30, 2018, we had 5,999,544 options and 2,220,687 warrants that were not included in the earnings per share calculation as their effect would be antidilutive. Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers |
Uses and Sources of Liquidity | Uses and Sources of Liquidity The financial statements have been prepared on a 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. Therefore, we believe it is appropriate to prepare the financial statements on a going concern basis. As of September 30, 2019, we had cash, cash equivalents and short-term investments of $47.9 million and net assets of $96.1 million. For the nine months ended September 30, 2019, we had cash outflows from operations of $48.6 million. In early 2019, the Company implemented a multi-faceted program to seek sufficient liquidity through at least the end of 2020. This program considered the possibility of accessing additional equity funding from current or new stockholders, out-licensing technology and/or other assets, deferring and/or eliminating planned expenditures, restructuring operations and/or reducing headcount and sales of assets. In September 2019, the Company announced that it has retained Jefferies LLC as its financial advisor to assist with the review of strategic options focused on advancing the Company’s mission and maximizing stockholder value. In an effort to unlock potential additional value, the Company initiated this more formal process to explore a broad range of strategic alternatives including but not limited to the partnering of its various clinical and pre-clinical programs, or a sale or merger of the Company. |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Investments Held | The following table summarizes the available-for-sale investments held: Description September 30, 2019 December 31, 2018 U.S. government and agency securities and treasuries $ - $ 66,218,000 |
Licensed Technology (Tables)
Licensed Technology (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Licensed Technology | Licensed technology consists of the following: September 30, 2019 December 31, 2018 Licensed technology $ 42,606,000 $ 44,859,000 Less accumulated amortization 5,135,000 1,817,000 Licensed technology, net $ 37,471,000 $ 43,042,000 |
Schedule of Amortization Expense for Intangible Assets | The aggregate estimated amortization expense for intangible assets remaining as of September 30, 2019 is as follows: 2019, remainder $ 1,293,000 2020 5,167,000 2021 5,167,000 2022 5,167,000 2023 5,167,000 Thereafter 15,510,000 Total $ 37,471,000 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019 and December 31, 2018 are summarized below: Description September 30, 2019 Level 1 Level 2 Level 3 Total Gains/(Losses) Non-recurring Assets: Licensed technology, net $ 37,471,000 $ - $ - $ 37,471,000 $ (367,000 ) Goodwill 32,466,000 - - 32,466,000 - Description December 31, 2018 Level 1 Level 2 Level 3 Total Gains/(Losses) Recurring Assets: Short-term investments $ 66,218,000 $ - $ 66,218,000 $ - $ - Non-recurring Assets: Licensed technology, net $ 43,042,000 $ - $ - $ 43,042,000 $ - Goodwill 32,466,000 - - 32,466,000 - |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Option-Based Compensation Expenses | The following table summarizes option-based compensation expense for the three and nine months ended September 30, 2019 and 2018: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Research and development $ 972,000 $ 1,012,000 $ 3,013,000 $ 2,756,000 General and administrative 854,000 1,487,000 2,594,000 4,316,000 Stock-based compensation expense included in operating expense 1,826,000 2,499,000 5,607,000 7,072,000 Total stock-based compensation expense 1,826,000 2,499,000 5,607,000 7,072,000 Tax benefit - - - - Stock-based compensation expense, net of tax $ 1,826,000 $ 2,499,000 $ 5,607,000 $ 7,072,000 |
Schedule of Weighted-average Assumptions to Estimate the Fair Value of the Options Granted | We used the following weighted-average assumptions to estimate the fair value of the options granted for the periods indicated: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Expected volatility 103 % 109 % 108 % 109 % Expected term 6.25 years 5.00 years 5.09 years 5.00 years Risk-free interest rate 1.83 % 2.78 % 2.21 % 2.54 % Expected dividend yield 0 % 0 % 0 % 0 % |
Schedule of Options Granted | The following table summarizes the options granted for the periods indicated: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Options granted 105,600 157,000 1,490,490 1,026,800 Weighted-average: Exercise price $ 2.58 $ 14.45 $ 6.53 $ 14.38 Grant date fair value $ 2.09 $ 11.44 $ 5.14 $ 11.36 |
Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of Option-Based Compensation Expenses | The following table summarizes restricted common stock-based compensation expense for the three and nine months ended September 30, 2019 and 2018: For the three months ended September 30, For the nine months ended September 30, 2019 2018 2019 2018 Research and development $ 66,000 $ - $ 66,000 $ - General and administrative 32,000 172,000 282,000 516,000 Stock-based compensation expense included in operating expense 98,000 172,000 348,000 516,000 Total stock-based compensation expense 98,000 172,000 348,000 516,000 Tax benefit - - - - Stock-based compensation expense, net of tax $ 98,000 $ 172,000 $ 348,000 $ 516,000 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of Components of Lease Cost | Components of lease cost are as follows: Three months ended September 30, 2019 Nine months ended September 30, 2019 Operating lease cost $ 434,000 $ 1,157,000 Variable lease cost $ 82,000 $ 241,000 Short-term lease cost $ 32,000 $ 113,000 |
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 as of September 30, 2019: Maturity of lease liabilities: 2019, remainder $ 422,000 2020 1,699,000 2021 1,713,000 2022 1,727,000 2023 1,741,000 Thereafter 3,667,000 Total undiscounted operating lease payments 10,969,000 Less: imputed interest 2,791,000 Present value of operating lease liabilities $ 8,178,000 Balance sheet classification: Current portion of lease liability $ 1,696,000 Long-term lease liability 6,482,000 Total operating lease liabilities $ 8,178,000 Other information: Weighted-average remaining lease term for operating leases 76 months Weighted-average discount rate for operating leases 9.6 % |
Nature of Operations and Sign_3
Nature of Operations and Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Cash, cash equivalents and short-term investments | $ 47,900,000 | ||||
Net assets | 142,772,000 | $ 174,399,000 | |||
Net cash used in operating activities | $ (48,574,000) | $ (22,144,000) | |||
Accounting Standards Update 2014-09 [Member] | |||||
New accounting pronouncement, effect of change on operating results | $ 543,000 | $ 2,067,000 | |||
New accounting pronouncement, effect of adoption, quantification | $ 543,000 | $ 2,067,000 | |||
New accounting pronouncement, effect of change on diluted earnings per share | $ 0.01 | $ 0.04 | |||
Options [Member] | |||||
Antidilutive securities excluded from computation of earnings per share, amount | 6,697,980 | 5,999,544 | |||
Warrants [Member] | |||||
Antidilutive securities excluded from computation of earnings per share, amount | 1,820,686 | 2,220,687 |
New Accounting Standard Imple_2
New Accounting Standard Implemented (Details Narrative) - USD ($) | Sep. 30, 2019 | Jan. 02, 2019 | Dec. 31, 2018 |
Operating lease, right-of-use asset | $ 8,286,000 | ||
Operating lease, liability | $ 8,178,000 | ||
Accounting Standards Update 2016-02 [Member] | |||
Operating lease, right-of-use asset | $ 8,900,000 | ||
Operating lease, liability | $ 8,900,000 |
Short-Term Investments - Schedu
Short-Term Investments - Schedule Of Available-for-sale Investments Held (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Investments, Debt and Equity Securities [Abstract] | ||
U.S. goverment and agency securities and treasuries | $ 66,218,000 |
Licensed Technology (Details Na
Licensed Technology (Details Narrative) | May 15, 2019shares | Nov. 04, 2018USD ($) | Aug. 03, 2016USD ($)Integer | Aug. 03, 2016USD ($)shares | May 15, 2015 | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Nov. 04, 2019USD ($) | Dec. 31, 2018USD ($) |
Due to licensor current | $ 10,000,000 | $ 10,000,000 | $ 10,000,000 | ||||||||
Value of licensed technology | 37,471,000 | 37,471,000 | $ 43,042,000 | ||||||||
Shares returned in connection with arbitration ruling on licensing agreement (in shares) | shares | 450,000 | ||||||||||
Non-cash loss on arbitration ruling on licensing agreement | 367,000 | ||||||||||
Amortization of intangible assets | $ 1,293,000 | $ 87,000 | $ 3,931,000 | $ 260,000 | |||||||
Abeona Therapeutics Llc [Member] | |||||||||||
Finite-lived intangible asset, useful life | 20 years | ||||||||||
Eb Agreement [Member] | |||||||||||
Finite-lived intangible asset, useful life | 20 years | ||||||||||
Number of license agreements research and development arrangements | Integer | 2 | ||||||||||
Original License Agreements [Member] | |||||||||||
License to be paid | $ 10,000,000 | ||||||||||
Amended Agreements [Member] | |||||||||||
License to be paid | 3,000,000 | ||||||||||
Amended Agreements [Member] | April 1 2020 [Member] | |||||||||||
License to be paid | $ 8,000,000 | ||||||||||
REGENXBIO [Member] | Licensing Agreements [Member] | |||||||||||
Guaranteed upfront payment | $ 20,000,000 | ||||||||||
Payment on Execution of Contracts | 10,000,000 | ||||||||||
Due to licensor current | 10,000,000 | ||||||||||
Annual fees | 100,000,000 | ||||||||||
Guaranteed and payable | $ 20,000,000 | ||||||||||
Maturity date | Nov. 4, 2020 | ||||||||||
Royalties payments | $ 60,000,000 | ||||||||||
Finite-lived intangible asset, useful life | 8 years | ||||||||||
EBRP [Member] | Eb Agreement [Member] | |||||||||||
Issuance of common shares | shares | 375,000 | ||||||||||
Value of licensed technology | $ 2,450,000 | $ 2,450,000 | |||||||||
EBMRF [Member] | Eb Agreement [Member] | |||||||||||
Issuance of common shares | shares | 375,000 | ||||||||||
Value of licensed technology | $ 2,450,000 | $ 2,450,000 |
Licensed Technology - Schedule
Licensed Technology - Schedule of Licensed Technology (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Licensed technology | $ 42,606,000 | $ 44,859,000 |
Less accumulated amortization | 5,135,000 | 1,817,000 |
Licensed technology, net | $ 37,471,000 | $ 43,042,000 |
Licensed Technology - Schedul_2
Licensed Technology - Schedule of Amortization Expense For Intangible Assets (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2019, remainder | $ 1,293,000 | |
2020 | 5,167,000 | |
2021 | 5,167,000 | |
2022 | 5,167,000 | |
2023 | 5,167,000 | |
Thereafter | 15,510,000 | |
Total | $ 37,471,000 | $ 43,042,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value, Assets and Liabilities Measured on Recurring and Non-Recurring Basis (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Licensed Technology Net [Member] | Fair Value Measurements Nonrecurring [Member] | ||
Fair value disclosure of assets | $ 37,471,000 | $ 43,042,000 |
Fair value disclosure of gain loss | (367,000) | |
Licensed Technology Net [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level1 [Member] | ||
Fair value disclosure of assets | ||
Licensed Technology Net [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | ||
Fair value disclosure of assets | ||
Licensed Technology Net [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level3 [Member] | ||
Fair value disclosure of assets | 37,471,000 | 43,042,000 |
Goodwill [Member] | Fair Value Measurements Nonrecurring [Member] | ||
Fair value disclosure of assets | 32,466,000 | 32,466,000 |
Fair value disclosure of gain loss | ||
Goodwill [Member] | Fair Value Measurements Nonrecurring [Member] | Fair Value Inputs Level1 [Member] | ||
Fair value disclosure of assets | ||
Goodwill [Member] | Fair Value Measurements Nonrecurring [Member] | Fair Value Inputs Level2 [Member] | ||
Fair value disclosure of assets | ||
Goodwill [Member] | Fair Value Measurements Nonrecurring [Member] | Fair Value Inputs Level3 [Member] | ||
Fair value disclosure of assets | $ 32,466,000 | 32,466,000 |
Short Term Investment [Member] | Fair Value Measurements Recurring [Member] | ||
Fair value disclosure of assets | 66,218,000 | |
Fair value disclosure of gain loss | ||
Short Term Investment [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level1 [Member] | ||
Fair value disclosure of assets | ||
Short Term Investment [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level2 [Member] | ||
Fair value disclosure of assets | 66,218,000 | |
Short Term Investment [Member] | Fair Value Measurements Recurring [Member] | Fair Value Inputs Level3 [Member] | ||
Fair value disclosure of assets |
Stock Based Compensation (Detai
Stock Based Compensation (Details Narrative) - shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Restricted common stock, granted | 376,625 | 376,625 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Option-Based Compensation Expenses (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-based compensation expense included in operating expense | $ 1,826,000 | $ 2,499,000 | $ 5,607,000 | $ 7,072,000 |
Tax benefit | ||||
Stock-based compensation expense, net of tax | 1,826,000 | 2,499,000 | 5,607,000 | 7,072,000 |
Research And Development Expense [Member] | ||||
Stock-based compensation expense included in operating expense | 972,000 | 1,012,000 | 3,013,000 | 2,756,000 |
Selling General And Administrative Expenses [Member] | ||||
Stock-based compensation expense included in operating expense | 854,000 | 1,487,000 | 2,594,000 | 4,316,000 |
Restricted Stock [Member] | ||||
Stock-based compensation expense included in operating expense | 98,000 | 348,000 | 172,000 | 516,000 |
Tax benefit | ||||
Stock-based compensation expense, net of tax | 98,000 | 348,000 | 172,000 | 516,000 |
Restricted Stock [Member] | Research And Development Expense [Member] | ||||
Stock-based compensation expense included in operating expense | 66,000 | 66,000 | 516,000 | |
Restricted Stock [Member] | Selling General And Administrative Expenses [Member] | ||||
Stock-based compensation expense included in operating expense | $ 32,000 | $ 282,000 | $ 172,000 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Weighted-average Assumptions to Estimate the Fair Value of the Options Granted (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Payment Arrangement [Abstract] | ||||
Expected volatility | 103.00% | 109.00% | 108.00% | 109.00% |
Expected term | 6 years 2 months 30 days | 5 years | 5 years 1 month 2 days | 5 years |
Risk-free interest rate | 1.83% | 2.78% | 2.21% | 2.54% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Options Granted (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Payment Arrangement [Abstract] | ||||
Options granted | 105,600 | 157,000 | 1,490,490 | 1,026,800 |
Weighted-average Exercise price | $ 2.58 | $ 14.45 | $ 6.53 | $ 14.38 |
Weighted-average Grant date fair value | $ 2.09 | $ 11.44 | $ 5.14 | $ 11.36 |
Operating Leases - Schedule of
Operating Leases - Schedule of Components of Lease Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019 | Sep. 30, 2019 | |
Leases [Abstract] | ||
Operating lease cost | $ 434,000 | $ 1,157,000 |
Variable lease cost | 82,000 | 241,000 |
Short-term lease cost | $ 32,000 | $ 113,000 |
Operating Leases - Schedule o_2
Operating Leases - Schedule of Supplemental Cash Flow Information Related to Leases (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2019, remainder | $ 422,000 | |
2020 | 1,699,000 | |
2021 | 1,713,000 | |
2022 | 1,727,000 | |
2023 | 1,741,000 | |
Thereafter | 3,667,000 | |
Total undiscounted operating lease payments | 10,969,000 | |
Less: imputed interest | 2,791,000 | |
Total operating lease liabilities | 8,178,000 | |
Current portion of lease liability | 1,696,000 | |
Long-term lease liability | $ 6,482,000 | |
Weighted-average remaining lease term for operating leases | 76 months | |
Weighted-average discount rate for operating leases | 9.60% |