Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
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 | 6555 Carnegie Avenue | |
Entity Address, Address Line Two | 4thFloor | |
Entity Address, City or Town | Cleveland | |
Entity Address, State or Province | OH | |
Entity Address, Postal Zip Code | 44103 | |
City Area Code | (646) | |
Local Phone Number | 813-4701 | |
Title of 12(b) Security | Common Stock, $0.01 par value | |
Trading Symbol | ABEO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,773,317 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 4,712 | $ 14,217 |
Short-term investments | 49,042 | 37,932 |
Restricted cash | 338 | 338 |
Other receivables | 2,209 | 188 |
Prepaid expenses and other current assets | 963 | 424 |
Total current assets | 57,264 | 53,099 |
Property and equipment, net | 3,999 | 5,741 |
Right-of-use lease assets | 4,685 | 5,331 |
Other assets | 139 | 43 |
Total assets | 66,087 | 64,214 |
Current liabilities: | ||
Accounts payable | 2,592 | 1,811 |
Accrued expenses | 3,972 | 3,991 |
Current portion of operating lease liability | 1,649 | 1,773 |
Other current liabilities | 199 | 204 |
Total current liabilities | 8,412 | 7,779 |
Long-term operating lease liabilities | 4,043 | 5,854 |
Warrant liabilities | 27,122 | 19,657 |
Total liabilities | 44,049 | 37,453 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | ||
Common stock - $0.01 par value; authorized 200,000,000 shares; 24,713,908 and 17,719,720 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 247 | 177 |
Additional paid-in capital | 754,823 | 722,049 |
Accumulated deficit | (732,933) | (695,336) |
Accumulated other comprehensive loss | (99) | (129) |
Total stockholders’ equity | 22,038 | 26,761 |
Total liabilities and stockholders’ equity | 66,087 | 64,214 |
Related Party [Member] | ||
Current liabilities: | ||
Payable to licensor | $ 4,472 | $ 4,163 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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 | 24,713,908 | 17,719,720 |
Common stock, shares outstanding | 24,713,908 | 17,719,720 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
License and other revenues | $ 3,500 | $ 1,346 | ||
Expenses: | ||||
Royalties | 30 | 1,605 | 350 | |
Research and development | 7,148 | 5,490 | 23,712 | 22,693 |
General and administrative | 4,156 | 3,890 | 13,174 | 11,574 |
Impairment of licensed technology | 1,355 | |||
Loss/(gain) on right-of-use lease assets | (1,065) | 1,561 | ||
Impairment of construction-in-progress | 1,792 | |||
Total expenses | 11,334 | 9,380 | 37,426 | 39,325 |
Loss from operations | (11,334) | (9,380) | (33,926) | (37,979) |
Interest income | 593 | 72 | 1,374 | 103 |
Interest expense | (105) | (157) | (309) | (558) |
Change in fair value of warrant liabilities | (1,101) | 3,050 | (7,465) | 5,995 |
Other income (expense) | 111 | (19) | 2,729 | (136) |
Net loss | (11,836) | (6,434) | (37,597) | (32,575) |
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | (3,782) | |||
Net loss attributable to Common Shareholders | $ (11,836) | $ (6,434) | $ (37,597) | $ (36,357) |
Loss per common share - basic | $ (0.48) | $ (1) | $ (1.89) | $ (6.05) |
Loss per common share - diluted | $ (0.48) | $ (1) | $ (1.89) | $ (6.05) |
Weighted average number of common shares outstanding - basic | 24,797,564 | 6,421,245 | 19,942,613 | 6,009,902 |
Weighted average number of common shares outstanding - diluted | 24,797,564 | 6,421,245 | 19,942,613 | 6,009,902 |
Other comprehensive income (loss): | ||||
Change in unrealized gains (losses) related to available-for-sale debt securities | $ (33) | $ (4) | $ 1 | $ (11) |
Foreign currency translation adjustments | 29 | (6) | 29 | (6) |
Comprehensive loss | $ (11,840) | $ (6,444) | $ (37,567) | $ (36,374) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series A Convertible Redeemable Preferred Stock [Member] | Preferred Stock [Member] Series B Convertible Redeemable Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 1,472,000 | $ 696,563,000 | $ (655,640,000) | $ (27,000) | $ 42,368,000 | ||
Beginning balance, shares at Dec. 31, 2021 | 5,888,217 | ||||||
Stock-based compensation expense | 2,218,000 | 2,218,000 | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations | $ 3,000 | (3,000) | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | 745,000 | ||||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 10,000 | 4,179,000 | 4,189,000 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 1,038,134 | ||||||
Net loss | (32,575,000) | (32,575,000) | |||||
Other comprehensive loss | (17,000) | (17,000) | |||||
Reverse stock-split adjustment | 1,408,000 | (1,408,000) | |||||
Issuance of Series A and Series B Convertible Redeemable Preferred Stock | $ 17,974,000 | $ 4,494,000 | |||||
Issuance of Series A and Series B Convertible Redeemable Preferred Stock, shares | 1,000,006 | 250,005 | |||||
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | $ 3,026,000 | $ 756,000 | (3,782,000) | (3,782,000) | |||
Redemption of Series A and Series B Convertible Redeemable Preferred Stock | $ (21,000,000) | $ (5,250,000) | |||||
Redemption of Series A and Series B Convertible Redeemable Preferred Stock, shares | (1,000,006) | (250,005) | |||||
Reverse stock-split adjustment | (1,408,000) | 1,408,000 | |||||
Ending balance, value at Sep. 30, 2022 | $ 77,000 | 700,583,000 | (688,215,000) | (44,000) | 12,401,000 | ||
Ending balance, shares at Sep. 30, 2022 | 7,671,351 | ||||||
Beginning balance, value at Jun. 30, 2022 | $ 1,467,000 | 694,372,000 | (681,781,000) | (34,000) | 14,024,000 | ||
Beginning balance, shares at Jun. 30, 2022 | 5,870,375 | ||||||
Stock-based compensation expense | 632,000 | 632,000 | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations | $ 8,000 | (8,000) | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | 762,842 | ||||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 10,000 | 4,179,000 | 4,189,000 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 1,038,134 | ||||||
Net loss | (6,434,000) | (6,434,000) | |||||
Other comprehensive loss | (10,000) | (10,000) | |||||
Reverse stock-split adjustment | (1,408,000) | 1,408,000 | |||||
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |||||||
Reverse stock-split adjustment | 1,408,000 | (1,408,000) | |||||
Ending balance, value at Sep. 30, 2022 | $ 77,000 | 700,583,000 | (688,215,000) | (44,000) | 12,401,000 | ||
Ending balance, shares at Sep. 30, 2022 | 7,671,351 | ||||||
Beginning balance, value at Dec. 31, 2022 | $ 177,000 | 722,049,000 | (695,336,000) | (129,000) | 26,761,000 | ||
Beginning balance, shares at Dec. 31, 2022 | 17,719,720 | ||||||
Stock-based compensation expense | 3,254,000 | 3,254,000 | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations | $ 18,000 | (31,000) | (13,000) | ||||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | 1,719,460 | ||||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 20,000 | 6,603,000 | 6,623,000 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 1,990,321 | ||||||
Net loss | (37,597,000) | (37,597,000) | |||||
Other comprehensive loss | 30,000 | 30,000 | |||||
Issuance of common stock, net of offering costs under direct placement offering | 32,000 | 22,948,000 | 22,980,000 | ||||
Issuance of common stock, net of offering costs under direct placement offering, shares | 3,284,407 | ||||||
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |||||||
Ending balance, value at Sep. 30, 2023 | $ 247,000 | 754,823,000 | (732,933,000) | (99,000) | 22,038,000 | ||
Ending balance, shares at Sep. 30, 2023 | 24,713,908 | ||||||
Beginning balance, value at Jun. 30, 2023 | $ 215,000 | 730,322,000 | (721,097,000) | (95,000) | 9,345,000 | ||
Beginning balance, shares at Jun. 30, 2023 | 21,478,157 | ||||||
Stock-based compensation expense | 1,557,000 | 1,557,000 | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations | (4,000) | (4,000) | |||||
Issuance of common stock in connection with restricted share awards, net of cancellations, shares | (48,656) | ||||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 32,000 | 22,948,000 | 22,980,000 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 3,284,407 | ||||||
Net loss | (11,836,000) | (11,836,000) | |||||
Other comprehensive loss | (4,000) | (4,000) | |||||
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |||||||
Ending balance, value at Sep. 30, 2023 | $ 247,000 | $ 754,823,000 | $ (732,933,000) | $ (99,000) | $ 22,038,000 | ||
Ending balance, shares at Sep. 30, 2023 | 24,713,908 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities: | |||||
Net loss | $ (11,836) | $ (6,434) | $ (37,597) | $ (32,575) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||
Depreciation and amortization | 1,797 | 2,364 | |||
Stock-based compensation expense | 1,557 | 632 | 3,254 | 2,218 | |
Change in fair value of warrant liabilities | 1,101 | (3,050) | 7,465 | (5,995) | |
Non-cash impairment of licensed technology | 1,355 | ||||
Non-cash loss/(gain) of right-of-use lease assets | (1,065) | 1,561 | |||
Non-cash impairment of construction-in-progress | 1,792 | ||||
Accretion and interest on short-term investments | 134 | (206) | |||
Amortization of right-of-use lease assets | 680 | 1,204 | |||
Non-cash interest | 309 | 558 | |||
Loss on disposal of property and equipment | 52 | 121 | |||
Change in operating assets and liabilities: | |||||
Accounts receivable | 3,000 | ||||
Other receivables | (2,021) | (1,047) | |||
Prepaid expenses and other current assets | (539) | 1,432 | |||
Other assets | (96) | 148 | |||
Accounts payable, accrued expenses and lease liabilities | (142) | (5,125) | |||
Other current liabilities | (5) | (296) | |||
Net cash used in operating activities | (27,774) | (29,491) | |||
Cash flows from investing activities: | |||||
Capital expenditures | (294) | (105) | |||
Proceeds from disposal of property and equipment | 187 | 1,590 | |||
Purchases of short-term investments | (48,219) | (43,866) | |||
Proceeds from maturities of short-term investments | 37,005 | 43,707 | |||
Net cash provided by (used in) investing activities | (11,321) | 1,326 | |||
Cash flows from financing activities: | |||||
Proceeds from ATM sales of common stock, net of issuance costs | 6,623 | 4,189 | |||
Proceeds from sales of common stock under direct placement offering, net of issuance costs | 22,980 | ||||
Proceeds from net settlement of restricted share awards | (13) | ||||
Proceeds from issuance of Series A and Series B Convertible Redeemable Preferred Stock, net of issuance costs | 22,468 | ||||
Redemption of Series A and Series B Convertible Redeemable Preferred Stock | (26,250) | ||||
Net cash provided by financing activities | 29,590 | 407 | |||
Net decrease in cash, cash equivalents and restricted cash | (9,505) | (27,758) | |||
Cash, cash equivalents and restricted cash at beginning of period | 14,555 | 38,829 | $ 38,829 | ||
Cash, cash equivalents and restricted cash at end of period | 5,050 | 11,071 | 5,050 | 11,071 | 14,555 |
Supplemental cash flow information: | |||||
Cash and cash equivalents | 4,712 | 5,733 | 4,712 | 5,733 | $ 14,217 |
Restricted cash | 338 | 5,338 | 338 | 5,338 | |
Total cash, cash equivalents and restricted cash | $ 5,050 | $ 11,071 | 5,050 | 11,071 | |
Supplemental non-cash flow information: | |||||
Right-of-use asset obtained in exchange for new operating lease liabilities | $ 419 |
NATURE OF OPERATIONS AND SIGNIF
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
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. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead clinical program is EB-101, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based gene therapies designed to treat highly unmet, medically needed ophthalmic diseases using the novel AIM™ capsid platform that the Company has exclusively licensed from the University of North Carolina at Chapel Hill, and internal AAV vector research programs. Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. 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. These unaudited interim condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The December 31, 2022 condensed consolidated balance sheet was derived from the audited statements, but does not include all disclosures required by U.S. GAAP. Therefore, these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with the SEC on April 10, 2023. Liquidity In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued. As a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development activities for EB-101 and other product candidates, business planning, raising capital, establishing its intellectual property portfolio, acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future. Since its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred recurring losses since its inception, including net losses of $ 11.8 6.4 37.6 36.4 732.9 54.1 While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from the issuance date of these condensed consolidated financial statements, the Company’s liquidity could be materially affected over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory events or unanticipated costs related to its EB-101; (4) any other unanticipated material negative events or costs. One or more of these events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty Use of Estimates The preparation of unaudited interim condensed consolidated financial statements in conformity with 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 unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported period. The Company’s significant estimates include, but are not limited to, fair value of warrant liabilities and stock-based compensation. Due to the uncertainty inherent in such estimates, actual results could differ from these estimates and assumptions. Other receivables Other receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As of September 30, 2023 and December 31, 2022, the Company had ERC receivables of $ 2.1 nil Summary of Significant Accounting Policies There have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022 other than those identified below. Correction of Error During the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021. The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The correction of the error resulted in the Company adjusting its quarterly information presented for the three and nine months ended September 30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A. The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations and comprehensive loss (in thousands, except for per share data): SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS For the three months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 3,050 $ 3,050 Net loss $ (9,484 ) $ 3,050 $ (6,434 ) Net loss attributable to Common Shareholders $ (9,484 ) $ 3,050 $ (6,434 ) Basic and diluted loss per common share $ (1.48 ) $ 0.48 $ (1.00 ) Comprehensive loss $ (9,494 ) $ 3,050 $ (6,444 ) For the nine months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 5,995 $ 5,995 Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Net loss attributable to Common Shareholders $ (42,352 ) $ 5,995 $ (36,357 ) Basic and diluted loss per common share $ (7.05 ) $ 1.00 $ (6.05 ) Comprehensive loss $ (42,369 ) $ 5,995 $ (36,374 ) The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’ equity (in thousands): As of September 30, 2022 Condensed Consolidated Statement of Stockholders’ Equity As Reported Adjustment As Revised Additional paid-in capital, December 31, 2021 $ 705,570 $ (9,007 ) $ 696,563 Total stockholders’ equity, December 31, 2021 $ 51,375 $ (9,007 ) $ 42,368 Additional paid-in capital, June 30, 2022 $ 703,379 $ (9,007 ) $ 694,372 Accumulated deficit, June 30, 2022 $ (684,726 ) $ 2,945 $ (681,781 ) Total stockholders’ equity, June 30, 2022 $ 20,086 $ (6,062 ) $ 14,024 Net loss for the three months ended September 30, 2022 $ (9,484 ) $ 3,050 $ (6,434 ) Net loss for the nine months ended September 30, 2022 $ (38,570 ) $ 5,995 $ (32,575 ) Additional paid-in capital, September 30, 2022 $ 709,590 $ (9,007 ) $ 700,583 Accumulated deficit, September 30, 2022 $ (694,210 ) $ 5,995 $ (688,215 ) Total stockholders’ equity, September 30, 2022 $ 15,413 $ (3,012 ) $ 12,401 The following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in thousands): For the nine months ended September 30, 2022 Condensed Consolidated Cash Flow Statement As Reported Adjustment As Revised Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Adjustments to reconcile net loss to cash used in operating activities: Change in fair value of warrant liabilities $ — $ (5,995 ) $ (5,995 ) Net cash used in operating activities $ (29,491 ) $ — $ (29,491 ) Credit Losses The Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the Company’s investment policy. As of September 30, 2023, the Company’s available-for-sale investments were in securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of September 30, 2023, the Company did not recognize a credit loss allowance for its investments or accounts receivable. Net Loss Per Share Basic and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of shares of common stock. The weighted average number of shares of common stock include the weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining unfunded exercise price is $0.0001 or less per share. The Company does 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. The following table sets forth the potential securities that could potentially dilute basic loss per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE 2023 2022 For the three and nine months ended September 30, 2023 2022 Stock options 223,323 242,644 Restricted stock 2,308,924 821,269 Warrants 9,397,879 1,788,000 Total 11,930,126 2,851,913 New Accounting Pronouncements No new accounting pronouncements issued is expected to have a material impact on the Company’s condensed consolidated financial statements. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments |
SHORT-TERM INVESTMENTS
SHORT-TERM INVESTMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
SHORT-TERM INVESTMENTS | NOTE 2 – SHORT-TERM INVESTMENTS The following table provides a summary of the short-term investments (in thousands): SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS September 30, 2023 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 4,916 — (22 ) $ 4,894 U.S. federal agency securities 44,225 — (77 ) 44,148 Total available-for-sale, short-term investments $ 49,141 — (99 ) $ 49,042 December 31, 2022 Amortized Cost Gross Gross Fair Value Available-for-sale, short-term investments: U.S. treasury and federal agency securities $ 38,032 — (100 ) $ 37,932 Total available-for-sale, short-term investments $ 38,032 — (100 ) $ 37,932 As of September 30, 2023, the available-for-sale securities classified as short-term investments mature in one year or less. The Company carries its available-for-sale securities at fair value in the condensed consolidated balance sheets. Unrealized losses on available-for-sale securities as of September 30, 2023, were not significant and were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. None of the short-term investments have been in a continuous unrealized loss position for more than 12 months. Accordingly, no other-than-temporary impairment was recorded for the three and nine months ended September 30, 2023. There were no |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 3 – PROPERTY AND EQUIPMENT, NET Property and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT Useful lives (years) September 30, 2023 December 31, 2022 Laboratory equipment 5 $ 7,182 $ 7,636 Furniture, software and office equipment 3 5 960 1,379 Leasehold improvements Shorter of remaining lease term or useful life 8,602 8,605 Subtotal 16,744 17,620 Less: accumulated depreciation (12,745 ) (11,879 ) Total property and equipment, net $ 3,999 $ 5,741 Depreciation expense was $ 0.5 0.8 1.8 2.3 On March 31, 2022, the Company announced that it was pursuing a strategic partner to take over development activities of ABO-102 and that it was discontinuing development of ABO-101. As a result, the Company determined the construction-in-progress that was dedicated to the ABO-101 and ABO-102 programs had no future value, and thus recorded an impairment charge of $ 1.8 |
LICENSED TECHNOLOGY
LICENSED TECHNOLOGY | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
LICENSED TECHNOLOGY | NOTE 4 – LICENSED TECHNOLOGY 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 B and Sanfilippo Syndrome Type A, respectively. The license was being amortized to expense over the life of the license of 20 years no 1.4 no Amortization expense on licensed technology was nil 29,000 no |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5 – FAIR VALUE MEASUREMENTS The Company calculates the fair value of the Company’s assets and liabilities that qualify as financial instruments and includes 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 other receivables, prepaid expenses and other current assets, other assets, accounts payable, accrued expenses, and payables to licensor 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 Company has 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. The following table provides a summary of financial assets measured at fair value on a recurring and non-recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description Fair Value at September 30, 2023 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 1,021 $ 1,021 $ — $ — Short-term investments U.S. treasury securities 4,894 4,894 — — U.S. federal agency securities 44,148 — 44,148 — Total assets measured at fair value $ 50,063 $ 5,915 $ 44,148 $ — Liabilities Payable to licensor $ 4,472 — — $ 4,472 Warrant liabilities 27,122 — — 27,122 Total liabilities measured at fair value $ 31,594 $ — $ — $ 31,594 Description Fair Value at December 31, 2022 Level 1 Level 2 Level 3 Recurring Assets: Cash equivalents Money market fund $ 12,923 $ 12,923 $ — $ — Short-term investments U.S. treasury securities and federal agency securities 37,932 — 37,932 — Total assets measured at fair value $ 50,855 $ 12,923 $ 37,932 $ — Liabilities Warrant liabilities 19,657 — — 19,657 Total liabilities measured at fair value $ 19,657 $ — $ — $ 19,657 Warrant Liabilities As of September 30, 2023 and December 31, 2022, the Company had outstanding warrant liabilities related to the 2022 private placement that allow the holders to purchase 7,609,879 4.75 1,788,000 9.75 The following table provides a summary of the activity on the warrant liabilities (in thousands): SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES Warrant liabilities as of December 31, 2022 $ 19,657 Loss recognized in earnings from change in fair value 7,465 Warrant liabilities as of September 30, 2023 $ 27,122 The warrant liabilities are valued using significant inputs not observable in the market. Accordingly, the warrant liability is measured at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the common stock warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the common stock warrants. The Company assessed these assumptions and estimates at the end of each reporting period. Assumptions used to estimate the fair value of the warrants in the Black-Scholes option-pricing model are as follows: SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS September 30, 2023 December 31, 2022 Common share price $ 4.21 $ 1.72 2.18 Expected term (years) 3.21 4.09 3.96 4.84 Risk-free interest rate (%) 4.56 4.65 3.91 4.01 Volatility (%) 100.00 106.99 102.40 107.55 Expected dividend yield (%) 0% 0% |
SETTLEMENT LIABILITY
SETTLEMENT LIABILITY | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SETTLEMENT LIABILITY | NOTE 6 – SETTLEMENT LIABILITY On November 12, 2021, the Company entered into a settlement agreement (“Settlement Agreement”) with the Company’s prior licensor REGENXBIO Inc. (“REGENXBIO”) to resolve all existing disputes between the parties. In accordance with the Settlement Agreement, the Company agreed to pay REGENXBIO a total of $ 30.0 (1) $20.0 million paid in November 2021 after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement, and (3) $5.0 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 As of September 30, 2023, the Company recorded the payable due to REGENXBIO in the condensed consolidated balance sheets based on the present value of the remaining payments due to REGENXBIO under the Settlement Agreement using an effective interest rate of 9.6 November 2024 4.5 4.2 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 7 – ACCRUED EXPENSES The following table provides a summary of the components of accrued expenses (in thousands): SCHEDULE OF ACCRUED EXPENSES September 30, 2023 December 31, 2022 Accrued employee compensation $ 2,126 $ 2,593 Accrued contracted services and other 1,846 1,398 Total accrued expenses $ 3,972 $ 3,991 |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
LEASES | NOTE 8 – LEASES The Company leases space under operating leases for administrative, manufacturing and laboratory facilities in Cleveland, Ohio. The Company also leases office space in New York, New York, that the Company sublets. The Company also leases certain office equipment under operating leases, which have a non-cancelable lease term of less than one year and, therefore, the Company has elected the practical expedient to exclude these short-term leases from the Company’s right-of-use assets and lease liabilities. In June 2023, the Company terminated one of its operating leases for office space. The termination resulted in a gain of $ 1.1 On March 31, 2022, the Company announced that they were pursuing a strategic partner to take over development activities of ABO-102 and that the Company was discontinuing development of ABO-101. As a result of this shift in priorities, the Company determined the portion of the lease that was dedicated to the future facility for the ABO-101 and ABO-102 programs, had no future value and thus, the Company recorded an impairment charge of $ 1.6 The following table provides a summary of the Company’s operating lease liabilities (in thousands): SUMMARY OF OPERATING LEASE LIABILITIES September 30, 2023 December 31, 2022 Current operating lease liability $ 1,649 $ 1,773 Non-current lease liability 4,043 5,854 Total lease liability $ 5,692 $ 7,627 Lease costs and rent are reflected in general and administrative expenses and research and development expenses in the condensed consolidated statements of operations and comprehensive loss, as determined by the underlying activities. The following table provides a summary of the components of lease costs and rent (in thousands): SCHEDULE OF COMPONENTS OF LEASE COST 2023 2022 2023 2022 For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022 Operating lease cost $ 340 $ 467 $ 1,048 $ 1,400 Variable lease cost 66 154 281 366 Short-term lease cost 19 17 50 58 Total operating lease costs $ 425 $ 638 $ 1,379 $ 1,824 Cash paid for amounts included in the measurement of operating lease liabilities was $ 0.3 0.2 0.9 1.1 Future minimum lease payments and obligations, which do not include short-term leases, of the Company’s operating lease liabilities as of September 30, 2023 were as follows (in thousands): SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Future minimum lease payments and obligations Operating Leases 2023, remainder $ 403 2024 993 2025 1,552 2026 791 2027 807 Thereafter 2,516 Total undiscounted operating lease payments 7,062 Less: imputed interest 1,370 Present value of operating lease liabilities $ 5,692 The weighted-average remaining term of the Company’s operating leases was 66 months and the weighted-average discount rate used to measure the present value of the Company’s operating lease liabilities was 7.4 % as of September 30, 2023. Future cash receipts from the Company’s sublease agreements as of September 30, 2023 are as follows (in thousands): SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE Operating Future cash receipts Subleases 2023, remainder $ 156 2024 634 2025 485 Total future cash receipts $ 1,275 |
EQUITY
EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
EQUITY | NOTE 9 – EQUITY Reverse Stock Split Effective July 1, 2022, the Company’s stock underwent a 25:1 Reverse Stock Split. 200,000,000 Public Offerings On December 21, 2021, the Company closed an underwritten public offering of 1,788,000 9.75 1,788,000 9.75 16.0 1.5 7.0 9.0 As of September 30, 2023, there were 1,788,000 December 21, 2026 Open Market Sale Agreement On August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock for an aggregate sales price of up to $ 150.0 1,990,321 6.6 1,038,134 4.2 Private Placement Offering On November 3, 2022, the Company sold 7,065,946 543,933 7,609,879 4.60 4.59 0.01 4.75 543,933 7,609,879 35.0 32.6 1.5 0.9 12.9 0.1 In the event of certain fundamental transactions involving the Company, the holders of the stock purchase warrants may require the Company to make a payment based on a Black-Scholes valuation, using specific inputs that are not considered indexed to the Company’s stock in accordance with ASC 815. Therefore, the Company is accounting for the stock purchase warrants as liabilities. On November 3, 2022, the stock purchase warrants were recorded at the closing date fair value of $ 22.0 As of September 30, 2023, there were 7,609,879 November 3, 2027 Direct Placement Offering On July 6, 2023, the Company sold 3,284,407 and in lieu of shares of common stock, pre-funded warrants exercisable for 2,919,140 (the “2023 Pre-Funded Warrants”) 25.0 23.0 4.03 2023 Pre-Funded Warrants 4.0299 which represents the per share offering price for the Company’s common stock less a $ 0.0001 The 2023 Pre-Funded Warrants are immediately exercisable at a nominal exercise price of $ 0.0001 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 10 – STOCK-BASED COMPENSATION The Company previously granted stock options under its 2005 Equity Incentive Plan (the “2005 Incentive Plan”), under which no further grants can be made. In addition, prior to May 17, 2023, the Company had previously granted stock options and stock awards under the Abeona Therapeutics Inc. 2015 Equity Incentive Plan (the “2015 Incentive Plan”). As of May 17, 2023, no further grants can be made under the 2015 Incentive Plan. The Company now grants stock options and stock awards under the Abeona Therapeutics Inc. 2023 Equity Incentive Plan (the “2023 Incentive Plan”) which was approved by stockholders on May 17, 2023. As of September 30, 2023, there were 156,591 The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): SCHEDULE OF STOCK BASED COMPENSATION 2023 2022 2023 2022 For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022 Research and development $ 339 $ 173 $ 743 $ 729 General and administrative 1,218 459 2,511 1,489 Total stock-based compensation expense $ 1,557 $ 632 $ 3,254 $ 2,218 Stock Options The Company estimates the fair value of each option award on the date of grant using the Black-Scholes option-pricing model. The Company 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 – the Company estimates the volatility of the share price at the date of grant using a “look-back” period which coincides with the expected term, defined below. The Company believes using a “look-back” period which coincides with the expected term is the most appropriate measure for determining expected volatility. ● Expected term – the Company estimates the expected term using the “simplified” method, as outlined in SEC Staff Accounting Bulletin No. 107, “Share-Based Payment.” ● Risk-free interest rate – the Company estimates 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 – the Company uses an expected dividend yield of zero because the Company has not declared nor paid a cash dividend, nor are there any plans to declare a dividend. The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED For the nine months ended September 30, 2023* 2022 Expected volatility (%) n/a 95.1 96.0 Expected term (years) n/a 6.07 6.08 Risk-free interest rate (%) n/a 1.7 3.3 Expected dividend yield (%) n/a 0% * the Company did not grant any stock options in the nine months ended September 30, 2023 . The following table summarizes stock option activity for the 2015 Incentive Plan and the 2005 Incentive Plan during the nine months ended September 30, 2023 (there were no stock options granted under the 2023 Incentive Plan during the nine months ended September 30, 2023): SCHEDULE OF STOCK OPTION ACTIVITY Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2022 240,770 $ 37.04 6.42 $ — Granted — $ — — $ — Cancelled/forfeited (17,447 ) $ 33.40 — $ — Exercised — $ — — $ — Outstanding at September 30, 2023 223,323 $ 37.33 5.69 $ — Exercisable 170,958 $ 36.81 5.09 $ — Unvested 52,365 $ 39.03 7.65 $ — The aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock. As of September 30, 2023, the total compensation cost related to non-vested option awards not yet recognized was approximately $ 1.7 1.5 Restricted Stock The following table summarizes restricted stock award activity for the 2023 Incentive Plan, 2015 Incentive Plan and Inducement Grants during the nine months ended September 30, 2023: SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY Number of Awards Weighted Average Grant Date Fair Value Per Unit Outstanding at December 31, 2022 816,958 $ 5.35 Granted 1,817,559 $ 3.96 Cancelled/forfeited (56,398 ) $ 4.32 Vested (269,195 ) $ 5.44 Outstanding at September 30, 2023 2,308,924 $ 4.27 As of September 30, 2023, there was approximately $ 8.5 2.4 1.5 |
LICENSE_SUPPLIER AGREEMENT
LICENSE/SUPPLIER AGREEMENT | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE/SUPPLIER AGREEMENT | NOTE 11 – LICENSE/SUPPLIER AGREEMENT Sublicense Agreement Relating to Rett Syndrome In October 2020, the Company entered into a sublicense agreement with Taysha Gene Therapies (“Taysha”) The transaction price of the contract includes (i) $ 3.0 26.5 30.0 26.5 Under this arrangement, the Company recognized no 3.5 1.0 no no Ultragenyx License Agreement On May 16, 2022, the Company and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered into an exclusive license agreement (the “License Agreement”) for AAV gene therapy, ABO-102, for the treatment of Sanfilippo syndrome type A (MPS IIIA). Under the License Agreement, Ultragenyx assumed responsibility for the ABO-102 program from the Company, with the exclusive right to develop, manufacture, and commercialize ABO-102 worldwide. Also pursuant to the License Agreement, following regulatory approval, the Company is eligible to receive tiered royalties from mid-single-digit up to 10% on net sales and up to $ 30.0 Additionally, pursuant to the License Agreement, Ultragenyx will reimburse the Company for certain development and transition costs actually incurred by the Company. These costs are passed through to Ultragenyx without mark-up. The Company has determined that these costs are not incurred for the purpose of satisfying any performance obligation under the License Agreement. Accordingly, the reimbursement of these costs is recognized as a reduction of research and development costs. There were no amounts due to the Company from Ultragenyx under the License Agreement as of September 30, 2023 and December 31, 2022, respectively. |
NATURE OF OPERATIONS AND SIGN_2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background | Background Abeona Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation, is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead clinical program is EB-101, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based gene therapies designed to treat highly unmet, medically needed ophthalmic diseases using the novel AIM™ capsid platform that the Company has exclusively licensed from the University of North Carolina at Chapel Hill, and internal AAV vector research programs. |
Basis of Presentation | Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. 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. These unaudited interim condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The December 31, 2022 condensed consolidated balance sheet was derived from the audited statements, but does not include all disclosures required by U.S. GAAP. Therefore, these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with the SEC on April 10, 2023. |
Liquidity | Liquidity In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued. As a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development activities for EB-101 and other product candidates, business planning, raising capital, establishing its intellectual property portfolio, acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future. Since its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred recurring losses since its inception, including net losses of $ 11.8 6.4 37.6 36.4 732.9 54.1 While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from the issuance date of these condensed consolidated financial statements, the Company’s liquidity could be materially affected over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory events or unanticipated costs related to its EB-101; (4) any other unanticipated material negative events or costs. One or more of these events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty |
Use of Estimates | Use of Estimates The preparation of unaudited interim condensed consolidated financial statements in conformity with 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 unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported period. The Company’s significant estimates include, but are not limited to, fair value of warrant liabilities and stock-based compensation. Due to the uncertainty inherent in such estimates, actual results could differ from these estimates and assumptions. |
Other receivables | Other receivables Other receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As of September 30, 2023 and December 31, 2022, the Company had ERC receivables of $ 2.1 nil |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2022 other than those identified below. |
Correction of Error | Correction of Error During the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021. The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The correction of the error resulted in the Company adjusting its quarterly information presented for the three and nine months ended September 30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A. The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations and comprehensive loss (in thousands, except for per share data): SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS For the three months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 3,050 $ 3,050 Net loss $ (9,484 ) $ 3,050 $ (6,434 ) Net loss attributable to Common Shareholders $ (9,484 ) $ 3,050 $ (6,434 ) Basic and diluted loss per common share $ (1.48 ) $ 0.48 $ (1.00 ) Comprehensive loss $ (9,494 ) $ 3,050 $ (6,444 ) For the nine months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 5,995 $ 5,995 Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Net loss attributable to Common Shareholders $ (42,352 ) $ 5,995 $ (36,357 ) Basic and diluted loss per common share $ (7.05 ) $ 1.00 $ (6.05 ) Comprehensive loss $ (42,369 ) $ 5,995 $ (36,374 ) The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’ equity (in thousands): As of September 30, 2022 Condensed Consolidated Statement of Stockholders’ Equity As Reported Adjustment As Revised Additional paid-in capital, December 31, 2021 $ 705,570 $ (9,007 ) $ 696,563 Total stockholders’ equity, December 31, 2021 $ 51,375 $ (9,007 ) $ 42,368 Additional paid-in capital, June 30, 2022 $ 703,379 $ (9,007 ) $ 694,372 Accumulated deficit, June 30, 2022 $ (684,726 ) $ 2,945 $ (681,781 ) Total stockholders’ equity, June 30, 2022 $ 20,086 $ (6,062 ) $ 14,024 Net loss for the three months ended September 30, 2022 $ (9,484 ) $ 3,050 $ (6,434 ) Net loss for the nine months ended September 30, 2022 $ (38,570 ) $ 5,995 $ (32,575 ) Additional paid-in capital, September 30, 2022 $ 709,590 $ (9,007 ) $ 700,583 Accumulated deficit, September 30, 2022 $ (694,210 ) $ 5,995 $ (688,215 ) Total stockholders’ equity, September 30, 2022 $ 15,413 $ (3,012 ) $ 12,401 The following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in thousands): For the nine months ended September 30, 2022 Condensed Consolidated Cash Flow Statement As Reported Adjustment As Revised Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Adjustments to reconcile net loss to cash used in operating activities: Change in fair value of warrant liabilities $ — $ (5,995 ) $ (5,995 ) Net cash used in operating activities $ (29,491 ) $ — $ (29,491 ) |
Credit Losses | Credit Losses The Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the Company’s investment policy. As of September 30, 2023, the Company’s available-for-sale investments were in securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of September 30, 2023, the Company did not recognize a credit loss allowance for its investments or accounts receivable. |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of shares of common stock. The weighted average number of shares of common stock include the weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining unfunded exercise price is $0.0001 or less per share. The Company does 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. The following table sets forth the potential securities that could potentially dilute basic loss per share in the future that were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented: SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE 2023 2022 For the three and nine months ended September 30, 2023 2022 Stock options 223,323 242,644 Restricted stock 2,308,924 821,269 Warrants 9,397,879 1,788,000 Total 11,930,126 2,851,913 |
New Accounting Pronouncements | New Accounting Pronouncements No new accounting pronouncements issued is expected to have a material impact on the Company’s condensed consolidated financial statements. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments |
NATURE OF OPERATIONS AND SIGN_3
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS | The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations and comprehensive loss (in thousands, except for per share data): SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS For the three months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 3,050 $ 3,050 Net loss $ (9,484 ) $ 3,050 $ (6,434 ) Net loss attributable to Common Shareholders $ (9,484 ) $ 3,050 $ (6,434 ) Basic and diluted loss per common share $ (1.48 ) $ 0.48 $ (1.00 ) Comprehensive loss $ (9,494 ) $ 3,050 $ (6,444 ) For the nine months ended September 30, 2022 Condensed Consolidated Statement of Operations and Comprehensive Loss As Reported Adjustment As Revised Change in fair value of warrant liabilities $ — $ 5,995 $ 5,995 Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Net loss attributable to Common Shareholders $ (42,352 ) $ 5,995 $ (36,357 ) Basic and diluted loss per common share $ (7.05 ) $ 1.00 $ (6.05 ) Comprehensive loss $ (42,369 ) $ 5,995 $ (36,374 ) The following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’ equity (in thousands): As of September 30, 2022 Condensed Consolidated Statement of Stockholders’ Equity As Reported Adjustment As Revised Additional paid-in capital, December 31, 2021 $ 705,570 $ (9,007 ) $ 696,563 Total stockholders’ equity, December 31, 2021 $ 51,375 $ (9,007 ) $ 42,368 Additional paid-in capital, June 30, 2022 $ 703,379 $ (9,007 ) $ 694,372 Accumulated deficit, June 30, 2022 $ (684,726 ) $ 2,945 $ (681,781 ) Total stockholders’ equity, June 30, 2022 $ 20,086 $ (6,062 ) $ 14,024 Net loss for the three months ended September 30, 2022 $ (9,484 ) $ 3,050 $ (6,434 ) Net loss for the nine months ended September 30, 2022 $ (38,570 ) $ 5,995 $ (32,575 ) Additional paid-in capital, September 30, 2022 $ 709,590 $ (9,007 ) $ 700,583 Accumulated deficit, September 30, 2022 $ (694,210 ) $ 5,995 $ (688,215 ) Total stockholders’ equity, September 30, 2022 $ 15,413 $ (3,012 ) $ 12,401 The following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in thousands): For the nine months ended September 30, 2022 Condensed Consolidated Cash Flow Statement As Reported Adjustment As Revised Net loss $ (38,570 ) $ 5,995 $ (32,575 ) Adjustments to reconcile net loss to cash used in operating activities: Change in fair value of warrant liabilities $ — $ (5,995 ) $ (5,995 ) Net cash used in operating activities $ (29,491 ) $ — $ (29,491 ) |
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE | SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE 2023 2022 For the three and nine months ended September 30, 2023 2022 Stock options 223,323 242,644 Restricted stock 2,308,924 821,269 Warrants 9,397,879 1,788,000 Total 11,930,126 2,851,913 |
SHORT-TERM INVESTMENTS (Tables)
SHORT-TERM INVESTMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS | The following table provides a summary of the short-term investments (in thousands): SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS September 30, 2023 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 4,916 — (22 ) $ 4,894 U.S. federal agency securities 44,225 — (77 ) 44,148 Total available-for-sale, short-term investments $ 49,141 — (99 ) $ 49,042 December 31, 2022 Amortized Cost Gross Gross Fair Value Available-for-sale, short-term investments: U.S. treasury and federal agency securities $ 38,032 — (100 ) $ 37,932 Total available-for-sale, short-term investments $ 38,032 — (100 ) $ 37,932 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT Useful lives (years) September 30, 2023 December 31, 2022 Laboratory equipment 5 $ 7,182 $ 7,636 Furniture, software and office equipment 3 5 960 1,379 Leasehold improvements Shorter of remaining lease term or useful life 8,602 8,605 Subtotal 16,744 17,620 Less: accumulated depreciation (12,745 ) (11,879 ) Total property and equipment, net $ 3,999 $ 5,741 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS | The following table provides a summary of financial assets measured at fair value on a recurring and non-recurring basis as of September 30, 2023 and December 31, 2022 (in thousands): SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description Fair Value at September 30, 2023 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 1,021 $ 1,021 $ — $ — Short-term investments U.S. treasury securities 4,894 4,894 — — U.S. federal agency securities 44,148 — 44,148 — Total assets measured at fair value $ 50,063 $ 5,915 $ 44,148 $ — Liabilities Payable to licensor $ 4,472 — — $ 4,472 Warrant liabilities 27,122 — — 27,122 Total liabilities measured at fair value $ 31,594 $ — $ — $ 31,594 Description Fair Value at December 31, 2022 Level 1 Level 2 Level 3 Recurring Assets: Cash equivalents Money market fund $ 12,923 $ 12,923 $ — $ — Short-term investments U.S. treasury securities and federal agency securities 37,932 — 37,932 — Total assets measured at fair value $ 50,855 $ 12,923 $ 37,932 $ — Liabilities Warrant liabilities 19,657 — — 19,657 Total liabilities measured at fair value $ 19,657 $ — $ — $ 19,657 |
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES | The following table provides a summary of the activity on the warrant liabilities (in thousands): SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES Warrant liabilities as of December 31, 2022 $ 19,657 Loss recognized in earnings from change in fair value 7,465 Warrant liabilities as of September 30, 2023 $ 27,122 |
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS | SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS September 30, 2023 December 31, 2022 Common share price $ 4.21 $ 1.72 2.18 Expected term (years) 3.21 4.09 3.96 4.84 Risk-free interest rate (%) 4.56 4.65 3.91 4.01 Volatility (%) 100.00 106.99 102.40 107.55 Expected dividend yield (%) 0% 0% |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | The following table provides a summary of the components of accrued expenses (in thousands): SCHEDULE OF ACCRUED EXPENSES September 30, 2023 December 31, 2022 Accrued employee compensation $ 2,126 $ 2,593 Accrued contracted services and other 1,846 1,398 Total accrued expenses $ 3,972 $ 3,991 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
SUMMARY OF OPERATING LEASE LIABILITIES | The following table provides a summary of the Company’s operating lease liabilities (in thousands): SUMMARY OF OPERATING LEASE LIABILITIES September 30, 2023 December 31, 2022 Current operating lease liability $ 1,649 $ 1,773 Non-current lease liability 4,043 5,854 Total lease liability $ 5,692 $ 7,627 |
SCHEDULE OF COMPONENTS OF LEASE COST | Lease costs and rent are reflected in general and administrative expenses and research and development expenses in the condensed consolidated statements of operations and comprehensive loss, as determined by the underlying activities. The following table provides a summary of the components of lease costs and rent (in thousands): SCHEDULE OF COMPONENTS OF LEASE COST 2023 2022 2023 2022 For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022 Operating lease cost $ 340 $ 467 $ 1,048 $ 1,400 Variable lease cost 66 154 281 366 Short-term lease cost 19 17 50 58 Total operating lease costs $ 425 $ 638 $ 1,379 $ 1,824 |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | Future minimum lease payments and obligations, which do not include short-term leases, of the Company’s operating lease liabilities as of September 30, 2023 were as follows (in thousands): SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Future minimum lease payments and obligations Operating Leases 2023, remainder $ 403 2024 993 2025 1,552 2026 791 2027 807 Thereafter 2,516 Total undiscounted operating lease payments 7,062 Less: imputed interest 1,370 Present value of operating lease liabilities $ 5,692 |
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE | Future cash receipts from the Company’s sublease agreements as of September 30, 2023 are as follows (in thousands): SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE Operating Future cash receipts Subleases 2023, remainder $ 156 2024 634 2025 485 Total future cash receipts $ 1,275 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK BASED COMPENSATION | The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): SCHEDULE OF STOCK BASED COMPENSATION 2023 2022 2023 2022 For the three months ended September 30, For the nine months ended September 30, 2023 2022 2023 2022 Research and development $ 339 $ 173 $ 743 $ 729 General and administrative 1,218 459 2,511 1,489 Total stock-based compensation expense $ 1,557 $ 632 $ 3,254 $ 2,218 |
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED | The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED For the nine months ended September 30, 2023* 2022 Expected volatility (%) n/a 95.1 96.0 Expected term (years) n/a 6.07 6.08 Risk-free interest rate (%) n/a 1.7 3.3 Expected dividend yield (%) n/a 0% |
SCHEDULE OF STOCK OPTION ACTIVITY | The following table summarizes stock option activity for the 2015 Incentive Plan and the 2005 Incentive Plan during the nine months ended September 30, 2023 (there were no stock options granted under the 2023 Incentive Plan during the nine months ended September 30, 2023): SCHEDULE OF STOCK OPTION ACTIVITY Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value Outstanding at December 31, 2022 240,770 $ 37.04 6.42 $ — Granted — $ — — $ — Cancelled/forfeited (17,447 ) $ 33.40 — $ — Exercised — $ — — $ — Outstanding at September 30, 2023 223,323 $ 37.33 5.69 $ — Exercisable 170,958 $ 36.81 5.09 $ — Unvested 52,365 $ 39.03 7.65 $ — |
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY | The following table summarizes restricted stock award activity for the 2023 Incentive Plan, 2015 Incentive Plan and Inducement Grants during the nine months ended September 30, 2023: SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY Number of Awards Weighted Average Grant Date Fair Value Per Unit Outstanding at December 31, 2022 816,958 $ 5.35 Granted 1,817,559 $ 3.96 Cancelled/forfeited (56,398 ) $ 4.32 Vested (269,195 ) $ 5.44 Outstanding at September 30, 2023 2,308,924 $ 4.27 |
SCHEDULE OF EFFECTS OF THE REST
SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Change in fair value of warrant liabilities | $ (1,101) | $ 3,050 | $ (7,465) | $ 5,995 | ||||
Net loss | (11,836) | (6,434) | (37,597) | (32,575) | ||||
Net loss attributable to Common Shareholders | $ (11,836) | $ (6,434) | $ (37,597) | $ (36,357) | ||||
Loss per common share - basic | $ (0.48) | $ (1) | $ (1.89) | $ (6.05) | ||||
Loss per common share - diluted | $ (0.48) | $ (1) | $ (1.89) | $ (6.05) | ||||
Comprehensive loss | $ (11,840) | $ (6,444) | $ (37,567) | $ (36,374) | ||||
Additional paid in capital | 754,823 | 700,583 | 754,823 | 700,583 | $ 722,049 | $ 694,372 | $ 696,563 | |
Stockholders equity | 22,038 | 12,401 | 22,038 | 12,401 | $ 9,345 | 26,761 | 14,024 | 42,368 |
Accumulated deficit | 732,933 | (688,215) | 732,933 | (688,215) | $ 695,336 | (681,781) | ||
Change in fair value of warrant liabilities | $ 1,101 | (3,050) | 7,465 | (5,995) | ||||
Net cash used in operating activities | $ (27,774) | (29,491) | ||||||
Previously Reported [Member] | ||||||||
Change in fair value of warrant liabilities | ||||||||
Net loss | (9,484) | (38,570) | ||||||
Net loss attributable to Common Shareholders | $ (9,484) | $ (42,352) | ||||||
Loss per common share - basic | $ (1.48) | $ (7.05) | ||||||
Loss per common share - diluted | $ (1.48) | $ (7.05) | ||||||
Comprehensive loss | $ (9,494) | $ (42,369) | ||||||
Additional paid in capital | 709,590 | 709,590 | 703,379 | 705,570 | ||||
Stockholders equity | 15,413 | 15,413 | 20,086 | 51,375 | ||||
Accumulated deficit | (694,210) | (694,210) | (684,726) | |||||
Change in fair value of warrant liabilities | ||||||||
Net cash used in operating activities | (29,491) | |||||||
Revision of Prior Period, Adjustment [Member] | ||||||||
Change in fair value of warrant liabilities | 3,050 | 5,995 | ||||||
Net loss | 3,050 | 5,995 | ||||||
Net loss attributable to Common Shareholders | $ 3,050 | $ 5,995 | ||||||
Loss per common share - basic | $ 0.48 | $ 1 | ||||||
Loss per common share - diluted | $ 0.48 | $ 1 | ||||||
Comprehensive loss | $ 3,050 | $ 5,995 | ||||||
Additional paid in capital | (9,007) | (9,007) | (9,007) | (9,007) | ||||
Stockholders equity | (3,012) | (3,012) | (6,062) | $ (9,007) | ||||
Accumulated deficit | 5,995 | 5,995 | $ 2,945 | |||||
Change in fair value of warrant liabilities | $ (3,050) | (5,995) | ||||||
Net cash used in operating activities |
SCHEDULE OF ANTI-DILUTIVE SECUR
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 11,930,126 | 2,851,913 | 11,930,126 | 2,851,913 |
Share-Based Payment Arrangement, Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 223,323 | 242,644 | 223,323 | 242,644 |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 2,308,924 | 821,269 | 2,308,924 | 821,269 |
Warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 9,397,879 | 1,788,000 | 9,397,879 | 1,788,000 |
NATURE OF OPERATIONS AND SIGN_4
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Net loss | $ 11,836 | $ 6,434 | $ 37,597 | $ 36,357 | ||
Accumulated deficit | 732,933 | $ (688,215) | 732,933 | $ (688,215) | $ 695,336 | $ (681,781) |
Cash, cash equivalents, restricted cash and short-term investments | 54,100 | 54,100 | ||||
Other receivables | $ 2,100 | $ 2,100 |
SCHEDULE OF AVAILABLE FOR SALE
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Marketable Securities [Line Items] | ||
Amortized cost | $ 49,141 | $ 38,032 |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (99) | (100) |
Fair Value | 49,042 | 37,932 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 4,916 | |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (22) | |
Fair Value | 4,894 | |
US Government Corporations and Agencies Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 44,225 | |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (77) | |
Fair Value | $ 44,148 | |
U.S. Treasury and Federal Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 38,032 | |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (100) | |
Fair Value | $ 37,932 |
SHORT-TERM INVESTMENTS (Details
SHORT-TERM INVESTMENTS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Available-for-sale securities realized gain loss | $ 0 | $ 0 | $ 0 | $ 0 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Subtotal | $ 16,744 | $ 17,620 |
Less: accumulated depreciation | (12,745) | (11,879) |
Total property and equipment, net | $ 3,999 | 5,741 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives (years) | 5 years | |
Subtotal | $ 7,182 | 7,636 |
Furniture, Software and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Subtotal | $ 960 | 1,379 |
Furniture, Software and Office Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives (years) | 3 years | |
Furniture, Software and Office Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives (years) | 5 years | |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Subtotal | $ 8,602 | $ 8,605 |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | Useful Life, Lease Term [Member] |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 0.5 | $ 0.8 | $ 1.8 | $ 2.3 |
Impairement of assets | $ 1.8 |
LICENSED TECHNOLOGY (Details Na
LICENSED TECHNOLOGY (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | May 15, 2015 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Impairment of licensed technology | $ 1,355,000 | |||||
Remaining net value of licenced technology | 0 | 0 | $ 0 | |||
License [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite-Lived Intangible Asset, Useful Life | 20 years | |||||
Amortization of licensed technology | $ 0 | $ 0 | $ 29,000 |
SCHEDULE OF FAIR VALUE, ASSETS
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | $ 27,122 | $ 19,657 |
Fair Value, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 50,063 | 50,855 |
Total liabilities measured at fair value | 31,594 | 19,657 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 5,915 | 12,923 |
Total liabilities measured at fair value | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 44,148 | 37,932 |
Total liabilities measured at fair value | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | ||
Total liabilities measured at fair value | 31,594 | 19,657 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents fair value | 1,021 | 12,923 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents fair value | 1,021 | 12,923 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents fair value | ||
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents fair value | ||
Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 4,894 | |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 4,894 | |
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 44,148 | |
Fair Value, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 44,148 | |
Fair Value, Recurring [Member] | US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | Payable to Licensor [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | 4,472 | |
Fair Value, Recurring [Member] | Payable to Licensor [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | ||
Fair Value, Recurring [Member] | Payable to Licensor [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | ||
Fair Value, Recurring [Member] | Payable to Licensor [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | 4,472 | |
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | 27,122 | 19,657 |
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | ||
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | ||
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | $ 27,122 | |
Fair Value, Recurring [Member] | U.S. Treasury and Federal Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 37,932 | |
Fair Value, Recurring [Member] | U.S. Treasury and Federal Agency Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | U.S. Treasury and Federal Agency Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 37,932 | |
Fair Value, Recurring [Member] | U.S. Treasury and Federal Agency Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | ||
Fair Value, Recurring [Member] | Licensed Technology Net [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | $ 19,657 |
SCHEDULE OF ACTIVITY OF WARRANT
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value Disclosures [Abstract] | |
Warrant liabilities as of December 31, 2022 | $ 19,657 |
Loss recognized in earnings from change in fair value | 7,465 |
Warrant liabilities as of September 30, 2023 | $ 27,122 |
SCHEDULE OF ESTIMATE FAIR VALUE
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS (Details) | Sep. 30, 2023 $ / shares | Dec. 31, 2022 $ / shares |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (years) | 3 years 2 months 15 days | 3 years 11 months 15 days |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (years) | 4 years 1 month 2 days | 4 years 10 months 2 days |
Measurement Input, Share Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 4.21 | |
Measurement Input, Share Price [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 1.72 | |
Measurement Input, Share Price [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 2.18 | |
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 4.56 | 3.91 |
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 4.65 | 4.01 |
Measurement Input, Price Volatility [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 100 | 102.40 |
Measurement Input, Price Volatility [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 106.99 | 107.55 |
Measurement Input, Expected Dividend Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Volatility | 0 | 0 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details Narrative) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 21, 2021 |
Subsidiary, Sale of Stock [Line Items] | |||
Warrants purchase, shares | 1,788,000 | ||
Warrants exercise price | $ 9.75 | ||
Private Placement [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Warrants purchase, shares | 7,609,879 | 7,609,879 | |
Warrants exercise price | $ 4.75 | $ 4.75 | |
2021 Public Offering [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Warrants purchase, shares | 1,788,000 | 1,788,000 | |
Warrants exercise price | $ 9.75 | $ 9.75 |
SETTLEMENT LIABILITY (Details N
SETTLEMENT LIABILITY (Details Narrative) - REGENXBIO [Member] - USD ($) $ in Millions | 9 Months Ended | ||
Nov. 12, 2021 | Sep. 30, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Settlement liabilities, current | $ 30 | ||
Loss contingency settlement agreement terms | (1) $20.0 million paid in November 2021 after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement, and (3) $5.0 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 | ||
Effective interest rate stated percentage | 9.60% | ||
Due In November 2024 [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Debt instrument maturity date | November 2024 | ||
Long term debt | $ 4.5 | $ 4.2 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation | $ 2,126 | $ 2,593 |
Accrued contracted services and other | 1,846 | 1,398 |
Total accrued expenses | $ 3,972 | $ 3,991 |
SUMMARY OF OPERATING LEASE LIAB
SUMMARY OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases | ||
Current operating lease liability | $ 1,649 | $ 1,773 |
Non-current lease liability | 4,043 | 5,854 |
Total lease liability | $ 5,692 | $ 7,627 |
SCHEDULE OF COMPONENTS OF LEASE
SCHEDULE OF COMPONENTS OF LEASE COST (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases | ||||
Operating lease cost | $ 340 | $ 467 | $ 1,048 | $ 1,400 |
Variable lease cost | 66 | 154 | 281 | 366 |
Short-term lease cost | 19 | 17 | 50 | 58 |
Total operating lease costs | $ 425 | $ 638 | $ 1,379 | $ 1,824 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases | ||
2023, remainder | $ 403 | |
2024 | 993 | |
2025 | 1,552 | |
2026 | 791 | |
2027 | 807 | |
Thereafter | 2,516 | |
Total undiscounted operating lease payments | 7,062 | |
Less: imputed interest | 1,370 | |
Present value of operating lease liabilities | $ 5,692 | $ 7,627 |
SCHEDULE OF FUTURE CASH RECEIPT
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Leases | |
2023, remainder | $ 156 |
2024 | 634 |
2025 | 485 |
Total future cash receipts | $ 1,275 |
LEASES (Details Narrative)
LEASES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases | ||||
Gain (Loss) on Termination of Lease | $ 1,100 | |||
Lease impairment charge | (1,065) | $ 1,561 | ||
Operating lease liabilities | $ 300 | $ 200 | $ 900 | $ 1,100 |
Operating Lease, Weighted Average Remaining Lease Term | 66 months | 66 months | ||
Operating Lease, Weighted Average Discount Rate, Percent | 7.40% | 7.40% |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Jul. 06, 2023 | Nov. 03, 2022 | Jul. 01, 2022 | Dec. 21, 2021 | Aug. 17, 2018 | Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Reverse stock split ratio | the Company’s stock underwent a 25:1 Reverse Stock Split. | ||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | ||||||
Shares issued | 1,788,000 | ||||||||||
Public offering price | $ 9.75 | ||||||||||
Warrants purchase, shares | 1,788,000 | ||||||||||
Exercise price | $ 9.75 | ||||||||||
Proceeds from public offering | $ 16,000,000 | ||||||||||
Stock issuance costs | 1,500,000 | ||||||||||
Additional paid-in capital | 7,000,000 | ||||||||||
Warrant liabilities | $ 9,000,000 | ||||||||||
Warrants outstanding | 1,788,000 | 1,788,000 | |||||||||
Warrants maturity date | Dec. 21, 2026 | Dec. 21, 2026 | |||||||||
Shares issuance costs | $ 6,623,000 | $ 4,189,000 | |||||||||
Common Stock [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares issued | 3,284,407 | 3,284,407 | 1,038,134 | 1,990,321 | 1,038,134 | ||||||
Offering price | $ 4.03 | ||||||||||
Common Stock [Member] | 2023-Pre-Funded Warrants [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Exercise price | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Warrants exercised | 2,919,140 | ||||||||||
Purchase price of common stock | $ 25,000,000 | ||||||||||
Shares issuance costs | $ 23,000,000 | ||||||||||
Offering price | $ 4.0299 | ||||||||||
Private Placement Offerings [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares issued | 7,065,946 | ||||||||||
Warrant liabilities | $ 22,000,000 | ||||||||||
Warrants maturity date | Nov. 03, 2027 | Nov. 03, 2027 | |||||||||
Exercise price | $ 4.75 | ||||||||||
Warrant outstanding | $ 7,609,879 | $ 7,609,879 | |||||||||
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Exercise price | $ 0.01 | ||||||||||
Additional paid-in capital | $ 100,000 | ||||||||||
Sale of stock | 7,609,879 | ||||||||||
Warrants exercised | 543,933 | 543,933 | |||||||||
Purchase price of common stock | $ 35,000,000 | ||||||||||
Additional paid in capital stock reduction | 900,000 | ||||||||||
Proceeds from warrant liability' | $ 12,900,000 | ||||||||||
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | General and Administrative Expense [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Stock issuance costs | $ 1,500,000 | ||||||||||
Private Placement Offerings [Member] | Common Stock And Accompanying Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Exercise price | $ 4.60 | ||||||||||
Private Placement Offerings [Member] | Pre Funded Warrant And Accompanying Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Exercise price | $ 4.59 | ||||||||||
Private Placement [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Warrants purchase, shares | 7,609,879 | 7,609,879 | 7,609,879 | 7,609,879 | |||||||
Exercise price | $ 4.75 | $ 4.75 | $ 4.75 | $ 4.75 | |||||||
Private Placement [Member] | Pre Funded Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Warrants purchase, shares | 7,609,879 | ||||||||||
ATM Agreement [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock value | $ 4,200,000 | $ 6,600,000 | $ 4,200,000 | ||||||||
Sale of stock | 1,038,134 | 1,990,321 | 1,038,134 | ||||||||
ATM Agreement [Member] | Jefferies LLC [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock value | $ 150,000,000 | ||||||||||
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Shares issuance costs | $ 32,600,000 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,557 | $ 632 | $ 3,254 | $ 2,218 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 339 | 173 | 743 | 729 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,218 | $ 459 | $ 2,511 | $ 1,489 |
SCHEDULE OF WEIGHTED-AVERAGE AS
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected dividend yield | 0% |
Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility | 95.10% |
Expected term | 6 years 25 days |
Risk-free interest rate | 1.70% |
Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility | 96% |
Expected term | 6 years 29 days |
Risk-free interest rate | 3.30% |
SCHEDULE OF STOCK OPTION ACTIVI
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - 2015 and 2005 Equity Incentive Plan [Member] - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Options, Beginning balance | 240,770 | |
Weighted Average Exercise Price, Beginning balance | $ 37.04 | |
Weighted Aaverage Remaining Contractual Term (years), Outstanding | 5 years 8 months 8 days | 6 years 5 months 1 day |
Aggregate Intrinsic Value, Beginning balance | ||
Number of Options, Granted | ||
Weighted Average Exercise Price, Granted | ||
Number of Options, Cancelled/forfeited | (17,447) | |
Weighted Average Exercise Price, Cancelled/forfeited | $ 33.40 | |
Number of Options, Exercised | ||
Weighted Average Exercise Price, Exercised | ||
Number of Options, Ending balance | 223,323 | 240,770 |
Weighted Average Exercise Price, Ending balance | $ 37.33 | $ 37.04 |
Aggregate Intrinsic Value, Ending balance | ||
Number of Options, Exerciasble | 170,958 | |
Weighted Average Exercise Price, Exercisable | $ 36.81 | |
Weighted Aaverage Remaining Contractual Term (years), Exercisable | 5 years 1 month 2 days | |
Aggregate Intrinsic Value, Exercisable | ||
Number of Options, Unvested options | 52,365 | |
Weighted Average Exercise Price, Unvested | $ 39.03 | |
Weighted Aaverage Remaining Contractual Term (years), Unvested | 7 years 7 months 24 days | |
Aggregate Intrinsic Value, Unvested |
SCHEDULE OF RESTRICTED STOCK AW
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY (Details) - 2015 Equity Incentive Plan Inducement Grants [Member] - Restricted Stock [Member] | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Awards, Beginning balance | shares | 816,958 |
Weighted Average Grant Date Fair Value Per Unit, Beginning balance | $ / shares | $ 5.35 |
Number of Awards, Granted | shares | 1,817,559 |
Weighted Average Grant Date Fair Value Per Unit, Granted | $ / shares | $ 3.96 |
Number of Awards, Cancelled/forfeited | shares | (56,398) |
Weighted Average Grant Date Fair Value Per Unit, Forfeited | $ / shares | $ 4.32 |
Number of Awards, Vested | shares | (269,195) |
Weighted Average Grant Date Fair Value Per Unit, Vested | $ / shares | $ 5.44 |
Number of Awards, Ending balance | shares | 2,308,924 |
Weighted Average Grant Date Fair Value Per Unit, Ending balance | $ / shares | $ 4.27 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | |
Stock Options [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Compensation cost related to non-vested options not recognized | $ 1.7 |
Weighted average vesting period | 1 year 6 months |
Restricted Stock [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Weighted average vesting period | 2 years 4 months 24 days |
Unrecognized compensation expense | $ 8.5 |
Fair value of restricted stock awards that vested | $ 1.5 |
2023 Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Shares available for grant | shares | 156,591 |
LICENSE_SUPPLIER AGREEMENT (Det
LICENSE/SUPPLIER AGREEMENT (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
May 16, 2022 | Oct. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | $ 3,500,000 | $ 1,346,000 | |||||
License Agreement Terms [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone payments | $ 30,000,000 | ||||||
Sublicense And Inventory Purchase Agreements [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Fixed consideration | $ 3,000,000 | ||||||
Contract assets | 0 | 0 | $ 0 | ||||
Contract liabilities | 0 | 0 | $ 0 | ||||
Sublicense And Inventory Purchase Agreements [Member] | Event Based Milestone Payments [Member] | Maximum [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Variable consideration | 26,500,000 | ||||||
Sublicense And Inventory Purchase Agreements [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Variable consideration | $ 30,000,000 | ||||||
Sublicense And Inventory Purchase Agreements [Member] | License [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | $ 0 | $ 0 | $ 3,500,000 | $ 1,000,000 |