Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
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, $0.01 par value | |
Trading Symbol | ABEO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 41,186,004 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 17,558 | $ 14,473 |
Short-term investments | 44,786 | 37,753 |
Restricted cash | 338 | 338 |
Other receivables | 2,232 | 2,444 |
Prepaid expenses and other current assets | 1,811 | 729 |
Total current assets | 66,725 | 55,737 |
Property and equipment, net | 3,767 | 3,533 |
Operating lease right-of-use assets | 4,222 | 4,455 |
Other assets | 114 | 277 |
Total assets | 74,828 | 64,002 |
Current liabilities: | ||
Accounts payable | 3,362 | 1,858 |
Accrued expenses | 2,791 | 5,985 |
Current portion of operating lease liability | 1,044 | 998 |
Current portion of payable to licensor | 4,691 | 4,580 |
Other current liabilities | 1 | 1 |
Total current liabilities | 11,889 | 13,422 |
Long-term operating lease liabilities | 4,046 | 4,402 |
Long-term debt | 18,079 | |
Derivative liabilities | 1,005 | |
Warrant liabilities | 48,690 | 31,352 |
Total liabilities | 83,709 | 49,176 |
Commitments and contingencies | ||
Stockholders’ (deficit) equity: | ||
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | ||
Common stock - $0.01 par value; authorized 200,000,000 shares; 27,550,593 and 26,523,878 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 276 | 265 |
Additional paid-in capital | 772,129 | 764,151 |
Accumulated deficit | (781,102) | (749,524) |
Accumulated other comprehensive loss | (184) | (66) |
Total stockholders’ (deficit) equity | (8,881) | 14,826 |
Total liabilities and stockholders’ equity | $ 74,828 | $ 64,002 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 27,550,593 | 26,523,878 |
Common stock, shares outstanding | 27,550,593 | 26,523,878 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues: | ||
License and other revenues | ||
Expenses: | ||
Research and development | 7,207 | 8,041 |
General and administrative | 7,123 | 3,997 |
Total expenses | 14,330 | 12,038 |
Loss from operations | (14,330) | (12,038) |
Interest income | 843 | 364 |
Interest expense | (952) | (101) |
Change in fair value of warrant and derivative liabilities | (17,301) | 2,265 |
Other income | 162 | 403 |
Net loss | $ (31,578) | $ (9,107) |
Loss per common share - basic | $ (1.16) | $ (0.54) |
Loss per common share - diluted | $ (1.16) | $ (0.54) |
Weighted average number of common shares outstanding - basic | 27,315,537 | 16,904,024 |
Weighted average number of common shares outstanding - diluted | 27,315,537 | 16,904,024 |
Other comprehensive income (loss): | ||
Change in unrealized (losses) gains related to available-for-sale debt securities | $ (118) | $ 64 |
Comprehensive loss | $ (31,696) | $ (9,043) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2022 | $ 177 | $ 722,049 | $ (695,336) | $ (129) | $ 26,761 |
Balance, shares at Dec. 31, 2022 | 17,719,720 | ||||
Stock-based compensation expense | 770 | 770 | |||
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | $ 1 | (5) | (4) | ||
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares | 111,064 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 1 | 255 | 256 | ||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 98,560 | ||||
Net loss | (9,107) | (9,107) | |||
Other comprehensive income | 64 | 64 | |||
Balance at Mar. 31, 2023 | $ 179 | 723,069 | (704,443) | (65) | 18,740 |
Balance, shares at Mar. 31, 2023 | 17,929,344 | ||||
Balance at Dec. 31, 2023 | $ 265 | 764,151 | (749,524) | (66) | 14,826 |
Balance, shares at Dec. 31, 2023 | 26,523,878 | ||||
Stock-based compensation expense | 1,546 | 1,546 | |||
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | $ 2 | (16) | (14) | ||
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares | 137,500 | ||||
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | $ 9 | 6,448 | 6,457 | ||
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares | 889,315 | ||||
Net loss | (31,578) | (31,578) | |||
Other comprehensive income | (118) | (118) | |||
Balance at Mar. 31, 2024 | $ 276 | $ 772,129 | $ (781,102) | $ (184) | $ (8,881) |
Balance, shares at Mar. 31, 2024 | 27,550,693 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (31,578) | $ (9,107) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 491 | 661 |
Stock-based compensation expense | 1,546 | 770 |
Change in fair value of warrant and derivative liabilities | 17,301 | (2,265) |
Accretion and interest on short-term investments | (59) | (117) |
Amortization of right-of-use lease assets | 233 | 227 |
Non-cash interest | 345 | 100 |
Change in operating assets and liabilities: | ||
Other receivables | 252 | (75) |
Prepaid expenses and other current assets | (1,232) | (1,199) |
Other assets | 163 | (56) |
Accounts payable and accrued expenses | (1,690) | (376) |
Lease liabilities | (310) | (308) |
Other current liabilities | 1 | |
Net cash used in operating activities | (14,538) | (11,744) |
Cash flows from investing activities: | ||
Capital expenditures | (725) | (218) |
Purchases of short-term investments | (29,343) | (7,964) |
Proceeds from maturities of short-term investments | 22,251 | 10,393 |
Net cash (used in) provided by investing activities | (7,817) | 2,211 |
Cash flows from financing activities: | ||
Proceeds from ATM sales of common stock, net of issuance costs | 6,417 | |
Payment from net settlement of restricted share awards | (14) | (4) |
Proceeds from issuance of long-term debt | 20,000 | |
Payment of debt issuance costs | (963) | |
Net cash provided by (used in) financing activities | 25,440 | (4) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 3,085 | (9,537) |
Cash, cash equivalents and restricted cash at beginning of period | 14,811 | 14,555 |
Cash, cash equivalents and restricted cash at end of period | 17,896 | 5,018 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 17,558 | 4,680 |
Restricted cash | 338 | 338 |
Total cash, cash equivalents and restricted cash | 17,896 | 5,018 |
Supplemental non-cash flow information: | ||
Derivative and warrant additions associated with loan and security agreement | 1,042 | |
Cash paid for interest | 607 | |
Cash paid for taxes | $ 8 | $ 6 |
NATURE OF OPERATIONS AND SIGNIF
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2024 | |
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 for pz-cel, 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™ capsids 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, 2023 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 for the year ended December 31, 2023, which was filed with the SEC on March 18, 2024. 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 pz-cel 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 $ 31.6 9.1 781.1 62.7 75.0 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 unaudited 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 pz-cel; (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. 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 March 31, 2024 and December 31, 2023, the Company had ERC receivables of $ 2.1 Summary of Significant Accounting Policies There have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that are of significance, or potential significance, to the Company. 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 March 31, 2024, 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 March 31, 2024, 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 outstanding during the period. The weighted average number of shares of common stock includes 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 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 2024 2023 For the three months ended March 31, 2024 2023 Shares of common stock issuable upon exercise of stock options 179,001 234,697 Shares of common stock underlying restricted stock 2,542,619 929,946 Shares of common stock issuable upon exercise of warrants 9,903,142 9,397,879 Total 12,624,762 10,562,522 In January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $ 2,400,000 4.75 4.75 505,263 nil 4.07 Recently Adopted Accounting Pronouncements The Company did not adopt any new accounting pronouncements during the three months ended March 31, 2024. Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, |
SHORT-TERM INVESTMENTS
SHORT-TERM INVESTMENTS | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 36,999 — (167 ) $ 36,832 U.S. federal agency securities 7,970 — (16 ) 7,954 Total available-for-sale, short-term investments $ 44,969 — (183 ) $ 44,786 December 31, 2023 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 8,406 — (13 ) $ 8,393 U.S. federal agency securities 29,413 — (53 ) 29,360 Total available-for-sale, short-term investments $ 37,819 — (66 ) $ 37,753 As of March 31, 2024, 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 March 31, 2024, 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 months ended March 31, 2024. There were no |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 3 Months Ended |
Mar. 31, 2024 | |
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) March 31, 2024 December 31, 2023 Laboratory equipment 5 $ 7,498 $ 6,935 Furniture, software and office equipment 3 5 1,045 986 Leasehold improvements Shorter of remaining lease term or useful life 8,706 8,603 Subtotal 17,249 16,524 Less: accumulated depreciation (13,482 ) (12,991 ) Total property and equipment, net $ 3,767 $ 3,533 Depreciation and amortization on property and equipment was $ 0.5 0.7 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 4 – 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 March 31, 2024 and December 31, 2023 (in thousands): SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description Fair Value at March 31, 2024 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 17,558 $ 17,558 $ — $ — Short-term investments U.S. treasury securities 36,832 36,832 — — U.S. federal agency securities 7,954 — 7,954 — Total assets measured at fair value $ 62,344 $ 54,390 $ 7,954 $ — Liabilities Payable to licensor $ 4,691 $ — $ — $ 4,691 Derivative liabilities 1,005 — — 1,005 Warrant liabilities 48,690 — — 48,690 Total liabilities measured at fair value $ 54,386 $ — $ — $ 54,386 Description Fair Value at December 31, 2023 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 1,034 $ 1,034 $ — $ — Short-term investments U.S. treasury securities 8,393 8,393 — — U.S. federal agency securities 29,360 — 29,360 — Total assets measured at fair value $ 38,787 $ 9,427 $ 29,360 $ — Liabilities Payable to licensor $ 4,580 $ — $ — $ 4,580 Warrant liabilities 31,352 — — 31,352 Total liabilities measured at fair value $ 35,932 $ — $ — $ 35,932 Warrant Liabilities As of March 31, 2024 and December 31, 2023, the Company had the following outstanding warrant liabilities: SCHEDULE OF OUTSTANDING WARRANT LIABILITIES March 31, 2024 December 31, 2023 Warrants issued as part of the 2021 Public Offering, expiration date December 2026 9.75 1,788,000 1,788,000 Warrants issued as part of the 2022 Private Placement, expiration date November 2027 4.75 7,609,879 7,609,879 Warrants issued as part of the 2024 loan agreement, expiration date January 2029 4.75 505,263 — Outstanding warrants 505,263 — For the warrants issued as part of the 2024 loan agreement, the Company utilized the exercise price of $ 4.75 505,263 nil The common stock warrants related to the 2021 Public Offering and the 2022 Private Placement are not indexed to the Company’s own stock and therefore have been classified as liabilities at their estimated fair value. The common stock warrants related to the Loan Agreement were determined to be liability classified under ASC 815 as the common stock warrants do not include an explicit share limit and the number of shares issuable under the warrant agreements are variable based on the exercise price. Changes in the estimated fair value of the warrant liabilities is recorded as changes in fair value of warrant liabilities in the consolidated statement of operations and comprehensive loss. 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, 2023 $ 31,352 Fair value of warrants issued in connection with Loan Agreement 220 Loss recognized in earnings from change in fair value 17,118 Warrant liabilities as of March 31, 2024 $ 48,690 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. SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS March 31, 2024 December 31, 2023 Common share price $ 7.25 $ 5.01 Expected term (years) 2.71 4.77 2.96 3.84 Risk-free interest rate (%) 4.12 4.34 3.84 3.92 Volatility (%) 100.00 103.15 100% Expected dividend yield (%) 0% 0% Derivative Liabilities The Conversion Right embedded within the Loan Agreement (see Note 8 below) required bifurcation as certain adjustments to the conversion price were not indexed to the Company’s own stock and therefore the Conversion Right was recorded as a derivative liability. The derivative liability is remeasured at each reporting period with the change in fair value recorded to changes in fair value of warrants and derivative liabilities in the condensed consolidated statement of operations until the derivative is exercised, expired, reclassified, or otherwise settled. The following table provides a summary of the activity on the derivative liabilities (in thousands): SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES Derivative liabilities as of December 31, 2023 $ — Fair value of derivatives issued in connection with Loan Agreement 822 Loss recognized in earnings from change in fair value 183 Derivative liabilities as of March 31, 2024 $ 1,005 The derivative liabilities are valued using significant inputs not observable in the market. Accordingly, the derivative 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 derivatives utilized the Monte Carlo simulation model, which incorporated assumptions and estimates to value the derivatives. The Company assessed these assumptions and estimates at the end of each reporting period. SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES March 31, 2024 December 31, 2023 Common share price $ 7.25 — Expected term (years) 3.25 — Risk-free interest rate (%) 4.27% — Volatility (%) 89.70% — |
SETTLEMENT LIABILITY
SETTLEMENT LIABILITY | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
SETTLEMENT LIABILITY | NOTE 5 – 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 (paid in November 2022), 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 March 31, 2024, 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 4.7 4.6 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | NOTE 6 – ACCRUED EXPENSES The following table provides a summary of the components of accrued expenses (in thousands): SCHEDULE OF ACCRUED EXPENSES March 31, 2024 December 31, 2023 Accrued employee compensation $ 1,328 $ 3,688 Accrued contracted services and other 1,463 2,297 Total accrued expenses $ 2,791 $ 5,985 |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2024 | |
Leases | |
LEASES | NOTE 7 – 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 the Company has elected the practical expedient to exclude these short-term leases from the Company’s right-of-use assets and lease liabilities. The Company has entered into two sublease agreements with unrelated third parties to occupy the Company’s administrative offices in New York, New York. The Company expects to receive $ 1.0 The following table provides a summary of the Company’s operating lease liabilities (in thousands): SUMMARY OF OPERATING LEASE LIABILITIES March 31, 2024 December 31, 2023 Current operating lease liability $ 1,044 $ 998 Non-current operating lease liability 4,046 4,402 Total operating lease liability $ 5,090 $ 5,400 Lease costs and rent are reflected in general and administrative expenses and research and development expenses in the 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 2024 2023 For the three months ended March 31, 2024 2023 Operating lease cost $ 334 $ 415 Variable lease cost 74 39 Short-term lease cost 23 18 Total operating lease costs $ 431 $ 472 Cash paid for amounts included in the measurement of operating lease liabilities was $ 0.3 Future minimum lease payments and obligations, which do not include short-term leases, related to the Company’s operating lease liabilities as of March 31, 2024 were as follows (in thousands): SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Future minimum lease payments and obligations Operating Leases 2024, remainder $ 591 2025 1,555 2026 791 2027 807 2028 823 Thereafter 1,693 Total undiscounted operating lease payments 6,260 Less: imputed interest 1,170 Present value of operating lease liabilities $ 5,090 The weighted-average remaining term of the Company’s operating leases was 63 7.3 The Company received $ 0.1 SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE Operating Future cash receipts Subleases 2024, remainder $ 477 2025 485 Total future cash receipts $ 962 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
DEBT | NOTE 8 – DEBT The following table provides a summary of the Company’s debt, net of debt issuance costs and discounts (in thousands): SCHEDULE OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS March 31, 2024 December 31, 2023 Loan Agreement principal $ 20,000 $ — Accreted final payment fee 74 — Unamortized debt issuance costs and discounts (1,995 ) — Total debt $ 18,079 $ — Loan and Security Agreement On January 8, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Agreement”) with Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership, as administrative agent and collateral agent (“Avenue” and the “Agent”) and Avenue Venture Opportunities Fund II, L.P. , a Delaware limited partnership (“Avenue 2” and, together with Avenue, the “Lenders”). Also on January 8, 2024, the Company entered into a Supplement to the Agreement (collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders. The Loan Agreement provides for senior secured term loans (the “Loans”) in an aggregate principal amount up to $ 50 20 10 20 The Loan principal is repayable in equal monthly installments beginning on April 8, 2025, with the possibility of deferring principal payments an additional nine to fifteen months contingent upon (i) the Company obtaining FDA approval of pz-cel in recessive dystrophic epidermolysis bullosa, with the issuance of a Priority Review Voucher and (ii) the Company raising $ 90 5.00 13.50 13.50 The Company may, subject to certain parameters, voluntarily prepay the Loans, in whole, at any time. If prepayment occurs on or before the one-year anniversary of the Closing Date, the Company is required to pay a prepayment fee equal to 3.00% of the principal amount of the Loans prepaid; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 2.00% of the principal amount of the Loans; if prepayment occurs after the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 1.00% of the principal amount of the Loans. A final payment fee of 5.00% of the principal amount of the funded Tranche 1, Tranche 2 Loans and Discretionary Tranche Loans is also due upon the Maturity Date or any earlier date of prepayment. The Company’s obligations under the Loan Agreement are secured by a pledge of substantially all of the Company’s assets. Pursuant to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $ 5 Pursuant to the Supplement to the Loan and Security Agreement, Avenue also has the right to convert up to $ 3 0.8 In addition, subject to applicable law and specified provisions set forth in the Supplement to the Loan and Security Agreement and solely to the extent permitted under applicable stock exchange rules without requiring stockholder approval, the Lenders may participate in certain equity financing transactions of the Company in an aggregate amount of up to $ 1 The Participation Right automatically terminates upon the earliest of (i) July 1, 2027, (ii) such time that the Lenders have purchased $1 million of the Company’s equity securities in the aggregate pursuant to the Participation Right, and (iii) the repayment in full of all of the obligations under the Loan Agreement. On the Closing Date and pursuant to the funding of Tranche 1 of the Loan Agreement, the Company issued to each of Avenue and Avenue 2 (collectively, the “Warrantholders”) warrants to purchase up to $ 480,000 1,920,000 The future payment obligations of the principal are as follows (in thousands): SCHEDULE OF FUTURE PAYMENT OBLIGATIONS 2024, remainder $ — 2025 6,667 2026 8,889 2027 4,444 Total principal $ 20,000 |
EQUITY
EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
EQUITY | NOTE 9 – EQUITY 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 Derivatives and Hed 9.0 As of March 31, 2024, there were 1,788,000 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 million. Any sales of shares pursuant to this agreement are made under the Company’s effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. The Company sold 889,315 and 98,560 shares of its common stock under the ATM Agreement during the three months ended March 31, 2024 and 2023, respectively, resulting in net proceeds of $ 6.5 million and $ 0.3 million during the three months ended March 31, 2024 and 2023, respectively. 1,013,061 3.5 Private Placement Offerings 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 March 31, 2024, there were 7,609,879 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 per share exercise price for each such 2023 Pre-Funded Warrant The 2023 Pre-Funded Warrants are immediately exercisable at a nominal exercise price of $ 0.0001 . Derivatives and Hedging Common Stock Warrants related to the Loan and Security Agreement On January 8, 2024, in connection with entering into the Loan and Security Agreement, the Company issued to each of Avenue and Avenue 2 (collectively, the “Warrantholders”) warrants to purchase up to $ 480,000 1,920,000 January 8, 2029 4.75 4.75 505,263 0.2 In connection with the underwritten common stock financing consummated on May 7, 2024, and pursuant to the term of the January Warrants, the exercise price of the January Warrants was reduced to the lesser of (i) $ 4.07 4.07 589,680 The Warrantholders may exercise the Warrants at any time, or from time to time up to and including the Expiration Date, by making a cash payment equal to the exercise price multiplied by the quantity of shares. The Warrantholders may also exercise the Warrants on a cashless basis by receiving a net number of shares calculated pursuant to the formula set forth in the Warrants. The Warrants are subject to anti-dilution adjustments for stock dividends, stock splits, and reverse stock splits. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, there were 156,591 721,900 The following table summarizes stock-based compensation expense for the three months ended March 31, 2024 and 2023 (in thousands): SCHEDULE OF STOCK BASED COMPENSATION 2024 2023 For the three months ended March 31, 2024 2023 Research and development $ 346 $ 584 General and administrative 1,220 186 Total stock-based compensation expense $ 1,546 $ 770 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 did not grant any stock options in the three months ended March 31, 2024 and 2023. The Company accounts for forfeitures as they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. The following table summarizes stock option activity during the three months ended March 31, 2024: SCHEDULE OF STOCK OPTION ACTIVITY Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2023 179,001 $ 38.58 6.83 $ 3 Granted — $ — — $ — Cancelled/forfeited — $ — — $ — Exercised — $ — — $ — Outstanding at March 31, 2024 179,001 $ 38.58 6.58 $ 14 Exercisable 143,907 $ 38.58 6.42 $ 6 Unvested 35,094 $ 38.59 7.24 $ 8 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 March 31, 2024, the total compensation cost related to non-vested option awards not yet recognized was approximately $ 1.0 1.1 Restricted Stock The following table summarizes restricted stock award activity during the three months ended March 31, 2024: SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY Number of Awards Weighted Average Grant Date Fair Value Per Unit Outstanding at December 31, 2023 2,448,169 $ 4.25 Granted 137,500 $ 5.31 Cancelled/forfeited — $ — Vested (43,050 ) $ 7.56 Outstanding at March 31, 2024 2,542,619 $ 4.18 As of March 31, 2024, there was $ 7.4 2.2 0.5 |
LICENSE_SUPPLIER AGREEMENT
LICENSE/SUPPLIER AGREEMENT | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE/SUPPLIER AGREEMENT | NOTE 11 – LICENSE/SUPPLIER AGREEMENT Sublicense and Inventory Purchase Agreements Relating to CLN1 Disease In August 2020, the Company entered into sublicense and inventory purchase agreements with Taysha Gene Therapies (“Taysha”) relating to a potential gene therapy for CLN1 disease. Under the sublicense agreement, Taysha received worldwide exclusive rights to intellectual property and know-how relating to the research, development, and manufacture of the potential gene therapy, which the Company had referred to as ABO-202. Under the inventory purchase agreement, the Company sold to Taysha certain inventory and other items related to ABO-202. The Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality and evaluated whether such functionality can be retained without ongoing activities by the Company and determined that the license has significant stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain the license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was at a point in time. The transaction price of the contract includes (i) $ 7.0 26.0 30.0 26.0 Under this arrangement, the Company has no no Sublicense Agreement Relating to Rett Syndrome In October 2020, the Company entered into a sublicense agreement with Taysha The Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality and evaluated whether such functionality can be retained without ongoing activities by the Company and determined that the license has significant stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain the license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was at a point in time. The transaction price of the contract includes (i) $ 3.0 26.5 30.0 26.5 Under this arrangement, the Company recognized 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. As of March 31, 2024 and December 31, 2023, the Company does not have any contract assets or contract liabilities as a result of this transaction. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 12 – SUBSEQUENT EVENTS On May 7, 2024, the Company closed on an underwritten offering of 12,285,056 6,142,656 4.07 4.0699 0.0001 0.0001 70.2 |
NATURE OF OPERATIONS AND SIGN_2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
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 for pz-cel, 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™ capsids 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, 2023 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 for the year ended December 31, 2023, which was filed with the SEC on March 18, 2024. |
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 pz-cel 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 $ 31.6 9.1 781.1 62.7 75.0 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 unaudited 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 pz-cel; (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. 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 March 31, 2024 and December 31, 2023, the Company had ERC receivables of $ 2.1 |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that are of significance, or potential significance, to the Company. |
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 March 31, 2024, 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 March 31, 2024, 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 outstanding during the period. The weighted average number of shares of common stock includes 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 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 2024 2023 For the three months ended March 31, 2024 2023 Shares of common stock issuable upon exercise of stock options 179,001 234,697 Shares of common stock underlying restricted stock 2,542,619 929,946 Shares of common stock issuable upon exercise of warrants 9,903,142 9,397,879 Total 12,624,762 10,562,522 In January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $ 2,400,000 4.75 4.75 505,263 nil 4.07 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company did not adopt any new accounting pronouncements during the three months ended March 31, 2024. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, |
NATURE OF OPERATIONS AND SIGN_3
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE | SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE 2024 2023 For the three months ended March 31, 2024 2023 Shares of common stock issuable upon exercise of stock options 179,001 234,697 Shares of common stock underlying restricted stock 2,542,619 929,946 Shares of common stock issuable upon exercise of warrants 9,903,142 9,397,879 Total 12,624,762 10,562,522 |
SHORT-TERM INVESTMENTS (Tables)
SHORT-TERM INVESTMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 36,999 — (167 ) $ 36,832 U.S. federal agency securities 7,970 — (16 ) 7,954 Total available-for-sale, short-term investments $ 44,969 — (183 ) $ 44,786 December 31, 2023 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Available-for-sale, short-term investments: U.S. treasury securities $ 8,406 — (13 ) $ 8,393 U.S. federal agency securities 29,413 — (53 ) 29,360 Total available-for-sale, short-term investments $ 37,819 — (66 ) $ 37,753 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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) March 31, 2024 December 31, 2023 Laboratory equipment 5 $ 7,498 $ 6,935 Furniture, software and office equipment 3 5 1,045 986 Leasehold improvements Shorter of remaining lease term or useful life 8,706 8,603 Subtotal 17,249 16,524 Less: accumulated depreciation (13,482 ) (12,991 ) Total property and equipment, net $ 3,767 $ 3,533 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023 (in thousands): SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS Description Fair Value at March 31, 2024 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 17,558 $ 17,558 $ — $ — Short-term investments U.S. treasury securities 36,832 36,832 — — U.S. federal agency securities 7,954 — 7,954 — Total assets measured at fair value $ 62,344 $ 54,390 $ 7,954 $ — Liabilities Payable to licensor $ 4,691 $ — $ — $ 4,691 Derivative liabilities 1,005 — — 1,005 Warrant liabilities 48,690 — — 48,690 Total liabilities measured at fair value $ 54,386 $ — $ — $ 54,386 Description Fair Value at December 31, 2023 Level 1 Level 2 Level 3 Recurring Assets Cash equivalents Money market fund $ 1,034 $ 1,034 $ — $ — Short-term investments U.S. treasury securities 8,393 8,393 — — U.S. federal agency securities 29,360 — 29,360 — Total assets measured at fair value $ 38,787 $ 9,427 $ 29,360 $ — Liabilities Payable to licensor $ 4,580 $ — $ — $ 4,580 Warrant liabilities 31,352 — — 31,352 Total liabilities measured at fair value $ 35,932 $ — $ — $ 35,932 |
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES | As of March 31, 2024 and December 31, 2023, the Company had the following outstanding warrant liabilities: SCHEDULE OF OUTSTANDING WARRANT LIABILITIES March 31, 2024 December 31, 2023 Warrants issued as part of the 2021 Public Offering, expiration date December 2026 9.75 1,788,000 1,788,000 Warrants issued as part of the 2022 Private Placement, expiration date November 2027 4.75 7,609,879 7,609,879 Warrants issued as part of the 2024 loan agreement, expiration date January 2029 4.75 505,263 — Outstanding warrants 505,263 — |
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, 2023 $ 31,352 Fair value of warrants issued in connection with Loan Agreement 220 Loss recognized in earnings from change in fair value 17,118 Warrant liabilities as of March 31, 2024 $ 48,690 |
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS | SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS March 31, 2024 December 31, 2023 Common share price $ 7.25 $ 5.01 Expected term (years) 2.71 4.77 2.96 3.84 Risk-free interest rate (%) 4.12 4.34 3.84 3.92 Volatility (%) 100.00 103.15 100% Expected dividend yield (%) 0% 0% |
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES | The following table provides a summary of the activity on the derivative liabilities (in thousands): SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES Derivative liabilities as of December 31, 2023 $ — Fair value of derivatives issued in connection with Loan Agreement 822 Loss recognized in earnings from change in fair value 183 Derivative liabilities as of March 31, 2024 $ 1,005 |
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES | SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES March 31, 2024 December 31, 2023 Common share price $ 7.25 — Expected term (years) 3.25 — Risk-free interest rate (%) 4.27% — Volatility (%) 89.70% — |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 December 31, 2023 Accrued employee compensation $ 1,328 $ 3,688 Accrued contracted services and other 1,463 2,297 Total accrued expenses $ 2,791 $ 5,985 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 December 31, 2023 Current operating lease liability $ 1,044 $ 998 Non-current operating lease liability 4,046 4,402 Total operating lease liability $ 5,090 $ 5,400 |
SCHEDULE OF COMPONENTS OF LEASE COST | Lease costs and rent are reflected in general and administrative expenses and research and development expenses in the 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 2024 2023 For the three months ended March 31, 2024 2023 Operating lease cost $ 334 $ 415 Variable lease cost 74 39 Short-term lease cost 23 18 Total operating lease costs $ 431 $ 472 |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | Future minimum lease payments and obligations, which do not include short-term leases, related to the Company’s operating lease liabilities as of March 31, 2024 were as follows (in thousands): SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Future minimum lease payments and obligations Operating Leases 2024, remainder $ 591 2025 1,555 2026 791 2027 807 2028 823 Thereafter 1,693 Total undiscounted operating lease payments 6,260 Less: imputed interest 1,170 Present value of operating lease liabilities $ 5,090 |
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE | SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE Operating Future cash receipts Subleases 2024, remainder $ 477 2025 485 Total future cash receipts $ 962 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS | The following table provides a summary of the Company’s debt, net of debt issuance costs and discounts (in thousands): SCHEDULE OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS March 31, 2024 December 31, 2023 Loan Agreement principal $ 20,000 $ — Accreted final payment fee 74 — Unamortized debt issuance costs and discounts (1,995 ) — Total debt $ 18,079 $ — |
SCHEDULE OF FUTURE PAYMENT OBLIGATIONS | The future payment obligations of the principal are as follows (in thousands): SCHEDULE OF FUTURE PAYMENT OBLIGATIONS 2024, remainder $ — 2025 6,667 2026 8,889 2027 4,444 Total principal $ 20,000 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK BASED COMPENSATION | The following table summarizes stock-based compensation expense for the three months ended March 31, 2024 and 2023 (in thousands): SCHEDULE OF STOCK BASED COMPENSATION 2024 2023 For the three months ended March 31, 2024 2023 Research and development $ 346 $ 584 General and administrative 1,220 186 Total stock-based compensation expense $ 1,546 $ 770 |
SCHEDULE OF STOCK OPTION ACTIVITY | The following table summarizes stock option activity during the three months ended March 31, 2024: SCHEDULE OF STOCK OPTION ACTIVITY Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2023 179,001 $ 38.58 6.83 $ 3 Granted — $ — — $ — Cancelled/forfeited — $ — — $ — Exercised — $ — — $ — Outstanding at March 31, 2024 179,001 $ 38.58 6.58 $ 14 Exercisable 143,907 $ 38.58 6.42 $ 6 Unvested 35,094 $ 38.59 7.24 $ 8 |
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY | The following table summarizes restricted stock award activity during the three months ended March 31, 2024: SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY Number of Awards Weighted Average Grant Date Fair Value Per Unit Outstanding at December 31, 2023 2,448,169 $ 4.25 Granted 137,500 $ 5.31 Cancelled/forfeited — $ — Vested (43,050 ) $ 7.56 Outstanding at March 31, 2024 2,542,619 $ 4.18 |
SCHEDULE OF ANTI-DILUTIVE SECUR
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 12,624,762 | 10,562,522 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 179,001 | 234,697 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,542,619 | 929,946 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 9,903,142 | 9,397,879 |
NATURE OF OPERATIONS AND SIGN_4
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | ||||
May 07, 2024 | Dec. 21, 2021 | Jan. 31, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Net loss | $ 31,600,000 | $ 9,100,000 | ||||
Accumulated deficit | 781,102,000 | $ 749,524,000 | ||||
Cash, cash equivalents, restricted cash and short-term investments | 62,700,000 | |||||
Gross proceeds from its underwritten offering | $ 16,000,000 | 75,000,000 | ||||
Other receivables | $ 2,100,000 | $ 2,100,000 | ||||
Unfounded exercise price per share | $ 0.0001 | |||||
Warrants exercise price | $ 9.75 | |||||
Shares of common stock issuable upon exercise of warrants | 1,788,000 | |||||
Subsequent Event [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Gross proceeds from its underwritten offering | $ 70,200,000 | |||||
Loan and Security Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Warrants to purchase shares | $ 2,400,000 | |||||
Warrants exercise price | $ 4.75 | |||||
2024 Loan Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Warrants exercise price | $ 4.75 | |||||
Shares of common stock issuable upon exercise of warrants | 505,263 | |||||
2024 Loan Agreement [Member] | Subsequent Event [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Warrants exercise price | $ 4.07 |
SCHEDULE OF AVAILABLE FOR SALE
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Marketable Securities [Line Items] | ||
Amortized cost | $ 44,969 | $ 37,819 |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (183) | (66) |
Fair Value | 44,786 | 37,753 |
US Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 36,999 | 8,406 |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (167) | (13) |
Fair Value | 36,832 | 8,393 |
US Government Corporations and Agencies Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized cost | 7,970 | 29,413 |
Gross Unrealized Gain | ||
Gross Unrealized Loss | (16) | (53) |
Fair Value | $ 7,954 | $ 29,360 |
SHORT-TERM INVESTMENTS (Details
SHORT-TERM INVESTMENTS (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | ||
Available-for-sale securities realized gain loss | $ 0 | $ 0 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Subtotal | $ 17,249 | $ 16,524 |
Less: accumulated depreciation | (13,482) | (12,991) |
Total property and equipment, net | $ 3,767 | 3,533 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives (years) | 5 years | |
Subtotal | $ 7,498 | 6,935 |
Furniture, Software and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Subtotal | $ 1,045 | 986 |
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 | $ 8,706 | $ 8,603 |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeTermOfLeaseMember |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 0.5 | $ 0.7 |
SCHEDULE OF FAIR VALUE, ASSETS
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 62,344 | $ 38,787 |
Total liabilities measured at fair value | 54,386 | 35,932 |
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 | 54,390 | 9,427 |
Total liabilities measured at fair value | ||
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 | 7,954 | 29,360 |
Total liabilities measured at fair value | ||
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 | 54,386 | 35,932 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents fair value | 17,558 | 1,034 |
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 | 17,558 | 1,034 |
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 | ||
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 | ||
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments fair value | 36,832 | 8,393 |
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 | 36,832 | 8,393 |
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 | ||
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 | ||
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 | 7,954 | 29,360 |
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 | ||
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 | 7,954 | 29,360 |
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 | ||
Payable to Licensor [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | 4,691 | 4,580 |
Payable to Licensor [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | ||
Payable to Licensor [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | ||
Payable to Licensor [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | 4,691 | 4,580 |
Derivative Liabilities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | 1,005 | |
Derivative Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | 1,005 | |
Warrant Liabilities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | 48,690 | 31,352 |
Warrant Liabilities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | ||
Warrant Liabilities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | ||
Warrant Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value, liabilities | $ 48,690 | $ 31,352 |
SCHEDULE OF OUTSTANDING WARRANT
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 |
Class of Warrant or Right [Line Items] | |||
Outstanding warrants | 1,788,000 | ||
2021 Public Offering Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Outstanding warrants | 1,788,000 | 1,788,000 | |
2022 Private Placement Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Outstanding warrants | 7,609,879 | 7,609,879 | |
2024 Loan Agreement Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Outstanding warrants | 505,263 |
SCHEDULE OF OUTSTANDING WARRA_2
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES (Details) (Parenthetical) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Dec. 21, 2021 | |
Class of Warrant or Right [Line Items] | ||
Warrants, exercise price | $ 9.75 | |
2021 Public Offering Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Warrants, expiration date | December 2026 | |
Warrants, exercise price | $ 9.75 | |
2022 Private Placement Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Warrants, expiration date | November 2027 | |
Warrants, exercise price | $ 4.75 | |
2024 Loan Agreement Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Warrants, expiration date | January 2029 | |
Warrants, exercise price | $ 4.75 |
SCHEDULE OF ACTIVITY OF WARRANT
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value Disclosures [Abstract] | |
Warrant liabilities as of December 31, 2023 | $ 31,352 |
Fair value of warrants issued in connection with Loan Agreement | 220 |
Loss recognized in earnings from change in fair value | 17,118 |
Warrant liabilities as of March 31, 2024 | $ 48,690 |
SCHEDULE OF ESTIMATE FAIR VALUE
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS (Details) | Mar. 31, 2024 $ / shares | Dec. 31, 2023 $ / shares |
Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (years) | 2 years 8 months 15 days | 2 years 11 months 15 days |
Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (years) | 4 years 9 months 7 days | 3 years 10 months 2 days |
Measurement Input, Share Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 7.25 | 5.01 |
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 4.12 | 3.84 |
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 4.34 | 3.92 |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 100 | |
Measurement Input, Price Volatility [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 100 | |
Measurement Input, Price Volatility [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 103.15 | |
Measurement Input, Expected Dividend Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants measurement input | 0 | 0 |
SCHEDULE OF ACTIVITY OF DERIVAT
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value Disclosures [Abstract] | |
Derivative liabilities as of December 31, 2023 | |
Fair value of derivatives issued in connection with Loan Agreement | 822 |
Loss recognized in earnings from change in fair value | 183 |
Derivative liabilities as of March 31, 2024 | $ 1,005 |
SCHEDULE OF ESTIMATE FAIR VAL_2
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 $ / shares | Dec. 31, 2023 $ / shares | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Expected term (years) | 3 years 3 months | 0 years |
Measurement Input, Share Price [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivatives measurement input | 7.25 | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivatives measurement input | 4.27 | |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivatives measurement input | 89.70 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details Narrative) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 21, 2021 |
Class of Warrant or Right [Line Items] | ||||
Warrants, exercise price | $ 9.75 | |||
Outstanding warrants | 1,788,000 | |||
2024 Loan Agreement Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, exercise price | $ 4.75 | |||
Outstanding warrants | 505,263 |
SETTLEMENT LIABILITY (Details N
SETTLEMENT LIABILITY (Details Narrative) - USD ($) $ in Thousands | Nov. 12, 2021 | Mar. 31, 2024 | Dec. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] | |||
Long term debt | $ 18,079 | ||
REGENXBIO [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Settlement liabilities, current | $ 30,000 | ||
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 (paid in November 2022), 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% | ||
REGENXBIO [Member] | Due in November 2024 [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Long term debt | $ 4,700 | $ 4,600 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued employee compensation | $ 1,328 | $ 3,688 |
Accrued contracted services and other | 1,463 | 2,297 |
Total accrued expenses | $ 2,791 | $ 5,985 |
SUMMARY OF OPERATING LEASE LIAB
SUMMARY OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases | ||
Current operating lease liability | $ 1,044 | $ 998 |
Non-current operating lease liability | 4,046 | 4,402 |
Total operating lease liability | $ 5,090 | $ 5,400 |
SCHEDULE OF COMPONENTS OF LEASE
SCHEDULE OF COMPONENTS OF LEASE COST (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases | ||
Operating lease cost | $ 334 | $ 415 |
Variable lease cost | 74 | 39 |
Short-term lease cost | 23 | 18 |
Total operating lease costs | $ 431 | $ 472 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases | ||
2024, remainder | $ 591 | |
2025 | 1,555 | |
2026 | 791 | |
2027 | 807 | |
2028 | 823 | |
Thereafter | 1,693 | |
Total undiscounted operating lease payments | 6,260 | |
Less: imputed interest | 1,170 | |
Total operating lease liability | $ 5,090 | $ 5,400 |
SCHEDULE OF FUTURE CASH RECEIPT
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases | |
2024, remainder | $ 477 |
2025 | 485 |
Total future cash receipts | $ 962 |
LEASES (Details Narrative)
LEASES (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Operating lease liabilities | $ 0.3 | $ 0.3 |
Operating Lease, Weighted Average Remaining Lease Term | 63 months | |
Operating Lease, Weighted Average Discount Rate, Percent | 7.30% | |
Sub Lease Agreement [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Sublease income | $ 0.1 | $ 0.1 |
September2025 [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Sublease income | $ 1 |
SCHEDULE OF COMPANY DEBT AND NE
SCHEDULE OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
Loan Agreement principal | $ 20,000 | |
Accreted final payment fee | 74 | |
Unamortized debt issuance costs and discounts | (1,995) | |
Total debt | $ 18,079 |
SCHEDULE OF FUTURE PAYMENT OBLI
SCHEDULE OF FUTURE PAYMENT OBLIGATIONS (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
2024, remainder | ||
2025 | 6,667 | |
2026 | 8,889 | |
2027 | 4,444 | |
Total principal | $ 20,000 |
DEBT (Details Narrative)
DEBT (Details Narrative) - Loan and Security Agreement [Member] - USD ($) | Apr. 08, 2025 | Jan. 08, 2024 | Mar. 31, 2024 |
Debt Instrument [Line Items] | |||
Aggregate principal amount | $ 50,000,000 | ||
Prime rate percentage | 13.50% | ||
Percentage fee, description | the Company is required to pay a prepayment fee equal to 3.00% of the principal amount of the Loans prepaid; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 2.00% of the principal amount of the Loans; if prepayment occurs after the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 1.00% of the principal amount of the Loans. A final payment fee of 5.00% of the principal amount of the funded Tranche 1, Tranche 2 Loans and Discretionary Tranche Loans is also due upon the Maturity Date or any earlier date of prepayment. | ||
Unrestricted cash | $ 5,000,000 | ||
Outstanding principal amount of loan | 3,000,000 | ||
Fair value of conversion right | 800,000 | ||
Aggregate transaction amount | $ 1,000,000 | ||
Participation right description | The Participation Right automatically terminates upon the earliest of (i) July 1, 2027, (ii) such time that the Lenders have purchased $1 million of the Company’s equity securities in the aggregate pursuant to the Participation Right, and (iii) the repayment in full of all of the obligations under the Loan Agreement. | ||
Warrant [Member] | Avenue [Member] | |||
Debt Instrument [Line Items] | |||
Warrants purchase amount | $ 480,000 | ||
Warrant [Member] | Avenue 2 [Member] | |||
Debt Instrument [Line Items] | |||
Warrants purchase amount | 1,920,000 | ||
Subsequent Event [Member] | |||
Debt Instrument [Line Items] | |||
Cumulative equity and nondilutive capital | $ 90,000,000 | ||
Subsequent Event [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Prime rate percentage | 5% | ||
Subsequent Event [Member] | Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Prime rate percentage | 13.50% | ||
Tranche 1 [Member] | |||
Debt Instrument [Line Items] | |||
Aggregate principal amount | 20,000,000 | ||
Tranche 1 [Member] | Warrant [Member] | Avenue [Member] | |||
Debt Instrument [Line Items] | |||
Warrants purchase amount | 480,000 | ||
Tranche 1 [Member] | Warrant [Member] | Avenue 2 [Member] | |||
Debt Instrument [Line Items] | |||
Warrants purchase amount | 1,920,000 | ||
Tranche 2 [Member] | |||
Debt Instrument [Line Items] | |||
Aggregate principal amount | 10,000,000 | ||
Discretionary Tranche [Member] | |||
Debt Instrument [Line Items] | |||
Aggregate principal amount | $ 20,000,000 |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
May 07, 2024 | Jan. 08, 2024 | Jul. 06, 2023 | Nov. 03, 2022 | Dec. 21, 2021 | Aug. 17, 2018 | Apr. 27, 2024 | Jan. 31, 2024 | Dec. 31, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
issuance of shares | 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 | $ 75,000,000 | |||||||||||
Stock issuance costs | 1,500,000 | ||||||||||||
Additional paid-in capital | 7,000,000 | ||||||||||||
Warrant liabilities | $ 9,000,000 | ||||||||||||
Warrants outstanding | 1,788,000 | ||||||||||||
Exercise price | $ 0.0001 | ||||||||||||
Shares issuance costs | $ 6,417,000 | ||||||||||||
Fair value of warrants | $ 17,301,000 | $ (2,265,000) | |||||||||||
Common Stock [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
issuance of shares | 3,284,407 | 889,315 | 98,560 | ||||||||||
Offering price | $ 4.03 | ||||||||||||
Common Stock [Member] | 2023 Pre-Funded Warrants [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Exercise price | $ 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] | |||||||||||||
issuance of shares | 7,065,946 | ||||||||||||
Exercise price | $ 4.75 | ||||||||||||
Fair value of warrants | $ 22,000,000 | ||||||||||||
Warrant outstanding | $ 7,609,879 | ||||||||||||
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Warrants purchase, shares | 7,609,879 | ||||||||||||
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 | ||||||||||||
Shares issuance costs | 32,600,000 | ||||||||||||
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 | ||||||||||||
Subsequent Event [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Proceeds from public offering | $ 70,200,000 | ||||||||||||
Subsequent Event [Member] | Common Stock [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
issuance of shares | 12,285,056 | ||||||||||||
Public offering price | $ 4.07 | ||||||||||||
Open Market Sale Agreements [Member] | Subsequent Event [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Sale of stock value | $ 3,500,000 | ||||||||||||
Sale of stock | 1,013,061 | ||||||||||||
Open Market Sale Agreements [Member] | Jefferies LLC [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Sale of stock value | $ 150,000,000 | $ 6,500,000 | $ 300,000 | ||||||||||
Sale of stock | 889,315 | 98,560 | |||||||||||
Loan and Security Agreement [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Exercise price | $ 4.75 | ||||||||||||
Proceeds from warrant liability' | $ 2,400,000 | ||||||||||||
Fair value of warrants | $ 200,000 | ||||||||||||
Loan and Security Agreement [Member] | Common Stock [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
issuance of shares | 505,263 | ||||||||||||
Loan and Security Agreement [Member] | Warrant [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Warrant expiration date | Jan. 08, 2029 | ||||||||||||
Exercise price per share | $ 4.75 | ||||||||||||
Exercise price per share | $ 4.75 | ||||||||||||
Loan and Security Agreement [Member] | Warrant [Member] | Avenue [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Warrants purchase amount | $ 480,000 | ||||||||||||
Loan and Security Agreement [Member] | Warrant [Member] | Avenue 2 [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Warrants purchase amount | $ 1,920,000 | ||||||||||||
Loan and Security Agreement [Member] | Subsequent Event [Member] | Common Stock [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
issuance of shares | 589,680 | ||||||||||||
Loan and Security Agreement [Member] | Subsequent Event [Member] | Warrant [Member] | |||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||
Exercise price per share | $ 4.07 | ||||||||||||
Exercise price per share | $ 4.07 |
SCHEDULE OF STOCK BASED COMPENS
SCHEDULE OF STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,546 | $ 770 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 346 | 584 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,220 | $ 186 |
SCHEDULE OF STOCK OPTION ACTIVI
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Number of options, balance | 179,001 | |
Weighted average exercise price, balance | $ 38.58 | |
Weighted average remaining contractual term (years), outstanding | 6 years 6 months 29 days | 6 years 9 months 29 days |
Aggregate intrinsic value, balance | $ 3 | |
Number of options, granted | ||
Weighted average exercise price, granted | ||
Number of options, cancelled/forfeited | ||
Weighted average exercise price, cancelled/forfeited | ||
Number of options, exercised | ||
Weighted average exercise price, exercised | ||
Number of options, balance | 179,001 | 179,001 |
Weighted average exercise price, balance | $ 38.58 | $ 38.58 |
Aggregate intrinsic value, balance | $ 14 | $ 3 |
Number of options, exerciasble | 143,907 | |
Weighted average exercise price, exercisable | $ 38.58 | |
Weighted average remaining contractual term (years), exercisable | 6 years 5 months 1 day | |
Aggregate intrinsic value, exercisable | $ 6 | |
Number of options, unvested | 35,094 | |
Weighted average exercise price, unvested | $ 38.59 | |
Weighted average remaining contractual term (years), unvested | 7 years 2 months 26 days | |
Aggregate intrinsic value, unvested | $ 8 |
SCHEDULE OF RESTRICTED STOCK AW
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY (Details) - Restricted Stock [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Restricted common stock awards, balance | shares | 2,448,169 |
Weighted-average grant date fair value, balance | $ / shares | $ 4.25 |
Restricted common stock awards, granted | shares | 137,500 |
Weighted-average grant date fair value, granted | $ / shares | $ 5.31 |
Restricted common stock awards, cancelled/forfeited | shares | |
Weighted-average grant date fair value, cancelled/forfeited | $ / shares | |
Restricted common stock awards, vested | shares | (43,050) |
Weighted-average grant date fair value, vested | $ / shares | $ 7.56 |
Restricted common stock awards, balance | shares | 2,542,619 |
Weighted-average grant date fair value, balance | $ / shares | $ 4.18 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Compensation cost related to restricted common stock not recognized | $ 7.4 | |
Weighted average compensation costs related to restricted common stock | 2 years 2 months 12 days | |
Fair value of restricted stock awards that vested | $ 0.5 | $ 0.5 |
Stock Options [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Compensation cost related to non-vested options not recognized | $ 1 | |
Weighted average period total compensation costs related to non-vested options | 1 year 1 month 6 days | |
2023 Incentive Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Shares available for grant | 156,591 | |
Inducement Plan [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Shares available for grant | 721,900 |
LICENSE_SUPPLIER AGREEMENT (Det
LICENSE/SUPPLIER AGREEMENT (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | ||||
May 16, 2022 | Oct. 31, 2020 | Aug. 31, 2020 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | ||||||
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 | $ 7,000,000 | |||||
Sublicense And Inventory Purchase Agreements [Member] | Event Based Milestone Payments [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Variable consideration | 26,000,000 | |||||
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 | ||||
Contract assets | 0 | $ 0 | ||||
Sublicense Agreement Relating to Rett Syndrome [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Fixed consideration | $ 3,000,000 | |||||
Sublicense Agreement Relating to Rett Syndrome [Member] | Event Based Milestone Payments [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Variable consideration | 26,500,000 | |||||
Sublicense Agreement Relating to Rett Syndrome [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Variable consideration | $ 30,000,000 | |||||
Sublicense Agreement Relating to Rett Syndrome [Member] | License [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue recognized | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||||
May 07, 2024 | Jul. 06, 2023 | Dec. 21, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | |
Subsequent Event [Line Items] | |||||
Issuance of shares | 1,788,000 | ||||
Purchase of warrants | 1,788,000 | ||||
Common stock exercise price | $ 9.75 | ||||
Warrants exercise price | $ 9.75 | ||||
Proceeds from issuance of offering | $ 16 | $ 75 | |||
Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Proceeds from issuance of offering | $ 70.2 | ||||
Common Stock [Member] | |||||
Subsequent Event [Line Items] | |||||
Issuance of shares | 3,284,407 | 889,315 | 98,560 | ||
Common Stock [Member] | Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Issuance of shares | 12,285,056 | ||||
Common stock exercise price | $ 4.07 | ||||
Pre Funded Warrants [Member] | Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Purchase of warrants | 6,142,656 | ||||
Common stock exercise price | $ 0.0001 | ||||
Warrants exercise price | 4.0699 | ||||
Common stock exercise price | $ 0.0001 |