Cover
Cover - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 04, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 000-22245 | ||
Entity Registrant Name | SEELOS THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001017491 | ||
Entity Tax Identification Number | 87-0449967 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | 300 Park Avenue | ||
Entity Address, Address Line Two | 2nd Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10022 | ||
City Area Code | 646 | ||
Local Phone Number | 293-2100 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | SEEL | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 261.5 | ||
Entity Common Stock, Shares Outstanding | 105,506,695 | ||
Documents Incorporated by Reference [Text Block] | Certain information required to be disclosed in Part III of this report is incorporated by reference from the information contained in the registrant's Definitive Proxy Statement for the 2022 Annual Meeting of Stockholders, which Proxy Statement will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year ended December 31, 2021. | ||
ICFR Auditor Attestation Flag | false | ||
Entity Listing, Par Value Per Share | $ 0.001 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Short Hills, NJ | ||
Auditor Firm ID | 185 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash | $ 78,734,000 | $ 15,662,000 |
Prepaid expenses and other current assets | 4,727,000 | 1,832,000 |
Total current assets | 83,461,000 | 17,494,000 |
Operating lease right-of-use asset | 39,000 | |
Total assets | 83,500,000 | 17,494,000 |
Current liabilities | ||
Accounts payable | 1,693,000 | 1,887,000 |
Accrued expenses | 3,728,000 | 1,924,000 |
Licenses payable | 200,000 | 125,000 |
Convertible debt | 2,431,000 | |
Short-term portion of convertible notes payable, at fair value | 1,030,000 | |
Derivative liability | 1,174,000 | |
Warrant liabilities, at fair value | 424,000 | 1,062,000 |
Operating lease liability | 38,000 | |
Total current liabilities | 8,287,000 | 7,429,000 |
Licenses payable, long-term | 200,000 | |
Note payable | 147,000 | |
Convertible notes payable, at fair value | 17,890,000 | |
Convertible debt, long-term | 7,146,000 | |
Total liabilities | 26,177,000 | 14,922,000 |
Commitments and contingencies (note 13) | ||
Stockholders’ equity | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value, 240,000,000 and 120,000,000 shares authorized, 105,500,445 and 54,535,891 issued and outstanding as of December 31, 2021 and December 31, 2020, respectively | 105,000 | 54,000 |
Additional paid-in-capital | 198,428,000 | 77,680,000 |
Accumulated deficit | (141,210,000) | (75,162,000) |
Total stockholders’ equity | 57,323,000 | 2,572,000 |
Total liabilities and stockholders’ equity | $ 83,500,000 | $ 17,494,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, per value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 240,000,000 | 120,000,000 |
Common stock, issued (in shares) | 105,500,445 | 54,535,891 |
Common stock, outstanding (in shares) | 105,500,445 | 54,535,891 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expense | ||
Research and development | $ 46,649 | $ 10,984 |
General and administrative | 15,020 | 7,775 |
Total operating expense | 61,669 | 18,759 |
Loss from operations | (61,669) | (18,759) |
Other income (expense) | ||
Interest income | 113 | 45 |
Interest expense | (1,598) | (164) |
Change in fair value of derivative liability | (369) | |
Change in fair value of convertible notes | 230 | |
Net loss on extinguishment of debt | (2,387) | |
Gain on forgiveness of debt | 149 | |
Change in fair value of warrant liabilities | (517) | (223) |
Total other income (expense) | (4,379) | (342) |
Net loss and comprehensive loss | $ (66,048) | $ (19,101) |
Net loss per share basic and diluted | $ (0.73) | $ (0.43) |
Weighted-average common shares outstanding basic and diluted | 90,890,061 | 44,766,640 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 27 | $ 56,027 | $ (56,061) | $ (7) |
Common Stock, Shares, Outstanding, Beginning Balance at Dec. 31, 2019 | 27,028,533 | |||
Stock-based compensation expense | 2,044 | 2,044 | ||
Issuance of common stock for prepaid services | 330 | 330 | ||
[custom:IssuanceOfCommonStockForPrepaidServicesShares] | 400,000 | |||
Issuance of common stock for license acquired | $ 2 | 2,441 | 2,443 | |
Issuance of common stock, net of issuance costs | $ 15 | 8,835 | 8,850 | |
Issuance of common stock for license acquired, shares | 1,809,845 | |||
Issuance of common stock, net of issuance costs, shares | 15,166,666 | |||
Net Income (Loss) Attributable to Parent | (19,101) | (19,101) | ||
Warrants exercised for cash | 169 | $ 169 | ||
Common Stock, Shares, Outstanding, Ending Balance at Dec. 31, 2020 | 54,535,891 | 54,535,891 | ||
Issuance of common stock and warrants, pursuant to September 2020 Securities Purchase Agreement, net of issuance costs | 8,865,000 | |||
Issuance of common stock and warrants, pursuant to Securities Purchase Agreement, net of issuance costs, shares | 1,112,219 | |||
Warrants exercised for cash, shares | 153,628 | |||
Issuance of common stock and warrants, pursuant to Securities Purchase Agreement, net of issuance costs | $ 1 | 1,378 | $ 1,379 | |
Issuance of common stock and warrants, pursuant to September 2020 Securities Purchase Agreement, net of issuance costs | 9 | 6,356 | 6,365 | |
Net loss | (19,101) | (19,101) | ||
Ending balance, value at Dec. 31, 2020 | 54 | 77,680 | (75,162) | 2,572 |
Stock-based compensation expense | 8,347 | 8,347 | ||
Issuance of common stock, options exercised | 102 | 102 | ||
Issuance of common stock, options exercised, shares | 79,138 | |||
Issuance of common stock for license acquired | $ 3 | 4,830 | 4,832 | |
Issuance of common stock for settlement of debt | 1,377 | 1,377 | ||
Issuance of common stock, net of issuance costs | $ 40 | 97,917 | 97,957 | |
Issuance of common stock for license acquired, shares | 2,570,266 | |||
Issuance of common stock, net of issuance costs, shares | 39,788,554 | |||
Net Income (Loss) Attributable to Parent | (66,048) | (66,048) | ||
Warrants exercised for cash | $ 7 | 8,401 | $ 8,408 | |
Common Stock, Shares, Outstanding, Ending Balance at Dec. 31, 2021 | 105,500,445 | 105,500,445 | ||
custom:IssuanceOfCommonStockPursuantTo2021SecuritiesPurchaseAgreement | 540,147 | |||
[custom:IssuanceOfCommonStockForConversionOfDebtShares] | 69,065 | |||
[custom:IssuanceOfCommonStockForExtinguishmentOfDebtShares] | 406,250 | |||
Warrants exercised for cash, shares | 7,431,125 | |||
Net loss | (66,048) | $ (66,048) | ||
Extinguishment of beneficial conversion feature | (1,519) | (1,519) | ||
Issuance of common stock for conversion of debt | 138 | 138 | ||
Issuance of common stock, ESPP | 104 | 104 | ||
Issuance of common stock, ESPP, shares | 80,009 | |||
Issuance of common stock, pursuant to 2021 Securities Purchase Agreements | $ 1 | 1,051 | 1,052 | |
Ending balance, value at Dec. 31, 2021 | $ 105 | $ 198,428 | $ (141,210) | $ 57,323 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (66,048) | $ (19,101) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 8,347 | 2,044 |
Shares issued for services | 124 | |
Research and development expenses - license acquired | 5,637 | 192 |
Change in fair value of warrant liability | 517 | 223 |
Change in fair value of convertible notes payable | (230) | |
Change in fair value of derivative liability | 369 | |
Gain on forgiveness of note payable | (149) | |
Net loss on extinguishment of convertible debt | 2,387 | |
Amortization of debt discount | 1,582 | 150 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | (2,894) | (791) |
Accounts payable | (194) | 1,091 |
Accrued expenses | 1,806 | 5 |
Licenses payable | (125) | (4,850) |
Net cash used in operating activities | (48,995) | (20,913) |
Cash flows provided by financing activities | ||
Payment of convertible note | (13,551) | |
Proceeds from issuance of common stock, net of issuance costs | 97,957 | 8,850 |
Proceeds from issuance of common stock and convertible notes payable | 20,203 | 10,907 |
Proceeds from issuance of common stock and warrants, pursuant to Securities Purchase Agreement, net of issuance costs | 6,365 | |
Proceeds from exercise of warrants | 7,252 | 45 |
Proceeds from exercise of options | 102 | |
Proceeds from sales of common stock under ESPP | 104 | |
Proceeds from note payable | 147 | |
Net cash provided by financing activities | 112,067 | 26,314 |
Net increase in cash | 63,072 | 5,401 |
Cash, beginning of period | 15,662 | 10,261 |
Cash, end of period | 78,734 | 15,662 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 10 | 11 |
Cash paid for income taxes | ||
Non-cash investing and financing activities: | ||
Reclass of warrant liabilities related to Series A warrants exercised for cash | 1,155 | 124 |
Right-of-use assets obtained in exchange for operating lease liabilities | 75 | |
Issuance of common stock for convertible notes | 69 | |
Issuance of common stock for settlement of debt | 1,377 | |
Extinguishment of beneficial conversion feature | 1,519 | |
Issuance of common stock for iX Biopharma license | 4,832 | |
Issuance of common stock for license payable | $ 2,443 |
1. Organization and Summary of
1. Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
1. Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Seelos Therapeutics, Inc. and its subsidiaries (the “Company”) is a clinical-stage biopharmaceutical company focused on achieving efficient development of products that address significant unmet needs in Central Nervous System (“CNS”) disorders and other rare disorders. The Company’s lead programs are SLS-002 for the potential treatment of acute suicidal ideation and behavior in patients with major depressive disorder (“ASIB in MDD”) and SLS-005 for the potential treatment of Amyotrophic Lateral Sclerosis (“ALS”) and Spinocerebellar Ataxia (“SCA”). SLS-005 for the potential treatment of Sanfilippo Syndrome currently requires additional natural history data, which is being considered. Additionally, the Company is developing several preclinical programs, most of which have well-defined mechanisms of action, including: SLS-004, SLS-006, SLS-007 for the potential treatment of Parkinson’s Disease (“PD”) and SLS-008, which is being developed for the potential treatment of an undisclosed indication, but may also be targeted at chronic inflammation in asthma and orphan indications such as pediatric esophagitis. Basis of Presentation and Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of these consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s financial statements relate to the valuation of warrants, valuation of convertible notes payable, and the valuation of stock options. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Fair Value of Financial Instruments The carrying amounts of financial instruments such as accounts payable and accrued expenses approximate their related fair values due to the short-term nature of these instruments. Leases The Company determines if an arrangement is a lease at inception. Fair Value Option As permitted under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 825, Financial Instruments (“ASC 825”), the Company elected the fair value option to account for its November 2021 and December 2021 convertible notes (collectively, the “2021 Convertible Notes”). In accordance with ASC 825, the Company records these convertible notes at fair value with changes in fair value recorded in the Consolidated Statement of Operations and Comprehensive Loss. As a result of applying the fair value option, direct costs and fees related to the convertible notes were expensed as incurred and were not deferred. Fair Value Measurements The Company follows the accounting guidance in the FASB ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Research and Development Research and development costs are expensed as incurred and include milestone and upfront payments for license arrangements, the cost of employee compensation and related expenses, as well as expenses for third parties who conduct research and development on the Company's behalf, pursuant to development and consulting agreements in place. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. Income (Loss) Per Common Share Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities outstanding for the year ended December 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Year Ended December 31, 2021 2020 Outstanding stock options 7,306 5,120 Restricted stock units 2,400 - Outstanding warrants 2,635 10,066 Convertible debt 3,704 8,556 16,045 23,742 Stock-Based Compensation The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant-date fair value of the awards and forfeitures rates. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations based upon the underlying individual’s role at the Company. Performance share awards are initially valued based on the Company’s closing stock price on the date of grant. The number of performance share awards that vest will be determined based on the achievement of specified performance milestones by the end of the performance period. Compensation expense for performance awards is recognized over the service period and will vary based on remeasurement during the performance period. If achievement of the performance milestone is not probable of achievement during the performance period, compensation expense is reversed. Segment Information The Company operates under one segment which develops pharmaceutical products. Recent Accounting Pronouncements In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of ASU 2019-12 did not have a material effect on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06: Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for convertible debt instruments by removing the separation models for convertible debt with a cash conversion feature, as well as convertible instruments with a beneficial conversion feature. As a result, entities will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. The elimination of these models will reduce non-cash interest expense for entities that have issued a convertible instrument that was within the scope of those models before the adoption of ASU 2020-06. Additionally, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share, and precludes the use of the treasury stock method for certain debt instruments. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020, and an entity should adopt the provisions at the beginning of its annual fiscal year. The Company does not expect the adoption of ASU 2020-06 to have an impact on its consolidated financial statements and related disclosures. |
2. Liquidity and Going Concern
2. Liquidity and Going Concern | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
2. Liquidity and Going Concern | 2. Liquidity and Going Concern The accompanying consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern. The Company has limited revenues, has incurred operating losses since inception, and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2021, the Company had $ 78.7 141.2 The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the release date of this Annual Report on Form 10-K. Based on such evaluation and the Company's current plans (including the ongoing clinical programs for SLS-002, SLS-005; and other product candidates), which are subject to change, management believes that the Company’s existing cash and cash equivalents as of December 31, 2021 are not sufficient to satisfy its operating cash needs for at least one year. The Company may raise substantial additional funds, and if it does so, it may do so through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one or more of the Company’s product candidates. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. Failure to obtain additional equity or debt financing will have a material, adverse impact on the Company’s business operations. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of the Company’s existing stockholders. |
3. Business Combination
3. Business Combination | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
3. Business Combination | 3. Business Combination On January 24, 2019, the Company (which was formerly known as “Apricus Biosciences, Inc.”) (“Apricus”) completed the business combination with Seelos Therapeutics, Inc., a Delaware corporation (“STI”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization entered into on July 30, 2018 (the “Merger Agreement”). Pursuant to the Merger Agreement, (i) a former subsidiary of the Company merged with and into STI, with STI (renamed “Seelos Corporation”) continuing as a wholly-owned subsidiary of the Company and the surviving corporation of the merger and (ii) the Company was renamed “Seelos Therapeutics, Inc.” (the “Merger”). The Merger was accounted for as a reverse recapitalization under U.S. GAAP because the primary assets of Apricus were nominal at the close of the Merger. STI was determined to be the accounting acquirer based upon the terms of the Merger and other factors, including: (i) STI stockholders and other persons holding securities convertible, exercisable or exchangeable directly or indirectly for STI common stock owned the majority of the Company immediately following the effective time of the Merger, (ii) STI holds the majority (four of five) of board seats of the combined company, and (iii) STI’s management holds all key positions in the management of the combined company. STI acquired no tangible assets and assumed no employees or operation from Apricus. Additionally, Apricus’ intellectual property was considered to have no value. The remaining Apricus liabilities had a fair value of approximately $300 thousand. In connection with the Merger, the Company and STI entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, Apricus stockholders received one contingent value right (“CVR”) for each share of Apricus common stock held of record immediately prior to the closing of the Merger. Each CVR represents the right to receive payments based on Apricus’ U.S. assets related to products in development, intended for the topical treatment of erectile dysfunction, which are known as Vitaros in certain countries outside of the United States (the “CVR Product Candidate”). In particular, CVR holders will be entitled to receive 90% of any cash payments (or the fair market value of any non-cash payments) exceeding $500,000 received, during a period of ten years from the closing of the Merger, based on the sale or out-licensing of Apricus’ CVR Product Candidate intangible asset, including any milestone payments (the “Contingent Payments”), less reasonable transaction expenses. The Company is entitled to retain the first $500,000 and 10% of any Contingent Payments. The Company has agreed to pay up to $500,000 of such Contingent Payments that it receives to a third party pursuant to a settlement agreement between the Company and the third party. The Company assigned no value to the CVR Product Candidate intangible asset as of December 31, 2021 or the CVR in the acquisition accounting. |
4. Fair Value Measurement
4. Fair Value Measurement | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
4. Fair Value Measurement | 4. Fair Value Measurement The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values. At time of issuance, the derivative liability at fair value was recognized using Level 3 inputs as no observable inputs were available at the time in the market. At December 31, 2021, the derivative liability has been reclassed as a Level 1 input as the significant inputs were known and observable. There were no Schedule of Fair Value Hierarchy Assets and Liabilities Fair Value Measurements as of December 31, 2021 (Level 1) (Level 2) (Level 3) Total Assets Cash $ 78,734 $ - $ - $ 78,734 Liabilities Convertible notes payable, at fair value $ - $ - $ 18,920 $ 18,920 Derivative liability, at fair value 1,174 - - 1,174 Warrant liabilities, at fair value - - 424 424 $ 1,174 $ - $ 19,344 $ 20,518 Fair Value Measurements as of December 31, 2020 (Level 1) (Level 2) (Level 3) Total Assets Cash $ 15,662 $ - $ - $ 15,662 Liabilities Warrant liabilities, at fair value $ - $ - $ 1,062 $ 1,062 The fair value of the Company’s money market funds is based on quoted active market prices for the funds and is determined using the market approach. The Company measures the 2021 Convertible Notes, derivative liability and warrant liabilities at fair value based on significant inputs not observable in the market, which causes them to be classified as a Level 3 measurement within the fair value hierarchy. The fair value of the convertible notes payable, derivative liability and warrant liabilities may change significantly as additional data is obtained, impacting the Company’s assumptions regarding probabilities of outcomes used to estimate the fair value of the liabilities. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Company’s results of operations in future periods. Derivative Liability The derivative liability represents the fair value of the “Shortfall Amount” provision provided for in the license agreement with iX Biopharma Europe Limited. See Note 7. At issuance, the fair value of the embedded derivative was estimated by using a Monte Carlo simulation model. As of December 31, 2021, the Company determined it was probable it would settle the Shortfall Amount in cash and estimated the fair value based on a probability weighted market approach. Summary of Fair Value Measurements Derivative Valuation Assumptions Year Ended December 31, 2021 Risk-free interest rate 0.13% Volatility 110% Dividend yield - Expected term (years) 0.11 Stock price $ 1.88 2021 Convertible Notes The 2021 Convertible Notes are valued using a Monte Carlo simulation model. The following assumptions were used in determining the fair value of the 2021 Convertible Notes as of December 31, 2021: Summary of Fair Value Measurements Convertible Notes Valuation Assumptions Year Ended December 31, 2021 Risk-free interest rate 0.90 0.95 Volatility 113 114 Dividend yield - Contractual term (years) 3 Stock price $ 1.74 1.95 Warrant Liabilities The common stock warrant liabilities were recorded at fair value using the Black-Scholes option pricing model. The following assumptions were used in determining the fair value of the warrant liabilities valued using the Black-Scholes option pricing model as of December 31, 2021 and 2020: Summary of Fair Value Measurements Warrant Valuation Assumptions Year Ended December 31, 2021 2020 Risk-free interest rate 0.75% 0.18% Volatility 110.55% 116.77% Dividend yield - - Expected term (years) 2.07 3.07 Weighted-average fair value $ 1.40 $ 1.40 The following table is a reconciliation for the common stock warrant liabilities, derivative liability, and convertible notes measured at fair value using Level 3 unobservable inputs (in thousands): Schedule of Fair Value Level 3 Reconciliation Warrant Derivative Convertible notes, liabilities liability at fair value Balance as of December 31, 2019 $ 963 $ - $ - Warrant liability reclassified to stockholders' equity (124) - - Change in fair value measurement of warrant liability 223 - - Balance as of December 31, 2020 $ 1,062 $ - $ - Warrant liability reclassified to stockholders' equity (1,155) - - Issuance of convertible notes, at fair value - - 19,150 Issuance of derivative liability - 805 - Change in fair value measurement of derivative liability - 369 - Change in fair value measurement of convertible notes - - (230) Change in fair value measurement of warrant liability 517 - - Balance as of December 31, 2021 $ 424 $ 1,174 $ 18,920 For the years ended December 31, 2021 and 2020, the changes in fair value of the convertible notes, derivative liability and warrant liability primarily resulted from the volatility of the Company’s common stock. |
5. Prepaid Expenses and Other C
5. Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
5. Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets are comprised of the following (in thousands): Schedule of Prepaid Expenses and Other Current Assets December 31, 2021 2020 Prepaid insurance $ 59 $ 50 Prepaid clinical costs 4,481 1,743 Other 187 39 Prepaid expenses and other current assets $ 4,727 $ 1,832 |
6. Common Stock Offerings
6. Common Stock Offerings | 12 Months Ended |
Dec. 31, 2021 | |
Common Stock Offerings | |
6. Common Stock Offerings | 6. Common Stock Offerings Securities Purchase Agreements November 2021 and December 2021 Convertible Notes and Private Placement Between November 2021 and December 2021, the Company issued an aggregate of 540,147 20.2 December 2020 Convertible Note and Private Placement In December 2020, the Company sold 1,112,219 10.9 2020 Registered Direct Offering and Concurrent Private Placement On September 4, 2020, the Company entered into a Securities Purchase Agreement with certain institutional investors (the “2020 Securities Purchase Agreement”) pursuant to which the Company issued and sold an aggregate of 8,865,000 6.4 The Company also issued to the investors warrants to purchase up to 6,648,750 shares of common stock in a concurrent private placement (the "September 2020 Warrants"). The September 2020 Warrants have an exercise price of $0.84 per share of common stock, became exercisable beginning on March 9, 2021 and will expire on March 9, 2026. The combined purchase price for one share and one warrant to purchase 0.75 of a share of common stock in the offerings was $ 0.79 2019 Registered Direct Offering and Concurrent Private Placement On August 23, 2019, the Company entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company issued and sold an aggregate of 4,475,000 6.7 The Company issued to the investors warrants to purchase up to 2,237,500 shares of common stock in a concurrent private placement (the “August 2019 Warrants”). The August 2019 Warrants have an exercise price of $1.78 per share of common stock, will be exercisable six months from the date of issuance and will expire four years following the date of issuance. The combined purchase price for one share and one warrant to purchase half of a share of common stock in the offerings was $1.50. Roth Capital Partners, LLC (“Roth”) served as the placement agent for the issuance and sale of the shares and the warrants, and the Company paid Roth an aggregate fee equal to 7.0% of the gross proceeds received by the Company in the offerings. Public Offerings On May 24, 2021, the Company completed an underwritten public offering, pursuant to which the Company sold 22,258,066 3.10 64.5 7.3 On January 28, 2021, the Company completed an underwritten public offering, pursuant to which the Company sold 17,530,488 2.05 33.5 3.8 On March 16, 2020, the Company completed an underwritten public offering pursuant to which it sold 7,500,000 0.60 4.0 On February 13, 2020, the Company completed an underwritten public offering, pursuant to which it sold 6,666,667 0.75 999,999 0.75 4.8 Stock Purchase Agreement with iX Biopharma Europe Limited On November 24, 2021, the Company entered in an exclusive license agreement and stock purchase agreement (the “iXBEL Stock Purchase Agreement”) with iX Biopharma Europe Limited (“iXBEL”). As consideration for the license under the license agreement, the Company paid iXBEL an upfront fee of $ 9.0 3.5 2,570,266 2,570,266 5.5 0.8 1.2 Stock Purchase Agreement with Vyera On January 2, 2020, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”) with Vyera, pursuant to which the Company issued to Vyera 1,809,845 Consulting Agreement On May 11, 2020, the Company entered into a consulting agreement (the “Consulting Agreement”) with an advisory firm, pursuant to which the advisory firm agreed to provide the Company with certain management consulting, business and advisory services. The Company agreed to issue the advisory firm 300,000 During the year ended December 31, 2020, the Company recognized approximately $ 431,000 Pre-Merger Financing On January 24, 2019, STI and Apricus closed a private placement transaction with certain accredited investors (the “Investors”), whereby, among other things, STI issued to investors shares of STI’s common stock immediately prior to the Merger in a private placement transaction (the “Financing”), pursuant to a Securities Purchase Agreement, made and entered into as of October 16, 2018, by and among STI, Apricus and the investors, as amended (the “Purchase Agreement”). Pursuant to the Purchase Agreement, STI (i) issued and sold to the Investors an aggregate of 2,374,672 shares of STI’s common stock which converted pursuant to the exchange ratio in the Merger into the right to receive 1,829,407 shares of the Company’s common stock and (ii) issued warrants representing the right to acquire 1,463,519 shares of common stock at a price per share of $4.15, subject to adjustment as provided therein (the “Series A Warrants”), most recently adjusted to a price per share of $0.2957 per share, and additional warrants initially representing the right to acquire no shares of common stock at a price per share of $0.001, subject to adjustment as provided therein (the “Series B Warrants” together with the Series A Warrants, the “Investor Warrants”), for aggregate gross proceeds of $18.0 million, or $16.5 million net of financing fees. The terms of the Investor Warrants included certain provisions that could result in adjustments to both the number of warrants issued and the exercise price of each warrant, which resulted in the warrants being classified as a liability upon issuance (see Note 10). The Investor Warrants were recorded at fair value of $21.5 million upon issuance and given that the liability exceeded the proceeds received, a loss of $5.0 million was recognized. On March 7, 2019, the Company entered into Amendment Agreements (collectively, the “Amendment Agreements”) with each Investor amending: (i) the Purchase Agreement, (ii) the Series A Warrants, and (iii) the Series B Warrants. The Amendment Agreements, among other things, fixed the aggregate number of shares of common stock issued and issuable pursuant to the Series A Warrants at 3,629,023 (none of which were exercised as of March 7, 2019). The terms of the Investor Warrants continue to include certain provisions that could result in a future adjustment to the exercise price of the Investor Warrants and accordingly, they continue to be classified as a liability after the Amendment Agreements. At December 31, 2021, 0.3 |
7. License Agreements
7. License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
7. License Agreements | 7. License Agreements Acquisition of License from Ligand Pharmaceuticals Incorporated On September 21, 2016, the Company entered into a License Agreement (the “License Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”), Neurogen Corporation and CyDex Pharmaceuticals, Inc. (collectively, the “Licensors”), pursuant to which, among other things, the Licensors granted to the Company an exclusive, perpetual, irrevocable, worldwide, royalty-bearing, nontransferable right and license under (i) patents related to a product known as Aplindore, which is now known as SLS-006, acetaminophen (as it may have been or may be modified for use in a product to be administered by any method in any form including, without limitation injection and intravenously, the sole active pharmaceutical ingredient of which is acetaminophen), which is now known as SLS-012, an H3 receptor antagonist, which is now known as SLS-010, and either or both of the Licensors’ two proprietary CRTh2 antagonists, which are now known collectively as SLS-008 (collectively, the “Licensed Products”), and (ii) copyrights, trade secrets, moral rights and all other intellectual and proprietary rights related thereto. The Company is obligated to use commercially reasonable efforts to (a) develop the Licensed Products, (b) obtain regulatory approval for the Licensed Products in the European Union (either in its entirety or including at least one of France, Germany or, if at the time the United Kingdom is a member of the European Union, the United Kingdom), the United Kingdom, if at the time the United Kingdom is not a member of the European Union, Japan or the People’s Republic of China (each, a “Major Market”) or the United States, and (c) commercialize the Licensed Products in each country where regulatory approval is obtained. The Company has the exclusive right and sole responsibility and decision-making authority to research and develop any Licensed Products and to conduct all clinical trials and non-clinical studies the Company believes appropriate to obtain regulatory approvals for commercialization of the Licensed Products. The Company also has the exclusive right and sole responsibility and decision-making authority to commercialize any of the Licensed Products. In connection with the closing of the Merger, the Company issued 801,253 2.2 The Company also agreed to pay to Ligand certain one-time, non-refundable regulatory milestone payments in connection with the Licensed Products, other than in connection with Aplindore for the indication of PD or Restless Leg Syndrome, consisting of (i) $ 750,000 3.0 1.125 1.125 The Company also agreed to pay to Ligand certain one-time, non-refundable regulatory milestone payments in connection with the Licensed Products in connection with Aplindore for the indication of PD or Restless Leg Syndrome, consisting of (i) $ 100,000 350,000 125,000 125,000 The Company agreed to pay to Ligand certain one-time, non-refundable commercial milestone payments in connection with the Licensed Products, consisting of (i) $ 10.0 10.0 10.0 10.0 20.0 20.0 20.0 20.0 The Company will also pay to Ligand middle single-digit royalties on aggregate annual net sales of Licensed Products other than in connection with Aplindore for the indication of PD or Restless Leg Syndrome in a country where such Licensed Products are covered under a licensed patent and a tiered incremental royalty in the upper single digit to lower double digit range on aggregate annual net sales of Licensed Products in connection with Aplindore for the indication of PD n or Restless Leg Syndrome in a country where such Licensed Products are covered under a licensed patent. Additionally, the Company will pay to Ligand low single digit royalties on aggregate annual net sales of Licensed Products other than in connection with Aplindore for the indication of PD or Restless Leg Syndrome in a country where such Licensed Products are not covered under a licensed patent and a tiered incremental royalty in the lower single digit to middle single digit range on aggregate annual net sales of Licensed Products in connection with Aplindore for the indication of PD or Restless Leg Syndrome in a country where such Licensed Products are not covered under a licensed patent. The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of Assets from Phoenixus AG f/k/a Vyera Pharmaceuticals, AG and Turing Pharmaceuticals AG (“Vyera”) On March 6, 2018, the Company entered into the Vyera Agreement with Vyera, pursuant to which the Company acquired the assets (the “Vyera Assets”) and liabilities (the “Vyera Assumed Liabilities”), of Vyera related to TUR-002 (intranasal ketamine), which is now known as SLS-002. The Company is obligated to use commercially reasonable efforts to seek regulatory approval in the United States for and commercialize SLS-002 As consideration for the Vyera Assets, the Company paid to Vyera a non-refundable cash payment of $ 150,000 150,000 191,529 1,000,000 Pursuant to the amendment to the Asset Purchase Agreement entered into by the Company and Vyera on October 15, 2019, the Company issued Vyera 1,809,845 750,000 750,000 1.0 1.0 Pursuant to the amendment to the asset purchase agreement entered into with Vyera on February 15, 2021, the Company made cash payments to Vyera in the amount of $ 3.0 In the event that the Company sells, directly or indirectly, all or substantially all of the Vyera Assets to a third party, then the Company must pay Vyera an amount equal to 4% of the net proceeds actually received by the Company as an upfront payment in such sale. The Company agreed to pay to Vyera certain one-time, non-refundable milestone payments consisting of (i) $ 10.0 5.0 2.5 5.0 10.0 15.0 20.0 25.0 The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of License from Stuart Weg, MD On August 29, 2019, the Company entered into an amended and restated exclusive license agreement with Stuart Weg, M.D. (the “Weg License Agreement”), pursuant to which the Company was granted an exclusive worldwide license to certain intellectual property and regulatory materials related to SLS-002. Under the terms of the Weg License Agreement, the Company paid an upfront license fee of $75,000 upon execution of the agreement. The Company agreed to pay additional consideration to Dr. Weg as follows: (i) $0.1 million on January 2, 2020, (ii) $0.125 million on January 2, 2021, and (iii) in the event the FDA has not approved an NDA for a product containing ketamine in any dosage on or before December 31, 2021, $ 0.2 0.1 0.125 0.1 0.15 0.5 3.0 2.0 1.5 6.6 2.25% The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of Assets from Bioblast Pharma Ltd. (“Bioblast”) On February 15, 2019, the Company entered into an Asset Purchase Agreement (the “Bioblast Asset Purchase Agreement”) with Bioblast. Pursuant to the Bioblast Asset Purchase Agreement, the Company acquired all of the assets of Bioblast relating to a therapeutic platform known as Trehalose (the “Bioblast Asset Purchase”). The Company paid to Bioblast $ 1.5 2.0 3.5 8.5 8.5 1% 1.5 The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of License from The Regents of the University of California On March 7, 2019, the Company entered into an exclusive license agreement (the “UC Regents License Agreement”) with The Regents of the University of California (“The UC Regents”) pursuant to which the Company was granted an exclusive license to intellectual property owned by The UC Regents pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-007. Upon entry into the UC Regents License Agreement, the Company paid to The UC Regents $ 0.1 0.1 50,000 0.1 0.3 1.0 1.0 2.5 The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of License from Duke University On June 27, 2019, the Company entered into an exclusive license agreement (the “Duke License Agreement”) with Duke University pursuant to which the Company was granted an exclusive license to a gene therapy program targeting the regulation of the synuclein alpha (“SNCA”) gene, which encodes alpha-synuclein expression. The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-004. Upon entry into the Duke License Agreement, the Company paid to Duke University $ 0.1 0.1 0.1 0.2 0.5 1.0 2.0 The potential regulatory and commercial milestones are not yet considered probable, and no Acquisition of License from iX Biopharma Europe Limited On November 24, 2021, the Company entered into an exclusive license agreement (the “iX License Agreement”) with iXBEL and the iXBEL Stock Purchase Agreement. Pursuant to the iX License Agreement, among other things, iXBEL granted the Company an exclusive, sublicensable, perpetual, worldwide (excluding certain jurisdictions identified in the iX License Agreement) and irrevocable right and license to certain of iXBEL’s licensed patents, know-how, and technological information, including access to iXBEL’s research, development and manufacturing capabilities, to enable the further development, manufacture, promotion and commercialization of Wafermine ™ As consideration for the license under the iX License Agreement, the Company agreed to (i) pay iXBEL an upfront fee of $ 9.0 3.5 2,570,266 Pursuant to the iXBEL Stock Purchase Agreement, the Company also agreed to reimburse iXBEL for the Shortfall Amount in the event the aggregate value of the 2,570,266 5.5 1.2 1.2 |
8. Accrued Expenses
8. Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
8. Accrued Expenses | 8. Accrued Expenses Accrued expenses are comprised of the following (in thousands): Schedule of Accrued Liabilities December 31, 2021 2020 Professional fees $ 181 $ 292 Personnel related 1,303 756 Outside research and development services 2,219 764 Other 25 112 Accrued expenses, net $ 3,728 $ 1,924 |
9. Debt
9. Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
9. Debt | 9. Debt Convertible Notes November 2021 and December 2021 Convertible Notes and Private Placement On November 23, 2021, the Company entered into a Securities Purchase Agreement (the “2021 Lind Securities Purchase Agreement”) with Lind Global Asset Management V, LLC (“Lind V”) pursuant to which, among other things, on November 23, 2021 (the “Closing Date”), the Company issued and sold to Lind V, in a private placement transaction (the “Private Placement”), in exchange for the payment by Lind V of $20.0 million, (i) a convertible promissory note (the “2021 Note”) in an aggregate principal amount of $22.0 million (the “Principal Amount”), which will bear no interest until the first anniversary of the issuance of the 2021 Note and will thereafter bear interest at a rate of 5% per annum, and mature on November 23, 2024 (the “Maturity Date”), and (ii) 534,759 shares of Company common stock. At the first anniversary of the Closing Date, the Company shall have the option, at its sole discretion, to issue to Lind V a convertible promissory note (the “Second Note”) in the principal amount of $11.0 million in exchange for the payment by Lind V of $10.0 million. At the earlier of (i) the two-year anniversary of the Closing Date, or (ii) the successful readout for SLS-005 in ALS, and subject to the mutual agreement of the Company and Lind V, the Company shall issue to Lind V a convertible promissory note (the “Third Note”) in the principal amount of $11.0 million in exchange for the payment by Lind V of $10.0 million. In the event of the filing of a new drug application with the U.S. Food & Drug Administration for either SLS-002 or SLS-005, and subject to the mutual agreement of the Company and Lind V, the Company shall issue to Lind V a convertible promissory note (the “Fourth Note”) in the principal amount of $11.0 million in exchange for the payment by Lind V of $10.0 million. The Second Note, the Third Note and the Fourth Note, if issued, would be in substantially the same form as the 2021 Note. At any time following August 23, 2022, from time to time and before the Maturity Date, Lind V shall have the option to convert any portion of the then-outstanding Principal Amount of the 2021 Note into shares of Common Stock at a price per share of $6.00, subject to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions (the “Conversion Price”). At any time prior August 23, 2022, the Company shall have the right to prepay, in whole or in part (exercisable by the Company at any time or from time to time during such period), up to an aggregate of $14.7 million of the outstanding Principal Amount of the 2021 Note with no penalty. If the Company does not prepay any amounts of the 2021 Note prior to August 23, 2022 then, commencing August 23, 2022, the Company shall have the right to prepay, in whole or in part (exercisable by the Company at any time or from time to time prior to the Maturity Date), up to the full remaining Principal Amount of the 2021 Note with no penalty; however, if the Company exercises such prepayment right, Lind V will have the option to convert up to thirty-three and one-third percent (33 1/3%) of the amount that the Company elects to prepay at the Conversion Price. If the Company prepays any amounts of the 2021 Note prior to August 23, 2022 then, commencing November 23, 2022, the Company shall not have the right to prepay any amounts of the 2021 Note between August 23, 2022 to November 23, 2022 and, commencing November 23, 2022, the Company shall have the right to prepay, in whole or in part (exercisable by the Company at any time or from time to time prior to the Maturity Date) up to the full remaining Principal Amount of the 2021 Note with no penalty; however, if the Company exercises such prepayment right, Lind V will have the option to convert up to thirty-three and one-third percent (33 1/3%) of the amount that the Company elects to prepay at the Conversion Price. Subject to certain exceptions, the Company will be required to direct proceeds from any subsequent debt financings (including subordinated debt, convertible debt or mandatorily redeemable preferred stock but other than purchase money debt or capital lease obligations or other indebtedness incurred in the ordinary course of business) to repay the 2021 Notes, unless waived by Lind V in advance. Beginning on November 23, 2022, the 2021 Note will amortize in twenty-four monthly installments equal to the quotient of (i) the then-outstanding Principal Amount of the 2021 Note, divided by (ii) the number of months remaining until the Maturity Date. All amortization payments shall be payable, at the Company’s sole option, in cash, shares of Common Stock or a combination of both. In addition, commencing on the last business day of the first month following November 23, 2022, the Company will pay, on a monthly basis, all interest that has accrued and remains unpaid on the then-outstanding Principal Amount of the 2021 Note. Any portion of an amortization payment or interest payment that is paid in shares of Common Stock shall be priced at 90% of the average of the five lowest daily volume weighted average prices of the Common Stock during the 20 trading days prior to the date of issuance of the shares. If, after the first amortization payment, the Company elects to make any amortization payments in cash, the Company shall pay a 5% premium on each cash payment. In conjunction with the 2021 Lind Securities Purchase Agreement and the 2021 Note, on the Closing Date, the Company and Lind V entered into a security agreement, which provides Lind V with a first priority lien on the Company’s assets and properties. On December 2, 2021, the Company entered into two separate securities purchase agreements with certain accredited investors on substantially the same terms as the 2021 Lind Securities Purchase Agreement, pursuant to which the Company sold, in private placement transactions, in exchange for the payment by the accredited investors of an aggregate of $201,534, (i) convertible promissory notes in an aggregate principal amount of $221,688, which will bear no interest and mature on December 2, 2024, and (ii) an aggregate of 5,388 shares of its common stock. These notes have substantially the same terms as the 2021 Note. The Company received aggregate gross proceeds of $ 20.2 19.2 0.2 18.9 As of December 31, 2021, the principal contractual balance of the notes totaled $22.2 million. Scheduled maturities with respect to the 2021 Convertible Notes are as follows (in thousands): Maturities of Long-term Debt Year Ending December 31: 2022 $ 917 2023 $ 11,111 2024 $ 10,194 2025 $ - 2026 $ - Total $ 22,222 December 2020 Convertible Note and Private Placement On December 11, 2020, the Company entered into a Securities Purchase Agreement (the “2020 Lind Securities Purchase Agreement”) with Lind Global Asset Management II, LLC (the “Investor”) pursuant to which, among other things, on December 11, 2020, the Company issued and sold to the Investor, in a private placement transaction, in exchange for the payment by the Investor of $10,000,000, (1) a convertible promissory note (the “2020 Note”) in an aggregate principal amount of $12,000,000 (the “Principal Amount”), which did not bear interest and was to mature on December 11, 2022 (the “Maturity Date”), and (2) 975,000 shares of the Company’s common stock. At any time following June 11, 2021, and from time to time before the Maturity Date, the Investor had the option to convert any portion of the then-outstanding Principal Amount of the Note into shares of common stock at a price per share of $1.60, subject to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions (the “Conversion Price”). Prior to June 11, 2021, the Company had the right to prepay up to sixty-six and two-thirds percent (66 2/3%) of the then-outstanding Principal Amount of the 2020 Note with no penalty. Subject to certain exceptions, the Company was required to direct proceeds from any subsequent debt financings (including subordinated debt, convertible debt or mandatorily redeemable preferred stock but other than purchase money debt or capital lease obligations or other indebtedness incurred in the ordinary course of business) to repay the 2020 Note, unless waived by the Investor in advance. The 2020 Note began amortizing in June 2021 and was to amortize in eighteen monthly installments equal to the quotient of (i) the then-outstanding Principal Amount of the 2020 Note, divided by (ii) the number of months remaining until the Maturity Date. All amortization payments were to be payable solely in cash, plus a 2% premium. During the first half of 2021, the Company made certain repayments on the outstanding principal balance of the convertible notes. On June 14, 2021, the Company and the Investor entered into an Acknowledgment and Termination Agreement, pursuant to which the Company agreed to issue to the Investor an aggregate of 406,250 additional shares of its common stock (the “Lind Shares”) and to pay the Investor the remaining principal amount of $790,804 (the “Final Payment”) in full satisfaction of our remaining obligations to the Investor under the 2020 Note. The Company issued the Lind Shares and made the Final Payment to the Investor, and the 2020 Lind Securities Purchase Agreement and the 2020 Note terminated, effective June 15, 2021. On December 17, 2020, the Company entered into three separate securities purchase agreements with certain accredited investors on substantially the same terms as the Lind Securities Purchase Agreement (the “December 17 SPAs”), pursuant to which the Company sold, in private placement transactions, in exchange for the payment by the accredited investors of an aggregate of $1,138,023, (1) convertible promissory notes (the “December 17 Notes”) in an aggregate principal amount of $1,365,628, which did not bear interest and were to mature on December 17, 2022, and (2) an aggregate of 110,956 shares of its common stock. On December 18, 2020, the Company entered into an additional securities purchase agreement with an accredited investor on substantially the same terms as the Lind Securities Purchase Agreement (the “December 18 SPA” and, together with the December 17 SPAs, the "Subsequent Securities Purchase Agreements"), pursuant to which the Company sold, in a private placement transaction, in exchange for the payment by the accredited investor of $269,373, (1) a convertible promissory note in an aggregate principal amount of $323,247, which did not bear interest and was to mature on December 18, 2022 (the “December 18 Note” and, together with the December 17 Notes, the “Subsequent Notes”), and (2) 26,263 shares of the Company’s common stock. The Subsequent Securities Purchase Agreements had substantially the same terms as the Lind Securities Purchase Agreement, and the Subsequent Notes had substantially the same terms as the Note. During the first half of 2021, the Company made certain repayments on the outstanding principal balance of the convertible notes. On July 7, 2021, the Company and the holder of the December 18 Note (the “December 18 Note Holder”) entered into an Acknowledgement and Termination Agreement, pursuant to which: (i) the December 18 Note Holder agreed to return to the Company $42,777 in cash (the “Repayment”) previously paid by the Company to the December 18 Note Holder as a payment against the Company’s obligations under the December 18 Note, and (ii) the Company agreed to issue to the December 18 Note Holder an aggregate of 43,664 additional shares of its common stock (the “December 18 Note Shares”) in full satisfaction of our remaining obligations to the December 18 Note Holder under the December 18 Note. The December 18 Note Holder paid the Company the Repayment and the Company issued the December Note Shares, and the December 18 SPA and the December 18 Note terminated, effective July 7, 2021. The Company received aggregate net proceeds of $10.9 million from the convertible note offering, net of $0.5 million of issuance costs. The total gross proceeds were allocated to the convertible notes and common stock issued under the agreements based on their relative fair values. Due to the principal payments made during the year, the Company remeasured the beneficial conversion feature discount at each payment date and recorded a loss on extinguishment of debt of approximately $1.0 million during the year ended December 31, 2021 as well as a reduction in additional paid-in capital of $1.5 million as of December 31, 2021. During the year ended December 31, 2021, the Company paid approximately $13.6 million in principal payments on the outstanding convertible notes and issued an aggregate of 475,315 shares of its common stock upon conversion of the convertible notes, and none of the 2020 convertible notes remain outstanding as of December 31, 2021. PPP Loan On May 4, 2020, the Company qualified for and received a loan pursuant to the Paycheck Protection Program, a program implemented by the U.S. Small Business Administration under the Coronavirus Aid, Relief, and Economic Security Act, from a qualified lender (the “PPP Lender”), for an aggregate principal amount of approximately $ 147,000 1.0 |
10. Stockholders' Equity
10. Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
10. Stockholders' Equity | 10. Stockholders' Equity Preferred Stock The Company is authorized to issue 10,000,000 0.001 No Common Stock The Company has authorized 240,000,000 120,000,000 Each share of common stock is entitled to one voting right Warrants September 2020 Warrants The September 2020 Warrants are exercisable for 6,648,750 0.84 March 9, 2021 During the year ended December 31, 2021, September 2020 Warrants were exercised for 5.6 4.7 1.0 million 0.84 August 2019 Warrants On August 23, 2019, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company issued and sold an aggregate of 4,475,000 February 27, 2020 During the year ended December 31, 2021, August 2019 Warrants for 1.3 2.4 900,000 1.78 Series A Warrants The Series A Warrants were initially exercisable for 1,463,519 shares of common stock at an exercise price per share equal to $4.15, which was adjusted several times pursuant to the terms thereof to 3,629,023 shares of common stock at an exercise price per share equal to $0.2957 per share. The most recent adjustment to the exercise price (from $0.60 to $0.2957 per share) occurred during the three months ended September 30, 2020 as a result of the announcement of the offerings pursuant to the September 2020 Securities Purchase Agreement. The Series A Warrants were immediately exercisable upon issuance and will expire on January 31, 2024. During the year ended December 31, 2021 and 2020, Series A Warrants for 0.5 million and 0.2 million shares of common stock, respectively, were exercised for approximately $ 0.1 million and $ 45,000 , respectively. As of December 31, 2021, Series A Warrants exercisable for 0.3 million shares of common stock remain outstanding at an exercise price of $ 0.2957 per share A summary of warrant activity during the year ended December 31, 2021 is as follows (in thousands): Summary of Warrant Activity Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of December 31, 2019 3,584 $ 3.86 Issued 6,648 $ 0.84 Exercised (154) $ 0.30 Cancelled (12) $ 18.00 Outstanding as of December 31, 2020 10,066 $ 1.84 4.4 Issued - $ - Exercised (7,431) $ 0.98 Cancelled - $ - Outstanding as of December 31, 2021 2,635 $ 4.29 2.4 Exercisable as of December 31, 2021 2,635 $ 4.29 2.4 The Series A Warrants were recognized as a liability at their fair value upon issuance. The warrant liability is remeasured to the then fair value prior to their exercise or at period end for warrants that are unexercised and the gain or loss recognized in earnings during the period. |
11. Stock-Based Compensation
11. Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
11. Stock-Based Compensation | 11. Stock-Based Compensation The Company has the Amended and Restated Apricus 2012 Stock Long Term Incentive Plan (the “2012 Plan”), which provides for the issuance of incentive and non-incentive stock options, restricted and unrestricted stock awards, stock unit awards and stock appreciation rights. Options and restricted stock units granted generally vest over a period of one to four years and have a maximum term of ten years from the date of grant. As of December 31, 2021, an aggregate of 11,110,431 1.4 On May 15, 2020, the Company’s stockholders approved the Company’s 2020 Employee Stock Purchase Plan (the “ESPP”), whereby qualified employees are allowed to purchase limited amounts of the Company’s common stock at the lesser of 85 1.0 On January 1, 2021, the Company added 545,358 shares for purchase by employees under the ESPP. 80,009 72,000 On July 28, 2019, the Compensation Committee adopted the Seelos Therapeutics, Inc. 2019 Inducement Plan (the “2019 Inducement Plan”), which became effective on August 12, 2019. The 2019 Inducement Plan is substantially similar to the 2016 Plan. The 2019 Inducement Plan provides for the grant of equity-based awards in the form of stock options, stock appreciation rights, restricted stock, unrestricted stock, stock units, including restricted stock units, performance units and cash awards, solely to prospective employees of the Company or an affiliate of the Company provided that certain criteria are met. Awards under the 2019 Inducement Plan may only be granted to an individual, as a material inducement to such individual to enter into employment with the Company, who (i) has not previously been an employee or director of the Company or (ii) is rehired following a bona fide period of non-employment with the Company. The maximum number of shares available for grant under the 2019 Inducement Plan is 1,000,000 Stock options During the year ended December 31, 2021, the Company granted 2,210,000 4.04 During the year ended December 31, 2021, the Company also granted 106,000 1.67 The fair value of stock option grants are estimated on the date of grant using the Black-Scholes option-pricing model. The Company was historically a private company and lacked sufficient company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following assumptions were used in determining the fair value of the stock options granted during the years ended December 31, 2021 and 2020: Schedule of Valuation Assumptions for Stock Options Year Ended December 31, 2021 2020 Risk-free interest rate 0.5 1.2 0.3 1.7 Volatility 118 125 109 119 Dividend yield - - Expected term (years) 5 6 5 7 Weighted-average fair value $ 3.46 $ 0.97 A summary of stock option activity during the year ended December 31, 2021 is as follows (in thousands, except exercise prices and years): Schedule of Valuation Assumptions for Stock Options Weighted Weighted Total Average Average Remaining Aggregate Stock Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding as of December 31, 2020 5,120 $ 1.97 Granted 2,316 3.94 Exercised (81) 1.40 Cancelled (49) 2.06 Outstanding as of December 31, 2021 7,306 $ 2.60 8.5 $ 2,180 Vested and expected to vest as of December 31, 2021 7,306 $ 2.60 8.5 $ 2,180 Exercisable as of December 31, 2021 2,245 $ 2.99 8.1 $ 856 The intrinsic value of options exercised during the years ended December 31, 2021 and 2020 was $ 0.3 0 7.4 2.1 Performance Stock Award During the year ended December 31, 2021, the Company’s Board of Directors awarded a performance stock unit award to the Company’s Chief Executive Officer for 2,400,000 4.31 4.9 1.3 0.2 4.1 The following table summarizes the total stock-based compensation expense resulting from share-based awards recorded in the Company's consolidated statements of operations (in thousands): Schedule of Stock-Based Compensation Expense Year Ended December 31, 2021 2020 Research and development $ 717 $ 394 General and administrative 7,630 1,650 $ 8,347 $ 2,044 |
12. Income Taxes
12. Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
12. Income Taxes | 12. Income Taxes The Company has incurred net operating losses since inception. At December 31, 2021, the Company has available net operating loss carryforwards of approximately $ 89.4 175.5 0.4 2036 89.0 175.5 2036 Deferred tax assets consist of the following (in thousands): Schedule of Deferred Tax Assets December 31, 2021 2020 Net operating tax loss carryforwards $ 30,751 $ 15,223 Accrued expenses - 66 Contingent payment obligations 407 - Stock-based compensation 3,208 521 Intangible assets 16,970 12,320 Total deferred tax asset 51,336 28,130 Less valuation allowance (51,336) (28,130) Net deferred tax asset $ - $ - The federal and state net operating loss carryforwards, not subject to the annual limitation under Internal Revenue Code Section 382, resulted in a noncurrent deferred tax asset as of December 31, 2021 and 2020 of approximately $ 30.8 15.2 The Company follows the provisions of income tax guidance which provides recognition criteria and a related measurement model for uncertain tax positions taken or expected to be taken in income tax returns. The guidance requires that a position taken or expected to be taken in a tax return be recognized in the financial statements when it is more likely than not that the position would be sustained upon examination by tax authorities. Tax positions that meet the more likely than not threshold are then measured using a probability weighted approach recognizing the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company's federal income tax returns for 2018 no The Company did not have any unrecognized tax benefits for the years ended December 31, 2021 and 2020. The reconciliation of income taxes computed using the statutory United States income tax rate and the provision (benefit) for income taxes for the years ended December 31, 2021 and 2020, are as follows: Schedule of Effective Income Tax Rate Reconciliation Year Ended December 31, 2021 2020 Federal statutory tax rate 21.0 % 21.0 % State and local taxes, net of federal benefit 12.9 % 11.2 % Permanent items (1.1) % (1.0) % Deferred rate changes 2.3 % 0.1 % Other 0.0 % 59.3 % Change in valuation allowance (35.1) % (90.6) % Income tax provision (benefit) - % - % |
13. Commitments and Contingenci
13. Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
13. Commitments and Contingencies | 13. Commitments and Contingencies Leases In March 2019, the Company entered into a nine-month office space rental agreement for its headquarters in New York, New York expiring November 2019. In November 2019 the Company renewed this rental agreement for an additional twelve-months for a base rent of approximately $9,000 per month. In November 2020, the Company renewed this rental agreement for an additional twelve-months for a base rent of approximately $3,800 per month. In March 2021, the Company was notified that the counterparty’s right to occupy the space at 300 Park Avenue, New York, NY was terminated, and the Company was required to vacate by March 26, 2021. The Company vacated the premises and has advised the counterparty that the counterparty is in breach of this rental agreement and therefore, the Company has no further obligations thereunder. In March 2021, the Company entered into an eighteen-month office space rental agreement for its headquarters at 300 Park Avenue, New York, NY, expiring July 2022. The rental agreement contains a base rent of approximately $4,000 per month. This agreement includes one or more renewal options. 39,000 38,000 Upon the commencement of the 300 Park Avenue, New York, NY office space in March 2021, in exchange for the new operating lease liability, the Company recognized a right-of-use asset of $ 74,000 0.8 8.0 As of December 31, 2021, future minimum lease payments for the Company’s operating leases with a non-cancelable term of more than one year is as follows (in thousands): Schedule of future minimum operating lease payments Operating Leases Remaining Period Ended December 31, 2021 $ - Year Ended December 31, 2022 40 Total 40 Less present value discount (2) Operating lease liabilities $ 38 For the years ended December 31, 2021 and 2020, rent expense totaled $ 0.1 Contractual Commitments The Company has entered into long-term agreements with certain manufacturers and suppliers that require it to make contractual payment to these organizations. The Company expects to enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require up-front payments and long-term commitments of cash. Litigation As of December 31, 2021, there was no material litigation against the Company. |
14. Subsequent Events
14. Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
14. Subsequent Events | 14. Subsequent Events In January 2022, the Company paid to iXBEL the Shortfall Amount (as described in Note 4) of $ 1.2 |
1. Organization and Summary o_2
1. Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Seelos Therapeutics, Inc. and its subsidiaries (the “Company”) is a clinical-stage biopharmaceutical company focused on achieving efficient development of products that address significant unmet needs in Central Nervous System (“CNS”) disorders and other rare disorders. The Company’s lead programs are SLS-002 for the potential treatment of acute suicidal ideation and behavior in patients with major depressive disorder (“ASIB in MDD”) and SLS-005 for the potential treatment of Amyotrophic Lateral Sclerosis (“ALS”) and Spinocerebellar Ataxia (“SCA”). SLS-005 for the potential treatment of Sanfilippo Syndrome currently requires additional natural history data, which is being considered. Additionally, the Company is developing several preclinical programs, most of which have well-defined mechanisms of action, including: SLS-004, SLS-006, SLS-007 for the potential treatment of Parkinson’s Disease (“PD”) and SLS-008, which is being developed for the potential treatment of an undisclosed indication, but may also be targeted at chronic inflammation in asthma and orphan indications such as pediatric esophagitis. |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of these consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s financial statements relate to the valuation of warrants, valuation of convertible notes payable, and the valuation of stock options. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of financial instruments such as accounts payable and accrued expenses approximate their related fair values due to the short-term nature of these instruments. |
Leases | Leases The Company determines if an arrangement is a lease at inception. |
Fair Value Option | Fair Value Option As permitted under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 825, Financial Instruments (“ASC 825”), the Company elected the fair value option to account for its November 2021 and December 2021 convertible notes (collectively, the “2021 Convertible Notes”). In accordance with ASC 825, the Company records these convertible notes at fair value with changes in fair value recorded in the Consolidated Statement of Operations and Comprehensive Loss. As a result of applying the fair value option, direct costs and fees related to the convertible notes were expensed as incurred and were not deferred. |
Fair Value Measurements | Fair Value Measurements The Company follows the accounting guidance in the FASB ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. |
Research and Development | Research and Development Research and development costs are expensed as incurred and include milestone and upfront payments for license arrangements, the cost of employee compensation and related expenses, as well as expenses for third parties who conduct research and development on the Company's behalf, pursuant to development and consulting agreements in place. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. |
Income (Loss) Per Common Share | Income (Loss) Per Common Share Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities outstanding for the year ended December 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Year Ended December 31, 2021 2020 Outstanding stock options 7,306 5,120 Restricted stock units 2,400 - Outstanding warrants 2,635 10,066 Convertible debt 3,704 8,556 16,045 23,742 |
Stock-Based Compensation | Stock-Based Compensation The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant-date fair value of the awards and forfeitures rates. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations based upon the underlying individual’s role at the Company. Performance share awards are initially valued based on the Company’s closing stock price on the date of grant. The number of performance share awards that vest will be determined based on the achievement of specified performance milestones by the end of the performance period. Compensation expense for performance awards is recognized over the service period and will vary based on remeasurement during the performance period. If achievement of the performance milestone is not probable of achievement during the performance period, compensation expense is reversed. |
Segment Information | Segment Information The Company operates under one segment which develops pharmaceutical products. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of ASU 2019-12 did not have a material effect on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06: Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for convertible debt instruments by removing the separation models for convertible debt with a cash conversion feature, as well as convertible instruments with a beneficial conversion feature. As a result, entities will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. The elimination of these models will reduce non-cash interest expense for entities that have issued a convertible instrument that was within the scope of those models before the adoption of ASU 2020-06. Additionally, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share, and precludes the use of the treasury stock method for certain debt instruments. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020, and an entity should adopt the provisions at the beginning of its annual fiscal year. The Company does not expect the adoption of ASU 2020-06 to have an impact on its consolidated financial statements and related disclosures. |
1. Organization and Summary o_3
1. Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities outstanding for the year ended December 31, 2021 and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Year Ended December 31, 2021 2020 Outstanding stock options 7,306 5,120 Restricted stock units 2,400 - Outstanding warrants 2,635 10,066 Convertible debt 3,704 8,556 16,045 23,742 |
4. Fair Value Measurement (Tabl
4. Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of Fair Value Hierarchy Assets and Liabilities | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values. At time of issuance, the derivative liability at fair value was recognized using Level 3 inputs as no observable inputs were available at the time in the market. At December 31, 2021, the derivative liability has been reclassed as a Level 1 input as the significant inputs were known and observable. There were no Schedule of Fair Value Hierarchy Assets and Liabilities Fair Value Measurements as of December 31, 2021 (Level 1) (Level 2) (Level 3) Total Assets Cash $ 78,734 $ - $ - $ 78,734 Liabilities Convertible notes payable, at fair value $ - $ - $ 18,920 $ 18,920 Derivative liability, at fair value 1,174 - - 1,174 Warrant liabilities, at fair value - - 424 424 $ 1,174 $ - $ 19,344 $ 20,518 Fair Value Measurements as of December 31, 2020 (Level 1) (Level 2) (Level 3) Total Assets Cash $ 15,662 $ - $ - $ 15,662 Liabilities Warrant liabilities, at fair value $ - $ - $ 1,062 $ 1,062 |
Schedule of Fair Value Level 3 Reconciliation | The following table is a reconciliation for the common stock warrant liabilities, derivative liability, and convertible notes measured at fair value using Level 3 unobservable inputs (in thousands): Schedule of Fair Value Level 3 Reconciliation Warrant Derivative Convertible notes, liabilities liability at fair value Balance as of December 31, 2019 $ 963 $ - $ - Warrant liability reclassified to stockholders' equity (124) - - Change in fair value measurement of warrant liability 223 - - Balance as of December 31, 2020 $ 1,062 $ - $ - Warrant liability reclassified to stockholders' equity (1,155) - - Issuance of convertible notes, at fair value - - 19,150 Issuance of derivative liability - 805 - Change in fair value measurement of derivative liability - 369 - Change in fair value measurement of convertible notes - - (230) Change in fair value measurement of warrant liability 517 - - Balance as of December 31, 2021 $ 424 $ 1,174 $ 18,920 |
Derivative Financial Instruments, Liabilities [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Summary of Fair Value Measurements Warrant Valuation Assumptions | At issuance, the fair value of the embedded derivative was estimated by using a Monte Carlo simulation model. As of December 31, 2021, the Company determined it was probable it would settle the Shortfall Amount in cash and estimated the fair value based on a probability weighted market approach. Summary of Fair Value Measurements Derivative Valuation Assumptions Year Ended December 31, 2021 Risk-free interest rate 0.13% Volatility 110% Dividend yield - Expected term (years) 0.11 Stock price $ 1.88 |
Long-term Debt [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Summary of Fair Value Measurements Warrant Valuation Assumptions | The 2021 Convertible Notes are valued using a Monte Carlo simulation model. The following assumptions were used in determining the fair value of the 2021 Convertible Notes as of December 31, 2021: Summary of Fair Value Measurements Convertible Notes Valuation Assumptions Year Ended December 31, 2021 Risk-free interest rate 0.90 0.95 Volatility 113 114 Dividend yield - Contractual term (years) 3 Stock price $ 1.74 1.95 |
Warrant [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Summary of Fair Value Measurements Warrant Valuation Assumptions | The following assumptions were used in determining the fair value of the warrant liabilities valued using the Black-Scholes option pricing model as of December 31, 2021 and 2020: Summary of Fair Value Measurements Warrant Valuation Assumptions Year Ended December 31, 2021 2020 Risk-free interest rate 0.75% 0.18% Volatility 110.55% 116.77% Dividend yield - - Expected term (years) 2.07 3.07 Weighted-average fair value $ 1.40 $ 1.40 |
5. Prepaid Expenses and Other_2
5. Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets are comprised of the following (in thousands): Schedule of Prepaid Expenses and Other Current Assets December 31, 2021 2020 Prepaid insurance $ 59 $ 50 Prepaid clinical costs 4,481 1,743 Other 187 39 Prepaid expenses and other current assets $ 4,727 $ 1,832 |
8. Accrued Expenses (Tables)
8. Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses are comprised of the following (in thousands): Schedule of Accrued Liabilities December 31, 2021 2020 Professional fees $ 181 $ 292 Personnel related 1,303 756 Outside research and development services 2,219 764 Other 25 112 Accrued expenses, net $ 3,728 $ 1,924 |
9. Debt (Tables)
9. Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Maturities of Long-term Debt | Scheduled maturities with respect to the 2021 Convertible Notes are as follows (in thousands): Maturities of Long-term Debt Year Ending December 31: 2022 $ 917 2023 $ 11,111 2024 $ 10,194 2025 $ - 2026 $ - Total $ 22,222 |
10. Stockholders' Equity (Table
10. Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Warrant Activity | A summary of warrant activity during the year ended December 31, 2021 is as follows (in thousands): Summary of Warrant Activity Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of December 31, 2019 3,584 $ 3.86 Issued 6,648 $ 0.84 Exercised (154) $ 0.30 Cancelled (12) $ 18.00 Outstanding as of December 31, 2020 10,066 $ 1.84 4.4 Issued - $ - Exercised (7,431) $ 0.98 Cancelled - $ - Outstanding as of December 31, 2021 2,635 $ 4.29 2.4 Exercisable as of December 31, 2021 2,635 $ 4.29 2.4 |
11. Stock-Based Compensation (T
11. Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Valuation Assumptions for Stock Options | The following assumptions were used in determining the fair value of the stock options granted during the years ended December 31, 2021 and 2020: Schedule of Valuation Assumptions for Stock Options Year Ended December 31, 2021 2020 Risk-free interest rate 0.5 1.2 0.3 1.7 Volatility 118 125 109 119 Dividend yield - - Expected term (years) 5 6 5 7 Weighted-average fair value $ 3.46 $ 0.97 |
Schedule of Valuation Assumptions for Stock Options | A summary of stock option activity during the year ended December 31, 2021 is as follows (in thousands, except exercise prices and years): Schedule of Valuation Assumptions for Stock Options Weighted Weighted Total Average Average Remaining Aggregate Stock Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding as of December 31, 2020 5,120 $ 1.97 Granted 2,316 3.94 Exercised (81) 1.40 Cancelled (49) 2.06 Outstanding as of December 31, 2021 7,306 $ 2.60 8.5 $ 2,180 Vested and expected to vest as of December 31, 2021 7,306 $ 2.60 8.5 $ 2,180 Exercisable as of December 31, 2021 2,245 $ 2.99 8.1 $ 856 |
Schedule of Stock-Based Compensation Expense | The following table summarizes the total stock-based compensation expense resulting from share-based awards recorded in the Company's consolidated statements of operations (in thousands): Schedule of Stock-Based Compensation Expense Year Ended December 31, 2021 2020 Research and development $ 717 $ 394 General and administrative 7,630 1,650 $ 8,347 $ 2,044 |
12. Income Taxes (Tables)
12. Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets | Deferred tax assets consist of the following (in thousands): Schedule of Deferred Tax Assets December 31, 2021 2020 Net operating tax loss carryforwards $ 30,751 $ 15,223 Accrued expenses - 66 Contingent payment obligations 407 - Stock-based compensation 3,208 521 Intangible assets 16,970 12,320 Total deferred tax asset 51,336 28,130 Less valuation allowance (51,336) (28,130) Net deferred tax asset $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation of income taxes computed using the statutory United States income tax rate and the provision (benefit) for income taxes for the years ended December 31, 2021 and 2020, are as follows: Schedule of Effective Income Tax Rate Reconciliation Year Ended December 31, 2021 2020 Federal statutory tax rate 21.0 % 21.0 % State and local taxes, net of federal benefit 12.9 % 11.2 % Permanent items (1.1) % (1.0) % Deferred rate changes 2.3 % 0.1 % Other 0.0 % 59.3 % Change in valuation allowance (35.1) % (90.6) % Income tax provision (benefit) - % - % |
13. Commitments and Contingen_2
13. Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum operating lease payments | As of December 31, 2021, future minimum lease payments for the Company’s operating leases with a non-cancelable term of more than one year is as follows (in thousands): Schedule of future minimum operating lease payments Operating Leases Remaining Period Ended December 31, 2021 $ - Year Ended December 31, 2022 40 Total 40 Less present value discount (2) Operating lease liabilities $ 38 |
Schedule of Antidilutive Securi
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded | 16,045,000 | 23,742,000 |
Share-based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded | 7,306,000 | 5,120,000 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded | 2,400,000 | |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded | 2,635,000 | 10,066,000 |
Convertible Debt Securities [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded | 3,704,000 | 8,556,000 |
2. Liquidity and Going Concern
2. Liquidity and Going Concern (Details Narrative) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash | $ 78,734 | $ 15,662 |
Retained Earnings (Accumulated Deficit) | $ 141,210 | $ 75,162 |
Schedule of Fair Value Hierarch
Schedule of Fair Value Hierarchy Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Assets [Abstract] | |||
Cash and Cash Equivalents, at Carrying Value | $ 78,734 | $ 15,662 | $ 10,261 |
Liabilities [Abstract] | |||
Derivative Liability | 1,174 | ||
Fair Value, Recurring [Member] | |||
Assets [Abstract] | |||
Cash and Cash Equivalents, at Carrying Value | 78,734 | 15,662 | |
Liabilities [Abstract] | |||
Derivative Liability | 20,518 | ||
Fair Value, Recurring [Member] | Long-term Debt [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | 18,920 | ||
Fair Value, Recurring [Member] | Derivative Financial Instruments, Liabilities [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | 1,174 | ||
Fair Value, Recurring [Member] | Warrant [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | 424 | 1,062 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | |||
Assets [Abstract] | |||
Cash and Cash Equivalents, at Carrying Value | 78,734 | 15,662 | |
Liabilities [Abstract] | |||
Derivative Liability | 1,174 | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | Long-term Debt [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | Derivative Financial Instruments, Liabilities [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | 1,174 | ||
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | Warrant [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | |||
Assets [Abstract] | |||
Cash and Cash Equivalents, at Carrying Value | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | Long-term Debt [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | Derivative Financial Instruments, Liabilities [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | Warrant [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | |||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | |||
Assets [Abstract] | |||
Cash and Cash Equivalents, at Carrying Value | |||
Liabilities [Abstract] | |||
Derivative Liability | 19,344 | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | Long-term Debt [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | 18,920 | ||
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | Warrant [Member] | |||
Liabilities [Abstract] | |||
Derivative Liability | $ 424 | $ 1,062 |
Summary of Fair Value Measureme
Summary of Fair Value Measurements Derivative Valuation Assumptions (Details) - Fair Value, Inputs, Level 3 [Member] - Derivative Financial Instruments, Liabilities [Member] | 12 Months Ended |
Dec. 31, 2021$ / shares | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 0.13% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 11000.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 1 month 9 days |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 1.88 |
Summary of Fair Value Measure_2
Summary of Fair Value Measurements Convertible Notes Valuation Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Long-term Debt [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 3 years | |
Long-term Debt [Member] | Minimum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 1.74 | |
Long-term Debt [Member] | Maximum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 1.95 | |
Share-based Payment Arrangement, Option [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | ||
Share-based Payment Arrangement, Option [Member] | Minimum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | 5 years |
Share-based Payment Arrangement, Option [Member] | Maximum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 6 years | 7 years |
Share-based Payment Arrangement, Option [Member] | Long-term Debt [Member] | Minimum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 90.00% | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 1130000.00% | |
Share-based Payment Arrangement, Option [Member] | Long-term Debt [Member] | Maximum [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 95.00% | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 1140000.00% |
Summary of Fair Value Measure_3
Summary of Fair Value Measurements Warrant Valuation Assumptions (Details) - Fair Value, Inputs, Level 3 [Member] - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 0.75% | 0.18% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 11055.00% | 11677.00% |
Dividend yield (in percent) | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 2 years 25 days | 3 years 25 days |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.40 | $ 1.40 |
Schedule of Fair Value Level 3
Schedule of Fair Value Level 3 Reconciliation (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Warrant [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | $ 424 | $ 1,062 | $ 963 |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Liability, Transfers out of Level 3 | (1,155) | (124) | |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | 517 | $ 223 | |
Long-term Debt [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | 18,920 | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | (230) | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Liability, Transfers Into Level 3 | 19,150 | ||
Derivative Financial Instruments, Liabilities [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability Value | 1,174 | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | 369 | ||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Liability, Transfers Into Level 3 | $ 805 |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 59 | $ 50 |
Prepaid clinical costs | 4,481 | 1,743 |
Other | 187 | 39 |
Prepaid expenses and other current assets | $ 4,727 | $ 1,832 |
6. Common Stock Offerings (Deta
6. Common Stock Offerings (Details Narrative) - USD ($) | 1 Months Ended | 2 Months Ended | 8 Months Ended | 12 Months Ended | ||||||||||||||||
Jan. 31, 2022 | Nov. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | May 31, 2020 | Mar. 31, 2020 | Feb. 28, 2020 | Jan. 31, 2020 | Aug. 31, 2019 | Aug. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | May 24, 2021 | Jan. 28, 2021 | Sep. 09, 2020 | Mar. 16, 2020 | Feb. 19, 2020 | Feb. 13, 2020 | |
Cash received from stock sale | $ 97,957,000 | $ 8,850,000 | ||||||||||||||||||
Research and Development Expense | 46,649,000 | $ 10,984,000 | ||||||||||||||||||
I X License Agreement [Member] | ||||||||||||||||||||
Research and Development Expense | $ 9,000,000 | |||||||||||||||||||
[custom:NonrefundableCashPayment] | $ 1,200,000 | $ 3,500,000 | ||||||||||||||||||
[custom:Issuanceofcommonstockforlicenseacquiredshares] | 2,570,266 | |||||||||||||||||||
[custom:MinimumStockValueOfSharesIssued] | $ 5,500,000 | |||||||||||||||||||
[custom:InitialStockValuationShortfallFrom5.5MillionValue] | $ 800,000 | |||||||||||||||||||
November And December 2021 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 540,147 | |||||||||||||||||||
Cash received from stock sale | $ 20,200,000 | |||||||||||||||||||
December 2020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 1,112,219 | |||||||||||||||||||
Cash received from stock sale | $ 10,900,000 | |||||||||||||||||||
September 42020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 8,865,000 | |||||||||||||||||||
Cash received from stock sale | $ 6,400,000 | |||||||||||||||||||
Warrant terms and provisions | The Company also issued to the investors warrants to purchase up to 6,648,750 shares of common stock in a concurrent private placement (the "September 2020 Warrants"). The September 2020 Warrants have an exercise price of $0.84 per share of common stock, became exercisable beginning on March 9, 2021 and will expire on March 9, 2026. | |||||||||||||||||||
Shares Issued, Price Per Share | $ 0.79 | |||||||||||||||||||
August 2019 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 4,475,000 | |||||||||||||||||||
Cash received from stock sale | $ 6,700,000 | |||||||||||||||||||
Warrant terms and provisions | The Company issued to the investors warrants to purchase up to 2,237,500 shares of common stock in a concurrent private placement (the “August 2019 Warrants”). The August 2019 Warrants have an exercise price of $1.78 per share of common stock, will be exercisable six months from the date of issuance and will expire four years following the date of issuance. The combined purchase price for one share and one warrant to purchase half of a share of common stock in the offerings was $1.50. Roth Capital Partners, LLC (“Roth”) served as the placement agent for the issuance and sale of the shares and the warrants, and the Company paid Roth an aggregate fee equal to 7.0% of the gross proceeds received by the Company in the offerings. | |||||||||||||||||||
May 242021 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 22,258,066 | |||||||||||||||||||
Cash received from stock sale | $ 64,500,000 | |||||||||||||||||||
Shares Issued, Price Per Share | $ 3.10 | |||||||||||||||||||
Offering proceeds used to partially repay certain convertible promissory notes | $ 7,300,000 | |||||||||||||||||||
January 282021 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 17,530,488 | |||||||||||||||||||
Cash received from stock sale | $ 33,500,000 | |||||||||||||||||||
Shares Issued, Price Per Share | $ 2.05 | |||||||||||||||||||
Offering proceeds used to partially repay certain convertible promissory notes | $ 3,800,000 | |||||||||||||||||||
March 162020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 7,500,000 | |||||||||||||||||||
Cash received from stock sale | $ 4,000,000 | |||||||||||||||||||
Shares Issued, Price Per Share | $ 0.60 | |||||||||||||||||||
February 132020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 6,666,667 | |||||||||||||||||||
Cash received from stock sale | $ 4,800,000 | |||||||||||||||||||
Shares Issued, Price Per Share | $ 0.75 | |||||||||||||||||||
February 192020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 999,999 | |||||||||||||||||||
Shares Issued, Price Per Share | $ 0.75 | |||||||||||||||||||
January 22020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 1,809,845 | |||||||||||||||||||
May 112020 [Member] | ||||||||||||||||||||
Number of shares of common stock issued | 300,000 | |||||||||||||||||||
Other Nonrecurring Expense | $ 431,000 | |||||||||||||||||||
January 242019 [Member] | ||||||||||||||||||||
Warrant terms and provisions | Pursuant to the Purchase Agreement, STI (i) issued and sold to the Investors an aggregate of 2,374,672 shares of STI’s common stock which converted pursuant to the exchange ratio in the Merger into the right to receive 1,829,407 shares of the Company’s common stock and (ii) issued warrants representing the right to acquire 1,463,519 shares of common stock at a price per share of $4.15, subject to adjustment as provided therein (the “Series A Warrants”), most recently adjusted to a price per share of $0.2957 per share, and additional warrants initially representing the right to acquire no shares of common stock at a price per share of $0.001, subject to adjustment as provided therein (the “Series B Warrants” together with the Series A Warrants, the “Investor Warrants”), for aggregate gross proceeds of $18.0 million, or $16.5 million net of financing fees. The terms of the Investor Warrants included certain provisions that could result in adjustments to both the number of warrants issued and the exercise price of each warrant, which resulted in the warrants being classified as a liability upon issuance (see Note 10). The Investor Warrants were recorded at fair value of $21.5 million upon issuance and given that the liability exceeded the proceeds received, a loss of $5.0 million was recognized. | |||||||||||||||||||
March 72019 [Member] | ||||||||||||||||||||
Warrant terms and provisions | On March 7, 2019, the Company entered into Amendment Agreements (collectively, the “Amendment Agreements”) with each Investor amending: (i) the Purchase Agreement, (ii) the Series A Warrants, and (iii) the Series B Warrants. The Amendment Agreements, among other things, fixed the aggregate number of shares of common stock issued and issuable pursuant to the Series A Warrants at 3,629,023 (none of which were exercised as of March 7, 2019). The terms of the Investor Warrants continue to include certain provisions that could result in a future adjustment to the exercise price of the Investor Warrants and accordingly, they continue to be classified as a liability after the Amendment Agreements. | |||||||||||||||||||
Series A Warrants unexercised | 300,000 | 300,000 |
7. License Agreements (Details
7. License Agreements (Details Narrative) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||||||||
Jan. 31, 2022 | Nov. 30, 2021 | Sep. 30, 2021 | Jan. 31, 2021 | Jul. 31, 2020 | Apr. 30, 2020 | Feb. 29, 2020 | Jan. 31, 2020 | Oct. 31, 2019 | Aug. 31, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | May 31, 2018 | Mar. 31, 2018 | Sep. 30, 2016 | Dec. 31, 2021 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
Research and development expense | $ 46,649,000 | $ 10,984,000 | ||||||||||||||||||||
Licensefrom Ligand Pharmaceuticals [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On September 21, 2016, the Company entered into a License Agreement (the “License Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”), Neurogen Corporation and CyDex Pharmaceuticals, Inc. (collectively, the “Licensors”), pursuant to which, among other things, the Licensors granted to the Company an exclusive, perpetual, irrevocable, worldwide, royalty-bearing, nontransferable right and license under (i) patents related to a product known as Aplindore, which is now known as SLS-006, acetaminophen (as it may have been or may be modified for use in a product to be administered by any method in any form including, without limitation injection and intravenously, the sole active pharmaceutical ingredient of which is acetaminophen), which is now known as SLS-012, an H3 receptor antagonist, which is now known as SLS-010, and either or both of the Licensors’ two proprietary CRTh2 antagonists, which are now known collectively as SLS-008 (collectively, the “Licensed Products”), and (ii) copyrights, trade secrets, moral rights and all other intellectual and proprietary rights related thereto. The Company is obligated to use commercially reasonable efforts to (a) develop the Licensed Products, (b) obtain regulatory approval for the Licensed Products in the European Union (either in its entirety or including at least one of France, Germany or, if at the time the United Kingdom is a member of the European Union, the United Kingdom), the United Kingdom, if at the time the United Kingdom is not a member of the European Union, Japan or the People’s Republic of China (each, a “Major Market”) or the United States, and (c) commercialize the Licensed Products in each country where regulatory approval is obtained. The Company has the exclusive right and sole responsibility and decision-making authority to research and develop any Licensed Products and to conduct all clinical trials and non-clinical studies the Company believes appropriate to obtain regulatory approvals for commercialization of the Licensed Products. The Company also has the exclusive right and sole responsibility and decision-making authority to commercialize any of the Licensed Products. | |||||||||||||||||||||
Shares of common stock issued | 801,253 | |||||||||||||||||||||
Research and development expense | $ 2,200,000 | |||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon submission of an application with the FDA or equivalent foreign body for a particular Licensed Product | $ 750,000 | 750,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon FDA approval of an application for a particular Licensed Product | 3,000,000 | 3,000,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon regulatory approval in a Major Market for a particular Licensed Product | 1,125,000 | 1,125,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon regulatory approval in a second Major Market for a particular Licensed Product | 1,125,000 | 1,125,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon submission of an application with the FDA or equivalent foreign body for such a particular Licensed Product | 100,000 | 100,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon FDA approval of an application for such a particular Licensed Product | 350,000 | 350,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon regulatory approval in a Major Market for such a particular Licensed Product | 125,000 | 125,000 | ||||||||||||||||||||
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon regulatory approval in a second Major Market for such a particular Licensed Product | 125,000 | 125,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon acetaminophen | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore | 20,000,000 | 20,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist | 20,000,000 | 20,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon acetaminophen | 20,000,000 | 20,000,000 | ||||||||||||||||||||
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists | 20,000,000 | 20,000,000 | ||||||||||||||||||||
Milestone payments accrued | 0 | 0 | ||||||||||||||||||||
Assetsfrom Vyera Pharmaceuticals [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On March 6, 2018, the Company entered into the Vyera Agreement with Vyera, pursuant to which the Company acquired the assets (the “Vyera Assets”) and liabilities (the “Vyera Assumed Liabilities”), of Vyera related to TUR-002 (intranasal ketamine), which is now known as SLS-002. The Company is obligated to use commercially reasonable efforts to seek regulatory approval in the United States for and commercialize SLS-002 | |||||||||||||||||||||
Shares of common stock issued | 1,809,845 | 191,529 | ||||||||||||||||||||
Milestone payments accrued | 0 | 0 | ||||||||||||||||||||
Non-refundable cash payment | $ 150,000 | $ 150,000 | $ 1,000,000 | |||||||||||||||||||
Cash payments agreed to in Amendment to the Asset Purchase Agreement | $ 1,000,000 | $ 1,000,000 | $ 750,000 | $ 750,000 | ||||||||||||||||||
[custom:CashPaymentsforLowerRoyaltyPercentageonPotentialNetSalesofSLS002] | $ 3,000,000 | |||||||||||||||||||||
Contingent non-refundable milestone payment upon approval by the FDA of an NDA, with respect to SLS-002 | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon approval by the EMA of the foreign equivalent to an NDA with respect to SLS-002 in a Major Market | 5,000,000 | 5,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon approval by the EMA of the foreign equivalent to an NDA with respect to SLS-002 in a second Major Market | 2,500,000 | 2,500,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon the achievement of $250.0 million in net sales of SLS-002 | 5,000,000 | 5,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon the achievement of $500.0 million in net sales of SLS-002 | 10,000,000 | 10,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon the achievement of $1.0 billion in net sales of SLS-002 | 15,000,000 | 15,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon the achievement of $1.5 billion in net sales of SLS-002 | 20,000,000 | 20,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon the achievement of $2.0 billion in net sales of SLS-002 | 25,000,000 | 25,000,000 | ||||||||||||||||||||
Weg License Agreement [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On August 29, 2019, the Company entered into an amended and restated exclusive license agreement with Stuart Weg, M.D. (the “Weg License Agreement”), pursuant to which the Company was granted an exclusive worldwide license to certain intellectual property and regulatory materials related to SLS-002. Under the terms of the Weg License Agreement, the Company paid an upfront license fee of $75,000 upon execution of the agreement. The Company agreed to pay additional consideration to Dr. Weg as follows: (i) $0.1 million on January 2, 2020, (ii) $0.125 million on January 2, 2021, and (iii) in the event the FDA has not approved an NDA for a product containing ketamine in any dosage on or before December 31, 2021, $0.2 million on January 2, 2022. The Company paid the required $0.1 million on January 2, 2020 and $0.125 million on January 2, 2021. As further consideration, the Company agreed to pay Dr. Weg certain milestone payments consisting of (i) $0.1 million and shares of common stock equal to $0.15 million divided by the closing sales price of the Company’s common stock upon the issuance of the first patent directed to an anxiety indication, (ii) $0.5 million after the locking of the database and unblinding the data for the statistically significant readout of a Phase III trial of an intranasal racemic ketamine product that has been conducted for the submission under an NDA or equivalent seeking regulatory approval in the United States, the United Kingdom, France, Germany, Italy, Spain, China or Japan, or seeking regulatory approval from the EMA in the EU, for such product (the “Milestone Product”), (iii) $3.0 million upon FDA approval of an NDA for the Milestone Product, (iv) $2.0 million upon regulatory approval by the EMA for the Milestone Product, and (v) $1.5 million upon regulatory approval in Japan for the Milestone Product; provided, however, that the maximum amount to be paid by the Company under milestones (i)-(v) will be $6.6 million. The Company will also pay to Dr. Weg a royalty percentage equal to 2.25% on the sale of each product containing ketamine in any dosage | |||||||||||||||||||||
Milestone payments accrued | 0 | 0 | ||||||||||||||||||||
Non-refundable cash payment | $ 200,000 | $ 125,000 | $ 100,000 | |||||||||||||||||||
Contingent non-refundable milestone payment upon the issuance of the first patent directed to an anxiety indication | 100,000 | 100,000 | ||||||||||||||||||||
Contingent non-refundable milestone share value of common stock payment upon the issuance of the first patent directed to an anxiety indication | 150,000 | 150,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment after the locking of the database and unblinding the data for the statistically significant readout of a Phase III trial of an intranasal racemic ketamine product that has been conducted for the submission unde | 500,000 | 500,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon FDA approval of an NDA for the Milestone Product | 3,000,000 | 3,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon regulatory approval by the EMA for the Milestone Product | 2,000,000 | 2,000,000 | ||||||||||||||||||||
Contingent non-refundable milestone payment upon regulatory approval in Japan for the Milestone Product | 1,500,000 | 1,500,000 | ||||||||||||||||||||
Maximum amount to be paid under milestones | $ 6,600,000 | $ 6,600,000 | ||||||||||||||||||||
Percentage of royalty payments | 2.25% | 2.25% | ||||||||||||||||||||
Assetsfrom Bioblast Pharma [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On February 15, 2019, the Company entered into an Asset Purchase Agreement (the “Bioblast Asset Purchase Agreement”) with Bioblast. Pursuant to the Bioblast Asset Purchase Agreement, the Company acquired all of the assets of Bioblast relating to a therapeutic platform known as Trehalose (the “Bioblast Asset Purchase”). The Company paid to Bioblast $1.5 million in February 2019 and an additional $2.0 million in February 2020. Accordingly, the Company recognized a $3.5 million charge to research and development expense during the three months ended March 31, 2019. Under the terms of the Bioblast Asset Purchase Agreement, the Company agreed to pay additional consideration to Bioblast upon the achievement of certain milestones in the future, as follows: (i) within 15 days following the completion of the Company’s first Phase II(b) clinical trial of Trehalose satisfying certain criteria, the Company will pay to Bioblast $8.5 million; and (ii) within 15 days following the approval for commercialization by the FDA or the Health Products and Food Branch of Health Canada of the first NDA or New Drug Submission, respectively, of Trehalose filed by the Company or its affiliates, the Company will pay to Bioblast $8.5 million. In addition, the Company agreed to pay Bioblast a cash royalty equal to 1% of the net sales of Trehalose. Under the terms of the Bioblast Asset Purchase, the Company assumed a collaborative agreement with Team Sanfilippo Foundation (“TSF”), a nonprofit medical research foundation founded by parents of children with Sanfilippo Syndrome. TSF, upon approval by the FDA, planned to begin an open label, Phase II(b) clinical trial in up to 20 patients with Sanfilippo Syndrome, which is now known under the study name SLS-005. The Company will provide the clinical supply of Trehalose. The terms of the Bioblast Asset Purchase Agreement entitle the Company access to all clinical data from this trial. On July 15, 2019, TSF and the Company amended the agreement whereby the Company agreed to assume responsibility for the Phase II(b)/III clinical trial and TSF agreed to provide a grant of up to $1.5 million towards the funding of the trial. | |||||||||||||||||||||
Research and development expense | 3,500,000 | |||||||||||||||||||||
Milestone payments accrued | $ 0 | $ 0 | ||||||||||||||||||||
Non-refundable cash payment | $ 2,000,000 | $ 1,500,000 | ||||||||||||||||||||
Percentage of royalty payments | 1.00% | 1.00% | ||||||||||||||||||||
Contingent additional milestone consideration within 15 days following the completion of the Company's first Phase II(b) clinical trial of Trehalose satisfying certain criteria | $ 8,500,000 | $ 8,500,000 | ||||||||||||||||||||
Contingent additional milestone consideration within 15 days following the approval for commercialization by the FDA or the Health Products and Food Branch of Health Canada of the first NDA or New Drug Submission, respectively, of Trehalose filed by the Company or its affiliates | 8,500,000 | 8,500,000 | ||||||||||||||||||||
Future grant revenue contingent on Phase II (b)/III Sanfilippo clinical trial | 1,500,000 | 1,500,000 | ||||||||||||||||||||
U C Regents License Agreement [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On March 7, 2019, the Company entered into an exclusive license agreement (the “UC Regents License Agreement”) with The Regents of the University of California (“The UC Regents”) pursuant to which the Company was granted an exclusive license to intellectual property owned by The UC Regents pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-007. Upon entry into the UC Regents License Agreement, the Company paid to The UC Regents $0.1 million and recognized a $0.1 million charge to research and development expense during the three months ended March 31, 2019. Under the terms of the UC Regents License Agreement, the Company agreed to pay additional consideration upon the achievement of certain milestones in the future, as follows: (i) within 90 days following the completion of dosing of the first patient in a Phase I clinical trial, the Company will pay $50,000; (ii) within 90 days following dosing of the first patient in a Phase II clinical trial, the Company will pay $0.1 million; (iii) within 90 days following dosing of the first patient in a Phase III clinical trial, the Company will pay $0.3 million; (iv) within 90 days following the first commercial sales in the U.S., the Company will pay $1.0 million; (v) within 90 days following the first commercial sales in any European market, the Company will pay $1.0 million; and (vi) within 90 days following $250 million in cumulative worldwide net sales of a licensed product, the Company will pay $2.5 million. The Company is also obligated to pay a single digit royalty on sales of the product, if any. In addition, if the Company fails to achieve certain milestones within a specified timeframe, The UC Regents may terminate the agreement or reduce the Company’s license to a nonexclusive license. | |||||||||||||||||||||
Research and development expense | $ 100,000 | |||||||||||||||||||||
Milestone payments accrued | 0 | 0 | ||||||||||||||||||||
Non-refundable cash payment | $ 100,000 | |||||||||||||||||||||
Contingent milestone payment within 90 days following the completion of dosing of the first patient in a Phase I clinical trial | 50,000 | 50,000 | ||||||||||||||||||||
Contingent milestone payment within 90 days following dosing of the first patient in a Phase II clinical trial | 100,000 | 100,000 | ||||||||||||||||||||
Contingent milestone payment within 90 days following dosing of the first patient in a Phase III clinical trial | 300,000 | 300,000 | ||||||||||||||||||||
Contingent milestone payment within 90 days following the first commercial sales in the U.S. | 1,000,000 | 1,000,000 | ||||||||||||||||||||
Contingent milestone payment within 90 days following the first commercial sales in any European market | 1,000,000 | 1,000,000 | ||||||||||||||||||||
Contingent milestone payment within 90 days following $250 million in cumulative worldwide net sales of a licensed product | 2,500,000 | 2,500,000 | ||||||||||||||||||||
Duke License Agreement [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On June 27, 2019, the Company entered into an exclusive license agreement (the “Duke License Agreement”) with Duke University pursuant to which the Company was granted an exclusive license to a gene therapy program targeting the regulation of the synuclein alpha (“SNCA”) gene, which encodes alpha-synuclein expression. The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-004. Upon entry into the Duke License Agreement, the Company paid to Duke University $0.1 million and recognized $0.1 million charge to research and development expense during the three months ended September 30, 2019. The Company agreed to pay additional consideration to Duke University upon the achievement of certain milestones in the future, as follows: (i) within 30 days following filing of an IND following the completion of preclinical studies including comprehensive validation of the platform, the Company will pay $0.1 million; (ii) within 30 days following dosing of the first patient in a Phase I clinical trial, the Company will pay $0.2 million; (iii) within 30 days following dosing of the first patient in a Phase II clinical trial, the Company will pay $0.5 million; (iv) within 30 days following dosing of the first patient in a Phase III clinical trial, the Company will pay $1.0 million; and (v) within 30 days following an NDA approval, the Company will pay $2.0 million. The Company is also obligated to pay a single digit royalty on sales of the product, if any. In addition, if the Company fails to achieve certain milestones within a specified timeframe, Duke University may terminate the agreement. | |||||||||||||||||||||
Research and development expense | $ 100,000 | |||||||||||||||||||||
Milestone payments accrued | 0 | 0 | ||||||||||||||||||||
Non-refundable cash payment | $ 100,000 | |||||||||||||||||||||
Contingent milestone payment within 30 days following filing of an IND following the completion of preclinical studies including comprehensive validation of the platform | 100,000 | 100,000 | ||||||||||||||||||||
Contingent milestone payment within 30 days following dosing of the first patient in a Phase I clinical trial | 200,000 | 200,000 | ||||||||||||||||||||
Contingent milestone payment within 30 days following dosing of the first patient in a Phase II clinical trial | 500,000 | 500,000 | ||||||||||||||||||||
Contingent milestone payment within 30 days following dosing of the first patient in a Phase III clinical trial | 1,000,000 | 1,000,000 | ||||||||||||||||||||
Contingent milestone payment within 30 days following an NDA approval | 2,000,000 | $ 2,000,000 | ||||||||||||||||||||
I X License Agreement [Member] | ||||||||||||||||||||||
Business Combination, Separately Recognized Transactions [Line Items] | ||||||||||||||||||||||
License agreement description | On November 24, 2021, the Company entered into an exclusive license agreement (the “iX License Agreement”) with iXBEL and the iXBEL Stock Purchase Agreement. Pursuant to the iX License Agreement, among other things, iXBEL granted the Company an exclusive, sublicensable, perpetual, worldwide (excluding certain jurisdictions identified in the iX License Agreement) and irrevocable right and license to certain of iXBEL’s licensed patents, know-how, and technological information, including access to iXBEL’s research, development and manufacturing capabilities, to enable the further development, manufacture, promotion and commercialization of Wafermine™ and certain other existing and to be developed iXBEL wafer-based delivery technologies, in all cases for sublingual administration of ketamine. In addition, iXBEL will supply the Company with sufficient product for the potential treatment of 400 patients, with further supplied amounts to be determined by the parties. The Company granted iXBEL an exclusive license to exploit technology developed under the iX License Agreement outside of the licensed territory and to undertake limited, non-exclusive research and development activities in the territory. The Company further agreed not to undertake certain activities with respect to products competitive with those licensed under the iX License Agreement during the term of the iX License Agreement. | |||||||||||||||||||||
Research and development expense | $ 9,000,000 | |||||||||||||||||||||
Non-refundable cash payment | $ 1,200,000 | $ 3,500,000 | ||||||||||||||||||||
[custom:Issuanceofcommonstockforlicenseacquiredshares] | 2,570,266 | |||||||||||||||||||||
Minimum stock value of shares issued | $ 5,500,000 | |||||||||||||||||||||
Stock valuation shortfall from 5.5 million value | $ 1,200,000 |
Schedule of Accrued Liabilities
Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Professional fees | $ 181 | $ 292 |
Personnel related | 1,303 | 756 |
Outside research and development services | 2,219 | 764 |
Other | 25 | 112 |
Accrued expenses, net | $ 3,728 | $ 1,924 |
Maturities of Long-term Debt (D
Maturities of Long-term Debt (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Year Ending December 31: | |
2022 | $ 917 |
2023 | 11,111 |
2024 | 10,194 |
2025 | |
2026 | |
Total | $ 22,222 |
9. Debt (Details Narrative)
9. Debt (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Dec. 31, 2021 | Nov. 30, 2021 | Dec. 31, 2020 | May 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 02, 2021 | |
Short-term Debt [Line Items] | |||||||
Proceeds from Convertible Debt | $ 20,203,000 | $ 10,907,000 | |||||
[custom:GainLossInFairValueOfConvertibleNotes] | 230,000 | ||||||
Vovember 2021 Lind Securities Purchase Agreement [Member] | |||||||
Short-term Debt [Line Items] | |||||||
Long-term Debt, Description | On November 23, 2021, the Company entered into a Securities Purchase Agreement (the “2021 Lind Securities Purchase Agreement”) with Lind Global Asset Management V, LLC (“Lind V”) pursuant to which, among other things, on November 23, 2021 (the “Closing Date”), the Company issued and sold to Lind V, in a private placement transaction (the “Private Placement”), in exchange for the payment by Lind V of $20.0 million, (i) a convertible promissory note (the “2021 Note”) in an aggregate principal amount of $22.0 million (the “Principal Amount”), which will bear no interest until the first anniversary of the issuance of the 2021 Note and will thereafter bear interest at a rate of 5% per annum, and mature on November 23, 2024 (the “Maturity Date”), and (ii) 534,759 shares of Company common stock. | ||||||
December 2021 S P As [Member] | |||||||
Short-term Debt [Line Items] | |||||||
Long-term Debt, Description | On December 2, 2021, the Company entered into two separate securities purchase agreements with certain accredited investors on substantially the same terms as the 2021 Lind Securities Purchase Agreement, pursuant to which the Company sold, in private placement transactions, in exchange for the payment by the accredited investors of an aggregate of $201,534, (i) convertible promissory notes in an aggregate principal amount of $221,688, which will bear no interest and mature on December 2, 2024, and (ii) an aggregate of 5,388 shares of its common stock. These notes have substantially the same terms as the 2021 Note. | ||||||
Proceeds from Convertible Debt | $ 20,200,000 | ||||||
Convertible Subordinated Debt | 18,900,000 | $ 18,900,000 | $ 19,200,000 | ||||
[custom:GainLossInFairValueOfConvertibleNotes] | $ 200,000 | ||||||
Lind Securities Purchase Agreement [Member] | |||||||
Short-term Debt [Line Items] | |||||||
Long-term Debt, Description | On December 11, 2020, the Company entered into a Securities Purchase Agreement (the “2020 Lind Securities Purchase Agreement”) with Lind Global Asset Management II, LLC (the “Investor”) pursuant to which, among other things, on December 11, 2020, the Company issued and sold to the Investor, in a private placement transaction, in exchange for the payment by the Investor of $10,000,000, (1) a convertible promissory note (the “2020 Note”) in an aggregate principal amount of $12,000,000 (the “Principal Amount”), which did not bear interest and was to mature on December 11, 2022 (the “Maturity Date”), and (2) 975,000 shares of the Company’s common stock. At any time following June 11, 2021, and from time to time before the Maturity Date, the Investor had the option to convert any portion of the then-outstanding Principal Amount of the Note into shares of common stock at a price per share of $1.60, subject to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions (the “Conversion Price”). Prior to June 11, 2021, the Company had the right to prepay up to sixty-six and two-thirds percent (66 2/3%) of the then-outstanding Principal Amount of the 2020 Note with no penalty. Subject to certain exceptions, the Company was required to direct proceeds from any subsequent debt financings (including subordinated debt, convertible debt or mandatorily redeemable preferred stock but other than purchase money debt or capital lease obligations or other indebtedness incurred in the ordinary course of business) to repay the 2020 Note, unless waived by the Investor in advance. The 2020 Note began amortizing in June 2021 and was to amortize in eighteen monthly installments equal to the quotient of (i) the then-outstanding Principal Amount of the 2020 Note, divided by (ii) the number of months remaining until the Maturity Date. All amortization payments were to be payable solely in cash, plus a 2% premium. During the first half of 2021, the Company made certain repayments on the outstanding principal balance of the convertible notes. On June 14, 2021, the Company and the Investor entered into an Acknowledgment and Termination Agreement, pursuant to which the Company agreed to issue to the Investor an aggregate of 406,250 additional shares of its common stock (the “Lind Shares”) and to pay the Investor the remaining principal amount of $790,804 (the “Final Payment”) in full satisfaction of our remaining obligations to the Investor under the 2020 Note. The Company issued the Lind Shares and made the Final Payment to the Investor, and the 2020 Lind Securities Purchase Agreement and the 2020 Note terminated, effective June 15, 2021. | ||||||
December 17 S P As [Member] | |||||||
Short-term Debt [Line Items] | |||||||
Long-term Debt, Description | On December 17, 2020, the Company entered into three separate securities purchase agreements with certain accredited investors on substantially the same terms as the Lind Securities Purchase Agreement (the “December 17 SPAs”), pursuant to which the Company sold, in private placement transactions, in exchange for the payment by the accredited investors of an aggregate of $1,138,023, (1) convertible promissory notes (the “December 17 Notes”) in an aggregate principal amount of $1,365,628, which did not bear interest and were to mature on December 17, 2022, and (2) an aggregate of 110,956 shares of its common stock. On December 18, 2020, the Company entered into an additional securities purchase agreement with an accredited investor on substantially the same terms as the Lind Securities Purchase Agreement (the “December 18 SPA” and, together with the December 17 SPAs, the "Subsequent Securities Purchase Agreements"), pursuant to which the Company sold, in a private placement transaction, in exchange for the payment by the accredited investor of $269,373, (1) a convertible promissory note in an aggregate principal amount of $323,247, which did not bear interest and was to mature on December 18, 2022 (the “December 18 Note” and, together with the December 17 Notes, the “Subsequent Notes”), and (2) 26,263 shares of the Company’s common stock. The Subsequent Securities Purchase Agreements had substantially the same terms as the Lind Securities Purchase Agreement, and the Subsequent Notes had substantially the same terms as the Note. During the first half of 2021, the Company made certain repayments on the outstanding principal balance of the convertible notes. On July 7, 2021, the Company and the holder of the December 18 Note (the “December 18 Note Holder”) entered into an Acknowledgement and Termination Agreement, pursuant to which: (i) the December 18 Note Holder agreed to return to the Company $42,777 in cash (the “Repayment”) previously paid by the Company to the December 18 Note Holder as a payment against the Company’s obligations under the December 18 Note, and (ii) the Company agreed to issue to the December 18 Note Holder an aggregate of 43,664 additional shares of its common stock (the “December 18 Note Shares”) in full satisfaction of our remaining obligations to the December 18 Note Holder under the December 18 Note. The December 18 Note Holder paid the Company the Repayment and the Company issued the December Note Shares, and the December 18 SPA and the December 18 Note terminated, effective July 7, 2021. | ||||||
P P P Loan [Member] | |||||||
Short-term Debt [Line Items] | |||||||
Long-term Debt, Description | On May 4, 2020, the Company qualified for and received a loan pursuant to the Paycheck Protection Program, a program implemented by the U.S. Small Business Administration under the Coronavirus Aid, Relief, and Economic Security Act, from a qualified lender (the “PPP Lender”), for an aggregate principal amount of approximately $147,000 (the “PPP Loan”). The PPP Loan bore interest at a fixed rate of 1.0% per annum, with the first six months of interest deferred, had a term of two years, and was unsecured and guaranteed by the U.S. Small Business Administration. The principal amount of the PPP Loan was subject to forgiveness under the Paycheck Protection Program upon the Company’s request to the extent that the PPP Loan proceeds were used to pay expenses permitted by the Paycheck Protection Program, including payroll costs, covered rent and mortgage obligations and covered utility payments incurred by the Company. The Company applied for and received full forgiveness of the PPP Loan with respect to these covered expenses and recorded a gain on forgiveness of debt during the year ended December 31, 2021 | ||||||
Debt Instrument, Face Amount | $ 147,000 | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 100.00% |
Summary of Warrant Activity (De
Summary of Warrant Activity (Details) - Warrant Derivative Financial Instruments [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Offsetting Assets [Line Items] | ||
Outstanding as of December 31, 2020 | 10,066,000 | 3,584,000 |
Outstanding as of December 31, weighted-average exercise price (in usd per share) | $ 1.84 | $ 3.86 |
Warrants issued | 6,648,000 | |
Warrants issued, warrant exercise price | $ 0.84 | |
Warrants exercised | (7,431,000) | (154,000) |
Warrants exercised, exercise price of warrants | $ 98 | $ 0.30 |
Warrants cancelled | (12,000) | |
Warrants cancelled, exercise price of warrants | $ 18 | |
[custom:ClassOfWarrantOrRightOutstandingWeightedAverageRemaingContractualLife] | 2 years 4 months 24 days | 4 years 4 months 24 days |
Outstanding as of December 31, 2021 | 2,635,000 | 10,066,000 |
Outstanding as of December 31, weighted-average exercise price (in usd per share) | $ 4.29 | $ 1.84 |
Warrants exercisable as of December 31 | 2,635,000 | |
Warrants exercisable, weighted-average exercise price (in usd per share) | $ 4.29 | |
Warrants exercisable as of December 31, 2021, weighted-average remaining contractual life (in years) | 2 years 4 months 24 days |
10. Stockholders' Equity (Detai
10. Stockholders' Equity (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Warrant or Right [Line Items] | |||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |
Preferred Stock, Shares Outstanding | 0 | 0 | |
Common stock, authorized (in shares) | 240,000,000 | 120,000,000 | |
Common stock voting right | Each share of common stock is entitled to one voting right | ||
Proceeds from Warrant Exercises | $ 7,252,000 | $ 45,000 | |
September 2020 Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of shares of common stock issued | 6,648,750 | ||
[custom:WarrantsExercisable-0] | 1,000,000 | ||
August 232019 [Member] | |||
Class of Warrant or Right [Line Items] | |||
Number of shares of common stock issued | 4,475,000 | ||
August 2019 Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
[custom:WarrantsExercisable-0] | 900,000 | ||
September 2020 Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrant description | The September 2020 Warrants are exercisable for 6,648,750 shares of common stock at an exercise price per share equal to $0.84. The September 2020 Warrants became exercisable beginning on March 9, 2021 and will expire on March 9, 2026. | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.84 | ||
Date on which warrants became exercisable | Mar. 9, 2021 | ||
[custom:NumberofWarrantsExercisedDuringPeriod] | 5,600,000 | ||
Proceeds from Warrant Exercises | $ 4,700,000 | ||
August 2019 Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrant description | On August 23, 2019, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company issued and sold an aggregate of | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.78 | ||
Date on which warrants became exercisable | Feb. 27, 2020 | ||
[custom:NumberofWarrantsExercisedDuringPeriod] | 1,300,000 | ||
Proceeds from Warrant Exercises | $ 2,400,000 | ||
Series A Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrant description | The Series A Warrants were initially exercisable for 1,463,519 shares of common stock at an exercise price per share equal to $4.15, which was adjusted several times pursuant to the terms thereof to 3,629,023 shares of common stock at an exercise price per share equal to $0.2957 per share. The most recent adjustment to the exercise price (from $0.60 to $0.2957 per share) occurred during the three months ended September 30, 2020 as a result of the announcement of the offerings pursuant to the September 2020 Securities Purchase Agreement. The Series A Warrants were immediately exercisable upon issuance and will expire on January 31, 2024. | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.2957 | ||
[custom:NumberofWarrantsExercisedDuringPeriod] | 500,000 | 200,000 | |
Proceeds from Warrant Exercises | $ 100,000 | $ 45,000 | |
[custom:WarrantsExercisable-0] | 300,000 |
Schedule of Valuation Assumptio
Schedule of Valuation Assumptions for Stock Options (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum | 50.00% | 30.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum | 120.00% | 170.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3.46 | $ 0.97 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 2,210,000 | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 4.04 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 300,000 | $ 0 |
Share-based Payment Arrangement, Option [Member] | Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Minimum | 118.00% | 109.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | 5 years |
Share-based Payment Arrangement, Option [Member] | Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Maximum | 125.00% | 119.00% |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 6 years | 7 years |
Stock Optionsand Director Options [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Beginning Balance | 5,120,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Beginning Balance | $ 1.97 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 2,316,000 | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 3.94 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | (81,000) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 1.40 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period | (49,000) | |
Share-based Compensation Arrangements by Share-based Payment Award, Options, Forfeitures in Period, Weighted Average Exercise Price | $ 2.06 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 7,306,000 | 5,120,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price, Ending Balance | $ 2.60 | $ 1.97 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 8 years 6 months | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 2,180,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 7,306,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ 2.60 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 8 years 6 months | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 2,180,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 2,245,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ 2.99 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 8 years 1 month 6 days | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ 856,000 |
Schedule of Stock-Based Compens
Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 8,347 | $ 2,044 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 717 | 394 |
General and Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 7,630 | $ 1,650 |
11. Stock-Based Compensation (D
11. Stock-Based Compensation (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,400,000 | ||
Share-based Payment Arrangement, Noncash Expense | $ 8,347,000 | $ 2,044,000 | |
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Description | The Company has the Amended and Restated Apricus 2012 Stock Long Term Incentive Plan (the “2012 Plan”), which provides for the issuance of incentive and non-incentive stock options, restricted and unrestricted stock awards, stock unit awards and stock appreciation rights. Options and restricted stock units granted generally vest over a period of one to four years and have a maximum term of ten years from the date of grant. As of December 31, 2021, an aggregate of 11,110,431 shares of common stock were authorized under the Apricus 2012 Plan, of which 1.4 million shares of common stock were available for future grants. Upon completion of the Merger, the Company assumed the Seelos Therapeutics, Inc. 2016 Equity Incentive Plan (the “2016 Plan”) and awards outstanding under the 2016 Plan became awards for common stock. Effective as of the Merger, no further awards may be issued under the 2016 Plan. | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 11,110,431 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | During the year ended December 31, 2021, the Company granted 2,210,000 stock options to employees with a weighted average exercise price per share of $4.04 and a 10-year term, subject to the terms and conditions of the 2012 Plan above. The stock options are subject to time vesting requirements. The stock options granted to employees vest 25% on the first anniversary of the grant and monthly thereafter over the next three years. | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 2,210,000 | ||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 4.04 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value | $ 300,000 | $ 0 | |
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 7,400,000 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 1 month 6 days | ||
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Description | On May 15, 2020, the Company’s stockholders approved the Company’s 2020 Employee Stock Purchase Plan (the “ESPP”), whereby qualified employees are allowed to purchase limited amounts of the Company’s common stock at the lesser of 85% of the market price at the beginning or end of the offering period. The stockholders authorized an initial amount of 1.0 million shares for purchase by employees under the ESPP. The ESPP provides that an additional number of shares will automatically be added annually to the shares authorized for issuance under the ESPP on January 1st of each year commencing on January 1, 2021 and ending on (and including) January 1, 2030, which amount shall be equal to the lesser of (i) 1% of the number of shares of the Company’s common stock issued and outstanding on the immediately preceding December 31, and (ii) a number of shares of common stock set by the Company’s Board of Directors or the Compensation Committee of the Board of Directors (the “Compensation Committee”) of the Company on or prior to each such January 1. On January 1, 2021, the Company added 545,358 shares for purchase by employees under the ESPP. During the year ended December 31, 2021, the Company sold 80,009 shares under the ESPP. The compensation costs are calculated as the fair value of the 15% discount from market price and were approximately $72,000 for the year ended December 31, 2021. | ||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 0.85% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,000,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Description and Terms | On January 1, 2021, the Company added 545,358 shares for purchase by employees under the ESPP. | ||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 80,009 | ||
Stock Issued During Period, Value, Employee Stock Purchase Plan | $ 72,000 | ||
Inducement Planof 2019 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Description | On July 28, 2019, the Compensation Committee adopted the Seelos Therapeutics, Inc. 2019 Inducement Plan (the “2019 Inducement Plan”), which became effective on August 12, 2019. The 2019 Inducement Plan is substantially similar to the 2016 Plan. The 2019 Inducement Plan provides for the grant of equity-based awards in the form of stock options, stock appreciation rights, restricted stock, unrestricted stock, stock units, including restricted stock units, performance units and cash awards, solely to prospective employees of the Company or an affiliate of the Company provided that certain criteria are met. Awards under the 2019 Inducement Plan may only be granted to an individual, as a material inducement to such individual to enter into employment with the Company, who (i) has not previously been an employee or director of the Company or (ii) is rehired following a bona fide period of non-employment with the Company. The maximum number of shares available for grant under the 2019 Inducement Plan is 1,000,000 shares of the Company’s common stock. The 2019 Inducement Plan is administered by the Compensation Committee and expires on August 12, 2029. | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,000,000 | ||
Performance Shares [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | During the year ended December 31, 2021, the Company also granted | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 106,000 | ||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 1.67 | ||
Performance Shares [Member] | P S Uto Executives [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Terms of Award | During the year ended December 31, 2021, the Company’s Board of Directors awarded a performance stock unit award to the Company’s Chief Executive Officer for 2,400,000 shares of common stock, with a grant date fair value of $4.31 per unit. Vesting of this award is subject to the Company achieving certain performance criteria established at the grant date and the individual fulfilling a service condition (continued employment). As of December 31, 2021, all performance stock unit awards are unvested and three of the five performance conditions have been satisfied. The Company recognized stock-based compensation related to this award of $4.9 million during the fourth quarter of 2021, which was recorded in general and administrative expense. The Company does not believe that the achievement of the remaining two performance criteria is probable at this time. Unrecognized compensation expense will be recognized only once the performance condition is probable of being achieved and only for the cumulative amount related to the service condition that has been fulfilled. As of December 31, 2021, the Company had $1.3 million of unrecognized compensation expense related to performance conditions considered probable which will be recognized over 0.2 years. As of December 31, 2021, the Company had unrecognized compensation expense of $4.1 million for performance conditions that were considered not probable of achievement. | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 months 12 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 2,400,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 4.31 | ||
Share-based Payment Arrangement, Noncash Expense | $ 4,900,000 | ||
Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount | $ 1,300,000 | ||
Share-based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized for Performance Not Probable, Amount | $ 4,100,000 |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
Net operating tax loss carryforwards | $ 30,751 | $ 15,223 |
Accrued expenses | 66 | |
Contingent payment obligations | 407 | |
Stock-based compensation | 3,208 | 521 |
Intangible assets | 16,970 | 12,320 |
Total deferred tax asset | 51,336 | 28,130 |
Less valuation allowance | (51,336) | (28,130) |
Net deferred tax asset |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory tax rate | 2100.00% | 2100.00% |
State and local taxes, net of federal benefit | 1290.00% | 1120.00% |
Permanent items | (110.00%) | (100.00%) |
Deferred rate changes | 230.00% | 10.00% |
Other | 0.00% | 5930.00% |
Change in valuation allowance | (3510.00%) | (9060.00%) |
Income tax provision (benefit) |
12. Income Taxes (Details Narra
12. Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Noncurrent deferred tax asset, gross | $ 30,800,000 | $ 15,200,000 |
Open Tax Year | 2018 | |
Tax examination penalties and interest expense | $ 0 | $ 0 |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforward | 89,400,000 | |
Deferred Tax Assets, Operating Loss Carryforwards, Subject to Expiration | $ 400,000 | |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2036 | |
Deferred Tax Assets, Operating Loss Carryforwards, Not Subject to Expiration | $ 89,000,000 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforward | $ 175,500,000 | |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2036 |
Schedule of future minimum oper
Schedule of future minimum operating lease payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remaining Period Ended December 31, 2021 | |
Year Ended December 31, 2022 | 40 |
Total | 40 |
Less present value discount | (2) |
Operating lease liabilities | $ 38 |
13. Commitments and Contingen_3
13. Commitments and Contingencies (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | |
Lessee, Lease, Description [Line Items] | |||
Operating Lease, Right-of-Use Asset | $ 39,000 | $ 74,000 | |
Operating Lease, Liability | $ 38,000 | ||
Operating Lease, Weighted Average Remaining Lease Term | 292 days | ||
Operating Lease, Weighted Average Discount Rate, Percent | 800.00% | ||
Operating Lease, Expense | $ 100,000 | $ 100,000 | |
March 2019 Lease [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Lessee, Operating Lease, Description | In March 2019, the Company entered into a nine-month office space rental agreement for its headquarters in New York, New York expiring November 2019. In November 2019 the Company renewed this rental agreement for an additional twelve-months for a base rent of approximately $9,000 per month. In November 2020, the Company renewed this rental agreement for an additional twelve-months for a base rent of approximately $3,800 per month. In March 2021, the Company was notified that the counterparty’s right to occupy the space at 300 Park Avenue, New York, NY was terminated, and the Company was required to vacate by March 26, 2021. The Company vacated the premises and has advised the counterparty that the counterparty is in breach of this rental agreement and therefore, the Company has no further obligations thereunder. | ||
March 2021 Lease [Member] | |||
Lessee, Lease, Description [Line Items] | |||
Lessee, Operating Lease, Description | In March 2021, the Company entered into an eighteen-month office space rental agreement for its headquarters at 300 Park Avenue, New York, NY, expiring July 2022. The rental agreement contains a base rent of approximately $4,000 per month. | ||
Lessee, Operating Lease, Option to Extend | This agreement includes one or more renewal options. | ||
Operating Lease, Right-of-Use Asset | $ 39,000 | ||
Operating Lease, Liability | $ 38,000 |
14. Subsequent Events (Details
14. Subsequent Events (Details Narrative) - USD ($) $ in Millions | 1 Months Ended | |
Jan. 31, 2022 | Nov. 30, 2021 | |
I X License Agreement [Member] | ||
Business Combination, Separately Recognized Transactions [Line Items] | ||
[custom:NonrefundableCashPayment] | $ 1.2 | $ 3.5 |