Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 21, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 000-22245 | ||
Entity Registrant Name | SEELOS THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Tax Identification Number | 87-0449967 | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 13,680,576 | ||
Entity Public Float | $ 144.9 | ||
Entity Central Index Key | 0001017491 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | KPMG LLP | ||
Auditor Firm ID | 185 | ||
Auditor Location | Short Hills, NJ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash | $ 2,996 | $ 15,533 |
Grant receivable | 763 | |
Prepaid expenses and other current assets | 1,644 | 7,141 |
Total current assets | 5,403 | 22,674 |
Operating lease right-of-use asset | 15 | 72 |
Total assets | 5,418 | 22,746 |
Current liabilities | ||
Accounts payable | 16,403 | 3,626 |
Accrued expenses | 2,516 | 7,282 |
Licenses payable | 2,195 | |
Short-term portion of convertible notes payable, at fair value | 14,213 | 11,865 |
Warrant liabilities, at fair value | 5,781 | 132 |
Operating lease liability | 15 | 58 |
Total current liabilities | 38,928 | 25,158 |
Convertible notes payable, at fair value | 8,184 | |
Operating lease liability, long-term | 15 | |
Total liabilities | 38,928 | 33,357 |
Commitments and contingencies (note 13) | ||
Stockholders' equity (deficit) | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2023 and December 31, 2022 | ||
Common stock, $0.001 par value, 16,000,000 and 8,000,000 shares authorized, 9,794,594 and 3,572,417 issued and outstanding as of December 31, 2023 and December 31, 2022, respectively (note 1) | 10 | 4 |
Additional paid-in-capital | 219,106 | 204,129 |
Accumulated deficit | (252,626) | (214,744) |
Total stockholders' equity (deficit) | (33,510) | (10,611) |
Total liabilities and stockholders' equity (deficit) | $ 5,418 | $ 22,746 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Preferred stock, par 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) | 16,000,000 | 8,000,000 |
Common stock, issued (in shares) | 9,794,594 | 3,572,417 |
Common stock, outstanding (in shares) | 9,794,594 | 3,572,417 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue | ||
Total revenue | $ 2,203 | |
Revenue, Product and Service [Extensible Enumeration] | us-gaap:GrantMember | us-gaap:GrantMember |
Operating expense | ||
Research and development | $ 30,117 | $ 58,620 |
General and administrative | 12,585 | 12,296 |
Total operating expense | 42,702 | 70,916 |
Loss from operations | (40,499) | (70,916) |
Other income (expense) | ||
Interest income | 198 | 121 |
Interest expense | (75) | (14) |
Change in fair value of convertible notes | (2,049) | (3,017) |
Loss on extinguishment of debt | (9,151) | |
Loss on issuance of common stock and warrants | (4,301) | |
Change in fair value of warrant liabilities | 17,995 | 292 |
Total other income (expense) | 2,617 | (2,618) |
Net loss and comprehensive loss | $ (37,882) | $ (73,534) |
Total loss per share basic (note 1) | $ (7.73) | $ (20.74) |
Total loss per share-diluted (note 1) | $ (7.73) | $ (20.74) |
Weighted-average common shares outstanding used for basic (note 1) | 4,900,222 | 3,545,691 |
Weighted-average common shares outstanding used for diluted (note 1) | 4,900,222 | 3,545,691 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning balance (note 1), value at Dec. 31, 2021 | $ 4 | $ 198,529 | $ (141,210) | $ 57,323 |
Beginning Balance (note 1) (in shares) at Dec. 31, 2021 | 3,516,817 | |||
Stock-based compensation expense | 5,073 | 5,073 | ||
Issuance of common stock, options exercised | 8 | $ 8 | ||
Issuance of common stock, options exercised (in shares) | 209 | 209 | ||
Agreement to repurchase common stock | (740) | $ (740) | ||
Issuance of common stock for prepaid services | 167 | 167 | ||
Issuance of common stock for prepaid services (in shares) | 6,668 | |||
Issuance of common stock for license acquired | 841 | 841 | ||
Issuance of common stock for license acquired (in shares) | 33,334 | |||
Issuance of common stock in at-the-market offering, net of issuance costs | 152 | 152 | ||
Issuance of common stock, ESPP | 99 | 99 | ||
Issuance of common stock, net of issuance costs (in shares) | 3,720 | |||
Issuance of common stock for settlement of debt (in shares) | 11,669 | |||
Net loss | (73,534) | (73,534) | ||
Ending balance, value at Dec. 31, 2022 | $ 4 | 204,129 | (214,744) | $ (10,611) |
Ending Balance (in shares) at Dec. 31, 2022 | 3,572,417 | 3,572,417 | ||
Stock-based compensation expense | 3,988 | $ 3,988 | ||
Issuance of common stock, options exercised (in shares) | 2,528 | 0 | ||
Issuance of common stock for prepaid services | 190 | $ 190 | ||
Issuance of common stock for prepaid services (in shares) | 8,334 | |||
Issuance of common stock in at-the-market offering, net of issuance costs | 68 | 68 | ||
Issuance of common stock, ESPP | 97 | 97 | ||
Issuance of common stock, ESPP (in shares) | 4,971 | |||
Repurchase and retirement of common stock (in shares) | (33,334,000) | |||
Issuance of common stock for payment of convertible notes payable | 5,139 | 5,139 | ||
Issuance of common stock for payment of convertible notes payable (in shares) | 455,425 | |||
Issuance of common stock, warrant exercise | $ 3 | 7 | 10 | |
Issuance of common stock, warrant exercise (in shares) | 3,067,008 | |||
Issuance of common stock and warrants | $ 3 | 4,478 | 4,481 | |
Issuance of common stock and warrants (in shares) | 2,683,911 | |||
Issuance of common stock for convertible note amendment | 1,010 | 1,010 | ||
Issuance of common stock for convertible note amendment (in shares) | 33,334 | |||
Net loss | (37,882) | (37,882) | ||
Ending balance, value at Dec. 31, 2023 | $ 10 | $ 219,106 | $ (252,626) | $ (33,510) |
Ending Balance (in shares) at Dec. 31, 2023 | 9,794,594 | 9,794,594 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (37,882) | $ (73,534) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 3,988 | 5,073 |
Change in fair value of warrant liability | (17,995) | (292) |
Change in fair value of convertible notes payable | 2,049 | 3,017 |
Research and development expense - license amendment | 1,296 | |
Loss on issuance of common stock and warrants | 4,301 | |
Amortization of right-of-use asset | 57 | 53 |
Net loss on extinguishment of debt | 9,151 | |
Changes in operating assets and liabilities | ||
Grant receivable | (763) | |
Prepaid expenses and other current assets | 5,687 | (2,247) |
Accounts payable | 12,777 | 1,933 |
Accrued expenses | (4,224) | 3,522 |
Derivative liability | (1,174) | |
Lease liability | (58) | (51) |
Licenses payable | (1,000) | 800 |
Net cash used in operating activities | (23,912) | (61,604) |
Cash flows (used in) provided by financing activities | ||
Payment on convertible notes | (7,641) | (1,888) |
Proceeds from issuance of common stock and warrants | 20,046 | |
Proceeds from issuance of common stock in at-the-market offering | 68 | 457 |
Payment of deferred offering costs | (273) | |
Payment for repurchase of common stock | (1,195) | |
Proceeds from exercise of options | 8 | |
Proceeds from sales of common stock under ESPP | 97 | 99 |
Net cash provided by (used in) financing activities | 11,375 | (1,597) |
Net (decrease) increase in cash | (12,537) | (63,201) |
Cash, beginning of period | 15,533 | 78,734 |
Cash, end of period | 2,996 | 15,533 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 505 | 11 |
Non-cash investing and financing activities: | ||
Fair value of warrants issued | 17,415 | |
Fair value of warrants issued in extinguishment of convertible notes | 3,247 | |
Increase in principal in extinguishment of convertible notes | 4,882 | |
Issuance of common stock for license payable | 840 | |
Deferred offering costs, accrued but not paid | 541 | 32 |
Issuance of common stock for cashless exercise | 2,000 | |
Issunce of common stock for modification of convertible debt | 1,010 | |
Issuance of common stock for principal payments on convertible notes | 4,538 | |
Issuance of common stock for interest payments on convertible notes | $ 601 | |
Right-of-use asset obtained in exchange for operating lease liabilites | 86 | |
Repurchase of common stock, accrued but not paid | $ 1,195 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Seelos Therapeutics, Inc. (together with 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 and SLS-007 for the potential treatment of Parkinson’s Disease (“PD”). On March 29, 2023, the Company announced that it plans to focus the majority of its resources on the Phase II study of SLS - 002 for ASIB in MDD and the fully enrolled Phase II/III study of SLS - 005 in ALS. The Company further announced that it has temporarily paused additional enrollment of patients in the SLS - 005 - 302 study in SCA. Patients already enrolled will continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future. The Company also announced that it is pausing all non - essential preclinical work. Reverse Stock Split On November 27, 2023, the Company filed a Certificate of Change with the Secretary of State of the State of Nevada to (i) effect a 1 - for - 30 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. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) asset, operating lease liability, current and operating lease liability, long-term in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liability represents its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of the lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if it borrowed on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. 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. The carrying amounts of financial instruments such as grant receivables, prepaid expenses, other current assets, accounts payable and accrued expenses approximate their related fair values due to the short - term nature of these instruments. Grant Revenue Revenue from grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as Grant receivable, in the Consolidated Balance Sheet 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, performance-based restricted stock unit awards and stock options that would result in the issuance of incremental shares of common stock. For warrants that are liability-classified, during periods when the impact is dilutive, the Company assumes share settlement of the instruments as of the beginning of the reporting period and adjusts the numerator to remove the change in fair value of the warrant liability and adjusts the denominator to include the dilutive shares calculated using the treasury stock method. The following potentially dilutive securities outstanding for the year ended December 31, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Year Ended December 31, 2023 2022 Outstanding stock options 511 347 Outstanding warrants 5,280 85 Convertible debt 77 123 5,868 555 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 August 2020, the FASB issued Accounting Standards Update (“ASU”) No. 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 the Company beginning after January 1, 2024, 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 has decided to early adopt the provisions of this ASU as of January 1, 2023 and the Company does not expect the adoption of ASU 2020-06 to have an impact on its consolidated financial statements and related disclosures. In June 2022, the FASB issued ASU No. 2022-03: ASC Subtopic 820 - Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”). ASU 2022-03 amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in ASU 2022-03 are effective for the Company for fiscal years beginning after December 15, 2023, and the interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures. |
Liquidity and Going Concern
Liquidity and Going Concern | 12 Months Ended |
Dec. 31, 2023 | |
Liquidity and Going Concern | |
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 generated 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, 2023, the Company had $3.0 million in cash and an accumulated deficit of $252.6 million. The Company has historically funded its operations through the issuance of convertible notes (see Note 9), the sale of common stock (see Note 6) and the exercise of warrants (see Note 10). On November 21, 2022, the Company received a written notice from Nasdaq indicating that, for the last thirty ten On November 1, 2023, the Company received an additional written notice from Nasdaq indicating that, for the last thirty provided an initial period of 180 calendar days, or until April 29, 2024, to regain compliance. On January 12, 2024, the Company received a letter from Nasdaq notifying the Company that it regained full compliance with Rule 5550 (a) (2) as of December 13, 2023, after the closing bid price of the Company’s common stock had been at $1.00 per share or greater for 11 consecutive business days from November 28, 2023 through December 12, 2023. In addition, on November 2, 2023, the Company received an additional written notice from Nasdaq indicating that, for the last thirty - two consecutive business days, the market value of the Company’s listed securities has been below the minimum requirement of $35 million for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550 (b) (2) (“Rule 5550 (b) (2)”). In accordance with Nasdaq Listing Rule 5810 (c) (3) (C), the Company has been provided a period of 180 calendar days, or until April 30, 2024, to regain compliance. The Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5550 (b) (2) if at any time before April 30, 2024, the market value of the Company’s common stock closes at $35 million or more for a minimum of ten consecutive business days. There can be no assurances that the Company will be able to regain compliance with Nasdaq’s minimum market value of listed securities rule or that the Company will otherwise be in compliance with the other listing standards for the Nasdaq Capital Market. If the Company does not regain compliance with Rule 5550 (b) (2) by April 30, 2024, the Company will receive written notification that its securities are subject to delisting. In the event the Company receives any such notification, the Company may appeal the Nasdaq staff’s determination to delist its securities, but there can be no assurances that the Nasdaq staff would grant any request for continued listing. On November 27, 2023, the Company filed a Certificate of Change (the “Certificate of Change”) with the Secretary of State of the State of Nevada to (i) effect a 1 Pursuant to the Company’s shelf registration statement on Form S - 3 (File No. 333 - 276119) filed with the SEC on December 18, 2023 and declared effective on December 27, 2023 (the “Registration Statement”), the Company may offer from time to time any combination of debt securities, common and preferred stock, warrants, units and rights. As of December 31, 2023, the Company had $250.0 million available under the Registration Statement. The Company also has the ability to raise funds through other means, such as through the filing of a registration statement on Form S - 1 or in private placements. The rules and regulations of the SEC or any other regulatory agencies may restrict the Company’s ability to conduct certain types of financing activities or may affect the timing of and amounts it can raise by undertaking such activities. 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 date of filing 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, 2023 are not sufficient to satisfy its operating cash needs for at least one year and that there is substantial doubt of its ability to continue as a going concern within one year The Company’s future liquidity and capital funding requirements will depend on numerous factors, including: ● its ability to raise additional funds to finance its operations; ● its ability to maintain compliance with the listing requirements of the Nasdaq Capital Market; ● the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates; ● potential litigation expenses; ● the emergence and effect of competing or complementary products or product candidates; ● its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; ● its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; ● the terms and timing of any collaborative, licensing, or other arrangements that it has or may establish; ● the trading price of its common stock; and ● its ability to increase the number of authorized shares as may be required to facilitate future financing events. 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. |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2023 | |
Business Combination | |
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 or the CVR in the acquisition accounting as of December 31, 2023. |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurement | |
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. There were no other transfers between fair value measurement levels during the years ended December 31, 2023 and 2022 (in thousands): Fair Value Measurements as of December 31, 2023 (Level 1) (Level 2) (Level 3) Total Assets: Cash $ 2,996 $ — $ — $ 2,996 Liabilities: Convertible notes payable, at fair value $ — $ — $ 14,213 $ 14,213 Warrant liabilities, at fair value — — 5,781 5,781 $ — $ — $ 19,994 $ 19,994 Fair Value Measurements as of December 31, 2022 (Level 1) (Level 2) (Level 3) Total Assets: Cash $ 15,533 $ — $ — $ 15,533 Liabilities: Convertible notes payable, at fair value $ — $ — $ 20,049 $ 20,049 Warrant liabilities, at fair value — — 132 132 $ — $ — $ 20,181 $ 20,181 The Company measures the 2021 Convertible Notes 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. These valuations use assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company assesses these assumptions and estimates on an on-going basis as additional data impacting the assumptions and estimates are obtained. Changes in the fair value of the 2021 Convertible Notes and warrant liabilities related to updated assumptions and estimates are recognized within the Consolidated Statements of Operations and Comprehensive Loss. The fair value of the 2021 Convertible Notes 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. 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, 2023 and 2022: December 31, 2023 December 31, 2022 Risk-free interest rate 4.89 % 4.24 % Volatility 125 % 105 % Dividend yield — % — % Contractual term (years) 0.9 1.9 Stock price $ 1.39 $ 20.40 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, 2023 and 2022: December 31, 2023 December 31, 2022 Risk-free interest rate 3.85% - 5.60 % 4.71 % Volatility 123% - 127 % 91.90 % Dividend yield — % — % Expected term (years) 0.07 4.91 1.07 Weighted-average fair value $ 1.10 $ 13.20 The following table is a reconciliation for the common stock warrant liabilities and convertible notes measured at fair value using Level 3 unobservable inputs (in thousands): Convertible notes, at fair Warrant liabilities Derivative liability value Balance as of December 31, 2021 $ 424 $ 1,174 $ 18,920 Settlement of derivative liability — (1,174) — Principal payment of convertible notes, at fair value — — (1,888) Issuance of derivative liability — — — Change in fair value measurement of derivative liability — — — Change in fair value measurement of convertible notes — — 3,017 Change in fair value measurement of warrant liability (292) — — Balance as of December 31, 2022 $ 132 $ — $ 20,049 Principal payment of convertible notes, at fair value — — (11,695) Interest payment of convertible notes, at fair value — — (1,085) Issuance of convertible note — — 4,882 Loss on extinguishment of debt — — 13 Change in fair value measurement of convertible notes — — 2,049 Fair value of warrants issued 25,644 — — Warrant exercised (2,000) — — Change in fair value measurement of warrant liability (17,995) — — Balance as of December 31, 2023 $ 5,781 $ — $ 14,213 For the years ended December 31, 2023 and 2022, the changes in fair value of the convertible notes and warrant liability primarily resulted from the volatility of the Company’s common stock and the change in risk-free interest rates. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets. | |
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): December 31, December 31, 2023 2022 Prepaid insurance $ 51 $ 104 Prepaid clinical costs 1,516 6,837 Other 77 200 Prepaid expenses and other current assets $ 1,644 $ 7,141 |
Common Stock Offerings
Common Stock Offerings | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock Offerings | |
Common Stock Offerings | 6. Common Stock Offerings Open Market Sale Agreement On May 12, 2022, the Company entered into an Open Market Sale Agreement SM March 2023 Registered Direct Offering On March 10, 2023, the Company entered into the March 2023 Securities Purchase Agreement, pursuant to which the Company issued and sold an aggregate of 401,977 shares of common stock, pre - funded warrants exercisable for an aggregate of 311,357 shares of common stock (the “March 2023 Pre - Funded Warrants”) and accompanying common stock warrants exercisable for an aggregate of 891,668 shares of common stock (“March 2023 Common Warrants” and together with the March 2023 Pre - Funded Warrants, the “March 2023 Warrants”) in the March 2023 RDO, resulting in total net proceeds of $10.4 million, after deducting financial advisor fees and other offering expenses. The securities were offered by the Company pursuant to the Prior Registration Statement. The March 2023 Pre - Funded Warrants were exercisable immediately upon issuance and had an exercise price of $0.03 per share of common stock. During the quarter ended September 30, 2023, all of the Pre - Funded Warrants were exercised in full on a cashless basis, and no March 2023 Pre - Funded Warrants remain outstanding. The March 2023 Common Warrants have an exercise price of $18.00 per share of common stock, became exercisable on September 11, 2023, and will expire on September 10, 2028. The combined purchase price for one share and one accompanying March 2023 Common Warrant to purchase 1.25 shares of common stock in the March 2023 RDO was $15.75 and the combined purchase price for one March 2023 Pre - Funded Warrant and one accompanying March 2023 Common Warrant to purchase 1.25 shares of common stock in the March 2023 RDO was $15.72. The closing of the March 2023 RDO occurred on March 14, 2023. On May 19, 2023, the Company entered into the 2023 Purchase Agreement Amendment pursuant to which the Investor agreed to, among other things, waive certain restrictions on issuing and registering shares of common stock contained within the 2023 Securities Purchase Agreement to permit the Company to make the May Through September Payments (as defined below) in a combination of cash and shares of common stock as contemplated in the 2021 Note Amendment (as defined below). In consideration for entering into the 2023 Purchase Agreement Amendment, on May 19, 2023, the Company issued to the Investor warrants to purchase up to an aggregate of 133,333 shares of common stock. The exercise price of the May 2023 Warrants is $31.80 per share, subject to adjustment as provided therein, and the May 2023 Warrants will be exercisable beginning on November 19, 2023 and will expire on November 20, 2028. The fair value of these warrants upon issuance was $3.2 million and such amount is included within loss on extinguishment of debt on the consolidated statement of operations and comprehensive loss. September 2023 Registered Direct Offering On September 21, 2023, The Company entered into the September 2023 Securities Purchase Agreement with certain Purchasers, pursuant to which the Company agreed to issue and sell 500,000 shares (the “Shares”) of its common stock and accompanying common stock warrants to purchase up to 333,667 shares of common stock in a registered direct offering. The Shares and the September 2023 Warrants were offered by the Company pursuant to its Prior Registration Statement. The exercise price of the September 2023 Warrants was $9.75 per share, subject to adjustment as provided therein, and the September 2023 Warrants were immediately exercisable upon issuance and expire on the date that is five years following the original issuance date. In addition, the September 2023 Warrants contained an alternative “cashless exercise” provision whereby a September 2023 Warrant could be exchanged cashlessly for shares of common stock at the rate of 0.999 of a share of common stock per full share otherwise issuable upon a cash exercise. The fair value of the September 2023 Warrants upon issuance was $1.9 million and such amount was included within warrant liabilities, at fair value on the consolidated balance sheets. On September 26, 2023 and September 27, 2023, the holders of the September 2023 Warrants elected to cashlessly exchange their September 2023 Warrants in full for an aggregate issuance of 74,075 and 259,260 shares of common stock, respectively, and, thereafter, no September 2023 Warrants remain outstanding. As a result of the exercise of the September 2023 Warrants the Company recognized a $0.1 million expense within change in fair value of warrant liabilities on the consolidated statement of operations and comprehensive loss. December 2023 Underwritten Public Offering Pursuant to the Underwriting Agreement with Titan, on December 1, 2023, the Company sold, in an underwritten public offering (i) 1,781,934 shares of its common stock, (ii) December 2023 Pre-Funded Warrants to purchase 2,422,612 shares of common stock and (iii) accompanying December 2023 Common Warrants to purchase up to 4,204,546 shares of common stock. The combined public offering price for each share of common stock and accompanying December 2023 Common Warrant to purchase one share of common stock was $1.32 and the combined public offering price for each share of common stock subject to a December 2023 Pre-Funded Warrant and accompanying December 2023 Common Warrant to purchase one share of common stock was $1.319. The net proceeds to the Company were approximately $5 million, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by us. The December 2023 Pre-Funded Warrants were exercisable immediately and had an exercise price of $0.001 per share. As of December 31, 2023, the December 2023 Pre-Funded Warrants have been exercised in full. The per share exercise price for the December 2023 Common Warrants is $1.32, subject to adjustment as provided therein. The December 2023 Common Warrants were exercisable immediately and expire on December 1, 2028. Each holder of a December 2023 Common Warrant does not have the right to exercise any portion of its December 2023 Common Warrant if the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the purchaser, 9.99%) of the number of shares of the common stock outstanding immediately after giving effect to such exercise (the “Common Warrant Beneficial Ownership Limitation”); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Common Warrant Beneficial Ownership Limitation, but not to above 9.99%. The exercise price and number of shares of common stock issuable upon the exercise of the December 2023 Common Warrants is subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the December 2023 Common Warrants. If a registration statement covering the issuance of the shares of common stock issuable upon exercise of the December 2023 Common Warrants is not available for the issuance, then the holders may exercise the Common Warrants by means of a “cashless exercise.” 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 million, comprised of $3.5 million in cash and 85,676 restricted shares of the Company’s common stock. Pursuant to the iXBEL Stock Purchase Agreement, the Company agreed to reimburse iXBEL for the difference in value (the “Shortfall Amount”) in the event the aggregate value of the 85,676 shares of the Company’s common stock at the time of registration and issuance was less than $5.5 million. The initial fair value of this Shortfall Amount was $0.8 million and in January 2022, the Company settled the Shortfall Amount by the payment of $1.2 million in cash to iXBEL. 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 79,156 shares of STI’s common stock, which converted pursuant to the exchange ratio in the Merger into the right to receive 60,981 shares of the Company’s common stock and (ii) issued warrants representing the right to acquire 48,784 shares of common stock at a price per share of $124.50, subject to adjustment as provided therein (the “Series A Warrants”), most recently adjusted to a price per share of $4.4705 per share, and additional warrants initially representing the right to acquire no shares of common stock at a price per share of $0.03, 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 the liability exceed 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 120,968 (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, 2023, 10,081 Series A Warrants remain unexercised. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
License Agreements | |
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 26,709 shares of common stock to Ligand and recognized research and development expense totaling approximately $2.2 million during the three months ended March 31, 2019 for the License Agreement. 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 Parkinson’s Disease (“PD”) or Restless Leg Syndrome, consisting of (i) $750,000 upon submission of an application with the FDA or equivalent foreign body for a particular Licensed Product, (ii) $3.0 million upon FDA approval of an application for a particular Licensed Product, (iii) $1.125 million upon regulatory approval in a Major Market for a particular Licensed Product, and (iv) $1.125 million upon regulatory approval in a second Major Market for a particular Licensed Product. 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 upon submission of an application with the FDA or equivalent foreign body for such a particular Licensed Product, (ii) $350,000 upon FDA approval of an application for such a particular Licensed Product, (iii) $125,000 upon regulatory approval in a Major Market for such a particular Licensed Product, and (iv) $125,000 upon regulatory approval in a second Major Market for such a particular Licensed Product. 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 million upon the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore, (ii) $10.0 million upon the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist, (iii) $10.0 million upon the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon 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), (iv) $10.0 million upon the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists, (v) $20.0 million upon the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore, (vi) $20.0 million upon the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist, (vii) $20.0 million upon the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon 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), and (viii) $20.0 million upon the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists. 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 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 milestone payments have been accrued at December 31, 2023. Acquisition of Assets from Phoenixus AG f/k/a Vyera Pharmaceuticals, AG and Turing Pharmaceuticals AG (“Vyera”) On April 8, 2022, Seelos Corporation (“STI”), a wholly-owned subsidiary of the Company, and Vyera, entered into an amendment (the “Amendment”) to the Asset Purchase Agreement by and between STI and Vyera, dated March 6, 2018 (as amended by a first amendment thereto entered into on May 18, 2018, a second amendment thereto entered into on December 31, 2018, a third amendment thereto entered into on October 15, 2019 and a fourth amendment thereto entered into on February 15, 2021, the “Vyera Purchase Agreement”). Pursuant to the Vyera Purchase Agreement, STI acquired the assets and liabilities of Vyera related to a product candidate currently referred to as SLS-002 (intranasal ketamine) (the “Vyera Assets”) and agreed, among other things, to make certain development and commercialization milestone payments and royalty payments related to the Vyera Assets (the “Milestone and Royalty Payment Obligations”) and further agreed that in the event that the Company sold, directly or indirectly, all or substantially all of the Vyera Assets to a third party, then the Company would pay Vyera an amount equal to 4% of the net proceeds actually received by the Company as an upfront payment in such sale (the “Change of Control Payment Obligation”). Pursuant to the Vyera Purchase Agreement, as amended by the Amendment, STI agreed to (i) make a cash payment to Vyera in the aggregate amount of $4.0 million on or before April 8, 2022 (the “Cash Payment”); (ii) issue to Vyera on or before April 11, 2022 16,667 shares of the Company’s common stock (the “Initial Shares”); (iii) issue to Vyera on or before July 11, 2022 an additional 16,667 shares of the Company’s common stock (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like) (the “July 2022 Shares”); and (iv) issue to Vyera on or before January 11, 2023 an additional number of shares of the Company’s common stock equal to $1.0 million divided by the volume weighted average closing price of the Company’s common stock for the ten consecutive trading days ending on the fifth trading day prior to the applicable date of issuance of the shares of the Company’s common stock (the “January 2023 Shares”, and together with the Cash Payment, the Initial Shares and the July 2022 Shares, the “Final Payments”). In consideration for the Final Payments, all of STI’s contingent payment obligations under the Vyera Purchase Agreement, including the Milestone and Royalty Payment Obligations and the Change of Control Payment Obligation, as well as all commercialization covenants of STI under the Vyera Purchase Agreement, will terminate in full upon the date that all of the Final Payments have been made. On December 22, 2022, the Company entered into a Share Repurchase Agreement (the “Repurchase Agreement”) with Vyera, pursuant to which the Company agreed to repurchase the 16,667 Initial Shares and the 16,667 July 2022 Shares previously issued to Vyera for an aggregate purchase price of $1.2 million in January 2023. The Company paid the $4.0 million Cash Payment and issued the 16,667 Initial Shares to Vyera in April 2022. The Company issued the 16,667 July 2022 Shares to Vyera in July 2022, and subsequently agreed to repurchase the Initial Shares and the July 2022 Shares in January 2023 pursuant to the Repurchase Agreement on December 22, 2022. The Company recognized $5.8 million in research and development expense during the three months ended June 30, 2022 related to the Amendment, which consisted of the initial cash payment of $4.0 million and $0.8 million for the Initial Shares and the July 2022 Shares, which were measured at their grant-date fair value. The Company also recognized a liability of $1.0 million related to the January 2023 Shares within accrued licenses payable. The Company recognized a liability of $1.2 million related to the Repurchase Agreement, as well as $0.5 million in research and development expense for the premium paid for the repurchased shares. On January 3, 2023, the Company paid $1.2 million in cash to Vyera under the Repurchase Agreement to repurchase the Initial Shares and the July 2022 Shares. On January 10, 2023, STI entered into Amendment No. 6 to the Vyera Purchase Agreement (“Amendment No. 6”) with Vyera, pursuant to which, STI agreed to make two cash payments to Vyera of $500,000 each on January 31, 2023 and February 28, 2023, in lieu of issuing the January 2023 Shares to Vyera. The Company paid the $500,000 cash payments on each of January 31, 2023 and February 28, 2023 in satisfaction of all Final Payments under the Vyera Purchase Agreement. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. 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 million on January 2, 2022. The Company paid the required $0.1 million on January 2, 2020, $0.125 million on January 2, 2021, and $0.2 million on January 3, 2022. 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, (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. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. 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 million in cash, and the Company paid to Bioblast an additional $2.0 million in February 2020. Accordingly, the Company recognized a $3.5 million charge to research and development expense during the year ended December 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. On July 15, 2019, TSF and the Company amended the agreement whereby the Company agreed to assume responsibility for a 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. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. 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 central nervous system (“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 year ended December 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 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. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. 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 SNCA gene, which encodes α-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 year ended December 31, 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. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. 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 WafermineTM 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. As consideration for the license under the iX License Agreement, the Company agreed to (i) pay iXBEL an upfront fee of $9.0 million, comprised of $3.5 million in cash and 85,676 restricted shares of its common stock; (ii) pay certain development, regulatory and commercial milestones, which, if achieved, aggregate to a total of $239.0 million; and (iii) pay royalty payments of ten percent on net sales, if any, as further set out in the iX License Agreement. 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 85,676 shares of its common stock issued to iXBEL pursuant to the iXBEL Stock Purchase Agreement was less than $5.5 million. The Shortfall Amount could be paid in cash, additional shares of common stock or a combination of both. As of December 31, 2021, the Company calculated the Shortfall Amount to be $1.2 million. The Company paid the Shortfall Amount of $1.2 million to iXBEL in cash in January 2022. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at December 31, 2023. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses | |
Accrued Expenses | 8. Accrued Expenses Accrued expenses are comprised of the following (in thousands): December 31, December 31, 2023 2022 Professional fees $ 250 $ 278 Personnel related 56 1,288 Outside research and development services 2,152 5,627 Other 58 89 Accrued expenses, net $ 2,516 $ 7,282 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt | |
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 bore no interest until the first anniversary of the issuance of the 2021 Note and thereafter bore interest at a rate of 5% per annum until October 1, 2023 when the 2021 Note began to bear interest at an annual rate of 12% per annum and is set to mature on November 23, 2024 (the “Maturity Date”), and (ii) 17,826 shares of Company common stock. Commencing August 23, 2022, and from time to time and before the Maturity Date, Lind V has 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 $180.00, subject to adjustment for stock splits, reverse stock splits, stock dividends and similar transactions (the “Conversion Price”). Commencing August 23, 2022, the Company has 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. However, pursuant to the 2023 Securities Purchase Agreement, the Company agreed that, until September 21, 2023, except for the May Through September Payments (as defined below) made by the Company to Lind under the 2021 Note, all other payments under the 2021 Note would be made in cash. 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 amortizes in twenty-four five priority lien on the Company’s assets and properties. During the year ended December 31, 2023, the Company issued 455,425 shares to Lind to satisfy interest and principal payments due under the 2021 Note. On May 19, 2023, the Company entered into Amendment No. 3 (the “2021 Note Amendment”) to the 2021 Note, pursuant to which the Company and Lind agreed, among other things, that: (A) effective as of May 19, 2023, the outstanding Principal Amount was increased by $1,250,000 to $17,750,000 and the fair value of $1.3 million is included within loss on extinguishment of debt on the consolidated statement of operations and comprehensive loss; (B) the Company shall not be required to maintain any minimum balance of cash or cash equivalents with one or more financial institutions prior to September 15, 2023, and that it shall thereafter be required to maintain an aggregate minimum balance equal to 50% of the then outstanding principal amount under the 2021 Note or more in cash or cash equivalents with one or more financial institutions (the “Minimum Cash Condition”); (C) effective as of September 15, 2023, upon an Event of Default (as defined in the 2021 Note), Lind shall have the right to convert the then outstanding principal amount of the 2021 Note into shares of common stock at the lower of (x) the then - current conversion price (which is currently $180.00 per share, subject to adjustment in certain circumstances as described in the 2021 Note) and (y) 85% of the average of the five 20 five 20 On September 13, 2023, pursuant to an Irrevocable Waiver, Lind agreed to unilaterally, unconditionally, irrevocably and permanently waive its right to assert that any Event of Default (as defined in the 2021 Note) would be deemed to occur pursuant to the 2021 Note or that the Company breached the 2021 Note if the Company failed to satisfy the Minimum Cash Condition at any time on or after September 15, 2023 and through and including September 30, 2023 (the “Waiver Period”), in each case solely in connection with the Company’s failure to satisfy the Minimum Cash Condition during the Waiver Period. On September 21, 2023, and concurrently with the execution of the September 2023 Securities Purchase Agreement, the Company entered into a letter agreement with Lind related to the 2021 Note (the “Letter Agreement”), pursuant to which the Company and Lind agreed that, in lieu of, and in full satisfaction of, both the monthly payment that would otherwise have been due under the 2021 Note on September 23, 2023 and the interest payment that would otherwise have been due on September 29, 2023, (i) the Company would, by no later than September 29, 2023, pay to Lind cash in an aggregate amount equal to $686,564 and (ii) Lind would have the right, at any time and from time to time, between the closing date of the September 2023 RDO and the date that is 45 five 20 On September 30, 2023, the Company and Lind entered into an Amendment No. 4 to the 2021 Note and Amendment to Letter Agreement (the “Amendment”), pursuant to which the Company and Lind agreed, among other things, that: (A) effective as of September 30, 2023, the outstanding principal amount of the 2021 Note was increased by $3.6 million to $16.8 million; (B) commencing October 1, 2023, the 2021 Note will bear interest at an annual rate of 12% per annum; (C) the Company shall not be required to maintain any minimum balance of cash or cash equivalents with one or more financial institutions prior to March 28, 2024, and that it shall thereafter be required to maintain an aggregate minimum balance equal to 50% of the then outstanding principal amount under the 2021 Note or more in cash or cash equivalents with one or more financial institutions; (D) subject to certain exceptions, if the Company issues securities for cash consideration, the Company will be required utilize 25% of the net cash proceeds to repay the 2021 Note unless Lind elects not to be repaid; (E) Lind will, through March 28, 2024, forebear from exercising any right to assert or claim a Material Adverse Effect (as defined in the 2021 Note) has occurred as a result of any event, occurrence, fact, condition or change that occurred on or prior to September 30, 2023; (F) the Company shall use its reasonable best efforts to seek, at a special or annual meeting of the stockholders of the Company to be scheduled to be held no later than January 16, 2024, the stockholder approval as contemplated by Nasdaq Listing Rule 5635 (d) with respect to the approval of the issuance of shares of Common Stock in excess of the limitation on the number of shares issuable under the 2021 Note as set forth in the 2021 Note and 2021 Lind Securities Purchase Agreement; and (G) subject to certain exceptions, as long as the 2021 Note remains outstanding, Lind will have the right to participate in any equity or debt financing by the Company in an amount equal to the lesser of 50% of the securities to be offered and $5,000,000 of the securities to be offered in such financing. The Amendment provides that the number of shares issuable pursuant to the Subsequent Conversion Right was limited to an aggregate of 62,570 shares of Common Stock. As a result of the modification, the Company recognized a loss on extinguishment of the debt, recorded as a component of the change in fair value of convertible notes on the consolidated statements of operations. The Company will continue to account for the 2021 Note using the fair value election. The Company issued 62,570 shares of its common stock in connection with Lind’s exercise of the Subsequent Conversion Right on October 5, 2023. 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 180 shares of its common stock. These notes have substantially the same terms as the 2021 Note. On February 22, 2023, the December 2021 Notes were repaid in full, and the Company recognized a loss on extinguishment of debt of $13,000 during the year ended December 31, 2023. During the years ended December 31, 2023 and 2022, the Company recognized a $2.0 million loss and a $3.0 million loss on change in fair value of convertible notes, respectively, on changes in fair value of convertible notes. During the years ended December 31, 2023 and 2022, the Company recognized losses of $4.3 million and nil, respectively, on the loss on issuance of convertible notes. During the years ended December 31, 2023 and 2022, the Company recognized losses of $9.2 million and nil, respectively, on loss on extinguishment of debt on the consolidated statement of operations and comprehensive loss. During the year ended December 31, 2023, the Company made principal payments of $11.7 million (consisting of $4.5 million of common stock and $7.2 million of cash) and interest payments of $1.1 million (consisting of $0.6 million of common stock and $0.5 million of cash), respectively, on the convertible notes. During the year ended December 31, 2022, the Company made principal and interest payments of $1.9 million of cash on the convertible notes. As of December 31, 2023 and December 31, 2022, the Company recognized a total convertible note liability of $14.2 million and $20.0 million, respectively. The 2021 Note contains certain restrictive covenants and event of default provisions, including a covenant requiring the Company to maintain an aggregate minimum balance equal to 50% of the then outstanding principal amount under the 2021 Note or more in cash and cash equivalents commencing on March 28, 2024. As of December 31, 2023, the outstanding principal amount of the 2021 Note was $13.9 million. If the Company is not able to comply or regain compliance with any of the covenants in, or otherwise trigger a default under, the 2021 Note, Lind could declare the 2021 Note immediately due and payable, which would require the Company to pay 120% of the outstanding principal amount of the 2021 Note and would have a material adverse effect on its liquidity, financial condition, operating results, business and prospects, and could cause the price of the Company’s common stock to decline. In addition, since the borrowings under the 2021 Note are secured by a first priority lien on the Company’s assets, Lind would be able to foreclose on the Company’s assets if it does not cure any default or pay any amounts due and payable under the 2021 Note. In addition, upon an Event of Default (as defined in the 2021 Note), Lind shall have the right to convert the then outstanding principal amount of the 2021 Note into shares of the Company’s common stock at the lower of (x) the then - current conversion price (which is currently $180.00 per share, subject to adjustment in certain circumstances as described in the 2021 Note) and (y) 85% of the average of the five 20 The outstanding 2021 Convertible Notes are scheduled to mature during 2024. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity Preferred Stock The Company is authorized to issue 10,000,000 shares of preferred stock, par value $0.001. No shares of preferred stock were outstanding as of December 31, 2023 or 2022. Common Stock The Company has authorized 16,000,000 and 240,000,000 shares of common stock as of December 31, 2023 and December 31, 2022, respectively. Each share of common stock is entitled to one voting right. Common stock owners are entitled to dividends when funds are legally available and declared by the Board of Directors. Warrants December 2023 Warrants On November 28, 2023, the Company entered into the Underwriting Agreement pursuant to which the Company issued and sold an aggregate of 1,781,934 shares of common stock, the December 2023 Pre - Funded Warrants exercisable for an aggregate of 2,422,612 shares of its common stock and the accompanying December 2023 Common Warrants exercisable for an aggregate of 4,204,546 shares of common stock in a underwritten public offering. The December 2023 Pre - Funded Warrants were exercisable immediately upon issuance and had an exercise price per share equal to $0.001. The December 2023 Common Warrants have an exercise price per share equal to $1.32. The December 2023 Common Warrants were exercisable immediately and will expire on December 1, 2028. As of December 31, 2023, the December 2023 Pre - Funded Warrants had been exercised in full, and December 2023 Common Warrants to purchase 4,204,546 million shares of common stock remain outstanding at an exercise price of $1.32 per share. September 2023 Warrants On September 21, 2023, the Company entered into the September 2023 Securities Purchase Agreement, pursuant to which the Company issued and sold an aggregate of 500,000 shares of its common stock and the September 2023 Warrants exercisable for an aggregate of 333,667 shares of its common stock in the September 2023 RDO. The September 2023 Warrants were exercisable immediately upon issuance and had an exercise price per share equal to $9.75 per share. In addition, the September 2023 Warrants contain an alternative “cashless exercise” provision whereby a September 2023 Warrant may be exchanged cashlessly for shares of common stock at a rate of 0.999 of a share of common stock per full share otherwise issuable upon a cash exercise. During the year ended December 31, 2023, September 2023 Warrants to purchase approximately 333,667 shares of common stock were cashlessly exchanged and no September 2023 Warrants remain outstanding. May 2023 Warrants On May 19, 2023, the Company entered into the 2023 Purchase Agreement Amendment, pursuant to which the Investor agreed to, among other things, waive certain restrictions on issuing and registering shares of common stock contained within the 2023 Securities Purchase Agreement to permit the Company to make the May Through September Payments in a combination of cash and shares of common stock as contemplated in the 2021 Note Amendment. In consideration for entering into the 2023 Purchase Agreement Amendment, on May 19, 2023, the Company issued to the Investor warrants to purchase up to an aggregate of 133,334 shares of common stock (the “May 2023 Warrants”). The exercise price of the May 2023 Warrants is $31.80 per share, subject to adjustment as provided therein, and the May 2023 Warrants will be exercisable beginning on November 19, 2023 and will expire on November 20, 2028. As of December 31, 2023, May 2023 Warrants to purchase 133,334 shares of common stock remain outstanding at an exercise price of $31.80 per share. March 2023 Warrants On March 10, 2023, the Company entered into a securities purchase agreement with a life sciences - focused investment fund pursuant to which the Company issued and sold an aggregate of 401,977 shares of common stock, the March 2023 Pre - Funded Warrants exercisable for an aggregate of 311,357 shares of its common stock and the accompanying March 2023 Common Warrants exercisable for an aggregate of 891,667 shares of common stock in a registered direct offering. The March 2023 Pre - Funded Warrants were exercisable immediately upon issuance and had an exercise price per share equal to $0.03. The March 2023 Common Warrants have an exercise price per share equal to $18.00. The March 2023 Common Warrants became exercisable beginning on September 11, 2023 and will expire on September 10, 2028. During the year ended December 31, 2023, March 2023 Pre - Funded Warrants to purchase approximately 311,357 shares of common stock were exercised on a cashless basis. As of December 31, 2023, March 2023 Pre - Funded Warrants to purchase 311,357 shares of common stock all have been exercised on a cashless basis and March 2023 Common Warrants to purchase 891,667 shares of common stock remain outstanding at an exercise price of $18.00 per share. September 2020 Warrants On September 4, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company issued and sold an aggregate of 295,500 shares of common stock in a registered direct offering and issued unregistered warrants to purchase up to 221,625 shares of common stock in a concurrent private placement (the “September 2020 Warrants”). The September 2020 Warrants are exercisable for 33,625 shares of common stock at an exercise price per share equal to $25.20. The September 2020 Warrants became exercisable beginning on March 9, 2021 and will expire on March 9, 2026. During the years ended December 31, 2023 and 2022, no September 2020 Warrants were exercised. As of December 31, 2023, September 2020 Warrants exercisable for 33,625 shares of common stock remain outstanding at an exercise price of $25.20 per share. 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 149,167 shares of common stock in a registered direct offering and issued warrants to purchase up to 74,584 shares of common stock in a concurrent private placement (the “August 2019 Warrants”). The August 2019 Warrants were initially exercisable for 74,584 shares of common stock at an exercise price per share equal to $53.40. The August 2019 Warrants became exercisable beginning on February 27, 2020 and expired on August 28, 2023. During the years ended December 31, 2023 and 2022, no August 2019 Warrants were exercised. As of December 31, 2023, all remaining August 2019 Warrants expired on August 28, 2023 and no shares of common stock remain outstanding. Series A Warrants On January 24, 2019, STI and the Company closed a private placement with certain accredited investors pursuant to which, among other things, the Company issued warrants representing the right to acquire 48,784 shares of common stock (the “Series A Warrants”). The Series A Warrants were initially exercisable for 48,784 shares of common stock at an exercise price per share equal to $124.50, which was adjusted several times pursuant to the terms thereof to an exercise price per share equal to $4.4705 per share. The most recent adjustment to the exercise price (from $8.202 to $4.4705 per share) occurred during the year ended December 31, 2023, as a result of the announcement of the December 2023 underwritten public offering. The Series A Warrants were immediately exercisable upon issuance and expired unexercised on January 31, 2024. During the years ended December 30, 2023 and 2022, no Series A Warrants were exercised. As of December 31, 2023, Series A Warrants exercisable for 10,081 shares of common stock remain outstanding at an exercise price of $4.4705 per share. The exercise price of the Series A Warrants was adjusted in December 2023 due to the adjustment provisions in the Series A Warrants as a result of the December 2023 underwritten public offering. A summary of warrant activity during the year ended December 31, 2023 is as follows (warrants in thousands): Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of December 31, 2022 85 $ 83.40 1.7 Issued 8,297 $ 3.11 Exercised (3,068) $ 0.00 Cancelled (34) $ 101.30 Outstanding as of December 31, 2023 5,280 $ 5.57 4.8 Exercisable as of December 31, 2023 5,280 $ 5.57 4.8 The December 2023 Warrants, September 2023 Warrants, the May 2023 Warrants, the March 2023 Common Warrants, the March 2023 Pre - Funded Warrants and the Series A Warrants were all 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. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Stock-Based Compensation | |
Stock-Based Compensation | 11. Stock-Based Compensation The Company has the Seelos Therapeutics, Inc. Amended and Restated 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 st 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 have 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 1 st 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 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 33,334 shares of the Company’s common stock, of which 21,756 shares of the Company’s common stock are available for future issuance as of December 31, 2023. The 2019 Inducement Plan is administered by the Compensation Committee and expires on August 12, 2029. Stock options During the year ended December 31, 2023, the Company granted 50,594 incentive stock options and 98,657 non-qualified stock options to employees with a weighted average exercise price per share of $20.80 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. During the year ended December 31, 2023, the Company also granted 11,274 non- qualified stock options to employees who elected to forgo a portion of their cash bonus for stock options with a weighted average exercise price per share of $20.76 and a 10-year term, subject to the terms and conditions of the 2012 Plan above. The stock options are not subject to time vesting requirements and are fully vested upon the date of grant. During the year ended December 31, 2023, the Company also granted 6,668 non-qualified stock options to non-employee directors with a weighted average exercise price per share of $24.30 and a 10-year term, subject to the terms and conditions of the 2012 Plan above. The stock options granted to non-employee directors vest monthly over the 12 months following the grant. 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 a weighted average blend of the historical volatility of a publicly traded set of peer companies, as well as its own historical volatility. 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. During the year ended December 31, 2023 , no stock options were exercised and 2,434 options were forfeited. During the year ended December 31, 2022, 209 stock options were exercised and no options were forfeited. The following assumptions were used in determining the fair value of the stock options granted during the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 December 31, 2022 Risk-free interest rate 3.6%-3.9 % 1.6%-3.4 % Volatility 116%-119 % 111%-113 % Dividend yield — % — % Expected term (years) 5-6 5-6 Weighted-average fair value $ 20.94 $ 36.60 A summary of stock option activity during the year ended December 31, 2023 is as follows (in thousands, except exercise prices and years): Weighted- Weighted- Average Total Average Remaining Aggregate Stock Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding as of December 31, 2022 347 $ 67.82 Granted 167 20.94 Exercised — — Forfeited (2) 57.28 Expired (1) 87.60 Outstanding as of December 31, 2023 511 $ 48.13 7.7 $ — Vested and expected to vest as of December 31, 2023 511 $ 48.13 7.7 $ — Exercisable as of December 31, 2023 272 $ 58.82 6.9 $ — The intrinsic value of options exercised during the years ended December 31, 2023 and 2022 was $0 and $0.1 million, respectively. As of December 31, 2023, unrecognized stock-option compensation expense of $6.4 million is expected to be realized over a weighted -average period of 2.4 years. 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 80,000 shares of common stock, with a grant date fair value of $129.30 per unit. Vesting of this award was 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 were unvested and three of the five performance conditions had 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. During the year ended December 31, 2022, the Company and its Chief Executive Officer entered into an agreement to cancel the performance stock unit award for no consideration. In connection with the cancellation of the award, no replacement awards were granted or authorized. At the time of cancellation, the Company recognized the remaining compensation expense of the three achieved milestones of $1.3 million. The two remaining milestones were not deemed probable of achievement at the time of cancellation, and no compensation cost related to these milestones was recognized. 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): Year Ended December 31, 2023 2022 Research and development $ 1,037 $ 932 General and administrative 2,951 4,141 $ 3,988 $ 5,073 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | 12. 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. The Company has incurred net operating losses since inception. At December 31, 2023, the Company has available net operating loss carryforwards of approximately $131.9 million for federal income tax reporting purposes and approximately $91.2 million for state and local income tax reporting purposes. The net operating loss carryover of $131.9 million will be carried forward indefinitely. Federal net operating loss carryforwards generated after tax year 2018 are subject to an 80% limitation on taxable income, do not expire and will carryforward indefinitely. State net operating loss carryforwards in the amount of $90.7 million begin expiring in 2036 and approximately $0.5 million have an indefinite life. Deferred tax assets consist of the following (in thousands): December 31, 2023 2022 Net operating tax loss carryforwards $ 33,190 $ 27,362 Contingent payment obligations — 461 Stock based compensation 803 1,559 R&E expenses 14,735 11,137 Intangible assets 7,256 8,577 Other 2 — Total deferred tax asset 55,986 49,096 Less valuation allowance (55,986) (49,096) 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, 2023 and 2022 of approximately $33.2 million and $27.4 million, respectively. In consideration of the Company’s accumulated losses and the uncertainty of its ability to utilize this deferred tax asset in the future, the Company has recorded a full valuation allowance as of such dates. Effective for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered incidental to research and experimentation (“R&E”) activities under IRC Section 174. While taxpayers historically had the option of deducting these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization of R&E expenses for tax years beginning after December 31, 2021. Expenses incurred in connection with R&E activities in the US must be amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period. R&E activities are broader in scope than qualified research activities considered under IRC Section 41 (relating to the research tax credit). For the years ended December 31, 2023 and 2022, the Company performed an analysis based on available guidance and determined that it will continue to be in a loss position even after the required capitalization and amortization of its R&E expenses. The Company will continue to monitor this issue for future developments, but it does not expect R&E capitalization and amortization to require it to pay cash taxes now or in the near future. 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 2019 to 2023 are still open and subject to audit. In addition, net operating losses arising from prior years are also subject to examination at the time they are utilized in future years. Unrecognized tax benefits, if recognized, would have no effect on the Company’s effective tax rate. The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. For the years ended December 31, 2023 and 2022, the Company has not recorded any interest or penalties related to income tax matters. The Company does not foresee any material changes to unrecognized tax benefits within the next twelve months. The Company did not have any unrecognized tax benefits for the years ended December 31, 2023 and 2022. 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, 2023 and 2022, are as follows: Year Ended December 31, 2023 2022 Federal statutory tax rate 21.0 % 21.0 % State and local taxes, net of federal benefit 0.1 % — % Permanent Items (0.1) % (1.0) % Mark-to-Market 1.4 % — % Stock Based Compensation (4.4) % — % Deferred rate changes 0.1 % (12.9) % Deferred true-up 0.1 % (10.2) % Change in valuation allowance (18.2) % 3.1 % Income tax provision (benefit) — % — % |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases In March 2021, the Company entered into an eighteen-month office space rental agreement for its headquarters at 300 Park Avenue, New York, NY, which ended in September 2022. In October 2022, the Company entered into a new eighteen-month office space rental agreement for its existing space, which provides for a base rent starting at approximately $4,000 per month subject to periodic increases. Under the new office space rental agreement in October 2022, in exchange for the new operating lease liability, the Company recognized a right-of-use asset of $86,000. As of December 31, 2023, the weighted-average remaining lease term of the operating lease was 0.3 years, and the weighted-average discount rate was 8.0%. As of December 31, 2023, future minimum lease payments for the Company’s operating lease with a non-cancelable term is as follows (in thousands): Operating Leases Year Ended December 31, 2024 $ 16 Total 16 Less present value discount (1) Operating lease liabilities $ 15 For each of the years ended December 31, 2023 and 2022, operating lease expense totaled $0.1million. 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, 2023, there was no material litigation against the Company. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events Effective January 10, 2024, the Company’s authorized shares of common stock was increased from 16,000,000 to 400,000,000 shares. Registered Direct Offering On January 26, 2024, the Company entered into a securities purchase agreement (the “January 2024 Securities Purchase Agreement”) with certain institutional investors identified on the signature pages thereto (the “January Purchasers”), pursuant to which, on January 30, 2024, the Company issued and sold 3,404,256 shares (the “Shares”) of its common stock in a registered direct offering (the “January 2024 RDO”). In a concurrent private placement (the “Private Placement” and together with the January 2024 RDO, the “Offering”), the Company also agreed to issue and sell to the January Purchasers unregistered common warrants to purchase up to 3,404,256 shares of Common Stock (the “Common Warrants”). The combined purchase price for one Share and accompanying Common Warrant to purchase one share for each share of common stock purchased was $1.175. The Common Warrants have an exercise price of $1.05 The Common Warrants are not and will not be listed for trading on any national securities exchange or other nationally recognized trading system. On January 26, 2024, the Company also entered into a placement agent agreement (the “Placement Agent Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”), pursuant to which the Placement Agent acted as placement agent for the Offering and the Company agreed to pay the Placement Agent a fee equal to 7% of the aggregate gross proceeds received by the Company from the sale of the securities in the Offering. The Placement Agent Agreement includes indemnity and other customary provisions for transactions of this nature. The Company also agreed to reimburse the Placement Agent for up to $50,000 for the Placement Agent’s legal fees and expenses and non-accountable expenses in an amount not to exceed $15,000. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of Significant Accounting Policies | |
Organization | Organization Seelos Therapeutics, Inc. (together with 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 and SLS-007 for the potential treatment of Parkinson’s Disease (“PD”). On March 29, 2023, the Company announced that it plans to focus the majority of its resources on the Phase II study of SLS - 002 for ASIB in MDD and the fully enrolled Phase II/III study of SLS - 005 in ALS. The Company further announced that it has temporarily paused additional enrollment of patients in the SLS - 005 - 302 study in SCA. Patients already enrolled will continue in the study and data will continue to be collected in order to make decisions for resuming enrollment in the future. The Company also announced that it is pausing all non - essential preclinical work. |
Reverse Stock Split | Reverse Stock Split On November 27, 2023, the Company filed a Certificate of Change with the Secretary of State of the State of Nevada to (i) effect a 1 - for - 30 |
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. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) asset, operating lease liability, current and operating lease liability, long-term in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liability represents its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of the lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if it borrowed on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
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. The carrying amounts of financial instruments such as grant receivables, prepaid expenses, other current assets, accounts payable and accrued expenses approximate their related fair values due to the short - term nature of these instruments. |
Grant Revenue | Grant Revenue Revenue from grants is recognized as the qualifying expenses related to the contracts are incurred, provided that there is reasonable assurance of recoverability. Revenue recognized upon incurring qualifying expenses in advance of receipt of funding is recorded as Grant receivable, in the Consolidated Balance Sheet |
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, performance-based restricted stock unit awards and stock options that would result in the issuance of incremental shares of common stock. For warrants that are liability-classified, during periods when the impact is dilutive, the Company assumes share settlement of the instruments as of the beginning of the reporting period and adjusts the numerator to remove the change in fair value of the warrant liability and adjusts the denominator to include the dilutive shares calculated using the treasury stock method. The following potentially dilutive securities outstanding for the year ended December 31, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Year Ended December 31, 2023 2022 Outstanding stock options 511 347 Outstanding warrants 5,280 85 Convertible debt 77 123 5,868 555 |
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 August 2020, the FASB issued Accounting Standards Update (“ASU”) No. 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 the Company beginning after January 1, 2024, 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 has decided to early adopt the provisions of this ASU as of January 1, 2023 and the Company does not expect the adoption of ASU 2020-06 to have an impact on its consolidated financial statements and related disclosures. In June 2022, the FASB issued ASU No. 2022-03: ASC Subtopic 820 - Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”). ASU 2022-03 amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in ASU 2022-03 are effective for the Company for fiscal years beginning after December 15, 2023, and the interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of antidilutive securities excluded from computation of diluted weighted average shares outstanding | The following potentially dilutive securities outstanding for the year ended December 31, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive (in thousands): Year Ended December 31, 2023 2022 Outstanding stock options 511 347 Outstanding warrants 5,280 85 Convertible debt 77 123 5,868 555 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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. There were no other transfers between fair value measurement levels during the years ended December 31, 2023 and 2022 (in thousands): Fair Value Measurements as of December 31, 2023 (Level 1) (Level 2) (Level 3) Total Assets: Cash $ 2,996 $ — $ — $ 2,996 Liabilities: Convertible notes payable, at fair value $ — $ — $ 14,213 $ 14,213 Warrant liabilities, at fair value — — 5,781 5,781 $ — $ — $ 19,994 $ 19,994 Fair Value Measurements as of December 31, 2022 (Level 1) (Level 2) (Level 3) Total Assets: Cash $ 15,533 $ — $ — $ 15,533 Liabilities: Convertible notes payable, at fair value $ — $ — $ 20,049 $ 20,049 Warrant liabilities, at fair value — — 132 132 $ — $ — $ 20,181 $ 20,181 |
Schedule of Fair Value Level 3 Reconciliation | The following table is a reconciliation for the common stock warrant liabilities and convertible notes measured at fair value using Level 3 unobservable inputs (in thousands): Convertible notes, at fair Warrant liabilities Derivative liability value Balance as of December 31, 2021 $ 424 $ 1,174 $ 18,920 Settlement of derivative liability — (1,174) — Principal payment of convertible notes, at fair value — — (1,888) Issuance of derivative liability — — — Change in fair value measurement of derivative liability — — — Change in fair value measurement of convertible notes — — 3,017 Change in fair value measurement of warrant liability (292) — — Balance as of December 31, 2022 $ 132 $ — $ 20,049 Principal payment of convertible notes, at fair value — — (11,695) Interest payment of convertible notes, at fair value — — (1,085) Issuance of convertible note — — 4,882 Loss on extinguishment of debt — — 13 Change in fair value measurement of convertible notes — — 2,049 Fair value of warrants issued 25,644 — — Warrant exercised (2,000) — — Change in fair value measurement of warrant liability (17,995) — — Balance as of December 31, 2023 $ 5,781 $ — $ 14,213 |
Long-Term Debt | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of Fair Value Measurements Warrant Valuation Assumptions | December 31, 2023 December 31, 2022 Risk-free interest rate 4.89 % 4.24 % Volatility 125 % 105 % Dividend yield — % — % Contractual term (years) 0.9 1.9 Stock price $ 1.39 $ 20.40 |
Outstanding warrants | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of Fair Value Measurements Warrant Valuation Assumptions | December 31, 2023 December 31, 2022 Risk-free interest rate 3.85% - 5.60 % 4.71 % Volatility 123% - 127 % 91.90 % Dividend yield — % — % Expected term (years) 0.07 4.91 1.07 Weighted-average fair value $ 1.10 $ 13.20 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses and Other Current Assets. | |
Schedule prepaid expenses and other current assets | December 31, December 31, 2023 2022 Prepaid insurance $ 51 $ 104 Prepaid clinical costs 1,516 6,837 Other 77 200 Prepaid expenses and other current assets $ 1,644 $ 7,141 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, December 31, 2023 2022 Professional fees $ 250 $ 278 Personnel related 56 1,288 Outside research and development services 2,152 5,627 Other 58 89 Accrued expenses, net $ 2,516 $ 7,282 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Schedule of warrant activity | A summary of warrant activity during the year ended December 31, 2023 is as follows (warrants in thousands): Weighted- Weighted- Average Average Remaining Exercise Contractual Life Warrants Price (in years) Outstanding as of December 31, 2022 85 $ 83.40 1.7 Issued 8,297 $ 3.11 Exercised (3,068) $ 0.00 Cancelled (34) $ 101.30 Outstanding as of December 31, 2023 5,280 $ 5.57 4.8 Exercisable as of December 31, 2023 5,280 $ 5.57 4.8 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stock-Based Compensation | |
Schedule of fair value of stock options granted | Year Ended December 31, 2023 December 31, 2022 Risk-free interest rate 3.6%-3.9 % 1.6%-3.4 % Volatility 116%-119 % 111%-113 % Dividend yield — % — % Expected term (years) 5-6 5-6 Weighted-average fair value $ 20.94 $ 36.60 |
Schedule of stock option activity | Weighted- Weighted- Average Total Average Remaining Aggregate Stock Exercise Contractual Intrinsic Options Price Life (in years) Value Outstanding as of December 31, 2022 347 $ 67.82 Granted 167 20.94 Exercised — — Forfeited (2) 57.28 Expired (1) 87.60 Outstanding as of December 31, 2023 511 $ 48.13 7.7 $ — Vested and expected to vest as of December 31, 2023 511 $ 48.13 7.7 $ — Exercisable as of December 31, 2023 272 $ 58.82 6.9 $ — |
Schedule of stock-based compensation expense resulting from share based awards | 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): Year Ended December 31, 2023 2022 Research and development $ 1,037 $ 932 General and administrative 2,951 4,141 $ 3,988 $ 5,073 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of Deferred Tax Assets | Deferred tax assets consist of the following (in thousands): December 31, 2023 2022 Net operating tax loss carryforwards $ 33,190 $ 27,362 Contingent payment obligations — 461 Stock based compensation 803 1,559 R&E expenses 14,735 11,137 Intangible assets 7,256 8,577 Other 2 — Total deferred tax asset 55,986 49,096 Less valuation allowance (55,986) (49,096) Net deferred tax asset $ — $ — |
Schedule of reconciliation of income taxes computed using the statutory United States income tax rate and the provision (benefit) for income taxes | 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, 2023 and 2022, are as follows: Year Ended December 31, 2023 2022 Federal statutory tax rate 21.0 % 21.0 % State and local taxes, net of federal benefit 0.1 % — % Permanent Items (0.1) % (1.0) % Mark-to-Market 1.4 % — % Stock Based Compensation (4.4) % — % Deferred rate changes 0.1 % (12.9) % Deferred true-up 0.1 % (10.2) % Change in valuation allowance (18.2) % 3.1 % Income tax provision (benefit) — % — % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Schedule of future minimum operating lease payments | As of December 31, 2023, future minimum lease payments for the Company’s operating lease with a non-cancelable term is as follows (in thousands): Operating Leases Year Ended December 31, 2024 $ 16 Total 16 Less present value discount (1) Operating lease liabilities $ 15 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization and Summary of Significant Accounting Policies | ||
Antidilutive securities excluded | 5,868 | 555 |
Employee Stock Option | ||
Organization and Summary of Significant Accounting Policies | ||
Antidilutive securities excluded | 511 | 347 |
Outstanding warrants | ||
Organization and Summary of Significant Accounting Policies | ||
Antidilutive securities excluded | 5,280 | 85 |
Convertible debt | ||
Organization and Summary of Significant Accounting Policies | ||
Antidilutive securities excluded | 77 | 123 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Reverse Stock Split (Details) | Nov. 27, 2023 shares | Dec. 31, 2023 shares | Dec. 31, 2022 shares |
Organization and Summary of Significant Accounting Policies | |||
Effect of Reverse stock split | 0.03 | ||
Common stock, authorized (in shares) | 480,000,000 | 16,000,000 | 8,000,000 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2023 segment | |
Organization and Summary of Significant Accounting Policies | |
Number of operating segment | 1 |
Liquidity and Going Concern (De
Liquidity and Going Concern (Details) - USD ($) | 12 Months Ended | ||||||||||||||
Jan. 12, 2024 | Nov. 27, 2023 | Nov. 01, 2023 | Jun. 26, 2023 | May 23, 2023 | May 22, 2023 | Nov. 21, 2022 | May 12, 2022 | Dec. 31, 2023 | Jan. 10, 2024 | Jan. 09, 2024 | Dec. 23, 2023 | Nov. 02, 2023 | Sep. 21, 2023 | Dec. 31, 2022 | |
Liquidity and Going Concern | |||||||||||||||
Cash | $ 2,996,000 | $ 15,533,000 | |||||||||||||
Accumulated deficit | $ (252,626,000) | $ (214,744,000) | |||||||||||||
Substantial Doubt about Going Concern, within One Year [true false] | false | ||||||||||||||
Common stock, authorized (in shares) | 480,000,000 | 16,000,000 | 8,000,000 | ||||||||||||
Market value for the common stock closes at the minimum requirement | $ 35,000,000 | $ 35,000,000 | |||||||||||||
Threshold consecutive trading days considered for bid price | 30 days | 30 days | |||||||||||||
Value of shares available under registration statement | $ 250,000,000 | ||||||||||||||
Common Stock | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Common stock, authorized (in shares) | 480,000,000 | 16,000,000 | 240,000,000 | ||||||||||||
Shares Issued, Price Per Share | $ 1 | ||||||||||||||
Reserve stock split ratio | 0.033% | ||||||||||||||
Subsequent events | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Common stock, authorized (in shares) | 400,000,000 | 16,000,000 | |||||||||||||
Minimum | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Shares Issued, Price Per Share | $ 1 | $ 1 | $ 1 | $ 1 | |||||||||||
Minimum requirement of listed securities for the market value | $ 5,000,000 | ||||||||||||||
Threshold consecutive trading days considered for bid price | 11 days | 10 days | |||||||||||||
Maximum | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Initial number of calender days to regain common stock price compliance | 180 days | ||||||||||||||
Threshold consecutive trading days considered for bid price | 180 days | ||||||||||||||
Secondary number of calendar days to regain common stock price compliance | 180 days | 180 days | |||||||||||||
2023 Securities Purchase Agreement | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Aggregate future offering amount | $ 50,000,000 | ||||||||||||||
2023 Securities Purchase Agreement | September 2023 Warrants | |||||||||||||||
Liquidity and Going Concern | |||||||||||||||
Term of warrants (in years) | 5 years |
Business Combination (Details)
Business Combination (Details) | Jan. 24, 2019 USD ($) item employee |
Business Combination | |
Total number of board seats of combined company | item | 5 |
Seelos Therapeutics, Inc | |
Business Combination | |
Number of board seats of combined company held | item | 4 |
Apricus Biosciences, Inc [Member] | |
Business Combination | |
Intangible asset | $ 0 |
Fair value of liabilities | 300,000 |
Merger Agreement | Seelos Therapeutics, Inc | |
Business Combination | |
Tangible assets acquired | $ 0 |
Number of employees assumed | employee | 0 |
Contingent Value Rights Agreement | |
Business Combination | |
Number of CVR issued for each share of Apricus common stock held of record | item | 1 |
Percentage of cash payments that CVR holders are entitled | 90% |
Threshold minimum amount for payment of cash at a certain percentage to CVR holders | $ 500,000 |
Period from Close of Merger for cash payments in excess of threshold specified amount | 10 years |
Amount that the Company is entitled to retain | $ 500,000 |
Percentage of Contingent Payments that the Company is entitled to retain | 10% |
Maximum amount of Contingent Payments that the Company has agreed to pay to a third party | $ 500,000 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Measurement | ||
Transfers between fair value measurement levels | $ 0 | $ 0 |
Fair Value Measurement - Schedu
Fair Value Measurement - Schedule of Fair Value Hierarchy Assets and Liabilities (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Cash | $ 2,996 | $ 15,533 |
Liabilities: | ||
Total financial liabilities | 19,994 | 20,181 |
Convertible notes, at fair value | ||
Liabilities: | ||
Convertible notes payable, at fair value | 14,213 | 20,049 |
Outstanding warrants | ||
Liabilities: | ||
Warrant liabilities, at fair value | 5,781 | $ 132 |
Derivative Liability, Statement of Financial Position [Extensible Enumeration] | Warrant Liabilities At Fair Value | |
Level 1 | ||
Assets: | ||
Cash | 2,996 | $ 15,533 |
Level 3 | ||
Liabilities: | ||
Total financial liabilities | 19,994 | 20,181 |
Level 3 | Convertible notes, at fair value | ||
Liabilities: | ||
Convertible notes payable, at fair value | 14,213 | 20,049 |
Level 3 | Outstanding warrants | ||
Liabilities: | ||
Warrant liabilities, at fair value | $ 5,781 | $ 132 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Fair Value Measurements Convertible Notes Valuation Assumptions (Details) - Convertible notes, at fair value - Level 3 - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Measurement | ||
Risk-free interest rate (in percent) | 4.89% | 4.24% |
Volatility (in percent) | 125% | 105% |
Contractual term (years) | 10 months 24 days | 1 year 10 months 24 days |
Stock price | $ 1.39 | $ 20.40 |
Fair Value Measurement - Summ_2
Fair Value Measurement - Summary of Fair Value Measurements Warrant Valuation Assumptions (Details) - Level 3 - Outstanding warrants - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Measurement | ||
Risk-free interest rate (in percent) | 4.71% | |
Volatility (in percent) | 91.90% | |
Expected term (years) | 1 year 25 days | |
Weighted-average fair value (in USD per share) | $ 1.10 | $ 13.20 |
Minimum | ||
Fair Value Measurement | ||
Risk-free interest rate (in percent) | 3.85% | |
Volatility (in percent) | 123% | |
Expected term (years) | 25 days | |
Weighted-average fair value (in USD per share) | $ 1.10 | |
Maximum | ||
Fair Value Measurement | ||
Risk-free interest rate (in percent) | 5.60% | |
Volatility (in percent) | 127% | |
Expected term (years) | 4 years 10 months 28 days |
Fair Value Measurement - Sche_2
Fair Value Measurement - Schedule of Fair Value Level 3 Reconciliation (Details) - Level 3 - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Outstanding warrants | ||
Fair Value Measurement | ||
Balance at beginning | $ 132 | $ 424 |
Principal payment of convertible notes, at fair value | (2,000) | |
Fair value of warrants issued | 25,644 | |
Change in fair value measurement | (17,995) | (292) |
Balance at ending | 5,781 | 132 |
Derivative liability | ||
Fair Value Measurement | ||
Balance at beginning | 1,174 | |
Settlement of derivative liability | (1,174) | |
Issuance of derivative liability | 1,174 | |
Convertible notes, at fair value | ||
Fair Value Measurement | ||
Balance at beginning | 20,049 | 18,920 |
Principal payment of convertible notes, at fair value | 11,695 | (1,888) |
Interest payment of convertible notes, at fair value | (1,085) | |
Fair value of warrants issued | 4,882 | |
Loss on extinguishment of debt | 13 | |
Change in fair value measurement | 2,049 | 3,017 |
Balance at ending | $ 14,213 | $ 20,049 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets. | ||
Prepaid insurance | $ 51 | $ 104 |
Prepaid clinical costs | 1,516 | 6,837 |
Other | 77 | 200 |
Prepaid expenses and other current assets | $ 1,644 | $ 7,141 |
Common Stock Offerings (Details
Common Stock Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||||||||||||||
Dec. 01, 2023 | Sep. 27, 2023 | Sep. 26, 2023 | Sep. 21, 2023 | Mar. 10, 2023 | May 12, 2022 | Nov. 24, 2021 | Feb. 15, 2019 | Jan. 24, 2019 | Jan. 31, 2022 | Dec. 31, 2021 | Nov. 30, 2021 | Feb. 29, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2019 | Nov. 28, 2023 | May 19, 2023 | Mar. 31, 2023 | Mar. 07, 2019 | Jan. 19, 2019 | |
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 48,784 | ||||||||||||||||||||
Exercise price | $ 124.50 | ||||||||||||||||||||
Warrant liabilities, at fair value | $ 5,781 | $ 132 | |||||||||||||||||||
Change in fair value of warrant liability | (17,995) | (292) | |||||||||||||||||||
Research and development | 30,117 | $ 58,620 | |||||||||||||||||||
2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Commission rate on gross proceeds of common stock sale | 14,193% | ||||||||||||||||||||
Exercise price | $ 18 | ||||||||||||||||||||
Aggregate net proceeds | $ 10,400 | ||||||||||||||||||||
Fair value of warrants | $ 3,200 | ||||||||||||||||||||
Receiving net proceeds | $ 500 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 401,977 | ||||||||||||||||||||
2023 Purchase Agreement Amendment | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Shares issuable upon exercise of warrants | 133,333 | ||||||||||||||||||||
Investor Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Change in fair value of warrant liability | $ 5,000 | ||||||||||||||||||||
Fair value of warrants | $ 21,500 | ||||||||||||||||||||
Series A Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 4.4705 | $ 4.4705 | |||||||||||||||||||
Common warrants | 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 18 | ||||||||||||||||||||
Warrants outstanding | 891,667 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 891,668 | ||||||||||||||||||||
Common warrants | December 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 4,204,546 | ||||||||||||||||||||
May 2023 warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 31.80 | $ 31.80 | |||||||||||||||||||
Warrants outstanding | 133,334 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 133,334 | ||||||||||||||||||||
May 2023 warrants | 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 31.80 | ||||||||||||||||||||
September 2023 Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 333,667 | ||||||||||||||||||||
Exercise price | $ 9.75 | ||||||||||||||||||||
Share price per common stock if warrants are exchanged in cash | $ 0.999 | ||||||||||||||||||||
Warrants outstanding | 0 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 333,667 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 500,000 | ||||||||||||||||||||
September 2023 Warrants | 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 333,667 | ||||||||||||||||||||
Exercise price | $ 9.75 | ||||||||||||||||||||
Term of warrants (in years) | 5 years | ||||||||||||||||||||
Share price per common stock if warrants are exchanged in cash | $ 0.999 | ||||||||||||||||||||
Warrant liabilities, at fair value | $ 1,900 | ||||||||||||||||||||
Number of shares issued as a result of warrants exchanged in cash | 259,260 | 74,075 | |||||||||||||||||||
Change in fair value of warrant liability | $ 100 | ||||||||||||||||||||
December 2023 Pre-Funded Warrants | December 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 2,422,612 | ||||||||||||||||||||
March 2023 Pre-Funded Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 0.03 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 311,357 | ||||||||||||||||||||
March 2023 Pre-Funded Warrants | 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 0.03 | ||||||||||||||||||||
Number of shares issued as a result of warrants exchanged in cash | 311,357 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 311,357 | ||||||||||||||||||||
Pre-Merger Financing | Seelos Therapeutics, Inc | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Sale of stock consideration received on transaction | $ 16,500 | ||||||||||||||||||||
Number of shares that the holder has right to receive upon merger | 60,981 | ||||||||||||||||||||
Adjusted exercise price of warrants | $ 4.4705 | ||||||||||||||||||||
Aggregate net proceeds | $ 18,000 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 79,156 | ||||||||||||||||||||
Pre-Merger Financing | Seelos Therapeutics, Inc | Series A Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 48,784 | ||||||||||||||||||||
Exercise price | $ 124.50 | ||||||||||||||||||||
Warrants outstanding | 10,081,000,000 | ||||||||||||||||||||
Number of warrants exercised | 0 | ||||||||||||||||||||
Shares issuable upon exercise of warrants | 120,968 | ||||||||||||||||||||
Pre-Merger Financing | Seelos Therapeutics, Inc | Series B Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 0 | ||||||||||||||||||||
Exercise price | $ 0.03 | ||||||||||||||||||||
Registered direct offering | 2023 Securities Purchase Agreement | One share and one accompanying Common Warrant | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Shares issuable upon exercise of combined warrants | 1.25 | ||||||||||||||||||||
Registered direct offering | 2023 Securities Purchase Agreement | One pre-funded warrant and one accompanying common warrant | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Combined purchase price per share | $ 15.72 | ||||||||||||||||||||
Registered direct offering | 2023 Purchase Agreement Amendment | One share and one accompanying Common Warrant | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Combined purchase price per share | $ 15.75 | ||||||||||||||||||||
Registered direct offering | 2023 Purchase Agreement Amendment | One pre-funded warrant and one accompanying common warrant | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Shares issuable upon exercise of combined warrants | 1.25 | ||||||||||||||||||||
Underwritten public offering | Common warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Exercise price | $ 1.32 | ||||||||||||||||||||
Underwritten public offering | December 2023 Pre-Funded Warrants | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 2,422,612 | ||||||||||||||||||||
Exercise price | $ 0.001 | $ 0.001 | |||||||||||||||||||
Underwritten public offering | December 2023 Pre-Funded Warrants | December 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Number of warrants to purchase common stock | 1 | ||||||||||||||||||||
Aggregate net proceeds | $ 5,000 | ||||||||||||||||||||
Combined purchase price per share | $ 1.32 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,781,934 | ||||||||||||||||||||
Underwritten public offering | December 2023 Common And Prefunded Warrants [Member] | December 2023 Securities Purchase Agreement | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Combined purchase price per share | $ 1.319 | ||||||||||||||||||||
I X License Agreement [Member] | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
Issuance of common stock for license acquired (in shares) | 85,676 | 85,676 | |||||||||||||||||||
[custom:NonrefundableCashPayment] | $ 3,500 | $ 1,200 | $ 1,200 | $ 3,500 | |||||||||||||||||
[custom:MinimumStockValueOfSharesIssued] | 5,500 | 5,500 | |||||||||||||||||||
[custom:InitialStockValuationShortfallFrom5.5MillionValue] | 800 | $ 1,200 | |||||||||||||||||||
Research and development | $ 9,000 | $ 9,000 | |||||||||||||||||||
Assets from Bioblast Pharma [Member] | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
[custom:NonrefundableCashPayment] | $ 1,500 | $ 2,000 | |||||||||||||||||||
Research and development | $ 3,500 | ||||||||||||||||||||
U C Regents License Agreement [Member] | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
[custom:NonrefundableCashPayment] | 100 | ||||||||||||||||||||
Research and development | 100 | ||||||||||||||||||||
Duke License Agreement [Member] | |||||||||||||||||||||
Common Stock Offerings | |||||||||||||||||||||
[custom:NonrefundableCashPayment] | 100 | ||||||||||||||||||||
Research and development | $ 100 |
License Agreements (Details)
License Agreements (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||||||||||
Feb. 28, 2023 USD ($) | Jan. 11, 2023 USD ($) | Jan. 03, 2023 USD ($) | Dec. 22, 2022 shares | Jul. 22, 2022 USD ($) shares | Apr. 11, 2022 shares | Apr. 08, 2022 | Jan. 03, 2022 USD ($) | Nov. 24, 2021 USD ($) shares | Jan. 02, 2021 USD ($) | Jan. 02, 2020 USD ($) | Aug. 29, 2019 USD ($) | Feb. 15, 2019 USD ($) | Jul. 31, 2022 USD ($) shares | Apr. 30, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Nov. 30, 2021 USD ($) shares | Jun. 30, 2022 USD ($) | Mar. 31, 2019 USD ($) shares | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2019 USD ($) | Jan. 02, 2022 USD ($) | |
License Agreements | |||||||||||||||||||||||
Issuance of common stock, net of issuance costs | $ 1,000,000 | ||||||||||||||||||||||
Research and development | $ 30,117,000 | $ 58,620,000 | |||||||||||||||||||||
Other | 58,000 | $ 89,000 | |||||||||||||||||||||
Non refundable cash payment | 1,200,000 | ||||||||||||||||||||||
Research and development expense - Vyera repurchase | 500,000 | ||||||||||||||||||||||
Total aggregate | 239,000,000 | ||||||||||||||||||||||
Assets from Vyera Pharmaceuticals | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Percentage of upfront payment | 4% | ||||||||||||||||||||||
Cash payments agreed to in amendment to the asset purchase agreement | 4,000,000 | ||||||||||||||||||||||
Number of shares issued and sold | shares | 16,667 | 16,667 | 16,667 | 16,667 | 16,667 | ||||||||||||||||||
Issuance of common stock, net of issuance costs | $ 800,000 | ||||||||||||||||||||||
Aggregate purchase price | $ 1,200,000 | ||||||||||||||||||||||
Cash payment | $ 1,200,000 | $ 4,000,000 | 4,000,000 | ||||||||||||||||||||
Research and development | $ 5,800,000 | ||||||||||||||||||||||
Other | $ 1,000,000 | ||||||||||||||||||||||
Number of cash payments made | 500,000 | ||||||||||||||||||||||
Amount per each cash payment | $ 500,000 | ||||||||||||||||||||||
License agreement description | On April 8, 2022, Seelos Corporation (“STI”), a wholly-owned subsidiary of the Company, and Vyera, entered into an amendment (the “Amendment”) to the Asset Purchase Agreement by and between STI and Vyera, dated March 6, 2018 (as amended by a first amendment thereto entered into on May 18, 2018, a second amendment thereto entered into on December 31, 2018, a third amendment thereto entered into on October 15, 2019 and a fourth amendment thereto entered into on February 15, 2021, the “Vyera Purchase Agreement”). Pursuant to the Vyera Purchase Agreement, STI acquired the assets and liabilities of Vyera related to a product candidate currently referred to as SLS-002 (intranasal ketamine) (the “Vyera Assets”) and agreed, among other things, to make certain development and commercialization milestone payments and royalty payments related to the Vyera Assets (the “Milestone and Royalty Payment Obligations”) and further agreed that in the event that the Company sold, directly or indirectly, all or substantially all of the Vyera Assets to a third party, then the Company would pay Vyera an amount equal to 4% of the net proceeds actually received by the Company as an upfront payment in such sale (the “Change of Control Payment Obligation”). | ||||||||||||||||||||||
License from Ligand Pharmaceuticals | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Number of shares issued and sold | shares | 26,709 | ||||||||||||||||||||||
Research and development expense - Vyera repurchase | $ 2,200,000 | ||||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon submission of an application | 750,000 | ||||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon FDA approval of an application for a particular Licensed Product | 1,125,000 | ||||||||||||||||||||||
Contingent non-refundable regulatory milestone payment upon FDA approval of an application for a particular Licensed Product | 350,000 | ||||||||||||||||||||||
contingent non-refundable regulatory milestone payment in connection with aplindore upon regulatory approval In major market for such particular licensed product | 100,000 | ||||||||||||||||||||||
Contingent Nonrefundable Regulatory Milestone Payment In Connection With Aplindore Upon Fda Approval Of Application For Such Particular Licensed Product | 3,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 1.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Aplindore | 10,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 1.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon H3 Receptor Antagonist | 10,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 1.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Acetaminophen | 10,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 1.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Crth2Antagonists | 10,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement of 2.0 billion of cumulative world wide net sales of licensed products based upon aplindore | 20,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 2.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Acetaminophen | 20,000,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 2.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Crth2 Antagonists | 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 | ||||||||||||||||||||||
Contingent nonrefundable regulatory milestone payment in connection with aplindore. | $ 125,000 | ||||||||||||||||||||||
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. | ||||||||||||||||||||||
Weg License Agreement | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Upfront license fee | $ 75,000 | ||||||||||||||||||||||
Additional consideration agreed to pay | $ 125,000 | $ 100,000 | $ 200,000 | ||||||||||||||||||||
Additional consideration paid | $ 200,000 | $ 125,000 | $ 100,000 | ||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
Contingent nonrefundable milestone share value of common stock payment upon issuance of first patent directed to anxiety indication | 150,000 | ||||||||||||||||||||||
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, $0.125 million on January 2, 2021, and $0.2 million on January 3, 2022. 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, (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. | ||||||||||||||||||||||
Contingent nonrefundable milestone payment upon fda approval of nda for milestone product. | $ 3,000,000 | ||||||||||||||||||||||
Contingent nonrefundable milestone payment | $ 100,000 | ||||||||||||||||||||||
Contingent nonrefundable milestone payment after locking of database | 500,000 | ||||||||||||||||||||||
Contingent nonrefundable milestone payment upon regulatory approval by ema for milestone product | 2,000,000 | ||||||||||||||||||||||
Contingent nonrefundable milestone payment upon regulatory approval in japan for milestone product | 1,500,000 | ||||||||||||||||||||||
Maximum amount to be paid under milestones | $ 6,600,000 | ||||||||||||||||||||||
Percentage of royalty payments | 2.25% | ||||||||||||||||||||||
Assets from Bioblast Pharma [Member] | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Research and development | $ 3,500,000 | ||||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
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 cash, and the Company paid to Bioblast an additional $2.0 million in February 2020. Accordingly, the Company recognized a $3.5 million charge to research and development expense during the year ended December 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. On July 15, 2019, TSF and the Company amended the agreement whereby the Company agreed to assume responsibility for a 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. | ||||||||||||||||||||||
Percentage of royalty payments | 1% | ||||||||||||||||||||||
Contingent additional milestone consideration | $ 8,500,000 | ||||||||||||||||||||||
Future grant revenue contingent | $ 1,500,000 | ||||||||||||||||||||||
U C Regents License Agreement [Member] | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Research and development | 100,000 | ||||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
Contingent Milestone Payment Within Ninety Days Following Completion Of Dosing Of First Patient In Phase I Clinical Trial | 50,000 | ||||||||||||||||||||||
Contingent Milestone Payment Within Ninety Days Following Dosing Of First Patient In Phase Ii Clinical Trial | 100,000 | ||||||||||||||||||||||
Contingent Milestone Payment Within Ninety Days Following First Commercial Sales In Any European Market | 1,000,000 | ||||||||||||||||||||||
Contingent milestone payment within 90 Days following 250 million in cumulative world wide net sales of licensed product | 2,500,000 | ||||||||||||||||||||||
Contingent Nonrefundable Commercial Milestone Payments In Connection With Achievement Of 1.0 Billion Of Cumulative Worldwide Net Sales Of Licensed Products Based Upon Aplindore | $ 125,000 | ||||||||||||||||||||||
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 central nervous system (“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 year ended December 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 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. | ||||||||||||||||||||||
Duke License Agreement [Member] | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Research and development | $ 100,000 | ||||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
Contingent Milestone Payment Within Thirty Days Following Filing Of Ind Following Completion Of Preclinical Studies Including Comprehensive Validation Of Platform | 100,000 | ||||||||||||||||||||||
Contingent Milestone Payment Within Thirty Days Following Dosing Of First Patient In Phase Clinical Trial | 200,000 | ||||||||||||||||||||||
Contingent Milestone Payment Within Thirty Days Following Nda Approval | 2,000,000 | ||||||||||||||||||||||
Contingent milestone payment within 30days following dosing Of first patient phase Iii clinical trial. | 1,000,000 | ||||||||||||||||||||||
Contingent milestone payment within 30 days following dosing Of first patient In phase Ii clinical trial | $ 500,000 | ||||||||||||||||||||||
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 SNCA gene, which encodes α-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 year ended December 31, 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. | ||||||||||||||||||||||
I X License Agreement [Member] | |||||||||||||||||||||||
License Agreements | |||||||||||||||||||||||
Research and development | $ 9,000,000 | $ 9,000,000 | |||||||||||||||||||||
Issuance of common stock for license acquired (in shares) | shares | 85,676 | 85,676 | |||||||||||||||||||||
Milestone payments accrued | $ 0 | ||||||||||||||||||||||
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 WafermineTM 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. | ||||||||||||||||||||||
Shortfall amount | $ 800,000 | $ 1,200,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
Professional fees | $ 250 | $ 278 |
Personnel related | 56 | 1,288 |
Outside research and development services | 2,152 | 5,627 |
Other | 58 | 89 |
Accrued expenses, net | $ 2,516 | $ 7,282 |
Debt (Details)
Debt (Details) - USD ($) | 12 Months Ended | ||||||||||
Dec. 02, 2023 | Sep. 30, 2023 | Sep. 21, 2023 | May 19, 2023 | Nov. 23, 2022 | Aug. 23, 2022 | Nov. 23, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Oct. 01, 2023 | May 18, 2023 | |
Debt | |||||||||||
Principal and interest payments of notes | $ 7,641,000 | $ 1,888,000 | |||||||||
Convertible note liability | 14,200,000 | 20,000,000 | |||||||||
Loss on extinguishment of debt | (9,151,000) | ||||||||||
Fair value of restricted common stock issued | 5,139,000 | ||||||||||
Gain (loss) on change in fair value of convertible notes | (2,049,000) | (3,017,000) | |||||||||
Loss on issuance of common stock and warrants | (4,301,000) | ||||||||||
Interest payment in cash | 1,900,000 | ||||||||||
Lind securities purchase agreement | Lind | |||||||||||
Debt | |||||||||||
Amount receivable in private placement transaction | $ 20,000,000 | ||||||||||
Number of shares issued and sold | 17,826 | ||||||||||
Convertible Promissory Note | |||||||||||
Debt | |||||||||||
Loss on extinguishment of debt | 9,200,000 | 0 | |||||||||
Loss on issuance of common stock and warrants | $ 4,300,000 | 0 | |||||||||
Convertible Promissory Note | 2021 Note | |||||||||||
Debt | |||||||||||
Conversion price | $ 180 | ||||||||||
Convertible note liability | $ 13,900,000 | ||||||||||
Percentage of minimum balance of outstanding principal balance to be maintained with one or more financial institutions | 50% | ||||||||||
Percentage of average of five lowest daily vwap during 20 trading days | 85% | ||||||||||
Number of days considered to calculate volume weighted average price | 5 days | ||||||||||
Threshold trading days for calculating volume weighted average price | 20 days | ||||||||||
Percentage of outstanding principal amount | 120% | ||||||||||
Convertible Promissory Note | Lind | |||||||||||
Debt | |||||||||||
Interest rate (in percent) | 12% | ||||||||||
Conversion price | $ 180 | ||||||||||
Number of shares issued to satisfy interest and principal payments | 62,570 | ||||||||||
Convertible note liability | $ 16,800,000 | ||||||||||
Percentage of minimum balance of outstanding principal balance to be maintained with one or more financial institutions | 50% | ||||||||||
Percentage of average of five lowest daily vwap during 20 trading days | 85% | ||||||||||
Number of days considered to calculate volume weighted average price | 5 days | ||||||||||
Threshold trading days for calculating volume weighted average price | 20 days | ||||||||||
Amount to be paid | $ 686,564 | ||||||||||
Threshold period for conversion of monthly payment | 45 days | ||||||||||
Increase in outstanding principal amount | $ 3,600,000 | ||||||||||
Percentage of net cash proceeds to repay debt | 25% | ||||||||||
Percentage of securities to be offered for participation in any equity or debt financing to lender | 50% | ||||||||||
Amount of securities to be offered to lender | $ 5,000,000 | ||||||||||
Number of shares issuable pursuant to conversion | 62,570 | ||||||||||
Convertible Promissory Note | Lind | Maximum | |||||||||||
Debt | |||||||||||
Aggregate amount for conversion into common stock | $ 400,000 | ||||||||||
Convertible Promissory Note | Lind securities purchase agreement | Lind | |||||||||||
Debt | |||||||||||
Amount receivable in private placement transaction | $ 201,534 | ||||||||||
Aggregate principal amount | $ 221,688 | $ 22,000,000 | |||||||||
Interest rate (in percent) | 5% | 5% | 12% | ||||||||
Number of shares issued and sold | 180 | ||||||||||
Conversion price | $ 180 | ||||||||||
Percentage of debt converted in case of exercising prepayment right | 33% | ||||||||||
Amortization period | 24 months | ||||||||||
Percentage of five day VWAP of common stock | 90% | ||||||||||
Period of VWAP of common stock | 5 days | ||||||||||
Number of shares issued to satisfy interest and principal payments | 455,425 | ||||||||||
2021 Note Amendment | Lind | |||||||||||
Debt | |||||||||||
Conversion price | $ 180 | ||||||||||
Convertible note liability | $ 17,750,000 | $ 1,250,000 | |||||||||
Loss on extinguishment of debt | $ 1,300,000 | ||||||||||
Percentage of minimum balance of outstanding principal balance to be maintained with one or more financial institutions | 50% | ||||||||||
Minimum monthly principal payments to be paid in cash | $ 600,000 | ||||||||||
Aggregate shares of common stock upon conversion of convertible notes | 33,334 | ||||||||||
Fair value of restricted common stock issued | $ 1,000,000 | ||||||||||
2021 Note Amendment | Lind | For conversion price | |||||||||||
Debt | |||||||||||
Percentage of average of five lowest daily vwap during 20 trading days | 85% | ||||||||||
Number of days considered to calculate volume weighted average price | 5 days | ||||||||||
Threshold trading days for calculating volume weighted average price | 20 days | ||||||||||
2021 Note Amendment | Lind | For issue price per share on shares issuable | |||||||||||
Debt | |||||||||||
Percentage of average of five lowest daily vwap during 20 trading days | 90% | ||||||||||
Number of days considered to calculate volume weighted average price | 5 days | ||||||||||
Threshold trading days for calculating volume weighted average price | 20 days | ||||||||||
December 2021 separate securities purchase agreements | |||||||||||
Debt | |||||||||||
Loss on extinguishment of debt | $ 13,000 | ||||||||||
Gain (loss) on change in fair value of convertible notes | 2,000,000 | $ 3,000,000 | |||||||||
Principal repayment | 11,700,000 | ||||||||||
Principal repayment in common stock | 4,500,000 | ||||||||||
Principal repayment in cash | 7,200,000 | ||||||||||
Interest payments | 1,100,000 | ||||||||||
Interest payment in common stock | 600,000 | ||||||||||
Interest payment in cash | $ 500,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||||||||||
Nov. 28, 2023 | Sep. 27, 2023 | Sep. 26, 2023 | Sep. 21, 2023 | Mar. 10, 2023 | Sep. 04, 2020 | Aug. 23, 2019 | Jan. 24, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 01, 2023 | Nov. 27, 2023 | May 19, 2023 | Mar. 31, 2023 | Aug. 31, 2019 | |
Stockholders' Equity | |||||||||||||||
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 | |||||||||||||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 | |||||||||||||
Preferred stock, outstanding (in shares) | 0 | 0 | |||||||||||||
Common stock, authorized (in shares) | 16,000,000 | 8,000,000 | 480,000,000 | ||||||||||||
Exercise price | $ 124.50 | ||||||||||||||
Number of warrants to purchase common stock | 48,784 | ||||||||||||||
Common Stock | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Common stock, authorized (in shares) | 16,000,000 | 240,000,000 | 480,000,000 | ||||||||||||
Number of shares issued and sold | 3,720 | ||||||||||||||
2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 18 | ||||||||||||||
Number of shares issued and sold | 401,977 | ||||||||||||||
Aggregate net proceeds | $ 10,400 | ||||||||||||||
September 2020 warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Warrants exercisable | 33,625,000,000 | ||||||||||||||
August 232019 | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Number of shares issued and sold | 149,167 | ||||||||||||||
September 2020 warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 33,625 | ||||||||||||||
Exercise price | $ 25.20 | ||||||||||||||
Number of shares issued and sold | 295,500 | 221,625 | |||||||||||||
Number of warrants exercised | 0 | 0 | |||||||||||||
August 2019 warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 53.40 | ||||||||||||||
Number of shares issued and sold | 74,584 | ||||||||||||||
Proceeds from warrant exercises | $ 0 | $ 0 | |||||||||||||
Warrants exercisable | 0 | 74,584 | |||||||||||||
May 2023 warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 133,334 | ||||||||||||||
Exercise price | $ 31.80 | $ 31.80 | |||||||||||||
Warrants outstanding | 133,334 | ||||||||||||||
May 2023 warrants | 2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 31.80 | ||||||||||||||
March 2023 Warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 891,667 | 311,357 | |||||||||||||
Exercise price | $ 18 | ||||||||||||||
March 2023 Warrants | 2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Number of shares issued and sold | 401,977 | ||||||||||||||
Series A Warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 4.4705 | $ 4.4705 | |||||||||||||
Proceeds from warrant exercises | $ 0 | $ 0 | |||||||||||||
Warrants exercisable | 10,081 | ||||||||||||||
Number of warrants issued | 48,784 | ||||||||||||||
Series A Warrants | Minimum | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 8.202 | ||||||||||||||
Series A Warrants | Maximum | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 4.4705 | ||||||||||||||
March 2023 Pre-Funded Warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 311,357 | ||||||||||||||
Exercise price | $ 0.03 | ||||||||||||||
March 2023 Pre-Funded Warrants | 2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 311,357 | ||||||||||||||
Exercise price | $ 0.03 | ||||||||||||||
Number of shares issued as a result of warrants exchanged in cash | 311,357 | ||||||||||||||
Common warrants | Underwritten public offering | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 1.32 | ||||||||||||||
Common warrants | 2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 891,668 | ||||||||||||||
Exercise price | $ 18 | ||||||||||||||
Warrants outstanding | 891,667 | ||||||||||||||
September 2023 Warrants | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Shares issuable upon exercise of warrants | 333,667 | ||||||||||||||
Exercise price | $ 9.75 | ||||||||||||||
Share price per common stock if warrants are exchanged in cash | $ 0.999 | ||||||||||||||
Warrants outstanding | 0 | ||||||||||||||
Number of shares issued and sold | 500,000 | ||||||||||||||
Number of warrants to purchase common stock | 333,667 | ||||||||||||||
September 2023 Warrants | 2023 Securities Purchase Agreement | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 9.75 | ||||||||||||||
Share price per common stock if warrants are exchanged in cash | $ 0.999 | ||||||||||||||
Number of shares issued as a result of warrants exchanged in cash | 259,260 | 74,075 | |||||||||||||
Number of warrants to purchase common stock | 333,667 | ||||||||||||||
December 2023 warrants | Underwritten public offering | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Number of shares issued and sold | 1,781,934 | ||||||||||||||
December 2023 Common Warrants | Underwritten public offering | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 1.32 | ||||||||||||||
Number of warrants to purchase common stock | 4,204,546 | 4,204,546 | |||||||||||||
December 2023 Pre-Funded Warrants | Underwritten public offering | |||||||||||||||
Stockholders' Equity | |||||||||||||||
Exercise price | $ 0.001 | $ 0.001 | |||||||||||||
Number of warrants to purchase common stock | 2,422,612 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Warrant Activity (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Jan. 24, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | |||
Outstanding as of September 30, 2023, weighted-average exercise price (in usd per share) | $ 124.50 | ||
Warrant Derivative Financial Instruments | |||
Stockholders' Equity | |||
Outstanding as of December 31, 2022 | 85 | ||
Issued | 8,297 | ||
Exercised | (3,068) | ||
Cancelled | (34) | ||
Outstanding as of September, 2023 | 5,280 | 85 | |
Warrants exercisable as of September 30, 2023 | 5,280 | ||
Outstanding as of December 31, 2022, weighted-average exercise price (in usd per share) | $ 83.40 | ||
Issued, weighted-average exercise price | 3.11 | ||
Exercised, weighted-average exercise price | 0 | ||
Cancelled, weighted-average exercise price | 101.30 | ||
Outstanding as of September 30, 2023, weighted-average exercise price (in usd per share) | 5.57 | $ 83.40 | |
Exercisable, weighted-average exercise price (in usd per share) | $ 5.57 | ||
Weighted-average remaining contractual life (in years) | 4 years 9 months 18 days | 1 year 8 months 12 days | |
Exercisable as of September 30, 2023, weighted-average remaining contractual life (in years) | 4 years 9 months 18 days |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Valuation Assumptions for Stock Options (Details) - Stock options - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||
Weighted-average fair value | $ 20.94 | $ 36.60 |
Minimum | ||
Stock-Based Compensation | ||
Risk-free interest rate, minimum | 0.036% | 0.016% |
Volatility, minimum | 1.16% | 1.11% |
Expected term (years) | 5 years | 5 years |
Maximum | ||
Stock-Based Compensation | ||
Risk-free interest rate, maximum | 0.039% | 0.034% |
Volatility, maximum | 1.19% | 1.13% |
Expected term (years) | 6 years | 6 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||
Granted | 11,274 | |
Exercised | 0 | (209) |
Granted in period (USD per share) | $ 20.76 | |
Employee Stock Option | ||
Stock-Based Compensation | ||
Outstanding, beginning of period (share) | 347,000 | |
Granted | 167,000 | |
Forfeited | (2,000) | |
Expired | (1,000) | |
Outstanding, end of period (shares) | 511,000 | 347,000 |
Vested and expected to vest, end of period (shares) | 511,000 | |
Exercisable, end of period (shares) | 272,000 | |
Outstanding, beginning of period (USD per share) | $ 67.82 | |
Granted in period (USD per share) | 20.94 | |
Forfeited (USD per share) | 57.28 | |
Expired (USD per share) | 87.60 | |
Outstanding, end of period (USD per share) | 48.13 | $ 67.82 |
Vested and expected to vest stock, end of period (USD per share) | 48.13 | |
Exercisable, end of period (USD per share) | $ 58.82 | |
Outstanding - weighted-average remaining contractual life (in years) | 7 years 8 months 12 days | |
Weighted-average remaining contractual life (in years) of vested and expected to vest stock options | 7 years 8 months 12 days | |
Weighted-average remaining contractual life (in years) of exercisable stock options | 6 years 10 months 24 days | |
Non qualified stock options to employees | ||
Stock-Based Compensation | ||
Granted | 98,657 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||
Stock-based compensation expense | $ 3,988 | $ 5,073 |
Research and development | ||
Stock-Based Compensation | ||
Stock-based compensation expense | 1,037 | 932 |
General and administrative | ||
Stock-Based Compensation | ||
Stock-based compensation expense | $ 2,951 | $ 4,141 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Jan. 01, 2022 | May 15, 2020 | Jan. 01, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | |||||
Term of option grant | 10 years | ||||
Stock-based compensation expense | $ 3,988 | $ 5,073 | |||
Options granted in period | 11,274 | ||||
Weighted-average exercise price per share granted in period | $ 20.76 | ||||
Stock option exercised | 0 | 209 | |||
Stock options forfeited | 2,434 | 0 | |||
2012 Plan | Minimum | |||||
Stock-Based Compensation | |||||
Vesting period | 1 year | ||||
2012 Plan | Maximum | |||||
Stock-Based Compensation | |||||
Vesting period | 10 years | ||||
Number of shares added each year as a percentage of the number of shares of common stock issued and outstanding | 4% | ||||
2019 Inducement Plan | |||||
Stock-Based Compensation | |||||
Number of shares authorized | 33,334 | ||||
Common stock are available for future issuance | 21,756 | ||||
Stock options | |||||
Stock-Based Compensation | |||||
Options granted in period | 167,000 | ||||
Weighted-average exercise price per share granted in period | $ 20.94 | ||||
Intrinsic value of options exercised | $ 0 | $ 100 | |||
Unrecognized stock option compensation expense | $ 6,400 | ||||
Weighted average period for recognition | 2 years 4 months 24 days | ||||
Stock options | 2012 Plan | |||||
Stock-Based Compensation | |||||
Number of additional shares authorized | 4,771,457 | ||||
Number of shares authorized | 686,317 | ||||
Number of shares available for future grants | 174,888 | ||||
Stock options | 2012 Plan | Minimum | |||||
Stock-Based Compensation | |||||
Vesting period | 4 years | ||||
Stock options | ESPP | |||||
Stock-Based Compensation | |||||
Purchase price of common stock (in percent) | 85% | ||||
Stock options | ESPP | Maximum | |||||
Stock-Based Compensation | |||||
Number of shares added each year as a percentage of the number of shares of common stock issued and outstanding | 1% | ||||
ESPP | ESPP | |||||
Stock-Based Compensation | |||||
Number of additional shares authorized | 35,448 | ||||
Number of shares authorized | 1,000,000 | ||||
Purchase price of common stock | 4,971 | ||||
Purchase price discount of common stock (in percent) | 15% | ||||
Stock-based compensation expense | $ 55,000 | ||||
Incentive stock option | |||||
Stock-Based Compensation | |||||
Vesting period | 3 years | ||||
Term of option grant | 10 years | ||||
Options granted in period | 50,594 | ||||
Weighted-average exercise price per share granted in period | $ 20.80 | ||||
Vesting percentage on the first anniversary | 25% | ||||
Non qualified stock options to employees | |||||
Stock-Based Compensation | |||||
Options granted in period | 98,657 | ||||
Non qualified stock options to non employee directors | |||||
Stock-Based Compensation | |||||
Vesting period | 12 months | ||||
Term of option grant | 10 years | ||||
Options granted in period | 6,668 | ||||
Weighted-average exercise price per share granted in period | $ 24.30 | ||||
Performance stock award | Performance stock unit award to Executive | |||||
Stock-Based Compensation | |||||
Stock-based compensation expense | $ 1,300 | $ 4,900 | |||
Fair value of common stock | 80,000 | ||||
Weighted-average fair value (in USD per share) | $ 129.30 | ||||
Compensation cost | $ 0 |
Income Taxes - Net operating lo
Income Taxes - Net operating loss carryforwards (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Tax Credit Carryforward Limitation On Taxable Income Rate | 80% | |
Noncurrent deferred tax asset, gross | $ 33,200,000 | $ 27,400,000 |
Tax examination penalties and interest expense | 0 | $ 0 |
Federal income tax reporting purposes | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 131,900,000 | |
Deferred tax assets, operating loss carryforwards, not subject to expiration | 131,900,000 | |
State and local income tax reporting purposes | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 91,200,000 | |
Deferred tax assets, operating loss carryforwards, subject to expiration | 90,700,000 | |
Deferred tax assets, operating loss carryforwards, not subject to expiration | $ 500,000 |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Net operating tax loss carryforwards | $ 33,190 | $ 27,362 |
Contingent payment obligations | 461 | |
Stock-based compensation | 803 | 1,559 |
R&E expenses | 14,735 | 11,137 |
Intangible assets | 7,256 | 8,577 |
Other | 2 | |
Total deferred tax asset | 55,986 | 49,096 |
Less valuation allowance | $ (55,986) | $ (49,096) |
Income Taxes - Income tax rate
Income Taxes - Income tax rate and the provision (benefit) (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of income taxes computed using the statutory United States income tax rate and the provision (benefit) for income taxes | ||
Federal statutory tax rate | 21% | 21% |
State and local taxes, net of federal benefit | 0.10% | |
Permanent items | (0.10%) | (1.00%) |
Mark-to-Market | 1.40% | |
Stock Based Compensation | (4.40%) | |
Deferred rate changes | 0.10% | (12.90%) |
Deferred true-up | 0.10% | (10.20%) |
Change in valuation allowance | (18.20%) | 3.10% |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2021 | |
Commitments and Contingencies | ||||
Operating lease right-of-use asset | $ 15 | $ 72 | ||
Rent expense | $ 100 | $ 100 | ||
March 2021 Lease | ||||
Commitments and Contingencies | ||||
Lease term | 18 months | |||
October 2022 Lease | ||||
Commitments and Contingencies | ||||
Lease term | 18 months | |||
Lease base rent per month | $ 4,000 | |||
Operating lease right-of-use asset | $ 86,000 | |||
weighted-average remaining lease term | 3 months 18 days | |||
Weighted-average discount rate | 8% |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Future minimum lease payments for the Company's operating lease with a non-cancelable term | |
Year Ended December 31, 2024 | $ 16 |
Total | 16 |
Less present value discount | (1) |
Operating lease liabilities | $ 15 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Jan. 26, 2024 | Jan. 10, 2024 | Jan. 09, 2024 | Dec. 31, 2023 | Nov. 27, 2023 | Dec. 31, 2022 | Jan. 24, 2019 |
Subsequent Events | |||||||
Common stock, authorized (in shares) | 16,000,000 | 480,000,000 | 8,000,000 | ||||
Number of shares called by warrants issued | 48,784 | ||||||
Exercise price | $ 124.50 | ||||||
Subsequent events | |||||||
Subsequent Events | |||||||
Common stock, authorized (in shares) | 400,000,000 | 16,000,000 | |||||
Subsequent events | Placement agent agreement | |||||||
Subsequent Events | |||||||
Placement agent fee (in percentage) | 7% | ||||||
Reimbursement of expenses incurred to agent | $ 50,000 | ||||||
Subsequent events | Placement agent agreement | Maximum | |||||||
Subsequent Events | |||||||
Reimbursement of non accountable expenses incurred to agent | $ 15,000 | ||||||
Subsequent events | Registered direct offering | January 2024 Securities Purchase Agreement | |||||||
Subsequent Events | |||||||
Issuance of common stock, net of issuance costs (in shares) | 3,404,256 | ||||||
Exercise price | $ 500,000 | ||||||
Subsequent events | Registered direct offering | January 2024 Securities Purchase Agreement | Common warrants | |||||||
Subsequent Events | |||||||
Number of shares called by warrants issued | 3,404,256 | ||||||
Term of warrants (in years) | 5 years | ||||||
Subsequent events | One share and one accompanying Common Warrant | Registered direct offering | January 2024 Securities Purchase Agreement | |||||||
Subsequent Events | |||||||
Combined purchase price per share | $ 1.175 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (37,882) | $ (73,534) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |