7. License Agreements (Details Narrative) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 12 Months Ended |
Jan. 31, 2022 | Nov. 30, 2021 | Sep. 30, 2021 | Jan. 31, 2021 | Jul. 31, 2020 | Apr. 30, 2020 | Feb. 29, 2020 | Jan. 31, 2020 | Oct. 31, 2019 | Aug. 31, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | May 31, 2018 | Mar. 31, 2018 | Sep. 30, 2016 | Dec. 31, 2021 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
Research and development expense | | | | | | | | | | | | | | | | | | | | | $ 46,649,000 | $ 10,984,000 |
Licensefrom Ligand Pharmaceuticals [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | | | | | | | | On September 21, 2016, the Company entered into a License Agreement (the “License Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”), Neurogen Corporation and CyDex Pharmaceuticals, Inc. (collectively, the “Licensors”), pursuant to which, among other things, the Licensors granted to the Company an exclusive, perpetual, irrevocable, worldwide, royalty-bearing, nontransferable right and license under (i) patents related to a product known as Aplindore, which is now known as SLS-006, acetaminophen (as it may have been or may be modified for use in a product to be administered by any method in any form including, without limitation injection and intravenously, the sole active pharmaceutical ingredient of which is acetaminophen), which is now known as SLS-012, an H3 receptor antagonist, which is now known as SLS-010, and either or both of the Licensors’ two proprietary CRTh2 antagonists, which are now known collectively as SLS-008 (collectively, the “Licensed Products”), and (ii) copyrights, trade secrets, moral rights and all other intellectual and proprietary rights related thereto. The Company is obligated to use commercially reasonable efforts to (a) develop the Licensed Products, (b) obtain regulatory approval for the Licensed Products in the European Union (either in its entirety or including at least one of France, Germany or, if at the time the United Kingdom is a member of the European Union, the United Kingdom), the United Kingdom, if at the time the United Kingdom is not a member of the European Union, Japan or the People’s Republic of China (each, a “Major Market”) or the United States, and (c) commercialize the Licensed Products in each country where regulatory approval is obtained. The Company has the exclusive right and sole responsibility and decision-making authority to research and develop any Licensed Products and to conduct all clinical trials and non-clinical studies the Company believes appropriate to obtain regulatory approvals for commercialization of the Licensed Products. The Company also has the exclusive right and sole responsibility and decision-making authority to commercialize any of the Licensed Products. | | | | | |
Shares of common stock issued | | | | | | | | | | | | | | | | | | | | 801,253 | | |
Research and development expense | | | | | | | | | | | | | | | | | | | | $ 2,200,000 | | |
Contingent non-refundable regulatory milestone payment upon submission of an application with the FDA or equivalent foreign body for a particular Licensed Product | | | | | | | | | | | | | | | | | | $ 750,000 | | | 750,000 | |
Contingent non-refundable regulatory milestone payment upon FDA approval of an application for a particular Licensed Product | | | | | | | | | | | | | | | | | | 3,000,000 | | | 3,000,000 | |
Contingent non-refundable regulatory milestone payment upon regulatory approval in a Major Market for a particular Licensed Product | | | | | | | | | | | | | | | | | | 1,125,000 | | | 1,125,000 | |
Contingent non-refundable regulatory milestone payment upon regulatory approval in a second Major Market for a particular Licensed Product | | | | | | | | | | | | | | | | | | 1,125,000 | | | 1,125,000 | |
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon submission of an application with the FDA or equivalent foreign body for such a particular Licensed Product | | | | | | | | | | | | | | | | | | 100,000 | | | 100,000 | |
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon FDA approval of an application for such a particular Licensed Product | | | | | | | | | | | | | | | | | | 350,000 | | | 350,000 | |
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon regulatory approval in a Major Market for such a particular Licensed Product | | | | | | | | | | | | | | | | | | 125,000 | | | 125,000 | |
Contingent non-refundable regulatory milestone payment in connection with Aplindore upon regulatory approval in a second Major Market for such a particular Licensed Product | | | | | | | | | | | | | | | | | | 125,000 | | | 125,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon acetaminophen | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $1.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon Aplindore | | | | | | | | | | | | | | | | | | 20,000,000 | | | 20,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon an H3 receptor antagonist | | | | | | | | | | | | | | | | | | 20,000,000 | | | 20,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon acetaminophen | | | | | | | | | | | | | | | | | | 20,000,000 | | | 20,000,000 | |
Contingent non-refundable commercial milestone payments in connection with the achievement of $2.0 billion of cumulative worldwide net sales of Licensed Products based upon CRTh2 antagonists | | | | | | | | | | | | | | | | | | 20,000,000 | | | 20,000,000 | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | 0 | | | 0 | |
Assetsfrom Vyera Pharmaceuticals [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | | | | | | | On March 6, 2018, the Company entered into the Vyera Agreement with Vyera, pursuant to which the Company acquired the assets (the “Vyera Assets”) and liabilities (the “Vyera Assumed Liabilities”), of Vyera related to TUR-002 (intranasal ketamine), which is now known as SLS-002. The Company is obligated to use commercially reasonable efforts to seek regulatory approval in the United States for and commercialize SLS-002 | | | | | | |
Shares of common stock issued | | | | | | | | 1,809,845 | | | | | | | | | | | | 191,529 | | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | 0 | | | 0 | |
Non-refundable cash payment | | | | | | | | | | | | | | $ 150,000 | $ 150,000 | | | | | $ 1,000,000 | | |
Cash payments agreed to in Amendment to the Asset Purchase Agreement | | | | | $ 1,000,000 | $ 1,000,000 | | $ 750,000 | $ 750,000 | | | | | | | | | | | | | |
[custom:CashPaymentsforLowerRoyaltyPercentageonPotentialNetSalesofSLS002] | | | $ 3,000,000 | | | | | | | | | | | | | | | | | | | |
Contingent non-refundable milestone payment upon approval by the FDA of an NDA, with respect to SLS-002 | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable milestone payment upon approval by the EMA of the foreign equivalent to an NDA with respect to SLS-002 in a Major Market | | | | | | | | | | | | | | | | | | 5,000,000 | | | 5,000,000 | |
Contingent non-refundable milestone payment upon approval by the EMA of the foreign equivalent to an NDA with respect to SLS-002 in a second Major Market | | | | | | | | | | | | | | | | | | 2,500,000 | | | 2,500,000 | |
Contingent non-refundable milestone payment upon the achievement of $250.0 million in net sales of SLS-002 | | | | | | | | | | | | | | | | | | 5,000,000 | | | 5,000,000 | |
Contingent non-refundable milestone payment upon the achievement of $500.0 million in net sales of SLS-002 | | | | | | | | | | | | | | | | | | 10,000,000 | | | 10,000,000 | |
Contingent non-refundable milestone payment upon the achievement of $1.0 billion in net sales of SLS-002 | | | | | | | | | | | | | | | | | | 15,000,000 | | | 15,000,000 | |
Contingent non-refundable milestone payment upon the achievement of $1.5 billion in net sales of SLS-002 | | | | | | | | | | | | | | | | | | 20,000,000 | | | 20,000,000 | |
Contingent non-refundable milestone payment upon the achievement of $2.0 billion in net sales of SLS-002 | | | | | | | | | | | | | | | | | | 25,000,000 | | | 25,000,000 | |
Weg License Agreement [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | On August 29, 2019, the Company entered into an amended and restated exclusive license agreement with Stuart Weg, M.D. (the “Weg License Agreement”), pursuant to which the Company was granted an exclusive worldwide license to certain intellectual property and regulatory materials related to SLS-002. Under the terms of the Weg License Agreement, the Company paid an upfront license fee of $75,000 upon execution of the agreement. The Company agreed to pay additional consideration to Dr. Weg as follows: (i) $0.1 million on January 2, 2020, (ii) $0.125 million on January 2, 2021, and (iii) in the event the FDA has not approved an NDA for a product containing ketamine in any dosage on or before December 31, 2021, $0.2 million on January 2, 2022. The Company paid the required $0.1 million on January 2, 2020 and $0.125 million on January 2, 2021. As further consideration, the Company agreed to pay Dr. Weg certain milestone payments consisting of (i) $0.1 million and shares of common stock equal to $0.15 million divided by the closing sales price of the Company’s common stock upon the issuance of the first patent directed to an anxiety indication, (ii) $0.5 million after the locking of the database and unblinding the data for the statistically significant readout of a Phase III trial of an intranasal racemic ketamine product that has been conducted for the submission under an NDA or equivalent seeking regulatory approval in the United States, the United Kingdom, France, Germany, Italy, Spain, China or Japan, or seeking regulatory approval from the EMA in the EU, for such product (the “Milestone Product”), (iii) $3.0 million upon FDA approval of an NDA for the Milestone Product, (iv) $2.0 million upon regulatory approval by the EMA for the Milestone Product, and (v) $1.5 million upon regulatory approval in Japan for the Milestone Product; provided, however, that the maximum amount to be paid by the Company under milestones (i)-(v) will be $6.6 million. The Company will also pay to Dr. Weg a royalty percentage equal to 2.25% on the sale of each product containing ketamine in any dosage | | | | | | | | | | | | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | 0 | | | 0 | |
Non-refundable cash payment | $ 200,000 | | | $ 125,000 | | | | $ 100,000 | | | | | | | | | | | | | | |
Contingent non-refundable milestone payment upon the issuance of the first patent directed to an anxiety indication | | | | | | | | | | | | | | | | | | 100,000 | | | 100,000 | |
Contingent non-refundable milestone share value of common stock payment upon the issuance of the first patent directed to an anxiety indication | | | | | | | | | | | | | | | | | | 150,000 | | | 150,000 | |
Contingent non-refundable milestone payment after the locking of the database and unblinding the data for the statistically significant readout of a Phase III trial of an intranasal racemic ketamine product that has been conducted for the submission unde | | | | | | | | | | | | | | | | | | 500,000 | | | 500,000 | |
Contingent non-refundable milestone payment upon FDA approval of an NDA for the Milestone Product | | | | | | | | | | | | | | | | | | 3,000,000 | | | 3,000,000 | |
Contingent non-refundable milestone payment upon regulatory approval by the EMA for the Milestone Product | | | | | | | | | | | | | | | | | | 2,000,000 | | | 2,000,000 | |
Contingent non-refundable milestone payment upon regulatory approval in Japan for the Milestone Product | | | | | | | | | | | | | | | | | | 1,500,000 | | | 1,500,000 | |
Maximum amount to be paid under milestones | | | | | | | | | | | | | | | | | | $ 6,600,000 | | | $ 6,600,000 | |
Percentage of royalty payments | | | | | | | | | | | | | | | | | | 2.25% | | | 2.25% | |
Assetsfrom Bioblast Pharma [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | | | | On February 15, 2019, the Company entered into an Asset Purchase Agreement (the “Bioblast Asset Purchase Agreement”) with Bioblast. Pursuant to the Bioblast Asset Purchase Agreement, the Company acquired all of the assets of Bioblast relating to a therapeutic platform known as Trehalose (the “Bioblast Asset Purchase”). The Company paid to Bioblast $1.5 million in February 2019 and an additional $2.0 million in February 2020. Accordingly, the Company recognized a $3.5 million charge to research and development expense during the three months ended March 31, 2019. Under the terms of the Bioblast Asset Purchase Agreement, the Company agreed to pay additional consideration to Bioblast upon the achievement of certain milestones in the future, as follows: (i) within 15 days following the completion of the Company’s first Phase II(b) clinical trial of Trehalose satisfying certain criteria, the Company will pay to Bioblast $8.5 million; and (ii) within 15 days following the approval for commercialization by the FDA or the Health Products and Food Branch of Health Canada of the first NDA or New Drug Submission, respectively, of Trehalose filed by the Company or its affiliates, the Company will pay to Bioblast $8.5 million. In addition, the Company agreed to pay Bioblast a cash royalty equal to 1% of the net sales of Trehalose. Under the terms of the Bioblast Asset Purchase, the Company assumed a collaborative agreement with Team Sanfilippo Foundation (“TSF”), a nonprofit medical research foundation founded by parents of children with Sanfilippo Syndrome. TSF, upon approval by the FDA, planned to begin an open label, Phase II(b) clinical trial in up to 20 patients with Sanfilippo Syndrome, which is now known under the study name SLS-005. The Company will provide the clinical supply of Trehalose. The terms of the Bioblast Asset Purchase Agreement entitle the Company access to all clinical data from this trial. On July 15, 2019, TSF and the Company amended the agreement whereby the Company agreed to assume responsibility for the Phase II(b)/III clinical trial and TSF agreed to provide a grant of up to $1.5 million towards the funding of the trial. | | | | | | | | | |
Research and development expense | | | | | | | | | | | | | | | | | | | | 3,500,000 | | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | $ 0 | | | $ 0 | |
Non-refundable cash payment | | | | | | | $ 2,000,000 | | | | | | $ 1,500,000 | | | | | | | | | |
Percentage of royalty payments | | | | | | | | | | | | | | | | | | 1.00% | | | 1.00% | |
Contingent additional milestone consideration within 15 days following the completion of the Company's first Phase II(b) clinical trial of Trehalose satisfying certain criteria | | | | | | | | | | | | | | | | | | $ 8,500,000 | | | $ 8,500,000 | |
Contingent additional milestone consideration within 15 days following the approval for commercialization by the FDA or the Health Products and Food Branch of Health Canada of the first NDA or New Drug Submission, respectively, of Trehalose filed by the Company or its affiliates | | | | | | | | | | | | | | | | | | 8,500,000 | | | 8,500,000 | |
Future grant revenue contingent on Phase II (b)/III Sanfilippo clinical trial | | | | | | | | | | | | | | | | | | 1,500,000 | | | 1,500,000 | |
U C Regents License Agreement [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | | | On March 7, 2019, the Company entered into an exclusive license agreement (the “UC Regents License Agreement”) with The Regents of the University of California (“The UC Regents”) pursuant to which the Company was granted an exclusive license to intellectual property owned by The UC Regents pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-007. Upon entry into the UC Regents License Agreement, the Company paid to The UC Regents $0.1 million and recognized a $0.1 million charge to research and development expense during the three months ended March 31, 2019. Under the terms of the UC Regents License Agreement, the Company agreed to pay additional consideration upon the achievement of certain milestones in the future, as follows: (i) within 90 days following the completion of dosing of the first patient in a Phase I clinical trial, the Company will pay $50,000; (ii) within 90 days following dosing of the first patient in a Phase II clinical trial, the Company will pay $0.1 million; (iii) within 90 days following dosing of the first patient in a Phase III clinical trial, the Company will pay $0.3 million; (iv) within 90 days following the first commercial sales in the U.S., the Company will pay $1.0 million; (v) within 90 days following the first commercial sales in any European market, the Company will pay $1.0 million; and (vi) within 90 days following $250 million in cumulative worldwide net sales of a licensed product, the Company will pay $2.5 million. The Company is also obligated to pay a single digit royalty on sales of the product, if any. In addition, if the Company fails to achieve certain milestones within a specified timeframe, The UC Regents may terminate the agreement or reduce the Company’s license to a nonexclusive license. | | | | | | | | | | |
Research and development expense | | | | | | | | | | | | | | | | | | | | $ 100,000 | | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | 0 | | | 0 | |
Non-refundable cash payment | | | | | | | | | | | | $ 100,000 | | | | | | | | | | |
Contingent milestone payment within 90 days following the completion of dosing of the first patient in a Phase I clinical trial | | | | | | | | | | | | | | | | | | 50,000 | | | 50,000 | |
Contingent milestone payment within 90 days following dosing of the first patient in a Phase II clinical trial | | | | | | | | | | | | | | | | | | 100,000 | | | 100,000 | |
Contingent milestone payment within 90 days following dosing of the first patient in a Phase III clinical trial | | | | | | | | | | | | | | | | | | 300,000 | | | 300,000 | |
Contingent milestone payment within 90 days following the first commercial sales in the U.S. | | | | | | | | | | | | | | | | | | 1,000,000 | | | 1,000,000 | |
Contingent milestone payment within 90 days following the first commercial sales in any European market | | | | | | | | | | | | | | | | | | 1,000,000 | | | 1,000,000 | |
Contingent milestone payment within 90 days following $250 million in cumulative worldwide net sales of a licensed product | | | | | | | | | | | | | | | | | | 2,500,000 | | | 2,500,000 | |
Duke License Agreement [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | | | | | | | | | | On June 27, 2019, the Company entered into an exclusive license agreement (the “Duke License Agreement”) with Duke University pursuant to which the Company was granted an exclusive license to a gene therapy program targeting the regulation of the synuclein alpha (“SNCA”) gene, which encodes alpha-synuclein expression. The Company plans to study this initial approach in PD and will further evaluate the potential clinical approach in other disorders affecting the CNS. This program is now known as SLS-004. Upon entry into the Duke License Agreement, the Company paid to Duke University $0.1 million and recognized $0.1 million charge to research and development expense during the three months ended September 30, 2019. The Company agreed to pay additional consideration to Duke University upon the achievement of certain milestones in the future, as follows: (i) within 30 days following filing of an IND following the completion of preclinical studies including comprehensive validation of the platform, the Company will pay $0.1 million; (ii) within 30 days following dosing of the first patient in a Phase I clinical trial, the Company will pay $0.2 million; (iii) within 30 days following dosing of the first patient in a Phase II clinical trial, the Company will pay $0.5 million; (iv) within 30 days following dosing of the first patient in a Phase III clinical trial, the Company will pay $1.0 million; and (v) within 30 days following an NDA approval, the Company will pay $2.0 million. The Company is also obligated to pay a single digit royalty on sales of the product, if any. In addition, if the Company fails to achieve certain milestones within a specified timeframe, Duke University may terminate the agreement. | | | | | | | | | | | |
Research and development expense | | | | | | | | | | | | | | | | | | | $ 100,000 | | | |
Milestone payments accrued | | | | | | | | | | | | | | | | | | 0 | | | 0 | |
Non-refundable cash payment | | | | | | | | | | | $ 100,000 | | | | | | | | | | | |
Contingent milestone payment within 30 days following filing of an IND following the completion of preclinical studies including comprehensive validation of the platform | | | | | | | | | | | | | | | | | | 100,000 | | | 100,000 | |
Contingent milestone payment within 30 days following dosing of the first patient in a Phase I clinical trial | | | | | | | | | | | | | | | | | | 200,000 | | | 200,000 | |
Contingent milestone payment within 30 days following dosing of the first patient in a Phase II clinical trial | | | | | | | | | | | | | | | | | | 500,000 | | | 500,000 | |
Contingent milestone payment within 30 days following dosing of the first patient in a Phase III clinical trial | | | | | | | | | | | | | | | | | | 1,000,000 | | | 1,000,000 | |
Contingent milestone payment within 30 days following an NDA approval | | | | | | | | | | | | | | | | | | 2,000,000 | | | $ 2,000,000 | |
I X License Agreement [Member] | | | | | | | | | | | | | | | | | | | | | | |
Business Combination, Separately Recognized Transactions [Line Items] | | | | | | | | | | | | | | | | | | | | | | |
License agreement description | | On November 24, 2021, the Company entered into an exclusive license agreement (the “iX License Agreement”) with iXBEL and the iXBEL Stock Purchase Agreement. Pursuant to the iX License Agreement, among other things, iXBEL granted the Company an exclusive, sublicensable, perpetual, worldwide (excluding certain jurisdictions identified in the iX License Agreement) and irrevocable right and license to certain of iXBEL’s licensed patents, know-how, and technological information, including access to iXBEL’s research, development and manufacturing capabilities, to enable the further development, manufacture, promotion and commercialization of Wafermine™ and certain other existing and to be developed iXBEL wafer-based delivery technologies, in all cases for sublingual administration of ketamine. In addition, iXBEL will supply the Company with sufficient product for the potential treatment of 400 patients, with further supplied amounts to be determined by the parties. The Company granted iXBEL an exclusive license to exploit technology developed under the iX License Agreement outside of the licensed territory and to undertake limited, non-exclusive research and development activities in the territory. The Company further agreed not to undertake certain activities with respect to products competitive with those licensed under the iX License Agreement during the term of the iX License Agreement. | | | | | | | | | | | | | | | | | | | | |
Research and development expense | | $ 9,000,000 | | | | | | | | | | | | | | | | | | | | |
Non-refundable cash payment | $ 1,200,000 | $ 3,500,000 | | | | | | | | | | | | | | | | | | | | |
[custom:Issuanceofcommonstockforlicenseacquiredshares] | | 2,570,266 | | | | | | | | | | | | | | | | | | | | |
Minimum stock value of shares issued | | $ 5,500,000 | | | | | | | | | | | | | | | | | | | | |
Stock valuation shortfall from 5.5 million value | | | | | | | | | | | | | | | | | | $ 1,200,000 | | | | |